Tianzhi granule improves cognition and BPSD of vascular dementia: a randomized controlled trial.

BACKGROUND AND PURPOSE: Tianzhi granule (TZ) is usually used for patients with vascular dementia (VaD) in China. The aim was to assess the effect of TZ by a randomized clinical trial (RCT). METHODS: A 24-week RCT was conducted in 16 centres. Participants were grouped into TZ, donepezil or placebo. The co-primary outcomes were the Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog) and Clinician's Interview-based Impression of Change-plus caregiver information (CIBIC-plus). RESULTS: A total of 543 patients with mild to moderate VaD were enrolled, of whom 242 took TZ granules, 241 took donepezil, and 60 took placebo. The least-squares mean changes from baseline and 95% CI were 6.20 (5.31, 7.09) (TZ group), 6.53 (5.63, 7.42) (donepezil group) and 3.47 (1.76, 5.19) (placebo group), both TZ and donepezil showed small but significantly improvement compared with placebo group. The percent of improvement on the global impression which was measured by CIBIC-plus was 73.71% in TZ and 58.18% in placebo, there was significant different between TZ and placebo group (P = 0.004). No significant differences were observed between TZ and donepezil. No significant differences of adverse events were found. CONCLUSIONS: TZ and donepezil could bring symptomatic benefit for mild to moderate VaD. Trial registration The protocol had retrospectively registered at clinical trial.gov, Unique identifier: NCT02453932, date of registration: May 27, 2015; https://www.clinicaltrials.gov/ct2/show/NCT02453932?term=NCT02453932&rank=1.

Efficacy and Safety of Toutongning Capsule in Patients with Migraine: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Objective: Toutongning (TTN) capsule, a Chinese patent medicine, is used as a prophylactic treatment for migraine. The present study was conducted as a postmarketing evaluation of the efficacy and safety of TTN capsule. Design: A randomized, double-blind, placebo-controlled trial. Location: Patients recruited from 14 medical centers in China from May 2014 to August 2015. Subjects: Patients between 18 and 65 years of age with a diagnosis of migraine. Interventions: The patients were randomly assigned to receive either TTN (1200 mg, three times daily) or a matched placebo (1:1) for 4 weeks. Outcome measures: The primary outcome measured was a minimum 50% reduction in the frequency of headaches from the 4-week baseline period to the last 4 weeks of the 12-week trial. Secondary outcomes included duration, days, and visual analog score of headache attack, interval between headache attacks, usage of acute analgesics, and score on the Headache Impact Test-6. In addition, all patients were evaluated for adverse events (AEs). Results: This study initially enrolled 400 patients; a total of 378 participants completed the experiment while fulfilling all study requirements. TTN had a superior effect compared with the placebo on both the primary and secondary outcome measures without any serious AEs or unexpected side effects. Conclusion: TTN can effectively prevent the occurrence of migraine headaches and is well-tolerated and safe. TTN may exhibit a persistent therapeutic effect even after cessation of use. Trial Registration number: ChiCTR-IPR-15007058.

Efficacy and Safety of Chinese Herbs for the Prevention of the Risk of Renal Damage in Henoch-Schonlein Purpura in Children: Meta-Analysis of Randomized Controlled Trials and GRADE Evaluation.

Objective. To evaluate the efficacy and safety of traditional Chinese medicine in preventing kidney damage caused by Henoch-Schonlein Purpura (HSP) in Children by meta-analysis. Methods. We systematically searched the main Chinese and English electronic databases and collected randomized controlled trials of Chinese herbs in children with HSP until July 2018. Then we used the bias risk assessment tool in Cochrane Handbook 5. 1. 0 to complete the risk assessment of the included studies. We utilized STATA12.0 and RevMan 5.3 for meta-analysis and GRADE pro. for quality evaluation of evidence. Result. (1) Meta-analysis: data from 39 studies, representing 3643 individuals, were included in the analysis. Thirty-seven studies were treated with traditional Chinese medicine for clearing away heat and cooling blood, which were combined. On this basis, subgroup analysis was conducted according to the bias risk of the original study. It showed that Chinese herbs can significantly improve the treatment effect (OR: 4.31, 95% CI [3.34, 5.57], P < 0.01) and reduce the risk of renal damage (RR: 0.36; 95% CI [0.21, 0.61], P < 0.01) and the risk of recurrence (RR: 0.43, 95% CI [0.34, 0.54], P<0.01). (2) Side effect: a total of 7 studies described adverse reactions, and 12 of 319 patients in therapy group had adverse events and 20 of 263 patients in control group. (3) Publication bias: the bias risk Egger's test for the incidence of kidney injury was P=0.572, the relapse rate Egger's test was P=0.175, the efficiency was combined with the low-risk original study, and the bias risk Egger's test was P=0.175. There was not any significant publication bias based on the funnel plot and Egger's test. (4) GRADE evaluation: GRADE evaluation showed that the quality of evidence in the risk of renal damage and recurrence rate was moderate. Conclusion. Chinese medicine treatment can prevent the occurrence of renal damage in children with HSP and can reduce the recurrence rate, the incidence of adverse reactions, and the effect in terms of efficiency. However, the quality of the included studies in the meta-analysis and the quality of the evidence of outcomes were not high; the clinical use of the evidence needs to be cautious.