Eric Manheimer

Meta-Analysis: Acupuncture for Low Back Pain

Context Many people with back pain seek treatment with acupuncture, but the effectiveness of acupuncture for low back pain is controversial. Contribution This meta-analysis of 33 randomized, controlled trials that compared acupuncture with sham, other active, or no treatment found evidence that acupuncture is more effective than sham or no treatment for patients with chronic low back pain. Evidence about acupunctures effectiveness compared with other active treatments or for patients with acute back pain is inconclusive. Cautions Quality of included trials varied. The Editors Low back pain is the most common cause of activity limitation in people younger than 45 years of age in the United States and is the second most frequent reason for visits to the physician (1). A 1997 U.S. survey showed that 54% of patients reporting back or neck pain had used a complementary therapy within the past year (2), while a 2002 study showed back pain to be the most common reason for visits to acupuncturists in the United States (3). Given this high degree of public interest, the question of whether acupuncture alleviates low back pain is relevant. Before our study, at least 3 publications systematically reviewed the primary research up to 1996 (4-6). Their conclusions, limited by the paucity, heterogeneity, and poor quality of the studies, were somewhat discordant. Several new studies have since been published. Some of these studies have been reviewed (7), but the review did not take full account of study quality and did not attempt a meta-analysis of the data. We decided to undertake a new systematic review and meta-analysis to test the hypotheses that, for treating low back pain, acupuncture is more effective than penetrating and nonpenetrating sham acupuncture, other sham treatments, active treatments, and no treatment. In addition, we address the hypothesis that treatment effect size is correlated with study quality, treatment factors, and patient factors. Methods Search We searched the following computerized databases from their inception until August 2004: MEDLINE; Cochrane Central; EMBASE; AMED; CINAHL; and 2 specialized European databases (CISCOM in London, United Kingdom [to February 2003], and GERA in La Garde, France) that include gray literature, such as unpublished studies and conference reports. We performed text word searches of titles and abstracts for acupuncture, electroacupuncture, percutaneous electrical nerve stimulation, and backache, back pain, low back pain, dorsalgia, and lumbago. We contacted experts in Japan who updated their earlier search of Igaku Chuo Zasshi (19872003) (8) and also hand-searched the Journal of the Japan Society of Acupuncture and Moxibustion (20002004). We reconsidered all studies that were included in previous reviews (4-7) for inclusion in our review. In addition, we screened our own files, and we contacted experts in the United Kingdom, United States, Germany, Italy, Sweden, and Norway and asked them to contribute any studies of which they were aware (see Acknowledgments). We obtained copies of all papers that could be reports of randomized, controlled trials (RCTs) or reviews of RCTs (9). We scanned the bibliographies of all papers retrieved for further references. We excluded unpublished reports. Study Selection Two authors independently considered articles reporting random assignment of human participants to acupuncture or a control group for the treatment of any type of low back pain for inclusion. We excluded studies that included both patients with neck and low back pain, unless the data for patients with low back pain were available separately. We defined acupuncture in an inclusive manner to reflect its use in various traditions and theoretical approaches: The intervention had to involve the insertion of needles into the skin, but not for the purpose of injection. This definition includes any intervention that the study author or authors described as acupuncture or that the reviewers clearly identified as acupuncture. We excluded therapies that are similar to acupuncture but do not involve needle insertion (for example, laser acupuncture and electroacupuncture without needles) because most authorities believe acupuncture entails needle insertion (10). We excluded trials that compared 1 form of acupuncture only with another form. We included studies that provided usable data for any of the following outcome measures: pain, measures of functional status (for example, Oswestry and Roland Disability Questionnaire), overall improvement, return to work, and analgesic consumption. We excluded studies that reported only relief of pain immediately after a single treatment with acupuncture. We included reports written in English, Japanese, Korean, and Chinese, as well as in Germanic (including Scandinavian) and Romance languages. Where necessary, we obtained translations of essential details. When more than 1 publication described a single trial, we included only 1 report. Data Abstraction Two authors abstracted data independently onto a piloted spreadsheet, except in the case of nonEnglish-language articles, from which an expert extracted data and checked them in-house (see Acknowledgments). Differences were settled by discussion with reference to the original article. In the few instances where disagreements persisted, we consulted an additional independent researcher who is an expert in review methods. For our purposes, we defined 3 styles of acupuncture and 3 methods (Table 1). Table 1. Acupuncture-Related Terms and Their Relevance We extracted data for 5 outcome categories (pain, functional status, overall improvement, return to full work, and analgesic consumption) where available. We extracted outcomes for all time intervals reported. We considered outcomes less than 6 weeks to be short-term, and we used the measurement closest to 3 weeks for the meta-analysis. We considered outcomes more than 6 weeks to be long-term, and we included the measurement closest to 6 months in the meta-analysis. For crossover studies, we considered the risk for carryover effects to be prohibitive, so we considered only the first group of the study. Quality Assessment We assessed the quality of the studies in 2 ways. First, by using a modification of a validated method (11), we awarded a maximum of 5 points in 3 categories: randomization (2 points for an appropriate method, 1 point if method not described, or 0 points for an inappropriate method); blinding (1 point for patient blinding and 1 point if blinding was tested after treatment); and withdrawals and dropouts (1 point if a statement gave full details of withdrawals and dropouts or confirmed that no patient withdrew or dropped out). As recommended (11), a score of 2 points or less indicates poor quality. Second, we assessed quality by using 10 criteria taken from the Cochrane Back Review Group (Table 2) (12), used in a recent review (13), extracted by 1 author with random confirmation by another author. A score of 4 points or less indicates poor quality. Table 2. Cochrane Back Review Group Criteria List for Methodologic Quality Assessment of Randomized, Controlled Trials Quantitative Data Synthesis We placed the studies into predefined subgroups defined according to the following criteria: 1) acute (3 months) or chronic (>3 months) low back pain (where not described, a decision was made from the trial setting and recruitment information [for example, we considered primary care to include acute pain and secondary care to cover chronic pain]); 2) style of acupuncture (Table 1); and 3) control group (sham acupuncture involving needle penetration, nonpenetrating sham acupuncture, sham transcutaneous electrical nerve stimulation [TENS] [Table 1], no additional treatment, and other active treatments). The no-additional-treatment control grouping includes studies that administered adjunctive treatment, such as physical therapy, to both the acupuncture and the control group and also includes those studies in which the control intervention consisted of providing patients with educational materials on low back pain. The primary outcome of the review was quantitative synthesis of the short-term effectiveness of acupuncture on pain in each category. To test whether sham acupuncture and controlled trials of sham TENS were sufficiently homogeneous to combine for the secondary analyses, we used the I2 method (14). We used Comprehensive Meta-Analysis software (Biostat, Inc., Englewood, New Jersey) for data analysis. We used the inverse-variance computational model, and we used the more conservative random-effects model to account for the expected heterogeneity. We performed separate analyses for each main outcome measure by using standardized mean difference (the Hedge g effect size) or odds ratio, depending on the nature of the measure. For the standardized mean difference, 1 unit of effect size for pain and functioning corresponds with a 25-point difference on the visual analogue scale (VAS) and a 6-point difference on the Roland Disability score. Using standards established by the Cochrane Back Group Editorial Board, we considered a minimum 10-mm difference on the VAS and a 2-point difference on the Roland Disability score to be clinically important (13). We analyzed short-term end points and long-term end points, as defined earlier. When the studies in any predefined subgroup were clinically very heterogeneous or insufficient data were reported for pooling, we planned to use a narrative synthesis rather than a meta-analysis. We assessed for the likelihood of small study bias by using a funnel plot. In reports that did not provide these values, we used the method previously described (13), in which the median is the mean and the SD is 25% of the measures range. To test the effect of these assumptions, we performed a sensitivity analysis on the short-term pain primary outcome measure, substituting imputed mean values both 1 SD higher and 1 SD lower th

Meta-analysis: Acupuncture for osteoarthritis of the knee

Context Previous studies have come to inconsistent conclusions about the effectiveness of acupuncture for treating knee osteoarthritis. Contribution This meta-analysis of 9 trials showed that sham-controlled trials identified no clinically meaningful short-term benefits in pain or function with acupuncture for knee osteo-arthritis, although trials that did not use a sham control identified some benefits. Implications The use of different types of comparisons (sham acupuncture vs. interventions in which the participant knew whether they were receiving acupuncture) explains the variability in the conclusions of published trials about the effectiveness of acupuncture for treating knee osteo-arthritis. Placebo or expectation effects probably account for the observed benefits. The Editors Osteoarthritis is the leading cause of disability among older adults (1, 2). The joint most commonly affected by osteoarthritis is the knee (3, 4). The prevalence, disability, and associated costs of knee osteoarthritis are expected to steadily increase over the next 25 years because of aging in the population (5). Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen are the most commonly used pharmacologic agents for treating knee osteoarthritis (6, 7). However, according to a recent systematic review (8), NSAIDs are only slightly better than placebo in providing short-term pain relief and their effects are probably too small to be meaningful to patients (8). Furthermore, many NSAIDs are associated with considerable side effects (9). Gastrointestinal bleeding, the most clinically substantial effect (10), causes approximately 2200 deaths and 12000 emergency hospital admissions each year in the United Kingdom alone (11) and is of particular concern to older patients (10). Acetaminophen may have a better toxicity profile than that of NSAIDs (6). However, a recent systematic review (12) suggests that acetaminophen is modestly less effective than NSAIDs and that the clinical significance of acetaminophen is questionable because it results in only a 5% greater improvement from baseline in pain than does placebo in the short term. The evidence for nonpharmacologic treatments for knee osteoarthritis is generally sparse and inconclusive (13). However, 2 effective nonpharmacologic treatments are exercise (14) and weight loss (15). Some patients with osteoarthritis, however, may have difficulty exercising or losing weight. The need for additional safe and effective treatments for osteoarthritis is clear. Acupuncture is a safe treatment that has a low risk for serious side effects (1619). Given its safety, whether acupuncture is effective for treating osteoarthritis of the knee is a highly relevant question. Our objective was to conduct a systematic review and meta-analysis of the effects of acupuncture for treating knee osteoarthritis. Methods Data Sources and Study Selection We searched the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases to January 2007 to identify randomized, controlled trials (RCTs). We combined acupuncture-related terms with osteoarthritis-related terms and limited the search to RCTs (20). We considered older RCTs that were included in previous reviews of acupuncture for osteoarthritis (2124) for inclusion. Two authors independently selected articles and resolved disagreements by discussion. Our selection criteria were published RCTs of acupuncture in patients who had received a diagnosis of knee osteoarthritis. We considered the 2 outcomes of pain and function. We applied no language restrictions. We included only RCTs in which the acupuncture treatment involved the insertion of needles into traditional meridian points. The needles could be inserted into tender points in addition to the traditional meridian points and could be electrically stimulated. We excluded RCTs of dry needling or trigger-point therapy. We also excluded RCTs that compared only 2 different forms of active acupuncture. We prespecified that trials have at least 6 weeks of observation. This criterion has not been validated as a threshold for study inclusion. However, we thought that RCTs with observation periods less than 6 weeks may also have methodological shortcomings (25, 26) that may exaggerate their results of benefits (27, 28). Data Extraction and Quality Assessment Two authors independently extracted data and resolved disagreements by discussion. They extracted information pertaining to the quality of the methods, participants, interventions, and outcomes (including adverse effects). When a study reported more than 1 pain or function outcome measure, we gave preference to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function measures because the WOMAC is the most widely used and thoroughly validated instrument for assessing patients with knee osteoarthritis (2931). We contacted corresponding authors via e-mail and requested that they review the information we extracted from their studies, clarify any ambiguities, and supply missing information. We evaluated internal validity of the RCTs by using an 11-item scale developed by the Cochrane Back Review Group (32). We considered a score of 6 or more points to indicate high internal validity on the basis of data from ongoing research, in which 1 of the authors is involved. For the patient and outcomes assessor blinding items on the scale, we assigned sham-controlled trials 0.5 point rather than 1 point because we could not be certain that all shams were sufficiently credible in fully blinding patients to the treatment being evaluated. However, we assigned 1 point to sham-controlled trials that evaluated the credibility of the sham and found it to be indistinguishable from true acupuncture. Acupuncture Assessment No consensus exists on how best to assess treatment adequacy in acupuncture RCTs, and no methods have been validated (26). We used a method that involved assessing the adequacy of the following 4 aspects of the acupuncture treatment: choice of acupuncture points, number of sessions, needling technique, and experience of the acupuncturist. The adequacy of the sham intervention was also assessed by using an open-ended question. Two acupuncturists, who had previously used this adequacy assessment instrument for an earlier systematic review (33) on acupuncture, made these assessments. The acupuncturists assessed adequacy independently and achieved consensus by discussion. Assessments were based on only the description of the study population and the acupuncture procedure. The assessors were blinded to the results of the study and the publication. We asked the assessors to guess the identity of each study being assessed to test the success of the blinding. Data Synthesis and Analysis We placed RCTs into categories according to control groups, which were sham, usual care, and waiting list. We defined sham control as a sham intervention that was designed to be credible as the active treatment. We defined the usual care control as groups that received some additional standard care therapy that was not provided to the acupuncture group and waiting list control as groups that received no care while waiting for acupuncture. For our meta-analyses, we defined the short-term follow-up point as the measurement point closest to 8 weeks but no longer than 3 months after randomization. We defined the long-term outcome as the measurement point closest to 6 months but longer than 3 months after randomization. Because some RCTs used the visual analogue scale version of the WOMAC instrument and others used the Likert version, we used standardized mean differences as the principal measure of effect size so that the results of the RCTs could be combined. We calculated standardized mean differences (Hedge adjusted g) for all RCTs by using differences in improvements between groups divided by the SDs of improvements pooled from the 2 groups (34). For 3 RCTs (3537), we made some conservative assumptions to compute the standardized mean differences (Appendix Table 1). Appendix Table 1. Original Data from Included Studies and Assumptions Used to Derive the Meta-analysis Study Data* We used the DerSimonian and Laird (38) model, which is the random-effects model used in RevMan software, version 4.2 (Nordic Cochrane Centre, Copenhagen, Denmark) (39). This model estimates the average treatment effect by incorporating heterogeneity among clinically diverse trials with different, but related, treatment effects (40). When heterogeneity exists, the model (38) assigns smaller studies more weight than they would receive in a fixed-effects model (40). To evaluate statistical heterogeneity within our trial categories, we used I 2 tests on all outcomes included in our meta-analysis. We conducted sensitivity analyses for the short-term outcome of sham-controlled RCTs, restricting the analyses to RCTs assessed as adequate based on each item of the 11-item Cochrane scale (32) and the 4 aspects of the acupuncture treatment adequacy. We performed additional sensitivity analyses for funding source (industry vs. nonindustry) and follow-up length (3 months). We also evaluated whether the pooled effects of acupuncture met the threshold for minimal clinically important differences, defined as the smallest differences in scores that patients would perceive to be beneficial (29). The clinically relevant effects for knee osteoarthritis have been estimated to be standardized mean differences of 0.39 for WOMAC pain and 0.37 for WOMAC function (29). Role of the Funding Source The study was funded by the National Institutes of Health, National Center for Complementary and Alternative Medicine. The funding source had no role in the design, conduct, or reporting of the study or in the decision to submit the manuscript for publication. Results Study Characteristics We included 11 RCTs (3537, 4148) of 2821 patients with osteoarthritis (Figure 1). All studies but 1 (42) we

Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis.

Objective To evaluate whether acupuncture improves rates of pregnancy and live birth when used as an adjuvant treatment to embryo transfer in women undergoing in vitro fertilisation. Design Systematic review and meta-analysis. Data sources Medline, Cochrane Central, Embase, Chinese Biomedical Database, hand searched abstracts, and reference lists. Review methods Eligible studies were randomised controlled trials that compared needle acupuncture administered within one day of embryo transfer with sham acupuncture or no adjuvant treatment, with reported outcomes of at least one of clinical pregnancy, ongoing pregnancy, or live birth. Two reviewers independently agreed on eligibility; assessed methodological quality; and extracted outcome data. For all trials, investigators contributed additional data not included in the original publication (such as live births). Meta-analyses included all randomised patients. Data synthesis Seven trials with 1366 women undergoing in vitro fertilisation were included in the meta-analyses. There was little clinical heterogeneity. Trials with sham acupuncture and no adjuvant treatment as controls were pooled for the primary analysis. Complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy (odds ratio 1.65, 95% confidence interval 1.27 to 2.14; number needed to treat (NNT) 10 (7 to 17); seven trials), ongoing pregnancy (1.87, 1.40 to 2.49; NNT 9 (6 to 15); five trials), and live birth (1.91, 1.39 to 2.64; NNT 9 (6 to 17); four trials). Because we were unable to obtain outcome data on live births for three of the included trials, the pooled odds ratio for clinical pregnancy more accurately represents the true combined effect from these trials rather than the odds ratio for live birth. The results were robust to sensitivity analyses on study validity variables. A prespecified subgroup analysis restricted to the three trials with the higher rates of clinical pregnancy in the control group, however, suggested a smaller non-significant benefit of acupuncture (odds ratio 1.24, 0.86 to 1.77). Conclusions Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilisation.

MEDITATIVE THERAPIES FOR REDUCING ANXIETY: A SYSTEMATIC REVIEW AND META‐ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

Anxiety disorders are among the most common psychiatric disorders and meditative therapies are frequently sought by patients with anxiety as a complementary therapy. Although multiple reviews exist on the general health benefits of meditation, no review has focused on the efficacy of meditation for anxiety specifically.

The Status and Future of Acupuncture Clinical Research

On November 8-9, 2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark National Institutes of Health Consensus Development Conference on Acupuncture. More than 300 acupuncture researchers, practitioners, students, funding agency personnel, and health policy analysts from 20 countries attended the SAR meeting held at the University of Maryland School of Medicine, Baltimore, MD. This paper summarizes important invited lectures in the area of clinical research. Specifically, included are: a review of the recently conducted German trials and observational studies on low-back pain (LBP), gonarthrosis, migraine, and tension-type headache (the Acupuncture Research Trials and the German Acupuncture Trials, plus observational studies); a systematic review of acupuncture treatment for knee osteoarthritis (OA); and an overview of acupuncture trials in neurologic conditions, LBP, womens health, psychiatric disorders, and functional bowel disorders. A summary of the use of acupuncture in cancer care is also provided. Researchers involved in the German trials concluded that acupuncture is effective for treating chronic pain, but the correct selection of acupuncture points seems to play a limited role; no conclusions could be drawn about the placebo aspect of acupuncture, due to the design of the studies. Overall, when compared to sham, acupuncture did not show a benefit in treating knee OA or LBP, but acupuncture was better than a wait-list control and standard of care, respectively. In womens health, acupuncture has been found to be beneficial for patients with premenstrual syndrome, dysmenorrhea, several pregnancy-related conditions, and nausea in females who have cancers. Evidence on moxibustion for breech presentation, induction of labor, and reduction of menopausal symptoms is still inconclusive. In mental health, evidence for acupunctures efficacy in treating neurologic and functional bowel disorder is still inconclusive. For chronic cancer-related problems such as pain, acupuncture may work well in stand-alone clinics; however, for acute or treatment-related symptoms, integration of acupuncture care into a busy and complex clinical environment is unlikely, unless compelling evidence of a considerable patient benefit can be established.

Adverse Events of Acupuncture: A Systematic Review of Case Reports

Acupuncture, moxibustion, and cupping, important in traditional Eastern medicine, are increasingly used in the West. Their widening acceptance demands continual safety assessment. This review, a sequel to one our team published 10 years ago, is an evaluation of the frequency and severity of adverse events (AEs) reported for acupuncture, moxibustion, and cupping between 2000 and 2011. Relevant English-language reports in six databases were identified and assessed by two reviewers. During this 12-year period, 117 reports of 308 AEs from 25 countries and regions were associated with acupuncture (294 cases), moxibustion (4 cases), or cupping (10 cases). Country of occurrence, patients sex and age, and outcome were extracted. Infections, mycobacterial, staphylococcal, and others, were the main complication of acupuncture. In the previous review, we found the main source of infection to be hepatitis, caused by reusable needles. In this review, we found the majority of infections to be bacterial, caused by skin contact at acupoint sites; we found no cases of hepatitis. Although the route of infection had changed, infections were still the major complication of acupuncture. Clearly, guidelines such as Clean Needle Technique must be followed in order to minimize acupuncture AEs.

Harpgophytum procumbens for osteoarthritis and low back pain: A systematic review

BackgroundThe objective of this review is to determine the effectiveness of Harpagophytum procumbens preparations in the treatment of various forms of musculoskeletal pain.MethodsSeveral databases and other sources were searched to identify randomized controlled trials, quasi-randomized controlled trials, and controlled clinical trials testing Harpagophytum preparations in adults suffering from pain due to osteoarthritis or low back pain.ResultsGiven the clinical heterogeneity and insufficient data for statistical pooling, trials were described in a narrative way, taking into consideration methodological quality scores. Twelve trials were included with six investigating osteoarthritis (two were identical trials), four low back pain, and three mixed-pain conditions.ConclusionsThere is limited evidence for an ethanolic Harpagophytum extract containing less than <30 mg harpagoside per day in the treatment of knee and hip osteoarthritis. There is moderate evidence of effectiveness for (1) the use of a Harpagophytum powder at 60 mg harpagoside in the treatment of osteoarthritis of the spine, hip and knee; (2) the use of an aqueous Harpagophytum extract at a daily dose of 100 mg harpagoside in the treatment of acute exacerbations of chronic non-specific low back pain; and (3) the use of an aqueous extract of Harpagophytum procumbens at 60 mg harpagoside being non-inferior to 12.5 mg rofecoxib per day for chronic non-specific low-back pain (NSLBP) in the short term. Strong evidence exists for the use of an aqueous Harpagophytum extract at a daily dose equivalent of 50 mg harpagoside in the treatment of acute exacerbations of chronic NSLBP.

Acupuncture for pelvic and back pain in pregnancy : a systematic review

The objective of our study was to review the effectiveness of needle acupuncture in treating the common and disabling problem of pelvic and back pain in pregnancy. Two small trials on mixed pelvic/back pain and 1 large high-quality trial on pelvic pain met the inclusion criteria. Acupuncture, as an adjunct to standard treatment, was superior to standard treatment alone and physiotherapy in relieving mixed pelvic/back pain. Women with well-defined pelvic pain had greater relief of pain with a combination of acupuncture and standard treatment, compared to standard treatment alone or stabilizing exercises and standard treatment. We used a narrative synthesis due to significant clinical heterogeneity between trials. Few and minor adverse events were reported. We conclude that limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy.

Survey of public information about ongoing clinical trials funded by industry: evaluation of completeness and accessibility

Abstract Objective: To evaluate the completeness and accessibility of public information about US clinical trials of drugs in development. Design: Review of online registers of clinical trials. Data sources: Drugs in phase III trials were identified using three drug industry sources: PhRMA Survey, Whats in the Pipeline, and the NDA Pipeline. Drug trials were then searched for on the following publicly accessible registers of clinical trials: CancerNet.gov, CenterWatch.com, ClinicalTrials.gov, and registers associated with the 37 “Comprehensive Cancer Centers” designated by the National Cancer Institute. Main outcome measure: Extent of availability of public information on phase III trials of drugs in development for treating either prostate or colon cancer. Results: Search of industry sources identified 12 drugs for prostate cancer and 20 for colon cancer undergoing phase III trials. The most comprehensive publicly available register, ClinicalTrials.gov, contained trial listings for only seven of the prostate cancer drugs and 10 of the colon cancer drugs. Trials of three prostate cancer and three colon cancer drugs were listed on only one register each. A substantial proportion of trials of prostate cancer drugs (3/12) and colon cancer drugs (8/20) were not associated with trial listings in any registers. Conclusions: Existing trials registers are unlikely to be meeting user needs since many ongoing drug trials are not listed. There is a clear need for a comprehensive clinical trials register encompassing all ongoing trials, including industry sponsored trials.

How Well Do Randomized Trials Inform Decision Making: Systematic Review Using Comparative Effectiveness Research Measures on Acupuncture for Back Pain

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.