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Sample records for acupuncture clinical trials

  1. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups

    Madsen, Matias Vested; Gøtzsche, Peter C; Hróbjartsson, Asbjørn

    2009-01-01

    OBJECTIVES: To study the analgesic effect of acupuncture and placebo acupuncture and to explore whether the type of the placebo acupuncture is associated with the estimated effect of acupuncture. DESIGN: Systematic review and meta-analysis of three armed randomised clinical trials. DATA SOURCES......: Cochrane Library, Medline, Embase, Biological Abstracts, and PsycLIT. Data extraction and analysis Standardised mean differences from each trial were used to estimate the effect of acupuncture and placebo acupuncture. The different types of placebo acupuncture were ranked from 1 to 5 according to...... assessment of the possibility of a physiological effect, and this ranking was meta-regressed with the effect of acupuncture. DATA SYNTHESIS: Thirteen trials (3025 patients) involving a variety of pain conditions were eligible. The allocation of patients was adequately concealed in eight trials. The...

  2. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  3. Randomized Clinical Trials on Acupuncture in Korean Literature: A Systematic Review

    Jae Cheol Kong

    2009-01-01

    Full Text Available The aim of this systematic review was to summarize randomized clinical trials (RCTs assessing the effectiveness of acupuncture as published in Korean literature. Systematic searches were conducted on eight Korean medical databases. Manual searches were also conducted through eight major Korean medical journals. The methodological quality was assessed using a Jadad score. Studies evaluating needle acupuncture or auricular acupuncture (AA with or without electrical stimulation were considered if they were sham or placebo-controlled or controlled against a comparative intervention. We also excluded acupuncture as an adjuvant to other treatments and other forms of acupuncture were excluded. Seven hundred and nine possibly relevant studies were identified and 10 RCTs were included. The methodological quality of the trials was generally poor. Manual acupuncture was compared to placebo acupuncture in four studies of patients with chronic low back pain, shoulder pain, premenstrual syndrome and allergic rhinitis. Three studies tested AA (two trials and electroacupuncture (one trial against no treatment, while three trials compared acupuncture with other active therapeutic controls. The methodological limitations of the included trials make their contribution to the current clinical evidence of acupuncture somewhat limited. The trial for premenstrual syndrome, shoulder pain and chronic low back pain added a limited contribution among those included RCTs. However, well-designed RCTs of acupuncture with a rigorous methodology are in progress or have been completed in Korea and will contribute to establish or contribute to the current progress of research in this field.

  4. Acupuncture for treating alopecia areata: a protocol of systematic review of randomised clinical trials

    Lee, Hye Won; Jun, Ji Hee; Lee, Ju Ah; Lim, Hyun-Ja; Lim, Hyun-Suk; Lee, Myeong Soo

    2015-01-01

    Introduction Acupuncture is frequently used in dermatology for treating a number of skin disorders. There is no critically appraised evidence of the potential benefits and harm of acupuncture for alopecia areata (AA). This review aims to systematically evaluate the efficacy of acupuncture for the management of AA in randomised clinical trials (RCTs). Methods and analysis 13 databases will be searched from their inception. These include PubMed, AMED, EMBASE, the Cochrane Library, 6 Korean medi...

  5. The Practice of Korean Medicine: An Overview of Clinical Trials in Acupuncture

    Yong-Suk Kim

    2005-01-01

    Full Text Available Acupuncture, one of the Oriental medical therapeutic techniques that can be traced back at least 2500 years, is growing in popularity all over the world. Korea has continued to develop its own unique tradition of medicine throughout its long history, and has formed different types of acupuncture methods. The purpose of this review is to summarize clinical case studies in acupuncture and related therapies, such as acupressure, electric acupuncture, auricular acupuncture and moxibustion in Korea. A survey of Korean journals revealed that a total of 124 studies were published from 1983 to 2001. Results obtained from the survey showed that most clinical studies using acupuncture, electric acupuncture, moxibustion and other traditional therapies could alleviate a relatively broad range of medical problems. However, it should be emphasized that almost all clinical case studies published in various local journals did not follow the ‘good clinical practice’ with respect to regulatory aspects. Since they were not conducted using the randomized double-blinded controls with a large sample size, all the results should be considered as therapeutic indications. This review is an attempt to show the scope of acupuncture in our country and the kind of diseases, after many years of clinical experience, that were deemed valid targets for clinical trials.

  6. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Krämer Jürgen; Knauer Christine; Mansmann Ulrich; Witte Steffen; Streitberger Konrad; Scharf Hanns-Peter; Victor Norbert

    2004-01-01

    Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third co...

  7. Randomised clinical trials on acupuncture in the Korean literature: bibliometric analysis and methodological quality

    Kim, Sina; Sagong, Hye Seon; Kong, Jae Cheol; Choi, Jun-Yong; Lee, Myeong Soo; Wieland, L Susan; Manheimer, Eric; Shin, Byung-Cheul

    2013-01-01

    Objective Acupuncture systematic reviewers have increasingly searched Chinese databases and journals to identify eligible randomised clinical trials (RCTs). However, reviewers have infrequently searched for eligible RCTs in Korean databases and journals. This study aimed to identify difficult to locate acupuncture RCTs in Korean databases and journals and to assess the characteristics and quality of the identified RCTs. Methods Eleven electronic databases and seven journals were searched up t...

  8. Acupuncture for Children with Autism Spectrum Disorders: A Systematic Review of Randomized Clinical Trials

    Lee, Myeong Soo; Choi, Tae-Young; Shin, Byung-Cheul; Ernst, Edzard

    2012-01-01

    This study aimed to assess the effectiveness of acupuncture as a treatment for autism spectrum disorders (ASD). We searched the literature using 15 databases. Eleven randomized clinical trials (RCTs) met our inclusion criteria. Most had significant methodological weaknesses. The studies' statistical and clinical heterogeneity prevented us from…

  9. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    2013-01-01

    -test and ANCOVA (P <0.05). Discussion The results of this study will allow evaluation of contralateral acupuncture from two aspects. First, if the contralateral acupuncture shows the effects similar to ipsilateral acupuncture, this will establish clinical basis for contralateral acupuncture. Second, if the effects of contralateral acupuncture are not comparable to the effects of ipsilateral acupuncture, but are shown to be similar to the effects of the sham acupuncture, we can establish the basis for using the same acupoints of the unaffected side as a control in acupuncture clinical studies. Trial registration This trial has been registered with the ‘Clinical Research Information Service (CRIS)’, Republic of Korea: KCT0000628. PMID:23768129

  10. Improved quality monitoring of multi-center acupuncture clinical trials in China

    Zheng Hui

    2009-12-01

    Full Text Available Abstract Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs. Methods A standard quality control program (QCP was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

  11. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial

    Luciano Ambrosio Ferreira

    2015-01-01

    Full Text Available Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study and the use of the occlusal splint plate alone (control. We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms (p<0.05. However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p<0.05 already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term.

  12. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial

    Ferreira, Luciano Ambrosio; Grossmann, Eduardo; Januzzi, Eduardo; Gonçalves, Rafael Tardin Rosa Ferraz; Mares, Fernando Antonio Guedes; de Paula, Marcos Vinicius Queiroz; Carvalho, Antonio Carlos Pires

    2015-01-01

    Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study) and the use of the occlusal splint plate alone (control). We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms (p < 0.05). However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p < 0.05) already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term. PMID:26351510

  13. Early ifliform needle acupuncture for poststroke depression:a meta-analysis of 17 randomized controlled clinical trials

    Jiping Zhang; Jing Chen; Junqi Chen; Xiaohui Li; Xueyan Lai; Shaoqun Zhang; Shengxu Wang

    2014-01-01

    OBJECTIVE:To evaluate the effectiveness and safety of ifliform needle acupuncture for poststroke depression, and to compare acupuncture with the therapeutic efifcacy of antidepressant drugs. DATA RETRIEVAL:We retrieved data from the Chinese National Knowledge Infrastructure (1979-2012), Wanfang (1980-2012), VIP (1989-2012), Chinese Biomedical Literature (1975-2012), PubMed (1966-2012), Ovid Lww (-2012), and Cochrane Library (-2012) Database using the internet. SELECTION CRITERIA:Randomized controlled trials on ifliform needle acupuncture versus antidepressant drugs for treatment of poststroke depression were included. Moreover, the in-cluded articles scored at least 4 points on the Jadad scale. Exclusion criteria:other acupuncture therapies as treatment group, not stroke-induced depression patients, score MAIN OUTCOME MEASURES:These were the Hamilton Depression Scale scores, clinical ef-fective rate, Self-Rating Depression Scale scores, Side Effect Rating Scale scores, and incidence of adverse reaction and events. RESULTS:A total of 17 randomized controlled clinical trials were included. Meta-analysis results displayed that after 4 weeks of treatment, clinical effective rate was better in patients treated with ifli-form needle acupuncture than those treated with simple antidepressant drugs [relative risk =1.11, 95%conifdence interval (CI):1.03-1.21, P=0.01]. At 6 weeks, clinical effective rate was similar between ifliform needle acupuncture and antidepressant drug groups. At 2 weeks after ifliform needle acupuncture, Hamilton Depression Scale (17 items) scores were lower than in the antide-pressant drug group (mean difference=-2.34, 95%CI:-3.46 to-1.22, P CONCLUSION:Early ifliform needle acupuncture for poststroke depression can perfectly con-trol depression. Filiform needle acupuncture is safe and reliable. Therapeutic effects of ifliform needle acupuncture were better than those of antidepressant drugs.

  14. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  15. Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.

    Claire Shuiqing Zhang

    Full Text Available While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs. A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their

  16. Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.

    Zhang, Claire Shuiqing; Tan, Hsiewe Ying; Zhang, George Shengxi; Zhang, Anthony Lin; Xue, Charlie Changli; Xie, Yi Min

    2015-01-01

    While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and

  17. Acupuncture trials and informed consent

    Miller, F. G.; Kaptchuk, T J

    2007-01-01

    Participants are often not informed by investigators who conduct randomised, placebo‐controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo‐controlled acupuncture trials should be provided an accurate disc...

  18. Acupuncture for Treating Whiplash Associated Disorder: A Systematic Review of Randomised Clinical Trials

    Tae-Woong Moon

    2014-01-01

    Full Text Available The aim of this systematic review was to determine the effectiveness of acupuncture for the treatment of whiplash associated disorder (WAD. Twenty databases were searched from their inceptions to Oct. 2013. Randomised clinical trials (RCTs of acupuncture (AT, electroacupuncture (EA, or dry needling (DN for the treatment of WAD were considered eligible. The risk of bias was assessed using the Cochrane tool. Six RCTs met the inclusion criteria. Most of the included RCTs have serious methodological flaws. Four of the RCTs showed effectiveness of AT, AT in addition to usual care (UC, AT in addition to herbal medicine (HM or EA was more effective than relaxation, sham EA, sham EA in addition to HM or UC for conditioned pain modulation (CPM and alleviating pain. In one RCT, DN in addition to physiotherapy (PT had no effect compared to sham-DN in addition to PT for the reduction of pain. None of the RCTs showed that AT/EA/DN was more effective than various types of control groups in reducing disability/function. One RCT did not report between-group comparisons of any outcome measures. The evidence for the effectiveness of AT/EA/DN for the treatment of WAD is limited. Therefore, more research in this area is warranted.

  19. Acupuncture Anxiolytic Effects on Physiological and Psychological Assessments for a Clinical Trial

    Shayestehfar, Monir; Seif-Barghi, Tohid; Zarei, Sahar; Mehran, Amir

    2016-01-01

    In a randomized controlled trial we examined the effect of acupuncture on anxiety of the adolescent football players prior to the competition using psychological and physiological markers. A total of 45 athletes were equally allocated to either acupuncture group, sham group, or wait-list control group. Thereafter, all participants were asked to complete an anxiety questionnaire before and after the intervention. Their heart rate and skin conductance were also examined before and after the intervention. The results of ANOVA on posttest scores showed that acupuncture had a significant effect on cognitive anxiety (p = 0.001) and somatic anxiety (p 0.05). Furthermore, the results showed that acupuncture significantly decreased the skin conductance in acupuncture group compared to sham group (p = 0.006) and wait-list control group (p < 0.001). In conclusion, the results suggested that acupuncture has the capacity to decrease cognitive anxiety and somatic anxiety prior to competition in adolescent athletes, while this was accompanied by significant physiological changes. This trial is registered with IRCT138904074264N1 (IRCT is a Primary Registry in the WHO Registry Network). PMID:27127679

  20. How the psychosocial context of clinical trials differs from usual care: A qualitative study of acupuncture patients

    White Peter

    2011-05-01

    Full Text Available Abstract Background Qualitative studies of participants' experiences in randomised clinical trials (RCTs suggest that the psychosocial context of treatment in RCTs may be quite different to the psychosocial context of treatment in usual practice. This is important, as the psychosocial context of treatment is known to influence patient outcomes in chronic illness. Few studies have directly compared the psychosocial context of treatment across RCTs and usual practice. In this study, we explored differences in psychosocial context between RCT and usual practice settings, using acupuncture as our model. Methods We undertook a secondary analysis of existing qualitative interviews with 54 patients. 27 were drawn from a study of western and traditional acupuncture in usual practice (for a range of painful conditions. 27 were drawn from a qualitative study nested in an RCT of western acupuncture for osteoarthritis of the hip or knee. We used qualitative analysis software to facilitate an inductive thematic analysis in which we identified three main themes. Results In usual practice, starting acupuncture was more likely to be embedded in an active and ongoing search for pain relief, whereas in the RCT starting acupuncture was opportunistic. Usual practice patients reported few uncertainties and these had minimal consequences for them. In the RCT, patients experienced considerable uncertainties about their treatment and its effectiveness, and were particularly concerned about whether they were receiving real (or fake acupuncture. Patients stopped acupuncture only at the end of the fixed course of treatment in the RCT, which was similar to those receiving acupuncture in the public sector National Health Service (NHS. In comparison, private sector patients re-evaluated and re-negotiated treatments particularly when starting to use acupuncture. Conclusions Differences in psychosocial context between RCTs and usual practice could reduce the impact of

  1. Ethical Considerations for Acupuncture and Chinese Herbal Medicine Clinical Trials: A Cross-Cultural Perspective

    Christopher Zaslawski

    2010-01-01

    Many ethical concerns revolve around the four basic principles of research: merit and integrity, respect for human beings, weighting of risk–benefit and justice. These principles form the basis for any discussion concerning human research ethics and are applicable to all areas of research including acupuncture and Chinese herbal medicine. World Health Organisation document, Guidelines for Clinical Research on Acupuncture, states that ‘consideration should be given to the different value syste...

  2. Ethical Considerations for Acupuncture and Chinese Herbal Medicine Clinical Trials: A Cross-cultural Perspective.

    Zaslawski, Christopher

    2010-09-01

    MANY ETHICAL CONCERNS REVOLVE AROUND THE FOUR BASIC PRINCIPLES OF RESEARCH: merit and integrity, respect for human beings, weighting of risk-benefit and justice. These principles form the basis for any discussion concerning human research ethics and are applicable to all areas of research including acupuncture and Chinese herbal medicine. World Health Organisation document, Guidelines for Clinical Research on Acupuncture, states that 'consideration should be given to the different value systems that are involved in human rights such as social, cultural and historical issues' and that 'further studies should be conducted in relation to ethical issues involved in clinical research on acupuncture'. In addition to outlining the four basic principles, this paper will also examine the effect of Asian culture on Western human research ethics and how this may impact upon issues such as informed consent and weighting of risk-benefit. PMID:18955359

  3. The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial.

    Lisa Conboy

    Full Text Available Gulf War Illness is a Complex Medical Illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain affecting veterans of the first Gulf War. No standard of care treatment exists.This pragmatic Randomized Clinical Trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n = 52 or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n = 52. Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P and the secondary outcome is the McGill Pain scale.Of the 104 subjects who underwent randomization, 85 completed the protocol (82%. A clinically and statistically significant average improvement of 9.4 points (p = 0.03 in the SF-36P was observed for group 1 at month 6 compared to group 2, adjusting for baseline pain. The secondary outcome of McGill pain index produced similar results; at 6 months, group 1 was estimated to experience a reduction of approximately 3.6 points (p = 0.04 compared to group 2.Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for veterans with Gulf War Illness. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.ClinicalTrials.gov NCT01305811.

  4. Reduction of chronic non-specific low back pain: A randomised controlled clinical trial on acupuncture and baclofen

    Rastqar Ali

    2010-04-01

    Full Text Available Abstract Background Chronic non-specific low back pain (LBP is a prevalent (80% and multi-dimensional illness. This study aims to test whether acupuncture, baclofen, or combined treatment with acupuncture and baclofen alleviates symptoms of non-specific chronic LBP in men. Methods Eight-four (84 men aged 50-60 years with non-specific chronic LBP were randomly assigned to four groups: the baclofen group received only baclofen (30 mg/day; the acupuncture group received only acupuncture at selected acupoints; the acupuncture + baclofen group received combined treatment with acupuncture and baclofen treatments; and the control group received no pain reduction treatment. After five weeks of treatment, visual analogue scale (VAS and self-reported pain disability with the Roland-Morris Disability Questionnaire (RDQ were conducted for outcome measures. Results After treatment, the baclofen, acupuncture and acupuncture + baclofen groups all had lower VAS and RDQ scores. Significantly higher reduction and improvement in VAS and RDQ scores were found in the acupuncture and acupuncture + baclofen groups compared to the baclofen group. Conclusion The present study indicates that the combined treatment of acupuncture and baclofen is more effective than baclofen treatment alone to reduce pain in patients with non-specific chronic LBP. Trial registration number ACTRN12609000698279

  5. Getting inside acupuncture trials - Exploring intervention theory and rationale

    Godfrey Mary

    2011-03-01

    Full Text Available Abstract Background Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture. Methods Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer. Results When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue. Conclusion Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the

  6. Acupuncture

    2011-01-01

    2011272 Post-stroke speech disorder treated with acupuncture and psychological intervention combined with rehabilitation training:a randomized controlled trial. WANG Ling(王凌),et al.Health Care Dept,Shaanxi TCM Hosp,Xi’an 710003.Abstract:Objective To assess the clinical efficacy on post-stroke speech disorder treated with acupuncture and psychological intervention combined with rehabilitation training.Methods The multi-central randomized controlled study was adopted.One hundred and twenty cases of brain

  7. Comparison of clinical effectiveness of laser acupuncture and amitriptyline in diabetic peripheral neuropathy (DPN): a sham controlled randomized clinical trial

    Hassan Khan, Imran; Anwar, Shahzad; Hanif, Asif; Ayub, Muhammad; Jamil Raja, Arsalan

    2014-02-01

    Background: Painful neuropathy is a very common complication in diabetic patients. Various treatment strategies like manual therapies, conservative management, drug therapy and exercise have been opted for this problem. Studies have shown clinical effectiveness of laser acupuncture as well. On the other hand, Amitryptaline is also a commonly used treatment for this disease. We aim to compare the efficacy of both treatments. Objective: To assess the effect of laser acupuncture in patients suffering from painful diabetic neuropathy and its comparison with standard of care. Patients and Method: This study was conducted in Diabetic and Endocrine Management Center (DEMC) Lahore General Hospital, Lahore, Pakistan. A randomized control trial (RCT) was opted and a total of 164 patients were chosen using Non-probability purposive sampling technique. Pain was graded by using a patient friendly Visual Analogue Score (VAS), scoring from 0 to 10. Treatment was done involving organized fortnightly follow ups. Data of all patients was recorded on Performa and was entered and analyzed for descriptive statistics in PASW 18 (IBM®. SPSS). Results: A total of 164 subjects were included in the study who were subdivided into three groups labeled as A, B and C for laser therapy treatment, amitryptaline treatment and controls respectively. The mean age of subjects was 51.54+/-10.46 in Group A, 49.38+/-10.56 in Group B and 51.70+/-11.43 in Group C. The difference of mean ages in all study groups was statistically insignificant (p-value= 0.469). The average pain score in patients who received laser therapy was 5.95+/-0.91 before treatment, whereas after treatment it was 4.31+/-0.98. The mean pain score in subjects having Amitryptaline before starting the treatment was 6.87+/-0.71 and after treatment, it was 6.23+/-0.98. The mean score for daily life activities in subjects who received laser therapy was 9.562.37 before treatment, while after treatment it was 7.56+/-1.54. The average score

  8. Acupuncture for dry eye: a randomised controlled trial protocol

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  9. Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of sham-controlled randomized clinical trials.

    Yuan, Qi-Ling; Wang, Peng; Liu, Liang; Sun, Fu; Cai, Yong-Song; Wu, Wen-Tao; Ye, Mao-Lin; Ma, Jiang-Tao; Xu, Bang-Bang; Zhang, Yin-Gang

    2016-01-01

    The aims of this systematic review were to study the analgesic effect of real acupuncture and to explore whether sham acupuncture (SA) type is related to the estimated effect of real acupuncture for musculoskeletal pain. Five databases were searched. The outcome was pain or disability immediately (≤1 week) following an intervention. Standardized mean differences (SMDs) with 95% confidence intervals were calculated. Meta-regression was used to explore possible sources of heterogeneity. Sixty-three studies (6382 individuals) were included. Eight condition types were included. The pooled effect size was moderate for pain relief (59 trials, 4980 individuals, SMD -0.61, 95% CI -0.76 to -0.47; P fibromyalgia); however, the interactions between subgroups via these covariates were not significant (P < 0.05). Our review provided low-quality evidence that real acupuncture has a moderate effect (approximate 12-point reduction on the 100-mm visual analogue scale) on musculoskeletal pain. SA type did not appear to be related to the estimated effect of real acupuncture. PMID:27471137

  10. Clinical Application of Heat-Acupuncture Therapy

    Guan Zunhui; Wang Xinzhong

    2006-01-01

    @@ Heat-acupuncture therapy refers to a therapeutic method with which a GZH heat-acupuncture apparatus is used to warm the needle inserted in the human body, and to keep the needle in a constant temperature. It has been proved by clinical researches over 20 years that the heat-acupuncture therapy can yield a joint therapeutic effect of acupuncture,moxibustion, moxibustion with warming needle and fire needle, thus raising the clinical therapeutic effects in treating certain diseases.

  11. The design and protocol of acupuncture for migraine prophylaxis: A multicenter randomized controlled trial

    Li Jingdao

    2009-04-01

    Full Text Available Abstract Background Many studies have already reported encouraging results in the prophylactic therapy of migraine by acupuncture, but there seems to be a lack of high quality randomized controlled trials from China. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with flunarizine in the prophylactic therapy of patients with migraine without aura in China. Methods This trial is a multicenter, prospective, randomized controlled clinical trial. The 140 migraine patients are randomly allocated to two different groups. The acupuncture groups (n = 70 is treated with acupuncture and placebo medicine; while the control group (n = 70 is treated with sham acupuncture and medicine (Flunarizine. Both Flunarizine and placebo are taken 10 mg once per night for the first 2 weeks and then 5 mg once per night for the next 2 weeks. Patients in both groups receive 12 sessions of verum/sham acupuncture in 4 weeks. Discussion The study design and the long term clinical practice of acupuncturists guarantee a high external validity for the results. The results of our trial will be helpful to supply the evidence on the efficacy of acupuncture for migraine prophylaxis in China. Trial Registration The trial is registered at Controlled Clinical Trials: ISRCTN49839714.

  12. Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial

    Wang, Yan; Gao, Yun-xian; Sun, Qi; Bu, Qian; Shi, Jing; Zhang, Ya-ni; Xu, Qin; Ji, Yan; Tong, Min; Jiang, Guang-li

    2014-01-01

    Background Myopia is a public health problem worldwide and its incidence increases with age. The use of acupuncture to treat myopia is a common practice in China, however, the use of acupuncture to treat myopia is disputed in other parts of the world. This study aims to determine the safety of acupuncture to treat myopia and its efficacy over six months. Methods/Design A randomized, parallel, single-center, assessor- and statistician-blinded, controlled clinical trial will be performed. A tot...

  13. Can acupuncture have specific effects on health? A systematic review of acupuncture antiemesis trials.

    Vickers, A J

    1996-01-01

    The effects of acupuncture on health are generally hard to assess. Stimulation of the P6 acupuncture point is used to obtain an antiemetic effect and this provides an excellent model to study the efficacy of acupuncture. Thirty-three controlled trials have been published worldwide in which the P6 acupuncture point was stimulated for treatment of nausea and/or vomiting associated with chemotherapy, pregnancy, or surgery. P6 acupuncture was equal or inferior to control in all four trials in whi...

  14. Clinical Records for Acupuncture Treatment of Migraine

    陶莎

    2005-01-01

    @@ Migraine, characterized by periodic attacks that hampers the quality of the daily life, is an obstinate symptom complex commonly seen in the clinic. In contrast with the poor effects obtained in Western medicine, acupuncture is a safe and effective treatment for migraine. The following are the clinical records for acupuncture treatment of migraine in the recent 5 years.

  15. Reduction of chronic non-specific low back pain: A randomised controlled clinical trial on acupuncture and baclofen

    Rastqar Ali; Manaheji Homa; Zaringhalam Jalal; Zaringhalam Maryam

    2010-01-01

    Abstract Background Chronic non-specific low back pain (LBP) is a prevalent (80%) and multi-dimensional illness. This study aims to test whether acupuncture, baclofen, or combined treatment with acupuncture and baclofen alleviates symptoms of non-specific chronic LBP in men. Methods Eight-four (84) men aged 50-60 years with non-specific chronic LBP were randomly assigned to four groups: the baclofen group received only baclofen (30 mg/day); the acupuncture group received only acupuncture at s...

  16. Impact of including Korean randomized controlled trials in Cochrane reviews of acupuncture.

    Kun Hyung Kim

    Full Text Available OBJECTIVE: Acupuncture is commonly practiced in Korea and is regularly evaluated in clinical trials. Although many Cochrane reviews of acupuncture include searches of both English and Chinese databases, there is no information on the value of searching Korean databases. This study aimed to investigate the impact of searching Korean databases and journals for trials eligible for inclusion in existing Cochrane acupuncture reviews. METHODS: We searched 12 Korean databases and seven Korean journals to identify randomised trials meeting the inclusion criteria for acupuncture reviews in the Cochrane Database of Systematic Reviews. We compared risk of bias assessments of the Korean trials with the trials included in the Cochrane acupuncture reviews. Where possible, we added data from the Korean trials to the existing meta-analyses in the relevant Cochrane review and conducted sensitivity analyses to test the robustness of the results. RESULTS: Sixteen Korean trials (742 participants met the inclusion criteria for eight Cochrane acupuncture reviews (125 trials; 13,041 participants. Inclusion of the Korean trials provided data for 20% of existing meta-analyses (24 out of 120. Inclusion of the Korean trials did not change the direction of effect in any of the existing meta-analyses. The effect size and heterogeneity remained mostly unchanged. In only one meta-analysis did the significance change. Compared to the studies included in the Cochrane acupuncture reviews, the risk of bias in the Korean trials was higher in terms of outcome assessor blinding and allocation concealment. CONCLUSIONS: Many Korean studies contributed additional data to the existing meta-analyses in Cochrane acupuncture reviews. Although inclusion of these studies did not alter the results of the meta-analyses, comprehensive searches of the literature are important to avoid potential language bias. The identification and inclusion of eligible Korean trials should be considered for

  17. Crossover clinical trial to determine the effect of manual acupuncture at Siguan points (bilateral LI4 and LR3) on intestinal motility in healthy subjects.

    Yim, Y K; Kang, W C; Cho, J H; Shin, J W; Lee, N H; Choi, S M; Koo, S T; Park, K S; Son, C G

    2007-01-01

    This study examined whether manual acupuncture at the Siguan points (bilateral points LI4 and LR3) affects intestinal motility in healthy human subjects. Twenty healthy male subjects were randomly assigned either to real acupuncture (RA) at Siguan points or sham acupuncture (SA) groups in a crossover manner. All subjects underwent two experimental sessions; the RA group in the first session was treated with SA in the second session after a 2-week washout period, and vice versa. Each subject took 20 radio-markers and was treated with acupuncture 0, 12, 24, and 36 hours after radio-marker intake. Radiographs were taken at 6, 12.5, 24.5, and 48 hours, and the effect of acupuncture on intestinal motility was evaluated based on the distribution of the radio-markers in the ileum, ascending colon, transverse colon, descending colon, sigmoid/ rectum, and outside the body. Defecating habit was monitored during the trial, and complete blood counts were checked before and after the two acupuncture sessions. The RA and SA results showed extremely similar distributions of the radio-markers in these five regions of the alimentary canal and outside the body in radiographs taken at four different times, verifying that there was no effect of manual acupuncture at the Siguan points on intestinal motility, at least in healthy human subjects. PMID:17436362

  18. Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

    Caroline A. Smith

    2011-01-01

    Full Text Available We examined the effectiveness of acupuncture to reduce the severity and intensity of primary dysmenorrhea. A randomized controlled trial compared acupuncture with control acupuncture using a placebo needle. Eligible women were aged 14–25 years with a diagnosis of primary dysmenorrhea. Women received nine sessions of the study treatment over 3 months. The primary outcomes were menstrual pain intensity and duration, overall improvement in dysmenorrhea symptoms and reduced need for additional analgesia, measured at 3, 6 and 12 months from trial entry. A total of 92 women were randomly assigned to the intervention (acupuncture =46 and control =46. At 3 months although pain outcomes were lower for women in the acupuncture group compared with the control group, there was no significant difference between groups. Women receiving acupuncture reported a small reduction in mood changes compared with the control group, relative risk (RR 0.72, 95% confidence interval (CI 0.53–1.00, =.05. Follow-up at 6 months found a significant reduction in the duration of menstrual pain in the acupuncture group compared with the control group, mean difference –9.6, 95% CI –18.9 to –0.3, =.04, and the need for additional analgesia was significantly lower in the acupuncture group compared with the control group, RR 0.69, 95% CI 0.49–0.96, =.03, but the follow-up at 12 months found lack of treatment effect. To conclude, although acupuncture improved menstrual mood symptoms in women with primary dysmenorrhea during the treatment phase, the trend in the improvement of symptoms during the active phase of treatment, and at 6 and 12 months was non-significant, indicating that a small treatment effect from acupuncture on dysmenorrhea may exist. In the study, acupuncture was acceptable and safe, but further appropriately powered trials are needed before recommendations for clinical practice can be made.

  19. Clinical effects of acupuncture therapy for vascular dementia

    Lei Zhao; Yi Guo; Jun Xiong; Wei Wang; Yuanhao Du; Lijuan Yan

    2011-01-01

    OBJECTIVE: To evaluate clinical acupuncture treatment studies for vascular dementia, as well as to collect high-quality evidence related to clinical acupuncture treatment for clinical diagnosis.DATA SOURCES: PubMed database(1966-2010), Embase database(1986-2010), Cochrane Library(Issue 1,2010), Chinese Biomedical Literature Database(1979-2010), China HowNet database(1979-2010), VI P Journals Database(1989-2010), and Wanfang database(1998-2010)were analyzed by computer.DATA SELECTION: Any form of acupuncture(needles, electro-acupuncture, laser acupuncture,pointer, or ear acupuncture), as well as blank, placebo, Western medicine, acupuncture therapy combined with other therapies, and randomized or quasi-randomized controlled studies were included. The priority was given to high-quality randomized, controlled trials. Data were independently extracted from two reviewers and cross-checked in accordance with high to low standards utilizing evidence-based medicine to answer five relevant clinical questions. Statistical outcome indicators were measured using RevMan 5.0.20 software, such as overall function,Hasegawa Dementia Scale score, Functional Activities Questionnaire score, Mini Mental State Examination, and efficacy of daily living activities.MAIN OUTCOME MEASURES: The present study assessed standards of efficacy, including Hasegawa Dementia Scale score, Functional Activities Questionnaire score, Mini Mental State Examination, and efficacy of daily living activities.RESULTS: A total of 11 articles were included, including one with systematic reviews/meta-analysis,one with Cochrane A level, eight with Cochrane B level, and one with Cochrane C level evidence.Acupuncture resulting in improved overall function and cognitive function was superior than Western medicine. A system evaluation showed the following: weighted mean difference(WMD)=5.64, 95% confidence interval(CI): 2.87-11.09, P <0.01; WMD = 6.07, 95% CI:3.76-8.38, P<0.01.Two articles with Class B evidences

  20. Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials*

    Wu, Yan; Robinson, Nicola; Hardiman, Paul J.; Taw, Malcolm B.; Zhou, Jue; Wang, Fang-fang; Qu, Fan

    2016-01-01

    Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and the Wanfang databases. RCTs comparing either acupuncture with no/sham/pharmacological intervention or a combination of acupuncture and conventional therapy with conventional therapy in the treatment of PCOS were included in this review. A quality evaluation was performed for each of the included studies. Results: Thirty-one RCTs were included in the review and were divided into four categories according to the type of intervention used in the comparator or control group. Menstrual frequency, hormones, anthropometrics, insulin sensitivity, blood lipids, and fertility were used as the main measurements to assess the effects of acupuncture on the patients with PCOS. Thirty trials, except for one, showed an improvement in at least one of the indicators of PCOS after acupuncture treatment. However, normalizing the methodological and reporting format remains an issue. Conclusions: Based upon this review of current clinical trials concerning acupuncture for treating PCOS, we provide guidelines for better clinical trial design in the future. PMID:26984837

  1. Clinical Trials

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  2. Clinical Practice Guideline of Acupuncture for Bell's Palsy

    Xi Wu

    2016-10-01

    Full Text Available Backgroud: Acupuncture is common used for Bell's palsy in clinic, however, recent systematic reviews all shows that there is no sufficient evidence to support the effectiveness of acupuncture for Bell's palsy because ofthe poor quality and heterogeneity. It's urgently necessary to develop a guideline of acupuncture for Bell's palsy based on principles of evidence-based medicine to optimize acupuncture treating, standardize outcomes evaluating and to improve the quality of acupuncture for patients with Bell's palsy under general circumstances.

  3. The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH study: A study protocol of an ongoing multi-centre randomised controlled clinical trial

    Borud Einar K

    2007-02-01

    Full Text Available Abstract Background After menopause, 10–20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints. Methods/Design The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate. The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments. Discussion The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.

  4. Is Sham Laser a Valid Control for Acupuncture Trials?

    Dominik Irnich

    2011-01-01

    Full Text Available Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point and sham laser (red light treatment at three acupuncture points (LI4, LU7 and LR3 in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation. We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44% healthy volunteers (age: 28 ± 10.7 years identified the used laser device after the first session and 14 (41% after the second session. Hence, both treatments were undistinguishable (P = .26. Deqi-like sensations occurred in 46% of active laser (2.34 VAS and in 49.0% of sham laser beams (2.49 VAS. The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se.

  5. Is sham laser a valid control for acupuncture trials?

    Irnich, Dominik; Salih, Norbert; Offenbächer, Martin; Fleckenstein, Johannes

    2011-01-01

    Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se. PMID:21772922

  6. Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

    Kim Yong-Suk

    2011-03-01

    Full Text Available Abstract Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010

  7. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  8. Is Sham Laser a Valid Control for Acupuncture Trials?

    Dominik Irnich; Norbert Salih; Martin Offenbächer; Johannes Fleckenstein

    2011-01-01

    Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratin...

  9. [Enlightenment of big-data era on clinical research of TCM and acupuncture].

    Zhao, Tianyi; Chen, Bo; Pan, Xingfang; Guo, Yongming; Guo, Yi

    2015-09-01

    The big-data era has arrived, which involves all professions and trades. Its impact on the medical field has gradually revealed. With the characteristics of big data "4V" (volume, velocity, variety, value) and its theory generality with TCM (holistic thinking, correlativity) as well as regularity of disease development, combined with present status of acupuncture clinical research, the influences of big-data era on trial design, data collection, analysis and sharing of acupuncture clinical research are discussed in this paper, aiming to provide references for solving the difficulties of study design and determining the future research direction of acupuncture clinical research. PMID:26721155

  10. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China

    Zheng Hui

    2011-03-01

    Full Text Available Abstract Background In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. Methods This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. Results Among the 1968 patients, 74 patients (3.76% suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. Conclusions Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs were related to the patients' gender and age and the local

  11. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

    Jimin Park

    2015-01-01

    Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

  12. DEVELOPMENT OF ACUPUNCTURE TREATMENT AND CLINICAL RESEARCH OF THREATENED ABORTION

    LI Jing-xia; XIE Gan-gong

    2005-01-01

    In the present paper, the authors review recent development of acupuncture treatment of threatened abortion from 1) clinical application of "Linggui Bafa"(灵龟八法Eight Methods of Intelligent Turtle), 2) body acupoints, and 3) acupuncture combined with Chinese materia medica, and clinical study from 1) effect of acupuncture on the blood flow of uterus, and 2) effect of acupuncture on plasma progesterone level. In addition, acupuncture therapy is also used to help women in gestation and can effectively raise the pregnant rate. "Linggui Bafa" is rather effective in preventing threatened abortion and should be studied further.

  13. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  14. Validating a New Non-penetrating Sham Acupuncture Device:Two Randomised Controlled Trials

    Jongbae Park; Adrian White; Clare Stevinson; Edzard Ernst; Martin James

    2003-01-01

    @@ Introduction In clinical trials of the efficacy of manualtreatments like surgery or acupuncture,control groups are commonly given'sham' procedures. Sham procedures, inorder to be true placebos, must be 1) in-distinguishable from the real treatmentand 2) inactive.

  15. Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

    Wang Kangjun

    2011-06-01

    efficacy of using prednisolone and staging acupuncture to treat Bell's palsy, and to determine a best combination therapy with prednisolone and acupuncture for treating Bell's palsy. Trial Registration ClinicalTrials.gov: NCT01201642

  16. Acupuncture for the Treatment of Oculomotor Paralysis: A Pilot Randomised Controlled Trial

    Bi, Jia-Qi; Li, Wei; Yang, Qi; Li, Bao-lin; Meng, Qing-Gang; Liu, Yu-fu

    2016-01-01

    This study consisted of a single centre randomised controlled trial with two parallel arms: an acupuncture group (n = 20) with 27 affected eyes and a sham group (n = 20) with 23 affected eyes. Participants in the acupuncture group received acupuncture treatment once daily, three times weekly for four weeks. Participants assigned to the control group received sham acupuncture, the same protocol as that used for the acupuncture group but without insertion of needles into the skin. The primary outcome measure was the cervical range of motion (CROM) score. Secondary outcome measures were the palpebral fissure size, response rate, and adverse events. All 40 participants completed the study. In the comparison of acupuncture and sham acupuncture, a significant difference was observed between acupuncture and sham acupuncture in CROM score (21.37 ± 15.16 and 32.21 ± 19.54, resp.) (P acupuncture group (P acupuncture had a feasibility positive effect on oculomotor paralysis. PMID:27313646

  17. CLINICAL STUDY OF LASERNEEDLE ACUPUNCTURE

    Med. M. Weber

    2001-01-01

    We are reporting over 500 acupuncture cases, a wide range of illnesses ranging from orthopedic, internal, neurological and psychological diseases, all of which were treated with a newly developed and therefore available Laserneedle system. This system was highly successful in treatment of a variety of illnesses including HWS, BWS and LWS Syndromes, gonarthritis, coxarthritis, rhizarthrosis, periarthritis of the shoulder, epicondylitis humeri radiails, tendinitis, fibromyalgia and PCP, Morbus Bechterew, paralysis after stroke, migraine and other headache syndrome, tinnitus, trigeminal neuralgia, gastropathy, bronchial asthma, AVK, mental depression and other psychovegatative burnout syndrome by using both body acupoints and otopoints. Treatment was made by simultaneously using 8Laserneedles which were not pricked into, but stuck onto the skin. The Laserneedles emit red and infrared Laserrays with a high energy output, so that perceptible, vegetative stimulation can be detected at the acupunctrured sites. We found out, that especially in the therapy resistant, long standing cases and cases with chronic back and spine problems, considerable improvements in easing pain and increasing mobility could be made. Recognizable success was made by using Laserneedles in cases suffering from psychological illnesses, especially psychosomatic related Burnoutsyndrome and cases of exhaustion. Usually after 2~ 3 treatments, efficient success was made, without any side effects what so ever.

  18. Efficacy of Acupuncture in Children with Nocturnal Enuresis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Zheng-tao Lv

    2015-01-01

    Full Text Available Background. Nocturnal enuresis (NE is recognized as a widespread health problem in young children and adolescents. Clinical researches about acupuncture therapy for nocturnal enuresis are increasing, while systematic reviews assessing the efficacy of acupuncture therapy are still lacking. Objective. This study aims to assess the effectiveness of acupuncture therapy for nocturnal enuresis. Materials and Methods. A comprehensive literature search of 8 databases was performed up to June 2014; randomized controlled trials which compared acupuncture therapy and placebo treatment or pharmacological therapy were identified. A meta-analysis was conducted. Results. This review included 21 RCTs and a total of 1590 subjects. The overall methodological qualities were low. The results of meta-analysis showed that acupuncture therapy was more effective for clinical efficacy when compared with placebo or pharmacological treatment. Adverse events associated with acupuncture therapy were not documented. Conclusion. Based on the findings of this study, we cautiously suggest that acupuncture therapy could improve the clinical efficacy. However, the beneficial effect of acupuncture might be overstated due to low methodological qualities. Rigorous high quality RCTs are urgently needed.

  19. Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol

    Janssen Patricia A

    2012-12-01

    Full Text Available Abstract Background The prevalence of maternal drug use during pregnancy in North America has been estimated to be as high as 6-10%. The consequences for the newborn include increased risk for perinatal mortality and ongoing physical, neurobehavioral, and psychosocial problems. Methadone is frequently used to wean women off street drugs but is implicated as a cause of adverse fetal/neonatal outcomes itself. The purpose of our study was to test the ability of maternal acupuncture treatment among mothers who use illicit drugs to reduce the frequency and severity of withdrawal symptoms among their newborns. Methods We randomly assigned chemically dependent pregnant women at BC Women’s Hospital in Vancouver, British Columbia to daily acupuncture treatments versus usual care. By necessity, neither our participants nor acupuncturists were blinded as to treatment allocation. Our primary outcome was days of neonatal morphine treatment for symptoms of neonatal withdrawal. Secondary neonatal outcomes included admission to a neonatal ICU and transfer to foster care. Results We randomized 50 women to acupuncture and 39 to standard care. When analyzed by randomized groups, we did not find benefit of acupuncture; the average length of treatment with morphine for newborns in the acupuncture group was 2.7 (6.3 compared to 2.8 (7.0 in the control group. Among newborns of women who were compliant with the acupuncture regime, we observed a reduction of 2.1 and 1.5 days in length of treatment for neonatal abstinence syndrome compared to the non-compliant and control groups, respectively. These differences were not statistically significant. Conclusions Acupuncture may be a safe and feasible treatment to assist mothers to reduce their dosage of methadone. Our results should encourage ongoing studies to test the ability of acupuncture to mitigate the severity of neonatal abstinence syndrome among their newborns. Clinical Trial Registration http

  20. Acupuncture as pain relief during delivery: a randomized controlled trial

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten;

    2009-01-01

    with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...

  1. Acupuncture

    Acupuncture has been practiced in China and other Asian countries for thousands of years. Acupuncture involves stimulating specific points on the body. This ... functions of the body. Research has shown that acupuncture reduces nausea and vomiting after surgery and chemotherapy. ...

  2. Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine

    Carbrera-Iboleón Justo

    2008-04-01

    Full Text Available Abstract Background Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment. Methods/Design The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only. Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment. Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham groups for a brain perfusion study (by single photon emission tomography. The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups. Discussion This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between

  3. Effects of warm acupuncture on breast cancer–related chronic lymphedema: a randomized controlled trial

    Yao, C.; Xu, Y.; Chen, L.; Jiang, H.; Ki, C.S.; Byun, J.S.; Bian, W.

    2016-01-01

    Background Effective treatment for breast cancer–related chronic lymphedema (bcrl) remains a clinical challenge. Acupuncture and moxibustion treatments have been shown to be beneficial and safe for treating bcrl. In the present randomized controlled trial, we compared the effectiveness of combined acupuncture and moxibustion (“warm acupuncture”) with that of diosmin in bcrl. Methods Breast cancer patients who met the inclusion and exclusion criteria (n = 30) were randomized to experimental and control groups (15 per group). On alternate days, patients in the experimental group received 30 minutes of acupuncture at 6 acupoints, with 3 of the needles each being topped by a 3-cm moxa stick. The control treatment was diosmin 900 mg 3 times daily. The control and experimental treatments were administered for 30 days. Outcome measures included arm circumferences (index of effectiveness), range of motion [rom (shoulder joint function)], quality of life, clinical safety, and adverse events. Results Measured by the index of effectiveness, bcrl improved by 51.46% in the experimental group and by 26.27% in the control group (p < 0.00001). Effects were greatest at 10 cm above the elbow and at the wrist, where the warm needling was provided. Impairments in shoulder joint rom were minimal at baseline in both treatment groups. However, the roms of rear protraction, abduction, intorsion, and extorsion in the experimental group improved significantly; they did not change in the control group. Self-reported quality of life was significantly better with warm acupuncture than with diosmin. No adverse effects were reported during the treatment period, and laboratory examinations for clinical safety fell within the normal ranges. Conclusions Compared with diosmin, warm acupuncture treatment can effectively reduce the degree of bcrl at the specific acupoints treated and can promote quality of life. Warm acupuncture showed good clinical safety, without any adverse effects on blood

  4. Acupuncture in treatment of carpal tunnel syndrome: A randomized controlled trial study

    Saeid Khosrawi

    2012-01-01

    Full Text Available BACKGROUND: Carpal tunnel syndrome (CTS is the most preva lent form of peripheral neuropathy. The efficacy of acupuncture in management of mild to moderate CTS has been investigated in limited studies with controversial results. The aim of this study was to assess the short-term effects of acupuncture in treatment of mild to moderate carpal tunnel syndrome. METHODS: In a randomized controlled trial study, participants were randomly assigned to either control group which night splinting, vitamin B1, B6 and sham acupuncture for four weeks were administered, or intervention group that un-derwent acupuncture in 8 sessions over 4 weeks and night splinting. The clinical symptoms using global symptom score (GSS and electrophysiological parameters were assessed at baseline and four weeks after the intervention. RESULTS: Of 72 patients met the inclusion criteria, 64 patients actually completed the 4 week intervention and were evaluated for the outcome. There was a statistically significant difference in GSS between two arms of treatment after the intervention (p 0.05. CONCLUSIONS: Our findings indicated that the acupuncture can improve the overall subjective symptoms of carpal tun-nel syndrome and could be adopted in comprehensive care programs of these patients.

  5. Clinical Observation on Acupuncture for Perimenopausal Depression

    周庆; 王健雄; 崔学军

    2009-01-01

    Objective: To observe the clinical effect of acupuncture for perimenopausal depression. Methods: Ninety cases were randomly allocated into treatment group (n=60) and control group (n=30) according to the visit sequence. Patients in the treatment group were treated with acupuncture, once daily, and 10 times constituted one treatment course. Patients in the control group took Premarin tablet and medroxyprogesterone acetate for 3 cycles of menses.Results: The total effective rate was 95.0% in the treatment group, and 87.7% in the control group (P<0.05). The HAMD scores were decreased in both groups, and it was lower in the treatment group than in the control group (P<0.05 or P<0.01). Conclusion: Acupuncture has good effects on perimenopausal depression.%目的:观察针刺治疗围绝经期抑郁症临床疗效.方法:将90例患者按就诊顺序随机分为治疗组(60例)和对照组(30例).治疗组给予针刺治疗,隔日1次,10次为1疗程;对照组口服倍美力片和安宫黄体酮片,共观察3个月经周期.结果:治疗组总有效率为95.0%,对照组为87.7%(P<0.05);两组治疗后HAMD因子评分明显降低,且治疗组优于对照组(P<0.05或P<0.01).结论:针刺治疗围绝经期抑郁症有较好疗效,

  6. Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial

    Barlow William E

    2008-02-01

    Full Text Available Abstract Background Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain. Methods and Design A total of 640 participants (160 in each of four arms between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM acupuncture needling (individualized or standardized, a "control" group (simulated acupuncture, or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for

  7. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  8. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  9. Acupuncture, psyche and the placebo response.

    Enck, Paul; Klosterhalfen, Sibylle; Zipfel, Stephan

    2010-10-28

    With growing use of acupuncture treatment in various clinical conditions, the question has been posed whether the reported effects reflect specific mechanisms of acupuncture or whether they represent placebo responses, as they often are similar in effect size and resemble similarities to placebo analgesia and its mechanisms. We reviewed the available literature for different placebos (sham procedures) used to control the acupuncture effects, for moderators and potential biases in respective clinical trials, and for central and peripheral mechanisms involved that would allow differentiation of placebo effects from acupuncture and sham acupuncture effects. While the evidence is still limited, it seems that biological differences exist between a placebo response, e.g. in placebo analgesia, and analgesic response during acupunture that does not occur with sham acupuncture. It seems advisable that clinical trials should include potential biomarkers of acupuncture, e.g. measures of the autonomic nervous system function to verify that acupuncture and sham acupuncture are different despite similar clinical effects. PMID:20359961

  10. Participating in Clinical Trials

    Full Text Available Home > Health topics A-Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks ... centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...

  11. Nuclear medicine methods in the assessment of acupuncture effects: a short review

    Deise Elisabete Souza; Bernardo Machado Rebello; Reginaldo de Carvalho Silva Filho; Raquel Terra Agostinho; Sohaku R. C. Bastos; Mario Bernardo-Filho

    2007-01-01

    The mechanisms of acupuncture are poorly understood. In consequence, numerous investigators have conducted clinical trials to test the efficacy of acupuncture in various conditions. We have used PubMed database system to evaluate the number of publications in acupuncture and nuclear medicine procedures in the period from 1964 to 2007, using the keywords: "nuclear medicine and acupuncture", "SPECT and acupuncture", "PET and acupuncture", "scintigraphy and acupuncture", "radionuclide and acupun...

  12. Acupuncture therapy for drug addiction

    Motlagh, Farid Esmaeili; Ibrahim, Fatimah; Rashid , Rusdi Abd.; SEGHATOLESLAM, Tahereh; Habil, Hussain

    2016-01-01

    Acupuncture therapy has been used to treat substance abuse. This study aims to review experimental studies examining the effects of acupuncture on addiction. Research and review articles on acupuncture treatment of substance abuse published between January 2000 and September 2014 were searched using the databases ISI Web of Science Core Collection and EBSCO’s MEDLINE Complete. Clinical trial studies on the efficacy of acupuncture therapy for substance abuse were classified according to substa...

  13. METHODOLOGICAL EVALUATION ON CLINICAL RESEARCH LITERATURE OF ACUPUNCTURE TREATMENT OF FACIAL PARALYSIS

    梁繁荣; 李瑛

    2003-01-01

    Objective: To try to give an objective evaluation on the clinical research situation about acupuncturetreatment of facial paralysis in the past 50 years and try to provide a possible evidence for clinical practice. Methods:All papers are searched and assessed according to the international standards and clinical epidemiology. Results:There is no systematic review (SR) on acupuncture treatment of facial palsy in a total of 1021 articles enlisted in thepresent paper. Comparing with the quantity of the descriptive studies and expert opinions (constituting 84.84% ), thatof the randomized controlled trials (RCTs) and clinical controlled trials (CCTs) is smaller (constituting 15. 16%), be-sides, the quality of RCTs and CCTs is unsatisfactory. Conclusion: At present, the quantity and quality of studies withRCTs about acupuncture treatment of facial paralysis can't meet the need of clinical practice, and in order to improvethe therapeutic effect, a higher quality of RCTs and SR is required.

  14. Clinical Research on Detoxification with Acupuncture

    HU Jun; XIN Yu-hu; ZONG Lei; IHAO Shan-xiang; LI Shen; XIAO Yuan-chun

    2003-01-01

    Purpose To confirm the effects of acupuncture, and Chinese medicines in controlling the withdrawal symptoms from the opium-like drugs. Method 96 heroin-dependent subjects were divided into four groups,which were treated respectively by western medicine (Agroup), acupuncture (B group), Chinese herbs (Cgroup), and acupuncture & Chinese herbs (D group).Before, during and after treatment, the concentration of serum testosterone and prolactin, and immune functions (serum CD3+ 、CD4+ 、CD8+ and CD4+/CD8+ ) were tested.Results After treatment, the concentration of serum testosterone in A and B group were higher than before and during treatment, and in C and D group, during treatment were higher. In the four groups, the concentration of serum prolactin before treatment was the highest. The levels of CD3+、CD4+、 CD8+ and CD4+/CD8+ were lowest before treatment and highest after treatment. Conclusion Acupuncture and Chinese medicines effective in relieving spasm and pain can control the opium-like drug withdrawal symptoms to different degrees, especially acupuncture. However, acupuncture cannot ease the withdrawal symptoms completely. Acupuncture does not strikingly cooperate with the Chinese medicines effective in relieving spasm and pain (including M-receptor antagonists). In detoxification, the Jiaji points are the primary ones and symptom-based points the secondary ones.

  15. Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP Trial

    Hurley D

    2008-03-01

    Full Text Available Abstract Background Evidence supports the use of exercise for chronic low back pain (CLBP; however, adherence is often poor due to ongoing pain. Auricular acupuncture is a form of pain relief involving the stimulation of points on the outer ear corresponding with specific body parts. It may be a useful adjunct to exercise in managing CLBP; however, there is only limited evidence to support its use with this patient group. Methods/Design This study was designed to test the feasibility of an assessor-blind randomised controlled trial which assess the effects on clinical outcomes and exercise adherence of adding manual auricular acupuncture to a personalised and supervised exercise programme (PEP for CLBP. No sample size calculation has been carried out as this study aims to identify CLBP referral rates within the catchment area of the study site. The researchers aim to recruit four cohorts of n = 20 participants to facilitate a power analysis for a future randomised controlled trial. A computer generated random allocation sequence will be prepared centrally and used to allocate participants by cohort to one of the following interventions: 1 six weeks of PEP plus manual auricular acupuncture; 2 six weeks of PEP alone. Both groups will also complete a further six weeks of self-paced exercise with telephone follow-up support. In addition to a baseline and exit questionnaire at the beginning and end of the study, the following outcomes will be collected at baseline, and after 7, 13 and 25 weeks: pain frequency and bothersomeness, back-specific function, objective assessment and recall of physical activity, use of analgesia, perceived self-efficacy, fear avoidance beliefs, and beliefs about the consequences of back pain. Since this is a feasibility study, significance tests will not be presented, and treatment effects will be represented by point estimates and confidence intervals. For each outcome variable, analysis of covariance will be performed on

  16. Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: Study protocol for a randomized controlled trial

    Cohen Marc

    2011-11-01

    Full Text Available Abstract Background Pain is the most common reason that patients present to an emergency department (ED and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED. The current study aims to assess the efficacy of acupuncture for providing effective analgesia to patients presenting with acute low back pain, migraine and ankle sprain at the EDs of four hospitals in Melbourne, Australia. Method The study is a multi-site, randomized, assessor-blinded, controlled trial of acupuncture analgesia in patients who present to an ED with low back pain, migraine or ankle sprain. Patients will be block randomized to receive either acupuncture alone, acupuncture as an adjunct to pharmacotherapy or pharmacotherapy alone. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA. Pain after one hour, measured using a visual analogue scale (VAS, is the primary outcome. Secondary outcomes measures include the following instruments; the Oswestry low back pain disability questionnaire, 24-hour Migraine Quality of Life questionnaire and Patient's Global Assessment of Ankle Injury Scale. These measures will be recorded at baseline, 1 hour after intervention, each hour until discharge and 48 ± 12 hours of ED discharge. Data will also be collected on the safety and acceptability of acupuncture and health resource utilization. Discussion The results of this study will determine if acupuncture, alone or as an adjunct to pharmacotherapy provides effective, safe and acceptable pain relief for patients presenting to EDs with acute back pain, migraine or ankle sprain. The results will also identify the impact that acupuncture treatment may have upon health resource utilisation in the ED setting. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12609000989246

  17. Randomized Clinical Trial Comparing Efficacy of Simo Decoction and Acupuncture or Chewing Gum Alone on Postoperative Ileus in Patients With Hepatocellular Carcinoma After Hepatectomy.

    You, Xue-Mei; Mo, Xin-Shao; Ma, Liang; Zhong, Jian-Hong; Qin, Hong-Gui; Lu, Zhan; Xiang, Bang-De; Wu, Fei-Xiang; Zhao, Xin-Hua; Tang, Juan; Pang, Yong-Hui; Chen, Jie; Li, Le-Qun

    2015-11-01

    To compare the efficacy of simo decoction (SMD) combined with acupuncture at the tsusanli acupoint or chewing gum alone for treating postoperative ileus in patients with hepatocellular carcinoma (HCC) after hepatectomy.In postoperative ileus, a frequent complication following hepatectomy, bowel function recovery is delayed, which increases length of hospital stay. Studies suggest that chewing gum may reduce postoperative ileus; SMD and acupuncture at the tsusanli acupoint have long been used in China to promote bowel movement.Patients with primary HCC undergoing hepatectomy between January 2015 and August 2015 were randomized to receive SMD and acupuncture (n = 55) or chewing gum (n = 53) or no intervention (n = 54) starting on postoperative day 1 and continuing for 6 consecutive days or until flatus. Primary endpoints were occurrence of postoperative ileus and length of hospital stay; secondary endpoints were surgical complications.Groups treated with SMD and acupuncture or with chewing gum experienced significantly shorter time to first peristalsis, flatus, and defecation than the no-intervention group (all P chewing gum group (mean 14.7, SD 6.2) and the no-intervention group (P = 0.147). Incidence of grades I and II complications was slightly lower in both intervention groups than in the no-intervention group.The combination of SMD and acupuncture may reduce incidence of postoperative ileus and shorten hospital stay in HCC patients after hepatectomy. Chewing gum may also reduce incidence of ileus but does not appear to affect hospital stay. (Clinicaltrials.gov registration number: NCT02438436.). PMID:26559269

  18. Participating in Clinical Trials

    Full Text Available ... Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms ... with Your Doctor Taking Medicines The information in this topic was provided by the National Library of ...

  19. Participating in Clinical Trials

    Full Text Available ... Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose of ...

  20. Participating in Clinical Trials

    Full Text Available ... on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose ...

  1. Acupuncture (PDQ)

    ... patients feel during acupuncture? Patients may have a needling feeling during acupuncture, known as de qi sensation , ... Studies of the effect of acupuncture on xerostomia (dry mouth) in patients treated for cancer Several clinical ...

  2. Bibliometrics study of the development trend of acupuncture-moxibustion clinical trials in foreign countries%从文献角度看针灸临床试验研究在国外的发展趋势

    何巍; 童元元; 赵英凯; 荣培晶; 王宏才

    2012-01-01

    On the basis of MEDLINE and EMBASE database, through bibliometrics, the quantitative research was conducted on the published literatures on the acupuncture-moxibustion clinical trial abroad. The situation of published articles in each continent, country and institution was analyzed statistically. It was found that the number of published articles was higher in Germany, America, England, Sweden, Austria, Japan, South Korea, etc. In Europe, the clinical trial of acupuncture and moxibustion was in the tendency of more country participants, wider distribution and larger amount of research. In North America, America was the main country for the study. In Asia, Japan and South Korea played the leading role. Of those countries, some institutions in Germany America, and South Korea were on the top of the list. In future, the ahove-mentioned countries and institutions should be monitored specifically so as to launch the active cooperation and strategic project.%以MEDLINE和EMBASE数据库为基础,通过文献计量的方法,对国外开展的针灸临床试验研究的载文情况进行计量研究,对各大洲、各国以及各机构的发文情况进行统计,其中德国、美国、英国、瑞典、奥地利、日本、韩国等国发文量较多,在欧洲针灸临床试验研究呈现国家多、分布广、研究数量大的态势,在北美洲则主要集中在美国,在亚洲日本和韩国具有主导优势;德国、美国、韩国等一些机构排名靠前,今后应对以上国家及机构重点监测,进行积极的合作与战略规划.

  3. Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol

    Kang Kyung-Won

    2009-07-01

    Full Text Available Abstract Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control. Methods This study consists of a multi-centre (two centres in Korea and two centres in China, randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group. The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping. The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure. Trial

  4. Acupuncture is a feasible treatment for post-thoracotomy pain: results of a prospective pilot trial

    Malhotra Vivek T; Rusch Valerie W; Vickers Andrew J; Downey Robert J; Cassileth Barrie R

    2006-01-01

    Abstract Background Thoracotomy is associated with severe pain that may persist for years. Acupuncture is a complementary therapy with a proven role in pain control. A randomized trial showed that acupuncture was effective in controlling pain after abdominal surgery, but the efficacy of this technique for the treatment of thoracotomy pain has not been established. We developed a novel technique for convenient application of acupuncture to patients undergoing thoracotomy, and in a Phase II tri...

  5. Auricular or body acupuncture: which one is more effective in reducing abdominal fat mass in Iranian men with obesity: a randomized clinical trial

    Darbandi, Mahsa; Darbandi, Sara; Owji, Ali Akbar; Mokarram, Pooneh; Mobarhan, Majid Ghayor; Fardaei, Majid; Zhao, Baxiao; Abdi, Hamid; Nematy, Mohsen; Safarian, Mohammad; Parizadeh, Mohammad Reza; Dabbaghmanesh, Mohammad Hossein; Abbasi, Parisa; FERNS, Gordon

    2014-01-01

    Background The prevalence of abdominal obesity is on the rise worldwide. Previous studies have indicated the higher diagnostic value of body fat distribution pattern compared with general body in abdominal obesity assessments. Several non-pharmacological methods have been suggested for obesity management, of which acupuncture has gained a great deal of research interest with promising results. This study aimed to comparatively evaluate the effects of conventional auricular and body electroacu...

  6. Participating in Clinical Trials

    Full Text Available ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  7. Acupuncture

    ... it is best to check with your insurance company to find out if all or part of your acupuncture treatment will be covered. If your insurance does not cover acupuncture, you can talk to your acupuncturist about their fees and possible discounts if you are a student. Some college or ...

  8. Participating in Clinical Trials

    Full Text Available ... Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ... lifestyle changes, such as exercising more, getting more sleep, keeping mentally active, or eating nutritious foods, can ...

  9. Participating in Clinical Trials

    Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The ...

  10. Acupuncture for Pediatric Pain

    Brenda Golianu

    2014-08-01

    Full Text Available Chronic pain is a growing problem in children, with prevalence as high as 30.8%. Acupuncture has been found to be useful in many chronic pain conditions, and may be of clinical value in a multidisciplinary treatment program. The basic principles of acupuncture are reviewed, as well as studies exploring basic mechanisms of acupuncture and clinical efficacy. Conditions commonly treated in the pediatric pain clinic, including headache, abdominal pain, fibromyalgia, juvenile arthritis, complex regional pain syndrome, cancer pain, as well as perioperative pain studies are reviewed and discussed. Areas in need of further research are identified, and procedural aspects of acupuncture practice and safety studies are reviewed. Acupuncture can be an effective adjuvant in the care of pediatric patients with painful conditions, both in a chronic and an acute setting. Further studies, including randomized controlled trials, as well as trials of comparative effectiveness are needed.

  11. Clinical Trials in Vision Research

    ... Eye Health Information > Clinical Trials in Vision Research Clinical Trials in Vision Research Listen Clinical studies depend on ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials are ...

  12. Acupuncture on the day of embryo transfer: a randomized controlled trial of 635 patients

    Andersen, Dorota; Løssl, Kristine; Nyboe Andersen, Anders; Fürbringer, Jeanette; Bach, Helle; Simonsen, Jannie; Larsen, Elisabeth C; Andersen, Dorthe; Simonsen, Helle Juhl

    2010-01-01

    This prospective, randomized, controlled and double-blinded trial studied whether acupuncture in relation to embryo transfer could increase the ongoing pregnancy rates and live birth rates in women undergoing assisted reproductive therapy. A total of 635 patients undergoing IVF or intracytoplasmic...... sperm injection (ICSI) were included. In 314 patients, embryo transfer was accompanied by acupuncture according to the principles of traditional Chinese medicine. In the control group, 321 patients received placebo acupuncture using a validated placebo needle. In the acupuncture group and the placebo...... group, the ongoing pregnancy rates were 27% (95% CI 22-32) and 32% (95% CI 27-37), respectively. Live birth rates were 25% (95% CI 20-30) in the acupuncture group and 30% (95% CI 25-30) in the placebo group. The differences were not statistically significant. These results suggest that acupuncture...

  13. Acupuncture and women's health: an overview of the role of acupuncture and its clinical management in women's reproductive health

    Cochrane S

    2014-03-01

    Full Text Available Suzanne Cochrane,1 Caroline A Smith,2 Alphia Possamai-Inesedy,3 Alan Bensoussan2 1School of Science and Health, 2Centre for Complementary Medicine Research, 3School of Social Sciences and Psychology, University of Western Sydney – Campbelltown Campus, Penrith, NSW, Australia Background: Acupuncture and other modalities of Chinese/East Asian medicine have been used to treat women's health for many centuries. Gynecology specialties focus particularly on menstrual and reproductive disorders. Both the adoption of the use of acupuncture outside Asia, and the incorporation of scientific analysis in Asia have challenged biomedical conceptions of what can be achieved with this treatment method. The scale of research activity in relation to acupuncture and women's health has increased over the last 20 years. Objective: This review aims to explore the research evidence in relation to acupuncture use for women's reproductive disorders, focusing on both clinical findings and experimental research on acupuncture's mechanisms of action in relation to women's health. Methods: A narrative literature search was undertaken using searches of electronic databases and manual searches of journals and textbooks. The search included all literature published prior to June 2013. The literature was assessed as to the nature of the study it was reporting and findings synthesized into a commentary. Results: For acupuncture's mechanism of action the search resulted in 114 relevant documents; in relation to clinical reports on the use of acupuncture for women's health 204 documents were found and assessed. Conclusion: There is preliminary data indicating acupuncture may improve menstrual health and coping for women experiencing delays falling pregnant. There is experimental data showing that acupuncture can influence female reproductive functioning, although the actual mechanisms involved are not yet clarified. Further well-conducted clinical research would benefit our

  14. Participating in Clinical Trials

    Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical ... researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies ...

  15. Clinical Experience in Acupuncture Treatment of Allergic Rhinitis

    ZHANG Yan-qiu

    2009-01-01

    Objective:To observe the clinical effects of acupuncture for allergic rhinitis.Methods:The body acupuncture, auricular seed-embedding and microwave irradiation were adopted for treatment of allergic rhinitis due to various causative factors, such as cold and insufficiency of the lung-qi weakening the body resistance, insufficiency of the spleen-qi with lucid yang failing to rise, insufficiency of the kidney-yang failing to warm the body surface, and the heat accumulated in the lung channels giving invading the nose.Results:After treatment, the symptoms and signs disappeared in all illustrative cases, with no recurrence found after a one-year follow-up.Conclusion:Acupuncture may help to improve the blood rheology indexes with an increased volume of blood flow, and regulate the immunological function of the human body, thus giving therapeutic effects for allergic rhinitis.

  16. Acupuncture in acute herpes zoster pain therapy (ACUZoster – design and protocol of a randomised controlled trial

    Pfab Florian

    2009-08-01

    and will provide valuable new information about the clinical and physiological effects of acupuncture and gabapentine in the treatment of acute herpes zoster pain. The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if acupuncture can be shown to be an effective treatment strategy in acute herpes zoster pain. Trial registration NCT00885586

  17. Clinical Trial Results: A Clinical Trial Bazaar!

    Fojo, Antonio Tito; Bates, Susan E.

    2014-01-01

    The Oncologist’s Clinical Trial Results section welcomes both positive and negative results in an effort to share information, speed discovery, and inform the field. Clinical Trial Results submissions have shown how succinctly the salient features of a submission can be presented, with more in-depth information to be found online.

  18. How Do Clinical Trials Work?

    ... Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  19. Acupuncture Treatment of Substance Use Disorders

    Zhu, Dan; Freeman, Sonya; Kong, Jian

    2013-01-01

    The use of acupuncture as a medical treatment over the course of thousands of years has led to the development of a variety of acupuncture administration techniques. Clinical trials testing the efficacy of acupuncture as a treatment for substance use disorder have produced contradictory results. This ambiguity may be, at least in part, the result of the numerous administration methods performed in the many acupuncture schools and protocols that exist today. Animal s...

  20. Participating in Clinical Trials

    Full Text Available ... that could identify a disease in its early stages. Usually, trial participants must show signs of the ... Trials Clinical trials of drugs are usually described based on their phase. The U.S. Food and Drug ...

  1. Towards sustainable clinical trials

    Group, Sustainable Trials Study

    2007-01-01

    Currently, few researchers think about the carbon footprint of their trial. The Sustainable Trials Study Group reports that clinical trials are carbon intensive and suggests ways to make them more efficient

  2. Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: A study protocol for a randomized controlled pilot trial

    Kim Yoon-Bum

    2011-03-01

    Full Text Available Abstract Background In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested. However, despite common use of a combination of herbal medicine and acupuncture in clinical practice, the current level of evidence is insufficient to draw a conclusion for an interaction and efficacy of herbal medicine and acupuncture. Therefore, considering these methodological flaws, this study was designed to assess the interaction and efficacy of an available herbal medicine, Keigai-rengyo-to extract (KRTE, and acupuncture for treatment of acne using the 2 × 2 factorial design and the feasibility of a large clinical trial. Methods/Design A randomized, assessor single blinded, 2 × 2 factorial pilot trial will be conducted. Forty four participants with acne vulgaris will be randomized into one of four groups: waiting list group (WL, KRTE only group (KO, acupuncture only group (AO, and KRTE and acupuncture combined treatment group (KA. After randomization, a total of 8 sessions of acupuncture treatment will be performed twice a week in the AO- and KA groups, respectively. Patients in the KO- and KA groups will be prescribed KRTE 3 times a day at a dose of 7.4 g after meals for 4 weeks. The following outcome measurements will be used in examination of subjects: the mean percentage change and the count change of inflammatory and non-inflammatory acne lesions, the Skindex 29, visual analogue scale (VAS and investigator global assessment (IGA from baseline to the end of the trial. Trial Registration The trial is registered with the Clinical Research Information Service (CRiS, Republic of Korea: KCT0000071.

  3. Research Areas - Clinical Trials

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  4. Research Areas: Clinical Trials

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  5. The Clinical Study on Acupuncture Sensation in CC, CF and BV Herbal Acupuncture -The Basic Study on Placebo Herbal Acupuncture-

    Seo Jung-Chul

    2004-02-01

    Full Text Available Objective : This study was designed to find out whether NS(normal saline is able to be constituted as an appropriate control group for CC(Cervi Cornu Parvum herbal acupuncture, CF(Carthami-Flos herbal acupuncture and BV(bee venom herbal acupuncture. Methods : NS and three herbal acupuncture were inserted into Quchi(LI 11 of the subjects. After 5 minutes the subjects completed a questionnaire rating the intensity of 21 kinds of acupuncture sensation; hurting, penetrating, sharp, aching, intense, spreading, radiating, tingling, pricking, stinging, pulling, heavy, dull, numb, electric, shocking, hot, burning, cool, pulsing, and throbbing. We compared subjective evaluations of acupuncture sensation between or among the groups. Results : As for CC half items of the acupuncture sensation were significantly different from NS. As for CF all items were not significantly different from NS. As for CC all items were significantly different from NS except one item. In general the score of CF acupuncture sensation was lower than the others and the score of BV acupuncture sensation was higher than the others from comparison of sensation among herbal acupunctures(CC, CF, BV. Conclusion : We found that NS is able to be an appropriate placebo herbal acupuncture for CF. Further study is needed for new placebo herbal acupuncture for CC and BV.

  6. Participating in Clinical Trials

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is ...

  7. Participating in Clinical Trials

    Full Text Available ... topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ...

  8. Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial

    Shi Guang-Xia

    2012-11-01

    Full Text Available Abstract Background Tinnitus is the perception of a sound in the absence of an objective physical source. Up to now, there is no generally accepted view how these phantom sounds come about, and also no efficient treatment. Patients are turning to complementary or alternative medical therapies, such as acupuncture. Based on the theory of traditional Chinese medicine, acupoints located on both the adjacent and distal area of the disease can be needled to treat disease. Furthermore, the way of combining acupoints is for strengthening the curative effect. We aim to evaluate the efficacy of acupuncture at local points in combination with distal points in subjective tinnitus patients. Method This trial is a randomized, single-blind, controlled study. A total of 112 participants will be randomly assigned to one of four treatment groups receiving acupuncture treatment for 4 weeks. The primary outcome measure is subjective tinnitus loudness and annoyance perception, which is graded using the Visual Analogue Scale (VAS. The assessment is at baseline (before treatment initiation, 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion Completion of this trial will help to identify whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN29230777

  9. Clinical research on abdominal acupuncture plus conventional acupuncture for knee osteoarthritis

    Meng, Chang-rong; Fan, Li; Fu, Wen-bin;

    2009-01-01

    OBJECTIVE: To probe the therapeutic effect of abdominal acupuncture plus conventional acupuncture on knee osteoarthritis. METHODS: PEMS3.1 software was used. The 105 patients with knee osteoarthritis were randomly divided into an abdominal acupuncture group, a conventional acupuncture group and a...... combined group (abdominal acupuncture plus conventional acupuncture). For the abdominal acupuncture group, the abdominal acupuncture was performed at Zhongwan (CV 12), Guanyuan (CV 4), Wailing (ST 26), Daheng (SP 15), Lower Rheumatism point and Qipang with needles retained for 30 minutes. For the....... Lysholm knee scoring scale was used to score the functions of knee before and after treatment. RESULTS: Of 35 cases in the abdominal acupuncture group, 8 cases were remarkably relieved, 10 cases relieved, 14 cases improved, and 3 cases failed, the total effective rate was 91.4%. Of 35 cases in the...

  10. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain.

    Claudia M Witt

    Full Text Available BACKGROUND: For Comparative Effectiveness Research (CER there is a need to develop scales for appraisal of available clinical research. Aims were to 1 test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2 evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making. METHODS: We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters. PRINCIPAL FINDINGS: From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60, which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness. CONCLUSION: Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

  11. Acupuncture for the treatment of urinary incontinence: A review of randomized controlled trials

    PAIK, SUN-HO; HAN, SU-RYUN; Kwon, Oh-Jun; AHN, YOUNG-MIN; Lee, Byung-Cheol; AHN, SE-YOUNG

    2013-01-01

    The aim of this study was to examine the effects of acupuncture on urinary incontinence and to discuss why these acupoints were selected. Seven databases were searched for any randomized controlled trials (RCTs) that investigated the use of acupuncture or acupressure as a treatment for urinary incontinence, and the Cochrane risk of bias tool was utilized to evaluate the risk of bias in each study. Four RCTs met all the inclusion criteria. The results from the selected RCTs failed to demonstra...

  12. Acupuncture in the Inpatient Acute Care Setting: A Pragmatic, Randomized Control Trial

    Jeannette Painovich; Herman, Patricia M.

    2012-01-01

    Purpose. To evaluate the acceptance and effectiveness of acupuncture in a hospital setting. Methods. This 18-month pragmatic randomized controlled trial used a two-tiered consent process for all patients admitted to the acute care unit by study physician groups. The primary study comparison was between those randomized (using biased-coin randomization after initial consent) to be offered acupuncture or not. The primary outcome was length of stay (LOS). Other measures include costs, self-repor...

  13. Is sham acupuncture as effective as traditional Chinese acupuncture? It's too early to say.

    Zhang, Li-Li; Chu, Qin; Wang, Shu; Lai, Hilary; Xie, Bing-Bing

    2016-07-01

    Many clinical trials and experimental studies claim that sham acupuncture is as effective as traditional Chinese acupuncture. However, these studies have no standard sham acupuncture control and many other factors can affect the clinical effect. These factors include needle retention time, treatment frequency, and the total number of treatments needed for satisfactory results, and all can change the clinical effect. The majority of existing acupuncture treatment studies do not consider these factors and lack standard dosage criteria. Therefore, it is still too early to conclude that sham acupuncture is as effective as traditional Chinese acupuncture. This article investigates the factors that influence the curative effect of acupuncture as to help set a standard for acupuncture studies in the future. PMID:27081001

  14. Nuclear medicine methods in the assessment of acupuncture effects: a short review

    The mechanisms of acupuncture are poorly understood. In consequence, numerous investigators have conducted clinical trials to test the efficacy of acupuncture in various conditions. We have used PubMed database system to evaluate the number of publications in acupuncture and nuclear medicine procedures in the period from 1964 to 2007, using the keywords: 'nuclear medicine and acupuncture', 'SPECT and acupuncture, 'PET and acupuncture', 'scintigraphy and acupuncture, 'radionuclide and acupuncture', 'radiopharmaceutical and acupuncture', 'radioisotope and acupuncture' and 99mTc and acupuncture'. Some papers published in English language were selected and a short review is presented The analysis of the number of publications shows that when a method is well accepted by the scientific community, as the methods used in nuclear medicine, the interest in the development of research increases. Moreover, important findings are presented when the nuclear medicine image is used to evaluate the effect of the acupuncture. (author)

  15. Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial.

    Foster, Nadine E; Bishop, Annette; Bartlam, Bernadette; Ogollah, Reuben; Barlas, Panos; Holden, Melanie; Ismail, Khaled; Jowett, Sue; Kettle, Christine; Kigozi, Jesse; Lewis, Martyn; Lloyd, Alison; Waterfield, Jackie; Young, Julie

    2016-01-01

    BACKGROUND Many pregnant women experience low back pain. Acupuncture appears to be a safe, promising intervention but evidence is needed about its clinical effectiveness and cost-effectiveness. OBJECTIVES To assess the feasibility of a future large randomised controlled trial (RCT) testing the additional benefit of adding acupuncture to standard care (SC) for pregnancy-related back pain. DESIGN Phase 1: a questionnaire survey described current care for pregnancy-related back pain. Focus groups and interviews with midwives, physiotherapists and pregnant women explored acceptability and feasibility of acupuncture and the proposed RCT. Phase 2: a single-centre pilot RCT. Participants were identified using six methods and randomised to SC, SC plus true acupuncture or SC plus non-penetrating acupuncture. PARTICIPANTS Phase 1: 1093 physiotherapists were surveyed and 15 midwives, 21 physiotherapists and 17 pregnant women participated in five focus groups and 20 individual interviews. Phase 2: 125 women with pregnancy-related back pain participated. INTERVENTIONS SC: a self-management booklet and onward referral for one-to-one physiotherapy (two to four sessions) for those who needed it. SC plus true acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising true (penetrating) acupuncture, advice and exercise. SC plus non-penetrating acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising non-penetrating acupuncture, advice and exercise. MAIN OUTCOME MEASURES Pilot RCT outcomes included recruitment rates, treatment fidelity, follow-up rate, patient-reported pain and function, quality of life and health-care resource use. Birth and neonatal outcomes were also assessed. Staff overseeing outcome data collection were blind to treatment allocation. RESULTS Phase 1: 629 (57.5%) physiotherapists responded to the survey, 499 were experienced in treating pregnancy-related back pain and

  16. Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials*

    Wu, Yan; Robinson, Nicola; Hardiman, Paul J.; Taw, Malcolm B.; Zhou, Jue; Wang, Fang-Fang; Qu, Fan

    2016-01-01

    Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and...

  17. CLINICAL OBSERVATION ON 36 CASES OF SCAPULOHUMERAL PERIARTHRITIS TREATED BY ABDOMINAL ACUPUNCTURE AND BODY-ACUPUNCTURE

    睢明河

    2001-01-01

    Objective: To compare the therapeutic effect of abdominal acupuncture plus body acupuncture and simple body acupuncture in treatment of scapulohumeral periarthritis. Methods: 68 cases of scapulohumeral periarthritis patients were randomly divided into abdominal acupuncture plus body acupuncture (AABA) group (n= 36) and simple body acupuncture (BA) group (n=32). In AABA group, abdominal acupuncture points used were Zhongwan(CV 12), Shangqu (KI 17) (on the healthy side) and Huaroumen-sanjiao (on the affected side); and body acupoints employed were Jianyu (LI 15), Jianliao(TE 14), Binao (LI 14), Quchi (LI 11), Waiguan (TE 5) and Hegu (LI 4) on the affected side. In BA group, the body acupoints used were the same to those mentioned above. The acupuncture needles were retained for 20 min. Acupuncture treatment was given once daily, with 10 sessions being a therapeutic course and the interval between two courses being one week. 2 courses of treatment were conducted altogether. Results: Following 2 courses of treatment, in AABA and BA groups, 6 (16.7%) and 1 (3.1%) cases were cured, 19 (52.8%) and 12 (37.5%) had remarkable improvement, 11 (30.6%) and 17 (53.1%) had improvement, 0 and 2 (6.25%) had no effect respectively. There was a significant difference between two groups in the therapeutic effect (P<0.05) .Conclusion: The therapeutic effect of abdominal acupuncture plus body acupuncture is superior to that of simple body acupuncture in treatment of scapulohumeral periarthritis.

  18. Compliance in clinical trials.

    Pullar, T; Kumar, S; Feely, M

    1989-01-01

    Compliance with treatment can be an important determinant of the outcome of clinical trials. To date there is no completely satisfactory method of measuring compliance and some of the most widely used methods are inadequate. The various methods of measuring compliance and how they have been applied to clinical trials are described, and improvements in the standard of the measurement and reporting of compliance in clinical trials are suggested.

  19. Minimal acupuncture is not a valid placebo control in randomised controlled trials of acupuncture: a physiologist's perspective

    Lundeberg Thomas; Näslund Jan; Lund Iréne

    2009-01-01

    Abstract Placebo-control of acupuncture is used to evaluate and distinguish between the specific effects and the non-specific ones. During 'true' acupuncture treatment in general, the needles are inserted into acupoints and stimulated until deqi is evoked. In contrast, during placebo acupuncture, the needles are inserted into non-acupoints and/or superficially (so-called minimal acupuncture). A sham acupuncture needle with a blunt tip may be used in placebo acupuncture. Both minimal acupunctu...

  20. Clinical Research on Abdominal Acupuncture plus Conventional Acupuncture for Knee Osteoarthritis

    MENG Chang-rong; FAN Li; FU Wen-bin; LI Yong; DUAN Shu-min

    2009-01-01

    Objective: To probe the therapeutic effect of abdominal acupuncture plus conventional acupuncture on knee osteoarthritis. Methods: PEMS3.1 software was used. The 105 patients with knee osteoarthritis were randomly divided into an abdominal acupuncture group, a conventional acupuncture group and a combined group (abdominal acupuncture plus conventional acupuncture). For the abdominal acupuncture group, the abdominal acupuncture was performed at Zhongwan (CV 12), Guanyuan (CV 4), Wailing (ST 26), Daheng (SP 15), Lower Rheumatism point and Qipang with needles retained for 30 minutes. For the conventional acupuncture group, the acupuncture was practiced at Neixiyan (EX-LE4) and Dubi (ST 35) of the affected limb, Yanglingquan (GB 34), Liangqiu (ST 34), Xuehai (SP 10) and Xiyangguan (GB 33). For the combined group, both methods were applied. Treatment was given once a day, 6 times a week, for 4 weeks. Lysholm knee scoring scale was used to score the functions of knee before and after treatment. Results: Of 35 cases in the abdominal acupuncture group, 8 cases were remarkably relieved, 10 cases relieved, 14 cases improved, and 3 cases failed, the total effective rate was 91.4%. Of 35 cases in the conventional acupuncture group, 7 cases were remarkably relieved, 8 cases relieved, 16 cases improved, and 4 cases failed, the total effective rate was 88.6%. Of 35 cases in the combined group, 13 cases were remarkably relieved, 16 cases relieved, 5 cases improved, and 1 cases failed, the total effective rate was 97.1%. There was a remarkable difference in the effect among 3 groups (P<0.05). The difference in scores of Lysholm knee scoring scale for knee joint after treatment among 3 groups was very significant (P<0.01). Conclusion: Abdominal acupuncture has reliable effect for knee osteoarthritis and it has the synergized function when combined with conventional acupuncture.

  1. Clinical Research on Acupuncture Treatment of Diabetic Peripheral Neuropathy

    QIAN Wei-hua; QIAN Hong; WU Tong; BEI Yan-hui; LI Lan; QING Liang-cai

    2004-01-01

    目的:探讨针刺治疗糖尿病周围神经病变的相关机理.方法:运用针刺疗法治疗糖尿病周围神经病变,并与口服钙离子拮抗剂加维生素疗法进行随机对照观察,同时作肌电图检测分析.结果:针刺治疗糖尿病周围神经病变可不同程度地改善病人的肢体麻木、疼痛和感觉异常等临床症状,肌电图结果提示神经运动传导速度和感觉传导速度也有明显改善.结论:针刺治疗糖尿病周围神经病变的临床疗效明显优于口服钙离子拮抗剂加维生素治疗.%Purpose: To investigate the mechanism of acupuncture treatment of diabetic peripheral neuropathy. Methods: Acupuncture therapy was used to treat diabetic peripheral neuropathy, and compared with oral calcium antagonist and vitamin therapy by random control observation.Electromyography was performed for analysis at the same time. Results: Acupuncture treatment alleviated symptoms such as extremity numbness, pain and paresthesia in varying degrees in diabetic patients with peripheral neuropathy. The results of electromyography showed a marked improvement in motor and sensory conduction velocities. Conclusion: It is indicated that acupuncture therapy is markedly superior to oral calcium antagonist and vitamin therapy in clinical effect on diabetic peripheral neuropathy, and electromyographic recovery.

  2. Clinical Study on the Visceral Differentiation-Based Acupuncture Therapy for Insomnia

    LING Li; JIANG Xin-mei; XUE Jin-wei; WANG Miao; KE Rui

    2008-01-01

    objective;To investigate the clinical effects of acupuncture for insomnia on the basis of visceral differentiation.Methods;Seventy cases of insomnia were randomly divided into a treatment group and a control group,The former was treated by acupuncture based on visceral differentiation and the latter by the routine acupuncture therapy.Results;The clinical effcts were significantly better in the treatment group than that of the control group(P<0.05).Conclusion;The visceral difrerentiation-based acupuncture therapy may enhance the therapeutic effects for insomnia patients.

  3. Participating in Clinical Trials

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ...

  4. Participating in Clinical Trials

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... years of experiments in the laboratory and in animals before they even ... this early research occurs at universities and medical centers across the ...

  5. CLINICAL TRIALS.GOV

    ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...

  6. Acupuncture is a feasible treatment for post-thoracotomy pain: results of a prospective pilot trial

    Malhotra Vivek T

    2006-05-01

    Full Text Available Abstract Background Thoracotomy is associated with severe pain that may persist for years. Acupuncture is a complementary therapy with a proven role in pain control. A randomized trial showed that acupuncture was effective in controlling pain after abdominal surgery, but the efficacy of this technique for the treatment of thoracotomy pain has not been established. We developed a novel technique for convenient application of acupuncture to patients undergoing thoracotomy, and in a Phase II trial evaluated the safety of this intervention and the feasibility of doing a randomized trial. Methods Adult patients scheduled for unilateral thoracotomy with preoperative epidural catheter placement received acupuncture immediately prior to surgery. Eighteen semi-permanent intradermal needles were inserted on either side of the spine, and four were inserted in the legs and auricles. Needles were removed after four weeks. Using a numerical rating scale, pain was measured on the first five postoperative days. After discharge, pain was assessed using the Brief Pain Inventory at 7, 30, 60 and 90 days. Results Thirty-six patients were treated with acupuncture. Of these, 25, 23, and 22 patients provided data at 30, 60, and 90 days, respectively. The intervention was well tolerated by patients with only one minor and transient adverse event of skin ulceration. Conclusion The rate of data completion met our predefined criterion for determining a randomized trial to be feasible (at least 75% of patients tolerated the intervention and provided evaluable data. This novel intervention is acceptable to patients undergoing thoracotomy and does not interfere with standard preoperative care. There was no evidence of important adverse events. We are now testing the hypothesis that acupuncture significantly adds to standard perioperative pain management in a randomized trial.

  7. The Effects of Positive or Neutral Communication during Acupuncture for Relaxing Effects: A Sham-Controlled Randomized Trial

    Annelie Rosén

    2016-01-01

    Full Text Available Introduction. The link between patient-clinician communication and its effect on clinical outcomes is an important clinical issue that is yet to be elucidated. Objective. Investigating if communication type (positive or neutral about the expected treatment outcome affected (i participants’ expectations and (ii short-term relaxation effects in response to genuine or sham acupuncture and investigating if expectations were related to outcome. Methods. Healthy volunteers (n=243, mean age of 42 were randomized to one treatment with genuine or sham acupuncture. Within groups, participants were randomized to positive or neutral communication, regarding expected treatment effects. Visual Analogue Scales (0–100 millimeters were used to measure treatment expectations and relaxation, directly before and after treatment. Results. Participants in the positive communication group reported higher treatment expectancy, compared to the neutral communication group (md 12 versus 6 mm, p=0.002. There was no difference in relaxation effects between acupuncture groups or between communication groups. Participants with high baseline expectancy perceived greater improvement in relaxation, compared to participants with low baseline levels (md 27 versus 15 mm, p=0.022. Conclusion. Our data highlights the importance of expectations for treatment outcome and demonstrates that expectations can be effectively manipulated using a standardized protocol that in future research may be implemented in clinical trials.

  8. Clinical Research on Acupuncture and Moxibustion Treatment of Chronic Atrophic Gastritis

    Gao Xiyan; Yuan Jing; Li Huijuan; Ren Shan

    2007-01-01

    Objective: To observe the clinical therapeutic effects of acupuncture and moxibustion in treating chronic atrophic gastritis. Methods: Patients who met the criteria were randomly divided into the treatment groups consisting of the acupuncture group (30 cases) and the acupuncture-moxibustion group (30 cases), and the control group (28 cases). After two months of treatment, observed were safety and the curative effects,through general physical check ups, routine examinations of blood, urine and feces, and symptoms,pathology and gastrin before, during and after the treatment. Results: 1) The treatment groups showed significant superiorities in the improvement of symptoms, with the acupuncture-moxibustion group showing the best therapeutic effects. 2) The acupuncture-moxibustion group showed marked differences before and after the treatment in the improvement of glandular atrophy and intestinal metaplasia, with a total effective rate of 66.67%. 3) After the treatment, the three groups all showed marked improvement in the level of serum gastrin, with the acupuncture-moxibustion group showing the best effects. Conclusion: Acupuncture and moxibustion have definite therapeutic effects for chronic atrophic gastritis, especially in improving the symptoms. Acupuncture or acupuncture combined with moxibustion can provide possibilities in reversing the pathologic changes of glandular atrophy and intestinal metaplasia for patients with chronic atrophic gastritis. Acupuncture-moxibustion is really an effective and safe therapy for chronic atrophic gastritis.

  9. Acupuncture

    Chao Ming Te

    1972-01-01

    M.Bloess présente le Docteur Chao Ming Te, un des plus grands experts en médecine chinoise (acupuncture). Il a commencé ses études en Chine en médecine occidentale. Après avoir vu des très grands effets par les aiguilles, il s'est intéressé à cette médecine qui est pour nous difficile à comprendre. Il est allé à la source et a appris cette médecin en Chine et a lu les anciens textes, qui sont la base de la médecine chinoise et datent de 1000 ans avant J.C. Il a essayé de transmettre ses connaissances en médecine chinoise aux médecins occidentales et a aussi écrit un livre.

  10. AIDS Clinical Trials Group Network

    ... Center Statistical and Data Management Center Glossaries Sites Clinical Trials About the Trial Process Trials Open to Enrollment Recent Study Results Access to Published Data Clinical Trials Resources Committees Executive Scientific Resource Community General Information ...

  11. Clinical Observation of Vascular Dementia Treated by Surrounding-acupuncture of the CT-located Area

    LUN Xin; FENG Bi-fang; RONG Li; YANG Wen-hui

    2003-01-01

    Purpose To observe the clinical effect of "Surrounding Needling Technigue through CT Location" in treating vascular dementia. Method Fifty cases of vascular dementia were randomly divided into surrounding Needling Technigue through CT location and routine acupuncture groups, 25 cases in each group,and were given surrounding Needling Technigue through CT location and routine acupuncture respectively. Results The effective rates in surrounding Needling Technigue through CT location and routine acupuncture groups were 88% and 60% respectively, and there was significant difference between the two groups, P < 0.01.Conclusion Therapeutic effect of surrounding Needling Technigue through CT location in treating vascular dementia was satisfactory, and better than that of routine acupuncture.

  12. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial

    Seo Byung-Kwan

    2013-01-01

    Full Text Available Abstract Background Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain. Methods/design This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck’s Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks. Discussion The results from this study

  13. Fundamentals of clinical trials

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  14. Ear Acupuncture versus  local anaestethic for pain relief during perineal repair - a randomised controlled trial

    Kindberg, Sara

    2007-01-01

    ACUPUNCTURE OR LOCAL ANAESTETICS FOR PAIN RELIEF DURING PERINEAL REPAIR AFTER VAGINAL DELIVERY: A RANDOMISED CONTROLLED TRIAL.   By:  Sara Kindberg. Midwife and PhD student, Sønderborg Hospital, Denmark. Objective: To evaluate acupuncture as a new method of pain relief for postpartum perineal...

  15. Acupuncture for Functional Dyspepsia: A Single Blinded, Randomized, Controlled Trial

    Yulian Jin

    2015-01-01

    Full Text Available In order to investigate the therapeutic potential of acupuncture on patients with functional dyspepsia (FD, patients were randomized to receive acupuncture at classic acupoints with manipulations (treatment group versus acupuncture at nonacupoints without manipulation (control group once every other day, three times a week, for one month and were followed up for three months. The primary outcomes included dyspeptic symptoms, quality of life, and mental status. The secondary outcomes included the fasting serum gastrin concentration, and frequency and propagation velocity of gastric slow waves. Sixty patients with FD were included, among whom, four dropped out. After one month's treatment, patients with FD showed significant improvements in primary (in both groups and secondary (in the eight patients of the treatment group outcomes as compared with baseline (P=0.0078 to <0.0001; treatment group has better outcomes in all primary outcome measures (P<0.0001 except for SDS (P=0.0005. Improvements on dyspeptic symptoms persist during follow-up (better in the treatment group. Acupuncture with manual manipulation had better effects on improving dyspeptic symptoms, mental status, and quality of life in patients with FD. These effects may be related to the increased frequency and propagation speed of gastric slow waves and serum gastrin secretion.

  16. Participating in Clinical Trials

    Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  17. Clinical Trial Basics

    ... Human Services Search the NIH Website NIH Employee Intranet Staff Directory En Español Site Menu Home Health ... am thinking about participating? Xsandra/iStock Risks and benefits Clinical trials involve risks, just as routine medical ...

  18. Participating in Clinical Trials

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials ...

  19. ClinicalTrials.gov

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  20. Participating in Clinical Trials

    Full Text Available ... Learn More Participating in Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in ...

  1. Participating in Clinical Trials

    Full Text Available ... Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in this topic was provided by the National ...

  2. Clinical Analysis of Acupuncture Combined with Tuina in Treating Cervical Vertigo

    Wang Zheng-xin; Chen Guang-hui; Zhang Jin-yi; Shi Xiao-cheng; Wu Li-chun; Feng Zhi-wei; Wang Kang; Ding Hui-chun

    2014-01-01

    Objective: To investigate the clinical efficacy of acupuncture combined with tuina in treating patients with cervical vertigo. Methods: According to the principle of randomization, 258 cases with cervical vertigo who met the inclusion criteria for the study were randomly divided into an observation group and a control group, with 129 cases in each. The patients in the observation group received acupuncture combined with tuina therapy, while those in the control group were just treated by the same acupuncture therapy as in the observation group. After 10-day continuous treatments, the clinical efficacies of the two groups were analyzed and compared. Results: The total effective rate of the observation group was 100%, versus 86.0% of the control group, and the difference was significant (P Conclusion: Compared with simple acupuncture treatment, acupuncture combined with tuina therapy has a better effect in improving the ROM of cervical vertigo patients, with higher clinical efficacy.

  3. Stellate Ganglion Block and Acupuncture for Idiopathic Facial Paralysis:A Clinical Controlled Trial%星状神经节阻滞联合针刺治疗特发性面神经麻痹临床观察

    崔超伟; 李春霞; 唐修明; 胡桑桑; 刘琦

    2012-01-01

    目的:观察星状神经节阻滞联合针刺治疗对特发性面神经麻痹的临床疗效.方法:将62例特发性面神经麻痹患者分为两组,对照组30例采用药物治疗+针灸理疗等常规治疗,治疗组32例采用常规治疗+星状神经节阻滞(SGB)疗法,疗程30天.采用House-Brackmann面神经功能分级评定及临床疗效指标判定.结果:治疗前两组H-B面神经功能分级具有可比性.治疗后,两组H-B评分比较差异有统计学意义(P<0.05);临床疗效指标比较显示两组总有效率分别为:治疗组96.9%,对照组80.00%,治疗组优于对照组,两组差异有统计学意义(P<0.05).结论:星状神经节阻滞联合针刺治疗对急性特发性面神经麻痹有效.%Objective: To evaluate the effect of stellate ganglion block and acupuncture on Idiopathic facial palsy. Methods: A total of 62 cases of idiopathic facial paralysis were randomly divided into the treatment group (32 cases), and the control group (30 cases). The basis of the two groups included medications and acupuncture therapy, as a routing therapy. The treatment group was treated by routing therapy and Stellate ganglion block.House-Brackmann facial nerve function classification and evaluation were used to determine clinical efficacy. Results: Before treatment H-B classification of facial nerve function in the two groups were comparable. At 30 days after treatment, H-B scores for the treatment group and the control group had significant differences (P<0.05); Comparison of efficacy of the two groups showed the total effective rate: 96.9% in the treatment group, 80.0% in the control group, and the efficacy of the treatment group was better than that of the control group (P<0.05). Conclusion: Stellate ganglion block and acupuncture for Idiopathic Facial Paralysis has significant effect.

  4. CLINICAL RESEARCH ON ACUPUNCTURE TREATMENT OF APHASIS IN AUTISM CHILDREN

    ZHANG Quan-ming; JIN Rui

    2005-01-01

    Objective: To observe the therapeutic effect of acupuncture therapy for aphasis in autism children. Methods: Thirty cases of autism children were divided into acupuncture group (n=20) and medication group (n=10). Intelligence quotient(IQ) and Social adaptive developmental quotient(ADQ) were used to assess the therapeutic effect. Results: After treatment, IQ values increased slightly in medication group and considerably in acupuncture group (P<0.001), and the difference between pre-treatment and post-treatment of acupuncture group was significantly bigger than that of control group (P<0.01). ADQ of two groups increased at different degrees, and that of acupuncture and the difference between post- and pre-treatment of acupuncture group were significantly bigger than those of control group (P<0.001). Conclusion: Acupuncture treatment is effective in improving autism children's speaking ability. raising IQ and ADQ.

  5. Dr. GUAN Zun-hui's Clinical Experience in Treating Simple Obesity by Acupuncture

    XIA Bo; XIAO Yuan-chun

    2003-01-01

    Objective The clinical effects of acupuncture and massaging abdomen with salt the treatment of simple obesity was observed. Methods: Eighty cases were randomized into two groups: treatment group in which 40 cases were treated by acupuncture and massaging abdomen with salt and control group in which another 40 cases were treated by conventional acupuncture. Their effects were observed and compared. Results: The clinical cure rate and marked effective rate in treatment group were significantly higher than in control group (P<0.01). Conclusion: The clinical effects in the treatment group are much better than those in the control group.

  6. The Role of Acupuncture in Assisted Reproductive Technology

    Cui Hong Zheng

    2012-01-01

    Full Text Available The aim of this paper was to provide reliable evidence by performing a systematic review and meta-analysis for evaluating the role of acupuncture in assisted reproductive technology. All randomized controlled trials that evaluated the effects of acupuncture, including manual, electrical, and laser acupuncture (LA techniques, on the clinical pregnancy rate (CPR and live birth rate (LBR of in vitro fertilization (IVF or artificial insemination were included. The controlled groups consisted of no acupuncture and sham acupuncture groups. The sham acupuncture included sham acupuncture at acupoints, sham acupuncture at non- or inappropriate points, sham LA, and adhesive tapes. Twenty-three trials (a total of 5598 participants were included in this paper. The pooled CPR from all acupuncture groups was significantly higher than that from all controlled groups, whereas the LBR was not significantly different between the two groups. However, the results were quite distinct when the type of control and/or different acupuncture times were examined in a sensitivity analysis. The results mainly indicate that acupuncture, especially around the time of the controlled ovarian hyperstimulation, improves pregnancy outcomes in women undergoing IVF. More positive effects from acupuncture in IVF can be expected if a more individualized acupuncture programs are used.

  7. ADVANCES IN CLINICAL AND EXPERIMENTAL STUDIES ON ACUPUNCTURE TREATMENT OF ACUTE CEREBRAL HEMORRHAGE

    DING Jing; SHI Xue-min

    2005-01-01

    In the present paper, the authors review recent advances in clinical and experimental studies on acupuncture treatment of cerebral hemorrhage(CH). Regarding clinical studies, the resuscitation-inducing needling maneuver, and main points of Shuigou(水沟GV 26),Baihui(百会 GV 20) and scalp-points Motor Area(MS 6), Sensory Area(MS 7), etc. are often involved. Concerning experimental studies, the underlying mechanisms of acupuncture of GV-26+"Neiguan"(内关 PC 6), GV-20,GV-26+GV-20, etc. in improving acute CH are introduced. In a word, acupuncture therapy works well in improving clinical symptoms and signs of CH patients, and acupuncture stimulation induced ameilioration of cerebral blood flow, favorable modulation of some bioactive substances as excitatory and inhibitory amino acids, endothelin, CGRP, heat shock protein 70, etc. and neuro-endocrine-immune network may contribute to the effect of acupuncture on CH. In addition, acupuncture combined with medicine and earlier application of acupuncture therapy in the acute stage of CH are recommended in clinical practice.

  8. Adverse effects of acupuncture. Which are clinically significant?

    2003-01-01

    OBJECTIVE: To review potentially serious adverse events associated with acupuncture. QUALITY OF EVIDENCE: Studies in the medical literature primarily provide level II evidence from retrospective reviews, case reports, and prospective surveys of practitioners. MAIN MESSAGE: Both the general public and physicians are becoming more interested in the ancient Chinese medical practice of acupuncture. This paper discusses the basic philosophy of acupuncture and describes adverse events that might be...

  9. Clinical Observation of Infantile Cerebral Palsy Mainly Treated by Scalp Acupuncture

    REN Yi-zhong; CHEN Rui-hua; LIAO Rong-gui; XIAO Yuan-chun

    2003-01-01

    Purpose: The clinical effects of scalp acupuncture in treating infantile cerebral palsy were observed. Methods: Forty-five patients were treated by scalp acupuncture, functional exercise, intravenous drip,and parents' instructive training. Results: Basic recovery occurred in 4 cases, marked effectiveness in 21 cases and effectiveness in 15 cases. The total effective rate was 88.9%. The shorter duration and the longer course were,the better curative effects got. Conclusion: A combined treatment of scalp acupuncture, physiotherapy and intravenous drip can markedly improve clinical symptoms, signs, and intelligence in children with cerebral palsy.

  10. Efficacy of Acupuncture for Bell's Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Pingping Li

    Full Text Available Acupuncture has emerged as an alternative therapy for Bell's palsy in both adults and children. However, the use of acupuncture is controversial. We conducted a systematic review and meta-analysis to assess the efficacy of acupuncture for Bell's palsy. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials, irrespective of any language restrictions. Randomized controlled trials comparing acupuncture with other therapies for Bell's palsy in adults or children were included. Fourteen randomized controlled trials involving 1541 individuals were included in this meta-analysis. Significant association was observed in acupuncture with a higher effective response rate for Bell's palsy (relative risk, 1.14; 95% confidence interval, 1.04-1.25; P = 0.005 but there was a heterogeneity among the studies (I2 = 87%. An assessment of the included studies revealed a high risk of bias in methodological quality. An evaluation of the incidence of complications was not available, owing to incomplete data. Acupuncture seems to be an effective therapy for Bell's palsy, but there was insufficient evidence to support the efficacy and safety of acupuncture. However, the results should be interpreted cautiously, because of the poor quality and heterogeneity of the included studies.

  11. Participating in Clinical Trials

    Full Text Available ... to find out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or ... universities and medical centers across the country. The National Institutes of ...

  12. Hepatitis C: Clinical Trials

    ... Reports Clinician Tools Clinician Tools Home Guidelines and Best Practices Topic Reviews Algorithms, Screens, Toolkits Provider Education Provider ... about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone ... Forms State and Local Resources Strat Plan FY 2014-2020 VA Plans, Budget, & ...

  13. OARSI Clinical Trials Recommendations

    Kraus, V B; Blanco, F J; Englund, M;

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from b...

  14. Clinical Observation of Adiponectin in Inhibiting Fatty Toxicity by Acupuncture

    徐斌; 袁锦虹; 刘志诚; 吕雅妮; 王欣君; 陈梅; 姜军作

    2006-01-01

    Objective:To investigate if acupuncture has an inhibitory effect on fatty toxicity and its possible mechanism. Methods: Thirty-four patients with simple obesity were clinically treated with acupuncture for 3 courses. Before and after treatment, body mass index(BMI) and fat percentage(F%) were determined, and serum insulin and adiponectin were measured by enzyme linked immunoassay, blood lipid and sugar by biochemical colorimetry and eight kinds of free fatty acids(FFAs) by high performance liquid chromatography. Twenty normal persons were selected as a control. Results:The total efficacy rate was 88.2%. Acupuncture could increase the decreased insulin sensitivity index(ISI) in the patients(t=-5.103, P=0.000). The correlation of a decrease in F% with an increase in unsaturated fatty acid after acupuncture was of significance(r=0.402, P=0.019) and its correlation with an increase in the ratio between unsaturated fatty acid and saturated fatty acid was also of significance(r=0.348, P=0.044). The correlation between increases in high density lipoprotein and in eicosapentaenoic acid was of significance(r=0.352, P=0.041). The correlation between a decrease in BMI and an increase in high density lipoprotein was of significance(r=0.357, P=0.038). Adiponectin level significantly rose after acupuncture (compared with pre-treatment, P=0.000). The correlation between a decrease in FFAs and an increase in adiponectin was of significance(r=-0.349, P=0.043). Conclusion: Acupuncture can lower the levels of free fatty acids in the patients and increase their sensitivity to insulin to inhibit the fatty toxicity. The inhibitory effect of acupuncture on fatty toxicity is somewhat related to a rise in adiponectin level.%目的:探讨针刺是否具有抑制脂毒性的作用,及其可能机制.方法:临床针刺治疗34例单纯性肥胖病患者3个疗程,治疗前后测量体重指数(BMI)、脂肪百分率(F%),酶联免疫法测定血清胰岛素、脂联素,生化比色法测

  15. Acupuncture

    2010-01-01

    2010390 Clinical observation on acupoint injection therapy for chronic gastritis of gastric blood stasis type.ZHANG Yunbo(张云波), et al.Dept Gastroen-terol, Liuzhou Municipal TCM Hosp, Liuzhou 545001.Chin Acupunct &Moxibust 2010;30(10):810-812. Objective To objectively evaluate

  16. A Systematic Review of Experimental and Clinical Acupuncture in Chemotherapy-Induced Peripheral Neuropathy

    Giovanna Franconi

    2013-01-01

    Full Text Available Chemotherapy-induced peripheral neuropathy (CIPN is a common side effect that can be very disabling and can limit or delay the dose of chemotherapy that can be administered. Acupuncture may be effective for treating peripheral neuropathy. The aim of this study was to review the available literature on the use of acupuncture for CIPN. The systematic literature search was performed using MEDLINE, Google Scholar, Cochrane Database, CINHAL, and ISI Proceedings. Hand searching was conducted, and consensus was reached on all extracted data. Only papers in the English language were included, irrespective of study design. From 3989 retrieved papers, 8 relevant papers were identified. One was an experimental study which showed that electroacupuncture suppressed CIPN pain in rats. In addition, there were 7 very heterogeneous clinical studies, 1 controlled randomised study using auricular acupuncture, 2 randomized controlled studies using somatic acupuncture, and 3 case series/case reports which suggested a positive effect of acupuncture in CIPN. Conclusions. Only one controlled randomised study demonstrated that acupuncture may be beneficial for CIPN. All the clinical studies reviewed had important methodological limitations. Further studies with robust methodology are needed to demonstrate the role of acupuncture for treating CIPN resulting from cancer treatment.

  17. Clinical Study on Treatment of Depression with Combined Acupuncture & Medicine

    XU Hong; WANG Qiao-chu; HAN Chou-ping

    2003-01-01

    Purpose To observe and compare the curative effects of combined acupuncture and medicine with simple herbal medicine on treatment of depression. Method Altogether 63 cases were enrolled according to the determination of internationally accepted self-evaluation depression scales (SDS), among them 33 cases were treated with combination of acupuncture and herbal medicine (acupuncture-medicine group) and the other 30 cases were in treated with herbal medicine alone (herbal medicine group) Results The total effective rate of acupuncture-medicine group was 90.9% and that of herbal group was 80.0%. And there was significant statistics difference between the curative effects of two groups (P <0.05) without obvious adverse reaction. Conclusion Combination of acupuncture and medicine has better effect in treating depression than herbal medicine group.

  18. Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

    Jae-Young Shin

    2015-01-01

    Full Text Available Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n=28 or the sham laser acupuncture group (n=28. Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

  19. Complementary and Alternative Medicine Cancer Clinical Trials

    ... Introduction Cancer CAM Clinical Trials Introduction What are clinical trials? A clinical trial is one of the final ... and effective. What are the different types of clinical trials? Treatment trials test new treatments (like a new ...

  20. Is Deqi an Indicator of Clinical Efficacy of Acupuncture? A Systematic Review

    Shuo Zhang

    2013-01-01

    Full Text Available Objective. Despite the systematic literature review of the current evidence, we aim to answer the question “ is Deqi an indicator of clinical effects in acupuncture treatment?” Methods. We systematically searched CNKI, VIP, Wanfang Data, PubMed, Embase, and the CENTRAL for three types of study: (1 empirical research probing into the role of Deqi in acupuncture; (2 mechanism studies examining the effect of Deqi on physiological parameters in animal models and human subjects; (3 clinical studies that compared the outcome of acupuncture with Deqi with that of acupuncture without Deqi. Two reviewers independently extracted data, undertook qualitative or quantitative analysis, and summarized findings. Results. The ancient Chinese acupuncturists valued the role of Deqi as a diagnostic tool, a prognosis predictor, and a necessary part of the therapeutic procedure. Findings from modern experimental research provided preliminary evidence for the physiological mechanism that produced Deqi. Few clinical studies generated conflicting evidence of the comparative effectiveness of acupuncture with Deqi versus acupuncture without Deqi for a variety of conditions. Conclusion. The current evidence base is not solid enough to draw any conclusion regarding the predicative value of natural Deqi for clinical efficacy or the therapeutic value of manipulation-facilitated Deqi.

  1. The Clinical study on the change of pain after needle acupuncture and needle acupuncture combined herbal acupuncture therapy in the musculoskeletal disorder

    Kim sung-chul; Lim jeong-a; Kim sung-nam; Lee sung-yong; Lee sang-kwan; Moon hyung-cheol; Koo sung-tae; Choi sun-mi

    2005-01-01

    Objective : This study was performed to compare needle acupuncture combined herbal acupuncture therapy with only needle acupuncture therapy in VAS and pain threshold. Methods : We used pressure algometer to evaluate the change of pain threshold before and after treatment. The numberical value of pressure algometer is obtained twice and averaged by identical acupuncturist. Visual analogue scale(VAS) was used to estimate the efficacy of needle acupuncture combined herbal acupuncture therapy....

  2. Laser acupuncture in patients with temporomandibular dysfunction: a randomized controlled trial.

    Ferreira, Luciano Ambrosio; de Oliveira, Rodrigo Guerra; Guimarães, Josemar Parreira; Carvalho, Antonio Carlos Pires; De Paula, Marcos Vinicius Queiroz

    2013-11-01

    A prospective, double-blind, randomized, and placebo-controlled trial was conducted in patients with chronic temporomandibular disorder (TMD) to check the analgesic efficacy of infrared low-power GaAlAs diode laser applied to acupuncture points. Forty female subjects, ranging in age from 20 to 40 years, with diagnoses of chronic myofascial pain and arthralgia were randomly allocated to two groups: an experimental group (EG) who received the laser acupuncture as adjunct to reversible occlusal splint therapy and a control group (CG) who received a placebo laser associated with occlusal splint therapy. Both approaches were applied once a week for 3 months. Laser acupuncture was defined by the following parameters: 50-mW continuous radiation for 90 s to acupoints ST6, SI19, GB20, GB43, LI4, LR3, NT3, and EX-HN3; defining 4.5-J energy; 1250-W/cm(2) density point; and 112.5-J/cm(2) total density. The outcome measurements included a symptom evolution assessment carried out by checking spontaneous and palpation pain intensity, which was indicated on a visual analog scale (VAS). All evaluations were made by an assessor who was blind to the treatment. The symptom reduction was significant in both groups (EG: VAS = 0, n = 20; CG: VAS between 2 and 4, n = 18). The measurements showed significantly faster and lower pain intensity values in the EG (p ≤ 0.002), where there was a higher proportion of patients with remission of symptoms related to the action of laser acupuncture. For patients in whom conservative treatment was adopted, the laser acupuncture is a secure, noninvasive, and effective treatment modality because it improves the chronic pain associated with TMD and has no side effects. PMID:23380907

  3. OARSI Clinical Trials Recommendations

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.;

    2015-01-01

    members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and......The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct, and...... reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the...

  4. Efficacy of Acupuncture versus Combined Oral Contraceptive Pill in Treatment of Moderate-to-Severe Dysmenorrhea: A Randomized Controlled Trial

    Intira Sriprasert; Suparerk Suerungruang; Porntip Athilarp; Anuchart Matanasarawoot; Supanimit Teekachunhatean

    2015-01-01

    This open-label randomized controlled trial was designed to compare the efficacy of acupuncture and combined oral contraceptive (COC) pill in treating moderate-to-severe primary dysmenorrhea. Fifty-two participants were randomly assigned to receive either acupuncture (n = 27) or COC (n = 25) for three menstrual cycles. Mefenamic acid was prescribed as a recue analgesic drug with both groups. The statistical approach used for efficacy and safety assessments was intention-to-treat analysis. By ...

  5. Acupuncture-Point Stimulation for Postoperative Pain Control: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Xian-Liang Liu; Jing-Yu Tan; Alex Molassiotis; Suen, Lorna K P; Yan Shi

    2015-01-01

    The purpose of this study was to evaluate the effectiveness of Acupuncture-point stimulation (APS) in postoperative pain control compared with sham/placebo acupuncture or standard treatments (usual care or no treatment). Only randomized controlled trials (RCTs) were included. Meta-analysis results indicated that APS interventions improved VAS scores significantly and also reduced total morphine consumption. No serious APS-related adverse effects (AEs) were reported. There is Level I evidence ...

  6. Acupuncture for the treatment of phantom limb pain in lower limb amputees: study protocol for a randomized controlled feasibility trial

    Trevelyan, Esmé G; Turner, Warren A; Robinson, Nicola

    2015-01-01

    Background Phantom limb pain is a prevalent condition that is difficult to manage, with a lack of robust evidence to support the use of many adjunctive treatments. Acupuncture can be effective in the management of many painful conditions but little is known about its effectiveness in treating phantom limb pain. The aim of this study is to explore the feasibility of conducting a randomized controlled trial comparing acupuncture and routine care in a group of lower limb amputees with phantom li...

  7. HIV/AIDS Clinical Trials

    ... Home Apps APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español small ... Renal (Kidney) Complications/Damage Skin Diseases FDA-Approved HIV Drugs Abacavir Atazanavir Atripla Cobicistat Combivir Complera Darunavir ...

  8. Randomised clinical trial

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  9. Clinical Observation of Warm Acupuncture in Treating Diabetic Peripheral Neuropathy

    孙远征; 徐莺莺; 肖元春

    2010-01-01

    Objective:To observe the clinical efficacy of warm acupuncture in the treatment of diabetic peripheral neuropathy and its effects on the conduction velocity of the tibial nerve and common fibular nerve.Methods:Fifty.two subjects were evenly randomized into two groups and treated by conventional therapy;in addition,the control group was given mecobalamin injection at 500 μg,once a day for four weeks,and treatment group was given warm acupuncture,6 times a week for 4 weeks.The clinical efficacy and the conduction velocity of the tibial nerve and common fibular nerve were observed and compared between the two groups.Results:After four-week treatments.the total effective rate Was 88.5% in the treatment group and 61.5% in the control group,with a higher rate in the treatment group than in the control group (P<0.05):the conduction velocity of tibial nerve and common fibular nerve Was higher in both groups(P<0.05),with higher conduction velocity in the treatment group than in the control group (P<0.05).Conclusion:Warm acupuncture is quite effective to treat diabetic peripheral neuropathy and to improve nerve velocity.%目的:观察温针治疗糖尿病周围神经病患者的临床疗效及对胫神经和腓总神经传导速度的影响.方法:把52例符合纳入标准的患者随机分为治疗组和对照组,每组26例.两组均在基础治疗上,治疗组采用温针疗法.每日1次,每星期治疗6次,共治疗4星期.对照组肌注弥可保(甲钴胺针)500 μg,每日1次,共治疗4星期.检查并记录治疗前后两组患者临床症状及胫神经、腓总神经传导速度,并进行比较.结果:治疗4星期后,治疗组总有效率为88.5%,对照组为61.5%,两组临床疗效比较治疗组优于对照组(P<0.05);神经传导速度比较两组治疗后均优于治疗前,差异有统计学意义(P<0.05);治疗后比较治疗组胫神经感觉神经传导速度及腓总神经运动传导速度均优于对照组(P<0.05).

  10. Participating in Clinical Trials

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  11. Clinical Studies on Herbal Acupuncture Therapy in Peripheral Facial Palsy

    Shin, Min-Seop

    2001-06-01

    Full Text Available Objectives : The treatment of Bell's palsy must be divided into three states(acute, subacute and healing state. 41 cases of the patient suffering from Bell's palsy were treated and observed from january 2000 to July 2001. The usage of herbal acupunctures on that disease have been effective. So I propose a method of herbal acupunctures on Bell's palsy. Methods : By the states(acute, subacute and healing state of Bell's palsy, SY(消炎 herbal acupuncture is used at the acute state, Hominis Placenta(紫河車 at the subacute, JGH(中氣下陷 at the healing state. Results : 1. At the acute state, SY(消炎 herbal acupuncture is effective to postauricular pain. 2. At the subacute state, Hominis Placenta(紫河車 herbal acupuncture is effective to decreasing pain and improving symptoms. 3. By the states(acute, subacute and healing state of Bell's palsy, SY(消炎, Hominis Placenta(紫河車 and JGH(中氣下陷 herbal acupuncture is effective to improving symptoms of Bell's palsy.

  12. Participating in Clinical Trials

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  13. Acupuncture treatment in gastrointestinal diseases: A systematic review

    Antonius Schneider; Konrad Streitberger; Stefanie Joos

    2007-01-01

    The purpose of this work was to assess the evidence for effectiveness of acupuncture (AC) treatment in gastrointestinal diseases. A systematic review of the Medline-cited literature for clinical trials was performed up to May 2006. Controlled trials assessing acupuncture point stimulation for patients with gastrointestinal diseases were considered for inclusion. The search identified 18 relevant trials meeting the inclusion criteria. Two irritable bowel syndrome (IBS) trials, 1 Crohn's disease and 1 colitis ulcerosa trial had a robust random controlled trial (RCT) design. In regard to other gastrointestinal disorders, study quality was poor. In all trials, quality of life (QoL) improved significantly independently from the kind of acupuncture, real or sham. Real AC was significantly superior to sham acupuncture with regard to disease activity scores in the Crohn and Colitis trials. Efficacy of acupuncture related to QoL in IBS may be explained by unspecific effects.This is the same for QoL in inflammatory bowel diseases (IBD), whereas specific acupuncture effects may be found in clinical scores. Further trials for IBDs and in particular for all other gastrointestinal disorders would be necessary to evaluate the efficacy of acupuncture treatment. However, it must be discussed on what terms patients benefit when this harmless and obviously powerful therapy with regard to QoL is demystified by further placebo controlled trials.

  14. Effectiveness guidance document (EGD for acupuncture research - a consensus document for conducting trials

    Witt Claudia M

    2012-09-01

    Full Text Available Abstract Background There is a need for more Comparative Effectiveness Research (CER to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making. Methods Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review. To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved. Results Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.

  15. Clinical investigation compared with the effects of the bee-venom Acupuncture on knee joint with osteoarthritis

    Wang Wu-Hao

    2001-12-01

    Full Text Available Objective: This study is designed to find out the effects of the Bee-Venom Acupuncture on knee joint with osteoarthritis. Methods: We are investigated that outpatients suffer from knee joint pain deciphered at the division of Acupuncture in Jaseng oriental medicine hospital from the 13, July 1999 to unti111, November 2000. We make an estimated of the score from both before or after its treatment about 70 cases of diagnostic patient with the osteoarthritis of knee joints by biochemical method and X-RAY analysis, we observed in the progress of symptoms. Results: These results found that sex distinction with a disease caused much more female than male at the ratio of I to 5.36 in the proportion of males to females, jobs is mainly ranked with a housewife and approximately 82.9% of cases before our hospital have ever treated at the other clinics or hospitals. On the hand, the distribution interval of a case history is mainly followed by disease in below 6 month, interval of the period-treatment is mainly gone within 3 month and frequency of treatment is examined into II to 15 times, more than 16 times and below 10 times, respectively. We are estimated with the score of functional barrier from both before or after its treatment against osteoarthritis' patients and produced in the usefulness from the totally point of fields except the aid-device after its treatment In summary, these results demonstrated that Bee Venom, Acupuncture enhanced more than 82.9% to the improvement of treatment and p<0.05 considered to be statistically significant. Conclusion: These results suggest that Bee-venom Acupuncture may be playa role in the significant usefulness and have need of actively application for the clinical trials against osteoarthritis' patients.

  16. Gateways to clinical trials.

    Bayes, M; Rabasseda, X; Prous, J R

    2002-01-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses, which has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, providing information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abacavir sulfate; abciximab; abetimus sodium; adalimumab; aldesleukin; almotriptan; alteplase; amisulpride; amitriptyline hydrochloride; amoxicillin trihydrate; atenolol; atorvastatin calcium; atrasentan; Beclometasone dipropionate; bosentan; Captopril; ceftriaxone sodium; cerivastatin sodium; cetirizine hydrochloride; cisplatin; citalopram hydrobromide; Dalteparin sodium; darusentan; desirudin; digoxin; Efalizumab; enoxaparin sodium; ertapenem sodium; esomeprazole magnesium; estradiol; ezetimibe; Famotidine; farglitazar; fluorouracil; fluticasone propionate; fosamprenavir sodium; Glibenclamide; glucosamine sulfate; Heparin sodium; HSPPC-96; hydrochlorothiazide; Imatinib mesilate; implitapide; Lamivudine; lansoprazole; lisinopril; losartan potassium; l-Propionylcarnitine; Melagatran; metformin hydrochloride; methotrexate; methylsulfinylwarfarin; Nateglinide; norethisterone; Olmesartan medoxomil; omalizumab; omapatrilat; omeprazole; oseltamivir phosphate; oxatomide; Pantoprazole; piperacillin sodium; pravastatin sodium; Quetiapine hydrochloride; Rabeprazole sodium; raloxifene hydrochloride; ramosetron hydrochloride; ranolazine; rasburicase; reboxetine mesilate; recombinant somatropin; repaglinide; reteplase; rosiglitazone; rosiglitazone maleate; rosuvastatin calcium; Sertraline; simvastatin; sumatriptan succinate; Tazobactam sodium; tenecteplase; tibolone; tinidazole; tolterodine tartrate; troglitazone; Uniprost; Warfarin sodium; Ximelagatran. PMID:11980386

  17. Gateways to clinical trials.

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  18. Gateways to clinical trials.

    Tomillero, A; Moral, M A

    2010-11-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil

  19. CLINICAL OBSERVATION ON SCALP ACUPUNCTURE TREATMENT OF EINDSTROKE—CAUSED DYSKPHAGIA—DYSPHONIA SYNDRONE

    韩舰华; 董颖丽; 等

    2002-01-01

    Objective:To observe the therapeutic effect of scalp acupuncture on cerebral blood flow in pseudobulbar paralysis patients for analyzing mechanisms of scalp-acupuncture in the treatment of wind strokek.Methods:A total of 38 inpatients (26 males and 12 females) were treated with electroacupuncture (EA) of scalp-point Dingzhougxian (MS 5),Dingnie Houxiexian (MS 7),Dingpangxian Ⅱ (MS 9) and Dingnie Qianxiexian (MS 6).Before and after acupuncture treatment,clinical symptoms of dysphadia and dyskphonia sere compared,and the mean blood flow speed (MBFS) values of the anterior cerebral artery (ACA),middle cerebral artery (MCA) and posterior cerebral artery (PCA) detected by using Doppler blood flow meter.Results:Following two courses (4 weeks) of scalp-acupuncture treatment,of the 38 cases,23 had their dysphagia and dyskphonia cured (60.5%),10 (25.3%) had remarkable improvement,3(7.9%) experienced improvement and 2(5.3%) had no apparent changes.Simultaneously.MBFS of ACA,MCA and PCA increased significantly in comparison with that of pre-treatment (P<0.01).Additionally,results also showed that scalp acupuncture could stabilize the blood circulation between both hemispheres of the brain.Conclusion:Scalp acupuncture has a fairly good therapeutic effect in improving stroke caused dysphagia and dysphonia and in facilitating carebral blood flow.

  20. The Role of Acupuncture in Assisted Reproductive Technology

    Cui Hong Zheng; Ming Min Zhang; Guang Ying Huang; Wei Wang

    2012-01-01

    The aim of this paper was to provide reliable evidence by performing a systematic review and meta-analysis for evaluating the role of acupuncture in assisted reproductive technology. All randomized controlled trials that evaluated the effects of acupuncture, including manual, electrical, and laser acupuncture (LA) techniques, on the clinical pregnancy rate (CPR) and live birth rate (LBR) of in vitro fertilization (IVF) or artificial insemination were included. The controlled groups consisted ...

  1. Gateways to clinical trials.

    Tomillero, A; Moral, M A

    2008-10-01

    Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar

  2. [Discussion on clinical research thinking of insulin resistance and its related di-seases treated with acupuncture and moxibustion].

    Liang, Feng-Xia; Chen, Rui; Wang, Hua

    2012-07-01

    According to the analysis of current clinical research situation on insulin resistance and its related diseases: obesity, type 2 diabetes mellitus, hypertension, polycystic ovary syndrome (PCOS) treated with acupuncture and moxibustion, some clinical research thinking are proposed: based on national, international acupuncture-moxibustion standard, setting a normalized clinical research programme in accordance with the clinical practice; addressing effective acupoints combination and prescription, emphasizing the role played by vital qi strengthening in the treatment of insulin resistance and its related diseases; taking advantage of acupuncture and moxibustion in treatment apportunity, that is to say , mainly focus on prevention; setting proper control group, grasping the theoretical and clinical characteristics of acupuncture and moxibustion. In this way, some reference could be provided for insulin resistance and its related diseases treated with acupuncture and moxibustion. PMID:22997798

  3. Clinical Study on Electro-acupuncture plus Traction in Treating Cervical Disk Extrusion in 100 Cases

    宓轶群

    2006-01-01

    Objective:To seek out an effective treatment method for cervical disc extrusion and a significant laboratory examination.Methods: Randomized controlled trial was established into two groups: control group in which 50 subjects were given simple cervical traction and treatment group in which another 50 cases were given electro-acupuncture plus cervical traction. Results:The total effective rate was 92% in treatment group, obviously higher than 80% in control group; electromyogram examination showed decreased spontaneous potential. Conclusion:Electro-acupuncture plus cervical traction is an effective therapy for cervical disc extrusion and electromyogram can help clinical practice.%目的:寻求临床治疗颈椎间盘突出症的有效方法-电针结合牵引,寻求对临床有指导意义的实验室检查-肌电图检查.方法:本文运用随机对照的原则,分别设立:单纯牵引组50例和电针结合牵引组50例.结果:电针结合牵引治疗颈椎间盘突出症的疗效(有效率92%)明显优于单纯牵引组(有效率80%),电针结合牵引治疗颈突症具有确切疗效,经肌电图检查,其自发电位的减少与临床疗效相符合.结论: 电针结合牵引治疗颈突症是目前有效的方法,肌电图检查能有效指导临床.

  4. Unanticipated Insights into Biomedicine from the Study of Acupuncture.

    MacPherson, Hugh; Hammerschlag, Richard; Coeytaux, Remy R; Davis, Robert T; Harris, Richard E; Kong, Jiang-Ti; Langevin, Helene M; Lao, Lixing; Milley, Ryan J; Napadow, Vitaly; Schnyer, Rosa N; Stener-Victorin, Elisabet; Witt, Claudia M; Wayne, Peter M

    2016-02-01

    Research into acupuncture has had ripple effects beyond the field of acupuncture. This paper identifies five exemplars to illustrate that there is tangible evidence of the way insights gleaned from acupuncture research have informed biomedical research, practice, or policy. The first exemplar documents how early research into acupuncture analgesia has expanded into neuroimaging research, broadening physiologic understanding and treatment of chronic pain. The second describes how the acupuncture needle has become a tool to enhance biomedical knowledge of connective tissue. The third exemplar, which illustrates use of a modified acupuncture needle as a sham device, focuses on emergent understanding of placebo effects and, in turn, on insights into therapeutic encounters in treatments unrelated to acupuncture. The fourth exemplar documents that two medical devices now in widespread use were inspired by acupuncture: transcutaneous electrical nerve stimulators for pain control and antinausea wrist bands. The final exemplar describes how pragmatic clinical trial designs applied in acupuncture research have informed current general interest in comparative effectiveness research. In conclusion, these exemplars of unanticipated outcomes of acupuncture research comprise an additional rationale for continued support of basic and clinical research evaluating acupuncture and other under-researched therapies. PMID:26745452

  5. Acupuncture in Primary Care

    Mao, Jun J; Kapur, Rahul

    2010-01-01

    Acupuncture is an ancient traditional Chinese medical therapy that is used widely around the world. When practiced by a certified provider, it is safe and often perceived as calming and relaxing for patients. Animal and human studies have found a physiological basis for acupuncture needling in that it affects the complex central and peripheral neuro-hormonal network. Although it is unclear whether acupuncture is beneficial over sham/placebo acupuncture, acupuncture care yields clinically rele...

  6. Randomized Controlled Trials of Acupuncture (1997–2007): An Assessment of Reporting Quality with a CONSORT- and STRICTA-Based Instrument

    Mikel Aickin; Scott Mist; Beth Yohalem-Ilsley; Jeffrey Weih; Agatha Colbert; Richard Hammerschlag; Ryan Milley

    2011-01-01

    The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997–2007. This Oregon CONSORT STRICTA Instrument (OCSI) is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedu...

  7. Acupuncture therapy for drug addiction.

    Motlagh, Farid Esmaeili; Ibrahim, Fatimah; Rashid, Rusdi Abd; Seghatoleslam, Tahereh; Habil, Hussain

    2016-01-01

    Acupuncture therapy has been used to treat substance abuse. This study aims to review experimental studies examining the effects of acupuncture on addiction. Research and review articles on acupuncture treatment of substance abuse published between January 2000 and September 2014 were searched using the databases ISI Web of Science Core Collection and EBSCO's MEDLINE Complete. Clinical trial studies on the efficacy of acupuncture therapy for substance abuse were classified according to substance (cocaine, opioid, nicotine, and alcohol), and their treatment protocols, assessments, and findings were examined. A total of 119 studies were identified, of which 85 research articles addressed the efficacy of acupuncture for treating addiction. There were substantial variations in study protocols, particularly regarding treatment duration, frequency of electroacupuncture, duration of stimulation, and choice of acupoints. Contradictory results, intergroup differences, variation in sample sizes, and acupuncture placebo effects made it difficult to evaluate acupuncture effectiveness in drug addiction treatment. This review also identified a lack of rigorous study design, such as control of confounding variables by incorporating sham controls, sufficient sample sizes, reliable assessments, and adequately replicated experiments. PMID:27053944

  8. Effect of Siguan Acupuncture on Gastrointestinal Motility: A Randomized, Sham-Controlled, Crossover Trial

    Kyung-Min Shin; Ji-Eun Park; Sanghun Lee; Sun-Mi Choi; Yo-Chan Ahn; Jin-Woo Lee; Jin-Hee Kim; Chang-Gue Son

    2013-01-01

    Siguan acupoints have been used to treat gastrointestinal symptoms in acupuncture practices for a long time. This study aimed to investigate the effects of Siguan acupuncture on gastrointestinal motility under accelerated conditions using a randomized, sham-acupuncture-controlled, crossover study. Twenty-one healthy male subjects were hospitalized and randomized into either a real acupuncture group (at Siguan acupoints) or a sham acupuncture group. Subjects were administered with mosapride ci...

  9. Clinical trials of homoeopathy.

    Kleijnen, J.; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURE...

  10. Clinical Study on Acupoint Injection plus Acupuncture for Insomnia Due to Heart-kidney Disharmony

    Zheng Qiao-ping; Zhang Bi-meng; Zhou Jun-mei; Hu Qi-long

    2014-01-01

    Objective: To observe the clinical efficacy of acupoint injection at Neiguan (PC 6) plus acupuncture in treating insomnia due to heart-kidney disharmony. Methods: A hundred patients with insomnia due to heart-kidney disharmony were randomized into an observation group and a control group. Fifty-three cases in the observation group were intervened by acupoint injection at Neiguan (PC 6) plus acupuncture; while 54 cases in the control group were intervened by acupuncture alone. The Pittsburgh sleep quality index (PSQI) was evaluated before and after intervention, and the therapeutic efficacies of the two groups were compared. Results: Acupoint injection at Neiguan (PC 6) plus acupuncture produced significantly higher efficacies in improving sleep quality, shortening sleep latency, and enhancing sleep efficiency than acupuncture alone (P Conclusion: The two groups both can improve the condition of insomnia; acupoint injection at Neiguan (PC 6) has significant advantages, manifested by a higher therapeutic efficacy for insomnia due to heart-kidney disharmony, higher safety evaluation, efficiency, and less adverse events, thus proper for clinical application.

  11. Teasing apart quality and validity in systematic reviews: an example from acupuncture trials in chronic neck and back pain.

    Smith, L A; Oldman, A D; McQuay, H J; Moore, R A

    2000-05-01

    The objectives of the study were (1) to carry out a systematic review to assess the analgesic efficacy and the adverse effects of acupuncture compared with placebo for back and neck pain and (2) to develop a new tool, the Oxford Pain Validity Scale (OPVS), to measure validity of findings from randomized controlled trials (RCTs), and to enable ranking of trial findings according to validity within qualitative reviews. Published RCTs (of acupuncture at both traditional and non-traditional points) were identified from systematic searching of bibliographic databases (e.g. MEDLINE) and reference lists of retrieved reports. Pain outcome data were extracted with preference given to standardized outcomes such as pain intensity. Information on adverse effects was also extracted. All included trials were scored using a five-item 0-16 point validity scale (OPVS). The individual RCTs were ranked according to their OPVS score to enable more weight to be placed on the trials of greater validity when drawing an overall conclusion about the efficacy of acupuncture for relieving neck and back pain. Statistical analyses were carried out on the OPVS scores to assess the relationship between trial finding (positive or negative) and validity. Thirteen RCTs met the inclusion criteria. Five trials concluded that acupuncture was effective, and eight concluded that it was not effective for relieving back or neck pain. There was no obvious difference between the findings of trials using traditional and non-traditional points. Using the new OPVS scale, the validity scores of the included trials ranged from 4 to 14. There was no significant relationship between OPVS score and trial finding (positive versus negative). Authors' conclusions did not always agree with their data. We drew our own conclusions (positive/negative) based on the data presented in the reports. Re-analysis using our conclusions showed a significant relationship between OPVS score and trial finding, with higher validity

  12. Acupuncture for Spinal Cord Injury and Its Complications: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    In Heo

    2013-01-01

    Full Text Available To evaluate the evidence supporting the effectiveness of acupuncture treatment for SCI and its complications, we conducted search across 19 electronic databases to find all of the randomized controlled trials (RCTs that used acupuncture as a treatment for SCI and its complications. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool and the PEDro scale. Sixteen RCTs, including 2 high-quality RCTs, met our inclusion criteria (8 for functional recovery from SCI, 6 for bladder dysfunction, and 2 for pain control. The meta-analysis showed positive results for the use of acupuncture combined with conventional treatments for the functional recovery in terms of motor ASIA scores and total FIM scores when compared to conventional treatments alone. Positive results were also obtained for the treatment of bladder dysfunction, in terms of the total efficacy rate, when comparing acupuncture to conventional treatments. However, 2 RCTs for pain control reported conflicting results. Our systematic review found encouraging albeit limited evidence for functional recovery, bladder dysfunction, and pain in SCI. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend sham-controlled RCTs or comparative effectiveness research for each condition to test the effectiveness of acupuncture.

  13. Participating in Clinical Trials

    Full Text Available ... determine if the drug can be approved for use. A Phase I trial tests an experimental treatment ... the correct drug dosage. A Phase II trial uses more people (100 to 300). While the emphasis ...

  14. Participating in Clinical Trials

    Full Text Available ... the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  15. [Acupuncture in orthopedics].

    Molsberger, A

    2012-02-01

    Large randomized controlled trials have shown the effectiveness of acupuncture in comparison to various control treatments for low back pain, osteoarthrosis, shoulder pain, tension type headache, and migraine. For most of these diseases the cost-effectiveness of acupuncture has been proven. A few smaller controlled trials exist for tennis elbow and osteoarthrosis of the hip. The use of acupuncture for other locomotive disorders is based on textbook literature and expert opinion. Current data show that acupuncture is a relatively safe method. Internationally several guidelines for chronic low back pain have integrated acupuncture. In Germany acupuncture has been reimbursed by the state insurance system for chronic low back pain and osteoarthritis since 2007 and the estimated costs are between EUR 300-700 million annually. Acupuncture is offered by at least 12,000 medical doctors and acupuncture is mostly used for locomotive disorders. PMID:22349367

  16. Acupuncture Treatment for Low Back Pain and Lower Limb Symptoms—The Relation between Acupuncture or Electroacupuncture Stimulation and Sciatic Nerve Blood Flow

    Megumi Itoi; Naoto Ishizaki; Tadashi Yano; Hiroshi Kitakoji; Motohiro Inoue; Yasukazu Katsumi

    2007-01-01

    To investigate the clinical efficacy of acupuncture treatment for lumbar spinal canal stenosis and herniated lumbar disc and to clarify the mechanisms in an animal experiment that evaluated acupuncture on sciatic nerve blood flow. In the clinical trial, patients with lumbar spinal canal stenosis or herniated lumbar disc were divided into three treatment groups; (i) Ex-B2 (at the disordered level), (ii) electrical acupuncture (EA) on the pudendal nerve and (iii) EA at the nerve root. Primary o...

  17. Gateways to clinical trials.

    Bayés, M; Rabasseda, X; Prous, J R

    2005-06-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abiraterone acetate, acyline, adalimumab, adenosine triphosphate, AEE-788, AIDSVAX gp120 B/B, AK-602, alefacept, alemtuzumab, alendronic acid sodium salt, alicaforsen sodium, alprazolam, amdoxovir, AMG-162, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, aminophylline hydrate, anakinra, anecortave acetate, anti-CTLA-4 MAb, APC-8015, aripiprazole, aspirin, atazanavir sulfate, atomoxetine hydrochloride, atorvastatin calcium, atrasentan, AVE-5883, AZD-2171; Betamethasone dipropionate, bevacizumab, bimatoprost, biphasic human insulin (prb), bortezomib, BR-A-657, BRL-55730, budesonide, busulfan; Calcipotriol, calcipotriol/betamethasone dipropionate, calcium folinate, capecitabine, capravirine, carmustine, caspofungin acetate, cefdinir, certolizumab pegol, CG-53135, chlorambucil, ciclesonide, ciclosporin, cisplatin, clofarabine, clopidogrel hydrogensulfate, clozapine, co-trimoxazole, CP-122721, creatine, CY-2301, cyclophosphamide, cypher, cytarabine, cytolin; D0401, darbepoetin alfa, darifenacin hydrobromide, DASB, desipramine hydrochloride, desloratadine, desvenlafaxine succinate, dexamethasone, didanosine, diquafosol tetrasodium, docetaxel, doxorubicin hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecallantide, efalizumab, efavirenz, eletriptan, emtricitabine, enfuvirtide, enoxaparin sodium, estramustine phosphate sodium, etanercept, ethinylestradiol, etonogestrel, etonogestrel/ethinylestradiol, etoposide, exenatide; Famciclovir, fampridine, febuxostat, filgrastim, fludarabine phosphate, fluocinolone acetonide, fluorouracil, fluticasone propionate

  18. Clinical Research and Clinical Trials

    ... Meetings, Conferences & Events Partnering & Donating to the NICHD Staff Directory ... Clinical Research Skip sharing on social media links Share this: Page Content Clinical research is research that directly involves a ...

  19. CLINICAL OBSERVATION ON SCALP ACUPUNCTURE TREATMENT OF WINDSTROKE-CAUSED DYSPHAGIA-DYSPHONIA SYNDRONE

    HAN Jianhua; DONG Yingli; ZHANG Ru

    2002-01-01

    Objective: To observe the therapeuticeffect of scalp acupuncture on cerebral blood flow in pseudobulbar paralysis patients for analyzing mechanisms of scalp-acupunoture in the treatment of wind stroke. Methods: A total of 38 inpatients (26 males and 12 females) were treated with electroacupuncture (EA) of scalp-point Dingzhongxian (MS 5), Dingnie Houxiexian (MS 7), Dingpangxian Ⅱ (MS 9) and Dingnie Qianxiexian (MS 6). Before and after acupuncture treatment, clinical symptoms of dysphagia and dysphonia were compared, and the mean blood flow speed (MBFS) values of the anterior cerebral artery (ACA), middle cerebral artery (MCA) and posterior cerebral artery (PCA) detected by using Doppler blood flow meter. Results: Following two courses (4 weeks) of scalp-acupuncture treatment, of the 38 cases, 23 had their dysphagia and dysphonia cured (60.5%), 10 (25.3%) had remarkable improvement, 3(7.9% ) experienced improvement and 2 (5.3%) had no apparent changes. Simultaneously, MBFS of ACA, MCA and PCA increased significantly in comparison with that of pre-treatment (P < 0.01 ). Additionally, results also showed that scalp acupuncture could stabilize the blood circulation between both hemispheres of the brain. Conclusion: Scalp acupuncture has a fairly good therapeutic effect in improving stroke caused dysphagia and dysphonia and in facilitating cerebral blood flow.

  20. Acupuncture for Treatment of Autism Spectrum Disorders

    Xue Ming

    2012-01-01

    Full Text Available Background. There has been lack of reviews of evidence on efficacy, methodology, and/or safety of acupuncture in autism spectrum disorders. This paper examines the emerging evidence of the effects of acupuncture in the treatment of autistic children. Method. A literature review was completed via Medline and three Chinese search engines. A total of 31 studies were evaluated for acupuncture methodology, study design, treatment effects, and tolerability. Results. The acupoints used, the duration of needling, the frequency of treatment, the choice of stimulation, and the course of the treatment were highly variable amongst the studies. Behavioral and/or developmental improvements were reported in all acupuncture treatment studies. All studies reported general tolerability. Weakness of experimental designs was discussed. Conclusions. Vigorously controlled double-blinded clinical trials are needed to evaluate the efficacy and safety of acupuncture in children with autism spectrum disorders.

  1. Can acupuncture treatment be double-blinded?

    Vase, Lene; Baram, Sara; Takakura, Nobuari;

    2015-01-01

    acupuncturists were asked about perceived treatment allocation at the end of the study. To test if there were clues which led to identification of the treatment, deep dull pain associated with needle application and rotation (termed "de qi" in East Asian medicine), and patients' pain levels were assessed......Blinding protects against bias but the success of blinding is seldom assessed and reported in clinical trials including studies of acupuncture where blinding represents a major challenge. Recently, needles with the potential for double-blinding were developed, so we tested if acupuncture can be...... double-blinded in a randomized study of sixty-seven patients with acute pain ≥ 3 (0-10 scale following third molar removal) who received active acupuncture with a penetrating needle or placebo acupuncture with a non-penetrating needle. To test if acupuncture was administered double-blind, patients and...

  2. The Clinical Study on Bee Venom Acupuncture Treatment on Osteoarthritis of Knee Joint

    Lim Jeong a

    2005-06-01

    Full Text Available Objective : This study is performed for the purpose of examining into the efficacy of the Bee Venom Acupuncture Treatment for Osteoarthritis of Knee Joint Methods : We investitigated 25 cases of patients with Osteoarthritis of Knee Joint from 1st June 2005 to 13th July 2005. The 25 patients were taken Bee Venom Acupuncture over three times irregularly. Treatment efficiency was monitored through VAS (Visual Analog Scale and improvement degree of the grade of clinical symptoms Conclusion : We brought to the conclusion that the Bee Venom Acupuncture has possibility to be efficient to cure the Osteoarthritis of Knee Joint patients. So we suggest the possibility to use this new remedy for the Osteoarthritis of Knee Joint

  3. Clinical Observation on the Effects of Bo's Abdominal Acupuncture in 40 Cases of Chronic Fatigue Syndrome

    HUANG Yong; LIAO Xiao-ming; LI xiao-xi; SONG Yuan-bin

    2008-01-01

    objective;To observe the curative effect of Bo's abdominal acupuncture on chronic fatigue syndrome(CFS).Methods;Forty cases with CFS were treated by Bo's abdominal acupuncture at me points for conducting qi back to its origin and 4 points on the abdomen once a dav for 2 weeks.Scores for symptoms and scores for fatigue questionnaires were compared before and after treatment.Results;After treatment,the clinical symptoms of patients were differently alleviated,and scores for symptoms,mental condition and neural feeling in questionnaires on fatigue were obviously reduced(P<0.01-0.05).Conclusion;Bo's abdominal acupuncture has a good curative effect on general disease with complex symptoms,especially on lassitude,anorlexia,insomnia,amnesia,diarrhea,and general pain.

  4. Clinical Observation on Simple Obesity Treated by Acupuncture plus Ear Point-Sticking Method

    CAO Xue-mei; PI Min; YU Lei; TAO Jia-ping; YU Hai-bo; HUANG Guo-qi

    2007-01-01

    Objective: In order to observe the clinical therapeutic effect of acupuncture plus ear point-sticking for simple obesity. Methods: Fifty-two cases of the patients with simple obesity were treated by acupuncture and ear point-sticking method for one course. Results:After the treatments, the results showed remarkable effect in 22 cases, effect in 25 cases and failure in 5 cases, and the total effective rate was 90.4%. There was no obvious change in various indexes of the body in the male and female patients before and after the treatment.Conclusion: Acupuncture plus ear point-sticking for simple obesity is stable in the therapeutic effect, simple and safe in application, without side effects, and cheap in cost and needs to be greatly popularized.

  5. The clinical observations of 3 cases of metatarsal tendinitis treated with anti-inflammatory herbal acupuncture

    Sung-lae,Kim

    2007-02-01

    Full Text Available Objective : The objective of this study is to observe the effect of anti-inflammatory herbal acupuncture on the metatarsal tendinitis. Methods : After the application of herbal acupuncture, the VAS and Baumgaertner's nine point scale were assessed. If there were any restraints on the ROM, ROM was also assessed alongside the previous scales. Results : 1. The pain was reduced significantly according to the VAS scale. 2. As to the assessment of satisfaction in treatment, by the Baumgaertner's nine point scale, 2 out of 3 cases scored Excellent, and one case scored Good. Conclusions : The anti-inflammatory herbal acupuncture is effective to the metatarsal tendinitis, and can be used more frequently in the clinical practices.

  6. CLINICAL RESEARCH ON ACUPUNCTURE TREATMENT OF DEPRESSIVE PSYCHOSIS

    FU Wenbin

    2002-01-01

    Objective: To evaluate the therapeutic effect of acupuncture in the treatment of depressive psychosis.Methods: A total of 62 cases of depressive psychosis patients were randomly divided into treatment group (n=32) and control group (n=30). Acupoints used in treatment group were bilateral Hegu (LI 4), bilateral Taichong (LR 3), Baihui (GV 20) and Yintang (EX-HN 3). Patients of control group were asked to take Fluoxertine hydrochloride 20 mg/d.The therapeutic effect was assessed using Hamilton's depression (HAMD) scales. Results: After 8 weeks' treatment,in treatment and control groups, 4 and 3 cases were cured, 8 and 6 experienced marked improvement, 14 and 14 had improvement, 6 and 7 had no effect, with the effective rates being 81.25% and 76. 66% separately, and no significant difference was found between two groups in HAMD scales (P>0.05). Conclusion: Acupuncture therapy is an effective method for treatment of depressive psychosis.

  7. Clinical Study on Treatment of Senile Vascular Dementia by Acupuncture

    高汉义; 闫乐法; 刘百波; 王燕; 魏学礼; 孙鲁燕; 崔华勤

    2001-01-01

    63 patients with senile vascular dementia were randomly divided into the treatment group (treated by acupuncture) and the control group (treated with piracetam). The authors observed the changes in the score of Hasegawa's dementia scale (HDS), p300, rheoencephalogram, topographic EEG, superoxide dismutase (SOD) activity in erythrocytes, and lipid peroxide (LPO) level in plasma before and after treatment. The statistical data showed that the total effective rate in the treatment group (80.6%) was significantly higher than that in the control group (25%), and the differences in the observed indexes before and after treatment were significant (P0.05), indicating that the acupuncture treatment was superior in immediate therapeutic effect on senile vascular dementia to drug treatment.

  8. The Dynamo Clinical Trial

    Ayres, Thomas R.

    2016-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  9. Clinical Observation on the Treatment of Diabetic Gastroparesis with Acupuncture

    刘瑞云; 赵鹏台; 洪珏

    2010-01-01

    Objective: This study was to observe the therapeutic effect of acupuncture in the treatment of diabetic gastroparesis.Methods: Ninety patients with diabetic gastroparesis were randomly allocated into 2 groups,a treatment group(45 subjects)to receive acupuncture treatment,and a control group(45 subjects)to take domperidone tablet.Results: Four treatment courses later,the total effective rate was 91.1% in the treatment group and 64.4% in the control group,and the difference was statistically significant(P<0.05).Conclusion: The diabetic gastroparesis responds well to acupuncture treatment.%目的:观察针刺治疗糖尿病胃轻瘫的疗效.方法:将90例糖尿病胃轻瘫患者随机分为两组.治疗组45例采用针刺治疗;对照组45例采用多潘立酮片治疗.结果:4个疗程后,治疗组总有效率为91.1%,对照组总有效率为64.4%,两组差异具有统计学意义(P<0.05).结论:针刺是治疗糖尿病胃轻瘫的有效方法.

  10. Acupuncture Analgesia in Migraine

    吴根诚

    2009-01-01

    There is no curative treatment for migraine, although there does exist various options for pharmacological treatment.Drug treatment withβ-adrenoceptor blockers,calcium antagonists,or other agents has been shown to reduce the frequency of migraine attacks;however,the success of treatment is usually modest.Acupuncture has been increasingly used as adjunctive treatment in primary headache syndromes and there is growing evidences from clinical trials that it might be beneficial in the treatment of migraine,w...

  11. Acupuncture in stroke rehabilitation Literature retrieval based on international databases

    Feng Sun; Jinchun Wang; Xia Wen

    2012-01-01

    OBJECTIVE: To identify global research trends of acupuncture in stroke rehabilitation using a bibliometric analysis of the Web of Science and the Clinical Trials registry database (ClinicalTrials.gov). DATA RETRIEVAL: We performed a bibliometric analysis of data retrievals for acupuncture in stroke rehabilitation from 1992 to 2011 using the Web of Science and ClinicalTrials.gov. SELECTION CRITERIA: Inclusion criteria: (1) Web of Science: (a) Peer-reviewed articles on acupuncture in stroke rehabilitation that were published and indexed in the Web of Science. (b) Type of articles: original research articles, reviews, meeting abstracts, proceedings papers, book chapters, editorial material and news items. (c) Year of publication: 1992-2011. (2) ClinicalTrials.gov: All clinical trials relating to acupuncture in stroke rehabilitation were searched in this database. Exclusion criteria: (1) Web of Science: (a) Articles that required manual searching or telephone access. (b) We excluded documents that were not published in the public domain. (c) We excluded a number of corrected papers from the total number of articles. (2) ClinicalTrials.gov: (a) We excluded clinical trials that were not in the ClinicalTrials.gov database. (b) We excluded clinical trials that dealt with magnetic stimulation other than acupuncture in stroke rehabilitation in the ClinicalTrials.gov database. MAIN OUTCOME MEASURES: (1) Type of literature; (2) annual publication output; (3) distribution according to journals; (4) distribution according to country; (5) distribution according to institution; (6) top cited articles over the last 20 years; and (7) clinical trials registered.RESULTS: (1) In all, 92 studies on acupuncture in stroke rehabilitation appeared in the Web of Science from 1992 to 2011, almost half of which derived from Chinese and American authors and institutes. The number of studies addressing acupuncture in stroke rehabilitation has gradually increased over the past 20 years. Most

  12. Participating in Clinical Trials

    Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...

  13. Participating in Clinical Trials

    Full Text Available ... can include imaging tests that produce pictures of what is inside the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  14. Participating in Clinical Trials

    Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...

  15. Participating in Clinical Trials

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... IV trial for drugs or devices takes place after the U.S. Food and Drug Administration approves their ...

  16. Social media in clinical trials.

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape. PMID:24857086

  17. Acupuncture therapy for sudden sensorineural hearing loss: a systematic review and meta-analysis of randomized controlled trials.

    Xin-chang Zhang

    Full Text Available Acupuncture has commonly been used in China, either alone or in combination with Western medicine, to treat sudden sensorineural hearing loss (SSHL. The purpose of this systematic review is to assess the efficacy and safety of acupuncture therapy for patients with SSHL.We searched PubMed, the Cochrane Library, Embase, China National Knowledge Internet (CNKI, Database for Chinese Technical Periodicals (VIP, and Chinese Biomedical literature service system (SinoMed to collect randomized controlled trials of acupuncture for SSHL published before July 2014. A meta-analysis was conducted according to the Cochrane systematic review method using RevMan 5.2 software. The evidence level for each outcome was assessed using the GRADE methodology.Twelve trials involving 863 patients were included. A meta-analysis showed that the effect of manual acupuncture combined with Western medicine comprehensive treatment (WMCT was better than WMCT alone (RR 1.33, 95%CI 1.19-1.49 and the same as the effect of electroacupuncture combined with WMCT (RR 1.33, 95%CI 1.19-1.50. One study showed a better effect of electroacupuncture than of WMCT (RR 1.34, 95%CI 1.24-1.45. For mean changes in hearing over all frequencies, the meta-analysis showed a better effect with the combination of acupuncture and WMCT than with WMCT alone (MD 10.85, 95%CI 6.84-14.86. However, the evidence levels for these interventions were low or very low due to a high risk of bias and small sample sizes in the included studies.There was not sufficient evidence showing that acupuncture therapy alone was beneficial for treating SSHL. However, interventions combining acupuncture with WMCT had more efficacious results in the treatment of SSHL than WMCT alone. Electroacupuncture alone might be a viable alternative treatment besides WMCT for SSHL. However, given that there were fewer eligible RCTs and limitations in the included trials, such as methodological drawbacks and small sample sizes, large

  18. Sphenopalatine ganglion stimulation with one acupuncture needle for moderate-severe persistent allergic rhinitis: study protocol for a multicenter randomized controlled trial

    Zhang, Lu; Li, Lei(Beijing Institute of Petrochemical Technology, Beijing, 102617, People's Republic of China); Shi, Da-Zhuo; Chen, Lu-Quan; Zheng, Kai-Min; Cheng, Kai; Tao, Ye; Guo, Hai-yan; Li, Shu-Liang; Liu, Jing; Xu, Feng; Shen, Jian-Wu

    2015-01-01

    Background Allergic rhinitis is a symptomatic allergic disease of the nose that affects 10 to 20% of the global population. Chinese otolaryngologists use one acupuncture needle to stimulate the sphenopalatine ganglion because of its potential advantages for treating moderate-severe persistent allergic rhinitis compared with traditional Chinese acupuncture (verum acupuncture); however, little evidence is available to support the wide clinical use thus far. Therefore, we propose a protocol for ...

  19. Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: A study protocol for a randomized controlled pilot trial

    Kim Yoon-Bum; Kim Kyu

    2011-01-01

    Abstract Background In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested. However, despite common use of a combination of herbal medicine and acupuncture in clinical practice, the current level of evidence is insufficient to draw a conclusion for an interaction and efficacy of herbal medicine and acupuncture. Therefore, considering ...

  20. Participating in Clinical Trials

    Full Text Available ... out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or ... specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  1. Participating in Clinical Trials

    Full Text Available ... radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in animals ... term side effects. This phase can last several years. A Phase III trial gathers more information about ...

  2. Participating in Clinical Trials

    Full Text Available ... Drug Administration typically requires Phase 1, 2 and 3 trials to be conducted to determine if the ... subjects usually ranges from several hundred to about 3,000 people. If the U.S. Food and Drug ...

  3. OARSI Clinical Trials Recommendations

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  4. Participating in Clinical Trials

    Full Text Available ... ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging ... getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as ...

  5. Participating in Clinical Trials

    Full Text Available ... Researchers may study the role of caregivers, support groups, and various types of social interventions. Supportive care ... trial tests an experimental treatment on a small group of often healthy people (20 to 80), to ...

  6. Participating in Clinical Trials

    Full Text Available ... in this topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ...

  7. Randomized clinical trials in HEPATOLOGY

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  8. Topics in clinical trial management

    B.A. Kirwan (Bridget Anne)

    2004-01-01

    textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients with

  9. Types of Treatment: Clinical Trials

    ... Previous Article Palliative Care Next Article How a Clinical Trial Works Follow us Subscribe to a newsletter This field is required ... Fundraising Disclosure Refund Policy Work for LLS Contact Us Email Subscription Center

  10. Efficacy of acupuncture and moxibustion in treating Bell's palsy:a multicenter randomized controlled trial in China

    李瑛; 梁繁荣; 余曙光; 李常度; 胡玲香; 周东; 袁秀丽; 李怡; 夏晓红

    2004-01-01

    Background Bell's palsy involves acute facial paralysis due to inflammation of the facial nerve. Acupuncture and moxibustion (acu-moxi) is beneficial in treating facial palsy. In order to verify the efficacy of acu-moxi on Bell's palsy, a randomized single-blind, multicenter clinical trial was performed.Methods A total of 480 patients from four clinical centers were involved in this trial, of whom 439 completed the trial and 41 did not. All patients were randomly assigned to either the control group or to one of two treatment groups. The control group was treated with prednisone, vitamin B1, vitamin B12, and dibazole; the treatment groups were treated either with acu-moxi alone or in combination with prednisone, Vitamin B1, vitamin B12, and dibazole. Symptoms and signs, the House-Brackmann scale, and facial disability index (FDI) scores were assessed and determined both pre- and post-treatment to evaluate the effectiveness of the treatment methods.Results The characteristics of the control and two treatment groups were comparable without statistically significant differences before treatment. There were significant differences between the control and treatment groups after treatment (χ2=15.265, P=0.018). According to evaluations based on the House-Brackmann scale and FDI scores, the effectiveness of treatment in the two treatment groups was better than in the control group and was most effective in patients receiving acu-moxi treatment alone (Z=-2.827, P=0.005). Conclusion The efficacy of acu-moxi treatment for Bell's palsy is verified scientifically.

  11. CLINICAL RESEARCH ON ACUPUNCTURE TREATMENT OF DEPRESSIVE PSYCHOSIS

    符文彬

    2002-01-01

    Objective:To evaluate the therapeutic effect of acupuncture in the treatment of depressive psychosis.Methods:A total of 62 cases of depressive psychosis patients were randomly divided into treatment group(n=32) and control group(n=30).Acupoints used in treatment group were bilateral Hegu (LI 4),bilateral Taichong (LR 3),Baihui (GV 20) and Yintang (EX-HN 3).Patients of control group were asked to take Fluoxertine hydrochioride 20mg/d.The therapeutic effect was assessed using Hamilton's depression (HAMD) scales.Results:After 8 weeks' treatment,in treatment and control groups,4 and 3 cases were cured,8 and 6experienced marked improvement,14 and 14 had improvement,6 and 7 had no effect,with the effective rates being 81.25% and 76.66% separately,and no significant difference was found between two groups in HAMD scales (P>0.05).Conclusion:Acupuncture therapy is an effective method for treatment of depressive psychosis.

  12. Malaria Diagnostics in Clinical Trials

    Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann

    2013-01-01

    Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wi...

  13. Acupuncture to Reduce HIV-Associated Inflammation

    Barbara Swanson

    2015-01-01

    Full Text Available Background. HIV infection is associated with systemic inflammation that can increase risk for cardiovascular events. Acupuncture has been shown to have immunomodulatory effects and to improve symptoms in persons with inflammatory conditions. Objective. To test the anti-inflammatory effects of an acupuncture protocol that targets the cholinergic anti-inflammatory pathway (CAIP, a neural mechanism whose activation has been shown to reduce the release of proinflammatory cytokines, in persons with HIV-associated inflammation. Design, Setting, Participants, and Interventions. Double-blind, placebo-controlled clinical trial conducted in an outpatient clinic located in a medically underserved urban neighborhood. Twenty-five clinically-stable HIV-infected persons on antiretroviral therapy were randomized to receive once weekly CAIP-based acupuncture or sham acupuncture. Main Outcome Measures. Outcomes included plasma concentrations of high sensitivity C-reactive protein and D-dimer and fasting lipids. Results. Twenty-five participants completed the protocol (treatment group n=12, control group n=13. No adverse events related to the acupuncture protocol were observed. Compared to baseline values, the two groups did not significantly differ in any outcome measures at the end of the acupuncture protocol. Conclusions. CAIP-based acupuncture did not favorably modulate inflammatory or lipid parameters. Additional studies are warranted of CAIP-based protocols of different frequencies/durations.

  14. CHoosing Options for Insomnia in Cancer Effectively (CHOICE): Design of a patient centered comparative effectiveness trial of acupuncture and cognitive behavior therapy for insomnia.

    Garland, Sheila N; Gehrman, Philip; Barg, Frances K; Xie, Sharon X; Mao, Jun J

    2016-03-01

    Insomnia is a prevalent and persistent side effect of cancer, which if left unaddressed, can be unremitting and negatively influence physical and mental well-being. Acupuncture and Cognitive Behavioral Therapy (CBT) are commonly used non-pharmacological treatments that are efficacious for treating insomnia in cancer patients; however, little is known about the comparative effectiveness of these options. The goal of personalized medicine is to determine which treatments are most effective for which individuals, and patient preference for treatment is a particularly important contributor to adherence and outcomes. Here we describe the design of a clinical trial that begins to determine how best to personalize the treatment of insomnia for cancer survivors. This project is a randomized controlled comparative effectiveness trial with a nested qualitative study comparing acupuncture and CBT for insomnia and co-morbid symptoms in a heterogeneous sample of 160 cancer survivors. The primary aim is to determine which treatment is associated with the largest reduction in insomnia severity. The secondary aim is to examine the demographic, clinical, and psychological characteristics that predict and/or moderate treatment effect. Patients will receive ten treatments of acupuncture or 7 sessions of CBT over eight weeks and complete validated patient-reported outcome measures of sleep and co-morbid symptoms at baseline, mid-treatment, post-treatment, and at three-months to assess durability of effect. The results of the proposed study have the potential to improve healthcare outcomes by helping cancer survivors and their caregivers make informed and evidence-based decisions, leading to patient-centered and personalized care for cancer survivors with insomnia. PMID:26956541

  15. OBSERVATION ON CLINICAL THERAPEUTIC EFFECTS OF SCALP ACUPUNCTURE FOR FACIAL SPASM

    WANG Shun; CAI Yu-ying; SHANG Yan-jie; SANG Peng

    2005-01-01

    Objective: To observe clinical therapeutic effect of scalp acupuncture in the treatment of facial spasm. Methods: Sixty-five cases of facial spasm were randomly divided into control group (n=31) and treatment group(n=34). Patients of the treatment group were treated with penetrative acupuncture from Qianshencong(前神聪Extra) to Xuanli(悬厘GB 6), Baihui(百会GV 20) to Qubin(曲鬓GB 7), etc., and those of control group treated with acupuncture of Taiyang(太阳EX-HN 5), Yangbai(阳白GB 14), Quanliao(颧髎 SI 18) and Xiaguan(下关ST 7), etc. once daily, 20 sessions altogether. Results: After treatment, of the 31 cases and 34 cases in control and treatment groups, 5 and 12 were cured, 8 and 13 had remarkable improvement, 11 and 8 had improvement, 7 and 1 failed, with the total effective rates being 77.42% and 97.06% respectively; and the therapeutic effect of treatment group was significantly superior to that of control group(P<0.01). Conclusion: Scalp acupuncture has an obvious therapeutic effect for facial spasm.

  16. Participating in Clinical Trials

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... experimental treatment on a small group of often healthy people (20 to 80), to judge its safety ...

  17. Participating in Clinical Trials

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... to obtain preliminary data on whether the drug works in people who have a certain disease or ...

  18. Randomised clinical trial

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  19. Randomized clinical trial

    Olesen, Anne Estrup; Nielsen, Lecia Møller; Larsen, Isabelle Myriam;

    2015-01-01

    : The study was a randomized, double-blinded, placebo-controlled, crossover trial in healthy males. Esophageal electrical, thermal, mechanical, and chemical stimulations were performed, pain perception was rated, and referred pain areas were drawn. Sensitization was induced by intraluminal esophageal acid...

  20. Participating in Clinical Trials

    Full Text Available ... are usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, ... hundred to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial ...

  1. Participating in Clinical Trials

    Full Text Available ... usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 ... to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, ...

  2. Clinical Observation on Treatment of Migraine with Acupuncture

    CHEN Ze-lin

    2006-01-01

    Objective: To study the effect of puncturing points Taiyang (Ex-HN 5), Jiaosun (TE 20), Qiuxu (GB 40) and Shenmai (BL 62) on migraine. Methods: The 120 cases in the treatment group were treated with routine acupuncture therapy, while the 40 cases in the control group were treated with Ergotamine and Caffeine Tablet, and then the therapeutic effect and recovery time of the two groups were compared. Results: The recovery rate of the treatment group was 90.0%, which is higher than 70.0% of the control group (P< 0.01). The total effective rate of the treatment group was 100%, which is better than 92.5% of the control group (P < 0.05),The therapeutic effect of the treatment group was significantly better than the control group and the treatment group needed shorter treatment period (P< 0.05). Conclusions: Acupuncture has higher recovery rate and total effective rate as well as shorter treatment period than oral ergotamine and caffeine tablets, which indicated that acupuncture is superior to the routinely-administered oral western tablets in treating migraine.%目的:研究针刺太阳、角孙、丘墟和申脉对偏头痛的影响.方法:观察组120例患者采用常规针刺疗法,对照组40例患者采用口服麦咖片法,并将两组的治疗效果和痊愈时间进行对比观察.结果:观察组痊愈率90.0%高于对照组痊愈率70.0%(P<0.05).观察组总有效率100%好于对照组总有效率92.5%(P<0.01).观察组疗效明显优于对照组.而且观察组患者的治疗时间短(P<0.05).结论:针刺疗法痊愈率、总有效率均高于麦角胺咖啡因片,且疗程短,提示本法疗效优于口服常规西药的方法.

  3. Paradoxes in Acupuncture Research: Strategies for Moving Forward

    Helene M. Langevin

    2011-01-01

    Full Text Available In November 2007, the Society for Acupuncture Research (SAR held an international symposium to mark the 10th anniversary of the 1997 NIH Consensus Development Conference on Acupuncture. The symposium presentations revealed the considerable maturation of the field of acupuncture research, yet two provocative paradoxes emerged. First, a number of well-designed clinical trials have reported that true acupuncture is superior to usual care, but does not significantly outperform sham acupuncture, findings apparently at odds with traditional theories regarding acupuncture point specificity. Second, although many studies using animal and human experimental models have reported physiological effects that vary as a function of needling parameters (e.g., mode of stimulation the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. This White Paper, collaboratively written by the SAR Board of Directors, identifies gaps in knowledge underlying the paradoxes and proposes strategies for their resolution through translational research. We recommend that acupuncture treatments should be studied (1 “top down” as multi-component “whole-system” interventions and (2 “bottom up” as mechanistic studies that focus on understanding how individual treatment components interact and translate into clinical and physiological outcomes. Such a strategy, incorporating considerations of efficacy, effectiveness and qualitative measures, will strengthen the evidence base for such complex interventions as acupuncture.

  4. [Survey of clinical and experimental researches on mechanisms of acupuncture treatment of bronchial asthma].

    Tan, Cheng; Zhao, Ji-ping; Zhang, Chang

    2011-08-01

    In the present paper, the authors review the development of experimental and clinical studies on acupuncture treatment of bronchial asthma in recent 10 years. Regarding clinical studies, results showed that acupuncture could (1) regulate cardiac-pulmonary function; and (2) adjust immune state and relieve inflammatory reactions in bronchial asthma patients. Animal experiments showed that acupuncture could function in (1) improving pulmonary function; (2) reducing accumulation of the peripheral eosinophile granulocytes (EOS), relieving the infiltration of inflammatory cells in the air-passage mucosa and promoting the apoptosis of EOS in the lung and air-passages; (3) down-regulating the expression of air-passage remodeling-related protein insulin growth factor-1; (4) suppressing the secretion of tumor necrosis factor and endothelin; (5) attenuating allergic reaction; (6) regulating neuroendocrine activity; and (7) modulating intracellular second messenger activities. However, rigorous clinical study design is not enough, so that the reliability of the results is limited. In spite of many indicators of animal experiments have been selected, but their correlations are not in close association, resulting in poor complementation and mutual identification of the acquired findings. For this reason, its clinical efficacies need to be researched further according to principles of evidence-based medicine. PMID:21942186

  5. Integrating Massage, Chiropractic, and Acupuncture in University Clinics: A Guided Student Observation

    Estrin Dashe, Alejandra A.

    2012-01-01

    Background Several studies have reported on the health benefits of applying an integrated complementary health care model. Purpose This paper presents the results of pilot research focusing on the observations massage therapy students made about complementary health care education and integration during massage, chiropractic, and acupuncture treatments at two university clinics. Setting: Observations took place at Northwestern Health Sciences University’s associated clinics that offered massage, chiropractic, and acupuncture. Research Design: Students directly observed how clinicians and interns educated their patients and integrated other forms of complementary health care into their practice. Participants: chiropractors, massage therapists, and acupuncturists, and their patients. All participants were English-speaking and 18–65 years old. Main Outcome Measures: Observations recorded by students in journals about education and integration during massage therapy, chiropractic, and acupuncture treatments were coded and counted. Results Qualitative observations showed that clinicians and interns educated patients to some degree, but the clinicians were less apt to integrate other modalities than the interns. Conclusions Observations support that professional integrity may limit clinicians in their ability to integrate multiple modalities of health care while treating patients. Since it is well established that integration of multiple health care modalities is beneficial to patient health, it is recommended that clinics assist their clinical staff in applying an integrative approach to their practice. PMID:22811755

  6. Clinical Studies on Treatment of Chronic Prostatitis with Acupuncture and Mild Moxibustion

    Yu Yang; Kang Jingli; Duan Shumin

    2005-01-01

    To observe the therapeutic effect of acupuncture and mild moxibustion on chronic prostatitis and to probe into the mechanism of the therapy. Two hundred patients with chronic prostatitis were randomly divided into two groups so as to observe respectively the changes in clinical symptoms, count of WBC and lecithin corpuscles in succus prostaticus, prostatic capcules and internal echo, tenderness and elasticity of prostate by palpation before and after treatment. After treatment, a remarkable improvement was found in clinical symptoms, succus prostaticus test and ultrasonic examination in the treatment group with a statistically significant difference (P<0.05) as compared to the control group. The treatment of chronic prostatitis with acupuncture and mild moxibustion can remove the stagnation of succus prostaticus, improve the blood circulation in prostate, inhibit or kill the pathogenic micro-organisms, strengthen or regulate the immune function of the patients, improve local blood circulation, eliminate the accumulation of secretion and relieve the obstruction of the prostatic ducts.

  7. Eight-Points-Acupuncture and Ancient Chinese Contraindications in Acupuncture:Two Methods of Improving Acupuncture Treatment Based upon Ancient Chinese Sources,and Clinical Experiences

    SLOPEK, Axel; 冯海涛

    2006-01-01

    According to ancient and present Chinese sources the Eight Confluent Points are essentials of acupuncture and can treat all kinds of diseases. They exert a fundamental influence on the Twelve Regular Meridians and their mobilization can be seen as a necessity for a successful acupuncture treatment. For this they should play a major role in acupuncture. In European acupuncture teachings there is also the opinion that by too much needling of the Eight Confluent Points the qi of the organism might get exhausted which will deteriorate the patient's symptoms and eventually will create new symptoms. Here it will be shown that deterioration as well as the creation of new symptoms due to acupuncture is caused by not observing the contraindications in acupuncture as set up in ancient China provided that syndrome differentiation,point selection and stimulation have been correct. In opposition to this,all of the Eight Extraordinary Channels are to be activated at first and then the Twelve Regular Meridians are to be mobilized in order to achieve therapeutic effects.

  8. Clinical Trials | Division of Cancer Prevention

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  9. Nuclear medicine methods in the assessment of acupuncture effects: a short review

    Souza, Deise Elisabete; Rebello, Bernardo Machado; Agostinho, Raquel Terra [Universidade do Estado do Rio de Janeiro (UERJ), RJ (Brazil). Inst. de Biologia Roberto Alcantara Gomes. Lab. de Radiofarmacia Experimental; Academia Brasileira de Arte e Ciencia Oriental, Rio de Janeiro, RJ (Brazil); E-mail: deise_desouza@yahoo.com.br; Silva Filho, Reginaldo de Carvalho [Escola Brasileira de Medicina Chinesa, Sao Paulo, SP (Brazil). Centro Avancado de Pesquisas em Ciencias Orientais; Bastos, Sohaku R.C. [Academia Brasileira de Arte e Ciencia Oriental, Rio de Janeiro, RJ (Brazil); Bernardo-Filho, Mario [Instituto Nacional de Cancer (INCa), Rio de Janeiro, RJ (Brazil). Centro de Pesquisa Basica

    2007-09-15

    The mechanisms of acupuncture are poorly understood. In consequence, numerous investigators have conducted clinical trials to test the efficacy of acupuncture in various conditions. We have used PubMed database system to evaluate the number of publications in acupuncture and nuclear medicine procedures in the period from 1964 to 2007, using the keywords: 'nuclear medicine and acupuncture', 'SPECT and acupuncture, 'PET and acupuncture', 'scintigraphy and acupuncture, 'radionuclide and acupuncture', 'radiopharmaceutical and acupuncture', 'radioisotope and acupuncture' and {sup 99m}Tc and acupuncture'. Some papers published in English language were selected and a short review is presented The analysis of the number of publications shows that when a method is well accepted by the scientific community, as the methods used in nuclear medicine, the interest in the development of research increases. Moreover, important findings are presented when the nuclear medicine image is used to evaluate the effect of the acupuncture. (author)

  10. OARSI Clinical Trials Recommendations

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.; Finch, C. F.; Bennell, K. L.; Story, B.; Spindler, K.; Kemp, J.; Lohmander, L. S.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for...... will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact....

  11. Phantom Acupuncture: Dissociating Somatosensory and Cognitive/Affective Components of Acupuncture Stimulation with a Novel Form of Placebo Acupuncture

    Lee, Jeungchan; Napadow, Vitaly; Kim, Jieun; Lee, Seunggi; Choi, Woojin; Kaptchuk, Ted J.; Park, Kyungmo

    2014-01-01

    In a clinical setting, acupuncture treatment consists of multiple components including somatosensory stimulation, treatment context, and attention to needle-based procedures. In order to dissociate somatosensory versus contextual and attentional aspects of acupuncture, we devised a novel form of placebo acupuncture, a visual manipulation dubbed phantom acupuncture, which reproduces the acupuncture needling ritual without somatosensory tactile stimulation. Subjects (N = 20) received both real ...

  12. Acupuncture for Frequent Migraine: A Randomized, Patient/Assessor Blinded, Controlled Trial with One-Year Follow-Up

    Yanyi Wang

    2015-01-01

    Full Text Available Objectives. This study aimed to evaluate the efficacy and safety of manual acupuncture as a prophylaxis for frequent migraine. Methods. Fifty frequent migraineurs were randomly allocated to receive 16 sessions of either real acupuncture (RA = 26 or sham acupuncture (SA = 24 during 20 weeks. The primary outcomes were days with migraine over four weeks, duration, and intensity of migraine and the number of responders with more than 50% reduction of migraine days. The secondary outcomes were the relief medication, quality of migraine, quality of life, and pressure pain thresholds. Results. The two groups were comparable at baseline. At the end of the treatment, when compared with the SA group, the RA group reported significant less migraine days (RA: 5.2 ± 5.0; SA: 10.1 ± 7.1; P=0.008, less severe migraine (RA: 2.18 ± 1.05; SA: 2.93 ± 0.61; P=0.004, more responders (RA: 19 versus SA: 7, and increased pressure pain thresholds. No other group difference was found. Group differences were maintained at the end of the three-month follow-up, but not at the one-year follow-up. No severe adverse event was reported. Blinding was successful. Discussion. Manual acupuncture was an effective and safe treatment for short-term relief of frequent migraine in adults. Larger trials are warranted.

  13. Common statistical concerns in clinical trials

    Evans, Scott R.

    2010-01-01

    Statistics are an integral part of clinical trials. Elements of statistics span clinical trial design, data monitoring, analyses, and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of clinical trials. This manuscript outlines common statistical concerns in clinical trials that are important for clinicians to understand.

  14. Survey on Clinical Evidence of Acupuncture Therapy for Fibromyalgia Syndrome%针灸治疗纤维肌痛综合征的临床证据

    王栩; 杜元灏; 熊俊

    2011-01-01

    Objective To evaluate the clinical effect of acupuncture therapy for fibromyalgia syndrome (FMS) by analyzing the available studies so as to provide clinical decision-making reference. Methods The published papers on clinical trails for acupuncture treatment of FMS were widely retrieved from Chinese Biomedical Databases (1979 - 2010), www. cnki. net (1979-2010), VIP China Scientific Journal Database (1989- 2010), Digital Periodicals on Wanfang Data (1998- 2010), PubMed (1966-2010), etc. and by using key words of fibromyalgia syndrome and acupuncture. According to criterion of evidence-based medicine, the evidence from high to low quality levels was selected to answer corresponding clinical questions, and software RevMan 5.0 was used to analyze the final results. Results There has been no enough clinical evidence showing definite efficacy of acupuncture for FMS. However, a Level-A study (being in line with conditions of large sample, multi-centers, randomized controlled trails) and a level-C study (having control group, but without distinct randomizing method) showed respectively that acupuncture might be superior to Amitriptyline and Brufen in relieving FMS. Moreover, a piece of evidence that acupuncture combined with western medicine was superior to western medicine alone was allocated to a level-B (having correct randomizing method and control group). Finally, only a level-C evidence proved that laser irradiation on acupoint might be superior to traditional acupuncture in improving FMS. Conclusion Acupuncture for FMS has a positive effect, and acupuncture combined with western medicine can strengthen the curative effect. However this conclusion should be proved further by randomized controlled double blind clinical trials with large samples.%目的:通过对针灸治疗纤维肌痛综合征相关文献的整理评价,提炼出高质量的临床证据,以便于临床医师做出科学的决策.方法:全面检索相关文献,按照循证医学分级标准

  15. Clinical Observation on Acupuncture Plus Auricular Acupuncture in Treating Insomnia for 60 Cases%针灸配合耳针治疗失眠症60例

    赵云; 李志轩

    2014-01-01

    目的:观察针灸配合耳针治疗失眠症的临床疗效。方法对60例失眠患者,以针刺百会、神门、内关、三阴交为主穴,配合耳针皮质下、神门、心、肾、垂前。结果经治疗后,治愈30例,显效12例,有效12例,无效6例。总有效率90%。结论针刺配合耳穴治疗失眠疗效显著。%Objective To observe the clinical effect of treating insomnia by acupuncture and auricular acupuncture .Methods 60 cases of patients with insomnia were treated by acupoint , such as BaiHui, ShenMen, NeiGuan, SanYinJiao, coordinated auricular acupuncture point such as Subcortical, ShenMen, Xin, Shen, ChuiQian.Result After treatment, 48 cases were cured, 6 cases were markedly effective, 6 cases were ineffective .The cure rate fou 80%, The total effective rate was 90%.Conclusion The effect of treating insomnia by acupuncture and ear pressure was significant .

  16. Clinical Study on Electro-acupuncture Treatment for 30 Cases of Mental Depression

    韩毳; 李晓泓; 罗和春; 赵学英; 李学武

    2004-01-01

    To observe the clinical therapeutic effects of electro-acupuncture therapy for mental depression, 30 cases were treated by electro-acupuncture on Baihui (GV20), Yintang (EX-HN3) and the differential points.Maprotiline was used in the control group of 31 cases. After the treatment, the scores in HAMD for both groups were found to be obviously decreased as compared with those before the treatment (P<0.01),without significant between-group differences (P>0.05). The total effective rate in the treatment group was 96.7%, and that of the control group was 90.3%, showing no significant between-group differences (P>0.05). After the treatment, the two groups all showed obvious decrease in the TCM symptomatic integrals (P<0.01), with significant between-group differences (P<0.05), the integral of the treatment group showing obvious superiority to that of the control group. And the decrease of the Asberg scores testing the side effect of antidepressants of the treatment group was obviously superior to that of the control group. After the treatment, the cortisol (CORT) content and the endothelin-1 (ET-1) content of the two groups were all obviously decreased (P<0.01), and basically turned to normal, without significant between-group differences (P>0.05). Conclusion: Electro-acupuncture therapy can produce the same clinical therapeutic effect as that produced by the tetracyclic drug maprotiline, giving less side effect and better symptomatic improvement.

  17. LECTURE ON ACUPUNCTURE Part I Clinical Acupuncture Lecture Thirty-four UROLITHIASIS

    潘兴芳; 尚秀葵; 王卫

    2004-01-01

    @@ Urolithiasis is the general designation of urinary calculus occurring in every part of the urinary system, and is a commonly encountered disease in clinic. It is closely related to the environmental factors, systemic diseases and urinary diseases. It may mainly manifest lumbo-abdominal angina and hematuria, or be accompanied by symptoms of urinary obstruction and infection such as frequent and urgent micturition, urodynia, etc.. Urolithiasis corresponds to Shalin (砂淋 stranguria caused by urinary stones) or Xuelin (血淋 stranguria with blood) in TCM.

  18. Ongoing clinical trials in AKI.

    Faubel, Sarah; Chawla, Lakhmir S; Chertow, Glenn M; Goldstein, Stuart L; Jaber, Bertrand L; Liu, Kathleen D

    2012-05-01

    AKI is an important public health issue. AKI is a common hospital complication associated with increased in-hospital and long-term mortality, extensive morbidity (including prolonged hospital length of stay), and an estimated annual cost of at least $10 billion in the United States. At present, no specific therapy has been developed to prevent AKI, hasten recovery of kidney function, or abrogate the deleterious systemic effects of AKI. However, recent progress includes establishing a consensus definition of AKI and discovery of novel biomarkers that may allow early detection of AKI. Furthermore, significant insights into the pathophysiology of AKI and its deleterious systemic effects have been gleaned from animal studies. Urgently needed are large, definitive randomized clinical trials testing interventions to prevent and/or treat AKI. This review summarizes and analyzes current ongoing clinical trials registered with clinicaltrials.gov that address prevention or management of AKI. The purpose of this review is to provide a resource for people interested in potential prophylactic and therapeutic approaches to patient care and investigators hoping to plan and execute the next round of randomized clinical trials. Finally, this review discusses research needs that are not addressed by the current clinical trials portfolio and suggests key areas for future research in AKI. PMID:22442183

  19. LECTURE ON ACUPUNCTURE Part I Clinical Acupuncture Lecture Thirty- two ASTHMA

    徐立; 尚秀葵; 董洪英

    2003-01-01

    @@ Asthma is an allergic disease, characterized by paroxysmal dyspnea with wheezing sound in the throat and inability to lie flat. It may attack in people with different ages and in different seasons, especially in cold and cool seasons or during sudden changes of the weather. TCM thinks that asthma is often caused by retention of phlegm and fluid in the lungs due to disturbance of activities of qi. In the early stage of this disease, it generally belongs to excess syndrome. If attacking repeatedly, it may bring disasters to different zangfu-organs including spleen, lung,kidney and heart. Clinically this disease may be divided into 5 types: retention of cold-fluid in the lungs, accumulation of phlegm-heat, deficiency of both lung-qi and spleen-qi, deficiency of both lung-yin and kidney-yin, and deficiency of both heart-yang and kidney-yang.

  20. [Acupuncture in Oman].

    Wu, Bang-Qi

    2014-04-01

    The status quo and application of acupuncture therapy in Oman is introduced in this article. The gene -ral medical condition of Oman is comparatively backward. Function of local traditional medicine is limited. Indications of acupuncture in Oman are various pain syndromes and motor impairment after stroke. However, it is lack of systematic training and management of acupuncture practitioners. And the number of acupuncture clinic is comparatively inadequate. Therefore, qualified acupuncture training, publicity and cooperation with international organizations are highly recommended in the future. PMID:24946647

  1. Acupuncture for Pediatric Pain

    Brenda Golianu; Ann Ming Yeh; Meredith Brooks

    2014-01-01

    Chronic pain is a growing problem in children, with prevalence as high as 30.8%. Acupuncture has been found to be useful in many chronic pain conditions, and may be of clinical value in a multidisciplinary treatment program. The basic principles of acupuncture are reviewed, as well as studies exploring basic mechanisms of acupuncture and clinical efficacy. Conditions commonly treated in the pediatric pain clinic, including headache, abdominal pain, fibromyalgia, juvenile arthritis, complex re...

  2. Electroacupuncture in the treatment of chronic lameness in horses and ponies: a controlled clinical trial.

    Steiss, J E; White, N A; Bowen, J. M.

    1989-01-01

    Electroacupuncture was used to treat lameness in horses and ponies with chronic laminitis (n = 10) or navicular disease (n = 10). A clinical trial was conducted with random allocation of equal numbers of animals to control and treatment groups. Acupuncture was performed three times per week for four consecutive weeks. The degree of lameness was assessed by 1) a grading scheme, 2) measurement of stride lengths and 3) analysis of weight distribution using a force plate. Although seven out of te...

  3. Acupuncture in Pediatrics.

    Brittner, Mindy; Le Pertel, Noemie; Gold, Melanie A

    2016-06-01

    There has been extensive research on the use of acupuncture in adults with a wide array of conditions. Much less research has been conducted on the use of acupuncture in children. In this article, we review the history and philosophy of acupuncture, and the literature on its effectiveness and safety in children and adolescents, giving special attention to the pediatric and adolescent conditions that have been most studied in high-quality randomized controlled trials (RCTs). PMID:26867822

  4. A Multicentral Randomized Control Study on Clinical Acupuncture Treatment of Bell's Palsy

    2006-01-01

    Objective: To confirm the clinical therapeutic effects of acupuncture and moxibustion on Bell's palsy.Methods: 480 cases from 4 hospitals were enrolled for this study, among whom 439 cases completed the whole course of the study. The patients were randomly divided into the following 3 groups, a control group(treated with prednisone, vitamin B1, vitamin B12 and dibazol), an acu-moxibustion group (treated with filiform needle plus moxibustion), and a basic treatment plus acu-moxibustion group (treated with oral medicine like those in the control group plus acupuncture, and with moxibustion like in the acu-moxibustion group). The whole treatment course lasted 4 weeks. The therapeutic effects were evaluated according to the symptoms and signs, House-Brackmann grading scale and facial disability indexes(FDI). Results: All the 4 centers (hospitals) completed this study well, with no statistically significant difference found among the 4 centers in therapeutic effects. The patients with different conditions were well distributed in the 3 groups, thus the basic general data were comparable (P>0.05).The therapeutic effects of the two treatment groups were better than the control group (respectively P<0.05 and P<0.01), and it was the best in the acu-moxibustion group (P<0.01). Conclusion:Acupuncture and moxibustion may exert definite therapeutic effects on Bell's palsy, better than that of the basic treatment group or the basic treatment plus acu-moxibustion group.

  5. Clinical Observation on Scalp Acupuncture Combined with Rehabilitation Training for Hemiplegia After Stroke

    Qiu Ya-long

    2013-01-01

    Objective:To observe the clinical efficacy of the scalp acupuncture combined with rehabilitation training for hemiplegia.Methods:One hundred and thirty-six cases with hemiplegia after stroke who met the inclusion criteria were randomly divided into three groups according to visiting sequence.Forty-eight cases in the observation group were treated by scalp acupuncture combined with rehabilitation training,35 cases in the medicine group were treated by Chinese and Western medicines,and 53 cases in the medicine plus rehabilitation group were treated by Western medicine and rehabilitation training.Patients' consciousness,speech and limb functions were scored before and after treatment,and the results were compared.Results:After treatment,the scores of consciousness,speech and limb functions after treatment were lower than those before treatment.And their decrease in the observation group were more statically significant than that in the medicine group and the medicine plus rehabilitation group (P<0.01 or P<0.05).The total effective rates of the three groups were significantly different (P<0.01 or P<0.05).The total effective rate of the observation group was better than that of the other two groups (both P<0.01).Conclusion:Scalp acupuncture combined with rehabilitation therapy has better effect for stroke hemiplegia.

  6. [Human body meridian spatial decision support system for clinical treatment and teaching of acupuncture and moxibustion].

    Wu, Dehua

    2016-01-01

    The spatial position and distribution of human body meridian are expressed limitedly in the decision support system (DSS) of acupuncture and moxibustion at present, which leads to the failure to give the effective quantitative analysis on the spatial range and the difficulty for the decision-maker to provide a realistic spatial decision environment. Focusing on the limit spatial expression in DSS of acupuncture and moxibustion, it was proposed that on the basis of the geographic information system, in association of DSS technology, the design idea was developed on the human body meridian spatial DSS. With the 4-layer service-oriented architecture adopted, the data center integrated development platform was taken as the system development environment. The hierarchical organization was done for the spatial data of human body meridian via the directory tree. The structured query language (SQL) server was used to achieve the unified management of spatial data and attribute data. The technologies of architecture, configuration and plug-in development model were integrated to achieve the data inquiry, buffer analysis and program evaluation of the human body meridian spatial DSS. The research results show that the human body meridian spatial DSS could reflect realistically the spatial characteristics of the spatial position and distribution of human body meridian and met the constantly changeable demand of users. It has the powerful spatial analysis function and assists with the scientific decision in clinical treatment and teaching of acupuncture and moxibustion. It is the new attempt to the informatization research of human body meridian. PMID:26946752

  7. LECTURE ON ACUPUNCTURE PartⅠ Clinical Acupuncture Lecture Thirty-fiveCervical Spondylopathy

    罗汀; 王卫; 徐力

    2004-01-01

    @@ Cervical spondylopathy, also known as cervical syndrome, is a commonly encountered disease in the middle-aged and elderly people. This disease mostly results from the retrograde affection of the cervical intervertebral disc and hyperosteogeny of the cervical vertebrae. This hyperplastic substance may stimulate and give rise to oppression to the surrounding spinal cord, nerve roots, blood vessels and sympathetic nerves, resulting in a series of symptoms as numbness, pain, etc. in the neck, shoulder and the upper limbs. The cervical vertebra of the human spine is smallest in the size, weakest in the strength, higher in the motor range and frequency, and bigger in the bearing of per unit area. Along with the increasing of people's age and the accumulated aftereffect of chronic and acute injury, the pulpiform nucleus of the cervical intervertebral disc presents retrograde affection, dehydration, bulge and rupture of the fibrous ring, narrowing of the intervertebral space, and reduction in the stability of cervical vertebrae due to injury and slackening of intervertebral ligaments to stretch and to induce compression upon periosteum. All these changes may lead to break of blood vessels to cause bleeding and hematoma. With the organization of hematoma and calcium salt deposit, osteophyte is formed at last. When the protruded intervertebral disc and hyperplastic osteophyte stimulate and oppress the surrounding spinal nerve root, vertebral artery or spinal cord, the resultant injury, aseptic inflammation, reactions after renovation, etc. will generate a series of clinical symptoms of cervical spondylopathy. In Western medicine, there are five types of cervical spondylopathy including stiff-neck type, nerve root type, spinal cord type, vertebral artery type and sympathetic nerve type. The stiff-neck type, nerve root type and vertebral artery type will be introduced in this article.

  8. Pediatric Obstructive Uropathy: Clinical Trials

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  9. Using Guasha to treat musculoskeletal pain: A systematic review of controlled clinical trials

    Choi Sun-Mi

    2010-01-01

    Full Text Available Abstract Background Guasha is a therapeutic method for pain management using tools to scrape or rub the surface of the body to relieve blood stagnation. This study aims to systematically review the controlled clinical trials on the effectiveness of using Guasha to treat musculoskeletal pain. Methods We searched 11 databases (without language restrictions: MEDLINE, Allied and Complementary Medicine (AMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL, Korean Studies Information (KSI, DBPIA, Korea Institute of Science and Technology Information (KISTI, KoreaMed, Research Information Service System (RISS, China National Knowledge Infrastructure (CNKI and the Cochrane Library. The search strategy was Guasha (OR scraping AND pain. Risk of bias was assessed with the Cochrane criteria (i.e. sequence generation, blinding, incomplete outcome measures and allocation concealment. Results Five randomized controlled trials (RCTs and two controlled clinical trials (CCTs were included in the present study. Two RCTs compared Guasha with acupuncture in terms of effectiveness, while the other trials compared Guasha with no treatment (1 trial, acupuncture (4 trials, herbal injection (1 trial and massage or electric current therapy (1 trial. While two RCTs suggested favorable effects of Guasha on pain reduction and response rate, the quality of these RCTs was poor. One CCT reported beneficial effects of Guasha on musculoskeletal pain but had low methodological quality. Conclusion Current evidence is insufficient to show that Guasha is effective in pain management. Further RCTs are warranted and methodological quality should be improved.

  10. HIV/AIDS Clinical Trials Fact Sheet

    HIV Prevention HIV/AIDS Clinical Trials (Last updated 9/15/2015; last reviewed 9/15/2015) Key Points HIV/AIDS clinical ... safe and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help ...

  11. Literature study on clinical treatment of facial paralysis in the last 20 years using Web of Science Comparison between rehabilitation, physiotherapy and acupuncture

    Xiaoge Zhang; Ling Feng; Liang Du; Anxiang Zhang; Tian Tang

    2012-01-01

    BACKGROUND: Facial paralysis is defined as severe or complete loss of facial muscle motor function. OBJECTIVE: The study was undertaken to explore a bibliometric approach to quantitatively assess the research on clinical treatment of facial paralysis using rehabilitation, physiotherapy and acupuncture using Web of Science from 1992 to 2011. DESIGN: Bibliometric approach.DATA RETRIEVAL: A bibliometric analysis based on the publications on Web of Science was performed using key words such as "facial paralysis", "rehabilitation", "physiotherapy" and "acupuncture". INCLUSIVE CRITERIA: (1) Research articles on the clinical treatment of facial paralysis using acupuncture or physiotherapy (e.g. exercise, electro-stimulation) and other rehabilitation methods; (2) researches on human and animal fundamentals, clinical trials and case reports; (3) Article types: article, review, proceedings paper, note, letter, editorial material, discussion, book chapter. (4) Publication year: 1992-2011 inclusive. Exclusion criteria: (1) Articles on the causes and diagnosis on facial paralysis; (2) Type of articles: correction; (3) Articles from following databases: all databases related to social science and chemical databases in Web of Science.MAIN OUTCOME MEASURES: (1) Overall number of publications; (2) number of publications annually; (3) number of citations received annually; (4) top cited paper; (5) subject categories of publication; (6) the number of countries in which the article is published; (7) distribution of output in journals.RESULTS: Overall population stands at 3 543 research articles addressing the clinical treatment of facial paralysis in Web of Science during the study period. There is also a markedly increase in the number of publications on the subject "facial paralysis treatments using rehabilitation" during the first decade of the 21st century, except in 2004 and 2006 when there are perceptible drops in the number of articles published. The only other year during the

  12. Maximizing scientific knowledge from randomized clinical trials

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...

  13. A Clinical Study of Bee Venom Acupuncture Therapy on External Epicondylitis

    Kyung-Tae Kim

    2006-06-01

    Full Text Available Objective : This study was to evaluate the effectiveness of Bee Venom acupuncture therapy on external epicondylitis. Methods : We divided chronic arthritis of ankle patient into 2 groups; one group combined bee venom acupuncture therapy and acupuncture therapy, another group was only acupuncture therapy. To estimate the effectiveness of treatment that applied for two groups, we used visual analog scale(VAS. We compared the VAS score of two groups statistically. Results : 1. As a result of evaluation by using visual analog scale(VAS, treatment score at final was marked more higher than score before treatment on each groups. 2. treatment at final, acupuncture and bee venom acupuncture therapy group had significant result on visual analog scale(VAS compared with acupuncture therapy group. Conclusion : Bee Venom acupuncture therapy can be used with acupuncture therapy for highly effective treatment for external epicondylitis.

  14. Clinical Trials: Key to Medical Progress

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer 2008 ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well new ...

  15. Manipulation Therapy Relieved Pain More Rapidly Than Acupuncture among Lateral Epicondylalgia (Tennis Elbow) Patients: A Randomized Controlled Trial with 8-Week Follow-Up.

    Hsu, Chung-Yuan; Lee, Ko-Hung; Huang, Hsin-Chia; Chang, Zi-Yu; Chen, Hsing-Yu; Yang, Tsung-Hsien

    2016-01-01

    Radial bone adjustment manipulation treatment may be effective to reduce pain rapidly in lateral epicondylalgia patients and the pathological tension in the biceps brachii muscle is highly concerned. To prove this hypothesis, we conducted a randomized controlled trial and included 35 patients with lateral epicondylalgia for more than 2 months. Either manipulation treatment (n = 16) or acupuncture (n = 19) was given to these patients for 2 weeks and all patients' symptoms were followed up for 8 weeks after treatment. Both groups demonstrated changes in pain VAS score, grip strength, and DASH questionnaire. Lateral epicondylalgia patients who received manipulation treatment felt pain relief sooner than those who had acupuncture treatments during the first few treatments. However, both acupuncture and manipulation are effective, while the difference has no significance at the 8-week follow-up. The trial was registered with Current Controlled Trials ISRCTN81308551 on 5 February 2016. PMID:27143983

  16. Manipulation Therapy Relieved Pain More Rapidly Than Acupuncture among Lateral Epicondylalgia (Tennis Elbow Patients: A Randomized Controlled Trial with 8-Week Follow-Up

    Chung-Yuan Hsu

    2016-01-01

    Full Text Available Radial bone adjustment manipulation treatment may be effective to reduce pain rapidly in lateral epicondylalgia patients and the pathological tension in the biceps brachii muscle is highly concerned. To prove this hypothesis, we conducted a randomized controlled trial and included 35 patients with lateral epicondylalgia for more than 2 months. Either manipulation treatment (n=16 or acupuncture (n=19 was given to these patients for 2 weeks and all patients’ symptoms were followed up for 8 weeks after treatment. Both groups demonstrated changes in pain VAS score, grip strength, and DASH questionnaire. Lateral epicondylalgia patients who received manipulation treatment felt pain relief sooner than those who had acupuncture treatments during the first few treatments. However, both acupuncture and manipulation are effective, while the difference has no significance at the 8-week follow-up. The trial was registered with Current Controlled Trials ISRCTN81308551 on 5 February 2016.

  17. Human clinical trials in antiepileptogenesis

    Mani, Ram; Pollard, John; Dichter, Marc A.

    2011-01-01

    Blocking the development of epilepsy (epileptogenesis) is a fundamental research area with the potential to provide large benefits to patients by avoiding the medical and social consequences that occur with epilepsy and lifelong therapy. Human clinical trials attempting to prevent epilepsy (antiepileptogenesis) have been few and universally unsuccessful to date. In this article, we review data about possible pathophysiological mechanisms underlying epileptogenesis, discuss potential intervent...

  18. Acupuncture-Point Stimulation for Postoperative Pain Control: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Xian-Liang Liu

    2015-01-01

    Full Text Available The purpose of this study was to evaluate the effectiveness of Acupuncture-point stimulation (APS in postoperative pain control compared with sham/placebo acupuncture or standard treatments (usual care or no treatment. Only randomized controlled trials (RCTs were included. Meta-analysis results indicated that APS interventions improved VAS scores significantly and also reduced total morphine consumption. No serious APS-related adverse effects (AEs were reported. There is Level I evidence for the effectiveness of body points plaster therapy and Level II evidence for body points electroacupuncture (EA, body points acupressure, body points APS for abdominal surgery patients, auricular points seed embedding, manual auricular acupuncture, and auricular EA. We obtained Level III evidence for body points APS in patients who underwent cardiac surgery and cesarean section and for auricular-point stimulation in patients who underwent abdominal surgery. There is insufficient evidence to conclude that APS is an effective postoperative pain therapy in surgical patients, although the evidence does support the conclusion that APS can reduce analgesic requirements without AEs. The best level of evidence was not adequate in most subgroups. Some limitations of this study may have affected the results, possibly leading to an overestimation of APS effects.

  19. Acupuncture-Point Stimulation for Postoperative Pain Control: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Liu, Xian-Liang; Tan, Jing-Yu; Molassiotis, Alex; Suen, Lorna K P; Shi, Yan

    2015-01-01

    The purpose of this study was to evaluate the effectiveness of Acupuncture-point stimulation (APS) in postoperative pain control compared with sham/placebo acupuncture or standard treatments (usual care or no treatment). Only randomized controlled trials (RCTs) were included. Meta-analysis results indicated that APS interventions improved VAS scores significantly and also reduced total morphine consumption. No serious APS-related adverse effects (AEs) were reported. There is Level I evidence for the effectiveness of body points plaster therapy and Level II evidence for body points electroacupuncture (EA), body points acupressure, body points APS for abdominal surgery patients, auricular points seed embedding, manual auricular acupuncture, and auricular EA. We obtained Level III evidence for body points APS in patients who underwent cardiac surgery and cesarean section and for auricular-point stimulation in patients who underwent abdominal surgery. There is insufficient evidence to conclude that APS is an effective postoperative pain therapy in surgical patients, although the evidence does support the conclusion that APS can reduce analgesic requirements without AEs. The best level of evidence was not adequate in most subgroups. Some limitations of this study may have affected the results, possibly leading to an overestimation of APS effects. PMID:26568767

  20. Gatekeepers for pragmatic clinical trials.

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  1. Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol

    Kang Kyung-Won; Shin Mi-Suk; Kim Ae-Ran; Zhao Jiping; Zhao Hong; Ko Jeong-Min; Lee Sanghoon; Choi Jun-Yong; Jung So-Young; Lee Myeong Soo; Kim Jong-In; Jung Hee-Jung; Kim Tae-Hun; Liu Baoyan; Choi Sun-Mi

    2009-01-01

    Abstract Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with pe...

  2. Clinical Trials Management | Division of Cancer Prevention

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  3. What Are Clinical Trials? | NIH MedlinePlus the Magazine

    ... of this page please turn Javascript on. Feature: Clinical Trials What Are Clinical Trials? Past Issues / Fall 2010 Table of Contents Clinical ... conducted all the time. The Different Phases of Clinical Trials Clinical trials related to drugs are classified into ...

  4. Establishing an animal model for National Acupuncture Detoxification Association (NADA) auricular acupuncture protocol.

    Kattalai Kailasam, Vasanth; Anand, Preeti; Melyan, Zara

    2016-06-15

    The use of opioids in the treatment of chronic pain has increased dramatically in the past few decades making them one of the most commonly prescribed medications in the US. However, long-term use of opioids is limited by development of tolerance (decreased antinociceptive efficacy) and opioid-induced hyperalgesia - paradoxical sensitization to noxious (hyperalgesia) and non-noxious (allodynia) stimuli. Novel adjunctive therapies are needed to increase the efficacy and prolong the duration of action of opioids in chronic pain treatment. Acupuncture is often used as an adjunct therapy for the treatment of symptoms induced by non-clinical use of opioids. The National Acupuncture Detoxification Association (NADA) auricular acupuncture protocol is the most common form of acupuncture treatment for substance abuse. The standardized, easy to use and virtually painless procedure make it an attractive complementary treatment option for patients suffering from opioid-induced adverse effects. Clinical trials designed to test the efficacy of the NADA protocol yielded contradictory results. The mechanism by which NADA acupuncture could serve as a successful treatment remains unknown. Therefore, establishing an animal model of NADA acupuncture can provide a tool for investigating the efficacy and cellular mechanisms of NADA treatment. Previous studies have shown that repeated morphine administration in rodents can produce locomotor sensitization and reduce analgesic potency of a challenge dose of morphine, indicating development of morphine tolerance. Here we show that NADA acupuncture treatment can both reduce morphine-induced locomotor sensitization and prevent the development of morphine tolerance in rats, thus validating a new model for NADA acupuncture studies. Our data provides support for evidence-based use of NADA acupuncture as a new adjunctive approach that can potentially improve the side-effect profile of morphine and other prescription opioids. PMID:27155456

  5. Clinical Observations on 30 Cases of Chronic Simple Pharyngitis Treated by Acupuncture plus Cupping Method

    程玲; 张春燕; 甘志豪

    2006-01-01

    Objective:In order to investigate the clinical efficacy of acupuncture plus cupping method for treating chronic pharyngitis. Methods: Sixty patients with chronic simple pharyngitis were randomly divided into two groups. Thirty cases in the treatment group were treated by acupuncture plus cupping method and 30 cases in the control group by routine anti-inflammatory and antiviral therapy. The clinical effects were observed in the two groups. Results: The total effective rate was 93.3% in the treatment group and 80.0% in the control group. The therapeutic effect was significantly better in the treatment group than in the control group (P<0.05). Conclusion: Acupuncture plus cupping method has a good effect for chronic simple pharyngitis.%目的:观察针刺加拔罐治疗慢性咽炎的临床疗效.方法:将慢性咽炎患者60例随机分为两组,治疗组30例,采用针罐治疗;对照组30例,采用常规的抗炎、抗病毒治疗.观察两组的临床疗效.结果:治疗组总有效28/30,对照组为24/30.治疗组疗效明显优于对照组(P《0.05).结论:针刺加拔罐治疗慢性咽炎的疗效好.

  6. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

    Prayle, A.P.; Hurley, M.N.; Smyth, Alan R

    2012-01-01

    Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one...

  7. LECTURES ON ACUPUNCTURE—PartⅠ Clinical Acupuncture Lecture Nineteen INSOMNIA

    XuLi; MengHong; WangShaorong; WangWei

    2000-01-01

    Insomnia refers to a disorder in which patient can not have normal or enough sleep. Clinically, it has different manifestations. In mild cases, it is manifested as difficulty in getting to sleep, easy to wake up and unable to sleep againafter waking. In severe cases, it is manifested as sleeplessness during the whole night.

  8. Sample Size Estimation in Clinical Trial

    Tushar Vijay Sakpal

    2010-01-01

    Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and a...

  9. Pseudobulbar Paralysis Treated by Acupuncture - Clinical Observation in 36 Cases

    杜琳

    2001-01-01

    @@Pseudobulbar paralysis is a kind of common clinical syndromes of cerebral vascular diseases, which is manifested as dyslalia, dysphagia and choking. By several-year clinical observations, 36 cases were treated with satisfactory therapeutic effects as reported in the following. Clinical Data Of 36 in-patients, there were 24 males and 12 females, aged from 44 to 81 years, averaging 64.92 years. Of 36 cases, 24 were at the acute stage and 12 at the recovery stage. All the cases were diagnosed as cerebral vascular diseases by cranial CT scan and MRI, of which, 4 were cerebral infarction, 26 lacunar cerebral infarction, 5 cerebral hemorrhage and 1 mixed type. Of 36 cases, 15 were the first attack of wind-stroke, 15 the second attack, 5 the third attack and 1 the forth attack. There were 26 patients with hypertension among 36 cases, of which, 8 patients suffered from hypertension within 10 years, 6 for more than 10 years, 9 for more than 20 years and 3 for more than 30 years. All the 36 cases were associated with dysphagia and agreeable to Standard on Diagnosis and Evaluation of Therapeutic Effects of Wind-stroke issued by the State Scientific Committee 85-919-01-01, 1995.

  10. Clinical Observation The Thoughts and Methods for Clinical Research on Acupuncture Treatment of Chronic Fatigue Syndrome

    2007-01-01

    The general situation of chronic fatigue syndrome (CFS) and the criteria for its diagnosis are discussed, and it is put forward that making qi and blood of the zang-fu organs balanced is the key to acupuncture treatment of the disease. Such aspects as case selection, point selection and therapeutic assessment are also discussed in the present paper.

  11. Prior to Conception: The Role of an Acupuncture Protocol in Improving Women's Reproductive Functioning Assessed by a Pilot Pragmatic Randomised Controlled Trial

    Cochrane, Suzanne; Smith, Caroline A.; Possamai-Inesedy, Alphia; Bensoussan, Alan

    2016-01-01

    The global average of couples with fertility problems is 9%. Assisted reproductive technologies are often inaccessible. Evidence points to acupuncture offering an opportunity to promote natural fertility. This study asked whether providing a multiphasic fertility acupuncture protocol to women with sub/infertility would increase their awareness of fertility and achieve normalisation of their menstrual cycle compared with a lifestyle control. In a pragmatic randomised controlled trial sub/infertile women were offered an intervention of acupuncture and lifestyle modification or lifestyle modification only. There was a statistically significant increase in fertility awareness in the acupuncture group (86.4%, 19) compared to 40% (n = 8) of the lifestyle only participants (Relative Risk (RR) 2.38, 95% confidence interval (CI) of 1.25, 4.50), with an adjusted p value of 0.011. Changes in menstrual regularity were not statistically significant. There was no statistical difference in the pregnancy rate with seven women (adjusted p = 0.992) achieving pregnancy during the course of the study intervention. Those receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group (p = 0.422). The acupuncture protocol tested influenced women who received it compared to women who used lifestyle modification alone: their fertility awareness and wellbeing increased, and those who conceived did so in half the time.

  12. Clinical Observation on Therapeutic Effects of Acupuncture Treatment for 100 Cases of Type Ⅱ Diabetes

    YANG Dan; HUANG Guo-qi

    2004-01-01

    Purpose: To observe the therapeutic effect of acupuncture treatment for diabetes. Method:Based upon proper diet, 100 cases of patients with diabetes were treated with Pishu (BL 20), Shenshu (BL 23), Feishu (BL 13), Weiwanxiashu (Extra), Zusanli (ST 36), Sanyinjiao (SP 6), Hegu (LI 4), and Xuehai (SP 10) by electric acupuncture, with acupoints added or deducted upon syndrome differentiation.Results: Fasting blood sugar decreased in the patients after the treatments, with a significant difference (P<0.05) in comparison with before treatment. And the patients with obvious symptoms decreased from 85% before the treatment to 4% after the treatment. Conclusions: Acupuncture treatment can reduce fasting blood sugar in the patients with diabetes and is also remarkably effective in improving the clinical symptoms.%目的:观察针刺治疗糖尿病的疗效.方法:对100例患者在适当饮食控制的基础上,电针脾俞、肾俞、肺俞、胃脘下俞、足三里、内关、三阴交、合谷和血海,并辨证加减.结果:治疗后患者空腹血糖值下降,与治疗前比有显著差异(P<0.05);症状明显者由治疗前的85%下降到治疗后的4%.结论:针刺能降低糖尿病患者空腹血糖,在改善临床症状方面亦有明显效果.

  13. Clinical trials and gender medicine

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  14. Clinical Observation on the Effect of Earlobe-Bleeding plus Body Acupuncture in 85 Cases of Common Acne

    2008-01-01

    Objective: To observe the clinical effect of earlobe-bleeding plus body acupuncture for common acne. Methods: The earlobe-bleeding plus local and body acupuncture based on syndrome differentiation was adopted for 85 cases of common acne. Results: Of the 85 cases treated, 61 were cured, 12 markedly effective, 9 improved, and 3 failed. The total effective rate was 96.47%. Conclusions: The therapy can treat both the Biao-symptom and Ben-root of common acne, short in course and effective in result.

  15. Enhancing Adherence in Clinical Exercise Trials.

    O'Neal, Heather A.; Blair, Steven N.

    2001-01-01

    Discusses exercise adherence from the perspective of adhering to an exercise treatment in a controlled trial, focusing on: adherence (to intervention and measurement); the development of randomized clinical trials; exemplary randomized clinical trials in exercise science (exercise training studies and physical activity interventions); and study…

  16. Contraceptive development and clinical trials.

    Fraser, I S

    1986-02-01

    This article provides an overview of the contraceptive development process, with particular emphasis on the importance of clinical trials. Development of a new contraceptive drug begins with chemical synthesis of a large number of substances that may have antifertility effects. Before human trials are considered, drugs must undergo a complex process of animal toxicology testing. Such studies assess acute, subacute, and chronic toxicity. Once a drug has passed the initial screening process, human testing must follow a logical sequence of clinical trials: phase I, pharmacology testing; phase II, initial assessment of efficacy, safety, acceptability, and ease of use; phase III, acurate assessment of efficacy, side effects, and reasons for discontinuation under controlled conditions; and phase IV, evaluation of effectiveness under field conditions. When these have been satisfactorily completed, a detailed marketing application must be submitted to the drug regulatory agency in each country. The process of assessment of the application often takes as long as 2 years. Once marketing approval has been received, there is still a need for postmarketing surveillance of the performance of the new contraceptive method. In many cases, a careful program of training is required. Among the research and recording strategies for postmarketing surveillance are voluntary recording of possible adverse reactions, longterm prospective cohort studies, retrospective case-control studies, and registered release. As controls on the safety and performance of new contraceptive methods are being tightened, the time scale and costs of development are increasing. The time from the 1st synthesis of a drug to marketing approval often takes 13-14 years and costs US$25-50 million. Since the patent life of a new substance is limited to 17 years in most countries, pharmaceutical companies have little time to recoup development costs, which has caused fewer new methods to be developed. PMID:3708511

  17. Acupuncture for Limb Conditions: Pinpointing the Evidence.

    2016-06-01

    Acupuncture therapies include a range of interventions and are commonly used for managing musculoskeletal disorders of the extremities; however, their use is still controversial. A study published in the June 2016 issue of JOSPT conducted a systematic review of randomized clinical trials on the effectiveness of various acupuncture therapies for any musculoskeletal condition affecting the limbs. Importantly, the review critically appraised the quality of the evidence to reveal risks of bias. In this Perspectives for Practice, the authors explain the impact of their findings for clinicians treating patients with such musculoskeletal conditions. J Orthop Sports Phys Ther 2016;46(6):430. doi:10.2519/jospt.2016.0502. PMID:27245489

  18. CLINICAL OBSERVATION ON THE TREATMENT OF KNEE OSTEOARTHRITIS BY ACUPUNCTURE IN BA-HE TECHNIQUE

    LIANG Yun-wu; TAN Yuan-sheng; ZHOU Jun

    2005-01-01

    Objective:To observe the clinical therapeutic effect of Ba-He technique of acupuncture in the treatment of knee osteoarthritis. Methods: A total of 90 cases of knee osteoarthritis were evenly randomized into Ba-He technique group (observation group) and common technique group (control group), with 45 cases in each group. Zusanli (足三里 ST 36), Heding (鹤顶 EX-LE 2) and Dubi (犊鼻 ST 35) were punctured respectively in Ba-He technique and common technique in the two groups. The therapeutic effects of the two groups were compared after one course of treatment (10 sessions) in accordance with Japanese assessment criteria for knee-joint functions. Results: Aftertreatment, among the 74 and 71 affected knees in the observation and control groups, the therapeutic effect was excellent in 42 (56.8%) and 26 (36.6%) knees, fine in 14 (18.9%) and 20 (28.2%), OK in 10 (13.5%) and 11 (15.5%), and poor in 8 (10.8%) and 14 (19.7%) respectively. The therapeutic effect of the observation group was significantly better than that of control group (P<0.01). Conclusion: The Ba-He technique of acupuncture applied to the above-mentioned three acupoints exerted remarkable therapeutic effect for knee osteoarthritis, which is obviously better than that of the common needling technique.

  19. Maximizing scientific knowledge from randomized clinical trials

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...... discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed, in...

  20. Clinical trials: innovation, progress and controversy

    Martin GS

    2011-01-01

    Greg S MartinDepartment of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, Georgia, USAThe Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. T...

  1. The Clinical Trials Transformation Initiative (CTTI)

    Alberto Grignolo

    2011-01-01

    The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiative was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patient...

  2. Clinical Study on the Wrist-Ankle Acupuncture Treatment for 30 Cases of Diabetic Peripheral Neuritis

    2006-01-01

    Objective: To study the mechanisms of wrist-ankle acupuncture for prevention and treatment of diabetic peripheral neuritis. Methods: Ninety cases of diabetic peripheral neuritis were randomly divided into 3groups, and treated respectively with wrist-ankle acupuncture, body-acupuncture, and the western routine medical treatment, with 30 cases in each of the groups; and therapeutic effects and laboratory results compared. Results: It is proved that the therapeutic effects of the wrist-ankle acupuncture group and body acupuncture group were significantly superior to those of the control group, with no significant differences between the former two groups. Conclusion: Wrist-ankle acupuncture has the actions of improving the metabolisms of blood sugar and blood-lipid, lowering down blood viscosity, and restoring the functions of peripheral nerve cells, thus giving definite therapeutic effects for diabetic peripheral neuritis.

  3. Randomized controlled trial of traditional Chinese medicine (acupuncture and Tuina) in cerebral palsy: Part 1 - Any increase in seizure in integrated acupuncture and rehabilitation group versus rehabilitation group?

    Wu, Y; Zou, LP; Han, TL; Zheng, H.; Caspi, O; Wong, V; Su, Y.; Shen, KL

    2008-01-01

    Objective: The objective of this study was to observe for any change in baseline seizure frequency with acupuncture in children with cerebral palsy. Methods: A randomized controlled study was conducted: Group I consisted of integrated acupuncture, tuina, and rehabilitation (physiotherapy, occupational therapy, and hydrotherapy) for 12 weeks; and Group II consisted of rehabilitation (physiotherapy, occupational therapy, and hydrotherapy) for 12 weeks. After a washout period of 4 weeks, Group I...

  4. Clinical Observation of Depression Following Cerebral Apoplexy Treated by Scalp-acupuncture

    SONG Ying; LIANG Hao-rong

    2003-01-01

    Objective: To observe the therapeutic effect of scalp-acupuncture on post-apoplectic depression.Methods: Twenty-nine patients with depression due to cerebral apoplexy were treated by scalp-acupuncture and compared with 28 cases of medicine group chosen randomly. Results: In scalp-acupuncture group, the total effective rate was 89. 6%. In medicine group (control group), the total effective rate was 71.4%. Conclusion:The result showed that the therapeutic effect in scalp-acupuncture group was obviously better than that in medicine group (P<0.05).

  5. Clinical Observation on Treatment of Anxiety with Combined Acupuncture and Medicine

    ZHOU Zhi-hua; YU Wei-ying; WU Zhou-hong; WU Bo-xiang; DAI Xiao-ying; HAN Chou-ping

    2003-01-01

    Purpose To observe the curative effect of combined acupuncture and medicine on anxiety. Method An acupuncture plus medicine group and a medicine group were established for a comparison of their curative effects on anxiety. Results The total effective rate was 96% in the acupuncture plus medicine group and 64% in the medicine group, and there was a significant difference between the two groups (P<0.001). Conclusion The curative effect of combined acupuncture and medicine on anxiety is better than that of simple medicine.

  6. Analyzing the Study of Using Acupuncture in Delivery in the Past Ten Years in China

    Yingru Chen

    2014-01-01

    Full Text Available The use of acupuncture in inducing delivery has a long history in China. With progress over time, it has been applied in many aspects. For further study of acupuncture in delivery, this paper analyzed the papers using acupuncture in delivery in the past ten years in mainland China. 87 literatures were picked out by searching relevant electronic databases and bibliographies of relevant journals. The analysis showed randomized controlled trials that were the major type of research, while preclinical researches and literature reviews only account for around ten percent, respectively. Clinical researches indicated that acupuncture can relieve labor pain, promote maternal uterine contraction, shorten birth process, and treat postpartum disorders. Preclinical researches found that acupuncture can adjust certain hormones and improve uterus contraction of late-stage pregnant rats. However, due to lack of large multicenter randomized controlled clinical trials, standardized evaluations of clinical effects in clinical researches and detailed mechanism study in preclinical researches and unequivocal conclusions about the effectiveness, efficacy, and mechanisms of acupuncture in this field cannot be obtained from those researches yet. Further clinical and preclinical studies about the use of acupuncture in delivery with improved methodology is still needed.

  7. Understanding Central Mechanisms of Acupuncture Analgesia Using Dynamic Quantitative Sensory Testing: A Review

    Jiang-Ti Kong; Schnyer, Rosa N; Johnson, Kevin A.; Sean Mackey

    2013-01-01

    We discuss the emerging translational tools for the study of acupuncture analgesia with a focus on psychophysical methods. The gap between animal mechanistic studies and human clinical trials of acupuncture analgesia calls for effective translational tools that bridge neurophysiological data with meaningful clinical outcomes. Temporal summation (TS) and conditioned pain modulation (CPM) are two promising tools yet to be widely utilized. These psychophysical measures capture the state of the a...

  8. The Effect of Bee Venom Acupuncture(BVA on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study

    Song, Ho-Seub

    2005-06-01

    Full Text Available Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC participated in the study, who were divided into two groups (A and B randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41 of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo or BVA was done and then acupuncture at 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41, 足三里(ST36, 陽陵泉(G34 of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS and Visual Analogue Scale(VAS were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective

  9. Why are clinical trials necessary in India?

    Poongothai, Subramani; Unnikrishnan, Ranjit; Balasubramanian, Jeyakumar; Nair, Mohan Damodaran; Mohan, Viswanathan

    2014-01-01

    Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP). This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field. PMID:24741480

  10. Why are clinical trials necessary in India?

    Subramani Poongothai

    2014-01-01

    Full Text Available Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP. This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field.

  11. Ethics of clinical trials in Nigeria

    Patrick I Okonta

    2014-01-01

    Full Text Available The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  12. Registration of randomized clinical trials

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... starting enrolment before 2010 to 63.2% after 2010 (24/38, P randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  13. Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial

    Pirotta, Marie; Ee, Carolyn; Teede, Helena; Chondros, Patty; French, Simon; Myers, Stephen; Xue, Charlie

    2014-01-01

    Background Hot flushes and night sweats (vasomotor symptoms) are common menopausal symptoms, often causing distress, sleep deprivation and reduced quality of life. Although hormone replacement therapy is an effective treatment, there are concerns about serious adverse events. Non-hormonal pharmacological therapies are less effective and can also cause adverse effects. Complementary therapies, including acupuncture, are commonly used for menopausal vasomotor symptoms. While the evidence for th...

  14. Treating vascular mild cognitive impairment by acupuncture: a systematic review of randomized controlled trials

    周丽

    2014-01-01

    Objective To systematically evaluate the effect and safety of acupuncture in the treatment of vascular mild cognitive impairment(VMCI).Methods Recruited were China National Knowledge Infrastructure Database(CNKI)(1979—2012),Chinese Science and Technology Periodical Database(VIP)(1989—2012),Chinese Biomedical Database(CBM),Wanfang degree and conference papers database(1985—2012),PubMed Database(1966—2012),and The Cochrane Library(Issue 1,2012).The search date ended in

  15. Clinical Observations of Mind-regulating Acupuncture in Treating 100 Cases of Peripheral Facial Paralysis

    刘月芝; 杨玲

    2007-01-01

    Objective: To investigate the clinical effect of mind-regulating acupuncture therapy on peripheral facial paralysis. Methods: Two hundred subjects were divided into observation group (treated by mind-regulating acupuncture therapy) and control group (treated by points of Yang-ming meridians) with one hundred in each group. The points of Yang-ming meridians were mainly selected for control group, observation group were treated by points with the function of regulating mind besides the points of control group, for two courses with 10 treatments in course. Results: The cure rate was 65.0% and total effective rate was 99.0% in observation group, while in control group, the cure rate was 55.0% and total effective rate was 91.0%, the curative effect in observation group was prior to control group (P<0.05). Conclusion:The therapy of mind-regulating acupuncture gives a quicker response, a shorter course of treatment and a higher cure rate.%目的:观察调神法针刺治疗周围性面瘫的临床疗效.方法:200例患者随机分为观察组(调神法组)与对照组(取阳明经为主组)各100例.对照组取阳明经穴位为主,观察组在此基础上加调神穴位,10次为1疗程,观察2个疗程.结果:观察组治愈率65.0%,总有效率99.0%;对照组治愈率55.0%,总有效率91.0%,观察组疗效优于对照组(P<0.05).结论:调神法治疗周围性面瘫起效快,疗程短,治愈率高.

  16. Clinical Study of Acupuncture in Treating Insomnia%针灸治疗失眠的临床研究

    高希言; 时明伟

    2011-01-01

    目的:通过对近年来有关针灸治疗失眠的文献进行研究,探讨针灸治疗失眠的临床疗效.方法:将近年来针灸治疗失眠的文献资料按从心论治、从脑论治、营卫学说、辩证论治等四个方面进行探讨.结果与结论:针灸治疗失眠疗效显著.%objective:According to the literature of relevant acupuncture treatment of insomnia in recent years, to explore the clinical study of insomnia acupuncture treatment progress. Methods: For the past few years insomnia acupuncture treatment according to the literature from the heart from brain differentiation and treatment, camp guard theory, combination of disease differentiation discusses four aspects. Results and Conclusion:The curative effect of Acupuncture treatment insomnia is significant.

  17. Recruitment, Retention, and Blinding in Clinical Trials

    Page, Stephen J.; Persch, Andrew C.

    2013-01-01

    The recruitment and retention of participants and the blinding of participants, health care providers, and data collectors present challenges for clinical trial investigators. This article reviews challenges and alternative strategies associated with these three important clinical trial activities. Common recruiting pitfalls, including low sample size, unfriendly study designs, suboptimal testing locations, and untimely recruitment are discussed together with strategies for overcoming these b...

  18. Potential bias in ophthalmic pharmaceutical clinical trials

    Paul Varner

    2008-01-01

    Paul VarnerJohn J Pershing Veterans’ Administration Medical Center, Poplar Bluff, Missouri, USAAbstract: To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data an...

  19. The Progress in Clinical and Basic Research of the Effect ofAcupuncture in Treating Disorders of Gastrointestinal Motility

    2000-01-01

    Futu (ST32) and Liangqiu (ST34) and its bilateral control acupoints.(26) It was Zusanli and Weishu, but not Ximen, at which laser irradition could adjust amplitude of gastroelectricity.(34) Needling at Zusanli and Neiguan, but not Tiaokou (ST38) and Tianquan (PC2), could make disorder of GE in rabbit improve significantly.(30) It was demonstrated that there was a relative specificity of effects on GE among meridians and acupoints. Electroacupuncture at Zusanli could inhibit the gastroelectric excess induced by gastrin, but electroacupuncture at Heyang (BL55) could not. Needling at Zusanli in the patients with stomach and spleen diseases had more effect in influencing amplitude of GE than Yanglingquan and other acupoints belong to other meridians. So it is considered that there exists acupoint specificity in stomach meridian.  From the above, we can say there is certain effect of acupuncture in treating disorders of gastrointestinal motility, which was confirmed by a series of clinical and basic researches. Further studies in this field could do more to improve the curative effect and to elucidate the mechanism of acupuncture. In the future, research should focus on the perspective and double-blind controlled studies, and therapeutic effect should be estimated with standard criteria. Basic research should be performed at the cellular and molecular level. In brief, acupuncture is a safe, effective and economical method for treating disorders of gastrointestinal motility with a bright future.

  20. Acupuncture ( zhēn jiǔ) - an emerging adjunct in routine oral care.

    Gupta, Devanand; Dalai, Deepak Ranjan; Swapnadeep; Mehta, Parul; Indra, B Niranjanaprasad; Rastogi, Saurabh; Jain, Ankita; Chaturvedi, Mudita; Sharma, Saumya; Singh, Sanjeev; Gill, Shruti; Singh, Nisha; Gupta, Rajendra Kumar

    2014-10-01

    Acupuncture ( Zhēn Jiǔ) ('acus' (needle) + 'punctura' (to puncture)) is the stimulation of specific points along the skin of the body involving various methods such as penetration by thin needles or the application of heat, pressure, or laser light. Acupuncture ( Zhēn Jiǔ) aims to treat a range of medical and dental ailments, though is most commonly used for pain relief. This article reviews about the various possible roles of acupuncture ( Zhēn Jiǔ) in clinical dental practice. Acupuncture ( Zhēn Jiǔ) has potential in supplementing conventional treatment procedures by its diverse applicability outreach. Role of acupuncture ( Zhēn Jiǔ) in dental practice has been well supported by clinical trials. Its role in alleviating facial pain, pre-operative and post-operative dental pain has led to its widespread application. Its role as sole analgesic for treatment procedure has to be tested. It's It is a thought that acupuncture ( Zhēn Jiǔ) may prove an indispensible supplement to conventional treatment modalities and more of clinical trials and studies are required to prove the efficacy. Acupuncture ( Zhēn Jiǔ) is not a miracle cure and is not going to replace the drill. However, the technique can be a supplement to conventional treatments in TMDs, facial pain, pain management Sjoegrens syndrome, and in phobias and anxiety. The application and use of Acupuncture ( Zhēn Jiǔ) comes with some side effects. Proper training needs to be obtained before commencement of any procedure related to acupuncture ( Zhēn Jiǔ). Various training programs are offered to train clinical practitioners the apt method to use acupuncture ( Zhēn Jiǔ). PMID:25379462

  1. [Standardizing the manipulation procedure of acupuncture-moxibustion, reinforcing the training of' clinical skill: learning experience of Acupuncture-moxibustion Clinical Skills Training: Chapter of Commonly Used Needling and Moxibustion Techniques].

    Tian, Hongfang; Yang, Chao; Tang, Jie; Qin, Qiuguo; Zhao, Mingwen; Zhao, Jiping

    2015-07-01

    The book Acupuncture-moxibustion Clinical Skills Training is one of "Twelfth Five-Year Plan" in novative teaching materials, which is published by People's Medical Publishing House. Through learning the first half of the book commonly used needling and moxibustion techniques, it is realized that the selection of book content is reasonable and much attention is paid to needling and moxibustion techniques; the chapter arrangement is well-organized, and the form is novel, which is concise and intuitive; for every technique, great attention is paid to standardize the manipulation procedure and clarify the technique key, simultaneously the safety of acupuncture and moxibustion is also emphasized. The characteristics of the book, including innovativeness, practicability, are highlighted, and it greatly helps to improve students' clinical skills and examination ability. PMID:26521599

  2. Treatment of Diabetic Retinopathy with Acupuncture plus Herbal Decoction: Clinical Observation of 40 Cases

    HU Yong-he; WU Shen-tao; LI Jing; HAN Chou-ping

    2004-01-01

    The clinical effect on treatment of diabetic retinopathy with acupuncture plus herbal decoction has been observed. Eighty cases were randomly divided into treatment group and control group by the odd and even serial numbers. Forty cases in the treatment group were treated with needling Taiyang (Ex-HN 5), Yangbai (GB 14) toward Yuyao (Ex-HN 4) and Cuanzhu (BL 2) plus the herbal decoction called "Mingmu Wuzi Decoction". Forty cases in the control group were treated with intravenous drip of Venorutin and oral administration of dipyridamole and vitamin E. And the result showed the total effective rate of 92.5% in the treatment group and that of 55.0% in the control group with significant difference (P<0.01), which suggested that acupuncture plus herbal decoction had better therapeutic effect than western medications alone.%观察针刺结合口服中药汤剂治疗糖尿病视网膜病变临床疗效.将80例患者按单双号随机分成治疗组40例,予针刺太阳、阳白透鱼腰、攒竹等穴和服用中药"明目五子汤";对照组40例子静脉滴注维脑路通及口服双密达莫、维生素E,进行对照观察.治疗组总有效率为92.5%,对照组总有效率为55.0%,疗效相比差异有显著性意义(P<0.01).针刺结合中药汤剂有较好疗效,且优于单纯西药治疗.

  3. Clinical Observation on the Treatment of Chloasma by Chinese Herbs Combined with Acupuncture

    2007-01-01

    Objective: To evaluate the clinical effect of Chinese herbs combined with acupuncture (CH-A) in treating chloasma. Methods: Sixty-one patients with chloasma were randomly assigned to two groups: 30 in the control group and 31 in the treated group. Both groups received conventional Besides, the treated group also received CH-A, with the therapeutic course for both groups as 3 months. Results: The total effective rate in the treated group and the control group was 100.00% and 46.67% respectively, and the cure-effective rate was 74.19% and 13.33% respectively, all showing significant difference between the two groups (P<0.01). The scores of size and color of skin lesion and that of symptoms decreased in both groups, but the decrease in the treated group was more obvious,showing significant difference compared with those before treatment and also compared with those in the control group after treatment (P<0.05 or P<0.01). A follow-up study in 1 year to 2 years and 4 months showed that the long-term effect in the treated group showed an increasing trend compared with the effect immediately after treatment, but it showed a decreasing trend in the control group, though with no any statistical significance (both P>0.05). Conclusion: On the basis of conventional treatment,combined use of Chinese herbal medicine and acupuncture in treating chloasma could markedly improve the accompanied symptoms, lighten the color and shrink the size of skin lesions.

  4. The Cooperative Landscape of Multinational Clinical Trials.

    Hsiehchen, David; Espinoza, Magdalena; Hsieh, Antony

    2015-01-01

    The scale and nature of cooperative efforts spanning geopolitical borders in clinical research have not been elucidated to date. In a cross-sectional study of 110,428 interventional trials registered in Clinicaltrials.gov, we characterized the evolution, trial demographics, and network properties of multinational clinical research. We reveal that the relative growth of international collaboratives has remained stagnant in the last two decades, although clinical trials have evolved to become much larger in scale. Multinational clinical trials are also characterized by higher patient enrollments, industry funding, and specific clinical disciplines including oncology and infectious disease. Network analyses demonstrate temporal shifts in collaboration patterns between countries and world regions, with developing nations now collaborating more within themselves, although Europe remains the dominant contributor to multinational clinical trials worldwide. Performances in network centrality measures also highlight the differential contribution of nations in the global research network. A city-level clinical trial network analysis further demonstrates how collaborative ties decline with physical distance. This study clarifies evolving themes and highlights potential growth mechanisms and barriers in multinational clinical trials, which may be useful in evaluating the role of national and local policies in organizing transborder efforts in clinical endeavors. PMID:26103155

  5. Construction of ethics in clinical research: clinical trials registration

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  6. Acupuncture in the treatment of obesity: a narrative review of the literature.

    Belivani, Maria; Dimitroula, Charikleia; Katsiki, Niki; Apostolopoulou, Martha; Cummings, Mike; Hatzitolios, Apostolos I

    2013-03-01

    Obesity is one of the leading health risk factors worldwide and is associated with several other risk factors and health problems including type 2 diabetes mellitus, cardiovascular disease and malignancies. Current conventional therapeutic strategies for obesity cannot achieve adequate weight control in all patients, so complementary types of treatment are also performed. Acupuncture, one of the oldest healing practices, represents the most rapidly growing complementary therapy which is recognised by both the National Institutes of Health and the WHO. A previous review concluded that acupuncture was superior to lifestyle advice, to sham acupuncture and to conventional medication. In this narrative review, the possible mechanisms of actions and the results of recent experimental and clinical studies with different forms of acupuncture (eg, body, auricular, manual and electroacupuncture) are presented. In particular, the effects of acupuncture on anorexigenic and orexigenic peptides, insulin resistance, lipid metabolism and inflammatory markers are discussed. Both experimental and clinical current data suggest that acupuncture exerts beneficial effects on the mechanisms of obesity. Some data suggest that electroacupuncture may be more effective than manual acupuncture; however, the most effective frequency remains controversial. Combination of different forms of acupuncture with diet and exercise seems to be necessary for achieving and maintaining weight loss.  Further prospective clinical trials are needed to establish the effectiveness of this complementary method for obesity treatment. PMID:23153472

  7. 针刺治疗多囊卵巢综合征随机对照试验指南%Acupuncture for treating polycystic ovary syndrome:guidance for future randomized controlled trials

    Yan WU; Nicola ROBINSON; Paul J HARDIMAN; Malcolm B TAW; Jue ZHOU; Fang-fang WANG; Fan QU

    2016-01-01

    fertility were used as the main measurements to assess the effects of acupuncture on the patients with PCOS. Thirty trials, except for one, showed an improvement in at least one of the indicators of PCOS after acupuncture treatment. However, normalizing the methodological and reporting format remains an issue. Conclusions: Based upon this review of current clinical trials concerning acupuncture for treating PCOS, we provide guidelines for better clinical trial design in the future.

  8. ACUPUNCTURE FOR PRIMARY DYSMENORRHEA-A meta-analysis

    CHOU Chin-shan; LIU Bao-yan; ZHANG Lu; JIN Zhi-gao

    2005-01-01

    Recent literature search showed that up to now there are a total of 9 theses about clinical treatment of primary dysmenorrhea with acupuncture therapy, among them 5 clinical trials are from Chinese journals and the rest 4 from foreign journals. Majority of the trials have some methodological and/or reporting shortcomings. The frequency and intensity of dysmenorrhea are divided into intermittent and continuous types. Results of quantitative meta-analysis with Revman 4.1 software showed that the existing evidence supports the value of acupuncture for the treatment of dysmenorrhea. However, the quality of evidence is not fully convincing. There is an urgent need for well-planned, large-scale and multiple-center studies to assess the effectiveness and cost-effectiveness of acupuncture under real-life conditions.

  9. Paperless clinical trials: Myth or reality?

    Sandeep K Gupta

    2015-01-01

    Full Text Available There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

  10. Vulvodynia Treated with Acupuncture or Electromyographic Biofeedback

    Oroma B. Nwanodi; Melanie M. Tidman

    2014-01-01

    First, second, and third line medical treatments of vulvodynia are of limited efficacy. Surgical resection, the fourth line treatment of vulvodynia, may have unforgiving sequela. Therefore, acupuncture and electromyographic (EMG) biofeedback could bridge between medical and surgical treatments of vulvodynia. Of note, EMG biofeedback is more frequently recommended in treatment algorithms for vulvodynia than is acupuncture. Trials of acupuncture for unprovoked vulvodynia demonstrate variab...

  11. The Clinical Study on a Case of Transverse Myelitis With Bee Venom and Hominis Placenta Herbal Acupuncture

    Park Min-ho

    2005-06-01

    Full Text Available Objective : This study was performed to evaluate the treatment of acupuncture therapy including Bee Venom and Hominis Placenta herbal acupuncture on the patient with Transverse myelitis. Methods : We treated the patient with Transverse myelitis by Bee Venom herbal acupuncture at beginning, since then we treated him adding to Hominis Placenta herbal acupuncture. Conclusions : The patient was effectively reduced symptoms with Bee Venom herbal acupuncture, since then he get more effective improvement of symptoms by adding Hominis Placenta herbal acupuncture. Therefore we are able to expect Bee venom and Hominis Placenta herbal acupuncture will be more effective than simply acupuncture on the patient with Transverse myelitis.

  12. Microbicide clinical trial adherence: insights for introduction.

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-01-01

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs. PMID:23561044

  13. Microbicide clinical trial adherence: insights for introduction

    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  14. CLINICAL ANALYSIS ON TREATMENT OF LUMBAR VERTEBRAL RETROGRADE AFFECTION WITH ACUPUNCTURE, TDP-IRRADIATION AND CUPPING

    ZHOU Yi

    2002-01-01

    In the present paper, 70 cases of retrograde affection of the lumbar vertebrae are randomly and evenly divided into treatment group and control group. Shenshu (BL 23), Qihaishu (BL 24), Dachangshu (BL 25),Weizhong (BL 40), Jiaji (EX-B 2), etc. are used. In treatment group, acupuncture, TDP irradiation and cupping are performed, and in control group, only acupuncture is given. After 30 sessions (3 therapeutic courses) of treatment, in treatment and control groups, the total effective rates are 91.43 % and 71.43 % respectively. The therapeutic effect of comprehensive treatment is significantly superior to that of simple acupuncture therapy (P < 0.05).

  15. Clinical Observation on Acupuncture Treatment for Post-stroke Spastic Hemiplegia

    Zhang Yan; Liu Guo-cheng; Wang Jin-yu; Sun Yun-guang; Yang Liu-jiang

    2013-01-01

    Objective:To observe the clinical effect of contralateral needling plus rehabilitation for post-stroke spastic hemiplegia.Methods:Thirty-six patients with post-stroke spastic hemiplegia were randomly divided into a treatment group and a control group,18 cases in each group.The two groups were all given rehabilitation training.The contralateral needling was adopted in the treatment group on the acupoints group of brain-refreshing and orifice-opening needling method.The routine acupuncture was applied in the control group on the same acupoints.Respectively before and after the treatment,the modified Ashworth scale (MAS) and clinical spasticity index (CSI) were used to assess the therapeutic effects.Results:The total effective rate was 94.4% in the treatment group and 67.7% in the control group,with a statistical difference in comparison of the two groups (P<0.05).In comparison of MAS and CSl scores after the treatment between the treatment group and control group,the differences were statistically significant (P<0.05).Conclusion:The contralateral needling plus rehabilitation training is an effective method for the treatment of post-stroke spastic hemiplegia.

  16. Clinical Observation on Treatment of Depression by Electro-Acupuncture Combined with Paroxetine

    2007-01-01

    Objective: To observe the clinical efficacy and adverse reactions of Paroxetine combined with electro-acupuncture (EA) in treating depression. Methods: Forty-two patients with depression were randomly assigned to the observation group (22 patients) treated with EA combined with Paroxetine, and the control group (20 patients) treated with Paroxetine alone, and the therapeutic course for both groups was 6 weeks. The therapeutic efficacy and adverse reactions were evaluated with scores by Hamilton depression scale (HAMD) and treatment emergent symptoms scale (TESS),respectively. Results: HAMD scores determined at the end of the 1st, 2nd, 4th, and 6th week of the treatment course were significantly lower in the observation group than those in the control group (P<0.05). The significant improvement rate evaluated at the end of the 6-week treatment was remarkably higher in the observation group than that in the control group (72.7% vs 40.0%). No significant difference of TESS scores was found between the two groups. Conclusion: EA combined with Paroxetine has better clinical efficacy than that of Paroxetine alone, with milder adverse reaction and quicker initiation of effect.

  17. Marketing and clinical trials: a case study

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  18. Alexander Technique lessons, acupuncture sessions or usual care for patients with chronic neck pain (ATLAS) : study protocol for a randomised controlled trial.

    Macpherson, H.; Tilbrook, H.E.; Richmond, S.J.; Atkin, K; Ballard, K.; Bland, M; Eldred, J.; Essex, H.N.; Hopton, A; Lansdown, H; Usman, M.; Parrott, S.; Torgerson, D; Wenham, A.; Woodman, J.

    2013-01-01

    Background: Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. Methods/Design: We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least ...

  19. Understanding Central Mechanisms of Acupuncture Analgesia Using Dynamic Quantitative Sensory Testing: A Review

    Jiang-Ti Kong

    2013-01-01

    Full Text Available We discuss the emerging translational tools for the study of acupuncture analgesia with a focus on psychophysical methods. The gap between animal mechanistic studies and human clinical trials of acupuncture analgesia calls for effective translational tools that bridge neurophysiological data with meaningful clinical outcomes. Temporal summation (TS and conditioned pain modulation (CPM are two promising tools yet to be widely utilized. These psychophysical measures capture the state of the ascending facilitation and the descending inhibition of nociceptive transmission, respectively. We review the basic concepts and current methodologies underlying these measures in clinical pain research, and illustrate their application to research on acupuncture analgesia. Finally, we highlight the strengths and limitations of these research methods and make recommendations on future directions. The appropriate addition of TS and CPM to our current research armamentarium will facilitate our efforts to elucidate the central analgesic mechanisms of acupuncture in clinical populations.

  20. International Clinical Trials Registry Platform (ICTRP)

    2011-01-01

    @@ Introduction The mission of the WHO Intemational Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.This will improve research transparency and will ultimately strengthen tha validity and value of the scientific evidence base.The registration of all interventional trials is a scientific, ethical and moral responsibility.

  1. Efficacy and safety of acupuncture for chemotherapy-induced leucopoenia: protocol for a systematic review

    Nian, Jiayun; Sun, Xu; Guo, Jiao; Yan, Chen; Wang, Xiaomin; Yang, Guowang; YANG, LIN; Yu, Mingwei; Zhang, Ganlin

    2016-01-01

    Introduction Many cancer patients experience leucopoenia during chemotherapy. Granulocyte- colony-stimulating factor (G-CSF) is used to treat chemotherapy-induced leucopoenia (CIL) but has various limitations. Clinical trials have indicated that acupuncture may prevent bone marrow suppression and increase leucocyte counts after chemotherapy. The objective of this review is to assess the efficacy and safety of acupuncture for treating CIL. Methods and analysis This systematic review will elect...

  2. Randomized Controlled Trials of Acupuncture (1997-2007): An Assessment of Reporting Quality with a CONSORT- and STRICTA-Based Instrument.

    Hammerschlag, Richard; Milley, Ryan; Colbert, Agatha; Weih, Jeffrey; Yohalem-Ilsley, Beth; Mist, Scott; Aickin, Mikel

    2011-01-01

    The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997-2007. This Oregon CONSORT STRICTA Instrument (OCSI) is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedure, or usual biomedical care. The 333 RCTs that met inclusion criteria were dispersed among 27 countries and 141 journals. Mean quality of reporting score for all articles was 63.0% (SD 16.5). Mean OCSI scores revealed a 30.9% improvement over the ten-year period (P < .001). Our findings suggest that to enhance quality of reporting, authors should better attend to seven specific OCSI items in three categories: practitioner training, adverse events, and aspects of randomization and blinding (n = 5). The broad diversity in geographical origin, publication site and quality of reporting, viewed in light of the considerable room for improvement in mean OCSI scores, emphasizes the importance of making STRICTA as well as CONSORT more widely known to journals and to the acupuncture research community. PMID:20953418

  3. Blinding in randomized clinical trials: imposed impartiality

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations and...

  4. Blinding in randomized clinical trials: imposed impartiality

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  5. Importance of Children in Clinical Trials

    ... the time. Can we predict which drugs work differently in adults and children? No. The differences in ... to participate in a clinical trial, you should learn the key facts about it. To help you ...

  6. Subcutaneous electrical stimulation (acupuncture) in the clinical practice of physical medicine.

    Waylonis, G W

    1976-04-01

    There has been a rapid growth in both interest and concern over the value of acupuncture in this country during the last three years. Initially it was regarded with doubt, then with overwhelming interest, but only recently have any research data appeared as to its true value and applicability to western medicine. An acupuncture research project was initiated in November 1972 by the author to assess the immediate and long-range benefits of acupuncture in a group of 179 patients with various neuromuscular-skeletal pain and mobility problems. A total of 1,112 treatments have been administered. A follow-up survey of these patients was completed in October 1974 with 126 (70%) of the patients responding to a subjective questionnaire. In 49% of the patients the initial response to acupuncture treatments was some reduction of symptoms and in a significant percentage there was persistence of beneficial response for greater than three months. PMID:1083724

  7. Clinical Observation of 40 Cases of Acne Treated by Acupuncture plus Herbal Drugs

    CAI An-he; DAI Xi-ping; ZHANG Hai-bo; HUANG Guo-qi

    2003-01-01

    Acne is divided into the patterns of wind and heat in the lung meridian and accumulation of dampness and heat. Forty cases of acne were treated by acupuncture plus herbal drugs (acupuncture and drug group, A) and 30 cases were treated by simple acupuncture as the control group (acupuncture group, B). The results showed basic cure in 31 cases, remarkable effect in 5 cases, effect in 3 cases, failure in 1 case and the total effective rate of 97.5% in Group A, and basic cure in 16 cases, remarkable effect in 6 cases, effect in 3 cases, failure in 5 cases and the total effective rate of 83.3% in Group B. There was no significant difference ( P > 0.05 ) in the therapeutic effect and there was a significant difference (P < 0. 01 ) in the curative rate in the two groups. The therapeutic effect was obviously better in Group A than in Group B.

  8. Acupuncture for Lateral Epicondylitis: A Systematic Review

    Hongzhi Tang

    2015-01-01

    Full Text Available Objective. This systematic review aimed to assess the effectiveness and safety of acupuncture for lateral epicondylitis (LE. Methods. Seven databases and the WHO International Clinical Trials Registry Platform Search Portal were searched to identify relevant studies. The data were extracted and assessed by two independent authors, and Review Manager Software (V.5.3 was used for data synthesis with effect estimate presented as standard mean difference (SMD and mean difference (MD with a 95% confidence interval. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE was used to assess the level of evidence. Results. Four RCTs with 309 participants were included with poor methodological quality. Participants who received acupuncture and acupuncture plus moxibustion with material insulation were likely to have an improvement in elbow functional status and/or myodynamia. The overall quality rated by GRADE was from very low to low. Two studies reported that the needle pain would be the main reason for the dropout. Conclusion. For the small number of included studies with poor methodological quality, no firm conclusion can be drawn regarding the effect of acupuncture of elbow functional status and myodynamia for LE. This trial is registered with CRD42015016199.

  9. Randomization in substance abuse clinical trials

    Woolson Robert F; Hedden Sarra L; Malcolm Robert J

    2006-01-01

    Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distribu...

  10. Clinical Experience on Treatment of Cervical Spondylosis with Combined Acupuncture, Tuina and Psychotherapy

    陈莉秋; 苗荃; 马庭秀; 刘立飞; 韩丑萍

    2009-01-01

    @@ Cervical spondylosis is common in the middle-aged or senile population and can greatly affect their body-mind health[1]. The common treatment methods include traction, tuina, acupuncture and medication[2]. However, psychological factors, such as anxiety, depression or fear are often neglected during the treatment[3]. The authors investigated the effect of combined psycho- therapy, acupuncture and tuina on the cervical spondylosis.

  11. The clinical observations of 3 cases of metatarsal tendinitis treated with anti-inflammatory herbal acupuncture

    Sung-lae,Kim; Kwon-eui,Hong

    2007-01-01

    Objective : The objective of this study is to observe the effect of anti-inflammatory herbal acupuncture on the metatarsal tendinitis. Methods : After the application of herbal acupuncture, the VAS and Baumgaertner's nine point scale were assessed. If there were any restraints on the ROM, ROM was also assessed alongside the previous scales. Results : 1. The pain was reduced significantly according to the VAS scale. 2. As to the assessment of satisfaction in treatment, by the Baumgae...

  12. Barriers to Recruitment of Rural Patients in Cancer Clinical Trials

    Virani, Shamsuddin; Burke, Lola; Remick, Scot C.; Abraham, Jame

    2011-01-01

    Rates of clinical trial participation are lower among patients in rural areas. Oncologists should be trained to address patient concerns regarding clinical trial availability, utility, and accessibility.

  13. CLINICAL OBSERVATION ON LUMBAR INTERVERTEBRAL DISC HERNIATION TREATED BY TRACTION COMBINED WITH ACUPUNCTURE

    何涛; 何岚

    2004-01-01

    Objective: To observe the therapeutic effect of traction combined with acupuncture on lumbar intervertebral disc herniation (LIDH).Methods:Eighty-three patients diagnosed as LIDH were randomly divided into treatment group (n=42)and control group (n=41).In the treatment group, besides lumbar traction, electroacupuncture at Jiaji (EX-B 2, L3~5), Shenshu (BL 23), Qihai (CV 6), Mingmen (GV 4), Huantiao (GB 30), Chengshan (BL 57) and Yanglingquan (GB 34) was added.In the control group, only lumbar traction was applied.Results: In treatment group, the cure plus markedly effective rate was 80.95% with a total effective rate of 92.86%, while in control group, it was 39.02% with a total effective rate of 80.48%.The therapeutic effect in the treatment group was obviously better than that in the control group (P<0.001).Conclusion: Lumbar traction plus EA can effectively alleviate or even eliminate clinical symptoms and signs of lumbar intervertebral disc herniation.

  14. Acupuncture Treatment for Plantar Fasciitis: A Randomized Controlled Trial with Six Months Follow-Up

    Shi Ping Zhang

    2011-01-01

    Full Text Available Plantar fasciitis is a common cause of heel pain. It has been suggested that some acupoints have a specific effect on heel pain. The aim of this study was to determine the efficacy and specificity of acupuncture treatment for plantar fasciitis. Subjects were randomly assigned to the treatment group (n = 28 or control group (n = 25. The treatment group received needling at the acupoint PC 7, which is purported to have a specific effect for heel pain. The control group received needling at the acupoint Hegu (LI 4, which has analgesic properties. Treatment was administered five times a week for 2 weeks, with an identical method of manual needling applied to the two acupoints. The primary outcome measure was morning pain on a 100-point visual analog scale (VAS at one month post-treatment. Secondary outcome measures included a VAS for activity pain, overall pain rating as well as pressure pain threshold using algometry. Significant differences in reduction in pain scores, favoring the treatment group, were seen at one month for morning pain (22.6 ± 4.0 versus 12.0 ± 3.0, mean ± SEM, overall pain (20.3 ± 3.7 versus 9.5 ± 3.6 and pressure pain threshold (145.5 ± 32.9 versus −15.5 ± 39.4. No serious adverse event was observed in either group. The results indicate that acupuncture can provide pain relief to patient with plantar fasciitis, and that PC 7 is a relatively specific acupoint for heel pain.

  15. The effect of acupuncture on mood and working memory in patients with depression and schizophrenia

    Peggy Bosch; Maurits van den Noort; Sujung Yeo; Sabina Lim; Anton Coenen; Gilles van Luijtelaar

    2015-01-01

    BACKGROUND: In patients with depression, as wel as in patients with schizophrenia, both mood and working memory performance are often impaired. Both issues can only be addressed and improved with medication to some extent. OBJECTIVE: This study investigates the mood and the working memory performance in patients with depression or schizophrenia and whether acupuncture can improve these. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A pragmatic clinical trial design was used. The study was conducted in a psychiatric clinic. Fifty patients with depression and 50 with schizophrenia were randomly divided into an experimental and a waiting-list group. Additional y, 25 healthy control participants were included. Twelve weeks of individualized acupuncture treatment was used as the clinical intervention. MAIN OUTCOME MEASURES: Al patients were tested before (T1) and after (T2) acupuncture treatment on a mood scale (Beck Depression Inventory-II, BDI-II), a simple working memory task (digit span), and a complex working memory task (letter-number sequencing); the healthy controls were tested at T1 only. RESULTS: Patients with depression scored worse than the others on the BDI-II, and patients with schizophrenia scored worse than the healthy controls. On the digit span, patients with schizophrenia did not differ from healthy controls whereas they scored worse of al on the letter-number sequencing. With respect to the acupuncture findings, first, the present study showed that the use of acupuncture to treat patients with schizophrenia was both practical and safe. Moreover, acupuncture had a positive effect on the BDI-II for the depression group, but acupuncture had no effect on the digit span and on the letter-number sequencing performance for the two clinical groups. CONCLUSION: The clinical improvement in patients with depression after acupuncture treatment was not accompanied by any significant change in a simple working memory task or in a more complex working memory

  16. Developments in statistical evaluation of clinical trials

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  17. Clinical outcomes in clinical trials of anti-HIV treatment

    Reekie, J; Mocroft, A; J, Neaton; Lundgren, Jens Dilling

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  18. The Clinical Study on a Case of Transverse Myelitis With Bee Venom and Hominis Placenta Herbal Acupuncture

    Park Min-ho; Lim Sung-taek; Choi Seok-woo

    2005-01-01

    Objective : This study was performed to evaluate the treatment of acupuncture therapy including Bee Venom and Hominis Placenta herbal acupuncture on the patient with Transverse myelitis. Methods : We treated the patient with Transverse myelitis by Bee Venom herbal acupuncture at beginning, since then we treated him adding to Hominis Placenta herbal acupuncture. Conclusions : The patient was effectively reduced symptoms with Bee Venom herbal acupuncture, since then he get more effective ...

  19. 头针、腹针结合火针治疗腰椎间盘突出症临床研究%The clinical research on scalp acupuncture, abdominal acupuncture combining fire needle treating Lumbar Disc Herniation

    谭俊健

    2013-01-01

      目的:观察头针、腹针结合火针治疗腰椎间盘突出症的临床疗效.方法:选择我科2009年2月至2010年2月门诊治疗的腰椎间盘突出症患者68例,随机分为治疗组和对照组.治疗组用头针、腹针加火针的方法治疗,对照组用电针治疗.观察两组治疗前后症状改善情况.结果:两组相比治愈率及治疗次数均有显著性差异(P<0.01).结论:头针、腹针配合火针治疗腰椎间盘突出症效果明显优于电针.%Objective:To observe the efficacy of scalp acupuncture, abdominal acupuncture com-bining fire needle treating lumbar disc herniation (LDH). Methods:68 patients with LDH treating in outpatient Clinic were randomly divided into treatment group and control group. The treatment group was used the method of scalp acupuncture, abdominal acupuncture combining fire needle to treat LDH, While the control group used electroacupuncture. Observed the situation of symptoms improved between two groups before and after treatment. Results:The recovery rate and treatment times had significant difference between two groups (P<0.01). Conclusion: The effect of using scalp acupuncture, abdominal acupuncture combining fire needle treating LDH is better than that of electroacupuncture

  20. Evaluation of the effects of acupuncture on P6 and anti-gagging acupoints on the gag reflex

    Abbas Haghighat

    2015-01-01

    Full Text Available Introduction: Hyperactive gag reflex can make dental treatment procedures intolerable for some patients; so, it is highly important for the dentist to control it. Acupuncture is a technique used to control this phenomenon. In this study, the effects of two acupoints, anti-gagging and P6, on the gag r eflex control were analyzed. Materials and Methods: In this clinical trial study, a total number of 100 healthy people were classified into four groups. Acupuncture and psuedo-acupuncture procedures were performed on anti-gagging and P6 points based on the group. Before and after acupuncture or pseudo-acupuncture, gag reflex severity was measured via stimulation of the soft palate, tonsils, and root of the tongue. Obtained data was analyzed using statistical package of social sciences (SPSS 22 statistical software. Results: Acupuncture reduced gag reflex at both points, but psuedo-acupuncture did not reduce the gag reflex. Moreover, no significant difference was observed between acupuncture on P6 and anti-gagging points. Conclusion: Acupuncture on anti-gagging and P6 points can be effective in controlling the gag reflex during routine dental procedures.

  1. [Development of Researches on Acupuncture Treatment of Peripheral Nerve Injury].

    Tao, Xing; Ma, Tie-ming

    2016-02-01

    Peripheral nerve injury is a common clinical disease. Acupuncture therapy has been demonstrated to be effective in improving nerve injury in clinical practice, but its underlying mechanisms in prompting tissue repair basically remain unknown. In the present paper, the authors reviewed some descriptions of traditional Chinese medicine on peripheral nerve injury and treatment, and recent development of researches on acupuncture treatment of it in both clinical practice and animal studies. Clinical trials demonstrated that acupuncture treatment can relieve nerve injury induced pain, ameliorate both sensory and motor functions. Experimental studies showed that acupuncture stimulation may promote nerve repair by reducing desquamation of medullary sheath of nerve fibers, inhibiting apoptosis of nerve cells, and up-regulating expression of myelin basic protein, Slit-1 protein and gene, etc. In addition, acupuncture intervention may also improve the microenvironment of neural regeneration including increase of the proliferation and differentiation of Schwann cells and release of various types of neurotrophic factors. However, its mechanisms underlying accelerating rehabilitation of peripheral nerve injury need being researched further. PMID:27141630

  2. Sino-European Transcontinental Basic and Clinical High-Tech Acupuncture Studies—Part 2: Acute Stimulation Effects on Heart Rate and Its Variability in Patients with Insomnia

    Gerhard Litscher

    2012-01-01

    Full Text Available This second part of a series of Sino-European high-tech acupuncture studies describes the first clinical transcontinental teleacupuncture measurements in patients with insomnia. Heart rate (HR and heart rate variability (HRV measurements in 28 patients (mean age ± SD: 41.9 ± 14.6 years were performed under standardized conditions in Harbin, China, and the data analysis was performed in Graz, Austria. Similar to the first part of the series, the electrocardiograms (ECGs were recorded by an HRV Medilog AR12 system during acupuncture of the Shenmen point (HT7 on the left hand. HR decreased significantly (P<0.001 during and after acupuncture stimulation of the HT7 acupuncture point. Total HRV increased significantly (P<0.05 immediately after acupuncture stimulation, but there was no long-lasting effect. The values of the low-frequency (LF and high-frequency (HF band increased significantly after the stimulation compared to baseline values; however, the LF/HF ratio showed no significant changes. Together with the results of previous studies, the present results can serve as a solid basis for further development of acupressure or acupuncture stimulation equipment for complementary use in treating insomnia.

  3. Can Acupuncture Treatment Be Double-Blinded? An Evaluation of Double-Blind Acupuncture Treatment of Postoperative Pain

    Vase, Lene; Baram, Sara; Takakura, Nobuari; Takayama, Miho; Yajima, Hiroyoshi; Kawase, Akiko; Schuster, Lars; Kaptchuk, Ted J.; Schou, Søren; Jensen, Troels Staehelin; Zachariae, Robert; Svensson, Peter

    2015-01-01

    Blinding protects against bias but the success of blinding is seldom assessed and reported in clinical trials including studies of acupuncture where blinding represents a major challenge. Recently, needles with the potential for double-blinding were developed, so we tested if acupuncture can be double-blinded in a randomized study of sixty-seven patients with acute pain ≥ 3 (0-10 scale following third molar removal) who received active acupuncture with a penetrating needle or placebo acupuncture with a non-penetrating needle. To test if acupuncture was administered double-blind, patients and acupuncturists were asked about perceived treatment allocation at the end of the study. To test if there were clues which led to identification of the treatment, deep dull pain associated with needle application and rotation (termed “de qi” in East Asian medicine), and patients’ pain levels were assessed. Perceived treatment allocation depended on actual group allocation (p < 0.015) for both patients and acupuncturists, indicating that the needles were not successful in double-blinding. Up to 68% of patients and 83% of acupuncturists correctly identified the treatment, but for patients the distribution was not far from 50/50. Also, there was a significant interaction between actual or perceived treatment and the experience of de qi (p = 0.027), suggesting that the experience of de qi and possible non-verbal clues contributed to correct identification of the treatment. Yet, of the patients who perceived the treatment as active or placebo, 50% and 23%, respectively, reported de qi. Patients’ acute pain levels did not influence the perceived treatment. In conclusion, acupuncture treatment was not fully double-blinded which is similar to observations in pharmacological studies. Still, the non-penetrating needle is the only needle that allows some degree of practitioner blinding. The study raises questions about alternatives to double-blind randomized clinical trials in

  4. Can acupuncture treatment be double-blinded? An evaluation of double-blind acupuncture treatment of postoperative pain.

    Lene Vase

    Full Text Available Blinding protects against bias but the success of blinding is seldom assessed and reported in clinical trials including studies of acupuncture where blinding represents a major challenge. Recently, needles with the potential for double-blinding were developed, so we tested if acupuncture can be double-blinded in a randomized study of sixty-seven patients with acute pain ≥ 3 (0-10 scale following third molar removal who received active acupuncture with a penetrating needle or placebo acupuncture with a non-penetrating needle. To test if acupuncture was administered double-blind, patients and acupuncturists were asked about perceived treatment allocation at the end of the study. To test if there were clues which led to identification of the treatment, deep dull pain associated with needle application and rotation (termed "de qi" in East Asian medicine, and patients' pain levels were assessed. Perceived treatment allocation depended on actual group allocation (p < 0.015 for both patients and acupuncturists, indicating that the needles were not successful in double-blinding. Up to 68% of patients and 83% of acupuncturists correctly identified the treatment, but for patients the distribution was not far from 50/50. Also, there was a significant interaction between actual or perceived treatment and the experience of de qi (p = 0.027, suggesting that the experience of de qi and possible non-verbal clues contributed to correct identification of the treatment. Yet, of the patients who perceived the treatment as active or placebo, 50% and 23%, respectively, reported de qi. Patients' acute pain levels did not influence the perceived treatment. In conclusion, acupuncture treatment was not fully double-blinded which is similar to observations in pharmacological studies. Still, the non-penetrating needle is the only needle that allows some degree of practitioner blinding. The study raises questions about alternatives to double-blind randomized clinical

  5. Quality of clinical trials: A moving target

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  6. Problems for clinical trial with fast neutrons

    It has been confirmed through a clinical trial that the local control rate for radioresistant tumors or locally advanced tumors would be improved by applying such a high LET radiations. The treatment policy for various diseases candidated to this trial has reached an agreement among the oncologists. On the other hand, there were some problems to promote fast neutron therapy. These were as follows. (a) Evaluation of late effects of the normal tissues in the relation with local control of the tumors. (b) Promotion of a randomized clinical trial for accurate evaluation of the results. (c) Development of a system for high LET radiation therapy, including distribution of the machines. From this trial, improvement of the dose distribution for fast neutrons was urgently recommended in order to apply the special features of high LET radiations in radiotherapy. (author)

  7. Clinical Trials and their Impact on Society

    Olga Lidia Cuevas Pérez; Ana María Molina Gómez; Diana Rosa Fernández Ruiz

    2016-01-01

    Today there are countless examples that illustrate the nature of technoscience, including biotechnology and pharmacology. The clinical trial is the appropriate methodology used by clinical pharmacology to test the efficacy and safety of a treatment or intervention in humans. It constitutes the cornerstone of research. Once the preclinical research is completed, one of the biggest challenges currently facing the Cuban Pharmaceutical and Biotechnological Industry is precisely the clinical evalu...

  8. Marketing and clinical trials: a case study

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

  9. Clinical Observation on Acupuncture Treatment in 35 Cases of Diabetic Gastroparesis

    王玲

    2004-01-01

    In order to observe the therapeutic effects of acupuncture on diabetic gastroparesis, 80 cases were divided randomly into 3 groups. In addition to the routine treatment for diabetes, 35 cases in the treatment group were additionally treated with acupuncture, and 25 cases in the control group 1 with domperidone, while 20 cases in the control group 2 with nothing. The three groups were all observed for 25 days. The results turned out to be that the total effective rate in the treatment group reached 94.2%, that in the control group 1, 72%, and in the control group 2, 40%, the treatment group showing a better therapeutic effect than the other two control groups (P<0.05, P<0.01). It can be concluded that in addition to the routine treatment for controlling blood sugar, acupuncture can give quite good therapeutic effects on diabetic gastroparesis.

  10. Clinical Observation on Acupuncture Treatment for Alopecia Areata%针刺治疗斑秃的临床观察

    徐凯

    2015-01-01

    Objective:To observe the clinically curative effect of acupuncture treatment for alopecia areata and to explore the related mechanism from the aspects of CD4 +and CD8 +levels in peripheral blood.Methods:60 enrolled cases were divided into an acupuncture group and a western medicine group.30 cases were in each group randomly.The acupuncture group was treated by plum-blossom needle by means of local skin flushing mild bleeding,once every other day and body acupuncture once a day,20 mins a time, one month as a treatment course;the western medicine group was given 5%Minoxidil Tincture applied to the lesion,1 ml each time,two times a day,oral Vitamins with Minerals Tablets,one month as a treatment course.Results:After a course of treatment,the clinically therapeutic effect of acupuncture group was better than that of the western medicine group(P<0.05);the recurrence rate after three months was less than that of the western medicine group (P<0.05 );peripheral blood CD4 +,CD4 +/CD8 +levels in the acupuncture group were significantly improved com-pared with that of the western medicine group ( P <0 .05 ) .Conclusion:Acupuncture treatment for alopecia areata has an obviously curative effect and can significantly improve the immunological indexes in patients, which is probably one of the therapeutic mechanisms.%目的:观察针刺治疗斑秃的临床疗效,并从外周血CD4+、CD8+水平改变的角度探讨相关作用机理。方法:60例入选病例随机分为针刺组和西药组各30例。针刺组采用梅花针局部叩刺结合体针,梅花针叩刺以斑秃局部皮肤潮红轻度渗血为度,隔日1次,体针辨证取穴,留针20 min,每日1次,1个月为1个疗程;西药组给予5%米诺地尔酊涂抹患处,每次1 ml,每日2次,口服多维元素片,1个月为1个疗程。结果:经1个疗程治疗后,针刺组疗效明显优于西药组(P<0.05),针刺组外周血CD4+水平以及CD4+/CD8+值与西药

  11. Clinical Observation of 46 Cases of Scapulohumeral Periarthritis Treated by Acupuncture

    PAN Feng-qin; KUAI Le

    2003-01-01

    Forty-six cases of scapulohumeral periarthritis were treated by selecting the acupoints far from the affected part plus acupuncture differentiation of symptoms and signs, in comparison with 34 cases treated by simple acupuncture differentiation of symptoms and signs. The result showed that cure occurred in 21 cases,marked effectiveness in 19 cases, improvement in 3 cases and ineffectiveness in 1 case in the treatment group. In control group, cure occurred in 10 cases, marked effectiveness in 15 cases, improvement in 8 cases and ineffectiveness in 3 cases. There was a significant difference in the therapeutic effect between the two groups (P<0.05).

  12. Clinical Effect of Acupuncture Treatment in 109 Cases of Knee Osteoarthritis

    姜爱平; 张磊; 赵长信; 杨福贤

    2001-01-01

    @@ Knee Osteoarthritis, a retrograde disease, is mainly characterized by pain in the knee joints and limitation of the movement. It is a common and frequently occurring disease affecting the health and life quality of old people. In recent years, acupuncture treatment of knee osteoarthritis with satisfactory therapeutic results has been repeatedly reported,2-3, 5-6 but there has been few report on the observation of long-term therapeutic effects after treatment. With acupuncture as the main therapy, 109 cases of knee osteoarthritis were treated in this series. 91 cases with good therapeutic results were followed up for 6 months. A report is presented in the following.

  13. Point specificity in acupuncture

    Choi Emma M

    2012-02-01

    Full Text Available Abstract The existence of point specificity in acupuncture is controversial, because many acupuncture studies using this principle to select control points have found that sham acupoints have similar effects to those of verum acupoints. Furthermore, the results of pain-related studies based on visual analogue scales have not supported the concept of point specificity. In contrast, hemodynamic, functional magnetic resonance imaging and neurophysiological studies evaluating the responses to stimulation of multiple points on the body surface have shown that point-specific actions are present. This review article focuses on clinical and laboratory studies supporting the existence of point specificity in acupuncture and also addresses studies that do not support this concept. Further research is needed to elucidate the point-specific actions of acupuncture.

  14. Study in Clinical Effect of Sensory Dysosmia Patients in 10 Caeses Treated With Acupuncture%针刺治疗感受性嗅觉障碍10例

    赵红

    2014-01-01

    The two most common categories of dysosmia in clinical are respiratory dysosmia and sensory dysosmia .The curative effect of western medicine on sensory dysosmia is not so well because of the unidentified etiology .But in my clinical experience , acupuncture therapy can get expected curative effect on this disease , now I will report it in this paper .

  15. To fail or not to fail: clinical trials in depression

    Santen, Gijs Willem Eduard

    2008-01-01

    To fail or not to fail – Clinical trials in depression investigates the causes of the high failure rate of clinical trials in depression research. Apart from the difficulties in the search for new antidepressants during drug discovery, faulty clinical trial designs hinder their evaluation during drug development. This thesis focuses on three important aspects of clinical trials in depression: clinical endpoints, data analysis and trial design-related factors.

  16. A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov

    Bell, Stuart A; Tudur Smith, Catrin

    2014-01-01

    Objectives To provide a comprehensive characterisation of rare disease clinical trials registered in ClinicalTrials.gov, and compare against characteristics of trials in non-rare diseases. Design Registry based study of ClinicalTrials.gov registration entries. Methods The ClinicalTrials.gov registry comprised 133,128 studies registered to September 27, 2012. By annotating medical subject heading descriptors to condition terms we could identify rare and non-rare disease trials. A total of 24,0...

  17. Clinical Trials in Male Hormonal Contraception

    Nieschlag E

    2011-01-01

    Full Text Available Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers.

  18. Clinical outcomes in clinical trials of anti-HIV treatment

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and k...

  19. Neurobiological mechanisms of acupuncture for some common illnesses: a clinician's perspective.

    Cheng, Kwokming James

    2014-06-01

    This paper presents some previously proposed neurobiological mechanisms on how acupuncture may work in some clinical applications from a clinician's perspective. For the treatment of musculoskeletal conditions, the proposed mechanisms included microinjury, increased local blood flow, facilitated healing, and analgesia. Acupuncture may trigger a somatic autonomic reflex, thereby affecting the gastric and cardiovascular functions. Acupuncture may also change the levels of neurotransmitters such as serotonin and dopamine, thereby affecting the emotional state and craving. This mechanism may form the basis for the treatment of smoking cessation. By affecting other pain-modulating neurotransmitters such as met-enkephalin and substance P along the nociceptive pathway, acupuncture may relieve headache. Acupuncture may affect the hypothalamus pituitary axis and reduce the release of the luteinizing hormone in the treatment of polycystic ovary syndrome. In addition, two other approaches to the acupuncture mechanism, the fascia connective tissue network and the primo vascular system, are briefly reviewed. Finally, the idea of true versus sham acupuncture points, which are commonly used in clinical trials, is examined because the difference between true and sham points does not exist in the neurobiological model. PMID:24929454

  20. A clinical Meta-analysis of treating simple obesity by acupuncture%腹针治疗单纯性肥胖临床疗效Meta分析

    杨礼泛; 黄龙坚; 吕艳; 郑景辉

    2015-01-01

    目的:评价腹针治疗单纯性肥胖的临床疗效。方法:检索CNKI、维普、万方、PubMed、The Cochrane Library数据库2014年12月以前的腹针治疗单纯性肥胖的有关文献;用jadad评分量表对纳入的文献进行评分,并用Cochrane提供的RevMen5.2软件制作森林图。结果:共检索到2486篇文献,纳入16篇做分析,腹针与体针比较,P=0.73,无统计学差异,腹针治疗单纯性肥胖与体针治疗单纯性肥胖的疗效相等;腹针与药物比较,P<0.05,差异有统计学意义;腹针治疗单纯性肥胖疗效优于药物治疗单纯性肥胖。腹部透刺与单纯腹针组比较,P=0.05,差异无统计学意义,提示腹部透刺治疗单纯性肥胖与单纯腹针治疗单纯性肥胖的疗效相等。腹针与饮食、运动对比,P<0.05,差异有统计学意义,腹针治疗单纯性肥胖疗效优于饮食、运动疗法治疗单纯性肥胖的疗效。结论:腹针治疗单纯性肥胖与体针治疗单纯性肥胖及腹部透刺治疗单纯性肥胖的疗效相等,腹针治疗单纯性肥胖的疗效优于药物治疗单纯性肥胖及饮食、运动治疗单纯性肥胖的疗效,但因纳入文献质量低,结论需要高质量文献去支持。%Objective: To evaluate clinical efficacy of acupuncture treatment on simple obesity abdominal. Methods: CNKI, CSTJ, CSPD, PubMed, The Cochrane Iibrary database were searched for the relevant literature before December 2014 on the abdominal acupuncture treatment for simple obesity. Results:Totally 2486 document, included 16 for analysis, abdominal acupuncture and body acupuncture comparison, P=0.73, no statistically signiifcant difference;for simple obesity abdominal acupuncture and body acupuncture treatment showed equal efifcacy;compared with medicines, abdominal acupuncture showed statistically signiifcant difference, P<0.05;abdominal acupuncture more effective than medicine therapy. Comparing abdominal acupuncture

  1. Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT

    Frewer, L. J.; Coles, D.; van der Lans, I A; Schroeder, D.; Champion, K.; Apperley, J. F.

    2010-01-01

    The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. F...

  2. 捣法针刺治疗枕神经痛的临床疗效观察%CLINICAL OBSERVATION OF THERAPEUTIC EFFECT ON OCCIPITAL NEURALGIA TREATED WITH DAO FA IN ACUPUNCTURE MANIPULATION

    冯军

    2008-01-01

    Objective To observe the clinical therapeutic effect of Dao Fa in acupuncture treatment of occipital neuralgia and make the comparison with routine acupuncture. Methods Dao Fa was applied to Tiānzhù (天柱BL10), Fēngchí (风池GB20) to treat occipital neuralgia and compare its results with routine acupuncture. Results The total effective rate was 95.6% in Dao Fa group, 77.8% in routine group, indicating significant difference (P<0.05). Conclusion Comparing with routine acupuncture, Dao Fa is advantageous at selection of fewer acupoints, better therapeutic effect and quicker achievement of efficacy in treatment of occipital neuralgia.

  3. Needle Sensation and Personality Factors Influence Therapeutic Effect of Acupuncture for Treating Bell's Palsy: A Secondary Analysis of a Multicenter Randomized Controlled Trial

    Zhang, Chen-Yan; Xu, Sha-Bei; Huang, Bo; Du, Peng; Zhang, Gui-Bin; Luo, Xiang; Huang, Guang-Ying; Xie, Min-Jie; Zhou, Zong-Kui; Wang, Wei

    2016-01-01

    Background: It has not been solved what kind of needle sensation might influence outcomes of acupuncture treatment. Effects of personality factors on the therapeutic effect of acupuncture have not been investigated. This study aimed to find the effects of the traits of personality on the objective outcome when different acupuncture techniques were used in treating patients with Bell's palsy. Methods: We performed a secondary analysis of a prospective multicenter randomized controlled trial of acupuncture for Bell's palsy. Patients were randomly assigned to the de qi and control groups, respectively. The primary outcome was facial nerve function at month 6. The intensity of each needle sensation was rated by a visual analog scale. Psychosocial factors were assessed by the pretreatment mediator questionnaire; 16 Personality Factor Questionnaire (16PF) was used for assessing personality factors and digit cancellation test for assessing attention. Results: After 6 months, patients in the de qi group had better facial function (adjusted odds ratio [OR]: 4.16, 95% confidence interval [CI]: 2.23–7.78). Path analysis showed that intensity of needle sensation of fullness had direct effect on House-Brackmann (HB) score at month 6. In de qi group, the low HB score on day 1 (OR: 0.13, 95% CI: 0.03–0.45) and the low Social Boldness score (OR: 0.63, 95% CI: 0.41–0.97) in 16PF were associated with better facial function. In control group, low HB score on day 1 (OR: 0.25, 95% CI: 0.13–0.50), low Vigilance score (OR: 0.66, 95% CI: 0.50–0.88), and high Tension score (OR: 1.41, 95% CI: 1.12–1.77) in 16PF were related to better facial function. Conclusions: The needle sensation of fullness could predict better facial function and personality traits might influence outcomes of acupuncture treatment. Both of them should be considered seriously in acupuncture treatment and research. PMID:27453226

  4. Acupuncture for immune-mediated disorders. Literature review and clinical applications.

    Rogers, P A; Schoen, A M; Limehouse, J

    1992-03-01

    Acupuncture activates the defense systems. It influences specific and nonspecific cellular and humoral immunities; activates cell proliferation, including blood, reticuloendothelial, and traumatized cells; and activates leucocytosis, microbicidal activity, antibodies, globulin, complement, and interferon. It modulates hypothalamic-pituitary control of the autonomic and neuroendocrine systems, especially microcirculation, response of smooth and striated muscle, and local and general thermoregulation. Immunostimulant points include LI-4, LI-11, ST-36, GB-39, SP-6, GV-14, BL-11, BL-20, BL-23, BL-24, BL-25, BL-26, BL-27, BL-28, and CV-12. Some, such as BL-47, are immunosuppressive. Antifebrile points include GV-14 and ST-36. Reactive reflex SHU points, MU points, and earpoints are useful in organic diseases. In immunomediated diseases, some or all of these points can be used with other points, especially local points and points of the major symptoms or points of the affected body part, area, function, or organ. Applications of acupuncture include treatment of inflammation and trauma; stimulation of tissue healing in burns, ulcers, indolent wounds, ischemia, necrosis, and gangrene; infections; postinfection sequelae; fever; autoimmune disease; allergies; anaphylaxis and shock; and treatment or prevention of side effects from cytotoxic chemotherapy and ionizing radiation. Acupuncture therapy may inhibit neoplastic cells. Examples of acupuncture use in immunomediated conditions in small animals are given. PMID:1581655

  5. Clinical Observation on Acupuncture Treatment of Depressive Neurosis in 30 Cases

    Zhao Jiahui; Sang Peng

    2006-01-01

    @@ Depressive neurosis refers to a psychonosema disease,characterized by emotional depression with anxiety and dyssomnia. Usually antidepressants are used for this disease. However, they are slow in giving effects with more side-effects. The authors of this essay have adopted acupuncture for the treatment, and obtained good therapeutic results as reported in the following.

  6. Biomarkers in T cell therapy clinical trials

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  7. 针刺治疗糖尿病肾病的临床研究%Clinical research of acupuncture in the treatment of diabetic nephropathy

    黄涛

    2015-01-01

    Objective:To explore the clinical effect of acupuncture in treatment of diabetic nephropathy.Methods:90 cases of patients with diabetic nephropathy from December 2012 to April 2014 were randomly divided into the traditional Chinese medicine group,the acupuncture group and the acupuncture plus traditional Chinese medicine group.The traditional Chinese medicine group mainly adopted jiedutongluoyishen decoction;the acupuncture group mainly adopted acupuncture treatment;the acupuncture plus traditional Chinese medicine group adopted jiedutongluoyishen decoction combined with with acupuncture therapy.We compared the therapeutic effects of the three groups.Results:The FPG,2hPG,HbAlcand urine trace albumin of the three groups after the treatment were significantly decreased;compared with before the treatment,the differences were statistically significant(P<0.05).The FPG,2hPG,HbAlcand urine trace albumin of the acupuncture plus traditional Chinese medicine group were different from that of the acupuncture group and traditional Chinese medicine group,and the differences were statistical significant(P<0.05).The symptoms of the three groups improved significantly after the treatment.The symptoms of the acupuncture plus traditional Chinese medicine group improve more significantly than that of the acupuncture group and the traditional Chinese medicine group.The total effective rate of the traditional Chinese medicine group was 93.33% ;that of the acupuncture group was 90.0% ;that of the acupuncture plus traditional Chinese medicine group was 96.67% .Conclusion:Acupuncture plus traditional Chinese medicine in the treatment of diabetic nephropathy has significant effect as well as the feasibility and safety,worthy of clinical promotion.%目的:探讨针刺治疗糖尿病肾病的临床效果。方法:2012年12月-2014年4月收治糖尿病肾病患者90例,随机分为中药组、针刺组和针刺加中药组。中药组主要采用解毒通络益肾汤治疗,针刺组

  8. Acupuncture and Auricular Acupressure in Relieving Menopausal Hot Flashes of Bilaterally Ovariectomized Chinese Women: A Randomized Controlled Trial

    Jue Zhou; Fan Qu; Xisheng Sang; Xiaotong Wang; Rui Nan

    2011-01-01

    The objective of this study is to explore the effects of acupuncture and auricular acupressure in relieving menopausal hot flashes of bilaterally ovariectomized Chinese women. Between May 2006 and March 2008, 46 bilaterally ovariectomized Chinese women were randomized into an acupuncture and auricular acupressure group (n = 21) and a hormone replacement therapy (HRT) group (Tibolone, n = 25). Each patient was given a standard daily log and was required to record the frequency and severity of ...

  9. Efficacy and safety of acupuncture therapy for nerve deafness: a meta-analysis of randomized controlled trials

    Jiang, Yuebo; Shi, Xian; Tang, Yan

    2015-01-01

    Background: Acupuncture is one of the important parts of therapeutic methods in traditional Chinese medicine, and has been widely used for the treatment of nerve deafness in recent years. The current study was to evaluate the efficacy and safety of acupuncture therapy for nerve deafness compared with conventional medicine therapy. Methods: PubMed, the Chinese National Knowledge Infrastructure Database, the Chinese Science and Technology Periodical Database, the Chinese Biomedical Database, th...

  10. Family doctors and clinical trials

    Pierclaudio Brasesco

    2008-09-01

    Full Text Available There is a growing awareness that research in primary care is needed to provide excellent clinical and population-based care, to develop effective health systems and policies, and to educate future primary care professionals and researchers. The relevance of research undertaken in primary care is unquestionable: the results of researches conducted in other settings has limited relevance because primary care encounters health problems rarely managed in other sectors of health care (i.e. low probability of major acute disease and high prevalence of comorbidity. From legislative aspects to limits and difficulties of application, the article underlines the importance of research in primary care in the Italian context, where this kind of activity is almost absent. An example, concerning the Genova ASL 3, is reported to suggest strategies to promote and improve research as an integral component of family doctors skills.

  11. Clinical Trials in Male Hormonal Contraception

    Nieschlag E

    2011-01-01

    Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depo...

  12. Building data quality into clinical trials.

    Crerand, William J; Lamb, Jana; Rulon, Vera; Karal, Bilun; Mardekian, Jack

    2002-01-01

    Meaningful data begin with the collection process. Pharmaceutical companies are using several different strategies in clinical trials to ensure the highest quality of data. This article will examine these approaches, with an emphasis on case report form development through database release. PMID:12432815

  13. Acupuncture Treatment for Low Back Pain and Lower Limb Symptoms-The Relation between Acupuncture or Electroacupuncture Stimulation and Sciatic Nerve Blood Flow.

    Inoue, Motohiro; Kitakoji, Hiroshi; Yano, Tadashi; Ishizaki, Naoto; Itoi, Megumi; Katsumi, Yasukazu

    2008-06-01

    To investigate the clinical efficacy of acupuncture treatment for lumbar spinal canal stenosis and herniated lumbar disc and to clarify the mechanisms in an animal experiment that evaluated acupuncture on sciatic nerve blood flow. In the clinical trial, patients with lumbar spinal canal stenosis or herniated lumbar disc were divided into three treatment groups; (i) Ex-B2 (at the disordered level), (ii) electrical acupuncture (EA) on the pudendal nerve and (iii) EA at the nerve root. Primary outcome measurements were pain and dysesthesia [evaluated with a visual analogue scale (VAS)] and continuous walking distance. In the animal study, sciatic nerve blood flow was measured with laser-Doppler flowmetry at, before and during three kinds of stimulation (manual acupuncture on lumber muscle, electrical stimulation on the pudendal nerve and electrical stimulation on the sciatic nerve) in anesthetized rats. For the clinical trial, approximately half of the patients who received Ex-B2 revealed amelioration of the symptoms. EA on the pudendal nerve was effective for the symptoms which had not improved by Ex-B2. Considerable immediate and sustained relief was observed in patients who received EA at the nerve root. For the animal study, increase in sciatic nerve blood flow was observed in 56.9% of the trial with lumber muscle acupuncture, 100% with pudendal nerve stimulation and 100% with sciatic nerve stimulation. Sciatic nerve stimulation sustained the increase longer than pudendal nerve stimulation. One mechanism of action of acupuncture and electrical acupuncture stimulation could be that, in addition to its influence on the pain inhibitory system, it participates in causing a transient change in sciatic nerve blood blow, including circulation to the cauda equine and nerve root. PMID:18604251

  14. Acupuncture Treatment for Low Back Pain and Lower Limb Symptoms—The Relation between Acupuncture or Electroacupuncture Stimulation and Sciatic Nerve Blood Flow

    Motohiro Inoue

    2008-01-01

    Full Text Available To investigate the clinical efficacy of acupuncture treatment for lumbar spinal canal stenosis and herniated lumbar disc and to clarify the mechanisms in an animal experiment that evaluated acupuncture on sciatic nerve blood flow. In the clinical trial, patients with lumbar spinal canal stenosis or herniated lumbar disc were divided into three treatment groups; (i Ex-B2 (at the disordered level, (ii electrical acupuncture (EA on the pudendal nerve and (iii EA at the nerve root. Primary outcome measurements were pain and dysesthesia [evaluated with a visual analogue scale (VAS] and continuous walking distance. In the animal study, sciatic nerve blood flow was measured with laser-Doppler flowmetry at, before and during three kinds of stimulation (manual acupuncture on lumber muscle, electrical stimulation on the pudendal nerve and electrical stimulation on the sciatic nerve in anesthetized rats. For the clinical trial, approximately half of the patients who received Ex-B2 revealed amelioration of the symptoms. EA on the pudendal nerve was effective for the symptoms which had not improved by Ex-B2. Considerable immediate and sustained relief was observed in patients who received EA at the nerve root. For the animal study, increase in sciatic nerve blood flow was observed in 56.9% of the trial with lumber muscle acupuncture, 100% with pudendal nerve stimulation and 100% with sciatic nerve stimulation. Sciatic nerve stimulation sustained the increase longer than pudendal nerve stimulation. One mechanism of action of acupuncture and electrical acupuncture stimulation could be that, in addition to its influence on the pain inhibitory system, it participates in causing a transient change in sciatic nerve blood blow, including circulation to the cauda equine and nerve root.

  15. Clinical Observation of Combined Acupuncture and Scraping Therapy for Improving Phlegm-dampness Constitution of Simple Obesity

    彭月灵; 孟江; 冯德荣; 肖元春

    2009-01-01

    目的:观察针刺结合刮痧疗法治疗单纯性肥胖症的疗效及对痰湿体质的改善效果.方法:将70例单纯性肥胖症痰湿体质的患者按随机数字表随机分为治疗组和对照组.对照组仅给以健康教育,饮食指导;治疗组在对照组基础上加用针刺结合刮痧疗法.治疗4星期后,通过肥胖及痰湿评分的变化评定疗效.结果:两组单纯性肥胖症肥胖改善总有效率比较,有统计学差异(P<0.01);针刺结合刮痧疗法能明显改善痰湿症状(尸<0.01),而对照组不能改善(P>0.05).结论:针刺结合刮痧疗法能有效治疗单纯性肥胖症,并能明显改善单纯性肥胖症患者的痰湿体质.%Objective:To observe the clinical efficacy of combined acupuncture and scraping therapy for simple obesity and its effects on phlegm-dampness constitution.Methods:Seventy subjects with phlegm-dampness constitution were divided into treatment group and control group with a randomized digital table.Control group was given health education and dietary instructions,and treatment group was given acupuncture and scraping therapy besides health education and dietary instructions.After four-week treatments,the scores of obesity and phlegm-dampness constitution were recorded to assess the clinical efficacy.Results:There was a striking difierence in the total effective rate in treating obesity between the two groups (P<0.01);combined acupuncture and scraping therapy can relieve the phlegm-dampness symptoms(P<0.01);but the phlegm-dampness symptoms were not improved in the control group(P>0.05).Conclusion:Combined acupuncture and scraping therapy is quite effective for simple obesity and in improving phlegm-dampness constitution of simple obesity people.

  16. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  17. Ear acupuncture or local anaesthetics as pain relief during postpartum surgical repair: a randomised controlled trial

    Kindberg, S; Klünder, L; Strøm, J;

    2009-01-01

    with approximately 1600 annual deliveries. Population Primiparous women with a vaginal delivery at term who needed surgical repair of lacerations to the labia or the vagina, perineal lacerations of first or second degree or mediolateral episiotomies. Methods The trial was set up to evaluate the effect of a brief 2...

  18. New EORTC clinical trials for BNCT

    Due to ethical reasons, a separated optimization of the two components of BNCT in the frame of clinical investigations can only be performed applying the whole binary system. The ongoing trial at HFR (High Flux Reactor Petten) has proven the feasibility of BNCT under defined conditions. On that basis the European Commission supported a comprehensive research project on boron imaging including three further clinical studies. In the first trial the boron uptake related to the blood boron concentration and surrounding normal tissue in various solid tumours will be examined using BSH (Sodiumborocaptate), BPA (Boronophenylalanine) or both in order to explore tumour entities, which may gain benefit from BNCT. The major objectives of the second trial are to define the maximum tolerated single and cumulative dose, and the dose limiting toxicity of BSH. The third clinical trial, a phase II study is designed to evaluate the anti-tumour effect of fractionated BNCT at the Petten treatment facility against cerebral metastasis of malignant melanoma using BPA. (author)

  19. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design

    Lammertse, D; Tuszynski, MH; Steeves, JD; Curt, A.; Fawcett, JW; Rask, C; Ditunno, JF; Fehlings, MG; Guest, JD; Ellaway, PH; Kleitman, N; Blight, AR; Dobkin, BH; Grossman, R.; Katoh, H

    2006-01-01

    The International Campaign for Cures of Spinal Cord Injury Paralysis established a panel tasked with reviewing the methodology for clinical trials for spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the fourth of four papers. Here, we examine the phases of a clinical trial program, the elements, types, and protocols for valid clinical trial design. The most rigorous and valid SCI clinical trial would be a prospective double-blind randomized contro...

  20. -ctgov-: A suite of Stata commands for reporting trial results to ClinicalTrials.gov

    Phil Schumm; Theodore Karrison

    2014-01-01

    In response to the 1997 Food and Drug Administration Modernization Act (FDAMA), the National Institutes of Health (NIH) established ClinicalTrials.gov, an online, publicly-accessible registry for clinical trials. The 2007 Food and Drug Administration Amendments Act (FDAAA) broadened the scope of eligible trials, added outcomes reporting as a requirement, and established penalties for non-compliance. Although ClinicalTrials.gov increased the transparency with which clinical trials are conducte...

  1. Disclosure of investigators' recruitment performance in multicenter clinical trials

    Dal-Ré, Rafael; Moher, David; Gluud, Christian;

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  2. Randomization in substance abuse clinical trials

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  3. Placebo Acupuncture Devices: Considerations for Acupuncture Research

    Jian Kong; Jingling Chang; Ying Gao; Dan Zhu

    2013-01-01

    Determining an appropriate control for use in acupuncture research remains one of the largest methodological challenges acupuncture researchers face. In general, acupuncture controls fall under one of two categories: (1) sham acupuncture, in which the skin is punctured with real acupuncture needles either fully at nonacupoint locations or shallowly at acupoint locations or both and (2) placebo acupuncture, which utilizes nonpenetrating acupuncture devices. In this study, we will focus on non-...

  4. Creating clinical trial designs that incorporate clinical outcome assessments.

    Gilbert, Mark R; Rubinstein, Lawrence; Lesser, Glenn

    2016-03-01

    Clinical outcome assessments (COAs) are increasingly being used in determining the efficacy of new treatment regimens. This was typified in the recent use of a symptom-based instrument combined with an organ-based measure of response for the approval of ruxolitinib in myelofibrosis. There are challenges in incorporating these COAs into clinical trials, including designating the level of priority, incorporating these measures into a combined or composite endpoint, and dealing with issues related to compliance and interpretation of results accounting for missing data. This article describes the results of a recent panel discussion that attempted to address these issues and provide guidance to the incorporation of COAs into clinical trials, including novel statistical designs, so that the testing of new treatments in patients with cancers of the central nervous system can incorporate these important clinical endpoints. PMID:26989129

  5. Privacy and confidentiality in pragmatic clinical trials.

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations. PMID:26374682

  6. The Clinical report of Asthmatic Patients with CVA by treatment of Homins Placenta Aqua-Acupuncture

    Eun­Gon Kim; Sung-Kyun Kim; Jong-Hyun Han; Shim Yun­Sueb; Lee Jung­Hee

    2004-01-01

    Nowadays Asthma is considered to be an inflamatory disease characterized by airway hyperresponsiveness and pulmonary eosinophilia. Hominis Placenta is the dried placenta of a healthy women. It has correspondence to the meridians of lung and kindey. Hominis Placenta acupuncture therapy has effect on invigoration of vital energy nourishing blood and tonifying the essence. It can be applied to the disease as Asthma, pulmonary tuberculosis, chronic hepatitis, liver cirrhosis, degenerative change ...

  7. Clinical Observation on Acupuncture Treatment of Cerebrovascular Dementia- A Report of 32 Cases

    2001-01-01

    @@Cerebrovascular dementia is a common disease in the middle-aged and old people. Its incidence makes up about 10-20% of all kinds of dementia. It is mainly caused by general degeneration of the brain function resulted from cerebral arteriosclerosis and cerebral infarction. The author has treated 32 cases of cerebrovascular dementia with acupuncture in the recent years with satisfactory therapeutic results. A report follows.

  8. CLINICAL OBSERVATION ON TREATMENT OF CHRONIC PHARYNGITIS WITH ACUPUNCTURE PLUS CHINESE HERBAL MEDICINES

    聂荣华

    2003-01-01

    @@ Chronic pharyngitis is the diffuse inflammation of the pharyngeal mucus, submucosal and lymph tissues. Traditional Chinese medicine (TCM) considers it to be the category of "Meiheqi" (梅核气,globus hystericus), "Shiyin" (失音,aphonia) and "Houbi" (喉痹,inflammation of the throat). According to the theory of TCM, the author of the present paper adopted acupuncture plus Chinese herbal medicines to treat it from 1990 to 2002, and achieved a satisfactory result. It is reported as follows.

  9. CLINICAL ANALYSIS ON SCALP-PLUS BODY-ACUPUNCTURE FOR TREATMENT OF SENILE URINARY INCONTINENCE

    LU Zeqiang

    2002-01-01

    To observe the therapeutic effect of scalp-plus body-acupuncture for treatment of senile urinary incontinence. Methods: A total of 71 urinary incontinence outpatients were randomly divided into treatment group (n = 37)and control group (n= 34). In treatment group, scalp-plus body-acupuncture was conducted once daily, with 10 days being a therapeutic course. Scalp acupoints used were Epangxian Ⅲ (MS 4) and Dingzhongxian (MS 5), while body acupoints used were Guanyuan (CV 4), Shuidao (ST 28), Qichong (ST 30), Yanglingquan (GB 34), Sanyinjiao (SP 6), etc.. The treatment was given once daily, with 10 days being a therapeutic course. In control group, patients were ordered to take Centrofenoxine, ATP, Vitamin E and B12, with ten days being a therapeutic course. Results: After 3 courses of treatment, in treatment group, of the 37 patients, 26 (70.3%) were cured, 6 (16.0%) had marked improvement, 3 (8.1%) had improvement and 2 (5.4%) failed; in control group, of the 34 patients, 14 (41.1% ) were cured, 9 (26.5%) had remarkable improvement, 3 (8.8%) had improvement and 8 (23.5%) failed, showing that the therapeutic effect of the treatment group was significantly superior to that of control group ( P< 0.05). Conclusion:The therapeutic effect of scalp plus body acupuncture is fairly effective in treatment of senile urinary incontinence.

  10. Determining the Precise Cerebral Response to Acupuncture: An Improved fMRI Study

    Hua Liu; Jianyang Xu; Baoci Shan; Yongzhong Li; Lin Li; Jingquan Xue; Binbin Nie

    2012-01-01

    BACKGROUND: In acupuncture brain imaging trials, there are many non-acupuncture factors confounding the neuronal mapping. The modality of the placebo, subjects' psychological attitude to acupuncture and their physical state are the three most confounding factors. OBJECTIVE: To obtain more precise and accurate cerebral fMRI mapping of acupuncture. DESIGN AND SETTING: A 2×2 randomized, controlled, participant-blinded cross-over factorial acupuncture trial was conducted at Xuanwu Hospital in Bei...

  11. Narrative Review of Perioperative Acupuncture for Clinicians.

    Gliedt, Jordan A; Daniels, Clinton J; Wuollet, Adam

    2015-10-01

    Acupuncture is one of the oldest forms of the natural healing arts. The exact mechanisms of action are unknown at this time; however, current theories to explain the benefits experienced after acupuncture include Traditional Chinese Medicine and Western medicine concepts. Acupuncture may improve the quality of perioperative care and reduce associated complications. Perioperative acupuncture is apparently effective in reducing preoperative anxiety, postoperative nausea and vomiting, and postoperative pain. The Pericardium-6 (P-6; Nei Guan), Yintang (Extra 1), and Shenmen acupuncture points are the most studied and effective acupuncture points in reducing preoperative anxiety, postoperative nausea and vomiting, and postoperative pain experiences. Intraoperatively administered acupuncture may reduce immunosuppression in patients and lessen intraoperative anesthetic requirements, although the clinical usefulness of acupuncture in the intraoperative period remains inconclusive. Perioperative acupuncture is a promising intervention, but additional studies are needed to further understand and define acupuncture's role throughout the perioperative period and determine its clinical usefulness. The purpose of this article is to provide a brief clinical review concerning acupuncture and its application for common issues that occur in the perioperative period. PMID:26433805

  12. First clinical trial with iohexol in myelography

    This is a report of the first clinical trial with iohexol in lumbar myelography. The investigation was carried out as an open, non-comparative study in 30 patients and was part of a mulicentre trial. Iohexol doses of 10 to 15 ml (180 mg I/ml) were used and clinical and laboratory tests were performed before and during 48 h after myelography. Spinal repuncture 6 or 24 h after myelography was done in all patients. Only minor side effects of temporary duration were recorded in 8 patients. No seizures or spikes on EEG were seen. There was no significant increase in CSF parameters such as white cell counts, protein or IgG. (Auth.)

  13. Gateways to clinical trials. December 2008.

    Tomillero, A; Moral, M A

    2008-12-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV1/SERCA2a; Abatacept, ABT-263, Adalimumab, Aflibercept, Afobazole, Aliskiren fumarate, Anakinra, Atazanavir/ritonavir, Aviscumine, Axitinib, Azacitidine; Bevacizumab, Biphasic insulin aspart, Bortezomib, Briobacept; Carmoterol hydrochloride, CCX-282, Ceftobiprole medocaril, Certolizumab pegol, Cetuximab; Darifenacin hydrobromide, Dasatinib, Denosumab, Doripenem, Duloxetine hydrochloride; E-7080, Epratuzumab, Erlotinib hydrochloride, Everolimus, Exenatide, Ezetimibe/simvastatin; Gefitinib, Golimumab; gamma-Hydroxybutyrate sodium; Imatinib mesylate, Insulin detemir, Insulin glulisine, IVX-0142; Laquinimod sodium, Linezolid, Lopinavir/ritonavir; Ocrelizumab, Omalizumab; Parecoxib sodium, Pemetrexed disodium, Pregabalin; Rosuvastatin calcium, Rotigotine; Sorafenib, Sugammadex sodium; Tapentadol hydrochloride, Tenofovir disoproxil fumarate/emtricitabine, Tocilizumab; Ularitide, Ustekinumab; Valsartan/amlodipine besylate, Varenicline tartrate, Vatalanib succinate, Vildagliptin, Vorinostat. PMID:19271026

  14. Contribution of clinical trials to gross domestic product in Hungary

    Kaló, Zoltán; Antal, János; Pénzes, Miklós; Pozsgay, Csilla; Szepezdi, Zsuzsanna; Nagyjánosi, László

    2014-01-01

    Aim To determine the contribution of clinical trials to the gross domestic product (GDP) in Hungary. Methods An anonymous survey of pharmaceutical companies and clinical research organizations (CROs) was conducted to estimate their clinical trial-related employment and revenues. Clinical trial documents at the National Institute of Pharmacy (NIP) were analyzed to estimate trial-related revenues at health care institutions and the value of investigational medical products (IMPs) based on avoid...

  15. Differences Between Clinical Trials of Medical Devices and Drugs

    ZHANG Zhi-jun; LIU Wei

    2014-01-01

    How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of defi-nition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conduct-ing clinical trial design for medical devices.

  16. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Nissen, Steven E.; Krumholz, Harlan M.

    2009-01-01

    BACKGROUND: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. METHODS AND FINDINGS: We examined reporting of registration information among a cross-section of trials that had been registered at ...

  17. 针刺治疗突发性耳聋临床研究概述%Overview about Clinical Research on Acupuncture Treatment of Sudden Deafness

    侯文珍; 倪光夏

    2013-01-01

    Colleting the related literature of acupuncture treatment of sudden deafness in nearly 15 years, and carrying on the analysis, classification, it is summed up simple acupuncture method, point injection, electro-acupuncture, combined with hyperbaric oxygen and other common clinical treatments. We find that the therapy of electro-acupuncture or the combination with hyperbaric oxygen is superior to other treatments, and the clinical efficacy of electric acupuncture is the best. However, the stimulation parameters (frequency, waveform, current intensity, stimulus duration, etc. ) of the electro-acupuncture vary a lot, different stimulation parameters produce different effects. So far, there is no uniform standard about the choice of the electro-acupuncture parameters. In other words, the best EA parameters are not determined yet. It has affected the healing efficacy of electro-acupuncture treatment of sudden deafness. Looking forward to more scholars will be concerned about and committed to this research.%收集近15年来针刺治疗突发性耳聋的相关文献,对其进行分析、归类,总结出:单纯针刺法、穴位注射法、结合电针法、配合高压氧等临床常见治疗方法.其中结合电针、配合高压氧治疗疗效优于其他治疗方案,尤以电针治疗临床疗效最佳,但电针有不同的刺激参数(频率、波形、电流强度、刺激时间等),不同的刺激参数对针刺效应产生不同的影响,电针参数的选择量化目前还没有统一的标准,最佳电针参数尚未确定,影响了电针治疗突发性耳聋的疗效.冀望有更多的学者予以关注,并致力于此方面的研究.

  18. To fail or not to fail : clinical trials in depression

    Santen, Gijs Willem Eduard

    2008-01-01

    To fail or not to fail – Clinical trials in depression investigates the causes of the high failure rate of clinical trials in depression research. Apart from the difficulties in the search for new antidepressants during drug discovery, faulty clinical trial designs hinder their evaluation during dru

  19. Acupuncture and Counselling for Depression in Primary Care: A Randomised Controlled Trial

    Hugh MacPherson; Stewart Richmond; Martin Bland; Stephen Brealey; Rhian Gabe; Ann Hopton; Ada Keding; Harriet Lansdown; Sara Perren; Mark Sculpher; Eldon Spackman; David Torgerson; Ian Watt

    2013-01-01

    Editors' Summary Background Depression–overwhelming sadness and hopelessness–is responsible for a substantial proportion of the global disease burden and is a major cause of suicide. It affects more than 350 million people worldwide and about one in six people will have an episode of depression during their lifetime. Depression is different from everyday mood fluctuations. For people who are clinically depressed, feelings of severe sadness, anxiety, hopelessness, and worthlessness can last fo...

  20. Clinical Trials and Treatment of ATL

    Kunihiro Tsukasaki

    2012-01-01

    Full Text Available ATL is a distinct peripheral T-lymphocytic malignancy associated with human T-cell lymphotropic virus type I (HTLV-1. The diversity in clinical features and prognosis of patients with this disease has led to its subtype-classification into four categories, acute, lymphoma, chronic, and smoldering types, defined by organ involvement, and LDH and calcium values. In case of acute, lymphoma, or unfavorable chronic subtypes (aggressive ATL, intensive chemotherapy like the LSG15 regimen (VCAP-AMP-VECP is usually recommended if outside of clinical trials, based on the results of a phase 3 trial. In case of favorable chronic or smoldering ATL (indolent ATL, watchful waiting until disease progression has been recommended, although the long-term prognosis was inferior to those of, for instance, chronic lymphoid leukemia. Retrospective analysis suggested that the combination of interferon alpha and zidovudine was apparently promising for the treatment of ATL, especially for types with leukemic manifestation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT is also promising for the treatment of aggressive ATL possibly reflecting graft versus ATL effect. Several new agent trials for ATL are ongoing and in preparation, including a defucosylated humanized anti-CC chemokine receptor 4 monoclonal antibody, IL2-fused with diphtheria toxin, histone deacetylase inhibitors, a purine nucleoside phosphorylase inhibitor, a proteasome inhibitor, and lenalidomide.

  1. Clinical Experience on Treatment of Lumbar Intervertebral Disc Protrusion by Traditional Manual Techniques plus Electric Acupuncture

    LIANG Hao-wen; WU Fang; YANG Wan-zhang; ZHANG Min; HUANG Guo-qi

    2007-01-01

    52 cases of the patients with L4-S1 intervertebral disc protrusion were first treated by traditional Tuina manual techniques, including the rolling method, pressing method,oblique-plucking method and shaking method, and then treated by electric acupuncture on Shenshu (BL 23), Yaoyangguan (GV 3), Dachangshu (BL 25), Xiaochangshu (BL 27),Mingmen (GV 4) and Shangliao (BL 31). After 7-28 sessions of the treatments, the results showed cure in 40 cases, remarkable effect in 8 cases, effect in 3 cases, failure in 1 case, and the total effective rate in 98.1%.

  2. [Difficulties with conducting clinical trials in France].

    Zannad, F; Plétan, Y

    2001-01-01

    France ranks third among European countries as regards the level of investment in clinical R&D and, overall, accounts for a contributive effort proportional to the size of its population and pharmaceutical market respectively. However, there is a trend for phase II and III studies to become proportionally fewer than in the past, while the number of phase IV studies is increasing. In a growing proportion of the mega-trials, which are instrumental for establishing evidence-based practice, French experts, investigators and, even more seriously, French patients, are insufficiently represented. Though studies in France are initiated relatively fast due to a clear regulatory framework and perform equally well as far as quantitative and qualitative factors are concerned, compared with most European countries involved in clinical research the costs incurred per completed patient are higher than those recorded in the other countries. Academic research shares most of these constraints and suffers from a lack of financial and human resources, while it faces additional delays in implementing studies because of longer administrative processes. Given the stakes in play, specific solutions should be implemented to maintain and further develop French competitiveness in clinical R&D. At the patient level, positive perception and awareness of the usefulness and safety of participating in clinical trials need to be emphasized. Education at the school level and using the lay media should be developed. Intervention of institutional and government officials is much needed. Direct patient recruitment should be developed through advertisement and the Internet, as well as within doctors' offices and through collaboration with patients' organizations. Patient information and consent forms should be made much simpler than those imposed within the framework of global studies because of FDA requirements. The French health system discourages the recruitment of patients by investigators who are

  3. Tyranny of the randomised clinical trial.

    Rosenbek, John C

    2016-06-01

    Researchers and clinicians often disagree about what it means to provide the best possible care. This paper's purpose is to propose ways of resolving the disagreements. The first is to have both groups re-examine the three equal components of evidence-based practice, a re-examination that begins with rejection of the randomised clinical trial's tyranny. The second is for researchers to design rehabilitation research based on a biopsychosocial rather than a biomedical model. The third is for both groups to redefine translational research so that it means both translation from the laboratory to the clinic and from the clinic to the laboratory. The fourth is to advocate for a science of dissemination that is as robust as rehabilitation's present science of discovery. Most examples are drawn from the literature on acquired neurologic speech and language disorders. PMID:27124262

  4. The effectiveness of acupuncture on the sleep quality of elderly with dementia: a within-subjects trial

    Kwok T

    2013-07-01

    Full Text Available Timothy Kwok,1,2 Ping Chung Leung,3 Yun Kwok Wing,4 Isaac Ip,2 Bel Wong,2 Daniel Wai Hung Ho,2 Wai Ming Wong,3 Florence Ho2 1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; 2Jockey Club Centre for Positive Ageing, Hong Kong; 3Institute of Chinese Medicine, 4Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong Purpose: Elderly with dementia are often afflicted with sleep problems. Recent studies have suggested that acupuncture may be a feasible alternative to traditional sleep medicine for treating sleep disturbance. This study investigated the effectiveness of acupuncture on sleep quality of elderly with dementia. Patients and methods: Nineteen elders with dementia were followed through a control period and an acupuncture treatment period, each lasting 6 weeks. Outcome measures were subjects' sleep quality and cognitive function. Sleep parameters were recorded by wrist actigraphy. Cognitive function was assessed by the Alzheimer's Disease Assessment Scale – Cognitive (ADAS-Cog. Pretests and posttests were conducted immediately before and after the control and treatment periods. Changes in the outcome measures between control and treatment periods were compared. Results: Wilcoxon signed rank tests revealed that the subjects gained significantly more resting time and total sleep time in the treatment period than in the control period (P < 0.05. A nonsignificant trend for improvement in sleep efficiency was observed. Improvement in cognitive function was not statistically significant. A total of 86% of the subjects completed the treatment regime. Conclusion: Results reveal that acupuncture was effective in improving some domains of sleep quality of elderly with dementia, and the subjects showed acceptance towards the intervention. Strengths and limitations of the present study as well as suggestions for further studies were considered. Keywords: acupuncture, sleep disturbance, patients

  5. Clinical Study on 1 Case of Klippel-Trenaunay-Weber Syndrome

    Chang-Kil, Yoo

    2002-12-01

    Full Text Available Objective : This study was performed to evaluate the treatment of Acupuncture therapy including Herbal Acupuncture theraphy and Korean Bee Venom Theraphy in Klippel-Trenaunay-Weber Syndrome. Methods : We treated 1 case of Klippel-Trenaunay-Weber Syndrome patient with mainly Korean Bee Venom Theraphy, and herbal Acupuncture, acupuncture theraphy from 27th August, 2001 to February, 2003. Results : After 3 weeks of Korean Bee Venom Theraphy, and herbal Acupuncture, acupuncture theraphy, a remarkable improvement was made for Klippel-Trenaunay-Weber Syndrome. Conclusions : Korean Bee Venom Theraphy and other acupuncture therapies were effective in reducing the symptoms. We think that it need the further study and clinical trial for Klippel-Trenaunay-Weber Syndrome.

  6. [Clinical randomized controlled trials of acupoint catgut-embedding for simple obesity: a meta-analysis].

    Liao, Jian-Qiong; Song, Xiang; Chen, Ying; Liang, Li-Chang; Wang, Sheng-Xu

    2014-06-01

    The clinical therapeutic effect of acupoint catgut-embedding for simple obesity was systemically analyzed to provide reference and assistance for its clinical treatment and research. By searching in the CBM, CNKI, VIP, Wanfang, Pubmed, Springer and Medline databases, clinical randomized controlled trials (RCT) of acupoint catgut-embedding for simple obesity published from Jan, 2009 to July, 2013 were collected while Revman 5. 2 software was applied to perform the Meta-analysis. Totally 19 articles were acquired with 1 658 cases involved. The effective rate was selected as primary outcome measure in 19 articles. The Meta-analysis was performed among homogeneous researches. The results indicated that compared with other therapies, pooled OR of acupoint catgut-embedding was 2.45 with 95% CI [1.81, 3.32]; in the test for overall effect, Z = 5.81, implying the efficacy difference of two therapies was significant in the treatment of simple obesity (P embedding was 2.61 with 95% CI [1.53, 4.46]; in test for overall effect, Z = 3.51, implying the efficacy difference of two therapies was significant in the treatment of simple obesity (P embedding was 2.38 with 95% CI [1.65, 3.44]; in test for overall effect, Z = 4.46, implying in the treatment of simple obesity the efficacy difference of two therapies was significant (P embedding was 1.79, 95% CI [1.08, 2.95] (P = 0.02). Compared with acupuncture, OR of acupoint catgut-embedding was 1.89, 95% CI [1.16, 3.09] (P = 0.01), which explained that compared with electroacupuncture and acupuncture, the efficacy of acupoint catgut-embedding was significantly different. In a word, the clinical efficacy of acupoint catgut-embedding is superior to other therapies in the treatment of simple obesity. PMID:25112111

  7. Acupuncture and Moxibustion

    2015-01-01

    <正>2015135 Clinical observation on delayed encephalopathy after carbon monoxide poisoning treated with acupuncture to restore consciousness combined with hyperbaric oxygen treatment.MAO Min(茅敏),et al.Neurol Med Dept,Chengdu 1st People’s Hosp,Chengdu610041.Chin Acupunct&Moxibust 2015;35(3):213-216.Objective To compare the efficacy differences on

  8. The Clinical Study about Honilirls Placenta Herbal Acupuncture on Bell's Palsy

    Lee Chae-Woo

    2005-12-01

    Full Text Available Objectives : This study has been designed and performed to identify the effect on Bell's palsy according to the injection of herbal medicine induced from the Hominis Placenta. Methods : We measured the facial palsy changes of the patients who were admitted for Bell's palsy in the Oriental Medical hospital of Dongeui medical center from 03-01-2004 to 07-31-2004. Bell's palsy patients were divided into two groups. One group(A group was injected with Hominis Placenta herbal acupuncture. The other group(B group was injected with normal saline. Then effects of these treatment was evaluated by Yanagihara's unweighted grading system. Results : A group was marked more higher than B group in treatment outcome. we discovered that it is significant differences between two groups after 4 week. Conclusions : These results provided that A group is more effective than B group. For clearly proving the effect of Hominis Placenta herbal acupuncture on Bell's palsy, it is need more sample's number and more treatment's duration.

  9. A Clinical Experience of Acupuncture Treatment for Apoplexy with Pseudobular Paralysis

    WeiQX

    2002-01-01

    Aim:To examine the therapeutic effect of acupuncture in the treatment of with pseudobular paralysis patients.Methods:Pseudobular paralysis was confirmed by CT scanning examination.Relevant treatments were administered after syndrome differentiation.Acupoints:Fengchi (GB 20),Fengfu(GV 16) and Taichong (LR 3) were punctured and stimulated with uniform reinforcing-reducing method for subduing the liver-yang and eliminating wind.Upper Lianquan (RN 23) and Fenglong (ST 40) were punctured and stimulated by reducing method for resolving phlegm to clear away obstruction in the channels.Acupoint Zusanli(ST 36) was administered with reinforcing method to tonify qi.A treatment course comprised of 10 sessions,with 1 to 2 days' internal between two courses.Each case received a total of 20 treatment sessions.Acupoint on the nech such as Fengchi (GB 20) was administered with retaining the needle in the sitting position for 10 minutes.Results:A total of 14 cases were observed.After 2 courses of treatment,12 cases (86%) were cured,one case(7%) had improvement and the rest one had no apparent changes.13 cases(93%) had their nagogastric feeding tubes removed.Conclusions:Our experience showed that acupuncture treatment for pseudobular paralysis type apoplexy was satisfactory in the therapeutic effect.

  10. Clinical trials of conformal therapy - physics aspects

    If Conformal Therapy (CFRT) hadn't existed, physicists would have invented it! So many of the concepts involved are physicist ones: 3-D dose calculation/planning, Beam's-Eye-View, Dose-Volume Histograms, Multileaf Collimators, Computer-Controlled Delivery, Megavoltage Imaging, Optimization, Inverse Planning, Tomotherapy, Biological Modeling, even Protons. All the above developments, many of them involving fairly expensive technology, are on trial. If we wish to be able to use and to continue development of these physicist tools in the future then it has to be demonstrated conclusively that CFRT results in improved clinical outcome. Physicists should therefore be in the front line of planning, executing and evaluating Clinical Trials of Conformal Therapy, by which I mean Randomized, Prospective Phase-III trials i.e. ones that have improved complication-free local control/survival as their endpoint. A prospective, randomized trial to assess the effect of reducing the volume of irradiated normal tissue on acute side-effects in pelvic radiotherapy (93% prostate or bladder ca.) has been carried out at our centre, on 266 patients. In both arms a 3-field, 6 MV x-ray technique was used with identical dose prescriptions; in the conventional arm rectangular fields were employed whereas in the conformal arm the fields were shaped with customized blocks drawn according to the Beam's-Eye-View of the target volume. Substantial differences in normal-tissue volumes (rectum, bladder etc.) were achieved: mean High-Dose Volume (∼ PTV) of 690 cm3 for the conformal technique vs 940 cm3 conventionally. Comprehensive quality-of-life questionnaire were completed before the start of treatment, weekly during and for 3 weeks after the end of treatment and then monthly for a further 2 months. A clear pattern of an increase during followed by a decrease after treatment in symptoms relating to bowel and bladder functions was observed for the patient group as a whole. However, a very extensive

  11. Is acupuncture effective in the treatment of pain in endometriosis?

    Lund, Iréne; Lundeberg, Thomas

    2016-01-01

    Introduction Endometriosis is a multifactorial, estrogen-dependent, inflammatory gynecological condition – often with long-lasting visceral pelvic pain of different origin, and infertility among women. Current management options for patients’ are often inadequate, with side effects for many for whom acupuncture techniques could be an alternative. Earlier studies have discussed the efficacy of acupuncture, but not its methodological aspects. Objectives To summarize the documented clinical effects of acupuncture on rated visceral pelvic endometriosis-related pain, and associated variables among individuals, within and between studied groups, and to discuss the methodological treatment aspects. Methods Published full text clinical studies, case reports, and observational studies with abstracts written in English were searched by using the keywords “Acupuncture and Endometriosis” in databases such as PubMed, Web of Science, and CINAHL. The reporting guidelines, Standards for Reporting Interventions in Clinical Trials of Acupuncture was used for the methodological report. Results Three studies were found including 99 women, 13–40 years old, with diagnosed endometriosis. The studies were different in research design, needle stimulation techniques, and evaluation instruments. Methodological similarities were seven to12 needle insertions per subject/session, and 15–25 minutes of needle retention time. The needles were placed in lower back/pelvic-abdominal area, in the shank, feet, and hands. Treatment numbers varied from nine to 16 and patients received one to two treatments per week. Similarity in reported treatment effects in the quoted studies, irrespective of research design or treatment technique, was reported decrease of rated pain intensity. Discussion Meta-analysis is the standard procedure for the evaluation of evidence of treatment effects, ie, on a group level, usually without analysis of the individual responses even with obvious spread in the

  12. Needle Sensation and Personality Factors Influence Therapeutic Effect of Acupuncture for Treating Bell's Palsy: A Secondary Analysis of a Multicenter Randomized Controlled Trial

    Chen-Yan Zhang

    2016-01-01

    Conclusions: The needle sensation of fullness could predict better facial function and personality traits might influence outcomes of acupuncture treatment. Both of them should be considered seriously in acupuncture treatment and research.

  13. Interim analysis in long-term clinical trials

    G.A. van Es (Gerrit Anne)

    1990-01-01

    textabstractThe purpose of this dissertation is to evaluate the usefulness of both stopping rules and estimation methods in long-term clinical trials with interim analyses. The ASPECT trial, a long-term clinical trial to assess the effect of anticoagulant therapy on mortality in patients after myoca

  14. Clinical Trial Results Vary Widely, But Always Advance Research | NIH MedlinePlus the Magazine

    ... of this page please turn Javascript on. Feature: Clinical Trials Clinical Trial Results Vary Widely, But Always Advance Research Past ... very emotional." Should You Be Interested in a Clinical Trial People volunteer to take part in clinical trials ...

  15. Specification of phase I of new drugs' clinical tolerance trials

    LI Guo-xin

    2008-01-01

    Phase I of clinical trials is the first stage of clinical pharmacology and body safety evaluation, including body tolerance test and pharmacokinetics test. The aim is providing evidence for dosage regimen and be the cornerstone of the preliminary assessment of efficacy and safety of phase II of clinical trials. This text discussed the technique and requirement of phase I of new drugs' clinical tolerance trials.

  16. Statistical properties of randomization in clinical trials.

    Lachin, J M

    1988-12-01

    This is the first of five articles on the properties of different randomization procedures used in clinical trials. This paper presents definitions and discussions of the statistical properties of randomization procedures as they relate to both the design of a clinical trial and the statistical analysis of trial results. The subsequent papers consider, respectively, the properties of simple (complete), permuted-block (i.e., blocked), and urn (adaptive biased-coin) randomization. The properties described herein are the probabilities of treatment imbalances and the potential effects on the power of statistical tests; the permutational basis for statistical tests; and the potential for experimental biases in the assessment of treatment effects due either to the predictability of the random allocations (selection bias) or the susceptibility of the randomization procedure to covariate imbalances (accidental bias). For most randomization procedures, the probabilities of overall treatment imbalances are readily computed, even when a stratified randomization is used. This is important because treatment imbalance may affect statistical power. It is shown, however, that treatment imbalance must be substantial before power is more than trivially affected. The differences between a population versus a permutation model as a basis for a statistical test are reviewed. It is argued that a population model can only be invoked in clinical trials as an untestable assumption, rather than being formally based on sampling at random from a population. On the other hand, a permutational analysis based on the randomization actually employed requires no assumptions regarding the origin of the samples of patients studied. The large sample permutational distribution of the family of linear rank tests is described as a basis for easily conducting a variety of permutation tests. Subgroup (stratified) analyses, analyses when some data are missing, and regression model analyses are also

  17. Comparing the treatment effectiveness of body acupuncture and auricular acupuncture in preoperative anxiety treatment

    Shengjun Wu; Jie Liang; Xia Zhu; Xufeng Liu; Danmin Miao

    2011-01-01

    Background: Preoperative anxiety has become more frequent in preoperative patients and can bring negative impact on operation outcomes. Many studies have reported the effect of body acupuncture in reducing anxiety syndromes. The aim of this study is to compare the treatment effect of body acupuncture and auricular acupuncture in preoperative pa-tients with preoperative anxiety. Methods: Thirty five elective ambulatory surgery patients were selected in the randomized and blinded trial. Subj...

  18. Future clinical trials in DIPG: bringing epigenetics to the clinic

    Andres E. Morales La Madrid

    2015-07-01

    Full Text Available In spite of major recent advances in DIPG molecular characterization, this body of knowledge has not yet translated into better treatments.To date,more than 250 clinical trials evaluating radiotherapy along with conventional cytotoxic chemotherapy as well as newer biologic agents,have failed to improve the dismal outcome when compared to palliative radiation alone.The biology of DIPG remained unknown until recently when the neurosurgical expertise along with the recognition by the scientific and clinical community of the importance of tissue sampling at diagnosis;ideally in the context of a clinical trial and by trained neurosurgical teams to maximize patient safety.These pre-treatment tumor samples,and others coming from tissue obtained post-mortem,have yielded new insights into DIPG molecular biology.We now know that DIPG comprises a heterogeneous disease with variable molecular phenotypes, different from adult high grade glioma,other non-pontine pediatric high grade gliomas and even between pontine gliomas.The discovery of histone H3.3 or H3.1 mutations has been an important step forward in understanding tumor formation,maintenance and progression.Pharmacologic reversal of DIPG histone demethylation therefore offers an important potential intervention strategy for the treatment of DIPG.To date,clinical trials of newly diagnosed or progressive DIPG with epigenetic modifiers have been unsuccessful.Whether this failure represents limited activity of the agents used,their CNS penetration,redundant pathways within the tumor,or the possibility that histone mutations are necessary only to initiate DIPGs but not maintain their growth,suggest that a great deal still needs to be elucidated in both the underlying biology of these pathways,and the drugs designed to target them.In this review, we discuss the role of both epigenetic and genetic mutations within DIPG and the development of treatment strategies directed against the unique abnormalities

  19. The Effect of Acupuncture on Plasma Endothelin Content in Cerebral Infarction Patients——A Clinical Study

    2007-01-01

    Objective: To observe the effect of acupuncture on content of plasma endothelin in cerebral infarction patients. Methods: The plasma endothelin content in cerebral infarction patients was observed before and after acupuncture, which was compared with that of the medication group and the healthy subjects. Results: Before treatment, the content of plasma endothelin in cerebral infarction patients was significantly higher than that of the healthy subjects (P<0.01); after acupuncture treatment, the content greatly decreased (P<0.01), and there was a statistically significant difference between the acupuncture group and the medication group (P<0.05). Conclusion: Acupuncture may decrease the content of plasma endothelin in the cerebral infarction patients, improve the vascular elasticity, and improve the cerebral circulation of blood.

  20. Clinical Observation on Acupuncture Treatment of Post-windstroke Pseudobulbar Palsy

    LIU Xiang-hua; TANG Li-xin; LIU Ai-zhen; ZHANG Xue-li; DU Lin; HU Hui; LI Li; WANG Zheng

    2003-01-01

    In this research, X-ray photograph and kinescope were applied to observe the whole process of barium swallowing statically and dynamically before and after acupuncture treatment by the radiography of the upper alimentary tract (RART). The observation was made on the objective changes about the functional renovation of contractor muscle of pharynx and epiglottis muscle. Among 36 cases, function of speaking basically recovered in 3 cases, function of swallowing 16 cases,function of expectorating sputum 15 c ases, and for function of water drinking 13 cases. The total effective rate: 75.0% for function of speaking, 97.2% for function of swallowing, 75.0% for function of expectorating sputum, 97.2% for function of water drinking.

  1. Part Ⅰ Clinical Acupuncture Lecture Twenty-Seven Rhinorrhea (Nasosinusitis,"Bi Yuan") with Turbid Discharge

    SHANG Xiukui; GUO Ling; DONG Hongying

    2002-01-01

    @@ In traditional Chinese medicine, "Bi Yuan"(rhinorrhea 鼻渊 ), also known as Nao Lou ( nasosinusitis with purulent discharge), is mainly characterized by turbid nasal discharge. It is often divided into two types, namely excess syndrome and deficiency syndrome. The excess syndrome results from the flaring-up of the stagnant lung-heat affecting the nose due to chronic common cold, or from the upward attack of the excessive fire from the liver and gallbladder. The deficiency syndrome is usually caused by hypofunction of the lung in dispersing and descending actions and the spleen in transportation and transformation of the water and dampness. Excess type rhinorrhea should be treated by removing heat, eliminating dampness and dredging the orifices, while deficiency type rhinorrhea treated by warming the lung, strengthening the spleen,dispelling cold and eliminatingdampness. It has been proved that excess type rhinorrhea can be treated effectively with acupuncture.

  2. Neuroimaging and Neuromonitoring Effects of Electro and Manual Acupuncture on the Central Nervous System: A Literature Review and Analysis.

    Scheffold, Brigitte Elisabeth; Hsieh, Ching-Liang; Litscher, Gerhard

    2015-01-01

    The aim of this review is to provide an overview of the different effects of manual and electroacupuncture on the central nervous system in studies with different neuroimaging interventions. The Database PubMed was searched from 1/1/2000 to 1/6/2014 with restriction to human studies in English language. Data collection for functional magnetic resonance (fMRI) studies was restricted to the period from 1/1/2010 to 1/6/2014 due to a recently published review which included all published randomized and nonrandomized controlled clinical studies as well as observational studies with control groups, no blinding required. Only studies comparing manual or electroacupuncture with sham acupuncture were eligible. All participants were healthy adult men and women. A majority of 25 studies compared manual versus sham, a minority of 7 trials compared electro versus sham and only 1 study compared electro versus manual acupuncture. In 29 out of 33 studies verum acupuncture results were found to present either more or different modulation effects on neurological components measured by neuroimaging and neuromonitoring methods than sham acupuncture. Only four studies reported no effects of verum in comparison to sham acupuncture. Evaluation of the very heterogeneous results shows evidence that verum acupuncture elicits more modulation effects on neurological components than sham acupuncture. PMID:26339269

  3. The Effects of Acupuncture on Cerebral and Muscular Microcirculation: A Systematic Review of Near-Infrared Spectroscopy Studies

    Ming-Yu Lo

    2015-01-01

    Full Text Available Acupuncture produces physiological effects via stimulating acupoints, proximal or distal to the region of effect. Near-infrared spectroscopy (NIRS noninvasively measures tissue-level hemodynamics in real time. We review the literature investigating the effect of acupuncture on muscular and/or cerebral microcirculation. As the basis, we queried PubMed in June 2014 for articles mentioning both acupuncture and NIRS in title/abstract. The reviewed papers investigated either cerebral (n = 11 or muscular hemodynamics (n = 5 and, based on STRICTA for reporting acupuncture methodology, were overall poor in quality. Acupuncture was found to influence regional oxygen saturation in cerebral and muscular tissue. The cortical response in healthy subjects varied across studies. For subjects with stroke or cerebrovascular dementia, findings suggest that acupuncture may modulate dysfunction in cerebral autoregulation. The muscular response to pressure techniques was more intense than that to needling or laser. Probe proximity could impact measurement sensitivity. No one study simultaneously investigated the direct and remote responses. Research utilizing NIRS to investigate the hemodynamics of acupuncture presently lacks in scope and quality. Improved designs, for example, placebo-controlled, randomized trials, and standardized intervention reporting will raise study quality. Exploiting NIRS in clinical settings, such as stroke, migraine, or other pain conditions, is worthwhile.

  4. Clinical observation on acupuncture for diarrhea-predominant irritable bowel syndrome patients in syndrome of liver-stagnation and spleen-deficiency and its impact on Th1 /Th2

    吴晓亮

    2014-01-01

    Objective To observe clinical therapeutic effects of acupuncture for pattern of liver-stagnation and spleen-deficiency in diarrhea-predominant irritable bowel syndrome(D-IBS)and its impact on cell factors.Methods Forty cases were selected and divided into an acupuncture group(21 cases)in which acupuncture was applied and a medicine group(19 cases)in which oral administration of dicetel and bifidobacterium lactobacillus triple viable capsulas were applied.The symptom scores,level of Th1-type

  5. Material Base of Acupuncture Effects

    杨永清; 陈汉平; 王宇; 崔建美; 王燕; 刘艳艳

    2006-01-01

    @@ Acupuncture is one of the common treatment methods in China, and its clinical effectiveness has now been accepted in many countries or it has been expanded worldwide and applied as a medical modality. In China, clinical practice has proved that the indications of acupuncture include more than 300 disorders in nervous system, endocrine system, immune system, circulatory system, digestive system, respiratory system, urinary system, reproductive system, blood system, sensory system and motor system, and the indications are increasingly created with the development of the clinical application of acupuncture. Since 1949, China has attached great importance to the development of Chinese medicine cause, invested a large amount of money to finance Chinese medicine, and achieved fruitful results, as a result, to maintain the leading role of acupuncture in the world. Preceding researches have proven that acupuncture is effective in clinical practice, and it works in bi-directional regulation by many procedures such as nerve-endocrine-im-munenetwork, which undoubtedly shows the objectivity of acupuncture effects. Above research achievements have called extensive attention across the world.

  6. Nuclear medicine methods in the assessment of acupuncture effects: a short review

    Deise Elisabete Souza

    2007-09-01

    Full Text Available The mechanisms of acupuncture are poorly understood. In consequence, numerous investigators have conducted clinical trials to test the efficacy of acupuncture in various conditions. We have used PubMed database system to evaluate the number of publications in acupuncture and nuclear medicine procedures in the period from 1964 to 2007, using the keywords: "nuclear medicine and acupuncture", "SPECT and acupuncture", "PET and acupuncture", "scintigraphy and acupuncture", "radionuclide and acupuncture", "radiopharmaceutical and acupuncture", "radioisotope and acupuncture" and "99mTc and acupuncture". Some papers published in English language were selected and a short review is presented The analysis of the number of publications shows that when a method is well accepted by the scientific community, as the methods used in nuclear medicine, the interest in the development of research increases. Moreover, important findings are presented when the nuclear medicine image is used to evaluate the effect of the acupuncture.Os mecanismos de ação da acupuntura ainda não são completamente esclarecidos. Em conseqüência, diversos pesquisadores têm conduzido testes clínicos para verificar a eficiência da acupuntura em condições diversas. Nós utilizamos o sistema de base de dados PubMed para avaliar o número de publicações em acupuntura e procedimentos em medicina nuclear no período de 1964 até 2007, usando as palavras-chaves: "medicina nuclear e acupuntura", "SPECT e acupuntura", "PET e acupuntura", "cintilografia e acupuntura", "radionuclídeo e acupuntura", "radiofármaco e acupuntura", "radioisótopo e acupuntura" e "99mTc e acupuntura". Alguns artigos publicados em inglês foram selecionados e uma pequena revisão é apresentada. A análise do número de publicações mostra que quando um método é bem aceito pela comunidade científica, como os métodos utilizados em medicina nuclear, o interesse em desenvolver novos estudos aumenta. Al

  7. Gateways to Clinical Trials. June 2002.

    Bayes, M; Rabasseda, X; Prous, J R

    2002-06-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abacavir sulfate, abarelix, abciximab, alicaforsen sodium, almotriptan, alteplase, amlodipine, amoxicillin trihydrate, amprenavir, argatroban monohydrate, aspirin, atorvastatin calcium, azathioprine; Baclofen, benidipine hydrochloride, benserazide, BMS-214662, bosentan, botulinum toxin type B; Candesartan cilexetil, carbamazepine, carbidopa, carboplatin, ceftriaxone sodium, celecoxib, cetirizine hydrochloride, clarithromycin, clavulanate potassium, clopidogrel hydrogensulfate, clozapine, CPI-1189, cyclophosphamide, cytarabine; Darbepoetin alfa, denileukin diftitox, dexamethasone, dipyridamole, droperidol, DW-166HC; Ebastine, efalizumab, efavirenz, eletriptan, enalapril maleate, enfuvirtide, enoxaparin sodium, enrasentan, entacapone, epoetin, eprosartan mesilate, etanercept, etoricoxib; Fenofibratefexofenadine hydrochloride, filgrastim, fludarabine phosphate, fluoxetine hydrochloride fluvoxamine maleate, frovatriptan, furosemide; Gabapentin, galantamine hydrobromide, gatifloxacin, gefitinib, ghrelin (human), glatiramer acetate; Haloperidol; Ibuprofen, ibuprofen, guaiacol ester, idarubicin hydrochloride, imipramine hydrochloride, imiquimod, interferon beta, interferon beta-1a, interferon beta-1b, interferon omega, irbesartan, itraconazole; Ketorolac, ketorolac tromethamine; Lamifiban, lamotrigine, lanoteplase, lansoprazole, leflunomide, leuprorelin acetate, levetiracetam, levocetirizine, levodopa, lisinopril, loratadine; Manidipine, methylprednisolone, metronidazole, mirtazapine, mizolastine, modafinil, morphine sulfate; Naproxen sodium, naratriptan hydrochloride, nifedipine, NSC-683864; Ofloxacin, olanzapine

  8. Contemporary issues in clinical trials for medulloblastoma

    Medulloblastoma is the seminal pediatric brain tumor providing opportunities for clinical investigation to define improved treatment strategies for both disease control and ultimate functional integrity. Recent studies addressing neuraxis radiation dose provide a 'standard' for conventional therapy while establishing 5-year disease control rates for 'favorable' or 'low risk' presentations approximating 60% following surgery and irradiation. A highly visible recent report of combined post-operative irradiation and chemotherapy incorporating a platinum- and alkylator-based regimen indicates 5-year disease control approaching 90% in localized medulloblastoma. Despite unfavorable outcome with reduced-dose neuraxis irradiation in earlier trials, further data from recent studies suggest the addition of post-operative chemotherapy to similarly reduced-dose neuraxis irradiation (23.4 Gy) in 'favorable' presentations may result in progression-free survival rates at least equivalent to those achieved with full-dose neuraxis irradiation (36 Gy) absent chemotherapy. The panel will (1) provide updated information regarding the major clinical trials that form the basis for current and planned protocols and (2) debate the therapeutic modifications appropriate for contemporary clinical investigations. Critical in planning future studies in the analysis of risk factors that may identify 'favorable' patients versus 'high risk' patients. Risk-related studies appropriately address maintaining or improving current disease control rates in the context of diminishing late treatment sequelae for 'favorable' presentations. For those identified as 'high risk' (e.g., patients with disease beyond the primary site), studies are in development that increase the intensity of chemotherapy and explore modifications of radiation delivery. Study designs that permit assessment of innovations in surgical, radiotherapeutic, and chemotherapeutic approaches will be presented and debated by the panelists

  9. Key concepts of clinical trials: a narrative review.

    Umscheid, Craig A; Margolis, David J; Grossman, Craig E

    2011-09-01

    The recent focus of federal funding on comparative effectiveness research underscores the importance of clinical trials in the practice of evidence-based medicine and health care reform. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by enhancing the value of health care provided. However, clinical trials also have the potential to pose unknown risks to their participants, and biased knowledge extracted from flawed clinical trials may lead to the inadvertent harm of patients. Although conducting a well-designed clinical trial may appear straightforward, it is founded on rigorous methodology and oversight governed by key ethical principles. In this review, we provide an overview of the ethical foundations of trial design, trial oversight, and the process of obtaining approval of a therapeutic, from its pre-clinical phase to post-marketing surveillance. This narrative review is based on a course in clinical trials developed by one of the authors (DJM), and is supplemented by a PubMed search predating January 2011 using the keywords "randomized controlled trial," "patient/clinical research," "ethics," "phase IV," "data and safety monitoring board," and "surrogate endpoint." With an understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meet one of the essential goals of health care reform. PMID:21904102

  10. The Evaluation of Curative Effect of Acupuncture: A Review of Systematic and Meta-Analysis Studies.

    Salehi, Alireza; Marzban, Maryam; Imanieh, Mohammad Hadi

    2016-07-01

    The present study attempts to critically evaluate previously published research articles on the efficiency of acupuncture in the treatment of diseases. First, 35 systematic reviews or meta-analysis were found in the Cochrane database. Second, 54 related articles were selected by searching important scientific databases. Based on the results obtained regarding the efficacy of acupuncture for the treatment of various diseases, the articles were divided into 3 groups. The first group of articles confirmed the efficacy of treatment by acupuncture. In the second group of articles, the therapeutic effect of acupuncture was shown; however, further research is required to verify the results. In the third group of articles there is no evidence regarding the therapeutic effect of acupuncture till now. There is an urgent need to design and conduct double-blinded randomized clinical trials with high-quality methodologies. This provides a more careful evaluation of acupuncture efficiency in relation to the treatment of a vast array of diseases, based on scientific evidence. PMID:26260046

  11. Bacteriophage Therapy: Advances in Formulation Strategies and Human Clinical Trials.

    Vandenheuvel, Dieter; Lavigne, Rob; Brüssow, Harald

    2015-11-01

    Recently, a number of phage therapy phase I and II safety trials have been concluded, showing no notable safety concerns associated with the use of phage. Though hurdles for efficient treatment remain, these trials hold promise for future phase III clinical trials. Interestingly, most phage formulations used in these clinical trials are straightforward phage suspensions, and not much research has focused on the processing of phage cocktails in specific pharmaceutical dosage forms. Additional research on formulation strategies and the stability of phage-based drugs will be of key importance, especially with phage therapy advancing toward phase III clinical trials. PMID:26958930

  12. Immune checkpoints in cancer clinical trials

    Elad Sharon; Howard Streicher; Priscila Goncalves; Helen XChen

    2014-01-01

    Immunology-based therapy is rapidly developing into an effective treatment option for a surprising range of cancers. We have learned over the last decade that powerful immunologic effector cells may be blocked by inhibitory regulatory pathways controlled by specific molecules often called“immune checkpoints.” These checkpoints serve to control or turn off the immune response when it is no longer needed to prevent tissue injury and autoimmunity. Cancer cells have learned or evolved to use these mechanisms to evade immune control and elimination. The development of a new therapeutic class of drugs that inhibit these inhibitory pathways has recently emerged as a potent strategy in oncology. Three sets of agents have emerged in clinical trials exploiting this strategy. These agents are antibody-based therapies targeting cytotoxic T-lymphocyte antigen4 (CTLA4), programmed cell death1 (PD-1), and programmed cell death ligand 1 (PD-L1). These inhibitors of immune inhibition have demonstrated extensive activity as single agents and in combinations. Clinical responses have been seen in melanoma, renal cellcarcinoma, non-smal celllung cancer, and several other tumor types. Despite the autoimmune or inflammatory immune-mediated adverse effects which have been seen, the responses and overall survival benefits exhibited thus far warrant further clinical development.

  13. A data grid for imaging-based clinical trials

    Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

    2007-03-01

    Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

  14. Clinical trials in branch retinal vein occlusion

    Tandava Krishnan Panakanti

    2016-01-01

    Full Text Available Branch retinal vein occlusion (BRVO is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy.

  15. Two-stage adaptive designs in early phase clinical trials

    Xu, Jiajing; 徐佳静

    2013-01-01

    The primary goal of clinical trials is to collect enough scientific evidence for a new intervention. Despite the widespread use of equal randomization in clinical trials, response-adaptive randomization has attracted considerable interest in terms of ethical concerns. In this thesis, delayed response problems and innovative designs for cytostatic agents in oncology clinical trials are studied. There is typically a prerun of equal randomization before the implementation of response-adaptiv...

  16. Current Status and Challenges of Cancer Clinical Trials in Korea

    Shim, Byoung Yong; Park, Se Hoon; Lee, Soonil; Kim, Jin-Soo; Lee, Kyoung Eun; Kang, Yoon-Koo; Ahn, Myung-Ju

    2015-01-01

    Purpose Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems. Materials and Methods We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers...

  17. Automated Information Extraction of Key Trial Design Elements from Clinical Trial Publications

    de Bruijn, Berry; Carini, Simona; Kiritchenko, Svetlana; Martin, Joel; Sim, Ida

    2008-01-01

    Clinical trials are one of the most valuable sources of scientific evidence for improving the practice of medicine. The Trial Bank project aims to improve structured access to trial findings by including formalized trial information into a knowledge base. Manually extracting trial information from published articles is costly, but automated information extraction techniques can assist. The current study highlights a single architecture to extract a wide array of information elements from full...

  18. Perceptions of Reimbursement for Clinical Trial Participation

    Breitkopf, Carmen Radecki; Loza, Melissa; Vincent, Kathleen; Moench, Thomas; Stanberry, Lawrence R.; Rosenthal, Susan L.

    2012-01-01

    A greater understanding of participant views regarding reimbursement will help investigators plan studies that have better potential for reaching target enrollment, maximize efficient recruitment, maintain scientific integrity, and enhance retention over time. As part of a clinical trial in the area of sexual health, healthy women’s perceptions of reimbursement for research participation were investigated. Semi-structured, audio-recorded, qualitative interviews were conducted immediately upon women’s completion of the clinical trial to enable a participant-driven understanding of perceptions about monetary reimbursement. Audio-recordings were transcribed and analyzed using framework analysis. Women (N = 30) had a mean age of 29.5 ± 5.7 years (range 22–45 years). Sixty-three percent of participants (n = 19) were non-Hispanic (white n = 13, black n = 4, and Asian n = 2), while the remaining were Hispanic (n = 11). Seventy-three percent (n = 22) reported previous participation in research. In general, women viewed reimbursement as a benefit to research participation, the amount of which should reflect time, the inconvenience to the research subject, and the potential for unknown risks in the short- and long-term. They believed reimbursement should take into account the degree of risk of the study, with investigations of experimental products offering greater reimbursement. Women believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable. The results of this study can be used to provide guidance to those planning and evaluating reimbursement for research participation. PMID:21931235

  19. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  20. Systematic review on effect of abdominal acupuncture for cervical spondylosis%腹针治疗颈椎病有效性的系统评价

    杨蕾; 符文彬; 张光彩; 黄叶飞; 张敏敏

    2012-01-01

    Objective: To assess the clinical effect of abdominal acupuncture in the treatment for cervical spondylosis. Methods: Randomized controlled trials (RCTs) involving abdominal acupuncture for cervical spondylosis were identified from PubMed, Medline, CBM, CNKI, VIP electronic database, selected the trials which meet inclusion and exclusion criteria. Data statistical analyses were performed by Review Manager 5.0.24 software. Results: A total of 10 trials involving 1 104 patients were included. Meta analyses showed that compared with conventional acupuncture and electro-acupuncture the abdominal acupuncture showed abdominal acupuncture more effective than conventional acupuncture and electro-acupuncture; compared the abdominal acupuncture with the cervical vertebra traction, showed the effective rate of abdominal acupuncture was higher than the cervical vertebra traction. Conclusion: The Meta-analysis showed the abdominal acupuncture in the treatment for cervical spondylosis has advantages. However, the evidence is not strong enough because of some of the low-quality trials and publications bias. Large sample, high-quality, multicenter, rigorous designs trials of abdominal acupuncture for cervical spondylosis are needed to further assess the effect.%目的:评价腹针治疗颈椎病的临床有效性.方法:收集腹针治疗颈椎病的临床研究随机对照文献,计算机检索PubMed数据库、Medline数据库、CBM、CNKI、VIP数据库,筛选出符合纳入标准和排除标准的文献,采用Review Manager 5.0.24软件进行Meta分析.结果:共纳入10篇文献,共计患者1 104例.Meta分析结果显示,腹针治疗颈椎病效果和疗效优于常规针刺、电针和颈椎牵引.结论:腹针在治疗颈椎病方面有一定的优势,但由于纳入评价的文献质量普遍不高以及发表偏倚等因素,使本系统评价的证据强度不足,有待进一步进行大样本、高质量、多中心、方法学规范化的临床随机对照试验来证实.

  1. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Joseph S Ross

    2009-09-01

    Full Text Available BACKGROUND: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. METHODS AND FINDINGS: We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006. CONCLUSIONS: Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low

  2. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    Cofield, Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment and retention issues with specific strategies will help researchers deal with these issues in their funding applications and in turn develop the necessary infrastructure to participate in emergency medicine clinical trials. PMID:21040112

  3. Subjective and objective outcomes in randomized clinical trials

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G;

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial...

  4. One Medicine, One Acupuncture

    Narda G. Robinson

    2012-08-01

    Full Text Available “One Acupuncture”, like “One Medicine”, has the potential to improve research quality and clinical outcomes. However, while human acupuncture point locations have remained largely consistent over time, the veterinary versions remain imprecise and variable. Establishing anatomical criteria for veterinary acupuncture atlases in keeping with the human template will create congruence across species, benefiting both research and practice. Anatomic criteria for points based on objectively verifiable structures will facilitate translational research. Functionally comparative innervation, in particular, should be similar between species, as the nerves initiate and mediate physiologic changes that result from point stimulation. If researchers choose points that activate different nerves in one species than in another, unpredictable outcomes may occur. Variability in point placement will impede progress and hamper the ability of researchers and clinicians to make meaningful comparisons across species. This paper reveals incongruities that remain between human and veterinary acupuncture points, illustrating the need to analyze anatomical characteristics of each point to assure accuracy in selecting transpositional acupuncture locations.

  5. Treatment of Diabetic Nephropathy with Acupuncture

    CHU Qin; WANG Lin; LIU Guo-zhen; HAN Chou-ping

    2007-01-01

    Objective: to observe the clinical efficacy of acupuncture on diabetic nephropathy.Methods: altogether 54 cases were randomly allocated into acupuncture group (30 cases) and control group of western medications (24 cases), the latter was treated with routine western medication, while the former was combined acupuncture based on routine western medication,and the treatment course of the two groups were both 30 days. Results: the effect of treatment group was superior to the control group (P<0.05). Conclusion: acupuncture can improve symptoms of diabetic nephropathy, lower blood glucose, urine albumin, blood urine nitrogen,and creatinine and improve the function of kidney.

  6. Clinical Research on Acupuncture Combined with Penetrating Moxibustion in the Treatment of Insomnia%针刺配合透灸治疗失眠临床研究

    王晓明

    2012-01-01

    Objective:To investigate the clinical efficacy of acupuncture combined with penetrating moxibustion for the treatment of insomnia. Methods:The acuponts of bilateral Feishu (bl 13) ,Xinshu (bl 15) ,Pishu (bl 20) .Ganshu (bl 18) and Shenshu (bl 23) were acupunctured,while at the same time the penetrating moxibustion was used for 40 min,one time per day with 10 times as a course of treatment. The curative effects were evaluated after three courses of treatment. Results: Among 60 cases,33 cases were cured;15 cases were markedly effective;9 cases were effective;3 cases were ineffective. The efficiency rate was 95 %. Conclusion: Acupuncture combined with penetrating moxibustion has significant clinical efficacy in the treatment of insomnia.%目的:探讨针刺配合透灸治疗失眠的临床疗效.方法:针刺双侧肺俞、心俞、脾俞、肝俞、肾俞,同时采用艾灸透灸40 min,每日1次,10次为1个疗程,治疗3个疗程后评定疗效.结果:60例患者中痊愈33例,显效15例,有效9例,无效3例,有效率为95%.结论:针刺配合透灸治疗失眠临床疗效显著.

  7. APPLICATION OF SINGLE PHOTON EMMISSION COMPUTED TOMOGRAPHY TO CLINICAL STUDY ON THE THERAPEUTIC EFFECT OF ACUPUNCTURE IN TREATMENT OF CHILD CEREBRAL PARALYSIS

    于海波; 鞠琰莉; 贾少微

    2001-01-01

    Subjective: To identify the practicability and clinical values of acupuncture in the treatment of child cerebral paralysis, try to provide visualized evidence and mechanisms for acupuncture treatment of this disease. Methods: 13 cerebral palsy children including 9 cases of spasmodic type, 2 cases of ataxia type and 2 cases of mixed type, 9 males and 4 females were subjected into this study. Acupoints used were Hegu (LI 4), Quchi (LI 11 ), Zusanli (ST 36) and Sanyinjiao (SP 6) that were punctured and stimulated electrically with parameters of frequency 2/15 Hz, electric current 5 mA, and duration of stimulation 30 min. Under monitoring of Siemens ECAM/ICON SPECT System, blood flow volumes of different brain regions were observed before, during and after elctroacupuncture (EA) stimulation of the above-mentioned acupoints. Results: SPECT revealed that in these 13 infantile patients, 18 regions of the brain in-cluding 12 in the frontal lobe and 6 in the temporal lobe presented insufficiency of blood perfusion and hypofunction; during EA, these cerebral regions and parietal lobe, visual cortex, thalamus, basal ganglion and cerebellum showed improvement in blood perfusion and function in different degrees. Results of the quantitative analysis on blood flow function changing rate (BFCR)% showed a significant increase in 83.3 % of the focal regions during EA. Conclusion: Acupuncture therapy can effectively improve cerebral blood perfusion of the focus and is of clinical value in treatment of infantile cerebral paralysis.

  8. 腹针疗法治疗慢性结肠炎的临床观察%Clinical observation on treating chronic colitis with abdominal acupuncture

    陈杰

    2013-01-01

    目的:观察腹针疗法治疗慢性结肠炎的临床疗效。方法:选择62例慢性结肠炎患者,随机分为两组,分别与腹针治疗、药物治疗,观察患者的临床症状改善情况以及临床疗效。结果:腹针治疗组与药物治疗组经治疗后评分差值比较,差异有统计学意义(P<0.01),提示治疗组在改善患者症状方面优于对照组。腹针治疗组与药物治疗组间疗效比较差异有统计学意义(P<0.05),提示治疗组疗效优于对照组。结论:腹针疗法能够有效的改善患者的临床症状,有较好的临床疗效,值得临床推广。%Objective:To observe the abdominal acupuncture treatment of chronic colitis clinical efficacy. Methods:62 cases of chronic colitis patients were randomly divided into two groups, respectively, with abdominal acupuncture therapy, medicine therapy, observed in patients with clinical symptoms and clinical efficacy. Results:Abdominal acupuncture group and the medicine group compared score difference after treatment, the difference was statistically significant (P<0.01). In improving symptoms, the treated group was better than the control group. The difference between the efficacy of abdominal acupuncture group and medicine group was statistically significant (P<0.05), the efficacy of treated group was better than the control group. Conclusion:Abdominal acupuncture can effectively improve the patient’s clinical symptoms, has better clinical efficacy, is worthy of promotion.

  9. Beneficial effect of acupuncture in the management of anxiety related to dental treatment: a set of case series

    Rosted, P; Bundgaard, M; Gordon, S; Pedersen, AML

    2010-01-01

    the level of anxiety in patients with dental anxiety and may offer a simple and inexpensive method of treatment. However, the present results need to be tested in a larger randomised clinical trial in order to evaluate the effectiveness of the acupuncture treatment in patients with dental anxiety....

  10. Clinical Trials: A Crucial Key to Human Health Research

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...

  11. End points in dermatologic clinical trials: A review for clinicians.

    Wei, Erin X; Kirsner, Robert S; Eaglstein, William H

    2016-07-01

    Clinical trials are critical for the development of new therapies in dermatology, and their results help determine US Food and Drug Administration (FDA) approval and guide care. Of special relevance is the clinical trial efficacy end point, the metric from which statistically significant outcome is derived. Clinicians' understanding of a clinical trial's end point is necessary for critical analysis of the trial results and for applying those results to daily practice. This review provides practical knowledge and critical evaluation of end points used in treatment approvals by the FDA. The end points for actinic keratosis, acne vulgaris, atopic dermatitis, onychomycosis, and cutaneous ulcer serve as examples. PMID:26936300

  12. Review on clinical trials of targeted treatments in malignant mesothelioma

    Jakobsen, Jan Nyrop; Sørensen, Jens Benn

    2011-01-01

    Malignant mesothelioma (MM) is an aggressive tumor of the serosal surfaces with a poor prognosis. Advances in the understanding of tumor biology have led to the development of several targeted treatments, which have been evaluated in clinical trials. This article is a comprehensive review of all...... clinical trials evaluating the effect of targeted treatments in MM....

  13. Perspectives on randomized clinical trials : the case for albuminuria

    Lambers Heerspink, Hiddo Jan

    2008-01-01

    Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious random

  14. Implementation of the NCI’s National Clinical Trials Network

    NCI is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year. The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initia

  15. Observer bias in randomised clinical trials with binary outcomes

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida; Tendal, Britta; Hilden, Jørgen; Boutron, Isabelle; Ravaud, Philippe; Brorson, Stig

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  16. Acupuncture in ancient China: how important was it really?

    Lehmann, Hanjo

    2013-01-01

    Although acupuncture theory is a fundamental part of the Huangdi Neijing, the clinical application of the needle therapy in ancient China was always a limited one. From early times there have been warnings that acupuncture might do harm. In books like Zhang Zhongjing's Shanghanlun it plays only a marginal role. Among the 400 emperors in Chinese history, acupuncture was hardly ever applied. After Xu Dachun called acupuncture a "lost tradition" in 1757, the abolition of acupuncture and moxibustion from the Imperial Medical Academy in 1822 was a radical, but consequent act. When traditional Chinese medicine was revived after 1954, the "New Acupuncture" was completely different from what it had been in ancient China. The conclusion, however, is a positive one: The best time acupuncture ever had was not the Song dynasty or Yuan dynasty, but is now - and the future of acupuncture does not lie in old scripts, but in ourselves. PMID:23464646

  17. Towards a framework of success factors for clinical trials

    Buonansegna, Erika; Salomo, Søren; Maier, Anja;

    2012-01-01

    Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature...... clinical trials reducing failures and increasing profits. The framework directs managerial focus on the most important factors for success and helps managers in decision-making of operational tasks. The framework can also be applied as a checklist for assessing the status of a clinical trial and later as a...... benchmarking tool to compare clinical trial processes. Dependencies among the identified factors seem to exist, thus a set of propositions, can be developed from the success factors and be the basis for future empirical testing....

  18. Integrating pain metrics into oncology clinical trials.

    Cleeland, Charles S; O'Mara, Ann; Zagari, Martin; Baas, Carole

    2011-11-01

    Cancer-related pain is highly prevalent and often severe, and as a result is often one of the defining experiences for patients with malignancy. Patients and patients' families almost always live with the ever-present reality that cancer treatment and progression may be accompanied by pain. For patients nearing the end of life, most fear that their final days will be spent living with the terrible effects of the disease, the most important of which is pain. Despite this, there is far less systematic research on the mechanisms of cancer-related pain or on the development of new agents to reduce or eliminate pain in cancer patients compared with research to combat the disease itself. Further, even when the focus of research is treatment of the tumor, the effects of anticancer treatments on pain are often underreported in publications and other forums. To illustrate the relative drought in the cancer pain control area, there have been no new drugs approved for cancer-related pain in recent years. A number of methodologic and logistical challenges that hinder the ability to assess pain response in clinical trials are discussed in this article. Possible ways to address these challenges are also discussed. PMID:22046026

  19. Clinical Trial: Marine Lipid Suppositories as Laxatives

    Orri Thor Ormarsson

    2012-09-01

    Full Text Available Cod-liver oil and other marine products containing polyunsaturated fatty acids have anti-inflammatory, anti-bacterial and anti-viral effects and may be useful in the treatment of various inflammatory and infectious diseases. We developed suppositories and ointment with 30% free fatty acid (FFA extract from omega-3 fish oil. Our purpose was to evaluate the safety of marine lipid suppositories and ointment in healthy volunteers and to explore the laxative effect of the suppositories. Thirty healthy volunteers were randomized either to a study group administrating 30% FFA suppositories and applying 30% FFA ointment to the perianal region twice per day for two weeks, or to a control group using placebo suppositories and ointment in a double blinded manner. Results: No serious toxic effects or irritation were observed. In the study group 93% felt the urge to defecate after administration of the suppositories as compared to 37% in the control group (P = 0.001. Subsequently 90% in the study group defecated, compared to 33% in the control group (P = 0.001. Conclusion: The marine lipid suppositories and ointment were well tolerated with no significant toxic side effects observed during the study period. The suppositories have a distinct laxative effect and we aim to explore this effect in further clinical trials.

  20. Effectiveness of acupuncture and related therapies for palliative care of cancer: overview of systematic reviews

    Wu, Xinyin; Chung, Vincent CH; Hui, Edwin P; Ziea, Eric TC; Ng, Bacon FL; Ho, Robin ST; Tsoi, Kelvin KF; Wong, Samuel YS; Wu, Justin CY

    2015-01-01

    Acupuncture and related therapies such as moxibustion and transcutaneous electrical nerve stimulation are often used to manage cancer-related symptoms, but their effectiveness and safety are controversial. We conducted this overview to summarise the evidence on acupuncture for palliative care of cancer. Our systematic review synthesised the results from clinical trials of patients with any type of cancer. The methodological quality of the 23 systematic reviews in this overview, assessed using the Methodological Quality of Systematic Reviews Instrument, was found to be satisfactory. There is evidence for the therapeutic effects of acupuncture for the management of cancer-related fatigue, chemotherapy-induced nausea and vomiting and leucopenia in patients with cancer. There is conflicting evidence regarding the treatment of cancer-related pain, hot flashes and hiccups, and improving patients’ quality of life. The available evidence is currently insufficient to support or refute the potential of acupuncture and related therapies in the management of xerostomia, dyspnea and lymphedema and in the improvement of psychological well-being. No serious adverse effects were reported in any study. Because acupuncture appears to be relatively safe, it could be considered as a complementary form of palliative care for cancer, especially for clinical problems for which conventional care options are limited. PMID:26608664

  1. Effectiveness of acupuncture and related therapies for palliative care of cancer: overview of systematic reviews.

    Wu, Xinyin; Chung, Vincent C H; Hui, Edwin P; Ziea, Eric T C; Ng, Bacon F L; Ho, Robin S T; Tsoi, Kelvin K F; Wong, Samuel Y S; Wu, Justin C Y

    2015-01-01

    Acupuncture and related therapies such as moxibustion and transcutaneous electrical nerve stimulation are often used to manage cancer-related symptoms, but their effectiveness and safety are controversial. We conducted this overview to summarise the evidence on acupuncture for palliative care of cancer. Our systematic review synthesised the results from clinical trials of patients with any type of cancer. The methodological quality of the 23 systematic reviews in this overview, assessed using the Methodological Quality of Systematic Reviews Instrument, was found to be satisfactory. There is evidence for the therapeutic effects of acupuncture for the management of cancer-related fatigue, chemotherapy-induced nausea and vomiting and leucopenia in patients with cancer. There is conflicting evidence regarding the treatment of cancer-related pain, hot flashes and hiccups, and improving patients' quality of life. The available evidence is currently insufficient to support or refute the potential of acupuncture and related therapies in the management of xerostomia, dyspnea and lymphedema and in the improvement of psychological well-being. No serious adverse effects were reported in any study. Because acupuncture appears to be relatively safe, it could be considered as a complementary form of palliative care for cancer, especially for clinical problems for which conventional care options are limited. PMID:26608664

  2. 77 FR 35407 - Proposed Collection; Comment Request: Clinical Mythteries: A Video Game About Clinical Trials

    2012-06-13

    ... HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request: Clinical Mythteries: A Video Game About Clinical Trials SUMMARY: In compliance with the requirement of Section 3506(c)(2... Collection: Title: Clinical Mythteries: A Video Game About Clinical Trials. Type of Information...

  3. Observer bias in randomized clinical trials with measurement scale outcomes

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...... investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more...

  4. Statistical challenges for central monitoring in clinical trials: a review.

    Oba, Koji

    2016-02-01

    Recently, the complexity and costs of clinical trials have increased dramatically, especially in the area of new drug development. Risk-based monitoring (RBM) has been attracting attention as an efficient and effective trial monitoring approach, which can be applied irrespectively of the trial sponsor, i.e., academic institution or pharmaceutical company. In the RBM paradigm, it is expected that a statistical approach to central monitoring can help improve the effectiveness of on-site monitoring by prioritizing and guiding site visits according to central statistical data checks, as evidenced by examples of actual trial datasets. In this review, several statistical methods for central monitoring are presented. It is important to share knowledge about the role and performance capabilities of statistical methodology among clinical trial team members (i.e., sponsors, investigators, data managers, monitors, and biostatisticians) in order to adopt central statistical monitoring for assessing data quality in the actual clinical trial. PMID:26499195

  5. Observer bias in randomized clinical trials with measurement scale outcomes

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...... optimistic estimates of effect. We pooled the differences in effect size using inverse variance random-effects meta-analysis and used metaregression to identify potential reasons for variation. RESULTS: We included 24 trials in our review. The main meta-analysis included 16 trials (involving 2854 patients...

  6. Clinical trials with fast neutrons in Europe

    There is an increasing number of European centres with facilities for fast neutron treatment. To prepare protocols for multi-centre trials and to make treatment results intercomparable, many obstacles have to be overcome. A provision for two dose levels in the neutron treatment arm of a trial could enable the estimation of the local cure rate for an acceptable late complication rate. The considerations on which future trials are based as well as the main characteristics of trials in progress in Europe are reported. (author)

  7. New generation of breast cancer clinical trials implementing molecular profiling

    Dimitrios Zardavas; Martine Piccart-Gebhart

    2016-01-01

    The implementation of molecular profiling technologies in oncology deepens our knowledge for the molecular landscapes of cancer diagnoses, identifying aberrations that could be linked with specific therapeutic vulnerabilities. In particular, there is an increasing list of molecularly targeted anticancer agents undergoing clinical development that aim to block specific molecular aberrations. This leads to a paradigm shift, with an increasing list of specific aberrations dictating the treatment of patients with cancer. This paradigm shift impacts the field of clinical trials, since the classical approach of having clinico-pathological disease characteristics dictating the patients' enrolment in oncology trials shifts towards the implementation of molecular profiling as pre-screening step. In order to facilitate the successful clinical development of these new anticancer drugs within specific molecular niches of cancer diagnoses, there have been developed new, innovative trial designs that could be classified as follows: i) longitudinal cohort studies that implement (or not) "nested" downstream trials, 2) studies that assess the clinical utility of molecular profiling, 3) "master" protocol trials, iv) "basket" trials, v) trials following an adaptive design. In the present article, we review these innovative study designs, providing representative examples from each category and we discuss the challenges that still need to be addressed in this era of new generation oncology trials implementing molecular profiling. Emphasis is put on the field of breast cancer clinical trials.

  8. Do Japanese Style Acupuncture and Moxibustion Reduce Symptoms of the Common Cold?

    Kenji Kawakita

    2008-01-01

    Full Text Available We summarize the results from a series of investigations of Japanese style acupuncture and moxibustion therapies on symptoms of the common cold that have been conducted (FTLE 1999–03, supported by the Foundation for Training and Licensure Examination in Anma- Massage- Acupressure, Acupuncture and Moxibustion. We also discuss the various interventions and concerns that we faced during these investigations. The subjects were students and teachers. The pilot study (FTLE1999 of a two arm (real and non-treatment control RCT at a Japanese acupuncture school showed that manual acupuncture to a specific needling point at the throat clearly reduced symptoms of the common cold. The first multi-center (five centers RCT (FTLE 2000 revealed a significant reduction in cold symptoms, by general linear model analysis (between groups, P = 0.024. To reduce the technical variation, we employed indirect moxibustion to the neck points as a uniform intervention in the next project (FTLE 2001 without statistically significant results. Then we elongated the periods of treatment from 2 to a maximum of 12 weeks (FTLE 2002 with different interventions accompanied by 4 weeks follow-up. The results were still not statistically significant. As the final project, we tried to develop a new experimental design for individualized intervention by conducting n-of-1 trials using elderly subjects in a health care center but without detecting a clear effect. In conclusion, the safety of Japanese acupuncture or moxibustion was sufficiently demonstrated; however, a series of clinical trials could not offer convincing evidence to recommend the use of Japanese style acupuncture or moxibustion for preventing the common cold. Further studies are required as the present trials had several limitations.

  9. Money and morals: ending clinical trials for financial reasons.

    Eaton, Margaret L; Kwon, Brian K; Scott, Christopher Thomas

    2015-01-01

    Too often, biopharmaceutical companies stop their clinical trials solely for financial reasons. In this chapter, we discuss this phenomenon against the backdrop of a 2011 decision by Geron Corporation to abandon its stem cell clinical trial for spinal cord injury (SCI), the preliminary results of which were released in May 2014. We argue that the resultant harms are widespread and are different in nature from the consequences of stopping trials for scientific or medical reasons. We examine the ethical and social effects that arise from such decisions and discuss them in light of ethical frameworks, including duties of individual stakeholders and corporate sponsors. We offer ways that sponsors and clinical sites can ensure that trials are responsibly started, and once started adequately protect the interests of participants. We conclude with recommendations that industry sponsors of clinical trials should adopt in order to advance a collective and patient-centered research ethic. PMID:25062706

  10. Mitigating the Effects of Nonadherence in Clinical Trials.

    Shiovitz, Thomas M; Bain, Earle E; McCann, David J; Skolnick, Phil; Laughren, Thomas; Hanina, Adam; Burch, Daniel

    2016-09-01

    Accounting for subject nonadherence and eliminating inappropriate subjects in clinical trials are critical elements of a successful study. Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects. Inappropriate subjects (including those who do not have the illness under study, fail to report exclusionary conditions, falsely report medication adherence, or participate in concurrent trials) confound safety and efficacy signals. This paper, a product of the International Society for CNS Clinical Trial Methodology (ISCTM) Working Group on Nonadherence in Clinical Trials, explores and models nonadherence in clinical trials and puts forth specific recommendations to identify and mitigate its negative effects. These include statistical analyses of nonadherence data, novel protocol design, and the use of biomarkers, subject registries, and/or medication adherence technologies. PMID:26634893

  11. Sample size determination in clinical trials with multiple endpoints

    Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R

    2015-01-01

    This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...

  12. DICOM Structured Reporting and Cancer Clinical Trials Results

    David A. Clunie

    2007-01-01

    Full Text Available The use of biomarkers derived from radiological images as surrogate end-points in therapeutic cancer clinical trials is well established. DICOM is the ubiquitous standard for the interchange of images for both clinical use as well as research. It also has capabilities for the exchange of image-related information, including categorical and quantitative information derived from images. The use of DICOM Structured Reporting for the encoding and interchange of clinical trial results in a standard manner is reviewed.

  13. Metadata-based analysis to improve clinical trial exchange

    Luzi, Daniela; Ricci, Fabrizio L. (CNR-IRPPS); Serbanati, Luca D.; GreyNet, Grey Literature Network Service

    2006-01-01

    There are various, important information sources devoted to the diffusion of clinical trials, but they fail to achieve a complete coverage of clinical research. The demand for a mandatory public registration of clinical trials is emerging from different institutions, which are making efforts to develop common metadata schemas to both increase information exchange and make this information publicly available. The paper describes a metadata analysis of the various solutions of CT data represent...

  14. African American women's perceptions of cancer clinical trials

    Haynes-Maslow, Lindsey; Godley, Paul; DiMartino, Lisa; White, Brandolyn; Odom, Janice; Richmond, Alan; Carpenter, William

    2014-01-01

    Cancer clinical trials are important for resolving cancer health disparities for several reasons; however, clinical trial participation among African Americans is significantly lower than Caucasians. This study engaged focus groups of 82 female African American cancer survivors or cancer caregivers, including those in better resourced, more urban areas and less resourced, more rural areas. Informed by an integrated conceptual model, the focus groups examined perceptions of cancer clinical tri...

  15. DICOM Structured Reporting and Cancer Clinical Trials Results

    David A. Clunie

    2007-01-01

    The use of biomarkers derived from radiological images as surrogate end-points in therapeutic cancer clinical trials is well established. DICOM is the ubiquitous standard for the interchange of images for both clinical use as well as research. It also has capabilities for the exchange of image-related information, including categorical and quantitative information derived from images. The use of DICOM Structured Reporting for the encoding and interchange of clinical trial results in a standar...

  16. Differential brain effects of laser and needle acupuncture at LR8 using functional MRI

    Quah-Smith, Im; Williams, Mark A.; Lundeberg, Thomas; Suo, Chao; Sachdev, Perminder

    2013-01-01

    Objective While needle acupuncture is a well-accepted technique, laser acupuncture is being increasingly used in clinical practice. The differential effects of the two techniques are of interest. We examine this in relation to brain effects of activation of LR8, a putative acupuncture point for depression, using functional MRI (fMRI). Methods Sixteen healthy participants were randomised to receive low intensity laser acupuncture to LR8 on one side and needle acupuncture to the contralateral L...

  17. A pilot study on acupuncture for lower urinary tract symptoms related to chronic prostatitis/chronic pelvic pain

    Stone Brian A

    2007-02-01

    Full Text Available Abstract Background The etiology and treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS remain poorly understood. Pain, lower urinary tract voiding symptoms and negative impact on quality of life (QOL are the most common complaints. Acupuncture, which has been widely used to treat painful and chronic conditions, may be a potential treatment to alleviate the constellation of symptoms experienced by men with CP/CPPS. The purpose of our study was to assess the impact of standardized full body and auricular acupuncture in men refractory to conventional therapies and collect pilot data to warrant further randomized trials. Methods Ten men diagnosed with category IIIA or IIIB CP/CPPS >6 months, refractory to at least 1 conventional therapy (antibiotics, anti-inflammatory agents, 5-α reductase inhibitors, α-1 blockers and scoring >4 on the pain subset of the NIH-CPSI were prospectively analyzed in an Institutional Review Board (IRB approved, single-center clinical trial (Columbia University Medical Center IRB#AAAA-7460. Standardized full body and auricular acupuncture treatment was given twice weekly for 6 weeks. The primary endpoints were total score of the NIH-CPSI and assessment of serious adverse events. The secondary endpoints were individual scores of the NIH-CPSI and QOL questionnaire scores of the short-form 36 (SF-36. Results The median age of the subjects was 36 years (range 29–63. Decreases in total NIH-CPSI scores (mean ± SD after 3 and 6 weeks from baseline (25.1 ± 6.6 were 17.6 ± 5.7 (P Conclusion The preliminary findings, although limited, suggest the potential therapeutic role of acupuncture in the treatment of CP/CPPS. Data from this and previous studies warrant randomized trials of acupuncture for CP/CPPS and particular attention towards acupuncture point selection, treatment intervention, and durability of acupuncture.

  18. Randomization in clinical trials: conclusions and recommendations.

    Lachin, J M; Matts, J P; Wei, L J

    1988-12-01

    The statistical properties of simple (complete) randomization, permuted-block (or simply blocked) randomization, and the urn adaptive biased-coin randomization are summarized. These procedures are contrasted to covariate adaptive procedures such as minimization and to response adaptive procedures such as the play-the-winner rule. General recommendations are offered regarding the use of complete, permuted-block, or urn randomization. In a large double-masked trial, any of these procedures may be acceptable. For a given trial, the relative merits of each procedure should be carefully weighed in relation to the characteristics of the trial. Important considerations are the size of the trial, overall as well as within the smallest subgroup to be employed in a subgroup-specific analysis, whether or not the trial is to be masked, and the resources needed to perform the proper randomization-based permutational analysis. PMID:3203526

  19. Design and analyses of clinical trials

    The course will use RTOG studies to illustrate design and analysis issues for phase I, phase II, and phase III trials. The issues discussed will include types of statistical errors, the selection of study endpoints, choice of the appropriate study population, determination of sample sizes, randomization, and plans for statistical analyses. Estimation of the sample sizes will be discussed for both absolute survival (alive or dead) and cause specific failure (local failure). For phase III trials, Data Monitoring Committees are now widely used in multi-centered trials. Their main purpose is to determine if there are sufficient evidence to terminate a study for efficacy or safety reasons. The results of two such terminated trials will be used to illustrate the DMC's function. The question of when should a trial be reported at medical meeting and in the literature will be explored. The emphasis will be on concepts and statistical notations will be kept to a minimum

  20. A REVIEW ON CLINICAL TRIALS: WHY TO INTRODUCE ZERO PHASE

    MANINDER KAUR

    2016-04-01

    Full Text Available Objective: The main objective of this study is to know clinical trials in nutshell and phase 0 clinical trial are to establish at the very earliest opportunity-before large numbers of patients have been accrued and exposed to potential drug-associated toxicity-whether an agent is modulating its target in a tumor, and consequently whether further clinical development is warranted. We review here the fundamental requirements of clinical studies conducted under an exploratory IND and address some common misconceptions regarding phase 0 trials. Phase 0 clinical trials, developed in response to the United States Food and Drug Administration (FDA's recent exploratory Investigational New Drug (IND guidance, and are intended to expedite the clinical evaluation of new molecular entities. The exploratory IND supports the performance of first-in-human testing of new investigational agents at subtherapeutic doses based on reduced manufacturing and toxicologic requirements, allowing the demonstration of drug-target effects and assessment of pharmacokinetic-pharmacodynamic relationships in humans earlier in clinical development. Conclusion: From this present review study, we concluded that Phase “0” in clinical trials can work as a useful parameter to measure drug safety at subtherapeutic level and the fundamental requirements of clinical studies conducted under an exploratory IND and address some common misconceptions regarding phase 0 trials.