This blog was originally published by The Task Force for Global Health at: https://www.taskforce.org/two-year-study-finds-effective-treatment-for-…
Preliminary results from a two-year study in six countries suggest significant improvement for people affected by lymphedema, thanks particularly to daily hygiene of the affected limbs.
Lymphedema, the swelling of limbs caused by fluid build-up when the lymph system is dilated and dysfunctional, is a chronic condition of a neglected tropical disease (NTD) commonly known as elephantiasis. Since it leads to painful acute attacks and social stigma, such treatment holds great promise for the nearly 859 million people at risk of the disease and its complications.
The Task Force’s Neglected Tropical Diseases Support Center (NTD-SC) led the study (through its Coalition for Operational Research on NTDs) in cooperation with the University of Bonn (Germany), with principal investigators working in Cameroon, Ghana, Mali, India, Sri Lanka, and Tanzania, all of which are countries endemic for the disease and its accompanying lymphedema.
Nearly 1,800 patients participated in the LEDoxy and TAKeOFF clinical trials, which evaluated the effectiveness of using the antibiotic doxycycline in combination with daily hygiene to reduce progression of lymphedema and improve quality of life for people affected. The findings suggest that nearly all of the patients studied—about 90%—showed no lymphedema progression over the two-year study period and that they either maintained or experienced improvement in their quality of life. Whether the medicine or hygiene measures are the reason for stopping progression of the condition remains under analysis as they finish review of all the study data.
“In Alappuzha, where the India study site is located, lymphatic filariasis prevalence used to be very high,” said Professor Suma Krishnasastry, lead investigator for the trial’s India site and chief of the Government Filariasis Research Unit, India. “With mass drug administration, we were able to improve control of filariasis, but there is no relief for people suffering from the lingering condition, lymphedema, which can be very painful and disabling, so I’m happy that we’ve been able to be a part of this very important study.”
While the final analysis is being completed, Krishnasastry observed benefits both to the lymphedema patients they recruited and to the research capabilities of the trial site itself.
“You could tell that the patients were feeling happy with how they were improving, so we were happy that patients were eager to see us during follow-ups and explain how they were feeling,” she said. “Another benefit I found was that there wasn’t a lot of stigma like patients would normally experience in other social settings. We had patients come in groups to the clinic for their follow-ups and, because of these group activities, they started forming their own self-help groups and would motivate and encourage each other and others affected in their community to keep up the hygiene measures when they returned home.”
Once the final results are released later this year, they will contribute to the World Health Organization’s recommendations for lymphedema management, fulfilling Krishnasastry’s dream for all countries to have access to the data so that they will start implementing treatments like hygiene practices to improve the health of people living with lymphedema.
NTD-SC’s principal investigator Dr. Eric Ottesen emphasized that an additional benefit will be integrating recommendations from the study findings into national health systems.
“The length of the study and the close attention to patient evaluations provide us with a unique opportunity to see how well morbidity management measures for lymphedema hold up over time and to define what aspects of such patient management are really working,” he said. “If we can learn from the results of this research what local health systems can do to offer support to patients for things that they can do at home, like self-care hygiene measures, then it will both offer relief for the patient and be cost effective for the health system.”
Likewise, Ottesen noted the immense value of having the research workforce engaged across the six sites.
“There is lasting value of these studies even in the fact that these excellent trial sites have received support through this international collaborative effort,” he said. “These are high-quality research sites with immense expertise that will continue to be used for other projects locally.”
Krishnasastry also credited her team for their hard work and for staying so dedicated through all the challenges presented by COVID-19.
“There was a period where patients couldn’t come to the clinic due to lockdowns, so we would call every patient to continue the follow-ups and remind them to continue regularly washing their limbs,” she said. “If there were any issues, we would go to their houses, while following the appropriate COVID protocols.”
This work received financial support from the United States Agency for International Development (USAID) through its Neglected Tropical Diseases Program through their support of the Coalition for Operational Research on Neglected Tropical Diseases (COR-NTD) grant and from the German Ministry for Education and Research within their funding scheme “Research Networks for Health Innovations in sub-Saharan Africa.”
COR-NTD is funded at The Task Force for Global Health primarily by the Bill & Melinda Gates Foundation; USAID; and UK aid from the British people.