Intermittent Directly Observed Therapy for Abdominal Tuberculosis: A Multicenter Randomized Controlled Trial Comparing 6 Months Versus 9 Months of Therapy.

Abstract

BACKGROUND:

The duration of treatment of gastrointestinal tuberculosis continues to be a matter of debate. The World Health Organization advocates intermittent directly observed short-course therapy (DOTs), but there is a lack of data of its efficacy in abdominal tuberculosis. We therefore conducted a multicenter randomized controlled trial to compare 6 months and 9 months of antituberculosis therapy using DOTs.

METHODS:

One hundred ninety-seven patients with abdominal tuberculosis (gastrointestinal, 154; peritoneal, 40; mixed, 3) were randomized to receive 6 months (n = 104) or 9 months (n = 93) of antituberculosis therapy using intermittent directly observed therapy. Patients were followed up 1 year after completion of treatment to assess recurrence. Patients were evaluated for primary endpoint (complete clinical response, partial response, and no response) and secondary endpoint (recurrence of the disease at the end of 1 year of follow-up).

RESULTS:

Baseline characteristics were similar between the 2 randomized groups. There was no difference between the 6-month group and 9-month group in the complete clinical response rate on per-protocol analysis (91.5% vs 90.8%; P = .88) or intent-to-treat analysis (75% vs 75.8%; P = .89). Only 1 patient in the 9-month group and no patients in the 6-month group had recurrence of disease. Side effects occurred in 21 (21.3%) and 16 (18.2%) patients in the 6-month and 9-month groups, respectively.

CONCLUSIONS:

There was no difference in efficacy of antituberculosis therapy delivered for either 6 months or 9 months in either gastrointestinal or peritoneal tuberculosis, confirming the efficacy of intermittent directly observed therapy.

CLINICAL TRIALS REGISTRATION:

NCT01124929.

• Authors: Govind K Makharia, Uday C Ghoshal, Balakrishnan S Ramakrishna, Abhishek Agnihotri, Vineet Ahuja, Sudipta Dhar Chowdhury, Siddhartha Datta Gupta, John Mechenro, Asha Mishra, Asha Mishra, Manish K Pathak, Ravinder M Pandey, Raju Sharma, Surendra K Sharma
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 61 Issue 5 Pg. 750-7 (Sep 01 2015) ISSN: 1537-6591 [Electronic] United States
• PMID: 25969531 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: [email protected].

Chemical References

• Antitubercular Agents

Topics

• Adult
• Antitubercular Agents (administration & dosage, adverse effects, therapeutic use)
• Directly Observed Therapy (methods)
• Female
• Humans
• Male
• Medication Adherence (statistics & numerical data)
• Middle Aged
• Peritonitis, Tuberculous (drug therapy, epidemiology)
• Tuberculosis, Gastrointestinal (drug therapy, epidemiology)
• Young Adult