[Efficacy and safety of symphytum herb extract cream in the treatment of pressure ulcers]

Abstract

In an open, prospective use study, 161 patients with 198 decubitus ulcers (pressure ulcers, ITT population) in stages II and III were treated with the topical preparation symphytum herb extract cream. The bandages with the cream were changed every 2-3 days. The primary parameters evaluated were the area of the sore and the depth of the wound (planimetrically in mm). In all, 151 patients with a total of 184 pressure sores (PP population) were included and received treatment over a period of 4 weeks in order to evaluate the treatment results. Complete healing of the pressure sores within 4 weeks was observed in 85.9 % (PP population)/79.8 % (ITT population) of the treated ulcers. Over a treatment duration of 25-30 days, a 89.2 % reduction of the total decubitus area was observed. The same result was found for the depth of the pressure ulcer with a reduction of 88 %. The overall treatment success was from both the perspective of the physician and the patient considered successful in 90.4 % (5-point scale) of cases and 87.9% (100 mm VAS, PP population). Two cases of local irritation were observed after 25/30 days (1.2 % of the patients with exposure), thus showing very good skin compatibility. The efficacy of symphytum herb extract cream is surprisingly good in the treatment of pressure ulcers.