Electrotherapy for the treatment of haemorrhoids

5 Safety

This section describes safety 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.

5.1 Severe pain during the procedure (measured on a 10‑point visual analogue scale, with a higher score indicating more severe pain) was reported in 1 patient (out of 50) in the electrocoagulation group using 10–20 mA direct current and in none of the patients (out of 52) in the injection sclerotherapy group, in a randomised controlled trial of 102 patients. Moderate pain during the procedure was reported in 68% (34/50) of patients in the electrocoagulation group and in 4% (2/52) in the injection sclerotherapy group, and mild pain during the procedure was reported in 30% (15/50) and 96% (50/52) respectively (p value for overall difference between groups: p<0.001).

5.2 Procedural pain that resulted in stopping therapy was reported in 20% (5/25) of patients treated by electrotherapy using 16 mA direct current and in none of the patients treated by bipolar electrocoagulation in a randomised controlled trial of 50 patients (p=0.05). Prolonged pain (for more than 1 day following the procedure) was reported in 16% (4/25) of patients in the electrocoagulation group (2 of those patients also reported procedural pain) and in 1 patient in the bipolar electrocoagulation group (p=0.35). In a randomised controlled trial of 408 patients treated by electrotherapy with 16 mA direct current (n=136) or 30 mA direct current (n=136) or Ferguson haemorrhoidectomy (n=136), moderate pain 7 days after the procedure was reported in 7% (10/136) of patients, mild pain was reported in 15% (20/136) of patients and 78% (106/136) of patients had no pain when treated using 16 mA direct current. In the group treated using 30 mA direct current, 15% (20/136) of patients had mild pain and 85% (116/136) had no pain 7 days after the procedure, while all patients (136/136) treated by Ferguson haemorrhoidectomy continued to experience severe pain 7 days after the procedure (p value for overall difference between groups: p<0.05).

5.3 Rectal bleeding 48 hours after the procedure was reported in 16% (8/50) of patients treated by electrotherapy with 16 mA direct current and in 1 patient treated by rubber band ligation in a randomised controlled trial of 100 patients; bleeding 1–48 hours after the procedure was reported in 12% (6/50) and 34% (17/50) of patients respectively, and no bleeding after the procedure was reported in 72% (36/50) and 64% (32/50) of patients respectively (no significant difference observed between groups, p=0.5).

5.4 Rectal ulceration was reported in 1 patient treated by electrotherapy with 16 mA direct current and in 24% (6/25) of patients treated by bipolar electrocoagulation in the randomised controlled trial of 50 patients (p=0.10).

5.5 Retention of urine was reported in 8% of patients in a case series of 931 patients treated by electrotherapy using 27–30 mA direct current; 6% of patients needed catheterisation once and 2% of patients needed catheterisation 2 to 3 times (absolute numbers not given).

5.6 A vasovagal episode with syncope for 10 seconds immediately after the procedure was reported in 1 patient in a case series of 120 patients treated by electrotherapy with 8–16 mA direct current; the patient had no sequelae and subsequently returned for treatment without any adverse effects.

5.7 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not list any anecdotal adverse events. They considered that the following were theoretical adverse events: burning, perforation, infection, electrocution and thrombosed haemorrhoids.