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Comparing duloxetine and pregabalin for treatment of pain and depression in women with fibromyalgia: an open-label randomized clinical trial

  • Ali Bidari
  • Ehsan Moazen-Zadeh
  • Banafsheh Ghavidel-ParsaEmail author
  • Shahrzad Rahmani
  • Sajjad Hosseini
  • Amir Hassankhani
Research Article
  • 196 Downloads

Abstract

Background

Duloxetine and pregabalin are among the most widely used medications in the treatment of patients with fibromyalgia syndrome (FM).

Objectives

To add to the very few lines of evidence that exist on the comparative safety and efficacy of these two medications.

Methods

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).

Results

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.

Conclusion

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.

Keywords

Clinical trial Fibromyalgia Duloxetine Pregabalin 

Notes

Acknowledgements

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.

Funding

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.

Ethical approval

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).

Informed consent

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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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Ali Bidari
    • 1
  • Ehsan Moazen-Zadeh
    • 2
    • 3
  • Banafsheh Ghavidel-Parsa
    • 4
    Email author
  • Shahrzad Rahmani
    • 1
  • Sajjad Hosseini
    • 5
  • Amir Hassankhani
    • 5
  1. 1.Department of RheumatologyIran University of Medical SciencesTehranIran
  2. 2.Psychiatric Research Center, Roozbeh HospitalTehran University of Medical SciencesTehranIran
  3. 3.Institute of Mental Health, Department of PsychiatryUniversity of British ColumbiaVancouverCanada
  4. 4.Rheumatology Research Center, Razi Hospital, School of MedicineGuilan University of Medical SciencesRashtIran
  5. 5.Department of General Medicine, School of MedicineGuilan University of Medical SciencesRashtIran

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