Background: Mucositis is a significant burden for cancer treatment patients. Due to suboptimal interventions mucositis remains an insurmountable challenge for oncologists forcing dose reductions, treatment postponement or cancellation all of which directly impact clinical outcomes and survival.
New mucositis intervention with no clinical guideline status : Polymerized cross-linked sucralfate (PCLS) paste recently cleared by the US FDA for the management of oral mucositis. Mucositis registry data has been repeatedly associated PCLS with rapid reversal and complete prevention of oral mucositis. However the level evidence used are observational data from a mucositis registry. Evidence from randomized clinical trials is the goal standard of efficacy for inventions, except those interventions wherein the magnitude of clinical effect are dramatic, that is beyond 10 times that expected by placebo. In such circumstances efficacy of such interventions can be statistical assured with from non-randomized observational study, not level evidence commonly ranked high.
Discussion: Observational data on interventions with dramatic clinical effects (10 times that of placebo) should be included as a superior level of evidence appropriate for guideline recommendations of the Multinational Association of Support in Cancer Care/International Society of Oral Oncology (MASCC/ISOO). This call for revision in the categories of evidence by the MASCC/ISOO could compel discussion and possible recommendation for the use of PCLS in the management of oral mucositis. In turn, such a recommendation may possibly impact cancer treatment outcomes in patients with mucositis.
Conclusion: This article probes the pros and cons of this point decidedly in favor of establishing a Level IA evidence category for mucositis interventions. Repeated demonstrations of rapid, complete and simultaneous reversal of oral and alimentary mucositis within two to three days in 25 cancer treatment patient has prompted this suggestion.
Keywords: Sucralfate, mucositis, MASCC/ISOO, glasziou rate ratio, mucositis clinical guidelines