The Effect of Zao Ren An Shen Capsule on Insomnia among Patients with Anxiety: A Randomized Controlled Trial

Abstract

Background. Zao Ren An Shen capsule (ZRASC) is one of the most widely used Chinese herbal medicine (CHM) in treating insomnia, but its effect on insomnia patients with anxiety remains unclear. We aimed to examine the effect of ZRASC combined with alprazolam in anxiety patients compared with those only with alprazolam prescription. Methods. We conducted a single-blind, parallel-group, randomized trial involving persons from 2 hospitals in China. Participants were randomly assigned in a 1 : 1 ratio to the intervention group, in which the participants were provided with ZRASC and alprazolam, or to the control group, in which the participants were provided with alprazolam. The primary outcomes were insomnia symptoms measured by the insomnia severity index (ISI). The secondary outcomes were anxiety symptoms measured with the Hamilton anxiety rating scale (HAMA). All participants were followed up at 2-week and 4-week after the treatment. The effect was estimated using the mixed-effect models. Results. A total of 334 patients were enrolled in the trial. 167 of them (mean (SD) age, 44.4 (12.8) years; 43.1% female) were assigned to the usual treatment group, while 167 (mean (SD) age, 46.0 (13.4) years; 43.7% female) were assigned to the ZRASC group. From baseline to the 4-weekfollow-up, the mean differences in ISI and HAMA scores between the ZRASC group and the usual care group were −2.542 and −2.563, respectively (both $p<0.001$ ). Patients in the ZRASC group were more likely to have remission of insomnia and anxiety than those in the control group at the 4-weekfollow-up, with incidence rate ratios of 265% and 213%, respectively (both $p<0.001$ ). Proportions of remission were 74.93% ( $p<0.001$ ) for insomnia and 85.80% ( $p<0.001$ ) for anxiety at 4-weekfollow-up. Conclusions. This randomized study showed that adjunctive treatment with ZRASC was able to reduce insomnia and anxiety symptoms at the 4-weekfollow-up. Trial Registration. This study was registered in the Chinese Clinical Trial Registry (ChiCTR1800019913).