N-acetylcysteine as an add-on to Directly Observed Therapy Short-I therapy in fresh pulmonary tuberculosis patients: A randomized, placebo-controlled, double-blinded study.

PURPOSE: Pulmonary tuberculosis is associated with increased oxidative stress, enhanced lipid peroxidation, and decreased glutathione (GSH) levels. N-acetylcysteine (NAC) effectively increases GSH levels, improves lipid peroxidation, and decreases reactive oxygen species levels as reported by earlier studies. Hence, we planned to clinically evaluate the effect of NAC as add-on to Directly Observed Therapy Short-I (DOTS-I) regimen on treatment outcome in PTB with the objectives to study the effect of NAC as an add-on to intensive phase of DOTS-I (2 months) on sputum conversion, radiological improvement, GSH peroxidase (GPx) level, and weight and immunological response compared to placebo add-on at the end of 2 and 6 months. MATERIALS AND METHODS: This was a design-prospective, randomized, parallel group, add-on design, placebo-controlled, double-blinded, 24-week study. Parameters studied were sputum acid-fast bacillus examination, radiological improvements, GPx level, weight, and Mantoux response. NAC/placebo was added to DOTS Category I in intensive phase. RESULTS: Totally 48 patients completed the study. In NAC group, 23 patients achieved sputum negativity in 3 weeks while 14 patients in PLACEBO group. There was a significant clearing of infiltration and reduction in cavity size in NAC group compared to placebo at 2 months. At 2 and 6 months, NAC significantly raised GPx level and body weight. In 2 months, the patients with Mix ≤5 became Mx positive (100%) in NAC group while none in placebo group. CONCLUSION: NAC addition to DOTS-I significantly brings about faster sputum negativity, improves radiological response, weight, raises serum GPx level, and rectifies the deregulated immune response. Thus, NAC may be a useful adjuvant to DOTS in PTB.

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.

A comparative study of the clinical efficacy and safety of agomelatine with escitalopram in major depressive disorder patients: A randomized, parallel-group, phase IV study.

OBJECTIVE: To compare the efficacy of agomelatine with escitalopram in the treatment of major depressive disorder (MDD), improve sleep in MDD patients and study the adverse effects of agomelatine. MATERIALS AND METHODS: Randomized, parallel-group, open-label study. The primary efficacy outcome was change from baseline to last post-baseline value in Hamilton depression rating scale and Leeds sleep evaluation questionnaire scale. Both parametric and nonparametric tests were applied for analysis. RESULTS: Within-group and between-groups comparison of the mean HAMD17 scores showed statistically significant changes (P < 0.0001). Escitalopram showed early onset of response and remission compared to agomelatine at 10(th) week (P < 0.0001) and 14(th) week (P < 0.0001), respectively. In agomelatine, within-group and between-groups change of the mean LSEQ score was statistically significant at subsequent follow-up visits (P < 0.0001). CONCLUSION: Escitalopram is superior to agomelatine in efficacy, considering the early response, early remission, and better relief from symptoms of MDD in adults. Agomelatine may be preferred in MDD patients having insomnia as a predominant symptom. Liver function monitoring should be done in patients on long-term agomelatine therapy.