Preliminary results of an operational field study to compare side-effects, complaints and treatment results of a single-drug short-course regimen with a four-drug fixed-dose combination (4FDC) regimen in South Sulawesi, Republic of Indonesia

Tuberculosis (Edinb). 2003;83(1-3):183-6. doi: 10.1016/s1472-9792(02)00053-7.


Setting: Health centres in the South Sulawesi Province, Republic of Indonesia.

Objectives: To compare complaints, side-effects and treatment outcome in new smear-positive patients treated with a single-drug short-course (National TB Programme (NTP)) regimen with those treated with a four-drug fixed-dose combination (4FDC) regimen.

Design: A prospective study in which patients are randomly allocated to the NTP or the 4FDC regimen.

Results: Preliminary results of the first 360 patients (162 treated with the NTP regimen and 198 with the 4FDC regimen) show that two patients, treated with the NTP regimen, developed jaundice. During the intensive phase of treatment, gastro-intestinal and muscle-joint complaints of any duration and gastro-intestinal complaints lasting for 2 consecutive weeks or more were more frequent in patients treated with the NTP regimen. Sputum conversion was 89% in patients treated with the NTP regimen and 94% in those treated with the 4FDC regimen. Nine-five per cent of patients, both regimens, were cured.

Conclusion: The results so far show that complaints during the intensive phase of treatment are less frequent among patients treated with the 4FDC regimen. The lower dose of pyrazinamide might be the reason. Treatment results are excellent for both regimens.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antitubercular Agents / adverse effects*
  • Antitubercular Agents / therapeutic use
  • Directly Observed Therapy / adverse effects
  • Drug Administration Schedule
  • Drug Eruptions / etiology
  • Drug Therapy, Combination
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Male
  • Musculoskeletal Diseases / chemically induced
  • Prospective Studies
  • Sputum / microbiology
  • Treatment Outcome
  • Tuberculosis, Pulmonary / drug therapy*
  • Tuberculosis, Pulmonary / microbiology


  • Antitubercular Agents