Two groups of MB leprosy patients, one treated to the point of smear negati
vity (TSN) and the other given therapy for fixed duration (24 doses of WHO
MB regimen) (FDT), were compared for relapse rates during treatment and in
the posttreatment period. During the follow-up of 980.2 person yeats in 260
patients treated with FDT, 20 relapses (2.04/100 patient years) were obser
ved. In the other group of 301 patients, who received therapy till smear ne
gativity, 12 relapses in 1085.46 person yeats (1.10/100 patient years) occu
rred. Comparison of survival rates (without relapse) has shown that althoug
h there is no difference up to 4 years, the risk of relapse was significant
ly higher on longer follow-up in the FDT group. In addition, when patients
were compared on the basis of initial bacterial load, it was found that the
relapse rates in patients with BI greater than or equal to 4 was significa
ntly higher (P < 0.01) in the FDT group as compared to those receiving trea
tment till the point of smear negativity (4.29 versus 1.27/100 patient year
s). All the relapsed patients responded to retreatment with the same drug c
ombination, indicating that the exacerbation in their condition was because
of insufficient treatment, it is suggested that to prevent or reduce relap
ses, treatment where feasible would be continued till smear negativity, at
least in patients with high BI.