Chinese herbal medicine for insomnia: a systematic review of randomized controlled trials.

Chinese herbal medicine (CHM), either in single herb or in herbal formula, has been used to treat insomnia for more than 2000 years. A systematic review including Chinese and English literature of randomized controlled trials was conducted to examine the efficacy, safety, and composition of CHM for insomnia. Among the 217 studies we have reviewed, only eight had a Jadad score ≥3, and seven out of these eight studies had at least one domain with high risks of bias. Meta-analyses of the studies with Jadad score ≥3 found that CHM was similar to Western medication (three studies) and placebo (three studies) in treating insomnia. Due to the poor methodological quality of the studies and the small number of trials included in meta-analyses, the current evidence is insufficient to support the efficacy of CHM for insomnia. The frequency of adverse events associated with CHM was similar to that of placebo, but lower than with Western medication. Gui Pi Tang was the most commonly used standardized formula, while Suan Zao Ren (Ziziphus jujuba) was the most frequently used single herb. Further studies with a double-blind placebo-controlled design are needed to accurately determine the benefits and risks of CHM for insomnia.

Yeung WF ，Chung KF ，Poon MM ，Ho FY ，Zhang SP ，Zhang ZJ ，Ziea ET ，Wong VT ... -  《-》

Updated clinical evidence of Chinese herbal medicine for insomnia: a systematic review and meta-analysis of randomized controlled trials.

This systematic review is to evaluate the efficacy and safety of Chinese herbal medicine (CHM) for people with insomnia. Randomized controlled trials (RCTs) investigating oral CHM alone or in combination with conventional therapies for primary insomnia were identified by searching English and Chinese publications and databases of clinical trial registration. Risk of bias was assessed according to the Cochrane Handbook 5.1. Meta-analysis was conducted using RevMan 5.2.4. Seventy-nine trials (7886 participants) were finally included in the review, and 76 were included in the meta-analysis. Twenty-seven trials reported the methods of random sequence generation, and five of them used the allocation concealment. Blinding of participants and personnel were used in 10 studies. The main meta-analysis showed that CHM alone was more effective than placebo by reducing scores of Pittsburgh Sleep Quality Index (mean difference, MD: -3.06, 95% confidence interval, CI: -5.14 to -0.98, I(2) = 97%) and benzodiazepine drugs (BZDs) (MD: -1.94, 95% CI: -2.45 to -1.43, I(2) = 96%). The effect was also seen when CHM was combined with BZDs compared with placebo plus BZDs (MD: -1.88, 95% CI: -2.78 to -0.97, I(2) = 0%) or cognitive and behavioral therapy (MD: -3.80, 95% CI: -4.91 to -2.68, I(2) = 68%) alone. There was no significant difference between CHM and placebo regarding the frequency of adverse events (relative risk, RR: 1.65, 95% CI: 0.67-4.10, I(2) = 0). Overall, oral CHM used as a monotherapy or as an adjunct to conventional therapies appears safe, and it may improve subjective sleep in people with insomnia. However, the typical effect of CHM for insomnia cannot be determined due to heterogeneity. Further study focusing on individual CHM formula for insomnia is needed. The development of a comparable placebo is also needed to improve the successful blinding in RCTs.

Ni X ，Shergis JL ，Guo X ，Zhang AL ，Li Y ，Lu C ，Xue CC ... -  《-》

Traditional Use of Chinese Herbal Medicine for Insomnia and Priorities Setting of Future Clinical Research.

Ni X ，Shergis JL ，Zhang AL ，Guo X ，Lu C ，Li Y ，Xue CC ... -  《-》

Efficacy and safety of Wuling capsule, a single herbal formula, in Chinese subjects with insomnia: a multicenter, randomized, double-blind, placebo-controlled trial.

Wuling Capsule is a single herbal formula from mycelia of precious Xylaria nigripes (Kl.) Sacc and its pharmacological function have a tranquilizing effect on the central nervous system. The aim of the study to evaluate the efficacy and safety of Wuling capsule in treatment of insomnia. We performed a multicenter, randomized, double-blind, placebo-controlled study. The participants received either placebo (n=92) or Wuling capsule (n=94) for 4 weeks and a follow-up period for 2 weeks. Compared between pre-treatment and post-treatment, the global Pittsburgh sleep quality index (PSQI) scores in both Wuling capsule group and placebo group improved significantly (P<0.01). However, there was no significant difference between Wuling capsule group and placebo group (P>0.05). Scores of clinical global impressions scale (CGI-I) at each week in Wuling capsule group was similar to those in placebo group (P>0.05). Compared between pre-treatment and post-treatment, scores of the four components of world health organization on quality of life brief scale (WHOQOL-BREF) in both Wuling capsule group and placebo group improved significantly (P<0.01). However, there were no difference between the two groups (P>0.05). The rate of adverse events was 10.10% in Wuling group, and 6.73% in placebo group (P>0.05). Wuling capsule can improve insomnia when compared with pre-treatment for 4 weeks and be a well tolerated by all the patients at the 6 weeks of study period. However, there are no significant in the results of the variables tested when compared with placebo control. Further additional rigorous randomized clinical trials are still required.

Lin Y ，Wang XY ，Ye R ，Hu WH ，Sun SC ，Jiao HJ ，Song XH ，Yuan ZZ ，Zheng YY ，Zheng GQ ，He JC ... -  《-》

Zao Ren An Shen for insomnia: a systematic review with meta-analysis.

To assess the effectiveness and safety of Zao Ren An Shen (ZRAS), a Chinese herbal medicine formula, for the treatment of insomnia. Seven databases (ie, EMBASE, PubMed, the Cochrane library, and PsycINFO, Chinese National Knowledge Infrastructure, Wanfang and Chongqing VIP) were searched from their inception to 6 November 2018. Controlled trials comparing the effectiveness or safety of ZRAS to conventional treatments, a placebo or no-treatment in an insomnia population were selected. Primary outcomes were: sleep quality (assessed with the Pittsburgh Sleep Quality Index, PSQI), and the number of adverse events at post-treatment. The risk of bias was assessed with the Cochrane Collaboration's tool and meta-analyses were performed using RevMan 5.3. A total of 19 studies (1780 participants) were included. The effect of ZRAS on sleep quality (mean difference) was found to be superior compared to placebo in the sole placebo-controlled study located [-0.90 (-1.56, -0.24; 95% CI), p = 0.007] and similar to Benzodiazepine Receptor Agonists (BzRAs) [0.17 (-0.29, 0.64); 95% CI, p = 0.46]. The number of adverse events (relative risk) was lower for ZRAS than BzRAs [0.16 (0.12, 0.23; 95% CI), p < 0.001]. An overall high risk of bias was found in the selected studies. The results favor ZRAS against BzRAs and placebo for the treatment of insomnia. However, the poor methodology of the studies prevents strong recommendations for ZRAS. Clinical trials with higher quality designs are required.

Birling Y ，Jia M ，Li G ，Sarris J ，Bensoussan A ，Zhu X ... -  《-》