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- Title
Duloxetine for the Treatment of Patients with Suspected Sphincter of Oddi Dysfunction: A Pilot Study.
- Authors
Pauls, Qi; Durkalski-Mauldin, Valerie; Brawman-Mintzer, Olga; Lawrence, Chris; Whichard, Rebekah; Cotton, Peter; Cotton, Peter B
- Abstract
<bold>Objective: </bold>To examine the tolerability and efficacy of duloxetine in patients with suspected sphincter of Oddi dysfunction (SOD).<bold>Methods: </bold>An open-label, single-center, 12-week trial of duloxetine 60 mg once daily was conducted in 20 patients with suspected SOD. All patients were evaluated by expert pancreato-biliary specialists. The primary outcome measure was a Patient Global Impression of Change (PGIC) scale. Secondary measures included the pain burden, assessed by the Recurrent Abdominal Pain Intensity and Disability scale, the Short-Form Health Survey, and the Hospital Anxiety and Depression Scale. A positive clinical response was defined as a PGIC score of much or very much improved at 3 months and was estimated using a two-sided 90 % confidence interval. The primary outcome was analyzed using a one-sample binomial test at a significance level of 0.10.<bold>Results: </bold>Of the 20 screened patients, 18 were enrolled; 14 completed at least one post-baseline evaluation; and 10 patients completed the third month endpoint visit. Patients missing the third month visit were considered non-responders for the primary outcome. Response rates were 90 % for study completers (n = 10; 90 % CI 74-100; p = 0.02) and 64 % for patients who completed at least one post-baseline evaluation (n = 14; 90 % CI 43-85; p = 0.42). Seven patients did not complete the study due to adverse events (mostly fatigue and nausea).<bold>Conclusions: </bold>Duloxetine showed an indication of efficacy in the treatment of pain in patients with suspected SOD, but adverse events limited its use. These preliminary, open-label results justify definitive placebo-controlled trials.
- Subjects
UNITED States; DULOXETINE; SPHINCTER of Oddi; PILOT projects; DRUG tolerance; DRUG efficacy; PAIN management; DISEASES; THERAPEUTICS; ABDOMINAL pain; BILE duct diseases; CLINICAL trials; QUESTIONNAIRES; TREATMENT effectiveness; DISEASE complications
- Publication
Digestive Diseases & Sciences, 2016, Vol 61, Issue 9, p2704
- ISSN
0163-2116
- Publication type
journal article
- DOI
10.1007/s10620-016-4187-1