Adverse drug reactions among new sputum positive pulmonary tuberculosis patients on daily treatment regimen: a prospective study from Haryana, India

Abstract

Background: Daily regimen anti-tuberculosis treatment was adopted by Revised National Tuberculosis Control Programme (RNTCP) as a step to achieve tuberculosis elimination by 2025 in India. The change was implemented prior to completion of pilot study, which necessitated this study to note the self-reported Adverse Drug Reactions (ADRs).Methods: A prospective study with concurrent sampling design was carried on from June 2018 to June 2020 in the state of Haryana, India. Pre-tested semi-structured schedule was used to collect data based on RNTCP outcome definitions through two monthly (four visits) home visits. Mean±standard deviation, percentage, proportion and chi-square test was used. The p-value of <0.05 was considered as statistically significant.Results: Amongst 122 study participants 74 (60.7%) were males and 48 (39.3%) were females with mean age of 39.4±18.9 years. Majority were urban residents 87 (71.3%) and 35 (28.7%) rural residents. There were 25 (20.5%) tobacco smokers, nine (7.4%) alcohol consumers, and three (2.5%) smokeless tobacco users. Forty-five participants had ADRs and 54 ADR events had occurred, but none required change in treatment regimen. Sixteen (13.1%) reported loss of appetite followed by 10 (8.2%), flu-like symptoms, eight (6.6%) nausea, seven (5.7%) pain in joints, three (2.5%) abdomen pain, three (2.5%) headache, two (1.6%) itching and rash, one (0.8%) burning in hands and feet and one (0.8%) giddiness. Daily regimen ADR cases (36.9%) and events (44.3%) when comparatively higher than intermittent regimen (25.6%).Conclusions: The ADRs cases and events had occurred in higher proportion but were mild and hence did not require any regimen change.