TY - JOUR
T1 - History of early abuse as a predictor of treatment response in patients with fibromyalgia
T2 - A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release
AU - Pae, Chi Un
AU - Masand, Prakash S.
AU - Marks, David M.
AU - Krulewicz, Stan
AU - Han, Changsu
AU - Peindl, Kathleen
AU - Mannelli, Paolo
AU - Patkar, Ashwin A.
N1 - Funding Information:
This work was supported by a Collaborative Research Grant from GlaxoSmithKline.
Funding Information:
Dr Pae has received research grants from Glaxo SmithKline Korea, GlaxoSmithKline, AstraZeneca Korea, Janssen Pharmaceutcals Korea, Eli Lilly and Company Korea, Korean Research Foundation, Otsuka Korea, Wyeth Korea, and Korean Institute of Science and Technology Evaluation and Planning; has received honoraria and is on the speaker’s bureaus of GlaxoSmithKline Korea, Lundbeck Korea, AstraZeneca Korea, Janssen Pharmaceutcals Korea, Eli Lilly and Company Korea, McNeil Consumer and Specialty Inc, and Otsuka Korea.
Funding Information:
Dr Patkar is a Consultant for Bristol-Myers Squibb, GlaxoSmithKline, and Reckitt Benckiser; is on the speaker’s bureau and received honoraria from Bristol-Myers Squibb, Cephalon, Pfizer, and Reckitt Benckiser; has received grant support from National Institutes of Health, AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, Jazz Pharmaceuticals Lundbeck, McNeil Consumer & Specialty Inc, Organon, and Pfizer.
Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2009
Y1 - 2009
N2 - Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind, placebo-controlled trial of paroxetine controlled release (CR) (dose 12.562.5 mg/day) was conducted in patients with fibromyalgia for 12 weeks. A total of 112 subjects provided complete information on childhood history of abuse that was recorded using the Sexual and Physical Abuse Questionnaire and randomized to treatments. Outcome evaluations in the abuse subgroup were identical to those in the entire sample. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), and the Perceived Stress Scale (PSS). Fibromylagia symptom severity was determined using the Fibromyalgia Impact Questionnaire (FIQ) and the Visual Analogue Scale for Pain (VAS). The primary outcome was treatment response defined as ≥25% reduction in the FIQ-total score. Secondary outcomes include changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively) and SF-36. Results. The rate of childhood physical and/or sexual abuse was 52.7% (n=59). The baseline characteristics (health status, perceived stress, symptom severity) were not associated with abuse history. In logistic regression, the history of abuse did not predict treatment response as measured by ≥25% reduction in FIQ-total score (OR = 1.16, 95% CI = 1.181.60, P = 0.35), while the drug status (paroxetine CR) was significantly associated with treatment response (OR = 2.51, 95% CI = 1.125.64, P = 0.02). Abuse history did not predict CGI-I (P = 0.32) or CGI-S (P = 0.74) improvements during treatment. After 12 weeks of treatment, subjects with sexual abuse history showed significantly lower mean change in health status (SF-36) than those without sexual abuse history (P = 0.04). Conclusions. Although, a significant proportion of patients with fibromyalgia reported a history of abuse, it does not appear to have any significant clinical correlates at baseline. History of abuse did not predict response to treatment in patients with fibromyalgia participating in a controlled trial of paroxetine controlled release. Prospective, well-designed studies are needed to confirm whether selective serotonin uptake inhibitors are effective in patients with fibromyalgia irrespective of their abuse history.
AB - Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind, placebo-controlled trial of paroxetine controlled release (CR) (dose 12.562.5 mg/day) was conducted in patients with fibromyalgia for 12 weeks. A total of 112 subjects provided complete information on childhood history of abuse that was recorded using the Sexual and Physical Abuse Questionnaire and randomized to treatments. Outcome evaluations in the abuse subgroup were identical to those in the entire sample. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), and the Perceived Stress Scale (PSS). Fibromylagia symptom severity was determined using the Fibromyalgia Impact Questionnaire (FIQ) and the Visual Analogue Scale for Pain (VAS). The primary outcome was treatment response defined as ≥25% reduction in the FIQ-total score. Secondary outcomes include changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively) and SF-36. Results. The rate of childhood physical and/or sexual abuse was 52.7% (n=59). The baseline characteristics (health status, perceived stress, symptom severity) were not associated with abuse history. In logistic regression, the history of abuse did not predict treatment response as measured by ≥25% reduction in FIQ-total score (OR = 1.16, 95% CI = 1.181.60, P = 0.35), while the drug status (paroxetine CR) was significantly associated with treatment response (OR = 2.51, 95% CI = 1.125.64, P = 0.02). Abuse history did not predict CGI-I (P = 0.32) or CGI-S (P = 0.74) improvements during treatment. After 12 weeks of treatment, subjects with sexual abuse history showed significantly lower mean change in health status (SF-36) than those without sexual abuse history (P = 0.04). Conclusions. Although, a significant proportion of patients with fibromyalgia reported a history of abuse, it does not appear to have any significant clinical correlates at baseline. History of abuse did not predict response to treatment in patients with fibromyalgia participating in a controlled trial of paroxetine controlled release. Prospective, well-designed studies are needed to confirm whether selective serotonin uptake inhibitors are effective in patients with fibromyalgia irrespective of their abuse history.
KW - Abuse
KW - Fibromyalgia
KW - Paroxetine CR
KW - SSRI
KW - Treatment
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U2 - 10.1080/15622970902789155
DO - 10.1080/15622970902789155
M3 - Article
C2 - 19382010
AN - SCOPUS:77449128793
SN - 1562-2975
VL - 10
SP - 435
EP - 441
JO - World Journal of Biological Psychiatry
JF - World Journal of Biological Psychiatry
IS - 4 PART 2
ER -