Doxepin cream is not effective in reducing itch in burn scar patients: A multicenter triple-blind randomized clinical crossover trial. Issue 2 (March 2020)

• Record Type: Journal Article
• Authors: Kwa, K.A.A.; Legemate, C.M.; Pijpe, A.; Meij-de Vries, A.; Middelkoop, E.; van Baar, M.E.; Breederveld, R.S.; Nieuwenhuis, M.K.
• Is Part Of: Burns. Volume 46:Issue 2(2020)
• Page Start: 340
• Page End: 346
• Publication Date: 2020-03
• Subjects: AE adverse event -- BIQ Burn Itch Questionnaire -- IQR Inter Quartile Range -- MIC minimal important change -- POSAS Patient and Observer Scar Assessment Scale -- SD standard deviation -- TBSA total body surface area -- VAS Visual Analogue Scale; Itch -- Pruritus -- burn* -- Doxepin -- Antihistamines; Burns and scalds -- Periodicals; 617.11
• DOI: 10.1016/j.burns.2019.11.006
• Languages: English
• ISSNs: 0305-4179

Abstract

Highlights: There is no difference in itch between doxepin and placebo cream in burn patients. Doxepin cream does not significantly reduce pruritus in burn patients. Doxepin cream is not recommended as standard treatment against itch after burns. Abstract: Objective: To evaluate the effect of doxepin hydrochloride 5% cream on reducing pruritus in burn scar patients compared to a placebo cream. Method: We conducted a multicenter triple-blind randomized clinical placebo-controlled crossover trial in which burn patients ≥18 years with an itch intensity ≥3 on a Visual Analogue Scale (VAS) were randomized between a doxepin-placebo or placebo-doxepin treatment protocol. Patients used each cream during two weeks with a wash-out period of one week in between. Primary outcome was change in itch intensity in two weeks' time using the VAS. Secondary outcome included the impact of itch (Burn Itch Questionnaire). Other parameters were the use of hydrating cream, silicon treatment, pressure garments, and other antipruritic medication. Results: Twenty-seven patients were included. The change in itch intensity (VAS) was not different during the doxepin and placebo period (p = 0.994); neither the doxepin cream nor placebo cream reduced itch intensity. However, based on the Burn Itch Questionnaire, we observed a statistically significant decrease in itch intensity and improvement in impact scores in both treatment groups, but no difference in the degree of reduction between the groups. Conclusion: Doxepin cream was not effective in reducing pruritus in our burn patient study population.