AIM: In a randomized double-blind study the therapeutic effect of a novel zinc-aluminium ointment was compared with placebo in patients with faecal incontinence. METHOD: A randomized double-blind trial was performed. Patients who met the inclusion criteria were randomized to receive the ointment or a placebo. All were evaluated prior to and 3 weeks after ointment application, using the Wexner incontinence score and the Fecal Incontinence Quality of Life (FIQL) score. RESULTS:Fifty patients were randomized and six were lost to follow-up, leaving 24 in the treatment and 20 in the placebo group. The average ages were 61.3 and 60.7 years. The respective Wexner scores prior to intervention were 16.6 and 16.7. They decreased significantly after treatment to 8.5 and 13.1 (P<0.001 and P=0.002 respectively). There was a significant difference in the final scores, favouring the treatment group (P=0.001). The FIQL scores for the treatment group were also significantly better in all parameters compared with those of the placebo group. CONCLUSION: The study shows that the zinc-aluminium based ointment decreases faecal incontinence significantly compared with placebo.
RCT Entities:
AIM: In a randomized double-blind study the therapeutic effect of a novel zinc-aluminium ointment was compared with placebo in patients with faecal incontinence. METHOD: A randomized double-blind trial was performed. Patients who met the inclusion criteria were randomized to receive the ointment or a placebo. All were evaluated prior to and 3 weeks after ointment application, using the Wexner incontinence score and the Fecal Incontinence Quality of Life (FIQL) score. RESULTS: Fifty patients were randomized and six were lost to follow-up, leaving 24 in the treatment and 20 in the placebo group. The average ages were 61.3 and 60.7 years. The respective Wexner scores prior to intervention were 16.6 and 16.7. They decreased significantly after treatment to 8.5 and 13.1 (P<0.001 and P=0.002 respectively). There was a significant difference in the final scores, favouring the treatment group (P=0.001). The FIQL scores for the treatment group were also significantly better in all parameters compared with those of the placebo group. CONCLUSION: The study shows that the zinc-aluminium based ointment decreases faecal incontinence significantly compared with placebo.
Authors: Dimitri Beeckman; Nele Van Damme; Lisette Schoonhoven; Aurélie Van Lancker; Jan Kottner; Hilde Beele; Mikel Gray; Sue Woodward; Mandy Fader; Karen Van den Bussche; Ann Van Hecke; Dorien De Meyer; Sofie Verhaeghe Journal: Cochrane Database Syst Rev Date: 2016-11-10