A study published as an RCT28 was excluded because it was still in progress and the codes about concealment of randomisation had not yet been broken. Another study described as an RCT29 was excluded because it gave no separate clinical and mycological data for each group. I found two RCTs27,30 that were duplicate publications of other studies.23,241 think that all the other studies included are relevant in showing the efficacy of griseofulvin for tinea capitis, even though the definition of cure varies from study to study, and some investigators carefully follow microbiological findings, whereas others place greater emphasis on clinical response. The high patient dropout rate in most of the studies may have masked the improvement in griseofulvin groups as those who achieve cure may have less incentive to attend follow up visits. It will also have reduced the power to detect a difference between the groups, indicating that griseofulvin may be even more effective. Duration of follow up varies from study to study (6-24 weeks) and only RCTs with long-term follow up can show the relapse rates, which are very important in determining therapeutic efficacy. Five of nine studies were supported by the pharmaceutical industry.18-20'22'25
Data from some RCTs.18,21 indicate that ketoconazole may require a longer course of therapy than griseofulvin and it had no better cure rates. However, while ketoconazole is associated with rare but important hepatic and endocrine adverse events, none of these were noted in the paediatric studies described. Because oral itraconazole now exists and the safety of long-term use of oral ketoconazole is uncertain, I have not considered the latter further as a treatment of choice in children with tinea capitis. Three18-20 of the four RCTs with ketoconazole described in Table 34.1 were supported by companies producing this drug.
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