Abstract
Insomnia disorder is a widespread and refractory disease. Semen Ziziphi Spinosae, Suanzaoren, a well-known Chinese herbal medicine, has been used for treating insomnia for thousands of years. Here, we aimed to assess the available evidence of Chinese herbal formulae that contains Suanzaoren (FSZR) for insomnia according to high-quality randomized controlled trials (RCTs) and reviewed their possible mechanisms based on animal-based studies. Electronic searches were performed in eight databases from inception to November 2016. The primary outcome measures were polysomnography index and Pittsburgh sleep quality index. The secondary outcome measures were clinical effective rate and adverse events. The methodological quality of RCTs was assessed by Cochrane's collaboration tool, and only RCTs with positive for 4 out of 7 for the Cochrane risk of bias domains were included in analyses. Thirteen eligible studies with 1,454 patients were identified. Meta-analysis of high-quality RCTs showed that FSZR monotherapy was superior to placebo (P < 0.01); FSZR plus Diazepam was superior to Diazepam alone (P < 0.05); there were mixed results comparing FSZR with Diazepam (P > 0.05 or P < 0.05). Furthermore, FSZR caused fewer side effects than that of Diazepam. Suanzaoren contains complex mixtures of phytochemicals including sanjoinine A, Jujuboside A, spinosin and other flavonoids, which has sedative and hypnotic functions primarily mediated by the GABAergic and serotonergic system. In conclusion, the findings of present study supported that FSZR could be an alternative treatment for insomnia in clinic. FSZR exerted sedative and hypnotic actions mainly through the GABAergic and serotonergic system.
Highlights
Insomnia is characterized by sustained difficulties in initiating or maintaining sleep and cause significant impairment of daytime functioning (American Academy of Sleep Medicine, 2014)
The findings demonstrated that FSZR used as a monotherapy was superior to placebo and as an adjunct therapy was superior to Diazepam alone in terms of PSQI score and clinical effective rate, whereas there were mixed results comparing FSZR with Diazepam directly
The findings demonstrated that FSZR therapy was effective and well tolerated for insomnia through sedative and hypnotic actions primarily mediated by the GABAergic and serotonergic system
Summary
Insomnia is characterized by sustained difficulties in initiating or maintaining sleep and cause significant impairment of daytime functioning (American Academy of Sleep Medicine, 2014). Based on the International Classification of Sleep Disorder (ICSD)-3 of the American Academy of Sleep Medicine, chronic insomnia disorder referred to these symptoms that cause clinically significant functional distress or impairment at least three nights per week for at least 3 months, excluding other medical or mental disorders (Morin et al, 2006b). The treatments of insomnia include pharmacological therapies, psychological and behavioral therapies, and complementary and alternative therapies (CAM) (Krystal, 2009). The limited use of these pharmacological treatments is due to the undesirable side-effects such as performance and memory impairment, residual sedation, falls, undesired behaviors during sleep, somatic symptoms, and drug interactions (Wilt et al, 2016). There are rising numbers of insomniac patients who seek to various kinds of CAM around the world
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