Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste.
Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste.
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DOI：
10.1136/bmj.b4248
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发表时间：
2009-10-26
期刊：
影响因子：
--
通讯作者：
Kelly PM
中科院分区：
文献类型：
--
作者：
Martins N;Morris P;Kelly PM
目的确定提供全食物对提高结核病治疗完成率的有效性。设计平行组随机对照试验。东帝汶帝力的三个初级保健诊所。研究对象为270名18岁以上、既往未接受过治疗的新诊断肺结核患者。主要结果测量完成治疗（包括治愈）。次要结局包括治疗依从性、体重增加和痰涂片清除。远程评估结局，对分配状态设盲。参与者开始标准的结核病治疗，并被随机分配到干预组（营养，文化上适当的每日膳食（第1-8周）和食品包装（第9-32周）（n=137）或对照组（营养建议，n=133）。随机化序列由计算机生成，分配隐藏在顺序编号的不透明密封信封中。结果大多数结核病患者是生活在诊所附近的贫困、营养不良的男性; 265/270（98%）例患者参与了分析。干预对治疗结果（76% v78%完成，P=0.7）或依从性（两组均为93%，P=0.7）没有显著的有益或有害影响，但确实导致治疗结束时体重增加改善（10.1% v7.5%改善，P=0.04）。瘙痒发生率干预组为21%，对照组为9%（P<0.01）.在痰涂片阳性患者的亚组分析中，1个月痰液清除率（85% v67%，P=0.13）和治疗完成率（78% v68%，P=0.3）有临床意义的改善。结论在东帝汶，提供食物并不能改善结核病患者的治疗效果。需要在不同的环境中进行进一步的研究，并衡量不同的结果。临床试验NCT 0019256的试验注册。
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 ≥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 NCT0019256.
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