LAUSR

Abstract Aim Major depressive disorder (MDD) is one the most common diseases in the world and about one-third to one-half of the patients don’t respond to routine treatment. Thus, the role of alternative medicines, like herbal drugs, is important. The aim of this present randomized, double-blind, placebo-controlled, 6-week trial was to assess the efficacy and tolerability of Cinnamomum tamala as an adjuvant to sertraline in treatment of patients with MDD. Methods In a randomized double-blind clinical trial, 50 patients diagnosed with major depressive disorder (MDD) based on DSM V, were assigned into two parallel groups to receive sertraline (100 mg twice a day) plus placebo or sertraline (100 mg twice a day) plus Cinnamomum tamala (500 mg daily) for 6 weeks. Patients were evaluated for response to treatment using the HAM-D score at baseline and at weeks 2, 4 and 6. The main outcome measure was to assess the efficacy of C. tamala in improving the MDD symptoms. Results Forty-two patients completed the trial. Repeated-measure analysis of variance showed a significant effect for time × treatment interaction (Greenhouse-Geisser corrected: F = 5.12, df = 2.19, p-value = 0.006) in HAM-D score. There was significant improvement in HAM-D score of the C. tamala group compared with the placebo group from baseline to weeks 2, 4 and 6. [Ps = 0.012, 0.008 and 0.009; respectively]. The frequency of adverse effects was similar between the two groups. Conclusion The results of this study suggest that Cinnamomum tamala may be effective as an adjuvant agent in the treatment of MDD.