4 Efficacy

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 In a randomised controlled trial (RCT) of 80 patients with grade II haemorrhoids treated by radiofrequency or rubber band ligation, the mean time taken to return to work was 2 and 5 days respectively (p=0.051). In an RCT of 40 patients with grade III or IV haemorrhoids, the time off work was 5 days for patients who had radiofrequency treatment and 21 days for patients who had haemorrhoidectomy. In a case series of 50 patients with grade III or IV haemorrhoids, 44% (22/50) of patients returned to work within 5 days and the remaining 56% (28/50) returned within 1 week of the procedure.

4.2 In the RCT of 80 patients, recurrence of bleeding was reported in 14% (5/36) of patients who had radiofrequency treatment and 7% (3/44) of patients who had rubber band ligation (p=0.105) at 1‑year follow‑up. Recurrence of haemorrhoid prolapse was reported in 1 patient, who had radiofrequency treatment, in the same study. Recurrence of symptoms was reported in 14% (4/28) and 6% (2/32) of patients respectively (p<0.05) in an RCT of 60 patients with grade II haemorrhoids treated by radiofrequency or rubber band ligation. Recurrence of bleeding was reported in 16% (33/209) of patients in a case series of 240 patients with grade I or II haemorrhoids treated by radiofrequency, at a mean follow‑up of 18 months. Recurrence of bleeding was reported in 4% (8/210) of patients in a case series of 210 patients with grade I or II haemorrhoids treated by radiofrequency, at a mean follow‑up of 12 months. In an RCT of 100 patients who had radiofrequency or infrared coagulation, recurrence of bleeding was reported in 8% and 14% of patients respectively, at 12‑month follow‑up.

4.3 In the case series of 50 patients with grade III or IV haemorrhoids, asymptomatic recurrence (diagnosed on proctoscopy) was reported in 9% (4/44) of patients at 12‑month follow‑up. In the RCT of 80 patients, obliteration of treated haemorrhoids (confirmed by anoscopy) was reported in 82% of patients who had radiofrequency and 93% of patients who had rubber band ligation (p=0.004) at 1‑year follow‑up.

4.4 In the RCT of 60 patients, the mean satisfaction scores (using a visual analogue scale of 0 to 10, where higher scores show more satisfaction) were 9.1 for radiofrequency treatment and 8.2 for rubber band ligation (p<0.05; follow‑up period not reported). In the RCT of 100 patients, 89% of patients who had radiofrequency treatment were satisfied compared with 83% of patients who had infrared coagulation (p value not reported). In the case series of 50 patients, all of the patients expressed satisfaction with the results of the treatment.

4.5 The specialist adviser listed the key efficacy outcomes as symptomatic and clinical resolution of haemorrhoids.

  • National Institute for Health and Care Excellence (NICE)