Little clinical benefit of early systemic aciclovir for treatment of primary herpetic stomatitis

Abstract

The Cochrane Oral Health Group's Trials Register; Cochrane Central Register of Controlled Trials, Medline and Embase were used to search for studies. There were no language restrictions. Randomised controlled trials (RCT) were eligible if they compared aciclovir to placebo in children and young adults (<25 years of age) who had been diagnosed with primary herpetic gingivostomatitis with or without herpes labialis. Two review authors independently and in duplicate screened and extracted information from, and assessed the risk of bias, in the included clinical trials. The Cochrane Collaboration statistical guidelines were followed for data synthesis. Only two clinical trials, one with 72 participants and the other with 20, were included in this review. The second study failed to report details of its methods and was inconsistent in its reporting of the outcomes measured. The first trial, which had a moderate risk of bias, showed that aciclovir was better than placebo at reducing, in children of <6 years, the number with oral lesions [risk ratio (RR), 0.10; 95% confidence interval (CI), 0.02-0.38)], with new extra-oral lesions (RR; 0.04; 95% CI, 0.00-0.65), and difficulty in eating (RR, 0.14; 95% CI, 0.03-0.58) and drinking (RR, 0.11; 95% CI, 0.01-0.83) after 8 days of treatment. Following onset of treatment, three patients from the placebo group were admitted to hospital for rehydration (P 0.11 ). Four children (two from the aciclovir group and two taking placebo) suffered mild gastrointestinal symptoms that resolved spontaneously after 24-48 h without a change in the study regimen. Two relevant trials were found for this systematic review. Only one was able to provide weak evidence that aciclovir is an effective treatment in children under 6 years of age with primary herpetic gingivostomatitis, in reducing the number of oral lesions, preventing the development of new extra-oral lesions, decreasing the number of individuals experiencing difficulties eating and drinking and reducing hospital admission.