A double-blind controlled clinical trial to assess the role of anti-histamines in the treatment of multi-bacillary leprosy.

A double blind controlled clinical trial to assess the role of anti-histamines as a supplement in the treatment of leprosy was conducted in multi-bacillary cases of leprosy. In all, 120 patients with lepromatous or borderline leprosy were randomly allocated to a regimen of clofazimine and dapsone for 12 months with or without a supplement of pheniramine maleate for the first 3 months. During the 12-month period, 92% of the patients who received the supplement and 86% of the patients who had not received it had moderate or marked clinical improvement. The BI values decreased from 4.1 to 3.4 and 4.2 to 3.3, respectively. The results over the 12-month period showed that the addition of the antihistamine had not enhanced the efficacy of the regimen as evidenced by clinical and bacteriological findings.

Evaluation of levamisole, an immunopotentiator, in the treatment of lepromatous leprosy.

Twenty subpolar lepromatous leprosy patients under multidrug therapy for a period of 1 to 3 years, who continued to be bacteriologically positive (BI 2 to 1 in Dharmendra's grade) were taken in the study. Ten cases (trial group) were given levamisole as an immuno-stimulator for 1 year along with chemotherapy. Another 10 cases (control group) continued to take chemotherapy alone. There was no conversion of Mitsuda reactivity in any of the cases from both the groups. There was no improvement of leucocyte migration inhibition in either group. In both trial and control groups, statistically significant clinical and bacteriological improvements and increase of E. rosette counts are found at the end of one year. However, only the bacteriological improvement in the trial showed statistical significance, when the improvements were compared with those of the control group. No adverse effect due to levamisole therapy was encountered.

Use of Whatman chromatography paper for serological studies in leprosy in the field.

Recently W.H.O. recommended further serological studies on leprosy using samples collected on filter paper strips. A study was therefore taken up at C.L.T. and R.I., Chengalpattu, to find out the relative efficiency of the serological tests conducted on sera and filter paper eluates. FLA-ABS and FA-BCG tests were carried out on 100 paired samples. With the former, exactly the same titres were obtained in 42% and with the latter in 52% cases. Most of the others showed positivity at one-dilution-low titres. In 6-8% cases only, the filter paper technique showed negativity. The correlation co-efficient was +0.87 with FLA-ABS and +0.85 with FA-BCG test. The filter paper technique was operationally more convenient and was acceptable without substantially loosing the efficacy.

Anaerobic flora in trophic ulcers in leprosy patients.

Material from 108 trophic ulcers from leprosy cases were studied bacteriologically. 4 cases showed growth of pure anaerobes and 69 showed mixed growth of aerobic and anaerobic bacteria. The predominant anaerobes were Fusobacteria (41), anaerobic cocci (30) and Bacteroides (25). Clostridia were isolated only in 10 cases. Metronidazole, chloramphenicol, penicillin and ampicillin were found effective against anaerobes in in-vitro studies.

Hepatitis and multi-drug therapy in leprosy with special reference to prothionamide.

Hepatotoxicity in two drug regimens was studied at Central Leprosy Teaching and Research Institute, Chengalpattu (Tamil Nadu) during 1983-84. In 'P' regimen-prothionamide 350 mg daily, dapsone 100 mg daily and rifampicin 600 mg at monthly intervals were given. In' C' regimen-dapsone 100 mg daily, rifampicin 600 mg once a month and clofazimine 300 mg once a month and 100 mg alternate day were given. Trial was started with fifty multibacillary adult leprosy patients in each group. Enzymatic hepatic dysfunction was noted in 52-58 per cent of the cases even before the therapy was started. In 'P' regimen, four cases of clinical jaundice and six cases of high bilirubinaemia was noticed during the trial as against two cases each of clinical jaundice and high bilirubinaemia in 'C regimen. Of the two cases of clinical jaundice in 'C' regimen, one turned out to be a case of HBV infection. The study which is in progress, indicated higher hepatotoxicity in 'P' regimen which is probably explained by the simultaneous use of two hepatotoxic drugs. Viral hepatitis is endemic in this area and might have aggravated the hepatotoxicity observed.

Reversible acute renal failure due to monthly administration of rifampicin in a leprosy patient.

Special complications due to intermittent rifampicin administration have been well documented, specially for the treatment of tuberculosis. Multi-drug therapy recommended for the treatment of leprosy by W.H.O. (1982) advocates the administration of rifampicin at monthly interval and at this level of infrequent administration, complications linked with intermittent therapy are seldom noted. An adult male put on W.H.O. regimen for the treatment of lepromatous leprosy developed acute renal failure at the time of second and third monthly doses of rifampicin therapy, but recovered completely due to prompt treatment.

Gynaecomastia in leprosy in three districts of Tamil Nadu.

The prevalence of Gynaecomastia (GM), a well known complication of leprosy in adult male patients was studied in 790 cases of whom 641 were the inmates of five leprosy hospitals and the remaining 149 mostly from the clinics of field area attached to the Central Leprosy Teaching and Research Institute, Chengalpattu during 1982-83. The overall prevalence rate was found to be 19.24%. Among the hospitalised patients, it was 22.15% against 6.71% among the patients attending the clinics in the field area. The youngest and the oldest patient in this study was 16 years and 83 years respectively. The highest rate of 32.89% was in the 36-45 age group. Only 152 GM cases were detected; the rates in the lepromatous, borderline lepromatous, borderline tuberculoid were 29.21%, 9.64% and 3.68% respectively. Those who gave a history of frequent ENL reactions had a higher rate of GM i.e. 34.55 as against 21.52 without or with very infrequent ENL reaction. Early treatment had a remarkable effect in the reduction of GM. Only 14% developed GM when the treatment was started within 2 years after the onset of leprosy as against 46.9% when the same was started after 16 years. In the latter group, the longer duration of the disease could also play a contributory role. Sterility rate was more than double in those with GM i.e. 34.14% against 14% without it.

Dapsone resistance in patients attending Central Leprosy Teaching and Research Institute, Chengalpattu (South India).

The Central Leprosy Teaching and Research Institute (C.L.T. & R.I.) Chengalpattu, took up studies on dapsone resistance in M. leprae from 1974. From 1978, the study was further strengthened by a project under THELEP (TDR) for eliciting information on the efficacy of certain drug regimens. The Thelep studies were to be conducted only on the dapsone sensitive untreated cases and, therefore, directed towards the detection of primary resistance, while the non-THELEP institutional studies were concentrated on secondary dapsone resistance problem. These two studies together detected 99 cases of dapsone resistance in the patients who attended CLTRI Hospital during 1974-81; 23 of them, were of primary origin, 16, 6 and 1 showing mild (RI), moderate (RII), and high (RIII) grades respectively. Of the remaining 76 cases of secondary resistance, 7 and 69 were of RII and RIII grades respectively. The need for vertical and horizontal monitoring of the drug resistance problem has been pointed out.