Electrotherapy for the treatment of haemorrhoids

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 A randomised controlled trial of 102 patients treated by electrocoagulation with 10–20 mA direct current or injection sclerotherapy reported that, after 8 weeks, 88% (44/50) of patients in the electrocoagulation group had no rectal bleeding and 6% (3/50) had reduced rectal bleeding, while there was no effect on rectal bleeding symptoms in 6% (3/50). In the injection sclerotherapy group, 67% (35/52) had no rectal bleeding and 17% (9/52) had reduced rectal bleeding, while there was no effect on rectal bleeding symptoms in 15% (8/52) (p value for the overall difference between groups: p=0.0043). In a randomised controlled trial of 100 patients treated by electrotherapy with 16 mA direct current (n=50) or rubber band ligation (n=50), a complete response to the treatment (defined by disappearance of the symptoms and the lack of recurrence during the 1‑year follow‑up period) was reported for 82% (41/50) of patients in the electrotherapy group and 94% (47/50) in the rubber band ligation group. A relative response (defined as some improvement in severity, duration and interval of symptoms) was reported for 10% (5/50) of patients in the electrotherapy group and 2% (1/50) in the rubber band group, and no response was reported in 8% (4/50) and 4% (2/50) of patients respectively (no significant overall difference between groups, p=0.2).

4.2 In a randomised controlled trial of 100 patients treated by electrotherapy (monopolar electrocoagulation with 10–16 mA direct current; n=50) or by bipolar electrocoagulation using a probe with 1 positive and 1 negative electrode (n=50), the recurrence rates after 1 year were 34% and 29% respectively (absolute numbers and p values not given). Rebleeding was reported after 1 year in 5% and 20% of patients respectively (level of significance not stated). In a case series of 931 patients treated by electrotherapy with 27–30 mA direct current, new grade I or II haemorrhoids were reported in 6% (52/931) of patients during the 1–7 years follow‑up period.

4.3 In the randomised controlled trial of 100 patients treated by electrotherapy (monopolar electrocoagulation with 10–16 mA direct current) or bipolar electrocoagulation, the median times to treatment failure were 8 months and 2.7 months respectively and the mean numbers of sessions to failure were 6.5 and 3.4 respectively. Treatment failure was defined as the occurrence of a major complication (a painful fissure or ulceration, prolonged rectal spasm, severe persistent bleeding or refusal of further treatment because of discomfort) or persistence of bleeding despite a minimum of 8 treatments without improvement at examination or in symptoms. Treatment failure occurred in 12% of patients in the monopolar electrocoagulation group and in 14% of patients in the bipolar electrocoagulation group (level of significance not stated and absolute numbers not given).

4.4 In the case series of 931 patients treated by electrotherapy with 27–30 mA direct current, 93% of patients went back to work after 2 days, 5% of patients went back to work after 2–6 days and 2% had to stay at home for a maximum of 2 weeks because of pain and discomfort (level of significance not stated and absolute numbers not given).

4.5 In the randomised controlled trial of 102 patients treated by electrocoagulation with 10–20 mA direct current or injection sclerotherapy, 8 weeks after the procedure, 84% (42/50) and 63% (33/52) of patients respectively were fully satisfied with the treatment, 12% (6/50) and 21% (11/52) of patients respectively were moderately satisfied, and 4% (2/50) and 15% (8/52) respectively were not satisfied (p value for overall difference between groups: p=0.04).

4.6 The specialist advisers listed key efficacy outcomes as resolution of haemorrhoidal symptoms such as bleeding and prolapse, and pain after the procedure.