New treatment for faecal incontinence using zinc-aluminium ointment: a double-blind randomized trial
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Date
2012
Journal Title
Journal ISSN
Volume Title
Publisher
WILEY-BLACKWELL
Abstract
Aim In a randomized double-blind study the therapeutic effect of a novel zincaluminium 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.
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.
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Keywords
Fecal incontinence, aluminum, randomized trial, OF-LIFE SCALE, PREVALENCE, HOME