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Background <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusions <p>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.</p>

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Phase II randomized controlled trial comparing traditional Thai cannabis-based medicine with lorazepam for insomnia treatment

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  • 发表日期：

    2026年2月24日

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  • Thavatchai Kamoltham,
  • Suwadee Chokchaisiri,
  • Chawalit Yongram,
  • Panupan Sripan,
  • Surasak Im-iam,
  • Panupong Sanasit,
  • Varanon Intaravattana,
  • Chatchai Sawasdichai,
  • Patpong Udompat,
  • Tanawat Chaiphongpachara,
  • Tanawan Kummalue

摘要

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.