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Saffron (Crocus sativus) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial.

ABSTRACT: Objective:Saffron was found efficient and safe in treatment of neuropsychiatric disorders, in particular depression. We compared the efficacy of saffron with duloxetine in treatment of patients with fibromyalgia. Materials and Methods:In this double-blind parallel-group clinical trial, outpatients with fibromyalgia were randomized to receive either saffron 15 mg or duloxetine 30 mg starting with 1 capsule per day in the first week followed by 2 capsules per day from week 2 until the end of week 8. Participants were men and women aged 18-60 years diagnosed with fibromyalgia based on the American College of Rheumatology 2010 criteria who also had a pain score?40 based on visual analogue scale. Participants were excluded in case they had rheumatologic diseases, inflammatory/infectious/autoimmune arthritis, comorbid neuropsychiatric disorders except depressive disorders, pain due to traumatic injuries, drug history of duloxetine or saffron use, current use of psychoactive medications, recent use of muscle relaxants, steroids, opioid analgesics, benzodiazepines, anti-epileptics, or injective analgesics. Primary outcomes included differences in mean score changes from baseline to endpoint between the treatment arms for Hamilton Rating Scale for Depression, Fibromyalgia Impact Questionnaire, and Brief Pain Inventory. Results:Socio-demographic characteristics and baseline scores were similarly distributed between the two treatment arms (2n=46). No significant difference was detected for any of the scales neither in terms of score changes from baseline to endpoint between the two treatment arms (Mean score changes: -4.26 to 2.37; p-values: 0.182-0.900) nor in terms of timetreatment interactions (p-values: 0.209-0.964). Conclusions:Saffron and duloxetine demonstrated comparable efficacy in treatment of fibromyalgia symptoms.

SUBMITTER: Shakiba M

PROVIDER: S-EPMC6235666 | biostudies-other | 2018 Nov-Dec

REPOSITORIES: biostudies-other

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Saffron (<i>Crocus sativus</i>) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial.

Shakiba Mansoor M Moazen-Zadeh Ehsan E Noorbala Ahmad Ali AA Jafarinia Morteza M Divsalar Parisa P Kashani Ladan L Shahmansouri Nazila N Tafakhori Abbas A Bayat Hannaneh H Akhondzadeh Shahin S

Avicenna journal of phytomedicine 20181101 6

<h4>Objective</h4>Saffron was found efficient and safe in treatment of neuropsychiatric disorders, in particular depression. We compared the efficacy of saffron with duloxetine in treatment of patients with fibromyalgia.<h4>Materials and methods</h4>In this double-blind parallel-group clinical trial, outpatients with fibromyalgia were randomized to receive either saffron 15 mg or duloxetine 30 mg starting with 1 capsule per day in the first week followed by 2 capsules per day from week 2 until t ...[more]

PMID: 30456199

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Project description:IntroductionFibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia.MethodsThis randomized, double-blind, placebo-controlled, parallel-group trial was conducted in Japan. Outpatients who met the American College of Rheumatology 1990 criteria for fibromyalgia and whose Brief Pain Inventory (BPI) average pain score was ≥4 were randomized to duloxetine 60 mg or placebo once daily for 14 weeks. The primary efficacy measure was the change in the BPI average pain score from baseline. Secondary efficacy, quality of life (QoL), and safety outcomes were also evaluated. Mixed-effects model repeated-measures (MMRM) analysis and last observation carried forward (LOCF) analysis of covariance were used to evaluate the primary efficacy measure.ResultsOverall, 393 patients were randomized to receive either duloxetine (n = 196) or placebo (n = 197). The MMRM analysis revealed no significant difference between duloxetine and placebo regarding the change in BPI average pain scores at week 14. Based on LOCF analysis, a statistically significant improvement in the change in BPI average pain scores at week 14 was observed for patients treated with duloxetine compared with placebo. Duloxetine treatment was associated with improved outcomes in nearly all secondary and post hoc analyses. The treatment was generally well tolerated. Somnolence, nausea, and constipation were the most common treatment-emergent adverse events in the duloxetine group. The discontinuation rates due to treatment-emergent adverse events were similar in both groups.ConclusionsAlthough the MMRM analysis did not demonstrate superiority of duloxetine over placebo, duloxetine treatment was associated with improved outcomes in secondary and post hoc analyses of the mean change in the BPI average pain score and most of the secondary outcomes, including analgesia and QoL. Duloxetine treatment was safe and well tolerated. These results suggest that duloxetine treatment could be associated with improvements in pain relief and QoL in Japanese patients with fibromyalgia.Trial registrationClinicalTrials.gov Identifier: NCT01552057 . Registered 9 March 2012.

Project description:BackgroundCurrently, there are no medications approved for the treatment of juvenile fibromyalgia (JFM). We evaluated the safety and efficacy of duloxetine 30/60 mg once daily (QD) versus placebo in adolescents with JFM.MethodsIn this Phase 3b, multisite (US, Argentina, Puerto Rico, and India) trial, patients aged 13-17 years with JFM and a score of ≥4 on the Brief Pain Inventory-Modified Short Form: Adolescent Version (BPI) 24-h average pain severity score were randomized to duloxetine or placebo for the 13-week double-blind period. The starting duloxetine dose was 30 mg, with a target dose of 60 mg QD, as tolerated. The primary endpoint was the mean change in 24-h average pain severity of the Brief Pain Inventory (BPI) from baseline to Week 13, analyzed using mixed-model repeated measures (MMRM) technique. Secondary measures were BPI severity and interference scores; treatment response (≥30%, ≥50% reductions on BPI average pain severity); Pediatric Pain Questionnaire; Clinical Global Impression of Severity: Overall and Mental Illness scales; Functional Disability Inventory: child and parent versions; Children's Depression Inventory; Multidimensional Anxiety Scale for Children; and safety and tolerability. Continuous secondary efficacy measures were analyzed using analysis of covariance or MMRM, and categorical data using Cochran-Mantel-Haenszel test and Fisher's exact test, where appropriate.ResultsA total of 184 patients with JFM received duloxetine (N = 91) or placebo (N = 93), of which 149 patients (81.0%) completed the 13-week double-blind treatment period. Baseline characteristics were comparable between groups; majority of the patients were Caucasian (77.17%) and females (75.0%), with a mean age of 15.53 years. For the primary measure, BPI average pain severity, the mean change was not statistically different between duloxetine and placebo (- 1.62 vs. -0.97, respectively; p = .052). For secondary efficacy outcomes, statistically significantly more duloxetine- versus placebo-treated patients had a treatment response (≥30% and ≥50% reductions on BPI average pain severity) and improvement of the general activity and relationships items on the BPI interference subscale. The percentage of patients reporting at least 1 treatment-emergent adverse event was higher in the duloxetine versus placebo groups (82.42% vs. 62.37%, respectively; p = .003). The overall safety profile of duloxetine in this study was similar to that reported previously in duloxetine pediatric trials of other indications.ConclusionsThe primary study outcome, mean change in 24-h BPI average pain severity rating from baseline to Week 13, did not significantly improve with duloxetine compared to placebo in patients with JFM. However, significantly more patients on duloxetine compared to placebo had a ≥30% and ≥50% reduction in pain severity. There were no new safety concerns related to duloxetine in the study population.Trial registrationClinicalTrials.gov Identifier: NCT01237587 . Registered 08 November, /2010.

Project description:BackgroundPatented crystalline glucosamine sulfate (pCGS) and diacerein monotherapy have been recommended for treatment of mild to moderate osteoarthritis (OA), but evidence of efficacy for combined treatments is lacking. Therefore, the aim of this study was to compare clinical outcomes (i.e., pain and Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] score) at 6 months as well as the safety profile of treatment with combined pCGS and diacerein versus pCGS alone.MethodsA double-blind, parallel randomized controlled superiority trial was conducted between August 2013 and August 2014 at Ramathibodi Hospital, Bangkok, Thailand. A total of 148 patients (74 patients in each group) was randomly allocated to receive pCGS plus diacerein or pCGS plus placebo daily. Adult patients with OA were eligible if they had a Kellgren-Lawrence grade of 2-3. The primary outcomes were visual analogue scale score (VAS) for pain and WOMAC subscores measured at 24 weeks after receiving treatment, using the intention-to-treat principle (nonresponder imputation).ResultsAmong the 148 patients in the study, mean age and body mass index were 60 years and 28.1 kg/m2, respectively. Mean VAS and minimal joint space width at baseline were 5.1 and 2.5 mm, respectively. The mean VAS values measured at 24 weeks were 2.97 and 2.88 in the pCGS plus diacerein and pCGS plus placebo groups, respectively. The estimated mean difference was 0.09 (95 % CI -0.75 to 0.94), which was not statistically significant (P = 0.710). In addition, the mean WOMAC total, pain, function, and stiffness scores for both groups were not significantly different, with corresponding means of 48.59, 12.02, 32.74, and 3.85 for the pCGS plus diacerein group and 48.69, 11.76, 32.47, and 4.16 for the pCGS plus placebo group. The risk of diarrhea and dyspepsia was very similar between the two groups, with risk ratios of 1.03 (95 % CI 0.56-1.89) and 0.91 (95 % CI 0.43-1.92), respectively.ConclusionsThis study did not demonstrate that coadministration of diacerein with pCGS improves pain and WOMAC score compared with pCGS monotherapy in patients with mild to moderate OA of the knee.Trial registrationClinicalTrials.gov identifier: NCT01906801 . Registered on 20 July 2013.

Project description:UnlabelledMilnacipran, a serotonin/norepinephrine reuptake inhibitor, has been approved by the US Food and Drug Administration for the treatment of fibromyalgia (FM). This report presents the results of a randomized, double-blind, placebo-controlled trial of milnacipran conducted to test the hypotheses that a) similar to patients with chronic fatigue syndrome, patients with FM have increased ventricular lactate levels at baseline; b) 8 weeks of treatment with milnacipran will lower ventricular lactate levels compared with baseline levels and with ventricular lactate levels after placebo; and c) treatment with milnacipran will improve attention and executive function in the Attention Network Test compared with placebo. In addition, we examined the results for potential associations between ventricular lactate and pain. Baseline ventricular lactate measured by proton magnetic resonance spectroscopic imaging was found to be higher in patients with FM than in healthy controls (F1,37 = 22.11, P < .0001, partial η(2) = .37). Milnacipran reduced pain in patients with FM relative to placebo but had no effect on cognitive processing. At the end of the study, ventricular lactate levels in the milnacipran-treated group had decreased significantly compared with baseline and after placebo (F1,18 = 8.18, P = .01, partial η(2) = .31). A significantly larger proportion of patients treated with milnacipran showed decreases in both ventricular lactate and pain than those treated with placebo (P = .03). These results suggest that proton magnetic resonance spectroscopic imaging measurements of lactate may serve as a potential biomarker for a therapeutic response in FM and that milnacipran may act, at least in part, by targeting the brain response to glial activation and neuroinflammation.PerspectivePatients treated with milnacipran showed decreases in both pain and ventricular lactate levels compared with those treated with placebo, but, even after treatment, levels of ventricular lactate remained higher than in controls. The hypothesized mechanism for these decreases is via drug-induced reductions of a central inflammatory state.

Dataset Information

Saffron (Crocus sativus) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial.

Publications

Saffron (<i>Crocus sativus</i>) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial.

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