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.

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.

[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.