Effect of Adding a Six-Week Course of Doxycycline to Intensive Hygiene-Based Care for Improving Lymphedema in a Rural Setting of Mali: A Double-Blind, Randomized Controlled 24-Month Trial.
Yaya I Coulibaly, Abdoul F Diabate, Moussa Sangare, Sekou O Thera, Housseini Dolo, Salif S Doumbia, Siaka Y Coulibaly, Ayouba Diarra, Lamine Diarra, Diadje Tanapo, Michel E Coulibaly, Lamine Soumaoro, Abdallah A Diallo, Amatigue Zeguime, Yacouba Sanogo, Adama Berthe, Fatoumata Dite Nene Konipo, Charles Mackenzie, Mariana Stephens, Joseph P Shott, Jayla Norman, Ute Klarmann-Schulz, Achim Hoerauf, Andrew Majewski, John Horton, Sarah Sullivan, Eric A Ottesen, Thomas B Nutman
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引用次数: 0
Abstract
Lymphedema (LE) is one the most disfiguring chronic manifestations of lymphatic filariasis. Its management relies primarily on limb hygiene and local care. A previous study in Ghana demonstrating a beneficial effect of doxycycline on LE led to the current multicenter trial on the efficacy of doxycycline in filarial LE. A randomized placebo-controlled trial was initiated in two rural health districts in Mali. Patients with LE stages 1-3 were randomized to receive either doxycycline (200 mg/day) or placebo over a 6-week monitored treatment period and were then followed every 6 months for 2 years. Both groups received materials for limb hygiene that was carried out daily for the entire 2-year study. The primary endpoint was lack of progression in LE stage at 24 months. One hundred patients were enrolled in each study arm. The baseline sociodemographic characteristics of each group were largely similar. There was no significant difference at month 24 after treatment initiation in the number of subjects showing progression in LE stage between the two treatment arms (P = 0.5921). Importantly, however, the number of attacks of acute adenolymphangitis (ADLA) was reduced in both arms, but there was no significant difference between the two groups at any follow-up time point (all P >0.23). Doxycycline was well tolerated in those receiving the drug. When added to daily self-administered limb hygiene, a 6-week course of doxycycline (200 mg) was not superior to placebo in increasing the improvement associated with hygiene alone in LE volume, stage, or frequency of ADLA attacks over a 24-month period.
期刊介绍:
The American Journal of Tropical Medicine and Hygiene, established in 1921, is published monthly by the American Society of Tropical Medicine and Hygiene. It is among the top-ranked tropical medicine journals in the world publishing original scientific articles and the latest science covering new research with an emphasis on population, clinical and laboratory science and the application of technology in the fields of tropical medicine, parasitology, immunology, infectious diseases, epidemiology, basic and molecular biology, virology and international medicine.
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