Cinnamomum Tamala As an Adjuvant Therapy in the Treatment of Major Depressive Disorder: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial With Placebo Control Publisher



Ghaffari S¹ ; Ghobadi A² ; Jamshidi AH² ; Mortazavi SH³ ; Naderi S³ ; Aqamolaei A³ ; Mortezaei A³ ; Sahebolzamani E³ ; Shamabadi A³ ; Jalilvand S³ ; Daraei B⁴ ; Shalbafan MR⁵ ; Akhondzadeh S³
Source: Advances in Integrative Medicine Published:2020

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. © 2019 Elsevier Ltd