Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2002
Meta AnalysisLocal treatment of hemorrhoidal disease and perianal eczema. Meta-analysis of the efficacy and safety of an Escherichia coli culture suspension alone or in combination with hydrocortisone.
The objective of this paper was to assess the available clinical data on the efficacy and safety of ointments containing either a bacterial culture suspension (BCS) from Escherichia coli or a combination of BCS with hydrocortisone (CAS 50-23-7) (BCS: Posterisan, and BCS + HC: Posterisan forte). The BCS is assumed to act by immunomodulation in hemorrhoidal disease and perianal eczema. Six randomized, double-blind trials are reported: three of them using BCS ointment and one using BCS + HC, against ointment base, and two trials using BCS + HC against hydrocortisone ointment alone. ⋯ Symptom scores decreased consistently more after administration of BCS than after the ointment base (p = 0.095, p = 0.006, and p = 0.029), and likewise, the combination of BCS + HC was significantly superior to the ointment base (p < 0.001) and to hydrocortisone alone (p = 0.036 and p = 0.019). Adverse events were less frequent for BCS and BCS + HC than for the ointment base. It can therefore be concluded that ointments containing either only E. coli BCS or a combination of BCS and hydrocortisone provide significant relief in perianal eczema as well as in early stages of hemorrhoidal disease.