In a pragmatic, randomised, double-blind, placebo-controlled trial Dr.Andrew Jull and associates tried to determine the effect of low dose aspirin on ulcer healing in patients with venous leg ulcers.It was found that low dose aspirin does not increase the time to healing of venous leg ulcers, percentage healed, the estimated change in venous leg ulcer area, or change in health-related quality of life.
About 1% of the adult population will develop a venous leg ulcer during any one year. Compression therapy, either in the form of bandage systems or hosiery, is the mainstay of treatment, but in trials of venous leg ulcers about half the participants remain unhealed after three months of treatment. Pentoxifylline and micronized purified flavonoid fraction are recommended adjuvants to compression, but there are barriers to use, including frequency of dosing regimen, off-label use, cost, and the quality of evidence. Aspirin has been advocated as an adjuvant treatment for venous leg ulcers on the basis of previous trials.
In the present study total, 251 adults with venous leg ulcers were enrolled who could safely be treated with aspirin or placebo: 125 were randomized to aspirin and 126 to placebo.150 mg oral aspirin daily or matching placebo for up to 24 weeks treatment, with compression therapy as standard background treatment.
The primary outcome was time to complete healing of the reference ulcer (largest ulcer if more than one ulcer was present). Secondary outcomes included the proportion of participants healed, change in ulcer area, change in health-related quality of life, and adverse events. The analysis was by intention to treat.
It was found that the number of participants healed at the endpoint was 88 (70%) in the aspirin group and 101 (80%) in the placebo group (risk difference −9.8%, 95% confidence interval −20.4% to 0.9%, P=0.07). Estimated change in ulcer area was 4.1 cm2 in the aspirin group and 4.8 cm2 in the placebo group (mean difference −0.7 cm2, 95% confidence interval −1.9 to 0.5 cm2, P=0.25).40 adverse events occurred among 29 participants in the aspirin group and 37 adverse events among 27 participants in the placebo group (incidence rate ratio 1.1, 95% confidence interval 0.7 to 1.7, P=0.71).
The researchers concluded that the findings of the trial do not support the use of low dose aspirin as the adjuvant treatment for venous leg ulcers.Low dose aspirin does not increase healing of venous leg ulcers when used in addition to effective compression.
For more details click on the link: doi: https://doi.org/10.1136/bmj.j5157
Dr. Kamal Kant Kohli
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