Although the studies have significant methodological limitations, 5-FU appears to be of likely benefit in treating BD. As with AK, if patients are unable to tolerate the side-effects of 5-FU, then we would expect the cure rate to drop off dramatically.

The quasi-randomised controlled trial comparing 5-FU with interferon suffers from two methodological limitations in addition to the non-randomised allocation. No data are presented regarding the proportion of BD and AK in each treatment group, thus conclusions regarding therapeutic efficacy can only be generalised to BD and AK in aggregate. Furthermore, the significant difference in histological response in favour of interferon does not correlate with the higher efficacy of 5-FU in terms of clinical clearance. Thus, histological response may have been used as a surrogate outcome for clinical response and should be viewed accordingly in clinical decision making.

It is impossible to draw definitive conclusions from uncontrolled trials. However, it is worth noting that the disparity in recurrence rates may relate to different therapeutic regimens: the study reporting a higher recurrence employed weekly topical pulse therapy for a minimum of 12 weeks, whereas most other studies used once- or twice-daily applications for 2-16 weeks.58,78,79

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