Efficacy and safety of levamisole as an immunomodulator in the treatment of drug resistant tuberculosis

<b>Introduction:</b> Levamisole modulates immune response in tuberculosis (TB) and may help achieve the aims of TB control by reducing morbidity and cutting the chain of transmission. <b>Aims and Objectives:</b> To assess efficacy by sputum smear and culture conversion and improvement in patients of pulmonary and extra-pulmonary drug-resistant (DR) [including Multi-drug resistant (MDR) and Extensively-drug resistant(XDR)] TB receiving Levamisole along with anti-TB drug therapy and observe the safety profile of levamisole. <b>Methods:</b> In this prospective experimental case-control study, a total of 200 patients of DR TB were stratified into 3 groups: 1. Pulmonary(<i>n</i>=142) 2. Extra-pulmonary(<i>n</i>=43) 3. Pulmonary &amp; Extra-pulmonary(<i>n</i>=15) and further randomized by computer allocation to 2 arms: 1. Cases(<i>n</i>=89), receiving Levamisole thrice weekly along with individualized regimens of daily anti-TB therapy and 2. Controls(<i>n</i>=111), receiving daily anti-TB therapy for a total of 90 days. Treatment was partly supervised to ensure compliance. Sputum smear and culture conversion and clinical and radiological improvement were compared at baseline and 90 days, the results being analyzed by Fisher’s (two-tailed) exact test. <b>Results:</b> Sputum conversion was better (<i>p</i>=0.0011) in cases (60/71) than controls (54/86). Clinical and radiological improvement was better (<i>p</i>=0.0001) in cases (82/89) than controls (62/111). Gastritis was more common (<i>p</i>=0.013) in cases (27/89) than controls (19/111). <b>Conclusion:</b> Levamisole along with anti-TB therapy in patients of drug resistant tuberculosis led to significantly better sputum conversion and improvement in comparison to anti-TB therapy alone with acceptable adverse effects (gastritis).