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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
Authors
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Authors Affiliations
  1. 1. School of Persian Medicine, Iran University of Medical Sciences, Research Institute for Islamic and Complementory Medicine, Tehran, Iran
  2. 2. Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran
  3. 3. Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Department of Toxicology and Pharmacology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Iran
  5. 5. Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran

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
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