A double-blind comparative study of Chinese herbal medicine Jinlianqingre Effervescent Tablets in combination with conventional therapy for the treatment of uncomplicated hand, foot, and mouth disease

Background.This study was made to evaluate the efficacy of Chinese herbal medicines, Reduning injection, and a traditional Chinese medicine (TCM) granule, in patients with severe hand, foot, and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial.Methods.355 severe HFMD patients were randomly assigned to receive conventional therapy alone, Reduning injection plus conventional therapy, or TCM enema plus conventional therapy for 7–10 days.Results.There was no significant difference in the incidence of major complications between the groups. Median time to fever clearance was 20 hours (95% CI: 6.0–25.0) for conventional therapy recipients, 18 hours (95% CI: 4.0–24.0) for Reduning combination-treated patients, and 6 hours (95% CI: 4.0–16.0) for TCM combination-treated patients. Only the difference in time to fever clearance between TCM combination group and conventional group reached statistical significance (P=0.048). Reduning combination group showed a significant reduction in sedative administration compared with conventional therapy group (P=0.008). No HFMD-related death and no important adverse events were observed.Conclusions.Reduning injection plus conventional therapy significantly reduced the concomitant use of sedatives, which may help decrease HFMD-related neurologic complications in children. TCM effectively reduced time to fever clearance and may become a complementary therapy for relieving the symptoms of severe HFMD.

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Efficacy of quxie capsule in metastatic colorectal cancer: Update of a double-blind, randomized, placebo controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e15030 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e15030-e15030

Author(s):

Tong Zhang ◽

Wenting He ◽

Yun Xu ◽

Bin He ◽

Yufei Yang

Keyword(s):

Colorectal Cancer ◽

Treatment Group ◽

Herbal Medicine ◽

Metastatic Colorectal Cancer ◽

Chinese Herbal Medicine ◽

Conventional Therapy ◽

Controlled Trial ◽

Control Group ◽

Double Blind ◽

Chinese Herbal

e15030 Background: To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer (mCRC). Methods: This is a update of a randomized, double-blind, placebo-controlled trial. Between April 2014 and July 2015, 121 patients were enrolled in the study. Sixty patients were eligible and randomized to the two groups at a 1:1 ratio. Treatment group received conventional therapy and Chinese herbal medicine combined with Quxie Capsule for 3 months. Control group received conventional therapy and Chinese herbal medicine combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). As of Dec 31st 2018, one patient in the control group was still alive, and all the other patients reached the main clinical endpoint. Median follow-up time was 19.4 months. Bo Ao Tong (Beijing) Medical Technology Co. Ltd. was responsible for the protocols of blind and block randomization. Results: The median OS were 23.9 months in the treatment group [95% confidence interval (CI) 15.9–28.5] vs. 14.3 months in the control group (95% CI 11.3–21.4) (Kaplan–Meier, Log-rank P=0.032), hazard ratio (95%CI)= 0.55 (0.31, 0.95), P=0.04. In the subgroups of left-sided colon, RAS wild type, non-targeted therapy, colon cancer and ≥second-line therapy, the median OS of the treatment group and the control group were respectively: 20.9 vs 12.2m, 17.4 vs 14.4m, 20.8 vs 12.0m, 25.1 vs 18.5m, 25.1 vs 12.0m ( P=0.037, 0.019, 0.022, 0.018, 0.007). There were no significant differences between the two groups in PFS. Conclusions: Quxie Capsule showed good efficacy, can reduce the risk of death and prolong the OS of patients with mCRC. Clinical trial information: ChiCTR-IOR-16009733.

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Zao Ren An Shen capsule for insomnia: A double-blind, randomized, placebo-controlled trial

SLEEP ◽

10.1093/sleep/zsab266 ◽

2021 ◽

Author(s):

Yoann Birling ◽

Xiaoshu Zhu ◽

Nicole Avard ◽

Caterina Tannous ◽

Paul P Fahey ◽

...

Keyword(s):

Herbal Medicine ◽

Adverse Events ◽

Chinese Herbal Medicine ◽

Controlled Trial ◽

Double Blind ◽

Subjective Sleep ◽

Chinese Herbal ◽

Cohen’S D ◽

Cohen's D ◽

Insomnia Severity

Abstract Study Objectives The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. Methods We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for four weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events. Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. Results A non-significant (p > 0.05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with adverse events was not significantly different (p > 0.05) between the two groups. Except for subjective sleep onset latency, which had a non-significant (p > 0.05) medium effect (Cohen’s d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen’s d < 0.4) and non-significant (p > 0.05). The acceptability and tolerability were high in the active group. Conclusions ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.

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