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BMJ. 2009 Oct 26;339:b4248. doi: 10.1136/bmj.b4248.

Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste.

Author information

1
Menzies School of Health Research, Darwin, NT, Australia.

Abstract

OBJECTIVE:

To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis.

DESIGN:

Parallel group randomised controlled trial.

SETTING:

Three primary care clinics in Dili, Timor-Leste.

PARTICIPANTS:

270 adults aged >or=18 with previously untreated newly diagnosed pulmonary tuberculosis.

MAIN OUTCOME MEASURES:

Completion of treatment (including cure). Secondary outcomes included adherence to treatment, weight gain, and clearance of sputum smears. Outcomes were assessed remotely, blinded to allocation status. Interventions Participants started standard tuberculosis treatment and were randomly assigned to intervention (nutritious, culturally appropriate daily meal (weeks 1-8) and food package (weeks 9-32) (n=137) or control (nutritional advice, n=133) groups. Randomisation sequence was computer generated with allocation concealment by sequentially numbered, opaque, sealed envelopes.

RESULTS:

Most patients with tuberculosis were poor, malnourished men living close to the clinics; 265/270 (98%) contributed to the analysis. The intervention had no significant beneficial or harmful impact on the outcome of treatment (76% v 78% completion, P=0.7) or adherence (93% for both groups, P=0.7) but did lead to improved weight gain at the end of treatment (10.1% v 7.5% improvement, P=0.04). Itch was more common in the intervention group (21% v 9%, P<0.01). In a subgroup analysis of patients with positive results on sputum smears, there were clinically important improvements in one month sputum clearance (85% v 67%, P=0.13) and completion of treatment (78% v 68%, P=0.3).

CONCLUSION:

Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste. Further studies in different settings and measuring different outcomes are required.

TRIAL REGISTRATION:

Clinical Trials NCT00192556.

PMID:
19858174
PMCID:
PMC2767482
DOI:
10.1136/bmj.b4248
[Indexed for MEDLINE]
Free PMC Article

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