Levamisole as an Adjuvant to Short-Course Therapy in Newly Diagnosed Pulmonary Tuberculosis Patients

BACKGROUND: The estimated incidence and prevalence of tuberculosis in India are 2.1 and 2.6 million cases respectively. Immunotherapy may shorten tuberculosis treatments and improve the immunity of individuals as well. Hence we study the efficacy of levamisole (LVM) (immunomodulator) as an adjuvant to chemotherapy of pulmonary tuberculosis patients. MATERIALS AND METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted for 21 months in newly diagnosed sputum positive pulmonary tuberculosis patients. Patients were subjected initially to clinical examination, sputum acid-fast bacilli smear and culture, tuberculin skin test and weight record. During follow-up, above investigations were repeated. Sixty-five patients were randomly assigned into two groups to receive either tab LVM 100 mg once in a day or matching placebo, orally as a single dose, thrice a week, for 2 months with short-course antituberculosis chemotherapy. RESULTS: Sputum negativity at 1 week was observed in 11 (44%) patients in LVM group whereas only 3 (12%) in placebo group. All the patients 25 (100%) in LVM group were sputum negative compared to 14 (56%) in placebo group by the end of 3 weeks. In LVM group, 24 (96%) and 11 (44%) patients in placebo group show radiological improvement at 2 months. A direct correlation existed between quantum of immune response and weight gain with LVM. LVM rendered all anergic patients to positive tuberculin reactors. In LVM group, patients with initial Mantoux ≥20 mm and advanced cavitary disease, there was decrease in tuberculin reaction size. CONCLUSION: Adjuvant immunomodulation with levamisole has the potential of shortening the total duration of antitubercular therapy.