Meditation for the primary and secondary prevention of cardiovascular disease.

BACKGROUND: Interventions incorporating meditation to address stress, anxiety, and depression, and improve self-management, are becoming popular for many health conditions. Stress is a risk factor for cardiovascular disease (CVD) and clusters with other modifiable behavioural risk factors, such as smoking. Meditation may therefore be a useful CVD prevention strategy. OBJECTIVES: To determine the effectiveness of meditation, primarily mindfulness-based interventions (MBIs) and transcendental meditation (TM), for the primary and secondary prevention of CVD. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers on 14 November 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of 12 weeks or more in adults at high risk of CVD and those with established CVD. We explored four comparisons: MBIs versus active comparators (alternative interventions); MBIs versus non-active comparators (no intervention, wait list, usual care); TM versus active comparators; TM versus non-active comparators. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were CVD clinical events (e.g. cardiovascular mortality), blood pressure, measures of psychological distress and well-being, and adverse events. Secondary outcomes included other CVD risk factors (e.g. blood lipid levels), quality of life, and coping abilities. We used GRADE to assess the certainty of evidence. MAIN RESULTS: We included 81 RCTs (6971 participants), with most studies at unclear risk of bias. MBIs versus active comparators (29 RCTs, 2883 participants) Systolic (SBP) and diastolic (DBP) blood pressure were reported in six trials (388 participants) where heterogeneity was considerable (SBP: MD -6.08 mmHg, 95% CI -12.79 to 0.63, I2 = 88%; DBP: MD -5.18 mmHg, 95% CI -10.65 to 0.29, I2 = 91%; both outcomes based on low-certainty evidence). There was little or no effect of MBIs on anxiety (SMD -0.06 units, 95% CI -0.25 to 0.13; I2 = 0%; 9 trials, 438 participants; moderate-certainty evidence), or depression (SMD 0.08 units, 95% CI -0.08 to 0.24; I2 = 0%; 11 trials, 595 participants; moderate-certainty evidence). Perceived stress was reduced with MBIs (SMD -0.24 units, 95% CI -0.45 to -0.03; I2 = 0%; P = 0.03; 6 trials, 357 participants; moderate-certainty evidence). There was little to no effect on well-being (SMD -0.18 units, 95% CI -0.67 to 0.32; 1 trial, 63 participants; low-certainty evidence). There was little to no effect on smoking cessation (RR 1.45, 95% CI 0.78 to 2.68; I2 = 79%; 6 trials, 1087 participants; low-certainty evidence). None of the trials reported CVD clinical events or adverse events. MBIs versus non-active comparators (38 RCTs, 2905 participants) Clinical events were reported in one trial (110 participants), providing very low-certainty evidence (RR 0.94, 95% CI 0.37 to 2.42). SBP and DBP were reduced in nine trials (379 participants) but heterogeneity was substantial (SBP: MD -6.62 mmHg, 95% CI -13.15 to -0.1, I2 = 87%; DBP: MD -3.35 mmHg, 95% CI -5.86 to -0.85, I2 = 61%; both outcomes based on low-certainty evidence). There was low-certainty evidence of reductions in anxiety (SMD -0.78 units, 95% CI -1.09 to -0.41; I2 = 61%; 9 trials, 533 participants; low-certainty evidence), depression (SMD -0.66 units, 95% CI -0.91 to -0.41; I2 = 67%; 15 trials, 912 participants; low-certainty evidence) and perceived stress (SMD -0.59 units, 95% CI -0.89 to -0.29; I2 = 70%; 11 trials, 708 participants; low-certainty evidence) but heterogeneity was substantial. Well-being increased (SMD 0.5 units, 95% CI 0.09 to 0.91; I2 = 47%; 2 trials, 198 participants; moderate-certainty evidence). There was little to no effect on smoking cessation (RR 1.36, 95% CI 0.86 to 2.13; I2 = 0%; 2 trials, 453 participants; low-certainty evidence). One small study (18 participants) reported two adverse events in the MBI group, which were not regarded as serious by the study investigators (RR 5.0, 95% CI 0.27 to 91.52; low-certainty evidence). No subgroup effects were seen for SBP, DBP, anxiety, depression, or perceived stress by primary and secondary prevention. TM versus active comparators (8 RCTs, 830 participants) Clinical events were reported in one trial (201 participants) based on low-certainty evidence (RR 0.91, 95% CI 0.56 to 1.49). SBP was reduced (MD -2.33 mmHg, 95% CI -3.99 to -0.68; I2 = 2%; 8 trials, 774 participants; moderate-certainty evidence), with an uncertain effect on DBP (MD -1.15 mmHg, 95% CI -2.85 to 0.55; I2 = 53%; low-certainty evidence). There was little or no effect on anxiety (SMD 0.06 units, 95% CI -0.22 to 0.33; I2 = 0%; 3 trials, 200 participants; low-certainty evidence), depression (SMD -0.12 units, 95% CI -0.31 to 0.07; I2 = 0%; 5 trials, 421 participants; moderate-certainty evidence), or perceived stress (SMD 0.04 units, 95% CI -0.49 to 0.57; I2 = 70%; 3 trials, 194 participants; very low-certainty evidence). None of the trials reported adverse events or smoking rates. No subgroup effects were seen for SBP or DBP by primary and secondary prevention. TM versus non-active comparators (2 RCTs, 186 participants) Two trials (139 participants) reported blood pressure, where reductions were seen in SBP (MD -6.34 mmHg, 95% CI -9.86 to -2.81; I2 = 0%; low-certainty evidence) and DBP (MD -5.13 mmHg, 95% CI -9.07 to -1.19; I2 = 18%; very low-certainty evidence). One trial (112 participants) reported anxiety and depression and found reductions in both (anxiety SMD -0.71 units, 95% CI -1.09 to -0.32; depression SMD -0.48 units, 95% CI -0.86 to -0.11; low-certainty evidence). None of the trials reported CVD clinical events, adverse events, or smoking rates. AUTHORS' CONCLUSIONS: Despite the large number of studies included in the review, heterogeneity was substantial for many of the outcomes, which reduced the certainty of our findings. We attempted to address this by presenting four main comparisons of MBIs or TM versus active or inactive comparators, and by subgroup analyses according to primary or secondary prevention, where there were sufficient studies. The majority of studies were small and there was unclear risk of bias for most domains. Overall, we found very little information on the effects of meditation on CVD clinical endpoints, and limited information on blood pressure and psychological outcomes, for people at risk of or with established CVD. This is a very active area of research as shown by the large number of ongoing studies, with some having been completed at the time of writing this review. The status of all ongoing studies will be formally assessed and incorporated in further updates.

WITHDRAWN: Transcendental meditation for the primary prevention of cardiovascular disease.

BACKGROUND: A major determinant in cardiovascular disease (CVD) is stress. As transcendental meditation (TM) is thought to help in lowering negative stress indicators, it may be a beneficial strategy for the primary prevention of CVD. OBJECTIVES: To determine the effectiveness of TM for the primary prevention of CVD. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 10); MEDLINE (Ovid) (1946 to week three November 2013); EMBASE Classic and EMBASE (Ovid) (1947 to week 48 2013); ISI Web of Science (1970 to 28 November 2013); and Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment Database and Health Economics Evaluations Database (November 2013). We also searched the Allied and complementary Medicine Database (AMED) (inception to January 2014) and IndMed (inception to January 2014). We handsearched trial registers and reference lists of reviews and articles and contacted experts in the field. We applied no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of at least three months' duration involving healthy adults or adults at high risk of CVD. Trials examined TM only and the comparison group was no intervention or minimal intervention. We excluded trials that involved multi-factorial interventions. Outcomes of interest were clinical CVD events (cardiovascular mortality, all-cause mortality and non-fatal events) and major CVD risk factors (e.g. blood pressure and blood lipids, occurrence of type 2 diabetes, quality of life, adverse events and costs). DATA COLLECTION AND ANALYSIS: Two authors independently selected trials for inclusion, extracted data and assessed the risk of bias. MAIN RESULTS: We identified four trials (four papers) (430 participants) for inclusion in this review. We identified no ongoing studies. The included trials were small, short term (three months) and at risk of bias. In all studies, TM was practised for 15 to 20 minutes twice a day.None of the included studies reported all-cause mortality, cardiovascular mortality or non-fatal endpoints as trials were short term, but one study reported survival rate three years after the trial was completed. In view of the considerable statistical heterogeneity between the results of the studies for the only outcomes reported, systolic blood pressure (I2 = 72%) and diastolic blood pressure (I2 = 66%), we decided not to undertake a meta-analysis. None of the four trials reported blood lipids, occurrence of type 2 diabetes, adverse events, costs or quality of life. AUTHORS' CONCLUSIONS: Currently, there are few trials with limited outcomes examining the effectiveness of TM for the primary prevention of CVD. Due to the limited evidence to date, we could draw no conclusions as to the effectiveness of TM for the primary prevention of CVD. There was considerable heterogeneity between trials and the included studies were small, short term and at overall serious risk of bias. More and larger long-term, high-quality trials are needed.

Moxibustion for the treatment of chemotherapy-induced leukopenia: a systematic review of randomized clinical trials.

PURPOSE: The purpose of this study is to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. METHODS: Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias. RESULTS: Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts. CONCLUSIONS: There is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.

Feverfew for preventing migraine.

BACKGROUND: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews on 'Feverfew for preventing migraine' (2004, Issue 1). Feverfew (Tanacetum parthenium L.) extract is a herbal remedy, which has been used for preventing attacks of migraine. OBJECTIVES: To systematically review the evidence from double-blind randomised controlled trials (RCTs) assessing the clinical efficacy and safety of feverfew monopreparations versus placebo for preventing migraine. SEARCH METHODS: For this updated version of the review we searched CENTRAL, MEDLINE, EMBASE and AMED to January 2015. We contacted manufacturers of feverfew and checked the bibliographies of identified articles for further trials. SELECTION CRITERIA: We included randomised, placebo-controlled, double-blind trials assessing the efficacy of feverfew monopreparations for preventing migraine in patients of any age. We included trials using clinical outcome measures, while we excluded trials focusing exclusively on physiological parameters. There were no restrictions regarding the language of publication. DATA COLLECTION AND ANALYSIS: We systematically extracted data on patients, interventions, methods, outcome measures, results and adverse events. We assessed risk of bias using the Cochrane 'Risk of bias' tool and evaluated methodological quality using the Oxford Quality Scale developed by Jadad and colleagues. Two review authors (BW and MHP for this update, MHP and EE for the original version) independently selected studies, assessed methodological quality and extracted data. We resolved disagreements concerning evaluation of individual trials through discussion. MAIN RESULTS: We identified one new study for this update, resulting in six trials (561 patients) meeting the inclusion criteria. Five of the six trials reported on the main outcome, migraine frequency. Although five of the trials were generally of good methodological quality, all studies were either of unclear or high risk of bias with regards to sample size. Pooled analysis of the results was not possible due to the lack of common outcome measures and heterogeneity between studies in terms of participants, interventions and designs.The most recent trial added to this version of the review is rigorous and larger (n = 218), using a stable feverfew extract at a dose determined by a previous dose-finding trial. It reports that feverfew reduced migraine frequency by 1.9 attacks from 4.8 to 2.9 and placebo by 1.3 from to 4.8 to 3.5 per month, resulting in a difference in effect between feverfew and placebo of 0.6 attacks per month. For the secondary outcome measures intensity and duration of migraine attacks, incidence and severity of nausea and vomiting, and global assessment no statistically significant differences were reported. Results of previous trials are not convincing: three trials reporting positive effects of feverfew are all of small sample size (17 to 60 participants), while two rigorous trials (n = 50, 147) did not find significant differences between feverfew and placebo. Only mild and transient adverse events, most commonly gastrointestinal complaints and mouth ulcers, were reported in the included trials. AUTHORS' CONCLUSIONS: Since the last version of this review, one larger rigorous study has been included, reporting a difference in effect between feverfew and placebo of 0.6 attacks per month. This adds some positive evidence to the mixed and inconclusive findings of the previous review. However, this constitutes low quality evidence, which needs to be confirmed in larger rigorous trials with stable feverfew extracts and clearly defined migraine populations before firm conclusions can be drawn. It appears from the data reviewed that feverfew is not associated with any major safety concerns.

Qigong for the primary prevention of cardiovascular disease.

BACKGROUND: Two major determinants of cardiovascular disease (CVD) are a sedentary lifestyle and stress. Qigong involves physical exercise, mind regulation and breathing control to restore the flow of Qi (a pivotal life energy). As it is thought to help reduce stress and involves exercise, qigong may be an effective strategy for the primary prevention of CVD. OBJECTIVES: To determine the effectiveness of qigong for the primary prevention of CVD. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (November 2014, Issue 10 of 12); MEDLINE (Ovid) (1946 to 2014 October week 4); EMBASE Classic + EMBASE (Ovid) (1947 to 2014 November 4); Web of Science Core Collection (1970 to 31 October 2014); Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database and Health Economics Evaluations Database (November 2014, Issue 4 of 4). We searched several Asian databases (inception to July 2013) and the Allied and Complementary Medicine Database (AMED) (inception to December 2013), as well as trial registers and reference lists of reviews and articles; we also approached experts in the field and applied no language restrictions in our search. SELECTION CRITERIA: Randomised controlled trials lasting at least three months involving healthy adults or those at high risk of CVD. Trials examined any type of qigong, and comparison groups provided no intervention or minimal intervention. Outcomes of interest included clinical CVD events and major CVD risk factors. We did not include trials that involved multi-factorial lifestyle interventions or weight loss. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion. Two review authors extracted data from included studies and assessed the risk of bias. MAIN RESULTS: We identified 11 completed trials (1369 participants) and one ongoing trial. Trials were heterogeneous in participants recruited, qigong duration and length of follow-up periods. We were unable to ascertain the risk of bias in nine trials published in Chinese, as insufficient methodological details were reported and we were unable to contact the study authors to clarify this.We performed no meta-analyses, as trials were small and were at significant risk of bias. Clinical events were detailed in subsequent reports of two trials when statistically significant effects of qigong were seen for all-cause mortality, stroke mortality and stroke incidence at 20 to 30 years after completion of the trials. However, these trials were designed to examine outcomes in the short term, and it is not clear whether qigong was practised during extended periods of follow-up; therefore effects cannot be attributed to the intervention. None of the included studies reported other non-fatal CVD events.Six trials provided data that could be used to examine the effects of qigong on blood pressure. Reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were seen in three and two trials, respectively. Three trials examined the effects of qigong on blood lipids when favourable effects were seen in one trial for total cholesterol, low-density lipoprotein (LDL) cholesterol and triglycerides, and two trials showed favourable effects on high-density lipoprotein (HDL) cholesterol. The only trial considered at low risk of selection and detection bias did not demonstrate statistically significant effects on CVD risk factors with qigong, but this study was small and was underpowered. None of the included studies reported incidence of type 2 diabetes (T2D), adverse events, quality of life or costs. AUTHORS' CONCLUSIONS: Currently, very limited evidence is available on the effectiveness of qigong for the primary prevention of CVD. Most of the trials included in this review are likely to be at high risk of bias, so we have very low confidence in the validity of the results. Publication of the ongoing trial will add to the limited evidence base, but further trials of high methodological quality with sufficient sample size and follow-up are needed to be incorporated in an update of this review before the effectiveness of qigong for CVD prevention can be established.

Yoga for Heart Rate Variability: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

The objective of this systematic review is to summarize and critically assess the effects of yoga on heart rate variability (HRV). Nine databases were searched from their inceptions to June 2014. We included randomized clinical trials (RCTs) comparing yoga against any type of control intervention in healthy individuals or patients with any medical condition. Risk of bias was assessed using the Cochrane criteria. Two reviewers performed the selection of studies, data extraction, and quality assessments independent of one another. Fourteen trials met the inclusion criteria. Only two of them were of acceptable methodological quality. Ten RCTs reported favourable effects of yoga on various domains of HRV, whereas nine of them failed to do so. One RCT did not report between-group comparisons. The meta-analysis (MA) of two trials did not show favourable effects of yoga compared to usual care on E:I ratio (n = 61, SMDs = 0.63; 95% CIs [-0.72 to 1.99], p = 0.36; heterogeneity: r(2) = 0.79, χ(2) = 5.48, df = 1, (p = 0.02); I(2) = 82%). The MA also failed to show statistically significant differences between the groups regarding the 30:15 ratio (n = 61, SMDs = 0.20; 95% CIs [-0.43 to 0.84], p = 0.53; heterogeneity: r(2) = 0.07, χ(2) = 1.45, df = 1, (p = 0.23); I(2) = 31%). The data from the remaining RCTs were too heterogeneous for pooling. These results provide no convincing evidence for the effectiveness of yoga in modulating HRV in patients or healthy subjects. Future investigations in this area should overcome the multiple methodological weaknesses of the previous research.

Pyruvate supplementation for weight loss: a systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Several slimming aids being sold as food supplements are widely available. One of them is pyruvate. Its efficacy in causing weight reduction in humans has not been fully established. The objective of this systematic review was to examine the efficacy of pyruvate in reducing body weight. METHODS: Electronic and nonelectronic searches were conducted to identify all relevant human randomized clinical trials. The bibliographies of all located articles were also searched. No restrictions in language or time were applied. Two independent reviewers extracted the data according to predefined criteria. A fixed-effect model was used to calculate mean differences (MD) and 95% confidence interval (CI). RESULTS: Nine trials were identified and 6 were included. All had methodological weaknesses. The meta-analysis revealed a statistically significant difference in body weight with pyruvate compared to placebo (MD: -0.72 kg; 95% CI: -1.24 to -0.20). The magnitude of the effect is small, and its clinical relevance is uncertain. Adverse events included gas, bloating, diarrhea, and increase in low-density lipoprotein (LDL) cholesterol. CONCLUSION: The evidence from randomized clinical trials does not convincingly show that pyruvate is efficacious in reducing body weight. Limited evidence exists about the safety of pyruvate. Future trials involving the use of this supplement should be more rigorous and better reported.

The efficacy of glucomannan supplementation in overweight and obesity: a systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: The increased prevalence of obesity has resulted in the current high popularity of dietary supplements marketed as weight reducing agents. The efficacy of most of these supplements is not established. The soluble fiber, glucomannan, is often recommended for weight loss. The aim of this systematic review is to evaluate the evidence for or against the efficacy of glucomannan in body weight reduction. METHODS: Electronic searches were conducted in Medline, Embase, Amed, and The Cochrane Library. Hand searches of bibliography were also conducted. Outcomes of interest were body weight and body mass index. Studies involving only overweight and/or obese participants were included. Two reviewers independently determined the eligibility of studies and assessed the reporting quality of included randomized controlled trials (RCTs), using the CONSORT and PRISMA guidelines. RESULTS: Eighteen trials were identified, and 9 were included. There was a variation in the reporting quality of the included RCTs. A meta-analysis (random effect model) of 8 RCTs revealed a nonstatistically significant difference in weight loss between glucomannan and placebo (mean difference [MD]: -0.22 kg; 95% confidence interval [CI], -0.62, 0.19; I(2) = 65%). Adverse events included abdominal discomfort, diarrhea, and constipation. CONCLUSION: The evidence from available RCTs does not show that glucomannan intake generates statistically significant weight loss. Future trials should be more rigorous and better reported.

Transcendental meditation for the primary prevention of cardiovascular disease.

BACKGROUND: A major determinant in cardiovascular disease (CVD) is stress. As transcendental meditation (TM) is thought to help in lowering negative stress indicators, it may be a beneficial strategy for the primary prevention of CVD. OBJECTIVES: To determine the effectiveness of TM for the primary prevention of CVD. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 10); MEDLINE (Ovid) (1946 to week three November 2013); EMBASE Classic and EMBASE (Ovid) (1947 to week 48 2013); ISI Web of Science (1970 to 28 November 2013); and Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment Database and Health Economics Evaluations Database (November 2013). We also searched the Allied and complementary Medicine Database (AMED) (inception to January 2014) and IndMed (inception to January 2014). We handsearched trial registers and reference lists of reviews and articles and contacted experts in the field. We applied no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of at least three months' duration involving healthy adults or adults at high risk of CVD. Trials examined TM only and the comparison group was no intervention or minimal intervention. We excluded trials that involved multi-factorial interventions. Outcomes of interest were clinical CVD events (cardiovascular mortality, all-cause mortality and non-fatal events) and major CVD risk factors (e.g. blood pressure and blood lipids, occurrence of type 2 diabetes, quality of life, adverse events and costs). DATA COLLECTION AND ANALYSIS: Two authors independently selected trials for inclusion, extracted data and assessed the risk of bias. MAIN RESULTS: We identified four trials (four papers) (430 participants) for inclusion in this review. We identified no ongoing studies. The included trials were small, short term (three months) and at risk of bias. In all studies, TM was practised for 15 to 20 minutes twice a day.None of the included studies reported all-cause mortality, cardiovascular mortality or non-fatal endpoints as trials were short term, but one study reported survival rate three years after the trial was completed. In view of the considerable statistical heterogeneity between the results of the studies for the only outcomes reported, systolic blood pressure (I(2) = 72%) and diastolic blood pressure (I(2) = 66%), we decided not to undertake a meta-analysis. None of the four trials reported blood lipids, occurrence of type 2 diabetes, adverse events, costs or quality of life. AUTHORS' CONCLUSIONS: Currently, there are few trials with limited outcomes examining the effectiveness of TM for the primary prevention of CVD. Due to the limited evidence to date, we could draw no conclusions as to the effectiveness of TM for the primary prevention of CVD. There was considerable heterogeneity between trials and the included studies were small, short term and at overall serious risk of bias. More and larger long-term, high-quality trials are needed.

Tai chi for primary prevention of cardiovascular disease.

BACKGROUND: Stress and a sedentary lifestyle are major determinants of cardiovascular disease (CVD). As tai chi involves exercise and can help in stress reduction, it may be effective in the primary prevention of CVD. OBJECTIVES: To determine the effectiveness of tai chi for the primary prevention of CVD. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 11, 2013); MEDLINE (Ovid) (1946 to November week 3, 2013); EMBASE Classic + EMBASE (Ovid) (1947 to 6 December 2013); Web of Science (Thomson Reuters) (1970 to 6 December 2013); PsycINFO (Ovid) (1806 to December week 1, 2013); Database of Abstracts of Reviews of Effects (DARE); Health Technology Assessment Database and Health Economics Evaluations Database (Issue 4, 2013). We also searched the Allied and complementary Medicine Database (AMED) and OpenGrey (inception to October 2012) and several Asian databases. We searched trial registers and reference lists of reviews for further studies. We applied no language restrictions. SELECTION CRITERIA: Randomised controlled trials of tai chi lasting at least three months involving healthy adults or adults at high risk of CVD. The comparison group was no intervention or minimal intervention. The outcomes of interest were CVD clinical events and CVD risk factors. We excluded trials involving multifactorial lifestyle interventions or focusing on weight loss to avoid confounding. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, abstracted the data and assessed the risk of bias. MAIN RESULTS: We identified 13 small trials (1520 participants randomised) and three ongoing trials. All studies had at least one domain with unclear risk of bias, and some studies were at high risk of bias for allocation concealment (one study) and selective reporting (two studies). Duration and style of tai chi differed between trials. Seven studies recruited 903 healthy participants, the other studies recruited people with borderline hypertension or hypertension, elderly people at high risk of falling, and people with hypertension with liver and kidney yin deficiency syndrome.No studies reported on cardiovascular mortality, all-cause mortality or non-fatal events as most studies were short term (all studies had follow-up of one year or less). There was also considerable heterogeneity between studies, which meant that it was not possible to combine studies statistically for cardiovascular risk (I(2) statistic for systolic blood pressure (SBP) was 96%, for diastolic blood pressure (DBP) 96%, for total cholesterol 96%, low-density lipoprotein-cholesterol (LDL-C) 95%, high-density lipoprotein-cholesterol (HDL-C) 98%, triglycerides 75%). Nine trials measured blood pressure, six individual trials found reductions in SBP (reductions ranged from -22.0 mmHg (95% confidence interval (CI) -26.3 to -17.7) to -11.5 mmHg (95% CI -21.5 to -1.46)), two trials found no clear evidence of a difference (however, CIs were wide and an increase or decrease in SBP cannot be ruled out), and one trial found an increase in SBP with tai chi (increase 5.2 mmHg, 95% CI 3.73 to 6.67). A similar pattern was seen for DBP: three trials found a reduction in DBP (reductions ranged from -12.2 mmHg (95% CI -15.8 to -8.7) to -4.43 mmHg (95% CI -7.14 to -1.72)) and three trials found no clear evidence of a difference, however again with wide CIs. Three trials reported lipid levels and two found reductions in total cholesterol, LDL-C and triglycerides (total cholesterol reductions ranged from -1.30 mmol/L (95% CI -1.57 to -1.03) to -0.50 mmol/L (95% CI -0.74 to -0.26): LDL-C reductions ranged from -0.76 mmol/L (95% CI -0.93 to -0.59) to -0.59 mmol/L (95% CI -0.80 to -0.38): triglyceride reductions ranged from -0.46 mmol/L (95% CI -0.62 to -0.30) to -0.37 mmol/L (95% CI -0.67 to-0.07)) and increased HDL-C with the intervention (HDL-C increases ranged from 0.61 mmol/L (95% CI 0.51 to 0.71) to 0.16 mmol/L (95% CI 0.02 to 0.30)), while the third study found no clear evidence of a difference between groups on lipid levels. Quality of life was measured in one trial: tai chi improved quality of life at three months. None of the included trials reported on adverse events, costs or occurrence of type 2 diabetes. AUTHORS' CONCLUSIONS: There are currently no long-term trials examining tai chi for the primary prevention of CVD. Due to the limited evidence available currently no conclusions can be drawn as to the effectiveness of tai chi on CVD risk factors. There was some suggestion of beneficial effects of tai chi on CVD risk factors but this was not consistent across all studies. There was considerable heterogeneity between the studies included in this review and studies were small and at some risk of bias. Results of the ongoing trials will add to the evidence base but additional longer-term, high-quality trials are needed.

Acupuncture for treating acute ankle sprains in adults.

BACKGROUND: An acute ankle sprain is a sudden-onset injury of one or more of the ankle ligaments. It is one of the most common musculoskeletal injuries in the general population as well as in athletes. In some countries, such as China and Korea, acupuncture is frequently used in the treatment of ankle sprains, either as a single treatment or a secondary intervention accompanied by standard medical treatment. OBJECTIVES: To assess the effects (benefits and harms) of acupuncture for the treatment of ankle sprains in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (May 2013), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2013, Issue 4), MEDLINE (1948 to May week 2 2013), EMBASE (1980 to May week 2 2013), China National Knowledge Infrastructure databases (1994 to August week 4 2013), the Cumulative Index to Nursing and Allied Health Literature (1937 to May 2013), the Allied and Complementary Medicine Database (1985 to May 2013), Science Links Japan (1996 to August week 4 2013), several Korean medical databases (August week 4 2013), the World Health Organization International Clinical Trials Registry Platform (August week 4 2013), the bibliographic references of included trials and conference proceedings. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials involving adults with acute ankle sprains. We included all types of acupuncture practices, such as needle acupuncture, electroacupuncture, laser acupuncture, pharmacoacupuncture, non-penetrating acupuncture point stimulation (e.g. acupressure and magnets) and moxibustion. Acupuncture could be compared with control (no treatment or placebo) or another standard non-surgical intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results, assessed trial eligibility, assessed risk of bias and extracted data from the included trials. We calculated risk ratios (RRs) for dichotomous outcomes and mean differences for continuous outcomes. We conducted meta-analyses using the fixed-effect method or, where appropriate, the random-effects method, and used 95% confidence intervals (CI) throughout. MAIN RESULTS: We included a total of 20 heterogeneous studies (2012 participants with acute ankle sprains); three of which included more than one comparison. Seventeen trials were conducted in China. All of the studies had a high risk of bias due to lack of blinding. The results may also have been affected by selection bias, particularly as five studies were quasi-randomised controlled trials and 12 studies gave no information on their method of randomisation. Of our three prespecified primary outcomes, only cure rate was reported by the majority of studies. No study reported on patient-reported assessment of function and only one reported on adverse events (in which three participants receiving a control intervention experienced skin problems from over-the-counter Chinese herbal patches). The other 19 studies did not record or report on adverse events. We assessed the quality of evidence for cure rates as very low for all comparisons, which means we are very uncertain about the reliability of any of the estimates.The single study comparing acupuncture treatment with no treatment found acupuncture to be more effective with regard to cure rate at five days (31/31 versus 1/30; RR 20.34, 95% CI 4.27 to 96.68). Acupuncture plus another standard treatment versus that standard treatment alone was tested in eight studies; with cure rate data available for seven. Most of these studies reported higher cure rates in the acupuncture plus another standard treatment group than in the standard treatment alone group. However, while the results of an exploratory meta-analysis of cure rate data from eight trials testing acupuncture versus no acupuncture tended to favour acupuncture, the results were very inconsistent across the studies and the estimated effect was very imprecise (383/396 versus 272/355; RR 1.32, 95% CI 0.95 to 1.84; P value = 0.1; I(2) = 98%).Fourteen studies compared acupuncture with a variety of other non-surgical treatments, such as Chinese drug patches, hot and cold water, ice packs, oral Chinese herbal medicine and elastic bandage. Some studies found in favour of acupuncture, some in favour of the other treatment and some found a lack of evidence for a difference between the two interventions under test. The results of an exploratory meta-analysis of cure rate data from 11 trials testing acupuncture versus another non-surgical intervention tended to slightly favour acupuncture, but these were not statistically significant and the data were very heterogeneous (404/509 versus 416/497; RR 1.07, 95% CI 0.94 to 1.22; P value = 0.30; I(2) = 92%). AUTHORS' CONCLUSIONS: The currently available evidence from a very heterogeneous group of randomised and quasi-randomised controlled trials evaluating the effects of acupuncture for the treatment of acute ankle sprains does not provide reliable support for either the effectiveness or safety of acupuncture treatments, alone or in combination with other non-surgical interventions; or in comparison with other non-surgical interventions. Future rigorous randomised clinical trials with larger sample sizes will be necessary to establish robust clinical evidence concerning the effectiveness and safety of acupuncture treatment for acute ankle sprains.

Yoga for the primary prevention of cardiovascular disease.

BACKGROUND: A sedentary lifestyle and stress are major risk factors for cardiovascular disease (CVD). Since yoga involves exercise and is thought to help in stress reduction it may be an effective strategy in the primary prevention of CVD. OBJECTIVES: To determine the effect of any type of yoga on the primary prevention of CVD. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 11) in The Cochrane Library; MEDLINE (Ovid) (1946 to November Week 3 2013); EMBASE Classic + EMBASE (Ovid) (1947 to 2013 Week 48); Web of Science (Thomson Reuters) (1970 to 4 December 2013); Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database and Health Economics Evaluations Database (Issue 4 of 4, 2013) in The Cochrane Library. We also searched a number of Asian databases and the Allied and Complementary Medicine Database (AMED) (inception to December 2012). We searched trial registers and reference lists of reviews and articles, and approached experts in the field. We applied no language restrictions. SELECTION CRITERIA: Randomised controlled trials lasting at least three months involving healthy adults or those at high risk of CVD. Trials examined any type of yoga and the comparison group was no intervention or minimal intervention. Outcomes of interest were clinical CVD events and major CVD risk factors. We did not include any trials that involved multifactorial lifestyle interventions or weight loss. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials for inclusion, extracted data and assessed the risk of bias. MAIN RESULTS: We identified 11 trials (800 participants) and two ongoing studies. Style and duration of yoga differed between trials. Half of the participants recruited to the studies were at high risk of CVD. Most of studies were at risk of performance bias, with inadequate details reported in many of them to judge the risk of selection bias.No study reported cardiovascular mortality, all-cause mortality or non-fatal events, and most studies were small and short-term. There was substantial heterogeneity between studies making it impossible to combine studies statistically for systolic blood pressure and total cholesterol. Yoga was found to produce reductions in diastolic blood pressure (mean difference (MD) -2.90 mmHg, 95% confidence interval (CI) -4.52 to -1.28), which was stable on sensitivity analysis, triglycerides (MD -0.27 mmol/l, 95% CI -0.44 to -0.11) and high-density lipoprotein (HDL) cholesterol (MD 0.08 mmol/l, 95% CI 0.02 to 0.14). However, the contributing studies were small, short-term and at unclear or high risk of bias. There was no clear evidence of a difference between groups for low-density lipoprotein (LDL) cholesterol (MD -0.09 mmol/l, 95% CI -0.48 to 0.30), although there was moderate statistical heterogeneity. Adverse events, occurrence of type 2 diabetes and costs were not reported in any of the included studies. Quality of life was measured in three trials but the results were inconclusive. AUTHORS' CONCLUSIONS: The limited evidence comes from small, short-term, low-quality studies. There is some evidence that yoga has favourable effects on diastolic blood pressure, HDL cholesterol and triglycerides, and uncertain effects on LDL cholesterol. These results should be considered as exploratory and interpreted with caution.

Is Craniosacral Therapy Effective? A Systematic Review and Meta-Analysis.

OBJECTIVES: The aim of this study was to evaluate the clinical effectiveness of craniosacral therapy (CST) in the management of any conditions. METHODS: Two independent reviewers searched the PubMed, Physiotherapy Evidence Database, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases in August 2023, and extracted data from randomized controlled trials (RCT) evaluating the clinical effectiveness of CST. The PEDro scale and Cochrane Risk of Bias 2 tool were used to assess the potential risk of bias in the included studies. The certainty of the evidence of each outcome variable was determined using GRADEpro. Quantitative synthesis was carried out with RevMan 5.4 software using random effect models. DATA SYNTHESIS: Fifteen RCTs were included in the qualitative and seven in the quantitative synthesis. For musculoskeletal disorders, the qualitative and quantitative synthesis suggested that CST produces no statistically significant or clinically relevant changes in pain and/or disability/impact in patients with headache disorders, neck pain, low back pain, pelvic girdle pain, or fibromyalgia. For non-musculoskeletal disorders, the qualitative and quantitative synthesis showed that CST was not effective for managing infant colic, preterm infants, cerebral palsy, or visual function deficits. CONCLUSIONS: The qualitative and quantitative synthesis of the evidence suggest that CST produces no benefits in any of the musculoskeletal or non-musculoskeletal conditions assessed. Two RCTs suggested statistically significant benefits of CST in children. However, both studies are seriously flawed, and their findings are thus likely to be false positive.

Adverse events attributed to traditional Korean medical practices: 1999-2010.

OBJECTIVE: To investigate adverse events attributed to traditional medical treatments in the Republic of Korea. METHODS: Adverse events recorded in the Republic of Korea between 1999 and 2010 - by the Food and Drug Administration, the Consumer Agency or the Association of Traditional Korean Medicine - were reviewed. Records of adverse events attributed to the use of traditional medical practices, including reports of medicinal accidents and consumers' complaints, were investigated. FINDINGS: Overall, 9624 records of adverse events attributed to traditional medical practices - including 522 linked to herbal treatments - were identified. Liver problems were the most frequently reported adverse events. Only eight of the adverse events were recorded by the pharmacovigilance system run by the Food and Drug Administration. Of the 9624 events, 1389 - mostly infections, cases of pneumothorax and burns - were linked to physical therapy (n = 285) or acupuncture/moxibustion (n = 1104). CONCLUSION: In the Republic of Korea, traditional medical practices often appear to have adverse effects, yet almost all of the adverse events attributed to such practices between 1999 and 2010 were missed by the national pharmacovigilance system. The Consumer Agency and the Association of Traditional Korean Medicine should be included in the national pharmacovigilance system.

Herb-drug interactions: an overview of systematic reviews.

OBJECTIVES: The aim of this overview of systematic reviews (SRs) is to evaluate critically the evidence regarding interactions between herbal medicinal products (HMPs) and synthetic drugs. METHODS: Four electronic databases were searched to identify relevant SRs. RESULTS: Forty-six SRs of 46 different HMPs met our inclusion criteria. The vast majority of SRs were of poor methodological quality. The majority of these HMPs were not associated with severe herb-drug interactions. Serious herb-drug interactions were noted for Hypericum perforatum and Viscum album. The most severe interactions resulted in transplant rejection, delayed emergence from anaesthesia, cardiovascular collapse, renal and liver toxicity, cardiotoxicity, bradycardia, hypovolaemic shock, inflammatory reactions with organ fibrosis and death. Moderately severe interactions were noted for Ginkgo biloba, Panax ginseng, Piper methysticum, Serenoa repens and Camellia sinensis. The most commonly interacting drugs were antiplatelet agents and anticoagulants. CONCLUSION: The majority of the HMPs evaluated in SRs were not associated with drug interactions with serious consequences. However, the poor quality and the scarcity of the primary data prevent firm conclusions.

Contamination and adulteration of herbal medicinal products (HMPs): an overview of systematic reviews.

PURPOSE: The aim of this overview of systematic reviews is to summarise and critically evaluate the evidence from systematic reviews of the adulteration and contamination of herbal medicinal products (HMPs). METHODS: Five electronic databases were searched to identify all relevant systematic reviews. RESULTS: Twenty-six systematic reviews met our inclusion criteria. The most commonly HMPs were adulterated or contaminated with dust, pollens, insects, rodents, parasites, microbes, fungi, mould, toxins, pesticides, toxic heavy metals and/or prescription drugs. The most severe adverse effects caused by these adulterations were agranulocytosis, meningitis, multi-organ failure, perinatal stroke, arsenic, lead or mercury poisoning, malignancies or carcinomas, hepatic encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral edema, coma, intracerebral haemorrhage, and death. Adulteration and contamination of HMPs were most commonly noted for traditional Indian and Chinese remedies, respectively. CONCLUSIONS: Collectively these data suggest that there are reasons for concerns with regards to the quality of HMPs. Adulteration and contamination of HMPs can cause serious adverse effects. More stringent quality control and its enforcement seem to be necessary to avoid health risks.

Acupuncture for cancer-related fatigue: a systematic review of randomized clinical trials.

PURPOSE: Managing cancer-related fatigue (CRF) is an important element of the palliative care of cancer patients. The aim of this systematic review was to critically evaluate the effectiveness of acupuncture (AT) or electroacupuncture (EA) for CRF. METHODS: Fourteen databases were searched from their respective inception to November 2012. Randomized clinical trials (RCTs) of AT or EA for the treatment of CRF were considered for inclusion. The risk of bias/methodological quality was assessed using the method suggested by the Cochrane Collaboration. RESULTS: Seven RCTs met the eligibility criteria. Most were small pilot studies with serious methodological flaws. Four of the RCTs showed effectiveness of AT or AT in addition to usual care (UC) over sham AT, UC, enhanced UC, or no intervention for alleviating CRF. Three RCTs showed no effect of AT/EA over sham treatment. CONCLUSION: Overall, the quantity and quality of RCTs included in the analysis were too low to draw meaningful conclusions. Even in the positive trials, it remained unclear whether the observed outcome was due to specific effects of AT/EA or nonspecific effects of care. Further research is required to investigate whether AT/EA demonstrates specific effects on CRF.

Artichoke leaf extract for treating hypercholesterolaemia.

BACKGROUND: Hypercholesterolaemia is directly associated with an increased risk for coronary heart disease and other sequelae of atherosclerosis. Artichoke leaf extract (ALE) has been implicated in lowering cholesterol levels. Whether ALE is truly effective for this indication is still a matter of debate. This is an update of a review first published in 2002 and last updated in 2009. OBJECTIVES: To assess the efficacy and safety of ALE in the treatment of hypercholesterolaemia., SEARCH METHODS: We updated searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) (2012, Issue 5); MEDLINE Ovid (1966 to May Week 2, 2012); EMBASE Ovid (1980 to 2012 Week 19); and CINAHL Ebsco (1982 to May 2012) on 17 May 2012. CISCOM was last searched until June 2001, and AMED until June 2008. We checked reference lists of articles, and contacted manufacturers of preparations containing artichoke extract, and experts on the subject. No language restrictions were applied. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of ALE mono-preparations compared with placebo or reference medication for patients with hypercholesterolaemia. We excluded trials assessing ALE as one of several active components in a combination preparation or as a part of a combination treatment. DATA COLLECTION AND ANALYSIS: Data were extracted systematically and risk of bias was evaluated using the Cochrane 'Risk of bias' tool. Two authors independently performed the screening of studies, selection, data extraction and assessment of risk of bias. Disagreements in the evaluation of individual trials were resolved through discussion. MAIN RESULTS: We included three RCTs involving 262 participants. The trials were of adequate methodological quality but had some shortcomings. One trial was at low quality of risk, one at medium and one of unclear risk of bias. One trial is available as abstract only and includes a small sample. In the first trial the total cholesterol level in participants receiving ALE decreased by 4.2% from 7.16 (0.62) mmol/L to 6.86 (0.68) mmol/L after 12 weeks, and increased from 6.90 (0.49) mmol/L to 7.04 (0.61) mmol/L in patients receiving placebo, the total difference being statistically significant (P = 0.025). In the second trial ALE reduced total cholesterol levels by 18.5% from 7.74 mmol/L to 6.31 mmol/L after 42 ± 3 days of treatment, whereas placebo reduced cholesterol by 8.6% from 7.69 mmol/L to 7.03 mmol/L (P = 0.00001). The third trial, which is available as abstract only and provides limited data, stated that ALE significantly reduced blood cholesterol compared with placebo in a subgroup of patients with baseline total cholesterol levels of more than 230 mg/dL (P < 0.05). Trial reports indicate mild, transient and infrequent adverse events. AUTHORS' CONCLUSIONS: Data from three clinical trials assessing ALE for treating hypercholesterolaemia are available. Athough the trials are of adequate methodological quality they have some shortcomings and one is available as abstract only. There is an indication that ALE has potential in lowering cholesterol levels, but the evidence is, as yet, not convincing. The limited data on safety suggest only mild, transient and infrequent adverse events with the short term use of ALE.