Efficacy of Lysozme – Lactoferrin as a bioenhancer (immunomodulator) in the treatment of Tuberculosis

<p><strong>OBJECTIVES : </strong>Astudy was undertaken i) to assess sputum conversion of patients at 15, 30, 45 and 60 days in patients of sputum positive pulmonary tuberculosis (TB) with the combination of lysozyme and lactoferrin in comparison to placebo, ii) to make clinical assessment of these patients, and c). to observe hypersensitivity reactions and drug toxicity in both groups.</p> <p><strong>DESIGN: </strong>Open labelled , randomised, placebo controlled, single blinded trial</p> <p><strong>PATIENTS AND INTERVENTIONS :</strong> 120 patients of sputum positive pulmonary tuberculosis were enrolled. 2 groups of the study were planned, the first for newly diagnosed cases (Group 1- 60 patients) and the second for re-treatment cases (Group 2 - 60 patients). In each group, 2 arms, each of 30 patients were taken. In both groups, patients in Arm &ndash; 1 were given Lysozyme - lactoferrin capsules containing Lactoferrin 5 mg + Lysozyme 15 mg twice daily along with standard primary line anti-TB chemotherapy, whereas patients in Arm &ndash; 2 received placebo capsules instead. The sputum conversion was compared at 15, 30, 45 and 60 days in each arm in both groups.</p> <p><strong>RESULTS : </strong>a.) In newly diagnosed cases of TB (Group 1), Sputum conversion occurred earlier at 15 days (33 % ) and 30 days ( 84.85 %) in patients treated with BRM &ndash; 100 as compared to the group receiving placebo (16.6 % and 53.2 % at 15 and 30 days respectively) . However, there was no significant difference in the overall sputum conversion at 60 days (100 % in both groups). b) In Re-treatment cases (Group-2) of TB, sputum conversion was consistently higher at 15 days(23.3 %), 30 days (50 %) , 45 days ( 90 %) , and 60 days (96.66 %) with Lysozyme - lactoferrin than with placebo ( 3.33 % at 15 days , 16.6 % at 30 days, 46.6 % at 45 days and 66.66 % at 60 days respectively) . The overall success rate was 96.66 % with Lysozyme- lactoferrin and 66.66 % with placebo.</p> <p><strong>CONCLUSION </strong>: The combination of Lysozme and Lactoferrin is an oral, non-toxic, well tolerated, affordable biologic response modifier ( immunomodulator ) and it shows promising results in both newly diagnosed as well as Re-treatment cases in terms of early sputum conversion at 15, 30, 45 and 60 days and overall weight gain . This drug combination can be used as an immunomodulator, especially in Retreatment cases, where the results are appreciably better than in placebo group</p>