Controlled clinical trial comparing a 6-month and a 12-month regimen in the treatment of pulmonary tuberculosis in the Algerian Sahara. Algerian working group/British Medical Research Council cooperative study.

A 6-month short-course chemotherapy regimen and a 12-month standard duration regimen have been compared in the treatment of pulmonary tuberculosis in a rural area of Algeria in a population with a relatively high proportion of nomads. The 6-month regimen was isoniazid and rifampicin throughout, with ethambutol and pyrazinamide in addition for an initial 2-month intensive phase. The 12-month regimen was isoniazid and ethambutol throughout, supplemented by streptomycin during the first month. All 601 patients admitted had one or more sputum smears positive on examination in the local laboratory. Most patients were admitted to hospital initially for 1 to 2 months, where they received their chemotherapy under full supervision; thereafter, it was self-administered. In both nomads and settled residents known to have fully sensitive strains pretreatment, the 6-month regimen was highly effective, with no failures during chemotherapy and only 3% relapses after stopping chemotherapy in 131 patients compared with a combined failure rate during chemotherapy and relapse rate of 17% in the 154 patients receiving the 12-month regimen (p less than 0.001). The results in patients with isoniazid-resistant strains pretreatment were also significantly better for the 6-month than for the 12-month regimen, none of 15 and 7 of 15 patients, respectively, being classified as failures or relapses.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes