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Effectiveness of cevimeline to improve oral health in patients with postradiation xerostomia
Author(s) -
Witsell David L.,
Stinnett Sandra,
Chambers Mark S.
Publication year - 2012
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.21894
Subject(s) - medicine , sequela , head and neck cancer , placebo , quality of life (healthcare) , dry mouth , randomized controlled trial , oral health , head and neck , radiation therapy , clinical trial , saliva , surgery , dentistry , alternative medicine , nursing , pathology
Background We assessed the effectiveness of cevimeline 30 mg 3 times daily in patient‐reported oral health (Oral Health Impact Profile [OHIP‐49]) and quality of life (QOL) in patients with xerostomia. Methods In our investigator‐initiated, multicenter, randomized, double‐blind, placebo‐controlled study, patients who received >40 Gy of radiation therapy to the head and neck including at least 3 major salivary glands were randomized to cevimeline 30 mg or placebo orally 3 times daily for 6 weeks. Patients had to have grade 1 or 2 xerostomia and be >16 weeks posttreatment. Clinical data were collected and questionnaires administered at baseline and week 6. The primary outcome was change in OHIP‐49 total score from baseline to week 6. Results No statistically significant differences in oral health or QOL were observed. During the 6 weeks of the study, the severity of xerostomia decreased from baseline. Conclusions Xerostomia is a significant sequela of treatment of head and neck cancer that may improve with time. The role of oral parasympathetic muscarinic secretogogues in alleviating patient symptoms and complaints remains unclear. © 2012 Wiley Periodicals, Inc. Head Neck, 2012