Abstract | OBJECTIVE: DESIGN: Randomised, double blind, placebo controlled study with matching for grade and duration of disease, age, and sex. Treatment was given for 367 days, and subjects were followed up for another year. SETTING: A town in Shandong Province, China. SUBJECTS: 104 men and women with chronic unilateral filarial lymphoedema or elephantiasis of the leg: 64 were randomised to benzopyrone and 40 to placebo. By the end of the study 19 patients had dropped out of the treatment group and two out of the placebo group. INTERVENTIONS: MAIN OUTCOME MEASURES: Volumes of the affected and normal legs estimated every three months, and daily listing of any side effects. RESULTS: Benzopyrone reduced oedema for all grades of lymphoedema during the year of treatment (pW0.001) and the follow up year (p = 0.026). During treatment the mean monthly reductions in leg volume were 0.62% (95% confidence intervals 0.4% to 0.85%), 1.1% (0.71% to 1.6%), and 1.6% (0.89% to 2.3%) of the volume of the normal leg for grades 1, 2, and 3-5 ( elephantiasis) of lymphoedema respectively. During follow up the mean monthly reductions were 0.18% (0.01% to 0.35%), 0.54% (0.27% to 0.82%), and 0.87% (0.51% to 1.2%). At the end of the trial the total reduction in oedema was 100%, 95%, and 45% for grades 1, 2, and 3-5. Symptoms and complications were considerably reduced, including attacks of secondary acute inflammation, while side effects were minor and disappeared after one month. In the placebo group there were no changes in the severity of lymphoedema. CONCLUSIONS:
5,6-benzo-alpha-pyrone reduces the oedema and many symptoms of filarial lymphoedema and elephantiasis. It has few side effects, and its relatively slow action makes it ideal for use without compression garments.
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Authors | J R Casley-Smith, C T Wang, J R Casley-Smith, C Zi-hai |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 307
Issue 6911
Pg. 1037-41
(Oct 23 1993)
ISSN: 0959-8138 [Print] England |
PMID | 8251778
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Coumarins
(therapeutic use)
- Double-Blind Method
- Elephantiasis, Filarial
(drug therapy, pathology)
- Female
- Filariasis
(drug therapy, pathology)
- Humans
- Lymphedema
(drug therapy, pathology)
- Male
- Middle Aged
- Treatment Outcome
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