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Updated: Feb 26, 2026

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia

Published on: February 17, 2023

Ensayo aleatorizado controlado de fase II que compara la medicina tradicional tailandesa a base de cannabis con

Thavatchai Kamoltham¹, Suwadee Chokchaisiri², Chawalit Yongram²

¹Department of Cannabis Health Sciences, College of Allied Health Sciences, Suan Sunandha Rajabhat University, Samut Songkhram, 75000, Thailand. thavatchai.ka@ssru.ac.th.

Journal of cannabis research

|February 24, 2026

Abstracto

Background:

A traditional Thai cannabis-based multi-herbal formulation is legally recognized in Thailand for therapeutic use and clinical research. However, clinical evidence supporting its use for insomnia remains limited.

Methods:

This Phase II randomized, double-blind, active-controlled non-inferiority trial compared the efficacy and safety of the Anti-Pom-Leung Fever medicine with lorazepam in patients with chronic insomnia. One hundred participants were randomized to receive either the herbal formulation or lorazepam for 4 weeks. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Non-inferiority was evaluated at week 4 using a predefined margin of 2.1 based on the upper bound of the two-sided 95% confidence interval for the mean PSQI difference (experimental minus comparator). Longitudinal changes were analyzed using repeated-measures analysis of variance, and safety was evaluated through clinical and laboratory assessments.

Results:

Eighty-two participants completed the study (41 per group). Baseline characteristics were comparable between groups. Both treatments significantly improved sleep quality over 4 weeks. At week 4, mean PSQI scores were 3.44 in the experimental group and 4.78 in the comparator group, with a mean difference of -1.34 (95% CI: -2.99 to 0.31), demonstrating non-inferiority. A significant main effect of time on PSQI scores was observed, with no significant time-by-treatment interaction. Quality of life and stress improved in both groups, and safety profiles were comparable, with no clinically significant adverse effects.

Conclusions:

The traditional Thai cannabis-based multi-herbal formulation demonstrated non-inferior efficacy to lorazepam and was well tolerated, supporting its use as a short-term alternative for chronic insomnia.

Palabras clave:

Medicina Anti-Pom-Leung para la Fiebre Medicina Complementaria y Alternativa Tratamiento del Insomnio Cannabis Medicinal Medicina Herbal Tailandesa

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