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.
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 10th week (P < 0.0001) and 14th 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.
Background: Adverse drug reactions (ADRs) are prevalent in patients taking psychotropic medications and can occur even at the normal doses used in the management of acute and maintenance phases of psychiatric disorders. Pharmacovigilance have cardinal role in alerting the healthcare providers from the possible ADRs and thus protecting the patients who are using psychotropic medications. To Monitor and estimate the incidence and nature of ADRs in psychiatry OPD of tertiary care hospital in central India and assess the causality, preventability and severity of documented ADRs.Methods: A prospective observational study was conducted in psychiatry out-patient department (OPD). Patients diagnosed with any psychiatric disorder and receiving psychotropic medications was included in the study. The recorded data were filled in the ADR form obtained from pharmacovigilance program of India (PvPI). Causality assessment was done using Naranjo scale and severity was assessed using Hartwig scale and preventability assessment using modified Schumock and Thornton’s scale.Results: The incidence rate of ADR was found to be 15.8%. A total of 61 ADRs were documented. Weight gain 14 (18.1%) followed by nausea 11 (14.2%) was the most commonly reported ADR. Atypical antipsychotics were the most common class of psychotropic drugs implicated in ADRs. Clonazepam 21 (27.2%) followed by amitriptyline 20 (25.9%) were associated with a maximum number of ADRs. Majority of the suspected ADRs were probable in nature (40.9%) followed by possible type (31%).Conclusions: Study revealed a moderate incidence of ADRs in patients attending the psychiatry OPD. Majority of the ADRs reported during the study were mild in nature and definitely preventable type.
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