Prospective Randomized Trial of Six-Month versus Nine-Month Therapy for Intestinal Tuberculosis

Author:

Park Sang Hyoung1,Yang Suk-Kyun1,Yang Dong-Hoon1,Kim Kyung Jo1,Yoon Soon Man1,Choe Jae Won1,Ye Byong Duk1,Byeon Jeong-Sik1,Myung Seung-Jae1,Kim Jin-Ho1

Affiliation:

1. Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea

Abstract

ABSTRACT Intestinal tuberculosis (TB) continues to be a common disease worldwide. However, the optimal duration of anti-TB medication has not been well established. We therefore compared the efficacy of 6-month and 9-month therapy in the treatment of intestinal TB. Ninety patients definitely diagnosed with intestinal TB were randomized into 6-month ( n = 45) or 9-month ( n = 45) treatment groups, prospectively. The primary end point was complete response, defined as endoscopic healing of active lesions. Patients were followed up monthly for 3 months after therapy initiation, then every 3 months until the end of therapy, and finally 1 year later. Relapse was assessed 1 year after the end of therapy by patient interview and colonoscopy. Baseline characteristics were similar in the 6-month and 9-month groups. Intention-to-treat analysis revealed no significant differences between the two groups in complete response (6-month group, 93.3%; 9-month group, 91.1%; P = 1.00) or recurrence rate (6-month group, 2.4%; 9-month group, 0.0%; P = 1.00). Median follow-up duration was 39 months in the 6-month group and 32 months in the 9-month group. No surgery was performed on any patient in either group. In conclusion, the 6-month therapy was as effective as 9-month therapy in patients with intestinal TB and may have the additional benefits of reduced treatment cost and increased compliance.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Reference35 articles.

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