A randomized clinical trial to compare the efficacy of three treatment regimens along with footcare in the morbidity management of filarial lymphoedema

Abstract

The progression of lymphoedema to elephantiasis associated with increased incidence of episodic adeno-lymphangitis (ADL) is of great concern, as it causes physical suffering, permanent disability and economic loss to lymphatic filariasis patients. This randomized clinical trial aimed to assess the efficacy in terms of reduction of oedema and ADL frequency of three treatment regimens among lymphoedema patients from Orissa, India. The regimens were: (I) oral penicillin--one tablet of 800 000 U penicillin G potassium twice daily for 12 days--repeated every 3 months for 1 year; (II) diethylcarbamazine--6 mg/kg bodyweight for 12 days-repeated every 3 months for 1 year; and (III) topical antiseptic, i.e. betadine ointment. Foot care was part of all regimens. All three drug regimens are efficacious in reducing oedema and frequency of ADL episodes. Although the efficacy was slightly higher in regimen I, the difference was not significant. About half of all patients had reduced oedema after the 90 days of treatment, with oedema reduction of 75-100% in 20%. A major proportion of the remaining patients had oedema reduced by less than 25%. The proportion of people whose oedema reduced was slightly but not significantly lower in regimen II. anova revealed that lymphoedema reduction varied according to grade; being greatest at grade 1 lymphoedema, followed by grade 2. All three regimens significantly reduced ADL frequency after 1 year of treatment. This may be because of foot care as well as use of antibiotics. The estimated costs of treatment per patient for a period of 3 months are US$2.4, 1.5 and 4.0 respectively for regimen I, II and III. Thus affordable treatments with simple antibiotics and foot care can give substantial relief to the patients and reverse early lymphoedema.