Comparison of Saffron and Fluvoxamine in the Treatment of Mild to Moderate Obsessive- Compulsive Disorder: A Double Blind, Randomized Clinical Trial
Abstract
Objective: There are different pathophysiological mechanisms for obsessive- compulsive disorder (OCD) as suggested by the serotonergic, dopaminergic, and glutamatergic hypotheses. The present study aimed at comparing the efficacy and safety of saffron (stigma of Crocus sativus) and fluvoxamine in the treatment of mild to moderate obsessive- compulsive disorder.
Method: In this study, 50 males and females, aged 18 to 60 years, with mild to moderate OCD, participated. The patients were randomly assigned to receive either saffron (30 mg/day, 15 mg twice a day) or fluvoxamine (100 mg/day) for 10 weeks. Using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Adverse Event Checklist, we assessed the patients at baseline, and at the second, fourth, sixth, eighth, and tenth week. Finally, the data were analyzed using general linear repeated measures.
Results: In this study, 46 patients completed the trial. General linear repeated measures demonstrated no significant effect for time-treatment interaction on the Y-BOCS total scores [F (2.42, 106.87) = 0.70, P = 0.52], obsession Y-BOCS subscale scores [F (2.47, 108.87) = 0.77, p = 0.49], and compulsion Y-BOCS subscale scores [F (2.18, 96.06) = 0.25, P = 0.79]. Frequency of adverse events was not significantly different between the 2 groups.
Conclusion: Our findings suggest that saffron is as effective as fluvoxamine in the treatment of patients with mild to moderate OCD.
Sasson Y, Zohar J, Chopra M, Lustig M, Iancu I, Hendler T. Epidemiology of obsessive-compulsive disorder: a world view. J Clin Psychiatry 1997; 58: 12: 7-10.
Thomsen PH. Obsessive-compulsive disorders. Eur Child Adolesc Psychiatry 2013; 22: 1: S23-28.
Hauschildt M, Moritz S. [Obsessive-compulsive disorder: psychosocial consequences and quality of life: a review]. Nervenarzt 2011; 82: 281-282.
Denys D, van der Wee N, Janssen J, De Geus F, Westenberg HG. Low level of dopaminergic D2 receptor binding in obsessive-compulsive disorder. Biol Psychiatry 2004; 55: 1041-1045.
Aouizerate B, Guehl D, Cuny E, Rougier A, Burbaud P, Tignol J, et al. Updated overview of the putative role of the serotoninergic system in obsessive-compulsive disorder. Neuropsychiatr Dis Treat 2005; 1: 231-243.
Pittenger C, Bloch MH, Williams K. Glutamate abnormalities in obsessive compulsive disorder: neurobiology, pathophysiology, and treatment. Pharmacol Ther 2011; 132: 314-332.
Esalatmanesh S, Abrishami Z, Zeinoddini A, Rahiminejad F, Sadeghi M, Najarzadegan MR, et al. Minocycline combination therapy with fluvoxamine in moderate-to-severe obsessive-compulsive disorder: A placebo-controlled, double-blind, randomized trial. Psychiatry Clin Neurosci 2016; 70: 517-526.
Soomro GM, Altman D, Rajagopal S, Oakley-Browne M. Selective serotonin re-uptake inhibitors (SSRIs) versus placebo for obsessive compulsive disorder (OCD). Cochrane Database Syst Rev 2008; CD001765.
Seibell PJ, Hollander E. Management of obsessive-compulsive disorder. F1000Prime Rep 2014; 6: 68.
Brakoulias V. Managing obsessive compulsive disorder. Aust Prescr 2015; 38: 121-123.
Kashani L, Raisi F, Saroukhani S, Sohrabi H, Modabbernia A, Nasehi AA, et al. Saffron for treatment of fluoxetine-induced sexual dysfunction in women: randomized double-blind placebo-controlled study. Hum Psychopharmacol 2013 ;28: 54-60.
Khazaie H, Rezaie L, Rezaei Payam N, Najafi F. Antidepressant-induced sexual dysfunction during treatment with fluoxetine, sertraline and trazodone; a randomized controlled trial. Gen Hosp Psychiatry 2015; 37: 40-45.
Ahmadi SM, Mohammadi MR, Mostafavi SA, Keshavarzi S, Kooshesh SM, Joulaei H, et al. Dependence of the geriatric depression on nutritional status and anthropometric indices in elderly population. Iran J Psychiatry 2013; 8: 92-96.
Kashani L, Eslatmanesh S, Saedi N, Niroomand N, Ebrahimi M, Hosseinian M, et al. Comparison of Saffron versus Fluoxetine in Treatment of Mild to Moderate Postpartum Depression: A Double-Blind, Randomized Clinical Trial. Pharmacopsychiatry 2017; 50: 64-68.
Khazdair MR, Boskabady MH, Hosseini M, Rezaee R, A MT. The effects of Crocus sativus (saffron) and its constituents on nervous system: A review. Avicenna J Phytomed 2015; 5: 376-391.
Akhondzadeh S, Fallah-Pour H, Afkham K, Jamshidi AH, Khalighi-Cigaroudi F. Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: a pilot double-blind randomized trial [ISRCTN45683816]. BMC Complement Altern Med 2004; 4: 12.
Agha-Hosseini M, Kashani L, Aleyaseen A, Ghoreishi A, Rahmanpour H, Zarrinara AR, et al. Crocus sativus L. (saffron) in the treatment of premenstrual syndrome: a double-blind, randomised and placebo-controlled trial. Bjog 2008; 115: 515-519.
Shahmansouri N, Farokhnia M, Abbasi SH, Kassaian SE, Noorbala Tafti AA, Gougol A, et al. A randomized, double-blind, clinical trial comparing the efficacy and safety of Crocus sativus L. with fluoxetine for improving mild to moderate depression in post percutaneous coronary intervention patients. J Affect Disord 2014; 155: 216-222.
Akhondzadeh S, Sabet MS, Harirchian MH, Togha M, Cheraghmakani H, Razeghi S, et al. Saffron in the treatment of patients with mild to moderate Alzheimer's disease: a 16-week, randomized and placebo-controlled trial. J Clin Pharm Ther 2010; 35: 581-588.
Farokhnia M, Shafiee Sabet M, Iranpour N, Gougol A, Yekehtaz H, Alimardani R, et al. Comparing the efficacy and safety of Crocus sativus L. with memantine in patients with moderate to severe Alzheimer's disease: a double-blind randomized clinical trial. Hum Psychopharmacol 2014; 29: 351-359.
Georgiadou G, Tarantilis PA, Pitsikas N. Effects of the active constituents of Crocus sativus L., crocins, in an animal model of obsessive-compulsive disorder. Neurosci Lett 2012; 528: 27-30.
Goodman WK, Price LH, Rasmussen SA, Mazure C, Delgado P, Heninger GR, et al. The Yale-Brown Obsessive Compulsive Scale. II. Validity. Arch Gen Psychiatry 1989; 46: 1012-1016.
Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, et al. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry 1989; 46: 1006-1011.
Heidari M, Zarei M, Hosseini SM, Taghvaei R, Maleki H, Tabrizi M, et al. Ondansetron or placebo in the augmentation of fluvoxamine response over 8 weeks in obsessive-compulsive disorder. Int Clin Psychopharmacol 2014; 29: 344-350.
Shalbafan M, Mohammadinejad P, Shariat SV, Alavi K, Zeinoddini A, Salehi M, et al. Celecoxib as an Adjuvant to Fluvoxamine in Moderate to Severe Obsessive-compulsive Disorder: A Double-blind, Placebo-controlled, Randomized Trial. Pharmacopsychiatry 2015; 48: 136-140.
Emamzadehfard S, Kamaloo A, Paydary K, Ahmadipour A, Zeinoddini A, Ghaleiha A, et al. Riluzole in augmentation of fluvoxamine for moderate to severe obsessive-compulsive disorder: Randomized, double-blind, placebo-controlled study. Psychiatry Clin Neurosci 2016; 70: 332-341.
Ghaleiha A, Entezari N, Modabbernia A, Najand B, Askari N, Tabrizi M, et al. Memantine add-on in moderate to severe obsessive-compulsive disorder: randomized double-blind placebo-controlled study. J Psychiatr Res 2013; 47: 175-180.
Paydary K, Akamaloo A, Ahmadipour A, Pishgar F, Emamzadehfard S, Akhondzadeh S. N-acetylcysteine augmentation therapy for moderate-to-severe obsessive-compulsive disorder: randomized, double-blind, placebo-controlled trial. J Clin Pharm Ther 2016; 41: 214-219.
Sepideh Rajezi Esfahani YM, Kambiz Kamkari, Alireza Zahiredin, Masuod Janbozorgi. Reliability and Validity of the Persian Version of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). IJPCP 2012; 17: 297-303.
Askari N, Moin M, Sanati M, Tajdini M, Hosseini SM, Modabbernia A, et al. Granisetron adjunct to fluvoxamine for moderate to severe obsessive-compulsive disorder: a randomized, double-blind, placebo-controlled trial. CNS Drugs 2012; 26: 883-892.
Akhondzadeh S, Malek-Hosseini M, Ghoreishi A, Raznahan M, Rezazadeh SA. Effect of ritanserin, a 5HT2A/2C antagonist, on negative symptoms of schizophrenia: a double-blind randomized placebo-controlled study. Prog Neuropsychopharmacol Biol Psychiatry 2008; 32: 1879-1883.
Thoren P, Asberg M, Bertilsson L, Mellstrom B, Sjoqvist F, Traskman L. Clomipramine treatment of obsessive-compulsive disorder. II. Biochemical aspects. Arch Gen Psychiatry 1980; 37: 1289-1294.
Schilman EA, Klavir O, Winter C, Sohr R, Joel D. The role of the striatum in compulsive behavior in intact and orbitofrontal-cortex-lesioned rats: possible involvement of the serotonergic system. Neuropsychopharmacology 2010; 35: 1026-1039.
Wang Y, Han T, Zhu Y, Zheng CJ, Ming QL, Rahman K, et al. Antidepressant properties of bioactive fractions from the extract of Crocus sativus L. J Nat Med 2010; 64: 24-30.
Akhondzadeh Basti A, Moshiri E, Noorbala AA, Jamshidi AH, Abbasi SH, Akhondzadeh S. Comparison of petal of Crocus sativus L. and fluoxetine in the treatment of depressed outpatients: a pilot double-blind randomized trial. Prog Neuropsychopharmacol Biol Psychiatry 2007; 31: 439-442.
Lopresti AL, Drummond PD. Saffron (Crocus sativus) for depression: a systematic review of clinical studies and examination of underlying antidepressant mechanisms of action. Hum Psychopharmacol 2014; 29: 517-527.
Talaei A, Hassanpour Moghadam M, Sajadi Tabassi SA, Mohajeri SA. Crocin, the main active saffron constituent, as an adjunctive treatment in major depressive disorder: a randomized, double-blind, placebo-controlled, pilot clinical trial. J Affect Disord 2015; 174: 51-56.
Amin B, Nakhsaz A, Hosseinzadeh H. Evaluation of the antidepressant-like effects of acute and sub-acute administration of crocin and crocetin in mice. Avicenna J Phytomed 2015; 5: 458-468.
Mohamadpour AH, Ayati Z, Parizadeh MR, Rajbai O, Hosseinzadeh H. Safety Evaluation of Crocin (a constituent of saffron) Tablets in Healthy Volunteers. Iran J Basic Med Sci 2013; 16: 39-46.
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Issue | Vol 12 No 3 (2017) | |
Section | Original Article(s) | |
Keywords | ||
Crocus sativus OCD Saffron Serotonin Trial |
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