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USPHS Tuberculosis Short-Course Chemotherapy Trial 21: Effectiveness, Toxicity, and Acceptability: The Report of Final Results

Debra L. Combs, MPH; Richard J. O'Brien, MD; and Lawrence J. Geiter, MPH
[+] Article, Author, and Disclosure Information

This paper was presented in part at the annual meeting of the American Thoracic Society, 16 May 1989, Cincinnati, Ohio.

Grant Support: Financial support to clinics participating in the Rifater substudy was provided by Merrell Dow Research Institute.

Requests for Reprints: Richard J. O'Brien, MD, Clinical Research Branch (E-10), Division of Tuberculosis Control, Centers for Disease Control, Atlanta, GA 30333.

Current Author Addresses: Ms. Combs: Surveillance and Programs Branch (F-28), Division of Environmental Hazards and Health Effects, Center for Environmental Health and Injury Control, Centers for Disease Control, Atlanta, GA 30333.

Dr. O'Brien and Mr. Geiter: Clinical Research Branch (E-10), Division of Tuberculosis Control, Centers for Disease Control, Atlanta, GA 30333.

Ann Intern Med. 1990;112(6):397-406. doi:10.7326/0003-4819-76-3-112-6-397
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Study Objective: To determine the effectiveness, toxicity, and acceptability of a 6-month antituberculous regimen compared with a 9-month regimen.

Design: A nonblinded, unbalanced, randomized, multicenter clinical trial.

Setting: Twenty-two tuberculosis clinics in public health departments and hospitals in the United States.

Patients: Patients were eligible if Mycobacterium tuberculosis, isolated from sputum cultures, was susceptible to study drugs. Of 1451 patients enrolled, 75% (617 of 823) assigned to the 6-month regimen and 71% (445 of 628) assigned to the 9-month regimen were eligible.

Interventions: Patients took self-administered isoniazid and rifampin daily for 24 weeks (6-month regimen) or 36 weeks (9-month regimen). In addition, patients assigned to the 6-month regimen took self-administered pyrazinamide daily during the first 8 weeks.

Results: Patients on the 6-month regimen converted more rapidly than patients on the 9-month regimen (94.6% compared with 89.9% after 16 weeks of therapy, with a difference of 4.7% [95% CI, 0.7% to 8.7%]); had similar rates of adverse drug reactions (7.7% compared with 6.4%, with a difference of 1.3% [95% CI, 0.0% to 4.6%]); had lower noncompliance rates (16.8% compared with 29.2%, with a difference of 12.4% [95% CI, 6.8% to 18.0%]); and had similar relapse rates 96 weeks after completing therapy (3.5% compared with 2.8%, with a difference of 0.7% [95% CI, 0.0% to 3.9%]). A significantly greater proportion of patients assigned to the 6-month regimen successfully completed therapy (61.4% compared with 50.6%; χ2 = 11.976).

Conclusions: Our results suggest that this 6-month regimen is similar in effectiveness, toxicity, and acceptability to the 9-month regimen for treating pulmonary tuberculosis.





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