BACKGROUND: Botulinum toxin A (BT-A) is a powerful biological toxin. Nevertheless, it has proved to be a remarkable therapeutic agent for the treatment of benign anal disorders. Higher doses of BT-A could change the outcome of treatment. It is not known whether doses of BT-A higher than 20 units of Botox (or corresponding doses of Dysport) are as safe for patients as lower doses of BT-A. METHODS: The side effects of BT-A injections in the treatment of chronic anal fissure (105 patients) and functional outlet obstruction (34 patients) were analysed prospectively. The patients received at least 25 units of Botox or 150 units of Dysport. RESULTS: The patients with chronic anal fissure complained of incontinence of flatus (one severe case and eight mild cases), incontinence of faeces (five mild cases), anal haematoma (five cases), flu-like syndrome (three cases), an acute inflammation of external anal varices (two cases), epididymitis (one case) and haemorrhoid prolapse (one case). Patients with anismus suffered from intertrigo (one case); the pain after injection lasted for 2-4 days (four cases). No life-threatening side effects after 181 injections of BT-A were observed. Most of the side effects were only transient symptoms. No significant interdependence between injection methods (injection into one or two sites) and the risk of side effects was found. CONCLUSION: Treatment with BT-A is safe. Despite the application of higher doses of BT-A in the treatment of benign anal disorders so far, no severe side effects were observed.
BACKGROUND: Botulinum toxin A (BT-A) is a powerful biological toxin. Nevertheless, it has proved to be a remarkable therapeutic agent for the treatment of benign anal disorders. Higher doses of BT-A could change the outcome of treatment. It is not known whether doses of BT-A higher than 20 units of Botox (or corresponding doses of Dysport) are as safe for patients as lower doses of BT-A. METHODS: The side effects of BT-A injections in the treatment of chronic anal fissure (105 patients) and functional outlet obstruction (34 patients) were analysed prospectively. The patients received at least 25 units of Botox or 150 units of Dysport. RESULTS: The patients with chronic anal fissure complained of incontinence of flatus (one severe case and eight mild cases), incontinence of faeces (five mild cases), anal haematoma (five cases), flu-like syndrome (three cases), an acute inflammation of external anal varices (two cases), epididymitis (one case) and haemorrhoid prolapse (one case). Patients with anismus suffered from intertrigo (one case); the pain after injection lasted for 2-4 days (four cases). No life-threatening side effects after 181 injections of BT-A were observed. Most of the side effects were only transient symptoms. No significant interdependence between injection methods (injection into one or two sites) and the risk of side effects was found. CONCLUSION: Treatment with BT-A is safe. Despite the application of higher doses of BT-A in the treatment of benign anal disorders so far, no severe side effects were observed.