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

Abstract

SummaryThe progression of lymphoedema to elephantiasis associated with increased incidence of episodic adenolymphangitis (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.

A Longitudinal Analysis of the Effect of Mass Drug Administration on Acute Inflammatory Episodes and Disease Progression in Lymphedema Patients in Léogane, Haiti

“…51 The improvement of lymphedema observed in this cohort during this 13-year period clearly coincided with results of the lymphedema management study during 1995-1998. Consistent with other literature is the significant decrease in ADL episodes 14,16,17,20 and the decrease in foot and ankle circumference observed during the lymphedema management program. 20 In addition, the improvement in quality of life associated with lymphedema management programs is consistent with previous findings.…”

“…The failure to find an impact of DEC on ADL episodes is consistent with the findings of Beye and others, 33 but is inconsistent with other studies assessing DEC. 14,20,[24][25][26]28,32,36 Similarly, the failure to find an improvement in lymphedema after receiving DEC is consistent with some studies, [32][33][34] but inconsistent with several reports examining this question; although these studies used varied DEC dosages over varied treatment schedules. 20,[24][25][26][27][28][29][30]50 However, because of numerous differences in methods between studies, comparison with this study is difficult.…”

“…There is only one other study that has examined the effect of DEC on leg circumference. 20 The authors found a significant decrease in leg circumference after exposure to DEC, but only examined the effect over one year and failed to account for the correlation among persons. Although our research contributes to the literature examining the effect of DEC administered through MDA on lymphedema from a methods standpoint, it is clear that there is a need to better understand the effect of drugs used in the MDA (DEC and ivermectin), particularly in relation to albendazole, which is co-administered with these drugs, on filarial morbidity.…”

“…20,[24][25][26][27][28][29][30]50 However, because of numerous differences in methods between studies, comparison with this study is difficult. There is only one other study that has examined the effect of DEC on leg circumference.…”

“…12 Clinical and histopathologic studies suggest that lymphedema management can decrease the number of ADL episodes 9,[13][14][15][16][17][18][19] and halt or, in some cases, partially reverse disease progression. 14,[16][17][18]20 Although there are several studies demonstrating improvement in lymphedema in patients who adhere to a lymphedema management regimen, the literature exploring the effect of mass drug administration with DEC, either alone or in combination with albendazole, on filarial morbidity is inconclusive. Recent clinical research using ultrasonography and lymphoscintigraphy has documented the reversal of early lymph-vessel damage in Brugia malayi-infected children after MDA with DEC in India.…”