Abstract:
OBJECTIVE To evaluate the clinical efficacy of modified Guipi Decoction combined with Chaihu Jia Longgu Muli Decoction in the treatment of adolescent sleep disorders with the traditional Chinese medicine (TCM) pattern of heart-spleen deficiency combined with liver depression transforming into fire, and to investigate its effects on sedative-hypnotic reduction or discontinuation, chronotype, and nocturnal sleep status.
METHODS A multicenter, prospective cohort study was conducted. A total of 106 adolescents with sleep disorders were divided into TCM group and a control group according to their treatment preferences, with 53 patients in each group. During the study, 7 patients in the TCM group and 8 patients in the control group dropped out, and 46 and 45 patients, respectively, were ultimately included in the analysis. The control group received cognitive behavioral therapy for insomnia (CBT-I) as the first-line treatment; patients who were unable to accept CBT-I or had responded poorly to previous CBT-I were prescribed zolpidem tartrate after medical evaluation. The TCM group received modified Guipi Decoction combined with Chaihu Jia Longgu Muli Decoction. Both groups were treated for 1 month. Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Athens Insomnia Scale (AIS) scores were assessed at baseline and at 1, 3, and 6 months, while the 9-item Patient Health Questionnaire (PHQ-9) was assessed at baseline and at 1 month. Clinical efficacy, sedative-hypnotic reduction or discontinuation, chronotype, objective sleep-monitoring parameters, and adverse reactions were also evaluated.
RESULTS At 1, 3, and 6 months, the overall response rates in the TCM group were higher than those in the control group at the corresponding time points (all P<0.05). PSQI, ISI, and AIS scores decreased from baseline in both groups, with greater reductions in the TCM group than in the control group (P<0.05). At 1 month, PHQ-9 scores decreased from baseline in both groups, and the reduction was greater in the TCM group (P<0.05). At the 6-month follow-up, the sedative-hypnotic reduction or discontinuation rate was higher in the TCM group than in the control group (P<0.05). Chronotype showed a trend toward an earlier type in both groups, with a more pronounced change in the TCM group (P<0.05). Objective sleep monitoring showed that total sleep duration, deep sleep duration, rapid eye movement sleep duration, and sleep scores were higher, whereas the number of nocturnal awakenings was lower, in the TCM group than in the control group (P<0.05). No serious adverse reactions occurred in either group.
CONCLUSION Modified Guipi Decoction combined with Chaihu Jia Longgu Muli Decoction can improve insomnia symptoms and sleep quality in adolescents with sleep disorders of heart-spleen deficiency combined with liver depression transforming into fire pattern, and can contribute to sedative-hypnotic reduction or discontinuation, chronotype adjustment, and improvement in nocturnal sleep status.
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