The Study of Efficacy and Safety of a Modified Chaihu Shugan San Formula in the Treatment of Insomnia Associated with Stress: A Pilot Clinical Evaluation

Abstract

This pilot study aimed to evaluate the preliminary efficacy and safety of a modified Chaihu Shugan San formula (柴胡疏肝散加减方) in the treatment of insomnia associated with stress. Based on the theoretical framework of Traditional Chinese Medicine (TCM), "Liver Qi stagnation" (肝气郁结) serves as a key pathogenic mechanism underlying sleep disturbances. A quasi-experimental pre–post design was employed in a purposively selected sample of 30 patients aged 18–70 years. While the lack of a randomized control arm limits absolute internal validity against placebo effects, this preliminary evaluation incorporated both subjective metrics—the Suanprung Stress Test (SPST-20) and the Pittsburgh Sleep Quality Index (PSQI)—and objective laboratory safety biomarkers. Participants received the standardized herbal powder twice daily for 4 weeks. After treatment, mean PSQI scores significantly decreased from 12.300 \pm 3.164 to 6.833 \pm 4.145 (p < 0.05). Concurrently, stress levels measured by the ST-5 and SPST-20 declined significantly (p < 0.05). Regarding safety, over 90% reported no clinical adverse events. Crucially, pre- and post-treatment laboratory data for liver (ALT, AST) and renal (Creatinine, BUN) functions remained within normal physiological ranges, indicating no detectable hepatotoxicity or nephrotoxicity. In conclusion, these findings offer promising preliminary evidence supporting the formula's potential, though rigorous randomized controlled trials are required to establish definitive efficacy.