Effects of acupuncture at acupoints with lower versus higher pain threshold for knee osteoarthritis: a multicenter randomized controlled trial.

BACKGROUND: The acupoint selections impact the effects of acupuncture, and preliminary evidence showed potential connection between pain threshold (PT) and acupuncture response. This study examined whether acupuncture at acupoints with lower PT versus higher PT would yield different effects in patients with knee osteoarthritis (KOA). METHODS: In this multicenter randomized clinical trial, patients were randomly assigned (1:1:1) to receive acupuncture at acupoints with lower PT (LPT group), acupuncture at acupoints with higher PT (HPT group), and no acupuncture (waiting-list group). PT was measured with electronic von Frey detector. The primary outcome was the change in WOMAC total score from baseline to 16 weeks, and the secondary outcomes were SF-12 score, and active knee range of motion (ROM). Intention-to-treat analysis was conducted with linear mixed-effect model. RESULTS: Among 666 randomized patients, 625 (93.84%) completed the study. From baseline to 16 weeks, patients in the LPT group versus HPT group had similar effects in reducing WOMAC total score (adjusted mean difference (MD) 2.21, 95% confidence interval (CI) -2.51 to 6.92, P = 0.36), while a greater reduction in WOMAC total score was observed in LPT group (-9.77, 95% CI -14.47 to -5.07, P < 0.001) and HPT group (-11.97, 95% CI -16.71 to -7.24, P < 0.001) compared with waiting-list group. There were no differences in SF-12 score and knee ROM between LPT versus HPT groups. CONCLUSION: Our findings found that the effects of acupuncture at acupoints with lower versus higher PT were similar, both were effective for patients with KOA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03299439. Registered 3 October 2017, https://clinicaltrials.gov/ct2/show/NCT03299439.

Herbal Granules of Heat-Clearing and Detoxifying for Children with Mild Hand, Foot, and Mouth Disease: A Bayesian Network Meta-Analysis.

Background: Regarding ethical considerations of randomized controlled trials (RCTs) in children, limited evidence for mild hand, foot, and mouth disease (HFMD) is available. Recently, with the increasing but result-conflicting RCTs published around herbal granules of heat-clearing and detoxifying (HGs-HD), a head-to-head comparison is urgently needed to choose a suitable therapy for clinical practice. Materials and Methods: This study was conducted according to the preferred reporting items for systematic review and meta-analysis (PRISMA) extension statement for network meta-analysis (NMA). Eight databases (Medline, Embase, and so on) and two trial registry platforms (https://www.clinicaltrials.gov and https://www.chictr.org.cn) were searched from inception to May 26, 2021. The NMA was performed using a random-effect model. The treatment hierarchy was summarized and reported as the surface under the cumulative ranking curve (SUCRA) probability values. The rankings of each HGs-HD at primary outcomes were estimated by the inverse probability weighting (IPW) approach and averaged, which presents the comprehensive improvement effect. Results: Forty-five RCTs involving 18 interventions were included that studied 5,652 children with mild HFMD. The best performance probability for improving symptoms were respectively presented in terms of fever (Xiao'er Resuqing granules, XRGs, 94.9%), rash (Xiao'er Jinqiao granules, 83.9%), hospitalization (Xiao'er Chiqiao Qingre granules, XCQGs, 92.7%), vesicles (Jinlianhua granules, 91.0%), appetite (Xiao'er Chiqiao Qingre granules, XCQGs, 86.7%), and ulcers (Kouyanqing granules, KouGs, 88.8%). Furthermore, the top 5 rankings for comprehensive improvement effect were Yanning granules (YNGs, 2.256), XCQGs (2.858), XRGs (3.270), KouGs (7.223), and Houerhuan Xiaoyan granules (HXGs, 7.597). Conclusions: This is the first NMA of HGs-HD head-to-head comparisons for children with mild HFMD. Of those, YNGs, XCQGs, XRGs, KouGs, and HXGs could be recommended as potential choices for clinical practice. Of course, the results should be interpreted with caution due to the limited high-quality RCTs.

Effectiveness and safety of Danmu extract syrup for acute upper respiratory tract infection in children: A real-world, prospective cohort study.

AIM: To evaluate the effectiveness and safety of Danmu Extract Syrup for the treatment of acute upper respiratory tract infection (AURI) in children. METHODS: In this prospective cohort study, we enrolled children with AURI in the pediatric outpatient department and emergency department of West China Second Hospital. According to the treatment, they were divided into two groups: Danmu Extract Syrup Group (Danmu Group) and Xiaoer Chiqiao Granule Group (Chiqiao Group). The primary outcome was time to symptom remission, and the secondary outcomes were defervescence time, relief time, admission rate, and adherence. We used restricted mean survival time (RMST) to quantify the treatment effects and test noninferiority for primary outcome. Propensity score matching (PSM) was used to adjust confounding. Subgroup analysis and sensitivity analysis were used to verify the robustness of results. RESULTS: We enrolled 1036 children with AURI, including 516 in Danmu Group and 520 in Chiqiao Group. After PSM, no significant difference was observed in the baseline characteristics of the two groups. The primary results showed that the RMST difference was -3 h (95% CI: -15.1 to 9.1) and the upper limit of the 95% CI was less than the noninferiority margin of 11 h. There was no statistical difference in the secondary outcomes except for defervescence between the two groups. The results of safety analysis showed that the incidence of adverse events occurred is 4.1% in Danmu Group, which was lower than the incidence of Chiqiao Group (6.9%). CONCLUSION: This study indicated that Danmu extract syrup is noninferiority to Chiqiao Granule for AURI in children.

A Protocol of a Guideline to Establish the Evidence Ecosystem of Acupuncture.

This is a protocol for developing a guideline to establish the evidence ecosystem of acupuncture. It describes all steps that will be followed in line with the World Health Organization Handbook for Guideline Development and the Reporting Items for practice Guidelines in Healthcare (RIGHT). The key steps included guideline protocol development, guideline registration, systematic review of acupuncture evidence issues, systematic review of methods for establishing evidence ecosystem, survey of acupuncture stakeholders regarding potential acupuncture evidence issues, development of potential items for guidelines, Delphi method for guideline item development, consensus meeting, drafting guideline, peer review, approval, and publishing. This future guideline will help to establish evidence ecosystem of acupuncture, which will facilitate the application of acupuncture in clinical practice.

The effects of testosterone on bone health in males with testosterone deficiency: a systematic review and meta-analysis.

BACKGROUND: Testosterone deficiency (TD) may induce a series of clinical symptoms. Studies have shown that testosterone supplementation may prevent these unfavourable symptoms and improve patients' quality of life. Given the conflicting findings across studies, this systematic review aims to evaluate the effects and risks associated with testosterone supplementation in middle-aged or aging males with TD. METHODS: Electronic databases (MEDLINE, EMBASE, PubMed, and Cochrane. Library were searched to December 2019. The risk of bias of individual included studies and the quality of the aggregate evidence were assessed using the GRADE approach. Our primary outcome was bone mineral density (BMD). Meta-analyses were performed. This systematic review was reported according to the PRISMA statement. RESULTS: A total of 52 randomized controlled trials (RCTs) were included. When compared with placebo, testosterone supplementation did not increase total BMD (short-term: 1081 participants, MD - 0.01 g/cm2, 95% CI - 0.02 g/cm2 to 0.01 g/cm2; long-term: 156 participants, MD 0.04 g/cm2, 95% CI - 0.07 g/cm2 to 0.14 g/cm2), lumbar spine, hip, or femur neck BMD. Furthermore, testosterone supplementation did not decrease the risk of falling or fracture. Lastly, it was found that testosterone supplementation did not increase the risk of cardiovascular events (1374 participants, RR 1.28, 95% CI 0.62 to 2.64), all-cause mortality (729 participants, RR 0.55, 95% CI 0.29 to 1.04), or prostatic events. However, testosterone supplementation may improve sexual function and quality of life (1328 participants, MD -1.32, 95% CI - 2.11 to - 0.52). CONCLUSIONS: The effect of testosterone supplementation on BMD and the risk of falls or fracture remains inconclusive. However, supplementation may benefit patients in the areas of sexual function and quality of life without increasing the risk of cardiovascular events, all-cause mortality, or prostatic events. RCTs with a longer follow-up period are still required. TRIAL REGISTRATION: We registered our protocol in PROSPERO (CRD42018109738).

Overview of Cochrane reviews on Chinese herbal medicine for stroke.

BACKGROUND: Stroke is a major health issue worldwide. Since Chinese herbal medicine is widely used for the treatment of stroke, there is a need to evaluate its efficacy as an alternative treatment option. The aim of this paper is to carry out an overview of Chinese herbal medicine for the treatment of stroke by summarizing and evaluating all existing Cochrane reviews. METHODS: The Cochrane Database of Systematic Reviews was searched from its inception date to August 2019 using "stroke" and "herbal medicine" or "traditional medicine" as search terms. For the methodological quality assessment of the Cochrane reviews, the Assessment of Multiple Systematic Reviews (AMSTAR) tool was used. RESULTS: Eight Cochrane reviews that evaluated the efficacy of herbal medicine for the treatment of stroke were included in this overview. There were 71 randomized controlled trials, with 5770 patients in total. The AMSTAR scores of the Cochrane reviews included in this study ranged from 9 to 11 with a mean score of 10. Three reviews met all the 11-item criteria of the AMSTAR. All reviews presented potential efficacy of herbal medicine for stroke treatment in terms of improvement of neurological deficit. CONCLUSION: This overview reveals the potential efficacy of herbal medicines for the treatment of stroke in terms of neurological deficit improvement. However, due to the high risk of bias in the reviews' studies, an affirmative conclusion for the recommendation of herbal medicine for clinical practice could not be drawn.

Acupuncture treatment for knee osteoarthritis with sensitive points: protocol for a multicentre randomised controlled trial.

INTRODUCTION: There is a lack of curative medical treatment for patients with knee osteoarthritis (KOA). Acupuncture represents an important alternative therapy. According to the theory of traditional Chinese medicine and preliminary clinical evidence, the patients' acupoints and tender points may become sensitised when the body suffers from a disease state; stimulation of such sensitive points could lead to a disease improvement. It is thus hypothesised that acupuncture at highly sensitised points on patients with KOA would achieve better treatment outcomes than acupuncture at low/non-sensitised points. Previously, we conducted a pilot trial to prove the feasibility of further investigation. METHODS AND ANALYSIS: A three-arm, parallel, multicentre randomised controlled trial of 666 patients will be conducted at four hospitals of China. Eligible patients with KOA who consent to participate will be randomly assigned to a high-sensitisation group (patients receive acupuncture treatment at high-sensitive points), a low/non-sensitisation group (patients receive acupuncture treatment at low/non-sensitive points) or a waiting-list group (patients receive standard acupuncture treatment after the study is concluded) via a central randomisation system using 1:1:1 ratio. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index total score from baseline to 16 weeks. Outcome assessors and data analysts will be blinded and participants will be asked not to reveal their allocation to assessors. The outcome analyses will be performed both on the intention-to-treat and per-protocol population. The primary analyses will test if acupuncture at highly sensitised points would achieve statistically better treatment outcomes than acupuncture at low/non-sensitised points and no acupuncture (ie, waiting list), respectively. A small number of prespecified subgroup analyses will be conducted. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Bioethics Subcommittee of West China Hospital, Sichuan University: 2017 (Number 228). Results will be expected to be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03299439.

The quality of reporting in randomized controlled trials of acupuncture for knee osteoarthritis: A cross-sectional survey.

OBJECTIVE: To assess the reporting quality of acupuncture trials for knee osteoarthritis (KOA), and explore the factors associated with the reporting. METHOD: Three English and four Chinese databases were searched from inception to December 2016 for randomized control trials testing effects of acupuncture for knee osteoarthritis. We used the standard CONSORT (2010 version), CONSORT Extension for Non-Pharmacological Treatments, and STRICTA for measuring the quality of reporting. Using pre-specified study characteristics, we undertook regression analyses to examine factors associated with the reporting quality. RESULTS: A total of 318 RCT reports were included. For the standard CONSORT, ten items were substantially under-reported (reported in less than 5% of RCTs), including specification of important changes to methods after trial commencement (0.6%), description of any changes to trial outcomes (0.0%), implementation of interim analyses and stopping guidelines (0.6%), statement about why the trial ended or was stopped (1.6%), statement about the registration status (4.4%), accessibility of full trial protocol (4.7%), implementation of randomization (4.7%), description of the similarity of interventions (3.5%), conduct of ancillary analyses (3.8%) and presentation of methods for additional analyses (4.4%). Four of the STRICTA items were under-reported (reported in less than 10% of RCTs), including description of acupuncture style (8.5%), presentation of extent to which treatment varied (1.3%), statement of practitioner background (7.2%) and rationale for the control (9.1%). For CONSORT Extension, the reporting was poor across all items (reported in less than 10% of trials). Trials including authors with expertise in epidemiology or statistics, published in English, or enrolling patients from multiple centers were more likely to have better reporting. CONCLUSIONS: The reporting in RCTs of acupuncture for KOA was generally poor. To improve the reporting quality, journals should encourage strict adherence to the reporting guidelines.

Risk of bias and methodological issues in randomised controlled trials of acupuncture for knee osteoarthritis: a cross-sectional study.

OBJECTIVE: To assess risk of bias and to investigate methodological issues concerning the design, conduct and analysis of randomised controlled trials (RCTs) testing acupuncture for knee osteoarthritis (KOA). METHODS: PubMed, EMBASE, Cochrane Central Register of Controlled Trials and four major Chinese databases were searched for RCTs that investigated the effect of acupuncture for KOA. The Cochrane tool was used to examine the risk of bias of eligible RCTs. Their methodological details were examined using a standardised and pilot-tested questionnaire of 48 items, together with the association between four predefined factors and important methodological quality indicators. RESULTS: A total of 248 RCTs were eligible, of which 39 (15.7%) used computer-generated randomisation sequence. Of the 31 (12.5%) trials that stated the allocation concealment, only one used central randomisation. Twenty-five (10.1%) trials mentioned that their acupuncture procedures were standardised, but only 18 (7.3%) specified how the standardisation was achieved. The great majority of trials (n=233, 94%) stated that blinding was in place, but 204 (87.6%) did not clarify who was blinded. Only 27 (10.9%) trials specified the primary outcome, for which 7 used intention-to-treat analysis. Only 17 (6.9%) trials included details on sample size calculation; none preplanned an interim analysis and associated stopping rule. In total, 46 (18.5%) trials explicitly stated that loss to follow-up occurred, but only 6 (2.4%) provided some information to deal with the issue. No trials prespecified, conducted or reported any subgroup or adjusted analysis for the primary outcome. CONCLUSION: The overall risk of bias was high among published RCTs testing acupuncture for KOA. Methodological limitations were present in many important aspects of design, conduct and analyses. These findings inform the development of evidence-based methodological guidance for future trials assessing the effect of acupuncture for KOA.

Kangfuxinye Enema Combined with Mesalamine for Ulcerative Colitis: A Systematic Review and GRADE Approach.

OBJECTIVES: To critically appraise the efficacy and safety of Kangfuxinye enema combined with mesalamine for the ulcerative colitis (UC) patients and in addition to grade the quality of evidence by using the GRADE (grading of recommendations, assessment, development, and evaluation) approach. METHODS: A literature search was performed in the Cochrane Library, MEDLINE, EMBASE, CBM, CNKI, VIP, and WanFang Databases. The search restrictions were patients with UC and RCTs. Studies including other treatments except Kangfuxinye with mesalamine were excluded. RESULTS: Nineteen studies met the inclusion criteria. We found significant benefits of Kangfuxinye combined with mesalamine against mesalamine alone in improving response rate as well as reducing the recurrence rate and inflammation rate; meanwhile, the increase of the adverse events rate was not observed. Furthermore, the symptoms remission rate and the cure time were insignificant statistically. Additionally, GRADE results indicated that the quality of evidence regarding the above 6 outcomes was rated from very low to moderate quality. CONCLUSIONS: Although Kangfuxinye enema seems effective and safe for treating UC patients in this systematic review, Kangfuxinye enema combined with mesalamine was weakly recommended due to very low to moderate quality of available evidence by the GRADE approach.

Traditional Chinese Patent Medicine for Acute Ischemic Stroke: An Overview of Systematic Reviews Based on the GRADE Approach.

The aim of the study is to conduct an overview of systematic reviews (SRs) to provide a contemporary review of the evidence for delivery of Traditional Chinese Patent Medicine (TCPMs) for patients with acute ischemic stroke.SRs were assessed for quality using the Assessment of Multiple Systematic Reviews (AMSTAR) tool and the Oxman-Guyatt Overview Quality Assessment Questionnaire (OQAQ). We assessed the quality of the evidence of high methodological quality (an AMSTAR score ≥9 or an OQAQ score ≥7) for reported outcomes using the GRADE (the Grading of Recommendations Assessment, Development and Evaluation) approach.(1) Dan Shen agents: tiny trends toward the improvement in different neurological outcomes (RR = 1.16, 1.10, 1.23, 1.08, 1.12); (2) Mailuoning: a tiny trend toward improvement in the neurological outcome (RR = 1.18); (3) Ginkgo biloba: tiny trends toward improvement in the neurological outcome (RR = 1.18, MD = 0.81); (4) Dengzhanhua: a tiny trend toward an improvement in neurological (RR = 1.23); (5) Acanthopanax: a small positive (RR = 1.17, 1.31) result on neurological improvement reported; (6) Chuanxiong-type preparations: neurological functional improved (MD = 2.90);(7) Puerarin: no better effect on the rate of death or disability (OR = 0.81, 95% CI 0.35-1.87); (8) Milk vetch: no better effect on the rate of death (OR = 0.66, 95% CI: 0.11-2.83);(9) Qingkailing: rate of death reduced (OR = 0.66, 95% CI: 0.11-2.83). Limitations in the methodological quality of the RCTs, inconsistency and imprecision led to downgrading of the quality of the evidence, which varied by review and by outcome. Consequently, there are currently only weak evidences to support those TCPMs.The 9 TCPMs may be effective in the treatment of acute ischemic stroke, as the GRADE approach indicated a weak recommendation for those TCPMs' usage.

Effectiveness and safety of ShenXiong glucose injection for acute ischemic stroke: a systematic review and GRADE approach.

BACKGROUND: To appraise critically whether published trials of ShenXiong glucose injection for patients with acute ischemic stroke (AIS) are of sufficient quality, and in addition to rate the quality of evidence by using the GRADE approach (grading of recommendations, assessment, development, and evaluation, GRADE). METHODS: A literature search was performed in the Cochrane Library, MEDLINE, EMBASE, CBM, Chinese TCM (traditional Chinese medicine) Database, CNKI, VIP, WanFang Databases until January 2015. The limits were patients with AIS and randomized controlled trials (RCTs) or quasi-RCTs. Studies by which patients suffering intracerebral haemorrhage were excluded. RESULTS: Twelve studies fulfilled the inclusion criteria. We found significant benefits of ShenXiong glucose injection compared with conventional treatment in improving activities of daily living function at 4 weeks (MD = 34.12, 95 % CI: 29.07, 39.17), neurological function deficit at 2 weeks (MD = -5.39, 95% CI: -6.90, -3.87), 4 weeks (MD = -5.16, 95 % CI: -6.49, -3.83), and clinical effects at 4 weeks (RR = 1.17, 95% CI: 1.10, 1.24). No trials reported the effects of ShenXiong glucose injection on the risk of early, deterioration, or quality of life. No adverse events were reported within the whole follow-up period. CONCLUSIONS: The use of ShenXiong glucose injection may improve rehabilitation for patients with acute ischemic stroke, however, as the GRADE approach indicated low to moderate quality of available evidence as well as insufficient information about harm and patients preference, the recommendations were not provided for ShenXiong glucose injection taking as a therapeutic intervention to patients with acute ischemic stroke.

Impact of the Consolidated Standards of Reporting Trials (CONSORT) checklist on reporting of randomized clinical trials in traditional Chinese medicine.

OBJECTIVE: To examine the reporting characteristics and key methodological factors of randomized controlled trials (RCTs) in the field of traditional Chinese medicine and assess whether use of the Consolidated Standards of Reporting Trials (CONSORT) statement is associated with improvement in the quality of reports of RCTs. METHOD: RCTs published in two major traditional Chinese medicine journals were retrieved and were systematically reviewed. Of those journals, one adopted the CONSORT statement (Journal of Chinese Integrative Medicine (JCIM)) and one did not (Chinese Journal of Integrative Medicine (CJIM)). Items within the CONSORT 2001 and the CONSORT 2010 statements were taken to develop a 63-item coding manual. The Jadad scale was also used to assess methodological quality of RCTs. Two observers assessed the reporting of reports and extracted data independently. P < 0.05 was considered statistically significant. SPSS was used for all analyses. RESULTS: A total of 76 RCTs were included for the analysis (38 from JCIM and 38 from CJIM). Significant improvements both in the overall quality of reporting (CONSORT score) and reporting of methodological items (Jadad scale) over time were observed in adopter journal (JCIM) (P = 0.001). Overall CONSORT score of studies published during 2010 to 2011 (post-CONSORT) increased 15.30 averagely with 95%CI 8.34 to 22.26 (P = 0.001). Of those, items addressed on reporting of methodological quality were different significantly too. JCIM had more 1.30 items addressed than CJIM in average (95% CI 0.52 to 2.08, P = 0.003). In the multivariate analysis regression, the page length and CONSORT-promoting status have statistically significant associated with the (P = 0.001 and P = 0.040, respectively). CONCLUSION: Although a large room needs to improve the reporting of randomized clinical trials in traditional Chinese medicine, the impact for improvement of reporting of TCM RCTs has been proven in some extent.

Effectiveness and safety of Wuling capsule for post stroke depression: a systematic review.

OBJECTIVE: To review the effectiveness and safety of Wuling capsule for post stroke depression (PSD) systematically. METHODS: We searched electronic databases for randomized controlled trials (RCTs) that compared either Wuling capsule with placebo, no treatment or Wuling capsule plus conventional treatment with conventional treatment alone in adults with post stroke depression. Relevant resources were also retrieved. Two reviewers screened the citations, assessed the risk of bias and extracted data independently. RESULTS: A total of 16 studies involving 1378 patients were identified for this review. There were 3 trials comparing Wuling capsule with no treatment control and 13 trials comparing Wuling capsule plus conventional treatment (Deanxit, Fluoxetine, Sertraline, Paroxetine or Citalopram) with conventional treatment alone. Meta-analyses indicated Wuling capsule used alone or integrated with conventional treatment was effective for PSD in terms of HAMD (Hamilton depression scale) scores, response rate and with less adverse effects, of which, HAMD scores decreased significantly in favor of Wuling capsule from onset time to 1 week (SMD = 1.27, 95%CI: 0.71-1.83, P < 0.00001), 2 weeks (SMD = 1.45, 95%CI: 0.57-2.33, P = 0.001), 4 weeks (SMD = 2.84, 95%CI: 2.15-3.52, P < 0.00001), 6 weeks (SMD = 2.70, 95%CI: 2.15-3.24, P < 0.00001), and 8 weeks (SMD = 4.53, 95%CI: 3.55-5.50, P < 0.00001) and overall effect (SMD = 2.40, 95%CI: 1.75-3.05, P < 0.00001) (SMD = standardized mean difference). CONCLUSION: Wuling capsule appeared to present certain antidepressant effect compared to no treatment control. With a combination of several Western medicines, Wuling capsule could be helpful in strengthening efficacy and reducing the incidence of adverse events as an alternative choice in the treatment of PSD. However, due to the limited number of included trials and relatively moderate methodological quality in the majority of studies, further large scale and rigorously designed trials are warranted to confirm the effectiveness and safety of Wuling capsule for post stroke depression.

Shuganjieyu capsule for major depressive disorder (MDD) in adults: a systematic review.

OBJECTIVES: Shuganjieyu capsule is a pure herbal pharmaceutical product for depression. Our objective was to explore the effectiveness and safety of Shuganjieyu capsule for the treatment of major depressive disorder in adults. METHOD: Eight computerized databases were searched. In addition, randomized controlled trials (RCTs) on Shuganjieyu capsule were hand-searched on seven key Chinese journals. Data were extracted and evaluated by two reviewers independently. Analysis was performed by intention-to-treat where possible. Prespecified subgroup analyses were different-dose regimens, patient spectrum, publication status, and treatment duration. RESULTS: Seven RCTs with 595 participants were included. Shuganjieyu capsule was superior than placebo in terms of response rate (RR = 2.42, 95% CI: 1.55-3.79; P = 0.0001), remission rate (RR = 4.29, 95% CI: 1.61-11.45; P = 0.004), the scores of the mean change from baseline of the HAM-D17 (MD = -4.17, 95% CI: -5.61 to -2.73; P < 0.00001) and from baseline of traditional Chinese medicine (TCM) syndrome score scale scores (MD = -6.00, 95% CI: -8.25 to -3.75; P < 0.00001). In addition, Shuganjieyu plus venlafaxine had a significantly higher response rate (RR = 1.56, 95% CI: 1.29-1.88; P < 0.00001) and was superior in terms of the scores of the mean change from baseline of the treatment emergent symptoms scale scores (MD = -0.74, 95% CI:-1.12 to -0.35; P = 0.0002) than venlafaxine alone. CONCLUSION: Shuganjieyu capsule is superior to placebo in terms of overall treatment effectiveness and safety. Both response rate and remission rate among patients treated with the combination of Shuganjieyu plus venlafaxine were significantly higher than those treated with venlafaxine alone. Due to the considerable risk of bias in majority of trials, recommendations for practice should be cautious, and additional, well-designed RCTs are needed in next step.

Reliability and External Validity of AMSTAR in Assessing Quality of TCM Systematic Reviews.

Objective. The aim of this study is to measure the reliability and external validity of AMSTAR by applying it to a sample of TCM systematic reviews. Study Design and Methods. We tested the agreement, reliability, construct validity, and feasibility of AMSTAR through comparisons with OQAQ. Statistical analyses were performed by using SPSS 13.0. Results. A random of sample with 41 TCM systematic reviews was selected from a database. The interrater agreement of the individual items of AMSTAR was moderate with a mean kappa of 0.50 (95% CI: 0.26, 0.73). The ICC for AMSTAR against OQAQ (total score of 9 items, excluding item 10) was 0.87 (95% CI: 0.76, 0.93). Conclusions. Although there is room for improvement on few items, the new tool is reliable, valid, and easy to use for methodological quality assessment of systematic reviews on TCM.

Analysis on the distinguishing features of traditional Chinese therapeutics and related statistical issues.

Traditional Chinese medicine (TCM) is one of the rarely existing ancient traditional medicines that hold systematic theories as well as preventative and therapeutic methods for diseases in practice. From the 1950s, such research methods as mathematics, statistics, and data mining (DM) have been gradually introduced to TCM studies, making it more scientific. Meanwhile, the distinct features of TCM theories and diagnostic-model have constantly challenged the methodology of statistics. This paper introduces the following scientific features of traditional Chinese therapeutics: 1) its goal is to balance the functions and conditions of human body; 2) it emphasizes on holism and individualization; 3) it stresses the longitudinal regulation and evaluation mode, which is a circle of syndrome diagnosis, treatment and evaluation; 4) the interventions of TCM are abundant, compound and natural; and 5) humanistic thought is everywhere. Some statistical problems are raised based on these features. First, complex statistical methods that can analyze subjective indexes and latent variables, multidimensional and multistage data, non-equilibrium designed studies, and longitudinal data are required. Second, comprehensive evaluation on multiple-target mechanism has been brought in by combination treatment. Third, there is a need to analyze how humanity and related cultural factors may influence the effect of interventions. Thus, promoting implemented studies of statistics as well as carrying out the TCM scientific propositions have become the common expectations of both TCM and modern medicine.

[Methodological quality assessment of systematic reviews correlated to traditional Chinese medicine published in China].

OBJECTIVE: To assess the methodological quality of systematic reviews or Meta-analysis of traditional Chinese medicine published in China, and to validate the applicability of OQAQ (Overview Quality Assessment Questionnaire) and AMSTAR (a measurement tool to assess systematic reviews) in traditional Chinese medicine (Chinese Medical). METHODS: Comprehensive literature retrieve was performed in CBM, CNKI, VIP as well as hand searching in Chinese Journal of Evidence-Based Medicine. The retrieve was started from January 1, 1999 and terminated by December 2008. The methodological quality of traditional Chinese medicine correlated systematic reviews was evaluated using OQAQ and AMSTAR simultaneously. RESULTS: A total of 115 systematic reviews involved 17 types of diseases, of which, the cardio-/cerebrovascular diseases was dominant (36 papers, 31.30%). The mean OQAQ score was 2.50 (95% CI: 2.22, 2.76). No significant correlation was found in OQAQ score with publication year (P = 0.35) and different disease types (P = 0.28). High consistency was observed in evaluations of systematic reviews by using OQAQ and AMSTAR (both Kappa values > 0.75). Compared with the OQAQ, AMSTAR incorporated 3 additional items: the topics, publication bias, and conflict of interest, etc. Although 98.26% of systematic reviews proposed protocols in prior, 53.04% failed to analyze the publication bias. Besides, 57.39% neglected to address the potential conflict of interest. CONCLUSIONS: Poor methodological quality in systematic reviews of Chinese Medical published in China needs to be improved and emphasized. It is necessary to integrate the special characteristics of traditional Chinese medicine itself when choosing topics of systematic reviews. It is essential to establish quality assessment tools targeting systematic reviews of traditional Chinese medicine.