Comparative efficacy and safety of Chinese patent medicines for primary insomnia: A systematic review and network meta-analysis of 109 randomized trials.

Chinese patent medicine (CPM) is formulated using Chinese herbal medicines as raw materials according to prescribed methods and preparation processes. It is one of the most commonly used complementary and alternative therapies for insomnia in China. Dozens of CPMs have been applied in clinical settings to treat primary insomnia, and ample evidence has proven the efficacy and safety of various CPMs. We aimed to use the network meta-analysis method to simultaneously compare the efficacy and safety of Chinese patent medicines for primary insomnia. We systematically searched eight databases from their inception to July 2022. The relevant randomized controlled trials (RCTs) were eligible if they compared one CPM or one CPM plus a Western drug with another CPM or with Western drug/placebo in adults with primary insomnia. Two reviewers independently performed literature screening, data extraction, and risk of bias assessment. We evaluated the certainty of evidence utilizing CINeMA (Confidence in Network Meta-Analysis) framework. A total of 109 RCTs involved 11,488 patients (54.26% female) with a median age of 47.97 years. Forty-five CPMs were assessed in this study. Compared with placebo and Benzodiazepine drugs, Shugan Jieyu capsules, Shenqi Wuweizi tablets, and Tianmeng oral liquid/capsules combined with Benzodiazepine drugs significantly improved sleep quality. Compared to Benzodiazepine drugs, both Shenqi Wuweizi tablets and Anshen Bunao liquid/granules significantly prolonged subjective total sleep duration and reduced sleep onset latency. Considering safety, all CPMs showed an insignificant difference or lower risk of gastrointestinal and dizziness events compared to Western drugs or placebo. The certainty of evidences was rated as low or very low. This meta-analysis demonstrated the efficacy and safety of CPMs for primary insomnia, especially several CPMs such as Shugan Jieyu capsules, Shenqi Wuweizi tablets and Tianmeng oral liquid, which have shown their potential benefits. However, the present conclusions are based on low quality trials. Well-designed trials, including rigorous methods and patient-important outcomes, are required to verify these results.

Ma N ，Pan B ，Yang S ，Lai H ，Ning J ，Li Y ，Liu J ，Huang J ，Ma Y ，Hou L ，Li D ，Deng X ，Wang X ，He X ，Liu X ，Liu Y ，Jin J ，Tian J ，Ge L ，Zhao H ，Yang K ... -  《-》

[Network Meta-analysis of efficacy and safety of Chinese patent medicines in treatment of insomnia].

Shi ML ，Zhao M ，Wang YH ，Sun TY ，Li XL ，Ren F ，Bian SB ，Cui ZH ，Li SS ... -  《-》

Efficacy and safety of Chinese patent medicines combined with conventional therapies for endometriosis: A systematic review and bayesian network meta-analysis.

Conventional hormonal treatments for endometriosis (EMs) are often associated with significant side effects. In recent years, many clinical trials and studies have highlighted the remarkable efficacy of Chinese patent medicines (CPMs) in alleviating endometriosis-related pain, reducing CA125 markers, regulating hormone levels, and preventing symptom recurrence. Numerous randomized controlled trials (RCTs) have been conducted on CPMs such as Shaofu Zhuyu Decoction (SZD), Dan'e Fukang Plaster (DFP), Sanjie Zhentong Capsule (SZC), Guizhi Fuling Capsule (GFC), Xiaojin Capsule (XC), Gongliu Xiao Capsule (GLXC), Xuefu Zhuyu Capsule (XZC), Jingtong Yushu Granule (JYG), Zhitong Huazheng Capsule (ZHC), and Kuntai Capsule (KTC) for the treatment of endometriosis. However, these studies have yet to be evaluated through a network meta-analysis (NMA) compliant with PRISMA standards. This study aimed to compare the efficacy and safety of ten CPMs for treating EMs through a NMA on RCTs. PubMed, Cochrane, Embase, Web of Science, China National Knowledge Infrastructure, VIP Information, WanFang, and China Biomedicine databases were searched up to October 2024 for studies on the efficacy and safety of CPMs in treating EMs. Two researchers independently screened the studies, extracted data, and assessed quality using the Cochrane Risk of Bias 2.0 tool and the Confidence in Network Meta-Analysis framework. The NMA was conducted using Bayesian methods with StataSE and Rstudio, generating network diagrams, league tables, and Surface Under the Cumulative Ranking (SUCRA) line charts. This study was registered with PROSPERO (CRD42023477523). 148 eligible trials involving 10 CPMs and 16198 participants were included in this NMA; all subsequent estimates refer to the comparison with conventional therapies. All 10 CPMs effectively improved the total effective rate and VAS pain scores. SZC induced the most significant improvement in total effective rate(compared to hormone therapy: risk ratio 5.51, 95% confidence interval 4.21 to 7.2, SUCRA 86.3%, moderate confidence of evidence; compared to GnRH-a: 4.74, (3.18-7), moderate confidence of evidence). DFP proved to be the most effective CPM for lowering the VAS pain scores. (compared to hormone therapy: mean difference -2.1, (-2.94 to -1.29), 78.8%, moderate confidence of evidence; and GnRH-a (-2.07, (-2.73 to -1.41), low confidence of evidence). Moreover, this study demonstrated the safety of CPMs, particularly in reducing hormonal and liver-related side effects. Specific CPMs like XZC, SZC, DFP, KTC, and GFC showed markedly lower relative risks of adverse events when compared to conventional therapies. Chinese patent medicine may effectively treat EMs, excelling in total effective rate, pain relief, CA125 reduction, and safety. Nevertheless, these findings are preliminary and require validation through high-quality studies.

Huang W ，Liu T ，Yu Y ，Ou X ，Chen L ，Tang X ，Fang X ，Ling J ，Du X ... -  《-》

[Network Meta-analysis of Chinese patent medicines of Ziziphi Spinosae Semen in treatment of primary insomnia].

Yao WQ ，Zhao YH ，Zheng YW ，Zhang Q ，Han X ... -  《-》

Comparative efficacy and safety of Chinese patent medicines as an adjunctive therapy for diabetic peripheral neuropathy: systematic review and network meta-analysis of randomized controlled trials.

Wang Q ，Xie H ，Wang Z ，Huang R ，Xu M ，Li Y ，Shan L ，Zhang H ，Liu X ，Zhang H ，Xu Y ，Sun S ... -  《-》