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- antidepressive agents (second generation)
- colonic diseases
- functional
- healthcare costs
- paroxetine
- psychotherapy
QUESTION: In patients with severe irritable bowel syndrome (IBS), is psychotherapy or paroxetine more effective than usual care for reducing abdominal pain, and improving health related quality of life (HRQL), without incurring additional costs?
Design
Cost effectiveness analysis of a randomised (allocation concealed*), blinded (clinicians, {data collectors, data analysts, and data safety and monitoring committee}†),* controlled trial with follow up at 3 and 15 months.
Setting
7 gastroenterology clinics in the UK.
Patients
257 patients 18–65 years of age (mean age 40 y, 80% women) who met Rome I criteria for IBS, had symptoms for >6 months, failed to respond to “usual” medical treatment (antispasmodics and laxatives or antidiarrhoeal medication given for ≥3 mo), had severe abdominal pain (visual analogue scale >59), had no contraindication to psychotherapy or paroxetine, and were able to complete the study questionnaires. Follow up was 88% at 3 months; at 15 months, 90% of patients completed pain scores.
Intervention
Patients were stratified by hospital and by pain severity and allocated to psychotherapy (n=85), oral paroxetine, 20 mg daily (n=86), or usual care by a gastroenterologist or general practitioner (n = 86) for 3 months. 3 therapists administered psychotherapy, which consisted of encouraging patients to discuss symptoms, explore emotional factors, and identify the links between them. After 3 months, all groups received usual care for up to 15 months.
Main cost and outcome measures
Abdominal pain severity, physical component of the HRQL (measured by the SF-36), and direct healthcare costs (assessed by 1997–98 UK prices and reported in US dollars [£1 = $1.6]).
Main results
Analysis was by intention to treat. The groups did not differ in severity of abdominal pain at 3 or 15 months or improvement in the physical component of HRQL at 3 months (table). Both psychotherapy and paroxetine led to improvement on the physical component of HRQL at 15 months (based on 75% patient follow up and 96% imputation analysis) (table). Overall healthcare costs did not differ for paroxetine or psychotherapy relative to usual care.
Psychotherapy or paroxetine v usual care in irritable bowel syndrome at 3 months‡
Conclusions
In patients with severe irritable bowel syndrome, psychotherapy or paroxetine did not reduce abdominal pain but may improve quality of life at 15 months. Costs did not differ.
Commentary
Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed in IBS but their efficacy is unknown. The study by Creed et al showed no difference between paroxetine and psychotherapy for IBS symptoms, which was consistent with another recent small, randomised placebo controlled trial using fluoxetine.1 In the absence of other randomised placebo controlled trials, the cost effectiveness study by Creed et al comparing paroxetine to usual care is arguably premature, and usual treatment likely represents a very heterogeneous group. Any improvement in quality of life measures with paroxetine or psychotherapy could simply reflect greater contact with healthcare personnel in those groups.2
The study had other limitations. Firstly, the patients could not be blinded to the treatment allocation. Secondly, the generalisability of the findings to less severe cases is debatable because enrolment was limited to patients with severe abdominal pain and refractoriness to usual medical treatments. In addition, the study was powered to detect differences in abdominal pain that were not observed. A global disease specific outcome such as adequate IBS symptom relief would have allowed more useful comparison with other studies in the field.3
At 1 year, direct healthcare costs were less for psychotherapy than usual treatment, whereas no difference was observed between paroxetine and usual treatment. The cost results may also have been limited because 25% of the total sample did not complete the SF-36 assessment at 15 months, and a wide variability of cost data existed in the usual treatment group. Sensitivity analyses would have been useful to account for these factors.
Although other studies have suggested that psychotherapy is valuable for IBS4, we do not believe the evidence is convincing that either SSRIs or psychotherapy are superior to usual care in either relevant symptom relief or cost for IBS.
Footnotes
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Sources of funding:Medical Research Council of the UK and North Western Region Health Authority.
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For correspondence: Dr F Creed, University of Manchester, Manchester, UK. francis.creed{at}man.ac.uk
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↵† Information provided by the author.