Effect of Amitriptyline on Symptoms in Treatment Naive Patients With Interstitial Cystitis/Painful Bladder Syndrome

被引:128
作者
Foster, Harris E., Jr. [1 ]
Hanno, Philip M. [2 ]
Nickel, J. Curtis [4 ]
Payne, Christopher K. [5 ]
Mayer, Robert D. [7 ]
Burks, David A. [8 ]
Yang, Claire C. [10 ]
Chai, Toby C. [11 ]
Kreder, Karl J. [13 ]
Peters, Kenneth M. [9 ]
Lukacz, Emily S. [6 ]
FitzGerald, Mary P. [14 ,15 ]
Cen, Liyi [3 ]
Landis, J. Richard [3 ]
Propert, Kathleen J. [3 ]
Yang, Wei [3 ]
Kusek, John W. [12 ]
Nyberg, Leroy M. [12 ]
机构
[1] Yale Univ, Sch Med, Dept Surg, Urol Sect, New Haven, CT 06520 USA
[2] Univ Penn, Div Urol, Philadelphia, PA 19104 USA
[3] Univ Penn, Sch Med, Dept Biostat & Epidemiol, Philadelphia, PA 19104 USA
[4] Queens Univ, Dept Urol, Kingston, ON, Canada
[5] Stanford Univ, Med Ctr, Dept Urol, Stanford, CA 94305 USA
[6] Univ Calif San Diego, Dept Reprod Med, La Jolla, CA 92093 USA
[7] Univ Rochester, Dept Urol, Rochester, NY USA
[8] Henry Ford Hosp, Dept Urol, Detroit, MI 48202 USA
[9] William Beaumont Hosp, Royal Oak, MI 48072 USA
[10] Univ Washington, Dept Urol, Seattle, WA 98195 USA
[11] Univ Maryland, Div Urol, Baltimore, MD 21201 USA
[12] NIDDKD, Bethesda, MD 20892 USA
[13] Univ Iowa, Dept Urol, Iowa City, IA 52242 USA
[14] Loyola Univ, Dept Obstet & Gynecol, Maywood, IL 60153 USA
[15] Loyola Univ, Dept Urol, Maywood, IL 60153 USA
关键词
cystitis; interstitial; amitriptyline; patient education as topic; INDEX; INCONTINENCE; MANAGEMENT; URGENCY; SCALE; WOMEN;
D O I
10.1016/j.juro.2009.12.106
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
100201 [内科学]; 100221 [泌尿外科学];
摘要
Purpose: 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. Materials and Methods: We conducted a multicenter, randomized,double-blind, placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naive 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. Results: 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). Conclusions: When all randomized subjects were considered, amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naive 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.
引用
收藏
页码:1853 / 1858
页数:6
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