title: 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.
  
  
  BACKGROUND
  NCT01124929.
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi.
authors.forename: Govind K
authors.initials: GK
authors.lastname: Makharia
authors.affiliation: Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow.
authors.forename: Uday C
authors.initials: UC
authors.lastname: Ghoshal
authors.affiliation: Department of Gastroenterology, SRM Institute of Medical Sciences, Chennai Department of Gastroenterology, Christian Medical College, Vellore.
authors.forename: Balakrishnan S
authors.initials: BS
authors.lastname: Ramakrishna
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi.
authors.forename: Abhishek
authors.initials: A
authors.lastname: Agnihotri
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi.
authors.forename: Vineet
authors.initials: V
authors.lastname: Ahuja
authors.affiliation: Department of Gastroenterology, Christian Medical College, Vellore.
authors.forename: Sudipta Dhar
authors.initials: SD
authors.lastname: Chowdhury
authors.affiliation: Department of Pathology.
authors.forename: Siddhartha Datta
authors.initials: SD
authors.lastname: Gupta
authors.affiliation: Department of Gastroenterology, SRM Institute of Medical Sciences, Chennai Department of Gastroenterology, Christian Medical College, Vellore.
authors.forename: John
authors.initials: J
authors.lastname: Mechenro
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi.
authors.forename: Asha
authors.initials: A
authors.lastname: Mishra
authors.affiliation: Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow.
authors.forename: Asha
authors.initials: A
authors.lastname: Mishra
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi.
authors.forename: Manish K
authors.initials: MK
authors.lastname: Pathak
authors.affiliation: Department of Biostatistics.
authors.forename: Ravinder M
authors.initials: RM
authors.lastname: Pandey
authors.affiliation: Department of Radiodiagnosis.
authors.forename: Raju
authors.initials: R
authors.lastname: Sharma
authors.affiliation: Department of Medicine, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Surendra K
authors.initials: SK
authors.lastname: Sharma
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D023801:Directly Observed Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014395:Peritonitis, Tuberculous / Q000188:drug therapy* / Q000453:epidemiology; D014385:Tuberculosis, Gastrointestinal / Q000188:drug therapy* / Q000453:epidemiology; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D000995:Antitubercular Agents
keywords: duration of treatment; intestinal tuberculosis; peritoneal tuberculosis