| Childhood abuse and treatment response in patients with irritable bowel syndrome: a post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release. | |
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MedLine Citation:
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PMID: 19125906 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Although irritable bowel syndrome (IBS) is frequently comorbid with childhood trauma, information on the clinical implications of this comorbidity is limited. We investigated whether a history of abuse was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in IBS. METHODS: Seventy-two IBS subjects were randomized to receive paroxetine CR (dose 12.5-50 mg/day) or placebo for 12 weeks. Subject selection was independent of abuse history. Sixty-one subjects completed the Sexual and Physical Abuse Questionnaire about their childhood abuse history. IBS symptoms were recorded using the Interactive Voice Response System (IVRS). Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS) and Clinical Global Impression (CGI) were also measured. The primary outcome was treatment response defined as > or =25% reduction in composite pain scores (CPS) on the IVRS from randomization to end of treatment. RESULTS: The rate of abuse history was 50.8% (n = 31/61). Baseline demographic clinical characteristics (CPS, BDI, BAI, PSS, CGI scores) were not associated with abuse history. After 12 weeks of treatment, subjects with abuse history showed significantly higher CPS (t = 2.422, P = 0.018) than subjects without a history and less mean change of CPS (t = 3.506, P = 0.001). In a logistic regression analysis, history of abuse did not predict treatment response as measured by > or =25% reduction in CPS (OR = 0.481, CI = 0.164-1.406, P = 0.181), while the drug status (paroxetine CR) was significantly associated with treatment response as defined by a CGI improvement score of 1-2 (OR = 12.121, CI = 2.923-50.271, P = 0.001). Abuse history did not predict CGI-I (Fisher's exact, P = 0.500) improvements during the trial. CONCLUSIONS: History of abuse did not appear to have any significant clinical correlates at baseline and did not predict treatment response. Further studies are needed to confirm whether SSRIs are effective in IBS patients irrespective of their abuse history. |
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Authors:
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C Han; P S Masand; S Krulewicz; K Peindl; P Mannelli; I M Varia; C-U Pae; A A Patkar |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of clinical pharmacy and therapeutics Volume: 34 ISSN: 1365-2710 ISO Abbreviation: J Clin Pharm Ther Publication Date: 2009 Feb |
Date Detail:
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Created Date: 2009-01-07 Completed Date: 2009-02-26 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8704308 Medline TA: J Clin Pharm Ther Country: England |
Other Details:
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Languages: eng Pagination: 79-88 Citation Subset: IM |
Affiliation:
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Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA. |
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Child Child Abuse / psychology* Child Abuse, Sexual / psychology Delayed-Action Preparations Double-Blind Method Female Humans Irritable Bowel Syndrome / drug therapy*, epidemiology, psychology Male Middle Aged Paroxetine / administration & dosage, therapeutic use* Questionnaires Serotonin Uptake Inhibitors / administration & dosage, therapeutic use* Stress, Psychological* Treatment Outcome Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Delayed-Action Preparations; 0/Serotonin Uptake Inhibitors; 61869-08-7/Paroxetine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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