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

doi:10.1016/S1472-9792(02)00053-7

Tuberculosis

Volume 83, Issues 1–3, February 2003, Pages 183-186

https://doi.org/10.1016/S1472-9792(02)00053-7 Get rights and content

Abstract

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.

Section snippets

Background

In a study of 40 new smear-positive tuberculosis patients treated with the regimen 2HRZE/4H3R3 in 1999 in the South Sulawesi province of the Republic of Indonesia, 65% reported complaints, in particular gastro-intestinal symptoms and skin reactions. One-third of these patients reported that these were severe enough to disrupt their daily activities and thus endanger treatment compliance. Patients and staff related these complaints to the number of tablets (8) that patients have to swallow daily.

Methods

A study protocol was prepared, including criteria for inclusion (new smear-positive patients with body weight between 33 and 50 kg), informed consent, and standard recording and reporting. Patients fulfilling the inclusion criteria are randomly allocated to either the NTP or the 4FDC regimen. The drugs of both regimens are provided in blister packs and blisters for the full course of treatment for one patient are packed together. The dosages of the drugs of the two regimens are given in Table 1.

Results

The regimen and sex of the 360 patients enrolled in the study are presented in Table 2. Table 3 gives the frequencies of complaints during the intensive phase of the treatment, irrespective of the duration of the complaint. Gastro-intestinal complaints include nausea, vomiting, dyspepsia and diarrhoea, skin complaints such as itching and skin rash and muscle–joint complaints such as muscle aches, cramps and joint pains. The differences in frequency of gastro-intestinal and muscle–joint

Discussion

The results of the study so far show that gastro-intestinal complaints, of any duration, as well as lasting 2 or more consecutive weeks and muscle–joint complaints of any duration, 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. Sputum conversion and treatment outcome for both regimens are high. Compared to the satisfactory treatment results in the routine services, the study shows

Acknowledgements

The study has been supported technically and financially by the Royal Netherlands Tuberculosis Association.

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