- Doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash significantly reduced oral mucositis-related pain within 4 hours of administration compared with placebo mouthwash in patients undergoing radiotherapy for head and neck cancer.
Why this matters
- The study offers the first evidence that diphenhydramine-lidocaine-antacid mouthwash is effective for short-term reduction of radiotherapy-related oral mucositis-related pain.
- 3-group, double-blind, placebo-controlled phase 3 randomized trial.
- 275 patients with head and neck cancer radiotherapy-related oral mucositis pain were randomly assigned to doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash or placebo.
- Funding: National Cancer Institute.
- Compared with placebo, total pain during the first 4 hours significantly decreased in the doxepin mouthwash group (8.7 vs 11.6 points; P=.02) and in the diphenhydramine-lidocaine-antacid mouthwash group (vs 11.7 points; P=.004).
- During the first 4 hours, doxepin mouthwash was associated with higher incidence vs placebo in terms of:
- total drowsiness (difference, 1.5 points; P=.03),
- unpleasant taste (difference, 1.5 points; P=.002), and
- stinging or burning (difference, 4.0 points; P<.001>
- Grade 3 adverse event rate was 4% with doxepin mouthwash, 4% with diphenhydramine-lidocaine-antacid mouthwash, and 2% with placebo.
- 6% of patients experienced fatigue with doxepin mouthwash, and none with diphenhydramine-lidocaine-antacid mouthwash.
- Direct comparison of doxepin and diphenhydramine-lidocaine-antacid mouthwash was not available.
Coauthored with Antara Ghosh, PhD