Gurpreet Singh1, Seema Patrikar2, D R Basannar3, V K Bhatti4. 1. Graded Specialist (Community Medicine), Officer Commanding, Station Health Organization, Jalandhar Cantt, India. 2. Lecturer in Statistics and Demography, Department of Community Medicine, Armed Forces Medical College, Pune 411040, India. 3. Scientist 'F', Department of Community Medicine, Armed Forces Medical College, Pune 411040, India. 4. Director, Armed Forces Medical Services (Health), O/o DGAFMS, Ministry of Defence, New Delhi, India.
Abstract
BACKGROUND: Evidence-based policy decision-making is introduction of newer technology that it is 'not inferior' to existing technology. Multiple randomised clinical trials (RCTs) on tuberculosis (TB) treatment have shown mixture of favourable, unfavourable and non-significant changes in outcomes with the use of fixed-dose combination (FDC) regimens. The aim of this study was to assess clinical effectiveness of FDC regimen as compared to the use of separate drugs in anti-TB treatment. METHODS: Systematic literature search was carried out. RCTs with newly diagnosed smear-positive pulmonary TB cases were included. Defined outcomes were smear conversion, relapse, adverse reactions and patient compliance. RESULTS: Initial search revealed 457 articles, out of which 7 were included for meta-analysis. Pooled risk ratio for smear conversion rate at the end of intensive phase was 1.01 (95% confidence interval [CI], 0.99-1.03; p = 0.40). Similarly, smear conversion rate at the end of treatment showed no significant difference (relative risk (RR) = 1.01; 95% CI, 0.99-1.02; p = 0.45). Pooled risk ratio for combined smear conversion rates was 1.01 (95% CI, 0.99-1.02). However, relapse rates showed marginally higher trend with FDC regimens (RR, 1.56; 95% CI, 0.95-2.56; p = 0.49). Pooled analysis for adverse events showed no significant difference (RR = 0.98; 95% CI, 0.86-1.11; p = 0.70). Analysis of patient compliance showed marginal increase among FDC group (RR = 1.02; 95% CI, 0.96-1.09; p = 0.47)). CONCLUSION: Fixed-dose combination (FDC) formulations are not inferior in treatment outcomes. It may also ease programme managers and patients by improving compliance. However, increase in relapse rates needs further evaluation through large multicentric studies before implementing policy change in the national programme.
BACKGROUND: Evidence-based policy decision-making is introduction of newer technology that it is 'not inferior' to existing technology. Multiple randomised clinical trials (RCTs) on tuberculosis (TB) treatment have shown mixture of favourable, unfavourable and non-significant changes in outcomes with the use of fixed-dose combination (FDC) regimens. The aim of this study was to assess clinical effectiveness of FDC regimen as compared to the use of separate drugs in anti-TB treatment. METHODS: Systematic literature search was carried out. RCTs with newly diagnosed smear-positive pulmonary TB cases were included. Defined outcomes were smear conversion, relapse, adverse reactions and patient compliance. RESULTS: Initial search revealed 457 articles, out of which 7 were included for meta-analysis. Pooled risk ratio for smear conversion rate at the end of intensive phase was 1.01 (95% confidence interval [CI], 0.99-1.03; p = 0.40). Similarly, smear conversion rate at the end of treatment showed no significant difference (relative risk (RR) = 1.01; 95% CI, 0.99-1.02; p = 0.45). Pooled risk ratio for combined smear conversion rates was 1.01 (95% CI, 0.99-1.02). However, relapse rates showed marginally higher trend with FDC regimens (RR, 1.56; 95% CI, 0.95-2.56; p = 0.49). Pooled analysis for adverse events showed no significant difference (RR = 0.98; 95% CI, 0.86-1.11; p = 0.70). Analysis of patient compliance showed marginal increase among FDC group (RR = 1.02; 95% CI, 0.96-1.09; p = 0.47)). CONCLUSION: Fixed-dose combination (FDC) formulations are not inferior in treatment outcomes. It may also ease programme managers and patients by improving compliance. However, increase in relapse rates needs further evaluation through large multicentric studies before implementing policy change in the national programme.
Authors: Christian Lienhardt; Sharlette V Cook; Marcos Burgos; Victoria Yorke-Edwards; Leen Rigouts; Gladys Anyo; Sang-Jae Kim; Amina Jindani; Don A Enarson; Andrew J Nunn Journal: JAMA Date: 2011-04-13 Impact factor: 56.272