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A randomized double-blind clinical trial on analgesic efficacy of fluoxetine for persistent somatoform pain disorder
Authors:Yan-Li Luo  Ming-Yuan Zhang  Wen-Yuan Wu  Chun-Bo Li  Zheng Lu  Qing-Wei Li
Institution:1. Department of Psychiatry, Tongji Hospital of Tongji University, Shanghai, China;2. Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Abstract:

Objectives

To verify the efficacy and safety of fluoxetine in treating patients with persistent somatoform pain disorder (PSPD).

Methods

In this 8-week, randomized double-blind placebo-controlled study, 80 patients with an ICD-10 diagnosis of PSPD were randomly assigned to receive 20 mg fluoxetine or a placebo. Several psychological scales including Medical Outcomes Study Pain Measures (MOSPM), Hamilton Depression Scale-17 items (HAMD17) and Treatment Emergent Symptom Scale (TESS) were used to assess analgesic efficacy and safety of fluoxetine, and the possible analgesic mechanism of fluoxetine was preliminarily analyzed. All data were analyzed by SPSS11.5 with t-test, one-way ANOVA and a mixed-effects model repeated measures analysis. Intent-to-treat (ITT) analysis was performed and the last observation carry forward (LOCF) was used for missing values.

Results

There was a significant difference of MOSPM total score between the fluoxetine and placebo group after 2 weeks of treatment. The analgesic effect of fluoxetine was related with treatment time, and depressive patients showed a better analgesic effect than non-depressive patients. An adverse effect of fluoxetine was scarcely found.

Conclusions

Fluoxetine has a better analgesic effect than a placebo in treating persistent somatoform pain disorder, and is considered a safe treatment; its analgesic effect may be related to an antidepressant effect.
Keywords:ANOVA  one-way analysis of variance  BDNF  brain-derived neurotrophic factor  HAMD17  Hamilton Depression Scale-17 items  ICD-10  the International Classification of Diseases  10th ed  ITT  Intent-to-treat  LOCF  last observation carry forward  MOSPM  Medical Outcomes Study Pain Measurement  PSPD  persistent somatoform pain disorder  TESS  Treatment Emergent Symptom Scale
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