G Model
AJP-807; No. of Pages 3 Asian Journal of Psychiatry xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Asian Journal of Psychiatry journal homepage: www.elsevier.com/locate/ajp
Study the effects of saffron on depression and lipid profiles: A double blind comparative study Ali Sahraian a, Sina Jelodar a, Zahra Javid a, Arash Mowla b,*, Laaya Ahmadzadeh b a b
Research Centre for Psychiatry and Behavioral Sciences, Department of Psychiatry, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran Substance Abuse and Mental Health Research Center, Department of Psychiatry, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
A R T I C L E I N F O
A B S T R A C T
Article history: Received 19 May 2015 Received in revised form 16 October 2015 Accepted 25 October 2015 Available online xxx
Depression is a one of the most prevalent psychiatric disorder. Despite several pharmacological treatments, still treating depression is a challenge. Herbal medicine that is better culturally accepted may play an important role in treatment of depression. In this double blind placebo controlled clinical trial, 40 patients that were suffering from major depression according to DSM-IV criteria were randomly allocated to take either fluoxetine and saffron (20 patients) or fluoxetine and placebo (20 patients). The patients of the two groups were evaluated with Beck depression scale at the beginning of the study and after four weeks. Lipid profile (total Triglyceride (TG) level, total cholesterol level, low density lipoprotein (LDL) level and high density lipoprotein (HDL) level) of the patients also was measured at the beginning and end of the trial. 30 patients (19 in saffron group and 11 in placebo group) completed the study. The two groups improved significantly in depression severity at the end of the study without significant difference (P: 0.560). The lipid profile of the two groups did not change significantly. Our study did not demonstrate antidepressive effects for saffron. We did not observe any lipid lowering effect in saffron group too. Of note is that our study is preliminary and larger studies with more patients and longer duration are needed to prove our results. Clinical trial registration number: IRCT 2013110915334 ß 2015 Published by Elsevier B.V.
Keywords: Depression Fluoxetine Saffron
1. Introduction Major depressive disorder (MDD) is a severe and deteriorating illness that would cause a great decrease in human health and overall functioning (Hasin et al., 2006; Mathers and Loncar, 2006; Ustu¨n et al., 2000). Despite the availability of several antidepressants in recent decades, more than one third of patients will not respond to the first antidepressant prescribed, and 15 to 33% will get resistant to more than two antidepressant trials (Berlim et al., 2008; Cain, 2007). Many MDD patients suffer from a chronic course without sufficient improvement that would lead to disability (Little, 2009). Therefore more studies are needed to find new lines of treatment. Herbal medicine with better culturally acceptance are good lines for research for their efficacy in depression in future researches (Sarris et al., 2011; Velehorschi et al., 2014). More than 20 herbal remedies have been identified that may potentially be applied in medicine as antidepressive, anxiety relieving or
* Corresponding author. Tel.: +98 9173132001. E-mail address: [email protected] (A. Mowla).
sleep-inducing agents (Szafran´ski, 2014). St John’s wort is an example of herbal medicine which people use to manage their depression with better preference than generic medicines (Pirotta et al., 2014). Saffron, a spice derived from the flower of Crocus sativus L., has shown antidepressant effects in several surveys (Schmidt et al., 2007; Abdullaev and Espinosa-Aguirre, 2004). Hausenblas et al. in their review of clinical trials examining the effects of saffron on psychological symptoms found that saffron improves the clinical symptoms of patients with major depression (Hausenblas et al., 2013, 2015). In a systemic review of six clinical trials of the effects of saffron on depression, the improving effect of saffron for mild to moderate depression was observed (Lopresti and Drummond, 2014). The exact mechanism of effect of saffron on depression is not well known. C. sativus L. was found to have medical effects for persian physicians from long time ego. C. sativus L. is widely cultivated in Khorasan province in north east of Iran. In our study, we used saffron as add-on treatment along with standard antidepressants to survey its effects as a potentiating agent for standard antidepressant in treating depressive symptoms. We also aimed to study the side effects that emerged following adding saffron to fluoxetine.
http://dx.doi.org/10.1016/j.ajp.2015.10.012 1876-2018/ß 2015 Published by Elsevier B.V.
Please cite this article in press as: Sahraian, A., et al., Study the effects of saffron on depression and lipid profiles: A double blind comparative study. Asian J. Psychiatry (2015), http://dx.doi.org/10.1016/j.ajp.2015.10.012
G Model
AJP-807; No. of Pages 3 A. Sahraian et al. / Asian Journal of Psychiatry xxx (2015) xxx–xxx
2
Changes in serum lipid levels are associated with psychological problems like depression, suicidal behavior and impulsivity (Ainiyet and Rybakowski, 2014; Steegmans et al., 2000). Recent studies have demonstrated an association between depression and metabolic alterations (Tedders et al., 2011; Sjo¨gren et al., 2006; Patra et al., 2014). Saffron has demonstrated beneficial effects on lipid profile in one recent survey (Azimi et al., 2014). In another study, it was shown that saffron could prevent the metabolic syndrome associated with olanzapine treatment in schizophrenia patients (Fadai et al., 2014). Further studies need to be done regarding the metabolic effects of saffron. In this study the antidepressant effect of saffron will be surveyed in a double blind placebo control trial. The effects of saffron on lipid profile of the patients also will be probed. 2. Method
and control group as ‘‘Group-B’’. Group A received saffron capsule and 20 mg of fluoxetine and Group B received placebo capsule and 20 mg of fluoxetine daily for 4 weeks. Throughout the study, the examiner and the patients were blind to assignments. After four weeks, the patients were evaluated for depression severity with Beck depression scale. 2.4. Statistical analysis The data are shown with mean (SD). The demographic data and Depression severity of the groups were compared at the beginning of the study using 2 and Mann–Whitney U tests. We used Mann–Whitney U test to compare the groups for significantly different effects, and the Wilcoxon signed ranks test was used to assess the changes within groups. P value of
AJP-807; No. of Pages 3 Asian Journal of Psychiatry xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Asian Journal of Psychiatry journal homepage: www.elsevier.com/locate/ajp
Study the effects of saffron on depression and lipid profiles: A double blind comparative study Ali Sahraian a, Sina Jelodar a, Zahra Javid a, Arash Mowla b,*, Laaya Ahmadzadeh b a b
Research Centre for Psychiatry and Behavioral Sciences, Department of Psychiatry, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran Substance Abuse and Mental Health Research Center, Department of Psychiatry, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
A R T I C L E I N F O
A B S T R A C T
Article history: Received 19 May 2015 Received in revised form 16 October 2015 Accepted 25 October 2015 Available online xxx
Depression is a one of the most prevalent psychiatric disorder. Despite several pharmacological treatments, still treating depression is a challenge. Herbal medicine that is better culturally accepted may play an important role in treatment of depression. In this double blind placebo controlled clinical trial, 40 patients that were suffering from major depression according to DSM-IV criteria were randomly allocated to take either fluoxetine and saffron (20 patients) or fluoxetine and placebo (20 patients). The patients of the two groups were evaluated with Beck depression scale at the beginning of the study and after four weeks. Lipid profile (total Triglyceride (TG) level, total cholesterol level, low density lipoprotein (LDL) level and high density lipoprotein (HDL) level) of the patients also was measured at the beginning and end of the trial. 30 patients (19 in saffron group and 11 in placebo group) completed the study. The two groups improved significantly in depression severity at the end of the study without significant difference (P: 0.560). The lipid profile of the two groups did not change significantly. Our study did not demonstrate antidepressive effects for saffron. We did not observe any lipid lowering effect in saffron group too. Of note is that our study is preliminary and larger studies with more patients and longer duration are needed to prove our results. Clinical trial registration number: IRCT 2013110915334 ß 2015 Published by Elsevier B.V.
Keywords: Depression Fluoxetine Saffron
1. Introduction Major depressive disorder (MDD) is a severe and deteriorating illness that would cause a great decrease in human health and overall functioning (Hasin et al., 2006; Mathers and Loncar, 2006; Ustu¨n et al., 2000). Despite the availability of several antidepressants in recent decades, more than one third of patients will not respond to the first antidepressant prescribed, and 15 to 33% will get resistant to more than two antidepressant trials (Berlim et al., 2008; Cain, 2007). Many MDD patients suffer from a chronic course without sufficient improvement that would lead to disability (Little, 2009). Therefore more studies are needed to find new lines of treatment. Herbal medicine with better culturally acceptance are good lines for research for their efficacy in depression in future researches (Sarris et al., 2011; Velehorschi et al., 2014). More than 20 herbal remedies have been identified that may potentially be applied in medicine as antidepressive, anxiety relieving or
* Corresponding author. Tel.: +98 9173132001. E-mail address: [email protected] (A. Mowla).
sleep-inducing agents (Szafran´ski, 2014). St John’s wort is an example of herbal medicine which people use to manage their depression with better preference than generic medicines (Pirotta et al., 2014). Saffron, a spice derived from the flower of Crocus sativus L., has shown antidepressant effects in several surveys (Schmidt et al., 2007; Abdullaev and Espinosa-Aguirre, 2004). Hausenblas et al. in their review of clinical trials examining the effects of saffron on psychological symptoms found that saffron improves the clinical symptoms of patients with major depression (Hausenblas et al., 2013, 2015). In a systemic review of six clinical trials of the effects of saffron on depression, the improving effect of saffron for mild to moderate depression was observed (Lopresti and Drummond, 2014). The exact mechanism of effect of saffron on depression is not well known. C. sativus L. was found to have medical effects for persian physicians from long time ego. C. sativus L. is widely cultivated in Khorasan province in north east of Iran. In our study, we used saffron as add-on treatment along with standard antidepressants to survey its effects as a potentiating agent for standard antidepressant in treating depressive symptoms. We also aimed to study the side effects that emerged following adding saffron to fluoxetine.
http://dx.doi.org/10.1016/j.ajp.2015.10.012 1876-2018/ß 2015 Published by Elsevier B.V.
Please cite this article in press as: Sahraian, A., et al., Study the effects of saffron on depression and lipid profiles: A double blind comparative study. Asian J. Psychiatry (2015), http://dx.doi.org/10.1016/j.ajp.2015.10.012
G Model
AJP-807; No. of Pages 3 A. Sahraian et al. / Asian Journal of Psychiatry xxx (2015) xxx–xxx
2
Changes in serum lipid levels are associated with psychological problems like depression, suicidal behavior and impulsivity (Ainiyet and Rybakowski, 2014; Steegmans et al., 2000). Recent studies have demonstrated an association between depression and metabolic alterations (Tedders et al., 2011; Sjo¨gren et al., 2006; Patra et al., 2014). Saffron has demonstrated beneficial effects on lipid profile in one recent survey (Azimi et al., 2014). In another study, it was shown that saffron could prevent the metabolic syndrome associated with olanzapine treatment in schizophrenia patients (Fadai et al., 2014). Further studies need to be done regarding the metabolic effects of saffron. In this study the antidepressant effect of saffron will be surveyed in a double blind placebo control trial. The effects of saffron on lipid profile of the patients also will be probed. 2. Method
and control group as ‘‘Group-B’’. Group A received saffron capsule and 20 mg of fluoxetine and Group B received placebo capsule and 20 mg of fluoxetine daily for 4 weeks. Throughout the study, the examiner and the patients were blind to assignments. After four weeks, the patients were evaluated for depression severity with Beck depression scale. 2.4. Statistical analysis The data are shown with mean (SD). The demographic data and Depression severity of the groups were compared at the beginning of the study using 2 and Mann–Whitney U tests. We used Mann–Whitney U test to compare the groups for significantly different effects, and the Wilcoxon signed ranks test was used to assess the changes within groups. P value of
