Journal article
Effect of Amitriptyline on Symptoms in Treatment Naïve Patients With Interstitial Cystitis/Painful Bladder Syndrome
The Journal of urology, Vol.183(5), pp.1853-1858
05/01/2010
DOI: 10.1016/j.juro.2009.12.106
PMCID: PMC2861998
PMID: 20303115
Abstract
Amitriptyline is frequently used to treat patients with interstitial cystitis/painful bladder syndrome. The evidence to support this practice is derived mainly from a small, single site clinical trial and case reports.
We conducted a multicenter, randomized, double-blind, placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naïve to therapy. Study participants in both treatment arms received a standardized education and behavioral modification program. The drug dose was increased during a 6-week period from 10 up to 75 mg once daily. The primary outcome was a patient reported global response assessment of symptom improvement evaluated after 12 weeks of treatment.
A total of 271 subjects were randomized and 231 (85%) provided a global response assessment at 12 weeks of followup. Study participants were primarily women (83%) and white (74%), with a median age of 38 years. In an intent to treat analysis (271) the rate of response of subjects reporting moderate or marked improvement from baseline in the amitriptyline and placebo groups was 55% and 45%, respectively (p = 0.12). Of the subgroup of subjects (207) who achieved a drug dose of at least 50 mg, a significantly higher response rate was observed in the amitriptyline group (66%) compared to placebo (47%) (p = 0.01).
When all randomized subjects were considered, amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome. However, amitriptyline may be beneficial in persons who can achieve a daily dose of 50 mg or greater, although this subgroup comparison was not specified in advance.
Details
- Title: Subtitle
- Effect of Amitriptyline on Symptoms in Treatment Naïve Patients With Interstitial Cystitis/Painful Bladder Syndrome
- Creators
- Harris E. Foster - Yale UniversityPhilip M. Hanno - University of PennsylvaniaJ. Curtis Nickel - Queen's UniversityChristopher K. Payne - Stanford UniversityRobert D. Mayer - University of RochesterDavid A. Burks - Henry Ford HospitalClaire C. Yang - University of WashingtonToby C. Chai - University of Maryland, BaltimoreKarl J. Kreder - University of IowaKenneth M. Peters - Beaumont Hospital, TroyEmily S. Lukacz - University of California, San DiegoMary P. FitzGerald - Loyola University ChicagoLiyi Cen - University of PennsylvaniaJ. Richard Landis - University of PennsylvaniaKathleen J. Propert - University of PennsylvaniaWei Yang - University of PennsylvaniaJohn W. Kusek - National Institute of Diabetes and Digestive and Kidney DiseasesLeroy M. Nyberg - National Institute of Diabetes and Digestive and Kidney DiseasesInterstitial Cystitis Collaborative Research Network
- Resource Type
- Journal article
- Publication Details
- The Journal of urology, Vol.183(5), pp.1853-1858
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.juro.2009.12.106
- PMID
- 20303115
- PMCID
- PMC2861998
- ISSN
- 0022-5347
- eISSN
- 1527-3792
- Grant note
- 5U01 DK65255-06 National Institute of Diabetes and Digestive and Kidney Diseases U01 DK65192 U01 DK65190 U01 DK65255 U01 DK65215 U01 DK65271 U01 DK65214 U01 DK65213 U01 DK65178 5U01 DK65202 U01 DK65267 U01 DK65209
- Language
- English
- Date published
- 05/01/2010
- Academic Unit
- Obstetrics and Gynecology; Urology
- Record Identifier
- 9984383924802771
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