Effects and mechanisms of Tai Chi on mild cognitive impairment and early-stage dementia: a scoping review.

BACKGROUND: Dementia is associated with cognitive and functional decline that significantly impacts quality of life. There is currently no cure for dementia, thus, it is important to manage dementia in the early stages and delay deterioration. Previous studies have documented a range of health benefits of Tai Chi in people with early-stage dementia, however, none have systematically integrated these effects with their underlying mechanisms. The aims of this study were to (1) identify the neurocognitive, psychological, and physical health benefits of Tai Chi oi people with early-stage dementia, and (2) explore the underlying mechanisms of these effects. METHODS: We searched systematic reviews (SRs) and randomised control trials (RCTs) on Tai Chi for adults aged 50 years and older with mild cognitive impairment (MCI) or early-stage dementia in MEDLINE, PubMed, Cochrane Library, EMBASE, and major Chinese databases. No language or publication restrictions were applied. Risk of bias was assessed. RESULTS: Eight SRs with meta-analyses and 6 additional published RCTs revealed inconsistent findings of Tai Chi on improving global cognitive function, attention and executive function, memory and language, and perceptual-motor function. There was no significant between-group difference in depressive symptoms. The results from the RCTs showed that Tai Chi can reduce arthritis pain and slow the progress of dementia. No studies on MCI or early-stage dementia investigating the underlying mechanisms of Tai Chi were identified. Instead, nine mechanistic studies on healthy adults were included. These suggested that Tai Chi may improve memory and cognition via increased regional brain activity, large-scale network functional connectivity, and regional grey matter volume. CONCLUSION: The effects of Tai Chi on neurocognitive outcomes in people with MCI and early-stage dementia are still inconclusive. Further high-quality clinical trials and mechanistic studies are needed to understand if and how Tai Chi may be applied as a successful intervention to delay deterioration and improve the quality of life in people with an increased risk of cognitive decline.

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.

Factors associated with secondary immune thrombocytopenia in patients with primary Sjögren's syndrome: a retrospective study of 639 cases.

OBJECTIVES: To investigate the clinical characteristics and relevant factors of secondary immune thrombocytopenia (ITP) in patients with primary Sjögren's syndrome (pSS). METHODS: Patients with pSS being treated between 2013 and 2020 in China-Japan Friendship Hospital were retrospectively analysed. Clinical characteristics were compared between pSS patients with and without secondary ITP. Logistic regression analysis was performed to identify factors associated with secondary ITP in patients with pSS. RESULTS: 639 patients with pSS were included in this study, among which 566 (88.6%) were women. The prevalence of secondary ITP in patients with pSS were 12.4%. Among pSS patients with secondary ITP, 55.7% had mucocutaneous bleeding and 8.9% experienced visceral bleeding. Lymphopenia (OR=3.154, 95% CI 1.185-8.395, p=0.021), anaemia (OR=2.416, 95% CI 1.250-4.668, p=0.009), low C4 (OR=2.904, 95% CI 1.563-5.394, p=0.001), and positive anti-RNP (OR=2.777, 95% CI 1.070-7.202, p=0.036) were significantly related to secondary ITP, while interstitial lung disease (ILD, OR=0.429, 95% CI 0.203-0.907, p=0.027), ANA ≥1:320 (OR=0.469, 95% CI 0.221-0.996, p=0.049) and positive anti-SSB (OR=0.288, 95% CI 0.126-0.685, p=0.003) were negatively associated with secondary ITP in patients with pSS. CONCLUSIONS: Over 10% of patients with pSS had secondary ITP, among whom visceral bleeding was comparatively rare. Lymphopenia and anaemia were positively related to secondary ITP, while ILD was negatively associated with secondary ITP. Low C4 and positive anti-RNP seem to be two potential risk factors for secondary ITP in patients with pSS, while ANA ≥1:320 and positive anti-SSB may be two potential protective factors.

Chinese patent medicine Aidi injection for cancer care: An overview of systematic reviews and meta-analyses.

ETHNOPHARMACOLOGICAL RELEVANCE: Aidi injection is one of the China Food and Drug Administration approved Chinese herbal injections and the most competitive product in cancer care in China. It is composed of the extracts from Mylabris Phalerata, Astragalus Membranaceus, Panax Ginseng, and Acanthopanax Senticosus. AIM OF THE STUDY: This overview aims to map systematic reviews (SRs) of Aidi injection for cancer and provide a summarized evidence for clinical practice and decision making. MATERIALS AND METHODS: Seven databases were searched for SRs and/or meta-analyses of randomized controlled trials on Aidi injection for cancer care until December 2020. Six authors worked in pairs independently identified studies, collected data, and assessed the quality of included studies according to the revised Assessment of Multiple Systematic Reviews (AMSTAR 2) and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). A narrative synthesis was used for the evidence mapping. RESULTS: Fifty-two SRs on Aidi injection as adjuvant therapy were included, involving lung cancer (20 SRs), liver cancer (10), colorectal cancer (7), gastric cancer (6), lymphoma (2), breast cancer (2), esophageal cancer (1), ovary cancer (1), and a mix of different cancers (4). Except for one SR focusing on Aidi injection used alone, other SRs evaluated Aidi injection in combination with chemotherapy (43), radiotherapy (4), or chemo/radiology/targeting therapy (4). Aidi injection showed additional beneficial effects on survival (9), objective response rate (44), quality of life (42), and the reduction of side-effects from chemo/radiotherapy (48). Using AMSTAR 2 tool, two reviews were assessed as low and the rest as critically low methodological quality mainly due to the lack of prospective registration. The reporting quality was insufficient assessed with PRISMA in the reporting of search strategy (26, 50.0%), additional analysis (19, 36.5%), and the summary of evidence (2, 3.8%). CONCLUSION: Aidi injection has been evaluated for its adjuvant beneficial effects on cancer survival, tumor responses, quality of life, and reducing the side effects of chemo/radiotherapy, mainly focusing on lung, liver and colorectal cancer. The methodological and reporting quality are weak and need to be improved in the future.

Chinese Patent Medicine as Adjuvant for Mild-to-Moderate Active Ulcerative Colitis: A Network Meta-Analysis of Randomized Controlled Trials.

OBJECTIVE: To evaluate the effectiveness and safety of Chinese patent medicine for mild-to-moderate active ulcerative colitis (UC) using network meta-analysis (NMA). METHODS: We systematically searched PubMed, Cochrane library, Embase, Sino-Med, China National Knowledge Infrastructure (CNKI), Wanfang, and Chinese Scientific Journal Database (VIP) databases to October, 2020. We included randomized controlled trials (RCTs) on Chinese patent medicine for mild-to-moderate active UC. The main analysis was complemented by network subanalyses and standard pairwise comparisons. Statistical heterogeneity, inconsistencies, and ranking probability were also evaluated. RESULTS: The databases search identified 3222 citations, of which 33 RCTs involving 2971 patients met the inclusion criteria. A total of 15 Chinese patent medicines were analyzed. The overall quality of the included studies was low. Pairwise meta-analysis showed that Chinese patent medicine was superior to Mesalazine in improving disappearances of clinical symptoms, recurrence rate, and Mayo score. Based on decreases in adverse events, results from NMA showed that Xilei powder plus Mesalazine was more effective than other drugs. Other NMA results indicated that Danshen freeze-dried powder plus Mesalazine (RR: 0.13; 95% CI, 0.02-0.78) and Kangfuxin lotion plus Mesalazine (RR: 0.24; 95% CI, 0.07-0.57) were superior to Mesalazine in decreasing recurrence rate. Another NMA result indicated that Kangfuxin lotion plus Mesalazine (RR: 0.00; 95% CI, 0.00-0.02) and Zhi Kang capsule plus Mesalazine (RR: 0.00; 95% CI, 0.00-0.02) were superior to Mesalazine in increasing the disappearance of tenesmus. CONCLUSION: In the probability sorting, Xilei powder combined with Mesalazine ranked first for having the fewest adverse events, Maintaining Intestines Antidiarrheal Pills combined with Mesalazine ranked first for having the lowest recurrence rate, Xilei powder combined with Mesalazine ranked first for improving disappearance rate of mucopurulent bloody stool/abdominal pain, and Kangfuxin lotion combined with Mesalazine ranked first for improving the disappearance rate of diarrhea/tenesmus. However, there is a lack of direct comparisons among Chinese patent medicines for UC. More multiarm RCTs are needed in the future to provide direct comparative evidence.

Adjunctive effect of compound Kushen Injection to chemotherapy for non-small cell lung cancer: An evidence map and overview of systematic reviews.

ETHNOPHARMACOLOGICAL RELEVANCE: Extract from Kushen (Sophora flavescens Aiton) and Baituling (Heterosmilax japonica Kunth), Compound Kushen Injection has a long history for cancer treatment in China. As a common adjunctive drug in chemotherapy of non-small cell lung cancer (NSCLC), the evidence of effectiveness and safety of Compound Kushen Injection needs to be synthesized. AIM OF THE STUDY: The objective of this overview is to synthesize recent evidence and assess the methodological quality of systematic reviews (SRs) of Compound Kushen Injection, in treating NSCLC as an adjunctive treatment of chemotherapy. MATERIALS AND METHODS: We searched PubMed, PubMed Central, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform and VIP China Science and Technology Journal Database from inception to April 22, 2020. We included SRs of the efficacy and safety of Compound Kushen Injection combined with chemotherapy in the treatment of NSCLC. Two authors assessed eligibility and extracted data. The quality of SRs was assessed using AMSTAR-2. A meta-analysis was conducted for the original trials where good homogeneity was present. Evidence maps using bubble plots illustrated overall results. The quality of the evidence was graded by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS: Twelve SRs were included, with 91 randomized controlled trials and 7466 participants. Overall, the quality of the included SRs was low. Only six SRs reported specific chemotherapy regimens, three using vinorelbine combined with cisplatin (NP), one using paclitaxel combined with cisplatin (TP), one using gemcitabine combined with cisplatin (GP), and one discussed the three regimens in subgroups. Meta-analysis showed that CKI used as an adjuvant to chemotherapy was superior to chemotherapy alone in promoting tumor complete response rate, tumor partial response rate, Kamofsky score, and relieving some chemotherapy related side effects. Evidence mapping showed that Kushen Injection combined with NP and GP had better effect. The evidence quality of increasing Kamofsky score and decreasing the incidence of leukopenia were moderate, others were low or very low. CONCLUSIONS: There are some favorable effects in improving short-term effectiveness, quality of life and alleviating some side effects of chemotherapy in patients with NSCLC. Results are more promising when Compound Kushen injection is used as an adjunctive to NP and GP. Promising results are however, compromised by the poor quality overall of the clinical trials.

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.

Acupuncture for Depression: A Systematic Review and Meta-Analysis.

BACKGROUND: Depression is commonly treated with anti-depressant medication and/or psychological interventions. Patients with depression are common users of complementary therapies, such as acupuncture, either as a replacement for, or adjunct to, their conventional treatments. This systematic review and meta-analysis examined the effectiveness of acupuncture in major depressive disorder. METHODS: A search of English (Medline, PsychINFO, Google Scholar, and CINAL), Chinese (China National Knowledge Infrastructure Database (CNKI) and Wanfang Database), and Korean databases was undertaken from 1980 to November 2018 for clinical trials using manual, electro, or laser acupuncture. RESULTS: Twenty-nine studies including 2268 participants were eligible and included in the meta-analysis. Twenty-two trials were undertaken in China and seven outside of China. Acupuncture showed clinically significant reductions in the severity of depression compared to usual care (Hedges (g) = 0.41, 95% confidence interval (CI) 0.18 to 0.63), sham acupuncture (g = 0.55, 95% CI 0.31 to 0.79), and as an adjunct to anti-depressant medication (g = 0.84, 95% CI 0.61 to 1.07). A significant correlation between an increase in the number of acupuncture treatments delivered and reduction in the severity of depression (p = 0.015) was found. LIMITATIONS: The majority of the included trials were at a high risk of bias for performance blinding. The applicability of findings in Chinese populations to other populations is unclear, due to the use of a higher treatment frequency and number of treatments in China. The majority of trials did not report any post-trial follow-up and safety reporting was poor. CONCLUSIONS: Acupuncture may be a suitable adjunct to usual care and standard anti-depressant medication.

Acupuncture for Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis.

PURPOSE: To assess the effectiveness and safety of acupuncture for erectile dysfunction (ED). MATERIALS AND METHODS: We searched six major English and Chinese databases included randomized controlled trials (RCTs) testing acupuncture alone or in combination for ED. Dichotomous data were presented as risk ratio (RR) and continuous data were presented as mean difference (MD) both with 95% confidence interval (CI). The Revman (v.5.3) was used for data analyses. Quality of evidence across studies was assessed by the online GRADEpro tool. RESULTS: We identified 22 RCTs, fourteen of them involving psychogenic ED. Most of the included RCTs had high or unclear risk of bias. There was no difference between electro-acupuncture and sham acupuncture with electrical stimulation on the rate of satisfaction and self-assessment (RR, 1.50; 95% CI, 0.71-3.16; 1 trial). Acupuncture combined with tadalafil appeared to have better effect on increasing cure rate (RR, 1.31; 95% CI, 1.00-1.71; 2 trials), and International Index of Erectile Function-5 scores (MD, 5.38; 95% CI, 4.46-6.29; 2 trials). When acupuncture plus herbal medicine compared with herbal medicine alone, the combination therapy showed significant better improvement in erectile function (RR, 1.68; 95% CI, 1.31-2.15; 7 trials). Only two trials reported facial red and dizziness cases, and needle sticking and pruritus cases in acupuncture group. CONCLUSIONS: Low quality evidence shows beneficial effect of acupuncture as adjunctive treatment for people mainly with psychogenic ED. Safety of acupuncture was insufficiently reported. The findings should be confirmed in large, rigorously designed and well-reported trials.

Pediatric Tui Na for acute diarrhea in children under 5 years old: A systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: To evaluate the benefits and harms of pediatric Tui Na as a non-pharmaceutical Chinese medicine therapy for acute diarrhea in children under 5 years of age. DESIGN: Systematic review and meta-analysis of randomized clinical trials. METHODS: We searched seven major English and Chinese databases from their inception to January 2018 for randomized clinical trials (RCTs) comparing pediatric Tui Na therapy with conventional medicine (montmorillonite/diosmectite or probiotics used alone or in combination). Two authors extracted data and assessed the Cochrane risk of bias, independently. The primary outcomes are clinical cure rate and diarrhea duration from admission to the cessation of diarrhea. 'Clinical cure' is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms. We present dichotomous data as risk ratio (RR), and continuous data as mean difference (MD) with their 95% confidence interval (CI). We used the Cochrane's Revman software (v.5.3) for data analysis. Trial sequential analysis (TSA) was applied to calculate the required sample size in a meta-analysis and detect the robustness of the results. The GRADEpro was used to generate a summary of finding table. RESULTS: Totally 26 RCTs were included, involving 2410 children with acute diarrhea. Most of the included trials had high or unclear risk of bias in terms of random sequence generation, blinding, and incomplete outcome reporting. The pooled results demonstrated that pediatric Tui Na was superior to montmorillonite after three-session treatment (RR 1.45, 95% CI 1.29-1.62, n = 772, 10 trials), and also superior to montmorillonite combined with probiotics after three-session treatment (RR 2.04, 95% CI 1.49-2.78, n = 533, 7 trials) and after six-session treatment (RR 1.52, 95% CI 1.34-1.73, n = 631, 5 trials) in improving clinical cure rate. Pediatric Tui Na significantly decreased the duration of acute diarrhea (hrs) (MD -0.40 h, 95% CI -15.31 to -5.48 h, n = 410, 6 trials) and daily stool frequency (MD -1.71times, 95% CI -2.37 to -1.04, n = 217, 3 trials, after three-session treatment). No adverse event related to pediatric Tui Na was reported in the included trials. The quality of evidence of included trials was generally moderate to low. TSA for cure rate demonstrated that the pooled data reached a sufficient power regarding both numbers of trials and participants. CONCLUSIONS: This review shows pediatric Tui Na appears to be effective and safe in improving clinical cure rate and shortening diarrhea duration in childhood aged less than five years of age with acute diarrhea. However, rigorously designed well-reported RCTs are warranted to confirm the findings.

Zusanli (ST36) Acupoint Injection for Diabetic Peripheral Neuropathy: A Systematic Review of Randomized Controlled Trials.

Background: Acupuncture point (acupoint) injection is a common practice in China. Some trials showed that Chinese herbal extracts and/or conventional medication are injected at the Zusanli (ST36) acupoint for the treatment of diabetic peripheral neuropathy (DPN). The study aimed to assess the effectiveness and safety of acupoint injection for DPN at the ST36 by systematically evaluating the evidence published to date. Methods: Six databases were searched for randomized controlled trials (RCTs) of ST36 injection for DPN with primary outcome of pain, global symptom improvement, and quality of life. Methodological quality was assessed by the Cochrane risk of bias (ROB) tool. Data were analyzed using RevMan 5.3. Results: Fourteen RCTs involving 1,071 participants with DPN were included. All RCTs were assessed as unclear or high ROB. Few RCTs adequately reported methodology-related items and needling details according to Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) statement. Medications injected at ST36 included conventional medications (11 RCTs) and Chinese herbal extracts (3 RCTs). The authors of this study did not perform any meta-analysis due to the heterogeneity of medications used for injections. Two individual RCTs favored ST36 injection in relieving pain compared with intramuscular injection of the same medication. For global symptom measured by Toronto clinical scoring system, one RCT showed that ST36 injection of Fufang Danggui was more effective than intramuscular injection of vitamin B12, two RCTs demonstrated that ST36 injection of mecobalamin or Danhong with cointervention was superior, while one RCT showed no significant differences between ST36 injection and intramuscular injection of mecobalamin. For improving nerve conduction velocity (NCV), three of four individual RCTs showed that ST36 injection was better than intramuscular or intravenous injection of the same medication, two RCTs favored ST36 injection with cointervention, and one RCT favored ST36 injection without cointervention. Four RCTs reported monitoring adverse events, all of which showed no significant difference between groups. Conclusions: Limited evidence suggests that ST36 injection appears to be safe, and potentially effective in reducing pain score and improving NCV compared with intramuscular injection of the same medication. However, poor methodological and reporting quality reduced confidence in the findings. Rigorously designed and well-reported RCTs evaluating the effectiveness of ST36 injection for DPN are warranted.

Total glucosides of paeony for rheumatoid arthritis: A systematic review of randomized controlled trials.

BACKGROUND: Total glucosides of paeony (TGP) is commonly used to treat rheumatoid arthritis (RA) in China. However, clinical practice hasn't been well informed by evidence from appropriately conducted systematic reviews. This PRISMA-compliant systematic review aims at examining the effectiveness and safety of TGP for RA. METHODS: Randomized controlled trials (RCTs) comparing TGP with placebo, no treatment, or disease-modifying antirheumatic drugs (DMARDs) for patients with RA were retrieved by searching seven databases. Primary outcomes included disease improvement and disease remission. Secondary outcomes included adverse effects, pain, health-related quality of life, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Data extraction and analyses were conducted according to the Cochrane standards. We assessed risk of bias for each included studies and quality of evidence on pre-specified outcomes. RESULTS: Eight studies enrolling 1209 patients with active RA were included in this systematic review. On the basis of traditional DMARD(s), TGP might be beneficial for patients with RA in improvement of American College of Rheumatology (ACR) 20 response rate, ACR 50 response rate, ACR70 response rate, and in reduction of adverse effects, compared with no treatment. The overall methodological quality of included studies and the quality of evidence for each outcome were limited. CONCLUSIONS: Current trials suggested potential benefits of TGP for RA on the basis of traditional DMARD(s). Therefore, TGP may be a good choice for RA as an adjuvant therapy. However, considering the limited methodological quality and strength of evidence, high-quality RCTs are warranted to support the use of TGP for RA.

Clinical effects of a standardized Chinese herbal remedy, Qili Qiangxin, as an adjuvant treatment in heart failure: systematic review and meta-analysis.

BACKGROUND: Qili Qiangxin capsule is a standardized Chinese herbal treatment that is commonly used in China for heart failure (HF) alongside conventional medical care. In 2014, Chinese guidelines for the treatment of chronic HF highlighted Qili Qiangxin capsules as a potentially effective medicine. However, there is at present no high quality review to evaluate the effects and safety of Qili Qiangxin for patients with HF. METHODS: We conducted a systematic review and meta-analysis and followed methods described in our registered protocol [PROSPERO registration: CRD42013006106]. We searched 6 electronic databases to identify randomized clinical trials (RCTs) irrespective of blinding or placebo control of Qili Qiangxin used as an adjuvant treatment for HF. RESULTS: We included a total of 129 RCTs published between 2005 and 2015, involving 11,547 patients, aged 18 to 98 years. Meta-analysis showed no significant difference between Qili Qiangxin plus conventional treatment and conventional treatment alone for mortality (RR 0.53, 95 % CI 0.27 to 1.07). However, compared with conventional treatment alone, Qili Qiangxin plus conventional treatment demonstrated a significant reduction in major cardiovascular events (RR 0.46, 95 % CI 0.34 to 0.64) and a significant reduction in re-hospitalization rate due to HF (RR 0.49, 95 % CI 0.38 to 0.64). Qili Qiangxin also showed significant improvement in cardiac function measured by the New York Heart Association scale (RR 1.38, 95 % CI 1.29 to 1.48) and quality of life as measured by Minnesota Living with Heart Failure Questionnaire (MD -8.48 scores, 95 % CI -9.56 to -7.39). There were no reports of serious adverse events relating to Qili Qiangxin administration. The majority of included trials were of poor methodological quality. CONCLUSIONS: When compared with conventional treatment alone, Qili Qiangxin combined with conventional treatment demonstrated a significant effect in reducing cardiovascular events and re-hospitalization rate, though not in mortality. It appeared to significantly improve quality of life in patients with HF and data from RCTs suggested that Qili Qiangxin is likely safe. This data was drawn from low quality trials and the results of this review must therefore be interpreted with caution. Further research is warranted, ideally involving large, prospective, rigorous trials, in order to confirm these findings.

Total glucosides of paeony for rheumatoid arthritis: a protocol for a systematic review.

INTRODUCTION: Total glucosides of paeony (TGP) is a natural plant extract, which is widely used in China for treating rheumatoid arthritis (RA). Many relevant randomised controlled trials (RCTs) of TGP for RA are available, but they have not been systematically reviewed. This systematic review aims to examine the effectiveness and safety of TGP in patients with RA. METHODS AND ANALYSES: We will search for RCTs of TGP in the treatment of RA, performed up until February 2016, in PubMed, Embase, Cochrane Central Register of Controlled Trials, and four Chinese databases (Chinese Biomedical Database, China National Knowledge Infrastructure, Wanfang Database and Chinese Scientific Journal Database). Trial registers and reference lists of retrieved articles will also be searched to identify potential articles. RCTs comparing TGP with placebo, no treatment, or disease-modifying antirheumatic drugs for patients with RA will be retrieved. The primary outcomes will be disease improvement and disease remission. The secondary outcomes will be surrogate outcomes, symptoms, adverse effects, and quality of life. Two reviewers will independently extract data on participants, interventions, comparisons, outcomes, etc. The methodological quality of each included study will be evaluated using the Cochrane risk of bias tool, and the strength of evidence on prespecified outcomes will be assessed in accordance with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Review Manager 5.3 software will be used for data analyses. Meta-analyses will be performed if the data are sufficiently homogeneous, both statistically and clinically. Possible publication bias will also be checked using funnel plots once the number of included studies is sufficient. ETHICS AND DISSEMINATION: Ethics approval is not required, as this study will not involve patients. The results of this study will be submitted to a peer-reviewed journal for publication, to inform both clinical practice and further research. TRIAL REGISTRATION NUMBER: CRD42015026345.

Integrative treatment for low back pain: An exploratory systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Low back pain (LBP) is a common musculoskeletal condition often treated using integrative medicine (IM). Most reviews have focused on a single complementary and alternative medicine (CAM) therapy for LBP rather than evaluating wider integrative approaches. This exploratory systematic review aimed to identify randomized controlled trials (RCTs) and provide evidence on the effectiveness, cost effectiveness and adverse effects of integrative treatment for LBP. METHODS: A literature search was conducted in 12 English and Chinese databases. RCTs evaluating an integrative treatment for musculoskeletal related LBP were included. Reporting, methodological quality and relevant clinical characteristics were assessed and appraised. Metaanalyses were performed for outcomes where trials were sufficiently homogenous. RESULTS: Fifty-six RCTs were identified evaluating integrative treatment for LBP. Although reporting and methodological qualities were poor, meta-analysis showed a favourable effect for integrative treatment over conventional and CAM treatment for back pain and function at 3 months or less follow-up. Two trials investigated costs, reporting £ 5332 per quality adjusted life years with 6 Alexander technique lessons plus exercise at 12 months follow-up; and an increased total costs of $244 when giving an additional up to 15 sessions of CAM package of care at 12 weeks. Sixteen trials mentioned safety; no severe adverse effects were reported. CONCLUSION: Integrative treatment that combines CAM with conventional therapies appeared to have beneficial effects on pain and function. However, evidence is limited due to heterogeneity, the relatively small numbers available for subgroup analyses and the low methodological quality of the included trials. Identification of studies of true IM was not possible due to lack of reporting of the intervention details (registration No. CRD42013003916).

Influences of Deqi on Immediate Analgesia Effect of Needling SP6 (Sanyinjiao) in Patients with Primary Dysmenorrhea in Cold and Dampness Stagnation Pattern: Study Protocol for a Randomized Controlled Trial.

Deqi, according to traditional Chinese medicine, is a specific needle sensation during the retention of needles at certain acupoints and is considered to be necessary to produce therapeutic effects from acupuncture. Although some modern researches have showed that Deqi is essential for producing acupuncture analgesia and anesthesia, the data are not enough. It is a paper of a multicenter, randomized controlled study protocol, to evaluate the influences of Deqi on acupuncture SP6 in Cold and Dampness Stagnation pattern primary dysmenorrhea patients, in terms of reducing pain and anxiety, and to find out the relationship between Deqi and the temperature changes at SP6 (Sanyinjiao) and CV4 (Guanyuan). The results of this trial will be helpful to explain the role of Deqi in acupuncture analgesia and may provide a new objective index for measuring Deqi in the future study. This trial is registered with ChiCTR-TRC-13003086.

Is traditional Chinese medicine recommended in Western medicine clinical practice guidelines in China? A systematic analysis.

BACKGROUND: Evidence-based medicine promotes and relies on the use of evidence in developing clinical practice guidelines (CPGs). The Chinese healthcare system includes both traditional Chinese medicine (TCM) and Western medicine, which are expected to be equally reflected in Chinese CPGs. OBJECTIVE: To evaluate the inclusion of TCM-related information in Western medicine CPGs developed in China and the adoption of high level evidence. METHODS: All CPGs were identified from the China Guideline Clearinghouse (CGC), which is the main Chinese organisation maintaining the guidelines issued by the Ministry of Health of China, the Chinese Medical Association and the Chinese Medical Doctors' Association.TCM-related contents were extracted from all the CPGs identified. Extracted information comprised the institution issuing the guideline, date of issue, disease, recommendations relating to TCM, evidence level of the recommended content and references supporting the recommendations. RESULTS: A total of 604 CPGs were identified, only a small number of which (74/604; 12%) recommended TCM therapy and only five guidelines (7%) had applied evidence grading. The 74 CPGs involved 13 disease systems according to the International Classification of Diseases 10th edition. TCM was mainly recommended in the treatment part of the guidelines (73/74, 99%), and more than half of the recommendations (43/74, 58%) were related to Chinese herbal medicine (single herbs or herbal treatment based on syndrome differentiation). CONCLUSIONS: Few Chinese Western medicine CPGs recommend TCM therapies and very few provide evidence grading for the TCM recommendation. We suggest that future guideline development should be based on systematic searches for evidence to support CPG recommendations and involve a multidisciplinary approach including TCM expertise.

Evidence base of clinical studies on Tai Chi: a bibliometric analysis.

BACKGROUND: The safety and health benefits of Tai Chi mind-body exercise has been documented in a large number of clinical studies focused on specific diseases and health conditions. The objective of this systematic review is to more comprehensively summarize the evidence base of clinical studies of Tai Chi for healthcare. METHODS AND FINDINGS: We searched for all types of clinical studies on Tai chi in PubMed, the Cochrane Library and four major Chinese electronic databases from their inception to July 2013. Data were analyzed using SPSS17.0 software. A total of 507 studies published between 1958 and 2013 were identified, including 43 (8.3%) systematic reviews of clinical studies, 255 (50.3%) randomized clinical trials, 90 (17.8%) non-randomized controlled clinical studies, 115 (22.7%) case series and 4 (0.8%) case reports. The top 10 diseases/conditions was hypertension, diabetes, osteoarthritis, osteoporosis or osteopenia, breast cancer, heart failure, chronic obstructive pulmonary disease, coronary heart disease, schizophrenia, and depression. Many healthy participants practiced Tai Chi for the purpose of health promotion or preservation. Yang style Tai Chi was the most popular, and Tai Chi was frequently practiced two to three 1-hour sessions per week for 12 weeks. Tai Chi was used alone in more than half of the studies (58.6%), while in other studies Tai Chi was applied in combination with other therapies including medications, health education and other physical therapies. The majority of studies (94.1%) reported positive effects of Tai Chi, 5.1% studies reported uncertain effects and 0.8% studies reported negative effects. No serious adverse events related to Tai Chi were reported. CONCLUSIONS: The quantity and evidence base of clinical studies on Tai Chi is substantial. However, there is a wide variation in Tai Chi intervention studied and the reporting of Tai Chi intervention needs to be improved. Further well-designed and reported studies are recommended to confirm the effects of Tai Chi for the frequently reported diseases/conditions.

Songling Xuemaikang Capsule () for primary hypertension: A systematic review of randomized controlled trials.

OBJECTIVE: To evaluate the effectiveness and safety of Songling Xuemaikang Capsule (, SXC) for the treatment of primary hypertension. METHODS: An extensive search including Cochrane Library, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), KoreaMed, Japanese database, and online clinical trial registry websites was performed up to February 2013. Randomized controlled trials (RCTs) regarding SXC for the treatment of primary hypertension were searched without no language restrictions. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration. RESULT: A total of 17 RCTs involving 1,778 patients were included. Meta-analysis showed that there was no significant difference between SXC and antihypertensive agents on systolic blood pressure [mean difference (MD): -0.10 [-4.83, 4.63]; P=0.97] and diastolic blood pressure (MD: 1.00 [-1.16, 3.16]; P=0.36), but SXC combined with antihypertensive drugs was more effective in lowering systolic blood pressure (MD: -6.17 [-7.86, -4.49]; P<0.00001) and diastolic blood pressure (MD: -7.24 [-8.62, -5.85]; P<0.00001) compared with the antihypertensive drugs alone. CONCLUSIONS: SXC used alone or combined with antihypertensive drugs appear to be an effective treatment for lowering elevated blood pressure and improving symptoms in patients with primary hypertension. However, the conclusion cannot be drawn definitely due to the poor quality of the included studies. There is still an urgent need for well-designed, long-term studies to address the benefits of SXC for treating primary hypertension.

[Chinese medicine clinical trial protocol design and report specifications].

Clinical trial protocol is the document that illustrates the background of a clinical trial, theoretic basis, objective, design, methods, and organization, as well as statistical calculating, implement, and conditions for completion. Clinical trial protocol is the basic measure for ensuring the validity of scientific results and reducing bias. In order to optimize the design of clinical trial protocol, we generalize main problems in Chinese medicine clinical trials, key points of clinical trial protocol, as well as report standards.