Eric W Manheimer

Abstract: BACKGROUND: Irritable bowel syndrome (IBS) is a common, costly, and difficult to treat disorder that impairs health-related quality of life and work productivity. Evidence-based treatment guidelines have been unable to provide guidance on the effects of acupuncture for IBS because the only previous systematic review included only small, heterogeneous and methodologically unsound trials. OBJECTIVES: The primary objectives were to assess the efficacy and safety of acupuncture for treating IBS. SEARCH METHODS: MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health, and the Chinese databases Sino-Med, CNKI, and VIP were searched through November 2011. SELECTION CRITERIA: Randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and RCTs that evaluated acupuncture as an adjuvant to another treatment, in adults with IBS were included. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the risk of bias and extracted data. We extracted data for the outcomes overall IBS symptom severity and health-related quality of life. For dichotomous data (e.g. the IBS Adequate Relief Question), we calculated a pooled relative risk (RR) and 95% confidence interval (CI) for substantial improvement in symptom severity after treatment. For continuous data (e.g. the IBS Severity Scoring System), we calculated the standardized mean difference (SMD) and 95% CI in post-treatment scores between groups. MAIN RESULTS: Seventeen RCTs (1806 participants) were included. Five RCTs compared acupuncture versus sham acupuncture. The risk of bias in these studies was low. We found no evidence of an improvement with acupuncture relative to sham (placebo) acupuncture for symptom severity (SMD -0.11, 95% CI -0.35 to 0.13; 4 RCTs; 281 patients) or quality of life (SMD = -0.03, 95% CI -0.27 to 0.22; 3 RCTs; 253 patients). Sensitivity analyses based on study quality did not change the results. A GRADE analysis indicated that the overall quality of the evidence for the primary outcomes in the sham controlled trials was moderate due to sparse data. The risk of bias in the four Chinese language comparative effectiveness trials that compared acupuncture with drug treatment was high due to lack of blinding. The risk of bias in the other studies that did not use a sham control was high due to lack of blinding or inadequate methods used for randomization and allocation concealment or both. Acupuncture was significantly more effective than pharmacological therapy and no specific treatment. Eighty-four per cent of patients in the acupuncture group had improvement in symptom severity compared to 63% of patients in the pharmacological treatment group (RR 1.28, 95% CI 1.12 to 1.45; 5 studies, 449 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to a high risk of bias (no blinding) and sparse data. Sixty-three per cent of patients in the acupuncture group had improvement in symptom severity compared to 34% of patients in the no specific therapy group (RR 2.11, 95% CI 1.18 to 3.79; 2 studies, 181 patients). There was no statistically significant difference between acupuncture and Bifidobacterium (RR 1.07, 95% CI 0.90 to 1.27; 2 studies; 181 patients) or between acupuncture and psychotherapy (RR 1.05, 95% CI 0.87 to 1.26; 1 study; 100 patients). Acupuncture as an adjuvant to another Chinese medicine treatment was significantly better than the other treatment alone. Ninety-three per cent of patients in the adjuvant acupuncture group improved compared to 79% of patients who received Chinese medicine alone (RR 1.17, 95% CI 1.02 to 1.33; 4 studies; 466 patients). There was one adverse event (i.e. acupuncture syncope) associated with acupuncture in the 9 trials that reported this outcome, although relatively small sample sizes limit the usefulness of these safety data. AUTHORS' CONCLUSIONS: Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which have been shown to provide a modest benefit for IBS. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients' preferences for acupuncture or greater expectations of improvement on acupuncture relative to drug therapy.

Abstract: OBJECTIVES: Evidence-based treatment guidelines have been unable to provide evidence-based guidance on the effects of acupuncture for irritable bowel syndrome (IBS) because the only previous systematic review included only small, heterogeneous, and methodologically unsound trials. We conducted a new systematic review and meta-analysis of randomized controlled trials (RCTs) to estimate the effects of acupuncture for treating IBS. METHODS: MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, Cumulative Index to Nursing and Allied Health, and the Chinese databases Sino-Med, CNKI, and VIP were searched through November 2011. Eligible RCTs compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and evaluated acupuncture as an adjuvant to another treatment. Our outcomes were overall IBS symptom severity and health-related quality of life. Dichotomous data were pooled to provide a relative risk (RR) of substantial improvement after treatment, and continuous data were pooled to provide a standardized mean difference (SMD) in post-treatment scores between groups. RESULTS: A total of 17 RCTs (N=1,806) were included. We found no evidence of an improvement with acupuncture relative to sham acupuncture on symptom severity (SMD=-0.11, 95% confidence interval (95% CI): -0.35 to 0.13; 4 RCTs) or quality of life (SMD=-0.03, 95% CI: -0.27 to 0.22; 3 RCTs). Because of the homogeneity of the results of the sham-controlled trials, results were unaffected by restriction to the four sham-controlled RCTs that used adequate randomization, blinding, and had few withdrawals/dropouts. Among RCTs that did not use a placebo control, acupuncture was more effective than pharmacological therapy (RR of symptom improvement=1.28, 95% CI: 1.12 to 1.45; 5 RCTs) and no (specific) treatment (RR = 2.11, 95% CI: 1.18 to 3.79; 2 RCTs). There was no difference between acupuncture and Bifidobacterium (RR=1.07, 95% CI: 0.90 to 1.27; 2 RCTs) or between acupuncture and psychotherapy (RR=1.05, 95% CI: 0.87 to 1.26; 1 RCT). Acupuncture as an adjuvant to another Chinese medicine treatment was statistically significantly better than the other treatment alone, in trials with a high risk of bias (RR=1.17, 95% CI: 1.02 to 1.33; 4 RCTs). CONCLUSIONS: Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control on IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from pharmacological therapies. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients' preferences for acupuncture or patients' greater expectations of improvement on acupuncture relative to drugs.

Abstract: BACKGROUND: Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain. METHODS: We conducted a systematic review to identify randomized controlled trials (RCTs) of acupuncture for chronic pain in which allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible RCTs, with a total of 17 922 patients analyzed. RESULTS: In the primary analysis, including all eligible RCTs, acupuncture was superior to both sham and no-acupuncture control for each pain condition (P < .001 for all comparisons). After exclusion of an outlying set of RCTs that strongly favored acupuncture, the effect sizes were similar across pain conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs. These results were robust to a variety of sensitivity analyses, including those related to publication bias. CONCLUSIONS: Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.

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.

Abstract: BACKGROUND: 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. METHODS: Major medical databases were searched thoroughly with keywords related to various types of meditation and anxiety. Over 1,000 abstracts were screened, and 200+ full articles were reviewed. Only randomized controlled trials (RCTs) were included. The Boutron (Boutron et al., 2005: J Clin Epidemiol 58:1233-1240) checklist to evaluate a report of a nonpharmaceutical trial (CLEAR-NPT) was used to assess study quality; 90% of the authors were contacted for additional information. Review Manager 5 was used for meta-analysis. RESULTS: A total of 36 RCTs were included in the meta-analysis (2,466 observations). Most RCTs were conducted among patients with anxiety as a secondary concern. The study quality ranged from 0.3 to 1.0 on the 0.0-1.0 scale (mean = 0.72). Standardized mean difference (SMD) was -0.52 in comparison with waiting-list control (p < .001; 25 RCTs), -0.59 in comparison with attention control (p < .001; seven RCTs), and -0.27 in comparison with alternative treatments (p < .01; 10 RCTs). Twenty-five studies reported statistically superior outcomes in the meditation group compared to control. No adverse effects were reported. CONCLUSIONS: This review demonstrates some efficacy of meditative therapies in reducing anxiety symptoms, which has important clinical implications for applying meditative techniques in treating anxiety. However, most studies measured only improvement in anxiety symptoms, but not anxiety disorders as clinically diagnosed.

Abstract: BACKGROUND: Nonarteritic ischemic optic neuropathy (NAION) is characterized by sudden and painless loss of vision in the eye, accompanied by pallid swelling of the optic disc. Its etiology is unknown and no medical therapy has been proven effective in treating this condition. Optic nerve decompression surgery, a proposed treatment for NAION, involves making two or more slits or a window in the tissue surrounding the optic nerve, thereby allowing cerebrospinal fluid to escape, and theoretically reducing the pressure surrounding the optic nerve. OBJECTIVES: The objective of this review was to assess the safety and efficacy of surgery compared with other treatment or no treatment in people with nonarteritic ischemic optic neuropathy. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2011, Issue 11), MEDLINE (January 1950 to November 2011), EMBASE (January 1980 to November 2011), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (http://clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 19 November 2011. SELECTION CRITERIA: All randomized trials of surgical treatment of NAION were eligible for inclusion in this review. DATA COLLECTION AND ANALYSIS: We obtained full copies of all potentially relevant articles. One author extracted data which was verified by another author. No data synthesis was required. MAIN RESULTS: The one included trial randomized 258 participants and was stopped early for futility. At the time of the 24-month report the follow-up rate was 95.3% for six months and 67.4% for 24 months (174 participants; 89 careful follow up and 85 surgery). There was no evidence of a benefit of surgery on visual acuity. Measurements of visual acuity and visual fields were performed by a technician masked to the treatment received. At six months 32.0% of the surgery group had improved visual acuity by three or more lines compared with 42.6% of the careful follow up group (unadjusted relative risk (RR) 0.75, 95% confidence interval (CI) 0.54 to 1.04). At 24 months 29.4% of the surgery group had improved compared with 31.0% of the careful follow up group (unadjusted RR 0.95, 95% CI 0.60 to 1.49). Participants who underwent surgery had a greater risk of losing three or more lines of vision, although the increased risk was not statistically significant. At six months 18.9% in the surgery group had worsened compared with 14.8% in the careful follow up group (RR 1.28; 95% CI 0.73 to 2.24). At 24 months 20.0% in the surgery group had worsened compared with 21.8% in the careful follow up group (RR 0.92; 95% CI 0.51 to 1.64). Participants who received surgery experienced both intraoperative and postoperative adverse events, including central retinal artery occlusion during surgery and light perception vision at six months (one participant); and immediate loss of light perception following surgery and loss of vision that persisted to the 12-month visit (two participants). In the careful follow-up group, two participants had no light perception at the six-month follow-up visit; one of these had improved to light perception at 12 months. Pain was the most common adverse event in the surgery group (17% in surgery group versus 3% in the careful follow-up group at one week). Diplopia (double-vision) was the next most common complication (8% in the surgery group versus 1% in the careful follow-up group at one week); at three months there was no statistically significant difference in proportion of participants with diplopia between the two groups. AUTHORS' CONCLUSIONS: Results from the single trial indicate no evidence of a beneficial effect of optic nerve decompression surgery for NAION. Future research should focus on increasing our understanding of the etiology and prognosis of NAION. New treatment options should be examined in the context of randomized clinical trials.

Abstract: This project aims to assess the utility of bibliographic databases beyond the three major ones (MEDLINE, EMBASE and Cochrane CENTRAL) for finding controlled trials of complementary and alternative medicine (CAM). Fifteen databases were searched to identify controlled clinical trials (CCTs) of CAM not also indexed in MEDLINE. Searches were conducted in May 2006 using the revised Cochrane highly sensitive search strategy (HSSS) and the PubMed CAM Subset. Yield of CAM trials per 100 records was determined, and databases were compared over a standardized period (2005). The Acudoc2 RCT, Acubriefs, Index to Chiropractic Literature (ICL) and Hom-Inform databases had the highest concentrations of non-MEDLINE records, with more than 100 non-MEDLINE records per 500. Other productive databases had ratios between 500 and 1500 records to 100 non-MEDLINE records-these were AMED, MANTIS, PsycINFO, CINAHL, Global Health and Alt HealthWatch. Five databases were found to be unproductive: AGRICOLA, CAIRSS, Datadiwan, Herb Research Foundation and IBIDS. Acudoc2 RCT yielded 100 CAM trials in the most recent 100 records screened. Acubriefs, AMED, Hom-Inform, MANTIS, PsycINFO and CINAHL had more than 25 CAM trials per 100 records screened. Global Health, ICL and Alt HealthWatch were below 25 in yield. There were 255 non-MEDLINE trials from eight databases in 2005, with only 10% indexed in more than one database. Yield varied greatly between databases; the most productive databases from both sampling methods were Acubriefs, Acudoc2 RCT, AMED and CINAHL. Low overlap between databases indicates comprehensive CAM literature searches will require multiple databases.

Abstract: During the past decade, the Cochrane Collaboration has been an increasingly important source of information on complementary and alternative medicine (CAM) therapies. From 2007 to 2008, the Cochrane CAM Field developed a topics list that allowed us to categorize all 396 Cochrane reviews related to CAM (as of The Cochrane Library, Issue 4, 2009). This topics list is an advance in making Cochrane reviews on CAM topics accessible to the public. In this article, we discuss challenges in developing the topics list, including developing an operational efinition of CAM, deciding which reviews should be included within the CAM Field's scope, developing the structured list of CAM Field-specific topics, and determining where in the topics list the reviews should be placed. Although aspects of our operational definition of CAM are open to revision, a standardized definition provides us with an objective, reproducible, and systematic method for defining and classifying CAM therapies.

Abstract: BACKGROUND: Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. METHODS: Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. RESULTS: Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting.For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). CONCLUSIONS: An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement.

Abstract: OBJECTIVE: To examine the theoretical and methodologic rationales for the use of sham acupuncture controls in trials of adjuvant acupuncture for in vitro fertilization (IVF), and to identify the drawbacks of using a sham acupuncture control that may have its own effects on the pregnancy outcome. BACKGROUND: Acupuncture has typically been tested in trials that evaluate subjective, patient-reported outcomes such as pain. Ratings of pain and similar subjective states can be strongly influenced by respondents' prejudgments, preferences, and expectations about treatment benefits. Therefore, controlling for these expectations or "placebo effects" by using a sham acupuncture control group is critically important in trials of acupuncture for pain-related conditions. This need for sham acupuncture controls in trials of acupuncture for pain-related conditions may have led to the belief that sham acupuncture is always the most "rigorous" control, and that it should therefore be used for all acupuncture trials, including trials of adjuvant acupuncture for IVF. CONCLUSION(S): In trials of adjuvant acupuncture for IVF, the outcome is pregnancy, which is entirely objective and unlikely to be affected by a patient's expectations of a benefit of acupuncture. Because it seems unlikely that an IVF patient's knowledge of whether she was receiving adjuvant acupuncture would affect her ability to become pregnant from IVF, using sham acupuncture to control for expectation/placebo effects seems unnecessary in this context. Even if adjuvant acupuncture were to increase IVF success rates only through a psychosomatic effect mechanism, such as by reducing stress, this stress-reduction effect would be integral to the working mechanism by which adjuvant acupuncture increases IVF pregnancy rates; therefore, it seems inappropriate to control for and separate out any such stress-reduction effect by using a sham control. Because of the risk that the sham is not an inert placebo but rather an active treatment that may affect the pregnancy outcome, using sham acupuncture as the control may unnecessarily confuse rather than clarify the interpretation of the effects of IVF adjuvant acupuncture. Using both theoretical concerns and epidemiologic evidence, researchers should carefully weigh the benefits and drawbacks of using sham acupuncture to blind patients in adjuvant acupuncture for IVF trials, and should question, rather than automatically accept, whether "placebo effects" are an important risk of bias in this context.

Abstract: BACKGROUND: The purpose of clinical trials of acupuncture is to help clinicians and patients make decisions about treatment. Yet this is not straightforward: some trials report acupuncture to be superior to sham (placebo) acupuncture while others show evidence that acupuncture is superior to usual care but not sham, and still others conclude that acupuncture is no better than usual care. Meta-analyses of these trials tend to come to somewhat indeterminate conclusions. This appears to be because, until recently, acupuncture research was dominated by small trials of questionable quality. The Acupuncture Trialists' Collaboration, a group of trialists, statisticians and other researchers, was established to synthesize patient-level data from several recently published large, high-quality trials. METHODS: There are three distinct phases to the Acupuncture Trialists Collaboration: a systematic review to identify eligible studies; collation and harmonization of raw data; statistical analysis. To be eligible, trials must have unambiguous allocation concealment. Eligible pain conditions are osteoarthritis; chronic headache (tension or migraine headache); shoulder pain; and non-specific back or neck pain. Once received, patient-level data will undergo quality checks and the results of prior publications will be replicated. The primary analysis will be to determine the effect size of acupuncture. Each trial will be evaluated by analysis of covariance with the principal endpoint as the dependent variable and, as covariates, the baseline score for the principal endpoint and the variables used to stratify randomization. The effect size for acupuncture from each trial--that is, the coefficient and standard error from the analysis of covariance--will then be entered into a meta-analysis. We will compute effect sizes separately for comparisons of acupuncture with sham acupuncture, and acupuncture with no acupuncture control for each pain condition. Other analyses will investigate the impact of different sham techniques, styles of acupuncture or frequency and duration of treatment sessions. DISCUSSION: Individual patient data meta-analysis of high-quality trials will provide the most reliable basis for treatment decisions about acupuncture. Above all, however, we hope that our approach can serve as a model for future studies in acupuncture and other complementary therapies.

Abstract: BACKGROUND: Peripheral joint osteoarthritis is a major cause of pain and functional limitation. Few treatments are safe and effective. OBJECTIVES: To assess the effects of acupuncture for treating peripheral joint osteoarthritis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 1), MEDLINE, and EMBASE (both through December 2007), and scanned reference lists of articles. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing needle acupuncture with a sham, another active treatment, or a waiting list control group in people with osteoarthritis of the knee, hip, or hand. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We calculated standardized mean differences using the differences in improvements between groups. MAIN RESULTS: Sixteen trials involving 3498 people were included. Twelve of the RCTs included only people with OA of the knee, 3 only OA of the hip, and 1 a mix of people with OA of the hip and/or knee. In comparison with a sham control, acupuncture showed statistically significant, short-term improvements in osteoarthritis pain (standardized mean difference -0.28, 95% confidence interval -0.45 to -0.11; 0.9 point greater improvement than sham on 20 point scale; absolute percent change 4.59%; relative percent change 10.32%; 9 trials; 1835 participants) and function (-0.28, -0.46 to -0.09; 2.7 point greater improvement on 68 point scale; absolute percent change 3.97%; relative percent change 8.63%); however, these pooled short-term benefits did not meet our predefined thresholds for clinical relevance (i.e. 1.3 points for pain; 3.57 points for function) and there was substantial statistical heterogeneity. Additionally, restriction to sham-controlled trials using shams judged most likely to adequately blind participants to treatment assignment (which were also the same shams judged most likely to have physiological activity), reduced heterogeneity and resulted in pooled short-term benefits of acupuncture that were smaller and non-significant. In comparison with sham acupuncture at the six-month follow-up, acupuncture showed borderline statistically significant, clinically irrelevant improvements in osteoarthritis pain (-0.10, -0.21 to 0.01; 0.4 point greater improvement than sham on 20 point scale; absolute percent change 1.81%; relative percent change 4.06%; 4 trials;1399 participants) and function (-0.11, -0.22 to 0.00; 1.2 point greater improvement than sham on 68 point scale; absolute percent change 1.79%; relative percent change 3.89%). In a secondary analysis versus a waiting list control, acupuncture was associated with statistically significant, clinically relevant short-term improvements in osteoarthritis pain (-0.96, -1.19 to -0.72; 14.5 point greater improvement than sham on 100 point scale; absolute percent change 14.5%; relative percent change 29.14%; 4 trials; 884 participants) and function (-0.89, -1.18 to -0.60; 13.0 point greater improvement than sham on 100 point scale; absolute percent change 13.0%; relative percent change 25.21%). In the head-on comparisons of acupuncture with the 'supervised osteoarthritis education' and the 'physician consultation' control groups, acupuncture was associated with clinically relevant short- and long-term improvements in pain and function. In the head on comparisons of acupuncture with 'home exercises/advice leaflet' and 'supervised exercise', acupuncture was associated with similar treatment effects as the controls. Acupuncture as an adjuvant to an exercise based physiotherapy program did not result in any greater improvements than the exercise program alone. Information on safety was reported in only 8 trials and even in these trials there was limited reporting and heterogeneous methods. AUTHORS' CONCLUSIONS: Sham-controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre-defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list-controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.

Abstract: BACKGROUND: Acupuncture is often used for tension-type headache prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for migraine prophylaxis') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with episodic or chronic tension-type headache. SEARCH STRATEGY: The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. SELECTION CRITERIA: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another intervention in patients with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (at least 50% reduction of headache frequency; outcome of primary interest), headache days, pain intensity and analgesic use. MAIN RESULTS: Eleven trials with 2317 participants (median 62, range 10 to 1265) met the inclusion criteria. Two large trials compared acupuncture to treatment of acute headaches or routine care only. Both found statistically significant and clinically relevant short-term (up to 3 months) benefits of acupuncture over control for response, number of headache days and pain intensity. Long-term effects (beyond 3 months) were not investigated. Six trials compared acupuncture with a sham acupuncture intervention, and five of the six provided data for meta-analyses. Small but statistically significant benefits of acupuncture over sham were found for response as well as for several other outcomes. Three of the four trials comparing acupuncture with physiotherapy, massage or relaxation had important methodological or reporting shortcomings. Their findings are difficult to interpret, but collectively suggest slightly better results for some outcomes in the control groups. AUTHORS' CONCLUSIONS: In the previous version of this review, evidence in support of acupuncture for tension-type headache was considered insufficient. Now, with six additional trials, the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches.

Abstract: BACKGROUND: The Cochrane Collaboration, an international not-for-profit organization that prepares and maintains systematic reviews of randomized trials of health care therapies, has produced reviews summarizing much of the evidence on Traditional Chinese Medicine (TCM). Our objective was to review the evidence base according to Cochrane systematic reviews. METHODS: In order to detect reviews focusing on TCM, we searched the titles and abstracts of all reviews in Issue 4, 2008 of the Cochrane Database of Systematic Reviews. For each review, we extracted data on the number of trials included and the total number of participants. We provided an indication of the strength of the review findings by assessing the reviewers' abstract conclusions statement. We supplemented our assessment of the abstract conclusions statements with a listing of the comparisons and outcomes showing statistically significant meta-analyses results. RESULTS: We identified 70 Cochrane systematic reviews of TCM, primarily acupuncture (n = 26) and Chinese herbal medicine (n = 42), and 1 each of moxibustion and t'ai chi. Nineteen (19) of 26 acupuncture reviews and 22/42 herbal medicine reviews concluded that there was not enough good quality trial evidence to make any conclusion about the efficacy of the evaluated treatment, while the remaining 7 acupuncture and 20 herbal medicine reviews and each of the moxibustion and t'ai chi reviews indicated a suggestion of benefit, which was qualified by a caveat about the poor quality and quantity of studies. Most reviews included many distinct interventions, controls, outcomes, and populations, and a large number of different comparisons were made, each with a distinct forest plot. CONCLUSIONS: Most Cochrane systematic reviews of TCM are inconclusive, due specifically to the poor methodology and heterogeneity of the studies reviewed. Some systematic reviews provide preliminary evidence of Chinese medicine's benefits to certain patient populations, underscoring the importance and appropriateness of further research. These preliminary findings should be considered tentative and need to be confirmed with rigorous randomized controlled trials.

Abstract: BACKGROUND: Acupuncture is often used for migraine prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for tension-type headache') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with migraine. SEARCH STRATEGY: The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. SELECTION CRITERIA: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (no prophylactic treatment or routine care only), a sham acupuncture intervention or another intervention in patients with migraine. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (outcome of primary interest), migraine attacks, migraine days, headache days and analgesic use. Pooled effect size estimates were calculated using a random-effects model. MAIN RESULTS: Twenty-two trials with 4419 participants (mean 201, median 42, range 27 to 1715) met the inclusion criteria. Six trials (including two large trials with 401 and 1715 patients) compared acupuncture to no prophylactic treatment or routine care only. After 3 to 4 months patients receiving acupuncture had higher response rates and fewer headaches. The only study with long-term follow up saw no evidence that effects dissipated up to 9 months after cessation of treatment. Fourteen trials compared a 'true' acupuncture intervention with a variety of sham interventions. Pooled analyses did not show a statistically significant superiority for true acupuncture for any outcome in any of the time windows, but the results of single trials varied considerably. Four trials compared acupuncture to proven prophylactic drug treatment. Overall in these trials acupuncture was associated with slightly better outcomes and fewer adverse effects than prophylactic drug treatment. Two small low-quality trials comparing acupuncture with relaxation (alone or in combination with massage) could not be interpreted reliably. AUTHORS' CONCLUSIONS: In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of 'true' acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.

Abstract: 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.

Abstract: 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.

Abstract: 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, women's 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 women's 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 acupuncture's 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.

Abstract: BACKGROUND: Knee osteoarthritis is a major cause of pain and functional limitation. PURPOSE: To evaluate the effects of acupuncture for treating knee osteoarthritis. DATA SOURCES: Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases to January 2007. No language restrictions were applied. STUDY SELECTION: Randomized trials longer than 6 weeks in duration that compared needle acupuncture with a sham, usual care, or waiting list control group for patients with knee osteoarthritis. DATA EXTRACTION: Two authors independently agreed on eligibility, assessed methodological quality and acupuncture adequacy, and extracted outcome data on pain and function measures. DATA SYNTHESIS: Eleven trials met the selection criteria, and 9 reported sufficient data for pooling. Standardized mean differences were calculated by using differences in improvements from baseline between patients assigned to acupuncture and those assigned to control groups. Compared with patients in waiting list control groups, patients who received acupuncture reported clinically relevant short-term improvements in pain (standardized mean difference, -0.96 [95% CI, -1.21 to -0.70]) and function (standardized mean difference, -0.93 [CI, -1.16 to -0.69]). Patients who received acupuncture also reported clinically relevant short- and long-term improvements in pain and function compared with patients in usual care control groups. Compared with a sham control, acupuncture provided clinically irrelevant short-term improvements in pain (standardized mean difference, -0.35 [CI, -0.55 to -0.15]) and function (standardized mean difference, -0.35 [CI, -0.56 to -0.14]) and clinically irrelevant long-term improvements in pain (standardized mean difference, -0.13 [CI, -0.24 to -0.01]) and function (standardized mean difference, -0.14 [CI, -0.26 to -0.03]). LIMITATION: Sham-controlled trials had heterogeneous results that were probably due to the variability of acupuncture and sham protocols, patient samples, and settings. CONCLUSIONS: Sham-controlled trials show clinically irrelevant short-term benefits of acupuncture for treating knee osteoarthritis. Waiting list-controlled trials suggest clinically relevant benefits, some of which may be due to placebo or expectation effects.

Abstract: BACKGROUND: Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal. OBJECTIVE: To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee. DESIGN: Randomised, controlled trial. SETTING: Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and one clinical trials facility. PATIENTS: 570 patients with osteoarthritis of the knee (mean age [+/-SD], 65.5 +/- 8.4 years). INTERVENTION: 23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks. MEASUREMENTS: Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36). RESULTS: Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, -2.9 [95% CI, -5.0 to -0.8]; P=0.01) but not in WOMAC pain score (mean difference, -0.5 [CI, -1.2 to 0.2]; P=0.18) or the patient global assessment (mean difference, 0.16 [CI, -0.02 to 0.34]; P> 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, -2.5 [CI, -4.7 to -0.4]; P=0.01), WOMAC pain score (mean difference, -0.87 [CI, -1.58 to -0.16]; P=0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P=0.02). LIMITATIONS: At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis. CONCLUSIONS: Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups.

Abstract: Background Irritable bowel syndrome (IBS), a disorder of altered bowel habits associated with abdominal pain or discomfort. The pain, discomfort, and impairment from IBS often lead to healthcare medical consultation (Talley 1997) and workplace absenteeism, and associated economic costs (Leong 2003). A recent randomized controlled trial shows variable results but no clear evidence in support of acupuncture as an effective treatment for IBS (Fireman 2001). Objectives The objective of this systematic review is to determine whether acupuncture is more effective than no treatment, more effective than �sham� (placebo) acupuncture, and as effective as other interventions used to treat irritable bowel syndrome. Adverse events associated with acupuncture were also assessed. Search strategy The following electronic bibliographic databases were searched irrespective of language, date of publication, and publication status: MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, EMBASE, the Chinese Biomedical Database, the Cumulative Index to Nursing and Allied Health (CINAHL), and the Allied and Complementary Medicine Database (AMED). References in relevant reviews and RCTs were screened by hand. The last date for searching for studies was 7 February 2006. Selection criteria Published reports of randomized controlled trials (RCTs) and quasi-randomised trials of acupuncture therapy for IBS. Data collection and analysis All eligible records identified were dually evaluated for eligibility and dually abstracted. Methodological quality was assessed using the Jadad scale and the Linde Internal Validity Scale. Data fromindividual trials were combined formeta-analysis when the interventions were sufficiently similar.Heterogeneity was assessed using the I squared statistic. Main results Six trialswere included.The proportion of responders, as assessed by either the global symptomscore or the patient-determined treatment success rate, did not show a significant difference between the acupuncture and the sham acupuncture group with a pooled relative risk of 1.28 (95% CI 0.83 to 1.98;n=109). Acupuncture treatment was also not significantly more effective than sham acupuncture for overall general well-being, individual symptoms (e.g., abdominal pain, defecation difficulties, diarrhea, and bloating), the number of improved patients assessed by blinded clinician, or the EuroQol score. For two of the studies without a sham control, acupuncture was more effective than control treatment for the improvement of symptoms: acupuncture versus herbal medication with a RR of1.14(95% CI 1.00 to 1.31;n=132); acupuncture plus psychotherapy versus psychotherapy alone with a RR of 1.20 (95% CI 1.03 to 1.39;n=100). When the effect of ear acupuncture treatment was compared to an unclearly specified combination of one or more of the drugs diazepam, perphenazine or domperidone, the difference was not statistically significant with a RR of 1.49(95% CI 0.94 to 2.34;n=48). Authors� conclusions Most of the trials included in this review were of poor quality and were heterogeneous in terms of interventions, controls, and outcomes measured.With the exception of one outcome in common between two trials, data were not combined. Therefore, it is still inconclusive whether acupuncture is more effective than sham acupuncture or other interventions for treating IBS.

Abstract: BACKGROUND: Systematic reviewers generally evaluate randomized controlled trials (RCTs) based on the published reports. We evaluated whether the description of methods in the published reports is an accurate and complete reflection of study procedures used. METHODS: The authors of 51 RCTs included in a systematic review of acupuncture for chronic pain were sent a brief survey that included questions related to the following three important study quality dimensions: (1) generation of allocation sequence, (2) allocation concealment, and (3) blinding of outcomes assessor. RESULTS: We received 35 of 51 responses for an overall response rate of 68.6%. Of 35 studies described as randomized in published reports, associated survey responses indicated that four actually used quasi-randomized methods. Among published reports with missing information on these quality dimensions, 27 of 32 studies used adequate methods for the generation of allocation sequence, 13 of 34 used adequate allocation concealment and 2 of 10 were blinded, according to survey responses. Survey responses generally confirmed information about randomization and blinding already described in investigators' RCT publications. CONCLUSION: Surveying RCT investigators uncovered some information about study quality dimensions not described in published reports.

Abstract: BACKGROUND: Low back pain limits activity and is the second most frequent reason for physician visits. Previous research shows widespread use of acupuncture for low back pain. PURPOSE: To assess acupuncture's effectiveness for treating low back pain. DATA SOURCES: Randomized, controlled trials were identified through searches of MEDLINE, Cochrane Central, EMBASE, AMED, CINAHL, CISCOM, and GERA databases through August 2004. Additional data sources included previous reviews and personal contacts with colleagues. STUDY SELECTION: Randomized, controlled trials comparing needle acupuncture with sham acupuncture, other sham treatments, no additional treatment, or another active treatment for patients with low back pain. DATA EXTRACTION: Data were dually extracted for the outcomes of pain, functional status, overall improvement, return to work, and analgesic consumption. In addition, study quality was assessed. DATA SYNTHESIS: The 33 randomized, controlled trials that met inclusion criteria were subgrouped according to acute or chronic pain, style of acupuncture, and type of control group used. The principal [correction] measure of effect size was the standardized mean difference, since the trials assessed the same outcome but measured it in various ways. For the primary outcome of short-term relief of chronic pain, the meta-analyses showed that acupuncture is significantly more effective than sham treatment (standardized mean difference, 0.54 [95% CI, 0.35 to 0.73]; 7 trials) and no additional treatment (standardized mean difference, 0.69 [CI, 0.40 to 0.98]; 8 trials). For patients with acute low back pain, data are sparse and inconclusive. Data are also insufficient for drawing conclusions about acupuncture's short-term effectiveness compared with most other therapies. LIMITATIONS: The quantity and quality of the included trials varied. CONCLUSIONS: Acupuncture effectively relieves chronic low back pain. No evidence suggests that acupuncture is more effective than other active therapies.

Abstract: BACKGROUND: HIV-infected people and AIDS patients often seek complementary therapies including herbal medicines due to reasons such as unsatisfactory effects, high cost, non-availability, or adverse effects of conventional medicines. OBJECTIVES: To assess beneficial effects and risks of herbal medicines in patients with HIV infection and AIDS. SEARCH STRATEGY: Electronic searches included the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, LILACS, Science Citation Index, the Chinese Biomedical Database, TCMLARS; plus CISCOM, AMED, and NAPRALERT; combined with manual searches. The search ended in December 2004. SELECTION CRITERIA: Randomized clinical trials on herbal medicines compared with no intervention, placebo, or antiretroviral drugs in patients with HIV infection, HIV-related disease, or AIDS. The outcomes included mortality, HIV disease progression, new AIDS-defining event, CD4 cell counts, viral load, psychological status, quality of life, and adverse effects. DATA COLLECTION AND ANALYSIS: Two authors extracted data independently and assessed the methodological quality of trials according to randomization, allocation concealment, double blinding, and drop-out. MAIN RESULTS: Nine randomized placebo-controlled trials involving 499 individuals with HIV infection and AIDS met the inclusion criteria. Methodological quality of trials was assessed as adequate in five full publications and unclear in other trials. Eight different herbal medicines were tested.A compound of Chinese herbs (IGM-1) showed significantly better effect than placebo in improvement of health-related quality of life in 30 symptomatic HIV-infected patients (WMD 0.66, 95% CI 0.05 to 1.27). IGM-1 appeared not to affect overall health perception, symptom severity, CD4 count, anxiety or depression (Burack 1996a). An herbal formulation of 35 Chinese herbs did not affect CD4 cell counts, viral load, AIDS events, symptoms, psychosocial measure, or quality of life (Weber 1999). There was no statistical difference between SPV30 and placebo in new AIDS-defining events, CD4 cell counts, or viral load (Durant 1998) although an earlier pilot trial showed positive effect of SPV30 on CD4 cell count (Durant 1997). Combined treatment of Chinese herbal compound SH and antiretroviral agents showed increased antiviral benefit compared with antiretrovirals alone (Sangkitporn 2004). SP-303 appeared to reduce stool weight (p = 0.008) and abnormal stool frequency (p = 0.04) in 51 patients with AIDS and diarrhoea (Holodniy 1999). Qiankunning appeared not to affect HIV-1 RNA levels (Shi 2003), Curcumin ineffective in reducing viral load or improving CD4 cell counts (Hellinger 1996), and Capsaicin ineffective in relieving pain associated with HIV-related peripheral neuropathy (Paice 2000). The occurrence of adverse effects was higher in the 35 Chinese herbs preparation (19/24) than in placebo (11/29) (79% versus 38%, p = 0.003) (Weber 1999). Qiankunning was associated with stomach discomfort and diarrhoea (Shi 2003). AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of herbal medicines in HIV-infected individuals and AIDS patients. Potential beneficial effects need to be confirmed in large, rigorous trials.

Abstract: BACKGROUND: The objective of this review is to determine the effectiveness of Harpagophytum procumbens preparations in the treatment of various forms of musculoskeletal pain. METHODS: Several 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. RESULTS: Given 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. CONCLUSIONS: There 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.

Abstract: OBJECTIVES: To review randomized controlled trials (RCTs) evaluating the effects of Chinese herbal medicine for treating severe acute respiratory syndrome (SARS) systematically. DESIGN: Electronic and manual searches identified RCTs comparing Chinese medicine integrated to conventional medicine versus conventional medicine alone. Methodological quality of trials was assessed by generation of allocation sequence, allocation concealment, blinding, and intention-to-treat. RESULTS: Eight RCTs (488 patients with SARS) were included. The methodological quality was generally low. The combined therapy showed significant reduction of mortality (relative risk 0.32 [95% confidence interval {CI} 0.12 to 0.91]), shortened duration of fever, symptom relief, reductions in chest radiograph abnormalities, and reductions in secondary fungal infections among patients receiving glucocorticoids. There were no significant effects on quality of life or glucocorticoid dosage. CONCLUSION: Chinese herbal medicine combined with conventional medicine may have beneficial effects in patients with SARS. The evidence is insufficient because of the low methodological quality of the included trials.

Abstract: OBJECTIVE: The aim of this study was to assess beneficial and harmful effects of medicinal herbs for hepatitis C virus (HCV) infection. METHODS: The databases of the Cochrane Collaboration, MEDLINE, EMBASE, and BIOSIS were searched combined with manual searches of five Chinese and one Japanese journals. We included randomized trials comparing medicinal herbs with placebo, no intervention, nonspecific treatment, other herbs, or interferon and/or ribavirin. Trials of herbs with or without other drug(s) were included. Methodological quality of the trials was evaluated by randomization, double blinding, and the Jadad scale. RESULTS: Thirteen randomized trials (n = 818) evaluated 14 medicinal herbs. Four trials had adequate methodology. Compared with placebo, none of the herbs showed effects on HCV RNA or liver enzyme, except for silybin, which showed a significant reduction of serum AST and gamma-glutamyltranspeptidase levels in one trial. Oxymatrine showed effects on clearance of HCV RNA (relative risk = 9.20, 95% CI = 1.26-67.35) compared with vitamins. The herbal mixture Bing Gan Tang plus interferon-alpha showed better effects on clearance of HCV RNA (relative risk = 2.54, 95% CI = 1.43-4.49) and on normalization of serum ALT (relative risk = 2.54, 95% CI = 1.43-4.49) than interferon-alpha alone. The herbal mixture Yi Zhu decoction showed better effects on clearance of HCV RNA and normalization of ALT compared with glycyrrhizin plus ribavirin. Yi Er Gan Tang showed effects on normalizing serum ALT compared with silymarin plus glucurolactone. The herbs were associated with adverse events. CONCLUSIONS: There is no firm evidence supporting medicinal herbs for HCV infection, and further randomized trials are justified.

Abstract: Intravenous drug users often have many health conditions in addition to their drug addiction, yet may be isolated from conventional sources of care. They have never before been examined for their use of complementary and alternative medicine (CAM) therapies. Our purpose was to study the prevalence and predictors of CAM use among persons with a history of intravenous drug use through a cross-sectional survey of intravenous drug users examining their utilization of health services, including CAM therapies. A total of 548 persons with a history of intravenous drug use, recruited from a needle-exchange program and a methadone maintenance clinic, both in Providence, Rhode Island, participated. Overall prevalence of any CAM use in the past 6 months, frequency of use of individual named CAM therapies and domains, and demographic and clinical characteristics associated with CAM users, reasons for CAM use and self-perceived effectiveness of CAM were also measured. Of the 548 participants, 45% reported use of at least one CAM therapy. The top three therapies--religious healing, relaxation techniques, and meditation--were all from the mind-body domain. Having a higher education and lower self-rated health were the two strongest predictors of CAM use, followed by having a regular doctor or clinic, being white and younger. There was a high level of self-perceived effectiveness of CAM therapies (4.1 on a scale of 1-5), and CAM users were likely to use CAM for reasons related to their addiction.

Abstract: The Cochrane Collaboration has established a centralized database of controlled trials and other studies of health care interventions (called CENTRAL) that serves as the best available resource for all those preparing and maintaining systematic reviews or otherwise searching for trials. CENTRAL is available on The Cochrane Library. This article describes the history and methods of CENTRAL's development and the results of an analysis of the current composition of CENTRAL. As of September 2000, CENTRAL contained almost 300,000 citations to reports of trials, contributed mainly by Cochrane Groups and Centers around the world. Development of CENTRAL has been an ambitious, scholarly undertaking and has resulted in a valuable resource: CENTRAL includes citations to controlled trials that may not be indexed in MEDLINE, EMBASE, or other bibliographic databases; citations published internationally in many languages; and citations that are available only in conference proceedings or other hard-to-access sources.

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, What's in the Pipeline, and the NDA Pipeline. Drug trials were then searched for on the following publicly accessible registers of clinical trials:, 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, 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.

Abstract: BACKGROUND: Hepatitis C virus (HCV) infection is a serious health problem world-wide. Medicinal herbs are increasingly being used for hepatitis C. OBJECTIVES: To assess the efficacy and safety of medicinal herbs for hepatitis C virus infection. SEARCH STRATEGY: Searches were applied to The Controlled Trial Registers of The Cochrane Hepato-Biliary Group, The Cochrane Complementary Medicine Field, and The Cochrane Library as well as MEDLINE, EMBASE, BIOSIS, Chinese and Japanese databases. Five Chinese journals and one Japanese journal were handsearched. No language restriction was used. SELECTION CRITERIA: Randomised clinical trials comparing medicinal herbs (single herb or compound of herbs) versus placebo, no intervention, general non-specific treatment, other herbal medicine, or interferon and/or ribavirin treatment. Trials of medicinal herbs plus interferon and/or ribavirin versus interferon and/or ribavirin alone were also included. Trials could be double-blind, single-blind, or unblinded. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. The methodological quality of the trials was evaluated using the generation of allocation sequence, allocation concealment, double blinding, and the Jadad-scale. The outcomes were presented as relative risk or weighted mean difference, both with 95% confidence interval. MAIN RESULTS: Ten randomised trials, including 517 patients with mainly chronic hepatitis C, evaluated ten different medicinal herbs versus various control interventions (four placebo, four interferon, two other herbs). The methodological quality was considered adequate in four trials and inadequate in six trials. Compared with placebo in four trials, none of the medicinal herbs showed positive effects on clearance of serum HCV RNA or anti-HCV antibody or on serum liver enzymes, except one short-term trial in which a silybin preparation showed a significant effect on reducing serum aspartate aminotransferase and gamma-glutamyltranspeptidase activities. The herbal compound Bing Gan Tang combined with interferon-alpha showed significantly better effects on clearance of serum HCV RNA (relative risk 2.54; 95% confidence interval 1.43 to 4.49) and on normalisation of serum alanine aminotransferase activity (relative risk 2.54; 95% confidence interval 1.43 to 4.49) than interferon-alpha monotherapy. The herbal compound Yi Zhu decoction showed a significant effect on clearance of serum HCV RNA and normalisation of ALT levels compared to glycyrrhizin plus ribavirin. Yi Er Gan Tang showed a significant effect on normalising serum alanine aminotransferase compared to silymarin plus glucurolactone. There was no significant efficacy of the other examined herbs. The herbs were associated with adverse events. REVIEWER'S CONCLUSIONS: There is no firm evidence of efficacy of any medicinal herbs for HCV infection. Medicinal herbs for HCV infection should not be used outside randomised clinical trials.

Abstract:

Abstract:

Abstract:

Abstract:

Abstract:

Abstract:

Abstract:

Abstract:

Abstract: In order to facilitate the conduct and dissemination of high-quality systematic reviews in CAM further, three key issues were discussed at the Melbourne Cochrane Colloquium: (a) How to improve the overall methodological quality of CAM reviews in general, (b) how to improve the quality of Traditional Chinese Medicine reviews and trials; and (c) how to make the CAM reviews more accessible to the lay public throughout the world. A summary of each of these is presented.

Abstract:

Abstract:

Abstract: Americans use CAM therapies now more than ever before, yet there is a shortage of accessible high-quality evidence from clinical trials to show which CAM therapies work best and for which conditions. The need for such evidence is great, not only among people with serious, chronic health conditions, but also among healthcare providers, who often require clinical trial evidence before recommending a medical treatment. For the last few years, the University of Maryland Center for Integrative Medicine has been working steadily to meet this need for information by identifying published clinical trials of alternative therapies, summarizing these into rigorous scientific reviews, and disseminating these reviews to the general public and to healthcare providers. In May 2003, the Center was awarded a large 4-year research grant from the National Institutes of Health's National Center for Complementary and Alternative Medicine (NCCAM) to support and extend this important work.

Abstract:

Abstract:

Abstract:

Abstract:

Abstract:

Abstract: