This study assessed the effectiveness of oral
doxepin rinse for
mucositis-related
pain management in patients following 1 week of repeated dosing. Patients with
oral mucositis due to head and neck
radiation therapy or hematopoietic stem cell transplant (HSCT) were recruited to participate in a 1-week follow-up study. Subjects who gave informed consent rinsed with
doxepin (5 ml) during the initial visit and were then told to use
doxepin rinse over the next week as needed, three to six times per day, and return for a follow-up visit. At each visit,
mucositis was scored using the
Oral Mucositis Assessment Scale and oral
pain was assessed using a visual analogue scale before and after rinsing. The use of a systemic
analgesic was recorded, and side effects were documented. At the follow-up visit, subjects were also asked to retrospectively report average
pain scores they experienced over the past week, 5 and 15 minutes following rinse. Nine subjects were enrolled in the study. Statistically significant reductions in
pain scores were reported for 2 hours following
doxepin rinse during the initial visit (p < .05). Patients recalled that their
pain significantly dropped within 5 minutes of rinsing over the week of repeated dosing (p < .05). At the follow-up visit, subjects reported statistically significant
pain reduction 5 minutes after
doxepin rinsing (p < .05). These results indicate that
doxepin rinsing continues to produce reduced intensity of
pain levels over a 1-week span of repeated dosing.