TY - JOUR T1 - Disabilities in multibacillary leprosy following multidrug therapy with and without immunotherapy with Mycobacterium w antileprosy vaccine. AU - Sharma,P, AU - Kar,H K, AU - Misra,R S, AU - Mukherjee,A, AU - Kaur,H, AU - Mukherjee,R, AU - Rani,R, PY - 1999/11/27/pubmed PY - 1999/11/27/medline PY - 1999/11/27/entrez SP - 250 EP - 8 JF - International journal of leprosy and other mycobacterial diseases : official organ of the International Leprosy Association JO - Int J Lepr Other Mycobact Dis VL - 67 IS - 3 N2 - A vaccine based on autoclaved Mycobacterium w was administered, in addition to standard multidrug therapy (MDT), to 157 bacteriologically positive, lepromin-negative, multibacillary leprosy patients supported by a well-matched control group of 147 patients with similar type of disease who received a placebo injection in addition to MDT. The MDT was given for a minimum period of 2 years and continued until skin-smear negativity, while the vaccine/placebo was given at 3-month intervals up to a maximum of 8 doses in the initial 2 years. The overall incidence of type 1 and type 2 reactions and neuritis during treatment and follow up was nearly equal in the patients in the vaccine and placebo groups; the differences were not statistically significant. The occurrence of disabilities, such as anesthesia, trophic ulcers, claw hand and grade 3 deformities, were not different statistically in the vaccine and placebo groups, an observation valid both for deformities present at induction and for those which developed during the course of therapy and surveillance. A statistically significant difference was observed in the recovery of newly developed trophic ulcers; recovery was quicker in the vaccine group. The recovery rate for motor deformities was marginally higher in the vaccine group, although not significant (p = 0.068) statistically. There was a statistically significant reduction in the incidence of grade 3 deformities following MDT with and without immunotherapy. To conclude, the addition of vaccine to MDT did not precipitate neuritis or deformities over and above that encountered with MDT alone, although it did accelerate bacteriological clearance, histopathological upgrading, conversion to lepromin positivity, and clinical improvement. SN - 0148-916X UR - https://www.unboundmedicine.com/medline/citation/10575404/Disabilities_in_multibacillary_leprosy_following_multidrug_therapy_with_and_without_immunotherapy_with_Mycobacterium_w_antileprosy_vaccine_ L2 - https://ClinicalTrials.gov/search/term=10575404 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -