Although 5-FU has a high efficacy rate, one should note that it is associated with a high degree of morbidity, including pain, inflammation, and erosions. Thus, if patients are unable to tolerate these side-effects, we would expect the cure rate to drop off dramatically.

Of methodological note, the authors in the RCT did not perform an ITT analysis. If the subjects who dropped out of the study were included in the denominator, as prescribed in an ITT analysis, the efficacy rate (by investigator global assessment of cure) of 5-FU falls from 77% to 67% while that of masoprocol falls from 23% to 20%. Despite the lack of ITT analysis, however, the difference between 67% and 20% undoubtedly reaches statistical significance.

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