Comparing duloxetine and pregabalin for treatment of pain and depression in women with fibromyalgia: an open-label randomized clinical trial
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Duloxetine and pregabalin are among the most widely used medications in the treatment of patients with fibromyalgia syndrome (FM).
To add to the very few lines of evidence that exist on the comparative safety and efficacy of these two medications.
In this open-label randomized clinical trial, outpatient women, who were diagnosed with FM based on American College of Rheumatology 2010 criteria, and had an age range of 18–65 years old were assigned to either duloxetine 30-60 mg or pregabalin 75-150 mg per day for 4 weeks. Patients were excluded in cases of having used duloxetine, pregabalin, gabapentin, or antidepressants within 12 weeks prior to the study, having had a history of comorbid medical conditions that could provoke chronic pain, or having had comorbid neuropsychiatric disorders, except for major depressive/anxiety disorders. Primary outcomes were between-group differences in mean score changes from baseline to end point for Widespread Pain Index (WPI) and Beck Depression Inventory-II. Secondary outcomes were the same statistical estimates, but for Fibromyalgia Impact Questionnaire-Revised and 12-Item Short Form Survey. Descriptive statistics and independent samples t-test were the main methods of analysis. (www.irct.ir; IRCT2016030626935N1).
Among all the scales, only WPI scores improved with a statistically significant difference between the two treatment arms, favoring duloxetine (Mean difference in score change − 2.32, 95% CI, −4.46 to − 0.18; p = 0.034; Cohen’s d 0.53 95% CI, 0.04 to 1.02). Drop out rate and cumulative incidence of nausea was significantly higher in the duloxetine arm compared to the pregabalin arm.
This study provides further evidence on higher efficacy of duloxetine compared to pregabalin for the treatment of pain in patients with fibromyalgia. Future comprehensive pragmatic clinical trials are warranted.
KeywordsClinical trial Fibromyalgia Duloxetine Pregabalin
We would like to offer our special thanks to Dr. Nahid Kianmehr from Iran University of Medical Sciences for helping the authors with patient recruitment procedures, and Ms. Kimia Ziafat from University of British Columbia for language editing of the manuscript.
This study was supported by Iran University of Medical Sciences (Grant No. 2470). The academic institution had no role in design, conduct, data collection, analysis, data interpretation, manuscript preparation, review, or decision to submit this paper for publication.
Compliance with ethical standards
Conflict of interest
The authors of this manuscript declare that they have no competing interests.
All the procedures performed were approved by the ethics committee of Iran University of Medical Sciences (code: 25371–109,861) in accordance with the World Medical Association’s code of ethics (Declaration of Helsinki, revised in Brazil 2013).
Written informed consent was obtained from all patients and if necessary their caregivers. It was clearly explained for the participants that their relationship with the healthcare provider would not be affected should they chose to withdraw from the study at any time.
Research data policy
The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
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