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Randomized Clinical Trials on Acupuncture in Korean Literature: A Systematic Review  [PDF]
Jae Cheol Kong,Myeong Soo Lee,Byung-Cheul Shin
Evidence-Based Complementary and Alternative Medicine , 2009, DOI: 10.1093/ecam/nem130
Abstract: 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.
Randomized Clinical Trials of Constitutional Acupuncture: A Systematic Review  [PDF]
Myeong Soo Lee,Byung-Cheul Shin,Sun-Mi Choi,Jong Yeol Kim
Evidence-Based Complementary and Alternative Medicine , 2009, DOI: 10.1093/ecam/nep085
Abstract: The aim of this systematic review is to compile and critically evaluate the evidence from randomized clinical trials (RCTs) for the effectiveness of acupuncture using constitutional medicine compared to standard acupuncture. Ten databases were searched through to December 2008 without language restrictions. We also hand-searched nine Korean journals of oriental medicine. We included prospective RCTs of any form of acupuncture with or without electrical stimulation. The included trials had to investigate constitutional medicine. There were no restrictions on population characteristics. Forty-one relevant studies were identified, and three RCTs were included. The methodological quality of the trials was variable. One RCT found Sasang constitutional acupuncture to be superior to standard acupuncture in terms of the Unified PD Rating Scale and freezing gate in Parkinson's disease (PD). Another two RCTs reported favorable effects of eight constitutional acupuncture on pain reduction in patients with herniated nucleus pulposi and knee osteoarthritis. Meta-analysis demonstrated positive results for eight constitutional acupuncture compared to standard acupuncture on pain reduction (weighted mean difference: 10 cm VAS, 1.69, 95% CI 0.85–2.54, P < 0.0001; heterogeneity: τ2 = 0.00, Χ2 = 0.00, P = 0.96, I2 = 0%). Our results provide suggestive evidence for the effectiveness of constitutional acupuncture in treating pain conditions compared to standard acupuncture. However, the total number of RCTs and the total sample size included in our analysis were too small to draw definite conclusions. Future RCTs should assess larger patient samples with longer treatment periods and appropriate controls.
Are acupoints specific for diseases? A systematic review of the randomized controlled trials with sham acupuncture controls
Hongwei Zhang, Zhaoxiang Bian, Zhixiu Lin
Chinese Medicine , 2010, DOI: 10.1186/1749-8546-5-1
Abstract: Databases including Medline, Embase, AMED and Chinese Biomedical Database were searched to identify randomized controlled trials published between 1998 and 2009 that compared traditional body acupuncture on acupoints with sham acupuncture controls on irrelevant acupoints or non-acupoints with the same needling depth. The Cochrane Collaboration's tool for assessing risk of bias was employed to address the quality of the included trials.Twelve acupuncture clinical trials with sham acupuncture controls were identified and included in the review. The conditions treated varied. Half of the included trials had positive results on the primary outcomes and demonstrated acupoint specificity. However, among those six trials (total sample size: 985) with low risk of bias, five trials (sample size: 940) showed no statistically significant difference between proper and sham acupuncture treatments.This review did not demonstrate the existence of acupoint specificity. Further clinical trials with larger sample sizes, optimal acupuncture treatment protocols and appropriate sham acupuncture controls are required to resolve this important issue.In acupuncture, the acupoints for a specific treatment are selected from a group consisting of local acupoints, distal acupoints and symptomatic acupoints. The selection should be in accordance with the meridian principles and the characteristics of acupoints. However, it was claimed that acupuncture may be effective even when the needle is inserted anywhere in the appropriate segment or at motor points [1,2] for some disorders such as nausea but not others such as chronic pain [3,4]. Although acupuncture treatment may regulate physiological functions [5], the current understanding of its mechanisms in physiological and psychosocial aspects is inadequate to explain the effects of specific acupoints [6-8]. There have been many clinical trials and experimental studies on the specificity of acupoints [3,9,10] but systematic reviews are not availa
Manual Acupuncture for Treatment of Diabetic Peripheral Neuropathy: A Systematic Review of Randomized Controlled Trials  [PDF]
Wei Chen, Guo-yan Yang, Bo Liu, Eric Manheimer, Jian-Ping Liu
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0073764
Abstract: Objective Manual acupuncture has commonly been used in China, either alone or in combination with conventional medicine, to treat diabetic peripheral neuropathy (DPN). The objective of this study was to perform a systematic review to evaluate the potential benefits and harms of manual acupuncture for DPN to justify its clinical use. Methods We searched for published and unpublished randomized controlled trials of manual acupuncture for DPN till 31 March 2013. Revman 5.2 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Results A total of 25 trials involving 1649 participants were included. The methodological quality of included trials was generally poor. Meta-analysis showed that manual acupuncture had better effect on global symptom improvement compared with mecobalamin (RR 1.31, 95%CI 1.21 to 1.42), vitamin B1 and B12 (RR 1.55, 95%CI 1.33 to 1.80), and no treatment (RR 1.56, 95%CI 1.31 to 1.85), and that the combination of manual acupuncture and mecobalamin had better effect compared with mecobalamin alone on global symptom improvement (RR 1.56, 95%CI 1.28 to 1.90). Adverse events were not reported in any trials. The asymmetric funnel plot suggested publication bias. Conclusions Despite the number of trials of manual acupuncture for DPN and their uniformly positive results, no clinically relevant conclusions can be drawn from this review due to the trials’ high risks of bias and the possibility of publication bias. Clearly defined and internationally acknowledged outcome measures are required for future study. There remains an urgent need for training Chinese researchers in conducting unbiased trials as well as prospectively registering all initiated Chinese trials to avoid publication bias.
How Well Do Randomized Trials Inform Decision Making: Systematic Review Using Comparative Effectiveness Research Measures on Acupuncture for Back Pain  [PDF]
Claudia M. Witt, Eric Manheimer, Richard Hammerschlag, Rainer Lüdtke, Lixing Lao, Sean R. Tunis, Brian M. Berman
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0032399
Abstract: 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.
How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials
Klaus Linde, Karin Niemann, Antonius Schneider, Karin Meissner
BMC Medicine , 2010, DOI: 10.1186/1741-7015-8-75
Abstract: MEDLINE, Embase, Cochrane Central Register of Controlled Clinical Trials and reference lists were searched up to April 2010 to identify randomized trials of acupuncture for any condition, including both sham and no acupuncture control groups. Data were extracted by one reviewer and verified by a second. Pooled standardized mean differences were calculated using a random effects model with the inverse variance method.Thirty-seven trials with a total of 5754 patients met the inclusion criteria. The included studies varied strongly regarding patients, interventions, outcome measures, methodological quality and effect sizes reported. Among the 32 trials reporting a continuous outcome measure, the random effects standardized mean difference between sham acupuncture and no acupuncture groups was -0.45 (95% confidence interval, -0.57, -0.34; I2 = 54%; Egger's test for funnel plot asymmetry, P = 0.25). Trials with larger effects of sham over no acupuncture reported smaller effects of acupuncture over sham intervention than trials with smaller nonspecific effects (β = -0.39, P = 0.029).Sham acupuncture interventions are often associated with moderately large nonspecific effects which could make it difficult to detect small additional specific effects. Compared to inert placebo interventions, effects associated with sham acupuncture might be larger, which would have considerable implications for the design and interpretation of clinical trials.In recent years, there has been increasing evidence from large randomized trials and systematic reviews showing that patients receiving acupuncture report better outcomes than patients receiving no treatment or usual care only (for example, [1,2]). A large trial on low back pain [3] and a meta-analysis of migraine trials [4] even found superiority over guideline-oriented conventional care. At the same time, many recent high-quality trials comparing true acupuncture with a sham acupuncture intervention found only minor or even no differe
Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial
Shi Guang-Xia,Han Li-Li,Liu Li-Ying,Li Qian-Qian
Trials , 2012, DOI: 10.1186/1745-6215-13-224
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
Acupoint Stimulation for Fibromyalgia: A Systematic Review of Randomized Controlled Trials  [PDF]
Huijuan Cao,Xun Li,Mei Han,Jianping Liu
Evidence-Based Complementary and Alternative Medicine , 2013, DOI: 10.1155/2013/362831
Abstract: Background. Acupoint stimulation is popular for treatment of fibromyalgia though there is lack of comprehensive evaluation of current clinical evidence for its effect and safety. Objective. To systematically review the beneficial effects and safety of acupoint stimulation for fibromyalgia. Methods. We searched six electronic databases for randomized trials on acupoint stimulation for treatment of fibromyalgia. Two authors extracted data and assessed the trial quality independently. RevMan 5.2 software was used for data analyses with effect estimate presented as (standard) mean difference and a 95% confidence interval. We defined minimum, medium, and large SMD effect sizes as 0.3, 0.5, and 0.75. Results. 16 RCTs with 1081 participants were involved in this review. Only two trials were evaluated as low risk of bias. Meta-analysis showed that acupuncture alone or combined with cupping therapy was superior to conventional medications on reducing pain scores and/or the number of tender points. However, acupuncture showed no better than sham acupuncture on pain reduction. There was no serious adverse event reported to be related to acupoint stimulation. Conclusions. Acupoint stimulation appears to be effective in treating fibromyalgia compared with medications. However, further large, rigorously designed trials are warranted due to insufficient methodological rigor in the included trials. 1. Background As nonspecific rheumatism, fibromyalgia (FM) is a disorder in which typical symptoms are chronic widespread muscular-skeletal pain and stiffness accompanying with fatigue, anxiety, sleep disorder, and/or irritable bowel syndrome [1]. The well known diagnostic criterion for this disease was developed by the American College of Rheumatology (ACR) in 1990 [2], and the latest version of this diagnostic criterion was updated in 2009 [3]. The main purpose of treatment for FM is to alleviate the pain and improve the quality of life for FM patients [4]. Without the curative medications for the entire scope of symptoms and disabilities associated with FM [4], complementary therapies are commonly used by FM patients, such as acupuncture, herbal medicine, and massage. Systematic reviews were also conducted to summarize the clinical evidence of therapeutic effect of those complementary therapies in treating FM. Mayhew and Ernst [5] collected results from five randomized controlled trials in 2007 and demonstrated that due to the small sample size and low methodological quality of included trials, acupuncture could not be recommended for FM. Three years later, other two
Assessing the Quality of Reports about Randomized Controlled Trials of Acupuncture Treatment on Mild Cognitive Impairment  [PDF]
Xiao Lu,Shang Hongcai,Wang Jiaying,Hu Jing,Xiong Jun
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0016922
Abstract: To evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Mild Cognitive Impairment (MIC).
How to Design the Control Group in Randomized Controlled Trials of Acupuncture?
Jaung-Geng Lin,Chao-Hsun Chen,Yu-Che Huang,Yi-Hung Chen
Evidence-Based Complementary and Alternative Medicine , 2012, DOI: 10.1155/2012/875284
Abstract: In evidence-based medicine, randomized controlled trials (RCTs) are the preferred method for evaluating the efficacy of interventions. In regard to acupuncture RCTs, the most difficult issues are the design of the control group and implementation of the principle of “double-blinding.” We compared the advantages and limitations associated with different control group designs in acupuncture RCTs, to assist researchers in this field.
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