Some observations on the effect of Daflon (micronized purified flavonoid fraction of Rutaceae aurantiae) in bancroftian filarial lymphoedema

Abstract

BACKGROUND: Morbidity management is a core component of the global programme for the elimination of lymphatic filariasis. In a double-blind clinical trial, the tolerability and efficacy of Daflon (500 mg) + DEC (25 mg) or DEC (25 mg) alone, twice daily for 90 days, was studied in 26 patients with bancroftian filarial lymphoedema. RESULTS: None of the patients in either drug group reported any adverse reaction throughout the treatment period (90 days). Haematological and biochemical parameters were within normal limits and there was no significant difference between the pre-treatment (day 0) and post-treatment (day 90) values. The group receiving Daflon showed significant reduction in oedema volume from day 90 (140.6 PlusMinus; 18.8 ml) to day 360 (71.8 PlusMinus; 20.7 ml) compared to the pre-treatment (day 0, 198.4 PlusMinus; 16.5 ml) value. This accounted for a 63.8% reduction in oedema volume by day 360 (considering the pre-treatment (day 0) as 100%). In the DEC group, the changes in oedema volume (between day 1 and day 360) were not significant when compared to the pre-treatment (day 0) value. The percentage reduction at day 360 was only 9%, which was not significant (P > 0.05). CONCLUSION: This study has shown that Daflon (500 mg, twice a day for 90 days) is both safe and efficacious in reducing oedema volume in bancroftian filarial lymphoedema. Further clinical trials are essential for strengthening the evidence base on the role of this drug in the morbidity management of lymphatic filariasis.

Figure 1

Comparison of changes in mean (± SEM) oedema volume (in ml) over 360 days between patients treated with Daflon (500 mg) + DEC (25 mg), and patients treated with DEC (25 mg), twice daily for 90 days. Day 0: pre-treatment Day 1 – day 90 period of treatment Day 91 – day 360 period of follow-up *P = < 0.05 vs. day 0 **P = < 0.005 vs. day 0 ***P = < 0.001 vs. day 0

Figure 2

Comparison of percentage change in oedema volume (in ml) over 360 days between patients treated with Daflon (500 mg) + DEC (25 mg), and patients treated with DEC (25 mg), twice daily for 90 days. Day 0: pre-treatment Day 1 – day 90: period of treatment Day 91 – day 360: period of follow-up Day 0 oedema volume is considered as 100% *** P = < 0.001 vs. day 0