Clinical trial: effects of botulinum toxin on levator ani syndrome – a double‐blind, placebo‐controlled study

Abstract

SUMMARY BackgroundLevator ani syndrome is characterized by anorectal discomfort ⁄ pain, treatment of which is unsatisfactory. We hypothesized that Botulinum toxin relieves spasm and improves symptoms.

Is Botox for anal pain an effective treatment option?

“…Most studies that include Botox treatment for LS consist of very few patients and the dose of Botox injected has ranged between 20 and 100 units. One study showed that a dose of 100 units of Botox did not show any differences in physiological test results and pain scores between the placebo and Botox groups [19]. Another study showed symptom improvement after 80 units of Botox when compared to placebo [20].…”

“…Invasive options include bilateral injection therapy with a triamcinolone and Lidocaine mixture at trigger points in the levator muscle and Botox injections. All of these options have been described in the literature as having varied success rates [2,6,19,20,21]. Most studies that include Botox treatment for LS consist of very few patients and the dose of Botox injected has ranged between 20 and 100 units.…”

A Review of Botulinum Toxcin Use for Chronic Pelvic Pain Syndrome

“…Abbott et al [38] performed a randomized controlled trial of BTX injected transvaginally into the puborectalis and pubococcygeus for levator/pelvic floor spasms in women, and demonstrated a decrease in manometry pressures and an improvement in dyspareunia. In contrast, in a more recent study of a cohort of men and women, following peri-anal BTX-A injection for levator ani syndrome showed decreased anal manometry pressures but without significant changes in pain score [39]. The authors felt that the failure of the BTX to improve symptoms could be due too pain originating in the puborectalis and not the injected anal sphincter, or that pathophysiology of the pain does not involve spasms.…”

Anorectal motor disorders

“…Finally, a recent double-blind, placebo-controlled study showed that intrasphincteric injection of 25 IU of botulinum toxin A (Allergan, Irvine, California, USA) did not change the frequency, intensity or pain episodes when compared to placebo, suggesting that botox may be ineffective. 60 …”