Search

There are more than 20 completed Cochrane systematic reviews on botanical medicine presently published in the Cochrane Library. There are more than 40 that are planned or in progress. It is an opportune time to explore the information needs of readers of botanical systematic reviews and how those needs can be met better by Cochrane systematic reviews. It is proposed that Cochrane systematic reviews focus not only on efficacy but also on expanded safety and quality. Expanded safety refers not only to the occurrence of adverse events but also the contraindications for use such as drug-herb interactions or allergies to products. Quality pertains to whether or not there was a method of standardizing active ingredients in trials and methods for minimizing risks of contamination. Because there are no package inserts to accompany herbal products as there are for drugs, Cochrane systematic reviews offer the ideal forum to present this much-needed information on expanded safety and quality. [ABSTRACT FROM AUTHOR]

Looks at alternative and complementary medicine (CM), with focus on the establishment of a CM Field, funded by the United States National Institutes of Health's Office of Alternative Medicine, within the Cochrane Collaboration in 1996. Goals of the Cochrane Collaboration; Identification of the products of the Cochrane Collaboration.

Objectives: The aim of this systematic review update was to determine the average effect of massage for adults with neck pain (NP) contrasted against another standard treatment., Methods: Randomised controlled trials comparing massage to standard treatments were included; placebo/no treatment comparisons were excluded. Databases were searched (CENTRAL, MEDLINE, EMBASE, CINAHL, ICL, trial registries) from inception to Oct-1-2023. We used the standard Cochrane methodological procedures: rated Risk of Bias 1.0, abstracted mean differences (MD), meta-analysed data, and rated the level of certainty (GRADE)., Results: We included 42 studies (2656 participants; 67% high RoB) contrasted against 10 unique treatments. Trials studied ages 18-70, 70% female, and mean pain severity 52 Visual Analogue Scale (VAS). Very-low to moderate-certainty evidence for pain (MD VAS 0-100, 95% CI) at ≤12 weeks follow-up follows. The pre-stated minimal important difference margin was 10 VAS points. Massage was Massage may not increase risks of minor adverse events: RR 0.37 (95% CI 0.22 to 0.61)., Conclusion: For subacute-chronic NP, pain reduction varied by comparison. The evidence was limited by imprecision and high RoB. Focused planning for adequately dosed longer-term trials is needed., Competing Interests: Declaration of competing interest No conflicts of interest are declared., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Massage is widely used for neck pain, but its effectiveness remains unclear., Objectives: To assess the benefits and harms of massage compared to placebo or sham, no treatment or exercise as an adjuvant to the same co-intervention for acute to chronic persisting neck pain in adults with or without radiculopathy, including whiplash-associated disorders and cervicogenic headache., Search Methods: We searched multiple databases (CENTRAL, MEDLINE, EMBASE, CINAHL, Index to Chiropractic Literature, trial registries) to 1 October 2023., Selection Criteria: We included randomised controlled trials (RCTs) comparing any type of massage with sham or placebo, no treatment or wait-list, or massage as an adjuvant treatment, in adults with acute, subacute or chronic neck pain., Data Collection and Analysis: We used the standard methodological procedures expected by Cochrane. We transformed outcomes to standardise the direction of the effect (a smaller score is better). We used a partially contextualised approach relative to identified thresholds to report the effect size as slight-small, moderate or large-substantive., Main Results: We included 33 studies (1994 participants analysed). Selection (82%) and detection bias (94%) were common; multiple trials had unclear allocation concealment, utilised a placebo that may not be credible and did not test whether blinding to the placebo was effective. Massage was compared with placebo (n = 10) or no treatment (n = 8), or assessed as an adjuvant to the same co-treatment (n = 15). The trials studied adults aged 18 to 70 years, 70% female, with mean pain severity of 51.8 (standard deviation (SD) 14.1) on a visual analogue scale (0 to 100). Neck pain was subacute-chronic and classified as non-specific neck pain (85%, including n = 1 whiplash), radiculopathy (6%) or cervicogenic headache (9%). Trials were conducted in outpatient settings in Asia (n = 11), America (n = 5), Africa (n = 1), Europe (n = 12) and the Middle East (n = 4). Trials received research funding (15%) from research institutes. We report the main results for the comparison of massage versus placebo. Low-certainty evidence indicates that massage probably results in little to no difference in pain, function-disability and health-related quality of life when compared against a placebo for subacute-chronic neck pain at up to 12 weeks follow-up. It may slightly improve participant-reported treatment success. Subgroup analysis by dose showed a clinically important difference favouring a high dose (≥ 8 sessions over four weeks for ≥ 30 minutes duration). There is very low-certainty evidence for total adverse events. Data on patient satisfaction and serious adverse events were not available. Pain was a mean of 20.55 points with placebo and improved by 3.43 points with massage (95% confidence interval (CI) 8.16 better to 1.29 worse) on a 0 to 100 scale, where a lower score indicates less pain (8 studies, 403 participants; I 2 = 39%). We downgraded the evidence to low-certainty due to indirectness; most trials in the placebo comparison used suboptimal massage doses (only single sessions). Selection, performance and detection bias were evident as multiple trials had unclear allocation concealment, utilised a placebo that may not be credible and did not test whether blinding was effective, respectively. Function-disability was a mean of 30.90 points with placebo and improved by 9.69 points with massage (95% CI 17.57 better to 1.81 better) on the Neck Disability Index 0 to 100, where a lower score indicates better function (2 studies, 68 participants; I 2 = 0%). We downgraded the evidence to low-certainty due to imprecision (the wide CI represents slight to moderate benefit that does not rule in or rule out a clinically important change) and risk of selection, performance and detection biases. Participant-reported treatment success was a mean of 3.1 points with placebo and improved by 0.80 points with massage (95% CI 1.39 better to 0.21 better) on a Global Improvement 1 to 7 scale, where a lower score indicates very much improved (1 study, 54 participants). We downgraded the evidence to low-certainty due to imprecision (single study with a wide CI that does not rule in or rule out a clinically important change) and risk of performance as well as detection bias. Health-related quality of life was a mean of 43.2 points with placebo and improved by 5.30 points with massage (95% CI 8.24 better to 2.36 better) on the SF-12 (physical) 0 to 100 scale, where 0 indicates the lowest level of health (1 study, 54 participants). We downgraded the evidence once for imprecision (a single small study) and risk of performance and detection bias. We are uncertain whether massage results in increased total adverse events, such as treatment soreness, sweating or low blood pressure (RR 0.99, 95% CI 0.08 to 11.55; 2 studies, 175 participants; I 2 = 77%). We downgraded the evidence to very low-certainty due to unexplained inconsistency, risk of performance and detection bias, and imprecision (the CI was extremely wide and the total number of events was very small, i.e < 200 events)., Authors' Conclusions: The contribution of massage to the management of neck pain remains uncertain given the predominance of low-certainty evidence in this field. For subacute and chronic neck pain (closest to 12 weeks follow-up), massage may result in a little or no difference in improving pain, function-disability, health-related quality of life and participant-reported treatment success when compared to a placebo. Inadequate reporting on adverse events precluded analysis. Focused planning for larger, adequately dosed, well-designed trials is needed., (Copyright © 2024 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: More than one in five patients who undergo treatment for breast cancer will develop breast cancer-related lymphedema (BCRL). BCRL can occur as a result of breast cancer surgery and/or radiation therapy. BCRL can negatively impact comfort, function, and quality of life (QoL). Manual lymphatic drainage (MLD), a type of hands-on therapy, is frequently used for BCRL and often as part of complex decongestive therapy (CDT). CDT is a fourfold conservative treatment which includes MLD, compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LREs). Phase 1 of CDT is to reduce swelling; Phase 2 is to maintain the reduced swelling., Objectives: To assess the efficacy and safety of MLD in treating BCRL., Search Methods: We searched Medline, EMBASE, CENTRAL, WHO ICTRP (World Health Organization's International Clinical Trial Registry Platform), and Cochrane Breast Cancer Group's Specialised Register from root to 24 May 2013. No language restrictions were applied., Selection Criteria: We included randomized controlled trials (RCTs) or quasi-RCTs of women with BCRL. The intervention was MLD. The primary outcomes were (1) volumetric changes, (2) adverse events. Secondary outcomes were (1) function, (2) subjective sensations, (3) QoL, (4) cost of care., Data Collection and Analysis: We collected data on three volumetric outcomes. (1) LE (lymphedema) volume was defined as the amount of excess fluid left in the arm after treatment, calculated as volume in mL of affected arm post-treatment minus unaffected arm post-treatment. (2) Volume reduction was defined as the amount of fluid reduction in mL from before to after treatment calculated as the pretreatment LE volume of the affected arm minus the post-treatment LE volume of the affected arm. (3) Per cent reduction was defined as the proportion of fluid reduced relative to the baseline excess volume, calculated as volume reduction divided by baseline LE volume multiplied by 100. We entered trial data into Review Manger 5.2 (RevMan), pooled data using a fixed-effect model, and analyzed continuous data as mean differences (MDs) with 95% confidence intervals (CIs). We also explored subgroups to determine whether mild BCRL compared to moderate or severe BCRL, and BCRL less than a year compared to more than a year was associated with a better response to MLD., Main Results: Six trials were included. Based on similar designs, trials clustered in three categories.(1) MLD + standard physiotherapy versus standard physiotherapy (one trial) showed significant improvements in both groups from baseline but no significant between-groups differences for per cent reduction.(2) MLD + compression bandaging versus compression bandaging (two trials) showed significant per cent reductions of 30% to 38.6% for compression bandaging alone, and an additional 7.11% reduction for MLD (MD 7.11%, 95% CI 1.75% to 12.47%; two RCTs; 83 participants). Volume reduction was borderline significant (P = 0.06). LE volume was not significant. Subgroup analyses was significant showing that participants with mild-to-moderate BCRL were better responders to MLD than were moderate-to-severe participants.(3) MLD + compression therapy versus nonMLD treatment + compression therapy (three trials) were too varied to pool. One of the trials compared compression sleeve plus MLD to compression sleeve plus pneumatic pump. Volume reduction was statistically significant favoring MLD (MD 47.00 mL, 95% CI 15.25 mL to 78.75 mL; 1 RCT; 24 participants), per cent reduction was borderline significant (P=0.07), and LE volume was not significant. A second trial compared compression sleeve plus MLD to compression sleeve plus self-administered simple lymphatic drainage (SLD), and was significant for MLD for LE volume (MD -230.00 mL, 95% CI -450.84 mL to -9.16 mL; 1 RCT; 31 participants) but not for volume reduction or per cent reduction. A third trial of MLD + compression bandaging versus SLD + compression bandaging was not significant (P = 0.10) for per cent reduction, the only outcome measured (MD 11.80%, 95% CI -2.47% to 26.07%, 28 participants).MLD was well tolerated and safe in all trials.Two trials measured function as range of motion with conflicting results. One trial reported significant within-groups gains for both groups, but no between-groups differences. The other trial reported there were no significant within-groups gains and did not report between-groups results. One trial measured strength and reported no significant changes in either group.Two trials measured QoL, but results were not usable because one trial did not report any results, and the other trial did not report between-groups results.Four trials measured sensations such as pain and heaviness. Overall, the sensations were significantly reduced in both groups over baseline, but with no between-groups differences. No trials reported cost of care.Trials were small ranging from 24 to 45 participants. Most trials appeared to randomize participants adequately. However, in four trials the person measuring the swelling knew what treatment the participants were receiving, and this could have biased results., Authors' Conclusions: MLD is safe and may offer additional benefit to compression bandaging for swelling reduction. Compared to individuals with moderate-to-severe BCRL, those with mild-to-moderate BCRL may be the ones who benefit from adding MLD to an intensive course of treatment with compression bandaging. This finding, however, needs to be confirmed by randomized data.In trials where MLD and sleeve were compared with a nonMLD treatment and sleeve, volumetric outcomes were inconsistent within the same trial. Research is needed to identify the most clinically meaningful volumetric measurement, to incorporate newer technologies in LE assessment, and to assess other clinically relevant outcomes such as fibrotic tissue formation.Findings were contradictory for function (range of motion), and inconclusive for quality of life.For symptoms such as pain and heaviness, 60% to 80% of participants reported feeling better regardless of which treatment they received.One-year follow-up suggests that once swelling had been reduced, participants were likely to keep their swelling down if they continued to use a custom-made sleeve.

Background: The prevalence of mechanical neck disorders (MND) is known to be both a hindrance to individuals and costly to society. As such, massage is widely used as a form of treatment for MND., Objectives: To assess the effects of massage on pain, function, patient satisfaction, global perceived effect, adverse effects and cost of care in adults with neck pain versus any comparison at immediate post-treatment to long-term follow-up., Search Methods: We searched The Cochrane Library (CENTRAL), MEDLINE, EMBASE, MANTIS, CINAHL, and ICL databases from date of inception to 4 Feburary 2012., Selection Criteria: Studies using random assignment were included., Data Collection and Analysis: Two review authors independently conducted citation identification, study selection, data abstraction and methodological quality assessment. Using a random-effects model, we calculated the risk ratio and standardised mean difference., Main Results: Fifteen trials met the inclusion criteria. The overall methodology of all the trials assessed was either low or very low GRADE level. None of the trials were of strong to moderate GRADE level. The results showed very low level evidence that certain massage techniques (traditional Chinese massage, classical and modified strain/counter strain technique) may have been more effective than control or placebo treatment in improving function and tenderness. There was very low level evidence that massage may have been more beneficial than education in the short term for pain bothersomeness. Along with that, there was low level evidence that ischaemic compression and passive stretch may have been more effective in combination rather than individually for pain reduction. The clinical applicability assessment showed that only 4/15 trials adequately described the massage technique. The majority of the trials assessed outcomes at immediate post-treatment, which is not an adequate time to assess clinical change. Due to the limitations in the quality of existing studies, we were unable to make any firm statement to guide clinical practice. We noted that only four of the 15 studies reported side effects. All four studies reported post-treatment pain as a side effect and one study (Irnich 2001) showed that 22% of the participants experienced low blood pressure following treatment., Authors' Conclusions: No recommendations for practice can be made at this time because the effectiveness of massage for neck pain remains uncertain.As a stand-alone treatment, massage for MND was found to provide an immediate or short-term effectiveness or both in pain and tenderness. Additionally, future research is needed in order to assess the long-term effects of treatment and treatments provided on more than one occasion.

Massage is an increasingly popular complementary and alternative medicine modality used for a variety of conditions. Cochrane massage reviews are a gold mine of observations regarding the methodologic issues inherent in massage trials and have raised important questions, which can be used to guide future research. Among the research issues raised in Cochrane reviews are questions about combination trials, practitioner qualifications, adequate doses, and appropriate control groups. This article summarizes these key research issues.

Study Design: Systematic review., Objective: To assess the effects of massage on pain, function, patient satisfaction, cost of care, and adverse events in adults with neck pain., Summary of Background Data: Neck pain is common, disabling, and costly. Massage is a commonly used modality for the treatment of neck pain., Methods: We searched several databases without language restriction from their inception to September 2004. We included randomized and quasirandomized trials. Two reviewers independently identified studies, abstracted data, and assessed quality. We calculated the relative risks and standardized mean differences on primary outcomes. Trials could not be statistically pooled because of heterogeneity in treatment and control groups. Therefore, a levels-of-evidence approach was used to synthesize results., Results: Overall, 19 trials were included, with 12/19 receiving low-quality scores. Descriptions of the massage intervention, massage professional's credentials, or experience were frequently missing. Six trials examined massage as a stand-alone treatment. The results were inconclusive. Results were also inconclusive in 14 trials that used massage as part of a multimodal intervention because none were designed such that the relative contribution of massage could be ascertained., Conclusions: No recommendations for practice can be made at this time because the effectiveness of massage for neck pain remains uncertain. Pilot studies are needed to characterize massage treatment (frequency, duration, number of sessions, and massage technique) and establish the optimal treatment to be used in subsequent larger trials that examine the effect of massage as either a stand-alone treatment or part of a multimodal intervention. For multimodal interventions, factorial designs are needed to determine the relative contribution of massage. Future reports of trials should improve reporting of the concealment of allocation, blinding of outcome assessor, adverse events, and massage characteristics. Standards of reporting for massage interventions, similar to Consolidated Standards of Reporting Trials, are needed. Both short and long-term follow-up are needed.

The objective of this overview is to summarize existing knowledge about the effects of acupuncture-point stimulation on nausea and vomiting. Systematic reviews on postoperative nausea and vomiting, chemotherapy-induced nausea and vomiting, and pregnancy-related nausea and vomiting exist. Several randomised trials, but no reviews, exist for motion sickness. For postoperative nausea and vomiting, results from 26 trials showed acupuncture-point stimulation was effective for both nausea and vomiting. For chemotherapy-induced nausea and vomiting, results of 11 trials differed according to modality with acupressure appearing effective for first-day nausea, electroacupuncture appearing effective for first-day vomiting, and noninvasive electrostimulation appearing no more effective than placebo for any outcome. For pregnancy-related nausea and vomiting, results were mixed. Experimental studies showed effects of P6-stimulation on gastric myoelectrical activity, vagal modulation and cerebellar vestibular activities in functional magnetic resonance imaging. There is good clinical evidence from more than 40 randomised controlled trials that acupuncture has some effect in preventing or attenuating nausea and vomiting. A growing number of experimental studies suggest mechanisms of action.

Background: Mechanical neck disorders (MND) are common, disabling and costly. Massage is a commonly used modality for the treatment of neck pain., Objectives: To assess the effects of massage on pain, function, patient satisfaction and cost of care in adults with neck pain. To document adverse effects of treatment., Search Strategy: Cochrane CENTRAL, MEDLINE, EMBASE, MANTIS, CINAHL, and ICL databases were electronically searched, without language restriction, from their inception to September 2004, Selection Criteria: Studies using random or quasi-random assignment were included., Data Collection and Analysis: Two reviewers independently conducted citation identification, study selection, data abstraction and methodological quality assessment. Using a random-effects model, we calculated the relative risk and standardized mean difference., Main Results: Nineteen trials met the inclusion criteria. Overall, the methodological quality was low, with 12/19 assessed as low-quality studies. Trials could not be statistically pooled because of heterogeneity in treatment and control groups. Therefore, a levels-of-evidence approach was used to synthesize results. Assessment of the clinical applicability of the trials showed that the participant characteristics were well reported, but neither the descriptions of the massage intervention nor the credentials or experience of the massage professionals were well reported. Six trials examined massage as a stand-alone treatment. The results were inconsistent. Of the 14 trials that used massage as part of a multimodal intervention, none were designed such that the relative contribution of massage could be ascertained. Therefore, the role of massage in multimodal treatments remains unclear., Authors' Conclusions: No recommendations for practice can be made at this time because the effectiveness of massage for neck pain remains uncertain. Pilot studies are needed to characterize massage treatment (frequency, duration, number of sessions, and massage technique) and establish the optimal treatment to be used in subsequent larger trials that examine the effect of massage as either a stand-alone treatment or part of a multimodal intervention. For multimodal interventions, factorial designs are needed to determine the relative contribution of massage. Future reports of trials should improve reporting of the concealment of allocation, blinding of outcome assessor, adverse events and massage characteristics. Standards of reporting for massage interventions, similar to CONSORT, are needed. Both short- and long-term follow-up are needed.

Background: In 1998, the National Institutes of Health Consensus Statement on Acupuncture concluded that promising results have emerged showing the efficacy of acupuncture in adult postoperative and chemotherapy induced nausea and vomiting. The acupuncture point, P6 had been the point used in most of the trials., Objectives: To summarize Cochrane systematic reviews assessing P6 stimulation for nausea and vomiting., Results: Reviews were found on postoperative sickness, chemotherapy-induced nausea and vomiting, and pregnancy-related nausea and vomiting. Results for postoperative nausea and vomiting show the most consistent results with 26 trials and more than 3000 patients showing the superiority of real P6 stimulation over sham for both adults and children and for both nausea and vomiting. Pooled data of trials including different antiemetics showed that P6 stimulation seems to be superior to antiemetic medication for nausea and equivalent for vomiting. P6 stimulation was similarly effective across the different methods of stimulation, both invasive or noninvasive. Results for chemotherapy-induced nausea and vomiting showed 11 trials and over 1200 patients. Electroacupuncture, but not manual acupuncture, was beneficial for first-day vomiting. Acupressure was effective for first-day nausea but not vomiting. Wristwatch-like electrical devices were not effective for any outcome. Results for pregnancy-related nausea and vomiting comprised six trials and approximately 1150 patients. Results were mixed with some trials showing positive and other trials equivocal results with no favor to a certain kind of method., Conclusions: P6 stimulation may be beneficial for various conditions involving nausea and vomiting. The added value to modern antiemetics remains unclear. In patients on chemotherapy, future research should focus on patients for whom the problems are refractory. The next steps in research should include investigating whether acupuncture points added to P6 or individualizing treatment based on a Traditional Chinese Medicine diagnosis increases treatment effectiveness. It would also be worthwhile to identify predictors of response across the different conditions so that the individual patients can optimize acupuncture point therapy.

Background: There have been recent advances in chemotherapy-induced nausea and vomiting using 5-HT(3) inhibitors and dexamethasone. However, many still experience these symptoms, and expert panels encourage additional methods to reduce these symptoms., Objectives: The objective was to assess the effectiveness of acupuncture-point stimulation on acute and delayed chemotherapy-induced nausea and vomiting in cancer patients., Search Strategy: We searched MEDLINE, EMBASE, PsycLIT, MANTIS, Science Citation Index, CCTR (Cochrane Controlled Trials Registry), Cochrane Complementary Medicine Field Trials Register, Cochrane Pain, Palliative Care and Supportive Care Specialized Register, Cochrane Cancer Specialized Register, and conference abstracts., Selection Criteria: Randomized trials of acupuncture-point stimulation by any method (needles, electrical stimulation, magnets, or acupressure) and assessing chemotherapy-induced nausea or vomiting, or both., Data Collection and Analysis: Data were provided by investigators of the original trials and pooled using a fixed effect model. Relative risks were calculated on dichotomous data. Standardized mean differences were calculated for nausea severity. Weighted mean differences were calculated for number of emetic episodes., Main Results: Eleven trials (N = 1247) were pooled. Overall, acupuncture-point stimulation of all methods combined reduced the incidence of acute vomiting (RR = 0.82; 95% confidence interval 0.69 to 0.99; P = 0.04), but not acute or delayed nausea severity compared to control. By modality, stimulation with needles reduced proportion of acute vomiting (RR = 0.74; 95% confidence interval 0.58 to 0.94; P = 0.01), but not acute nausea severity. Electroacupuncture reduced the proportion of acute vomiting (RR = 0.76; 95% confidence interval 0.60 to 0.97; P = 0.02), but manual acupuncture did not; delayed symptoms for acupuncture were not reported. Acupressure reduced mean acute nausea severity (SMD = -0.19; 95% confidence interval -0.37 to -0.01; P = 0.04) but not acute vomiting or delayed symptoms. Noninvasive electrostimulation showed no benefit for any outcome. All trials used concomitant pharmacologic antiemetics, and all, except electroacupuncture trials, used state-of-the-art antiemetics., Authors' Conclusions: This review complements data on post-operative nausea and vomiting suggesting a biologic effect of acupuncture-point stimulation. Electroacupuncture has demonstrated benefit for chemotherapy-induced acute vomiting, but studies combining electroacupuncture with state-of-the-art antiemetics and in patients with refractory symptoms are needed to determine clinical relevance. Self-administered acupressure appears to have a protective effect for acute nausea and can readily be taught to patients though studies did not involve placebo control. Noninvasive electrostimulation appears unlikely to have a clinically relevant impact when patients are given state-of-the-art pharmacologic antiemetic therapy.

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.

Purpose: Assess the effectiveness of acupuncture-point stimulation on acute and delayed chemotherapy-induced nausea and vomiting in cancer patients., Materials and Methods: Randomized trials of acupuncture-point stimulation by needles, electrical stimulation, magnets, or acupressure were retrieved. Data were provided by investigators of the original trials and pooled using a fixed-effects model., Results: Eleven trials (N = 1,247) were pooled. Overall, acupuncture-point stimulation reduced the proportion of acute vomiting (relative risks [RR] = 0.82; 95% CI, 0.69 to 0.99; P = .04), but not the mean number of acute emetic episodes or acute or delayed nausea severity compared with controls. By modality, stimulation with needles reduced the proportion of acute vomiting (RR = 0.74; 95% CI, 0.58 to 0.94; P = .01), but not acute nausea severity. Electroacupuncture reduced the proportion of acute vomiting (RR = 0.76; 95% CI, 0.60 to 0.97; P = .02), but manual acupuncture did not; delayed symptoms were not reported. Acupressure reduced mean acute nausea severity (standardized mean difference = -0.19; 95% CI, -0.38 to -0.01; P = .03) and most severe acute nausea, but not acute vomiting or delayed symptoms. Noninvasive electrostimulation showed no benefit for any outcome. All trials used concomitant pharmacologic antiemetics, and all, except electroacupuncture trials, used state-of-the-art antiemetics., Conclusion: This review complements data on postoperative nausea and vomiting, suggesting a biologic effect of acupuncture-point stimulation. Electroacupuncture has demonstrated benefit for chemotherapy-induced acute vomiting, but studies with state-of-the-art antiemetics as well as studies for refractory symptoms are needed to determine clinical relevance. Acupressure seems to reduce chemotherapy-induced acute nausea severity, though studies did not involve a placebo control. Noninvasive electrostimulation seems unlikely to have a clinically relevant impact when patients are given state-of-the-art pharmacologic antiemetic therapy.

In the current issue of the Cochrane Library (Issue 3, 2004), there are more than 25 systematic reviews addressing the use of vitamins in the prevention or treatment of disease. Vitamins have been a mainstay of health since their discovery in the early 1900s, so a question arises as to when using vitamins is considered complementary as opposed to conventional medical practice. Complementary or alternative vitamin use encompasses those uses that are outside of accepted medical practice. The use of vitamin C to prevent scurvy is accepted medical practice. The use of vitamin C as a therapeutic adjunct to asthma is not. This paper summarizes 15 Cochrane systematic reviews on the complementary use of vitamins for an array of conditions including the common cold, Alzheimer's disease, asthma, chemotherapy-induced mucositis, and depression.

Background: Breast cancer is the most common cancer and the second most common cause of cancer-related death among North American and Western European women. Recent progress in understanding the genetic basis of breast cancer, along with rising incidence rates, have resulted in increased interest in prophylactic mastectomy as a method of preventing breast cancer, particularly in those with familial susceptibility., Objectives: The primary objective was to determine whether prophylactic mastectomy reduces death from any cause in women who have never had breast cancer and in women who have a history of breast cancer in one breast. The secondary objective was to examine the effect of prophylactic mastectomy on other endpoints including breast cancer incidence, breast cancer mortality, disease-free survival, physical morbidity, and psychosocial outcomes., Search Strategy: Electronic searches were performed in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Cancerlit, and the Science Citation Index., Selection Criteria: Inclusion criteria were studies in English of any design type including randomized or nonrandomized controlled trials, cohort studies, case-control studies, and case series with at least ten participants. Participants included women at risk for breast cancer in at least one breast. Interventions included all types of mastectomy performed for the purpose of preventing breast cancer, including subcutaneous mastectomy, total or simple mastectomy, modified radical mastectomy, and radical mastectomy., Data Collection and Analysis: Information on patients, interventions, methods, and results were extracted by at least two independent reviewers. Methodological quality was assessed based on how well each study minimized potential selection bias, performance bias, detection bias, and attrition bias. Data for each study were summarized descriptively; quantitative meta-analysis was not feasible due to heterogeneity of study designs and insufficient reporting. Data were analyzed separately for bilateral prophylactic mastectomy (BPM) and contralateral prophylactic mastectomy (CPM)., Main Results: Twenty-three studies, including more than 4,000 patients, met inclusion criteria. No randomized or nonrandomized controlled trials were found. Most studies were either case series or cohort studies. All studies had methodological limitations, with the most common source of potential bias being systematic differences between the intervention and comparison groups that could potentially be associated with a particular outcome. Thirteen studies assessed the effectiveness of BPM. No study assessed all-cause mortality after BPM. All studies reporting on incidence of breast cancer and disease-specific mortality reported reductions after BPM. Nine studies assessed psychosocial measures; most reported high levels of satisfaction with the decision to have prophylactic mastectomy (PM) but more variable satisfaction with cosmetic results. Only one study assessed satisfaction with the psychological support provided by healthcare personnel during risk counseling and showed that more women were dissatisfied than satisfied with the support they received in the healthcare setting. Worry over breast cancer was significantly reduced after BPM when compared both to baseline worry levels and to the groups who opted for surveillance rather than BPM. Three studies reported body image/feelings of femininity outcomes, and all reported that a substantial minority (about 20%) reported BPM had adverse effects on those domains. Six studies assessed contralateral prophylactic mastectomy. Studies consistently reported reductions in contralateral incidence of breast cancer but were inconsistent about improvements in disease-specific survival. Only one study attempted to control for multiple differences between intervention groups, and this study showed no overall survival advantage for CPM at 15 years. Two case series were exclusively focused on adverse events from prophylactic mastectomy with reconstruction, and both reported rates of unanticipated re-operations from 30% to 49%., Reviewers' Conclusions: While published observational studies demonstrated that BPM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies (ideally randomized trials) are needed. The studies need to be of sufficient duration and make better attempts to control for selection biases to arrive at better estimates of risk reduction. The state of the science is far from exact in predicting who will get or who will die from breast cancer. By one estimate, most of the women deemed high risk by family history (but not necessarily BRCA 1 or 2 mutation carriers) who underwent these procedures would not have died from breast cancer, even without prophylactic surgery. Therefore, women need to understand that this procedure should be considered only among those at very high risk of the disease. For women who had already been diagnosed with a primary tumor, the data were particularly lacking for indications for contralateral prophylactic mastectomy. While it appeared that contralateral mastectomy may reduce the incidence of cancer in the contralateral breast, there was insufficient evidence about whether, and for whom, CPM actually improved survival. Physical morbidity is not uncommon following PM, and many women underwent unanticipated re-operations (usually due to problems with reconstruction); however, these data need to be updated to reflect changes in surgical procedures and reconstruction. Regarding psychosocial outcomes, women generally reported satisfaction with their decisions to have PM but reported satisfaction less consistently for cosmetic outcomes, with diminished satisfaction often due to surgical complications. Therefore, physical morbidity and post-operative surgical complications were areas that should be considered when deciding about PM. With regard to emotional well-being, most women recovered well postoperatively, reporting reduced cancer worry and showing reduced psychological morbidity from their baseline measures; exceptions also have been noted. Of the psychosocial outcomes measured, body image and feelings of femininity were the most adversely affected.

Courses in complementary and alternative medicine (CAM) are increasing in medical schools in the United States and, currently, approximately two thirds of U.S. medical schools offer at least one such course. As these courses grow in popularity, however, concerns are also growing that these courses lack an evidence-based perspective. We propose that one interesting and easy way to bring an evidence-based perspective to the CAM classroom is to utilize the Cochrane Electronic Library (CLIB), which is available in many medical libraries, as a teaching tool. The CLIB currently houses more than 80 CAM-related, full-text systematic reviews and approximately 5000 CAM-related clinical trials, making it a valued resource for people who seek CAM evidence. Moreover, the CLIB commitment to publishing reviews regardless of the results make it a resource where one can find reviews concluding there is strong evidence of benefit or no evidence of benefit. In addition to the access to CAM evidence which the CLIB provides, students can learn basic critical appraisal skills by learning the rationale behind Cochrane systematic reviews. A survey of CAM course directors, however, shows that almost one half of these directors have never used the CLIB. For those who have never used the CLIB, this editorial explains the four main databases within the CLIB and presents ideas for using them in CAM school courses.

Objectives: The objectives of this paper were: a) to determine what can be learned from conclusions of systematic reviews about the evidence base of medicine; and b) to determine whether two readers draw similar conclusions from the same review, and whether these match the authors' conclusions., Methods: Three methodologists (two per review) rated 160 Cochrane systematic reviews (issue 1, 1998) using pre-established conclusion categories. Disagreements were resolved by discussion to arrive at a consensual score for each review. Reviews' authors were asked to use the same categories to designate the intended conclusion. Interrater agreements were calculated., Results: Interrater agreement between two readers was 0.68 and 0.72, and between readers and authors, 0.32. The largest categories assigned by methodologists were "positive effect" (22.5%), "insufficient evidence" (21.3%), and "evidence of no effect" (20.0%). The largest categories assigned by authors were "insufficient evidence" (32.4%), "possibly positive" (28.6%), and "positive effect" (26.7%)., Conclusions: The number of reviews indicating that the modern biomedical interventions show either no effect or insufficient evidence is surprisingly high. Interrater disagreements suggest a surprising degree of subjective interpretation involved in systematic reviews. Where patterns of disagreement emerged between authors and readers, authors tended to be more optimistic in their conclusions than the readers. Policy implications are discussed.

Objective: To assess the effectiveness of mind-body therapy (MBT) for fibromyalgia syndrome (FM) by systematically reviewing randomized/quasirandomized controlled trials using methods recommended by the Cochrane Collaboration., Methods: Nine electronic databases, 69 conference proceedings, and several citation lists were searched for relevant trials in any language. Eligible trials were scored for methodological quality using a validated instrument. Information on major outcomes was extracted. Insufficient data reporting prevented statistical pooling, therefore a best-evidence synthesis was performed., Results: Thirteen trials involving 802 subjects were included. Seven trials received a high methodological score. Compared to waiting list/treatment as usual, there is strong evidence that MBT is more effective for self-efficacy, limited evidence for quality of life, inconclusive evidence for all other outcomes. There is limited evidence that MBT is more effective than placebo (for pain and global improvement); inconclusive evidence that MBT is more effective than physiotherapy, psychotherapy, or education/attention control for all outcomes; strong evidence that moderate/high intensity exercise is more effective than MBT (for pain and function). There is moderate evidence that MBT plus exercise (MBT+E) is more effective than waiting list/treatment as usual (for self-efficacy and quality of life); limited evidence that MBT+E is more effective than education/attention control; inconclusive for other outcomes. There is inconclusive evidence for MBT+E vs other active treatments for all outcomes. Longterm within-groups results show greatest benefit for MBT+E., Conclusion: MBT is more effective for some clinical outcomes compared to waiting list/treatment as usual or placebo. Compared to active treatments, results are largely inconclusive, except for moderate/high intensity exercise, where results favor the latter. Further research needs to focus on the synergistic effects of MBT plus exercise and/or plus antidepressants.

Individuals with rheumatic disorders, particularly those with more severe, chronic conditions, are likely to be frequent users of complementary and alternative medical therapies. Although large-scale clinical trials have yet to be conducted, there is moderately strong evidence that acupuncture may be effective for treating both osteoarthritis and fibromyalgia. The utility of acupuncture in treating rheumatoid arthritis has not been demonstrated in large, randomized controlled trials. Physicians who treat patients with rheumatic conditions should become knowledgeable about the literature on both the effectiveness of acupuncture for these conditions as well as its potential to cause adverse side effects in particular patient groups.

Background: We conducted this study to assess the effectiveness of acupuncture in the treatment of fibromyalgia syndrome (FMS), report any adverse effects, and generate hypotheses for future investigation., Methods: We searched MEDLINE, EMBASE, Manual Therapy Information System, the Cochrane registry, the University of Maryland Complementary and Alternative Medicine in Pain, the Centralized Information Service for Complementary Medicine, and the National Institutes of Health Office of Alternative Medicine databases for the key words "acupuncture" and "fibromyalgia." Conference abstracts, citation lists, and letters supplemented the search. We selected all randomized or quasi-randomized controlled trials, or cohort studies of patients with FMS who were treated with acupuncture. Methodologic quality, sample characteristics, type of acupuncture treatment, and outcomes were extracted. Statistical pooling was not performed because of the differences in control groups., Results: Seven studies (3 randomized controlled trials and 4 cohort studies) were included; only one was of high methodologic quality. The high-quality study suggests that real acupuncture is more effective than sham acupuncture for relieving pain, increasing pain thresholds, improving global ratings, and reducing morning stiffness of FMS, but the duration of benefit following the acupuncture treatment series is not known. Some patients report no benefit, and a few report an exacerbation of FMS-related pain. Lower-quality studies were consistent with these findings. Booster doses of acupuncture to maintain benefit once regular treatments have stopped have been described anecdotally but not investigated in controlled trials., Conclusions: The limited amount of high-quality evidence suggests that real acupuncture is more effective than sham acupuncture for improving symptoms of patients with FMS. However, because this conclusion is based on a single high-quality study, further high-quality randomized trials are needed to provide more robust data on effectiveness.

Multielement analysis was performed on bone samples extracted from the femora of 39 adults from three mortuary sites (Johns Mound, Santa Catalina de Guale, and Santa Catalina de Guale de Santa Maria) and time periods (late preagricultural, early contact, and late contact) in the Georgia Bight. This study was used to investigate whether elemental analysis would support or contradict other lines of data regarding diets and dietary change previously generated for the region. The data are in agreement with an earlier interpretation, based on stable isotopes, that dietary maize increases through time but fails to support the idea that marine resources decreased in importance. Rather, it appears that the wild plant food component of the diets decreases as maize increases in importance; throughout the sequence, marine resources comprise a significant portion of the diets.