Effect of rifampin with bio-enhancer in the treatment of newly diagnosed sputum positive pulmonary tuberculosis patients: A double-center study.

OBJECTIVE: To compare a fixed-dose combination (FDC) of Rifampicin 450 mg, Isoniazid 300 mg, Pyrazinamide 1500 mg and Ethambutol 800 mg (usual care group) and regimen of Rifampicin 200 mg, Isoniazid 300 mg and piperine 10 mg along with Pyrazinamide 1500 mg and Ethambutol 800 mg (intervention care group). METHODS: A randomized, prospective, parallel group study was conducted on newly diagnosed tuberculosis patients. The drugs were given during intensive and continuous phase of treatment to newly diagnosed sputum positive pulmonary tuberculosis. All the patients were subjected to sputum examination, biochemical investigations followed by adverse drug event (ADE) monitoring. RESULTS: A total of 63 patients completed the study. No significant difference was observed in baseline characteristics of patients between the study groups. At the end of the continuous phase, both the groups showed zero bacteria detection. However, in the intervention group, the rate of sputum conversion was much faster than the usual care group. The rate of increase in SGOT and SGPT was much higher in the usual care group (p < 0.0001) than the interventional group (p < 0.05). Urea and creatinine has also increased from pre-treatment to end visit. The number of patients reported ADEs was less in the intervention care group (22.22%) when compared to the usual care group (36.84%). CONCLUSION: Rifampicin 200 mg with piperine 10 mg FDC is compatible with the usual CAT-1 regimen.