Clinical Effectiveness and Safety of Metta-Osot Cannabis Oil in Patients with Insomnia: A Quasi-Experimental Study

Abstract

This study aimed to evaluate the effectiveness and safety of Metta-osot cannabis oil in treating Insomnia. A total of 68 patients receiving care at the Thai Traditional and Alternative Medicine Center were enrolled in this quasi-experimental study using a pretest-posttest design without a control group. All participants received Metta-osot cannabis oil at a dosage of one drop once daily before bedtime for four consecutive weeks. Insomnia symtoms were assessed using the Insomnia Severity Index (ISI), and sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). Safety outcomes were assessed through laboratory investigations, including liver and kidney function tests, complete blood counts, cortisol levels, and monitoring of adverse events. The results demonstrated that the mean ISI and PSQI scores of participants decreased continuously throughout the 4-week follow-up period. Compared with baseline (week 0) values at weeks 2 and 4 (p < 0.05), statistically significant improvements were observed. Comparisons of mean liver and renal function parameters before and after treatment revealed no significant differences. Complete blood count values remained within normal ranges. Although cortisol levels showed a slight increase after treatment, they remained within normal limits. A total of 23 adverse events were reported among 20 patients (29.41%), with dizziness being the most frequently reported event. Other adverse events included palpitations, unsteady gait, dry throat and mouth, and anxiety. These events were primarily associated with initial side effect of cannabis oil use. After continued administration at the same dosage for approximately one week, the adverse symtoms decreased. This study supports the effectiveness of Metta-osot cannabis oil in the treatment of insomnia and suggest that it can be safely applied in clinical practice.