Double-blind comparative clinical study on TE-031 and Josamycin in treatment of acute lacunar tonsillisis

Abstract

An evaluation of the clinical efficacy, safety, and usefulness of TE-031 in the treatment of acute lacunar tonsillitis was undertaken in a double-blind comparative clinical trial using Josamycin (JM) as the control drug. Patients in the TE (test) group received 400mg/day (in two divided doses) and patients in the JM (control) group received 1,200mg/day (in three divided doses). The clinical efficacy of both drugs was evaluated independently by the drug study committee and by a team of investigators. No statistically significant differences emerged in the efficacy ratings done by both groups. The drug study committee calculated efficacy rates of 87.4% for the TE group and 81.0% for the JM group. Correspondingly, the team of investigators reported clinical efficacy rates of 85.4% and 87.3% for the TE group and the JM group respectively. In bacteriological studies, both drugs demonstrated high levels of bacteriolytic potency. The eradication rate (including cases of bacterial replacement) reached 100% in the TE group and 95.6% in the JM group. In drug safety studies, side effects were recorded in 7 (7.3%) of the 96 patients in the TE group and in 10 (11.0%) of the 91 patients in the JM group, results which indicate no statistically significant difference between the two drugs in the incidence of side effects. Similarly, no essential differences emerged between the two drugs in the incidence of abnormal laboratory test values. Such abnormal laboratory values were reported in one patient (2.4%) of the 41 TE group members and in 5 individuals (12.2%) of the 41 JM group patients. The clinical usefulness of the drug administered to the TE group was rated at 83.3%, not statistically different from a usefulness rate of 80.5% reported for the drug used to treat the JM group. On the basis of the results reported above, TE-031 administered in a daily dosage of 400mg (in two divided doses) is shown to be a clinically efficacious, highly useful antibiotic comparable to JM administered in a daily dose of 1,200mg (in three divided doses) for the treatment of acute lacunar tonsillitis.