Comparing doxepin cream to oral antihistamines for the treatment of itch in burn patients: A multi-center triple-blind randomized controlled trial

Abstract

Background: Doxepin cream, an antihistaminic agent, has shown promising results in the treatment of pruritus in burn patients. However, its effectiveness has not been studied comprehensively. Objective: To evaluate whether doxepin cream is more effective than oral antihistamines in reducing pruritus. Methods: We performed a multicenter triple-blind randomized controlled trial of twelve weeks randomizing burn patients ≥18 years with an itch intensity ≥3 on a Visual Analogue Scale (VAS) between doxepin hydrochloride 5% cream with placebo tablet or oral antihistamine (clemastine) with placebo cream. Primary endpoint was change in itch intensity. Secondary endpoints included impact of itch (Burn Itch Questionnaire), quality of life (SF-36), somnolence, and erythema (DermaSpectrometer). Results: Thirty-one (of the intended 108) subjects could be included: 13 were randomized to the doxepin and 18 to the clemastine group. The skewed distribution is attributable to the low inclusion rate. Both groups showed a significant reduction in itch intensity over a period of twelve weeks (doxepin p = 0.043, clemastine p = 0.019) with no difference between both groups in: mean itch intensity difference (p = 0.199), any of the domains (p = 0.940, p = 0.698, p = 0.859) of the Burn Itch Questionnaire, quality of life, somnolence (p = 0.143) and erythema (p = 0.796). Conclusion: The effectiveness of doxepin cream was similar to oral antihistamines in reducing itch. However, considering the study ’s limitations, a superior effect of doxepin cream cannot be completely ruled out. We recommend that future studies use a cross-over design so fewer inclusions are needed to obtain adequate power. Keywords: Itch, Pruritus, Burn, Treatment, Doxepin, Antihistamines