Background:Complementaryandalternativemedicinetreatmentforinsomniahasbeensoughtduetothepossible adverse effects of conventional pharmacotherapies. We performed a preliminary evaluation ofthe feasibility of using, and of the effect of a herbal tea (HT002), based on Traditional East Asian Medicine,in mild-to-moderate insomnia.Methods:Patients (n=40) with mild-to-moderate insomnia were randomized to the HT002 (n=20) orwaitlist (n=20) groups. The HT002 group consumed HT002 twice daily for 4 weeks. Outcomes wereassessed using the Insomnia Severity Scale (ISI), Pittsburgh Sleep Quality Index (PSQI), and 12-item ShortForm Health Survey (SF-12) at baseline and after 4 and 8 weeks.Results:The ISI score differences from baseline at weeks 4 and 8 were significantly greater in the HT002thanthatinthewaitlistgroup(week4:−4.0±0.8vs.−0.4±0.8,p<0.05;week8:−4.8±0.7vs.−0.9±0.7,p<0.05). Changes in PSQI and SF-12 physical component scores in the HT002 group were significantlygreater at weeks 4 and 8 (p<0.05), while SF-12 mental component scores were only significantly largerat 4 weeks (p<0.05). HT002 was well-tolerated, with only one (5.0%) dropout, and no significant meanliver and renal function test changes post-treatment.Conclusion:Our preliminary results suggest that a 4-week treatment with HT002 may reduce the severityof insomnia symptoms and improve the quality of life. Further studies devoid of the limitations of ourprotocol may provide stronger conclusions. |