Determining the safety and effectiveness of Tai Chi: a critical overview of 210 systematic reviews of controlled clinical trials.

BACKGROUND: This overview summarizes the best available systematic review (SR) evidence on the health effects of Tai Chi. METHODS: Nine databases (PubMed, Cochrane Library, EMBASE, Medline, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Sino-Med, and Wanfang Database) were searched for SRs of controlled clinical trials of Tai Chi interventions published between Jan 2010 and Dec 2020 in any language. Effect estimates were extracted from the most recent, comprehensive, highest-quality SR for each population, condition, and outcome. SR quality was appraised with AMSTAR 2 and overall certainty of effect estimates with the GRADE method. RESULTS: Of the 210 included SRs, 193 only included randomized controlled trials, one only included non-randomized studies of interventions, and 16 included both. Common conditions were neurological (18.6%), falls/balance (14.7%), cardiovascular (14.7%), musculoskeletal (11.0%), cancer (7.1%), and diabetes mellitus (6.7%). Except for stroke, no evidence for disease prevention was found; however, multiple proxy-outcomes/risks factors were evaluated. One hundred and fourteen effect estimates were extracted from 37 SRs (2 high, 6 moderate, 18 low, and 11 critically low quality), representing 59,306 adults. Compared to active and/or inactive controls, 66 of the 114 effect estimates reported clinically important benefits from Tai Chi, 53 reported an equivalent or marginal benefit, and 6 an equivalent risk of adverse events. Eight of the 114 effect estimates (7.0%) were rated as high, 43 (37.7%) moderate, 36 (31.6%) low, and 27 (23.7%) very low certainty evidence due to concerns with risk of bias (92/114, 80.7%), imprecision (43/114, 37.7%), inconsistency (37/114, 32.5%), and publication bias (3/114, 2.6%). SR quality was often limited by the search strategies, language bias, inadequate consideration of clinical, methodological, and statistical heterogeneity, poor reporting standards, and/or no registered SR protocol. CONCLUSIONS: The findings suggest Tai Chi has multidimensional effects, including physical, psychological and quality of life benefits for a wide range of conditions, as well as multimorbidity. Clinically important benefits were most consistently reported for Parkinson's disease, falls risk, knee osteoarthritis, low back pain, cerebrovascular, and cardiovascular diseases including hypertension. For most conditions, higher-quality SRs with rigorous primary studies are required. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021225708.

Chinese herbal injections versus intrapleural cisplatin for lung cancer patients with malignant pleural effusion: A Bayesian network meta-analysis of randomized controlled trials.

Background: Malignant pleural effusion (MPE) is a common complication in patients with advanced lung cancer that can severely compromise the quality of life and limit life expectancy. Randomized controlled trials (RCTs) have shown that Chinese herbal injections (CHIs) may be beneficial in improving quality of life. This network meta-analysis (NMA) aims to explore several CHIs used for lung cancer patients with MPE. Methods: Seven databases were systematically searched for eligible RCTs from inception to November 2021. The primary outcome was the clinical effective rate. Secondary outcomes were the improvement rate of Karnofsky performance status (KPS) score and incidence of adverse events (AEs). The Cochrane risk of bias 2 tool was used to assess the quality of included studies. Data analysis was performed using STATA 16.0 and R software 4.1.0. Both pairwise meta-analysis and Bayesian NMA were conducted. Competing interventions were ranked using the surface under the cumulative ranking (SUCRA) probabilities. Evidence grading was evaluated using the Confidence in Network Meta-Analysis online software (https://cinema.ispm.unibe.ch/). Results: A total of 44 studies involving 2,573 patients were included. The combined Huachansu injection (HCS) with intrapleural cisplatin (cis-diamminedichloro-platinum, DDP) had the highest probability of improving the clinical effective rate (SUCRA, 84.33%). The Kangai injection (KA) combined with DDP had the most improvement rate of KPS score (SUCRA, 80.82%), while the Fufangkushen injection (FFKS) alone was more likely to reduce AEs including gastrointestinal reactions (SUCRA, 89.92%), leukopenia (SUCRA, 91.85%), and chest pain (SUCRA, 98.17%). FFKS combined with DDP ranked the best in reducing the incidence of fever (SUCRA, 75.45%). Conclusions: Our NMA showed that CHIs alone or combined with DDP could improve clinical effectiveness and quality of life and reduce AEs, compared to DDP alone. HSC and KA, combined with DDP, may be the most effective considering clinical effective rate and improvement of KPS score, respectively. FFKS, either used alone or in combination therapy with DDP, may be the best in reducing AEs. However, high-quality RCTs with larger sample sizes are needed to further support the evidence. Systematic review registration: PROSPERO https://www.crd.york.ac.uk/prospero/, identifier CRD42021285275.

Tai Chi for health and well-being: A bibliometric analysis of published clinical studies between 2010 and 2020.

The objective of this bibliometric review was to identify the volume, breadth, and characteristics of clinical studies evaluating Tai Chi published between January 2010 and January 2020. Five English and four Chinese language databases were searched. Following independent screening, 1018 eligible publications representing 987 studies were identified, which was a three-fold increase from the previous decade. Most common were randomized controlled trials (548/987, 55.5 %), followed by systematic reviews (157/987, 15.9 %), non-randomized controlled clinical studies (152/987, 15.4 %), case series (127/987, 12.9 %) and case reports (3/987, 0.3 %) that were conducted in China (730/987, 74.0 %), followed by the United States of America (123/987, 12.5 %) and South Korea (20/987, 2.0 %). Study participants were mostly in the adult (55.2 %) and/or older adult (72.0 %) age groups. The top ten diseases/conditions were hypertension, chronic obstructive pulmonary disease, diabetes, knee osteoarthritis, heart failure, depression, osteoporosis/osteopenia, breast cancer, coronary heart disease and insomnia. A quarter of the studies enrolled healthy participants to evaluate the effects of Tai Chi on health promotion/preservation, balance/falls, and physiological/biomechanical outcomes. Yang style Tai Chi was the most popular, followed by Chen and Sun style. Tai Chi was mostly commonly delivered face-to-face by a Tai Chi instructor in group settings for 60 min, three times a week, for 12 weeks. Most studies (93.8 %) reported at least one outcome in favor of Tai Chi. Adverse events were underreported (7.2 %). Over half fell short of expected intervention reporting standards, signalling the need for Tai Chi extensions to existing guidelines.

The effect of e-cigarettes on smoking cessation and cigarette smoking initiation: An evidence-based rapid review and meta-analysis.

INTRODUCTION: The contribution made by e-cigarettes to smoking cessation continues to be controversial. Reports suggest that teenagers are becoming increasingly addicted to e-cigarettes and that e-cigarette use in adolescents is associated with subsequent cigarette smoking. METHODS: Systematic searches of eleven databases were conducted (January 2015 to June 2020). Systematic reviews, randomized controlled trials (RCTs) and cohort studies comparing e-cigarettes with placebo e-cigarettes, nicotine replacement therapy (NRT) or no e-cigarette use were included. The two primary outcomes were smoking cessation among smokers and smoking initiation among non-smoking teenagers. The secondary outcome was adverse events. Data were synthesized using risk ratio (RR) or adjusted odds ratio (AOR) with 95% confidence interval (CI). RESULTS: Six systematic reviews, 5 RCTs and 24 cohort studies were identified. For smoking cessation, findings from 4 systematic reviews indicated that e-cigarettes contributed to cessation while one found the opposite. Meta-analysis of 5 RCTs suggested that e-cigarettes were superior to NRT or placebo for smoking cessation (RR=1.55; 95% CI: 1.00-2.40; I2=57.6%; low certainty; 5 trials, n=4025). Evidence from 9 cohort studies showed that e-cigarette use was not associated with cessation (AOR=1.16; 95% CI: 0.88-1.54; I2=69.0%; n=22220). Subgroup analysis suggested that intensive e-cigarette use may be associated with cessation. In terms of smoking initiation, adolescents who ever used e-cigarettes had a greater risk for smoking initiation than non-users (AOR=2.91; 95% CI: 2.61-3.23; I2=61.0%; 15 trials, n=68943), the findings were consistent with one included systematic review. No serious adverse events were reported in the included studies. CONCLUSIONS: Low certainty evidence suggests that e-cigarettes appear to be potentially effective for smoking cessation. The use of e-cigarettes in adolescents may be associated with smoking initiation. No serious adverse events were reported.

Beneficial and harmful effects of sacubitril/valsartan in patients with heart failure: a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

Current guidelines recommend angiotensin receptor blocker neprilysin inhibitors (ARNI) (sacubitril/valsartan) as a replacement for angiotensin-converting-enzymeinhibitor (ACE-I) in heart failure with reduced ejection fraction (HFrEF) who remain symptomatic despite optimal medical therapy. The effects of ARNIs have not previously been assessed in a systematic review. We searched for relevant trials until October 2019 in CENTRAL, MEDLINE, Embase, LILACS, BIOSIS, CNKI, VIP, WanFang and CBM. Our primary outcomes were all-cause mortality and serious adverse events. We systematically assessed the risks of random errors and systematic errors. PROSPERO registration: CRD42019129336. 48 trials randomising 19 086 participants were included. The ARNI assessed in all trials was sacubitril/valsartan. ACE-I or ARB were used as control interventions. Trials randomising HFrEF participants (27 trials) and heart failure with preserved ejection fraction (HFpEF) participants (four trials) were analysed separately. In HFrEF participants, meta-analyses and Trial Sequential Analyses showed evidence of a beneficial effect of sacubitril/valsartan when assessing all-cause mortality (risk ratio (RR), 0.86; 95% CI, 0.79 to 0.94) and serious adverse events (RR, 0.89; 95% CI, 0.86 to 0.93); and the results did not differ between the guideline recommended target population and HFrEF participants in general. We found no evidence of an effect of sacubitril/valsartan in HFpEF participants. Sacubitril/valsartan compared with either ACE-I or ARB seems to have a beneficial effect in patients with HFrEF. Our results indicate that sacubitril/valsartan might be beneficial in a wider population of patients with heart failure than the guideline recommended target population. Sacubitril/valsartan does not seem to show evidence of a difference compared with valsartan in patients with HFpEF.

A systematic review of Tuina for irritable bowel syndrome: Recommendations for future trials.

OBJECTIVES: This systematic review assessed whether Tuina (therapeutic massage) is more effective and safer than no treatment or routine medical treatment for irritable bowel syndrome (IBS). METHODS: Eleven databases were searched for randomized controlled trials of IBS diagnosed based on Manning or Rome criteria. Tuina with or without routine treatments (RTs) was tested against RTs. The Cochrane risk of bias was evaluated for each trial. RevMan 5.3 was used to conduct a meta-analysis. RESULTS: A total of 8 trials (5 IBS-diarrhea and 3 IBS-constipation) with 545 participants using 8 different manipulations were included. All trials were published in Chinese. For overall symptom improving rate (> 30 % improvement in overall symptom scores), it had not been shown that Tuina was significantly better than RTs (RR 1.23, 95 % CI 0.94-1.60, 197 participants, 3 studies, I2 = 65 %) for IBS-diarrhea, and Tuina combined with RTs showed more benefit than RTs alone (RR 1.29, 95 % CI 1.08-1.54, 115 participants, 3 studies) for IBS-diarrhea. All trials did not report adverse effect in relation to Tuina. Risk of bias was generally unclear across all domains. CONCLUSIONS: Tuina combined with RTs may be superior to RTs for improving overall symptom of IBS-diarrhea. Due to the existing methodological issues and the heterogeneity of Tuina manipulation, current findings need to be confirmed in large scale, multicenter, and robust randomized trials (especially on outcome assessing blinding and allocation concealment).

Relationship between caffeine intake and infertility: a systematic review of controlled clinical studies.

BACKGROUND: For a long time, the relationship between caffeine consumption and infertility in the general population is unclear, this study is aimed to systematically review the evidence from any type of controlled clinical studies to explore whether caffeine intake is a risk factor for human infertility. METHODS: Seven databases were searched from inception to May 2019. We included women/men without a history of infertility but were willing to have children in prospective studies and women/men who were diagnosed with infertility in retrospective studies. The observed exposure factor should be caffeine or caffeine containing beverage. Diagnosis of infertility or not for participants was the key outcome. The Newcastle-Ottawa scale (NOS) or Cochrane risk of bias tool were used to assess the methodological quality of included studies. Meta-analysis was conducted if there were acceptable clinical and statistical heterogeneity among studies. The GRADE method was used to assess the certainty of the evidence. RESULTS: Four studies (one cohort study and three case-control studies) involving 12,912 participants were included. According NOS, the average score of case-control studies was 6, and the cohort study achieved 9. Meta-analysis and subgroup analysis were conducted. The results showed that low (OR 0.95, 95%CI 0.78-1.16), medium (OR 1.14, 95%CI 0.69-1.86) and high doses (OR 1.86, 95%CI 0.28-12.22) of caffeine intake may not increase the risk of infertility. The quality of the current evidence bodies were all low. CONCLUSION: Our study provides low quality evidence that regardless of low, medium and high doses of caffeine intake do not appear increase the risk of infertility. But the conclusion should be treated with caution.

The Potential Effects and Use of Chinese Herbal Medicine Pine Pollen (Pinus pollen): A Bibliometric Analysis of Pharmacological and Clinical Studies.

The objectives of this study are to conduct a comprehensive literature search and bibliometric analysis to identify the breadth and volume of pharmacological and clinical studies on pine pollen (Pinus pollen) and to identify the potential effects and the use of pine pollen. Three Chinese electronic databases and two English electronic databases were searched for pharmacological and clinical studies on pine pollen. Data were extracted and analyzed and included publication year, authors, study type, pharmacological research topics or clinical diseases/conditions, usage and type of preparation, authors' conclusions, and adverse effects. Of 239 publications identified, 180 were pharmacological studies, 37 were clinical trials, and 22 were reviews. Numbers of publications increased particularly from 2004 onward. The top 10 most frequent topics in pharmacological studies were immune regulation, antisenility, antioxidation, liver protection, inhibiting prostate hyperplasia, inhibiting tumor cell proliferation, lowering blood glucose, lowering blood lipids, antifatigue, and improving intestinal function. The top 10 most frequent clinical diseases treated or where pine pollen was used as an adjuvant were bedsores, diaper dermatitis, hyperlipidemia, oral mucositis, eczema, hyperplasia of prostate, hypertension, prostatitis, type 2 diabetes mellitus, and radiodermatitis. Eight trials reported no adverse events associated with pine pollen, one reported mild gastrointestinal reactions, but symptoms disappeared without special management. There have been an increasing number of publications on pine pollen during the past 20 years. Pharmacological studies have shown many potential benefits, and clinical studies have indicated some positive effects when it is either used as a single herb or as an adjuvant to treat disease. Its use as a topical agent, especially for skin diseases, was notable.

Bioequivalence of nifedipine softgel and capsule in healthy Chinese volunteers by liquid chromatography-mass spectrometry.

The study aimed to compare and evaluate the bioequivalence of Calcigard-10 softgel and Adalat 10 capsule in healthy Chinese volunteers in a randomized, two-way cross over study design with a washout period of 7 days. A sensitive and reproducible electro-spray ionization liquid chromatography-mass spectrometry (ESI-LCMS) assay was developed and validated to determine nifedipine in human plasma using nitrendipine as internal standard. Nifedipine and nitrendipine were extracted from plasma using liquid-liquid extraction with methylene chloride as extraction solvent. The separation was performed by a Diamonsil ODS column (150 x 4.6 mm, 5 microm). The mobile phase was consisted of acetonitrile-5 mM ammonium acetate (52:48, v/v), delivered at flow rate of 1 mL/min. The 90% confidence intervals for the ratio values of logarithmic transformed Cmax and AUC were calculated to evaluate the bioequivalence of two preparations. The values of Cmax (92.3-112.7%), AUC0-t (84.5-95.1%) and AUC0-inf (84.4-95.5%) are within the interval criterion of 70-143% for Cmax and 80-125% for AUC. The Calcigard-10 softgel and Adalat 10 capsule are bioequivalent.