A Controlled Trial of Chinese Herbal Medicine for Premenstrual Syndrome

Background. Chinese herbal medicine Dingji Fumai Decoction (DFD) is widely clinically used for ventricular premature contraction (VPC). This real-word trial was designed to assess the safety and effectiveness of DFD for VPC. Methods. This was a double-blinded, randomized placebo-controlled trial. Patients with VPC were randomized (1 : 1) to treatment with DFD combined with metoprolol (DFD arm) or metoprolol combined with placebo (MET arm). A primary end point was a composite of clinical symptoms and signs determined by the traditionalChinese medicine syndrome score and the number of VPC determined by the Holter examination. Second outcomes were adverse events, medication compliance, and laboratory examination. Results. 144 patients were randomized to DFD arm (76 patients) or MET arm (68 patients), and 136 cases (71 in DFD arm and 65 in MET arm) finally completed this trial. After a 12-week follow-up, DFD arm significantly decreased traditional Chinese medicine syndrome score and the number of VPC compared with MET arm (P=0.003 and 0.034, respectively). There was no adverse drug effect and patient medication compliance was good. Conclusions. Superiority with DFD arm for VPC was demonstrated over MET arm for both the safety and effectiveness end points.

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Efficacy of Chinese Herbal Medicine Jiangniaosuan Formula for Treatment of Hyperuricemia: Study Protocol For A Double-Blinded Non-Inferiority Randomized Controlled Clinical Trial

10.21203/rs.3.rs-707319/v1 ◽

2021 ◽

Author(s):

Yafang Guo ◽

Hong Lu ◽

Jing Gan ◽

Dongdong Li ◽

Jiandong Gao ◽

...

Keyword(s):

Herbal Medicine ◽

Chinese Herbal Medicine ◽

Serum Uric Acid Level ◽

Controlled Trial ◽

Secondary Outcome ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Chinese Herbal ◽

To Receive ◽

Be The Change

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.

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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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