• Volker Wienert and Jörg H Heusinger.
• University Hospital, Aachen, Germany. anvowie@aol.com
• Arzneimittel Forsch. 2002 Jan 1;52(7):515-23.

AbstractThe 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. Patients with hemorrhoids and/or perianal eczema were included and treated over 2 weeks with weekly assessments. Efficacy parameters included score changes for burning, itching, redness and soiling as well as the investigators' overall efficacy rating. Safety was assessed from adverse drug reactions and an overall safety rating. Out of 1,070 patients (mean age 50 years), 273 received BCS and 229 BCS + HC; 568 patients were given the various controls. In the overall efficacy rating, BCS ointment was significantly superior to the ointment base in all three studies (p = 0.028, p = 0.016, and p = 0.045). Moreover, BCS + HC was superior to the ointment base (p < 0.001) and to hydrocortisone alone (p = 0.156 and p = 0.021), confirming the distinct effect of the E. coli suspension. Satisfactory results were achieved in 83% of patients after the BCS + HC combination, 77% after BCS-containing ointment, 75% after hydrocortisone ointment and 52% after ointment base. 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.

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