{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,10,3]],"date-time":"2024-10-03T04:13:13Z","timestamp":1727928793390},"reference-count":28,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"4_Suppl","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,10,1]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n<jats:p>Morbidity management of filarial lymphedema remains a challenge even during the post-lymphatic filariasis elimination era in Sri Lanka despite provision of the predominantly hygiene-based WHO Essential Package of Care. Because prior studies have suggested that 6\u2009weeks of doxycycline may reduce progression of limb lymphedema, we conducted a randomized, placebo-controlled, superiority study to evaluate this possibility in Sri Lanka. Patients aged 14 to 65\u2009years with lymphedema in one or both legs received either 200\u2009mg of doxycycline daily for 6\u2009weeks or matching placebo. The primary efficacy endpoint was improvement or lack of progression in lymphedema stage at 24 months postenrollment. Secondary endpoints included change in lymphedema stage at 12 and 24 months, frequency of acute adenolymphangitis episodes, and perceived disability measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). Training and supplies for limb hygiene were provided throughout the study. Two hundred participants (100 in each arm) with lymphedema of Dreyer stages 1 to 3 were enrolled. By the end of the 2-year study, 29% of the doxycycline patients and 34% of those on placebo showed improvement (i.e., a decrease in lymphedema stage), whereas 11% and 15% of the two groups showed worsening of the lymphedema. Adenolymphangitis rates were comparable in the two groups (43 doxycycline and 38 placebo recipients), although attacks lasted slightly longer in placebo patients (6.5\u2009days versus 5.2\u2009days). In both groups, perceived disability improved initially, with partial rebound in the second year. Only 34 adverse events affecting 24 patients (11%) occurred during the 6-week treatment period. Although doxycycline did not significantly impact lymphedema progression in this study, the results clearly indicate that clinical and personal benefits can be obtained from intensive hygiene management alone.<\/jats:p>","DOI":"10.4269\/ajtmh.24-0050","type":"journal-article","created":{"date-parts":[[2024,7,23]],"date-time":"2024-07-23T21:13:43Z","timestamp":1721769223000},"page":"52-65","source":"Crossref","is-referenced-by-count":0,"title":["LEDoxy-SL: A Placebo-Controlled, Double-Blind, Randomized, 24-Month Trial of Six Weeks of Daily Doxycycline Plus Hygiene-Based Essential Care for Reducing Progression of Filarial Lymphedema in Sri Lanka"],"prefix":"10.4269","volume":"111","author":[{"given":"Thishan Channa","family":"Yahathugoda","sequence":"first","affiliation":[{"name":"Filariasis Research Training and Service Unit, Department of Parasitology, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nirmitha Lalindi","family":"De Silva","sequence":"additional","affiliation":[{"name":"Filariasis Research Training and Service Unit, Department of Parasitology, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janaka","family":"Ruben","sequence":"additional","affiliation":[{"name":"Filariasis Research Training and Service Unit, Department of Parasitology, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharmini","family":"Gunawardena","sequence":"additional","affiliation":[{"name":"Department of Parasitology, Faculty of Medicine, University of Colombo, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mirani Vasanthamala","family":"Weerasooriya","sequence":"additional","affiliation":[{"name":"Filariasis Research Training and Service Unit, Department of Parasitology, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Horton","sequence":"additional","affiliation":[{"name":"Tropical Projects, Hitchin, United Kingdom;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philip","family":"Budge","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, St. Louis, Missouri;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Ottesen","sequence":"additional","affiliation":[{"name":"Neglected Tropical Disease Support Center, Task Force for Global Health, Decatur. Georgia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah Mary","family":"Sullivan","sequence":"additional","affiliation":[{"name":"Neglected Tropical Disease Support Center, Task Force for Global Health, Decatur. Georgia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariana","family":"Stephens","sequence":"additional","affiliation":[{"name":"Neglected Tropical Disease Support Center, Task Force for Global Health, Decatur. Georgia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Shen","sequence":"additional","affiliation":[{"name":"Neglected Tropical Disease Support Center, Task Force for Global Health, Decatur. Georgia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ute","family":"Klarmann-Schulz","sequence":"additional","affiliation":[{"name":"Institute for Medical Microbiology, Immunology and Parasitology (IMMIP), German Centre for Infection Research (DZIF), Bonn-Cologne Site, University Hospital Bonn, Bonn, Germany;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Achim","family":"Hoerauf","sequence":"additional","affiliation":[{"name":"Institute for Medical Microbiology, Immunology and Parasitology (IMMIP), German Centre for Infection Research (DZIF), Bonn-Cologne Site, University Hospital Bonn, Bonn, Germany;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph Patrick","family":"Shott","sequence":"additional","affiliation":[{"name":"Division of Neglected Tropical Diseases, U.S. Agency for International Development, Washington, District of Columbia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Mackenzie","sequence":"additional","affiliation":[{"name":"Neglected Tropical Disease Support Center, Task Force for Global Health, Decatur. 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