Efficacy and Safety of Mirtazapine in Fibromyalgia Syndrome Patients: A Randomized Placebo-Controlled Pilot Study
| Autor: | Saithip Suttiruksa, I J Russell, Suwimon Yeephu, Chuthamanee Suthisisang, Pradit Prateepavanich, Patchara Limampai |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Adult
medicine.medical_specialty Fibromyalgia Visual analogue scale Mirtazapine Pilot Projects Mianserin Placebo Dizziness law.invention Double-Blind Method Randomized controlled trial Rating scale law medicine Humans Pharmacology (medical) Prospective Studies Prospective cohort study Fatigue Pain Measurement business.industry Syndrome Middle Aged medicine.disease Treatment Outcome Anesthesia Physical therapy Female business medicine.drug |
| Zdroj: | Annals of Pharmacotherapy. 47:921-932 |
| ISSN: | 1542-6270 1060-0280 |
| Popis: | BACKGROUND Data from an open-label trial suggest that mirtazapine might prove useful in treatment of fibromyalgia syndrome (FMS). OBJECTIVE To obtain preliminary efficacy data of mirtazapine for estimation of sample size requirements for a Phase 2 clinical trial in FMS. METHODS This 13-week randomized controlled trial compared the effects of mirtazapine 15 mg/day, mirtazapine 30 mg/day, and placebo in 40 patients with FMS. The primary outcomes were change in Pain Visual Analog Scale (PVAS) and proportion of pain responders (≥30% PVAS reduction). Secondary outcomes included scores from the Jenkins Sleep Scale (JSS), Patient Global Impression of Change (PGIC), Fibromyalgia Impact Questionnaire (FIQ), Hamilton Depression Rating Scale (HAM-D), Patient Global Assessment, and self-reported adverse events. RESULTS Significant within-group PVAS reductions from baseline were observed in all 3 groups, with the greatest improvement in the mirtazapine 30-mg group (p < 0.005); between-group difference was not significant. The proportion of pain responders did not meet significance criteria (66.67% for mirtazapine 30 mg, 50% for mirtazapine 15 mg, 41.67% for placebo). Significant within-group improvement in JSS scores was seen for mirtazapine 30 mg (p < 0.01) and mirtazapine 15 mg (p < 0.05). Between-group comparison achieved significance for JSS item 3, waking several times per night (p < 0.05). On the PGIC, 72.73% felt better with both mirtazapine dosages compared with 50% for placebo. Within-group FIQ responses indicated improvement in only mirtazapine-treated groups, whereas within-group improvement for HAM-D and Patient Global Assessment was observed in all groups. Based on our findings, the sample size requirement (80% power, 5% type I error) should be 83 per group to detect PVAS change difference between mirtazapine 30 mg and placebo. Common mirtazapine-related adverse events were increased appetite and weight gain. CONCLUSIONS Patients with FMS taking mirtazapine exhibited within-group significant improvement in most of the measured outcomes. Between-group analysis was predictably compromised by the small sample size. Mirtazapine was well tolerated. Further study with a larger sample size is likely to be useful. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|