A double-blind study to determine the maximum tolerated dose of ethionamide, when administered twice-weekly to patients with pulmonary tuberculosis.
Devadatta, S.; Menon, N.K.; Nazareth, O.; Radhakrishna, S.; Ramakrishnan, C.V.; Somasundaram, P.R.; Usha, S.P.; Velu, S.
Tubercle; 1970; 51; 263-269 and Indian Journal of Tuberculosis; 1970; 17; 150-154 .
A 'double-blind' study was undertaken to determine the maximum dose of ethionamide that could be tolerated for two weeks, when administered twice weekly together with isoniazid plus PAS. Of 27 patients, 10 (37%) tolerated the highest planned dose of 1.5 g.; on the other hand, nine (33%) could not tolerate even 1.0 g.
Of 22 patients who were prescribed their maximum tolerated dose for a further period of eight weeks, only two completed the eight-week period on this dose; two more completed an eight-week period on a reduced dose.
The omission of PAS, in another group of 30 patients, did not result in better tolerance of ethionamide, the number who failed to tolerate 1.0 g. for two weeks being 10 (33%).
These findings are discouraging for the use of even a moderately high dosage of ethionamide on a twice-weekly basis in Madras patients.
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