Short course chemoprophylaxis with rifampicin, isoniazid and pyrazinamide for tuberculosis evaluated in gold miners with chronic silicosis: a double-blind placebo controlled trial.
METHODS
A medical facility for approximately 90,000 gold miners employed on 24 South African gold mines.


OBJECTIVE
To evaluate the effectiveness of rifampicin, isoniazid and pyrazinamide given for 3 months for the prevention of tuberculosis in men with silicosis.


METHODS
A randomised double-blind placebo controlled trial with active 4-year follow up of subjects by routine radiographic screening.


RESULTS
A total of 382 gold miners with silicosis were randomised to receive rifampicin 600 mg, isoniazid 400 mg and pyrazinamide 1.25 g daily as Rifater or a placebo. These men have been followed for 4 years since the end of the treatment period. Eleven men who received the combination tablet and 15 men who received the placebo tablet have developed tuberculosis (chi 2 df1 = 0.66, P = 0.4).


CONCLUSIONS
This multi-drug short course chemoprophylaxis regimen has failed to prevent tuberculosis in miners with silicosis. Even if a larger study had demonstrated a statistically significant effect of the regimen as compared with placebo, the rate of tuberculosis in the men who received the three-drug regimen was unacceptably high.
Cowie
R L
RL
Department of Medicine, University of Calgary, Canada.
D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005500:Follow-Up Studies; D006046:Gold; D006801:Humans; D007538:Isoniazid / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D008906:Mining; D011718:Pyrazinamide / Q000627:therapeutic use; D012293:Rifampin / Q000627:therapeutic use; D012830:Silicotuberculosis / Q000517:prevention & control*
D000995:Antitubercular Agents; D004338:Drug Combinations; D011718:Pyrazinamide; D006046:Gold; D007538:Isoniazid; D012293:Rifampin