BackgroundInflammatory processes play a role in the etiopathogenesis of bipolar disorder type 1. Full therapeutic responses are seldom seen and the ongoing inflammatory processes in the brain could lead to neuronal loss. Curcumin, a relatively safe herbal compound, has been shown to have anti-inflammatory effects. The present randomized double-blind clinical trial study aimed to investigate the effect of adding curcumin to the treatment regimen of BID.Materials and methodsThis randomized double-blind clinical trial was conducted on 78 patients diagnosed with BID according to the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria. The sample were divided into two groups. Patients in both groups received sodium valproate starting at a dose of 600 milligrams per day and administered up to 20 milligrams per kilogram per day or the highest dosage of the patient’s tolerance. Patients in the intervention group also received curcumin as nanomicelle in soft gelatin capsules 40 milligrams per day. The control group received placebo tablets with the same characteristics as the curcumin tablets. They were assessed by a psychiatrist using the Young Mania Rating Scale (YMRS), Mini-Mental State Examination (MMSE), Clinical Global Impression (CGI), and a medication side effect questionnaire at the beginning of the study, as well as in the first, second, and fourth weeks of the study.ResultsAmong the 78 patients chosen to participate in the project, 54 people completed the trial. No specific side effect was observed in the two groups. Both groups showed an increase in their MMSE scores compared to the beginning of the study (value of p < 0.001). Although this increase was not statistically different between the two groups (value of p = 0.68). The YMRS score of both groups decreased significantly by the end of the study (value of p < 0.001); however, this decrease was not significantly different between the two groups (value of p = 0.64). In addition, the two groups experienced a significant increase in their CGI scores throughout the study (value of p < 0.001), this increase however was not statistically different between the two groups (value of p = 0.88).ConclusionThe present study suggested that curcumin may not be a useful adjuvant agent in the management of patients with BID receiving sodium valproate as treatment.Clinical trial registration: Iranian Registry of Clinical Trials (IRCT), identifier IRCT2016102530504N1.
Background: Inflammatory processes in the brain play an important role in etiopathogenesis of many psychiatric disorders including, bipolar mood disorder (BMD) as a life-long episodic disease. An inefficient therapeutic intervention especially for resistant cases makes the necessity of doing more precise investigation to find out new therapeutic approaches apparent. This double-blind study aims to investigate the effect of Crucumin as anti-inflammatory herbal based drug in the treatment of BMD. Results: 78 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for BMD screening to participate in the trial. The participants included 32 patients in the placebo group receiving sodium valproate and crucumin and 38 patients in the control group receiving placebo and sodium valproate. At the beginning of the study and weeks 1, 2, 4 the patients were assessed by a psychiatrist using Young mania score (YMRS). Fifty four patients completed the trial. Mean age in patients group was 36.28±10.73 and in control group was 32.42 ±9.60.Clinical characteristics of the patients, such as age, did not differ between groups P value ≥0.05. Results showed the process of changes were significant different in both group. The results showed that the changes in the resultss of YMRS, MMSE and CGI scores were significant in each group (P value≤0.001), but no significant difference has been detected between the two groups (p≥0.05).Conclusions: this study suggested that crucumin cannot be an effective adjuvant agent in management of patients with BMD under treatment with sodium valproate.
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