OBJECTIVETo subjectively and objectively assess the effect of Jiawei Xiaoyao Powder (JXYP) on sleep in patients with psychological stress insomnia. METHHODS: A randomized controlled study was conducted in 33 patients with psychological stress insomnia. They were assigned to 4 groups, 4 in the TCM group treated with JXYP, 5 in the Western medicine (WM) group treated with Estazolam, 9 in the integrated medicine (IM) group treated with JXYP plus Estazolam, and 10 in the control group treated with placebo. Quality of sleep in patients was assessed subjectively and objectively before treatment and 6 weeks after treatment by Pittsburgh sleep quality index (PSQI), self-rating scale of sleep (SRSS) and polysomnography (PSG), respectively.

RESULTSSubjective assessment on sleep showed that after 6-week treatment, the scores of PSQI and SRSS remarkably reduced in the TCM, IM and control groups (P < 0.05), while the decrease was insignificant in the WM group (P > 0.05), but no significant difference between groups was shown. The objective assessment by PSG showed that no significant change was found after treatment in parameters of total sleep time (TST), sleep time of phase 1 and 2, slow wave phase, rapid-eye-movement (REM) phase, sleep latency, REM sleep latency, also in long waking and short waking times in all group (P > 0.05), but a significant increase of sleep efficacy (P < 0.05) and an increasing trend of TST (P > 0.05) were shown in the IM group, and an increasing trend of both in the TCM group (P > 0.05).

CONCLUSIONJXYP, combined with or without Estazolam, can improve the quality of sleep subjectively, and the combination of the two could enhance the efficacy of sleep in patients with psychological stress insomnia.