title: Efficacy and safety of sclerotherapy with polidocanol foam in comparison with fluid sclerosant in the treatment of first-grade haemorrhoidal disease: a randomised, controlled, single-blind, multicentre trial.
abstract: OBJECTIVE
  Sclerotherapy is the treatment of choice for first-grade haemorrhoidal disease. Numerous studies have shown that sclerotherapy with foamed sclerosants is more efficacious than liquid in the treatment of varicose veins. The aim of this study was to assess the efficacy and safety of polidocanol foam in comparison with liquid for haemorrhoidal disease.
  
  
  METHODS
  A total of 130 patients were randomised to foam or liquid sclerotherapy (polidocanol 3%). Patients with first-grade haemorrhoidal disease were included and blinded to treatment assignment. The primary endpoint was the stopping of perianal bleeding after one sclerotherapy session. Sclerotherapy was repeated until patients were free of bleeding (2-week intervals). The final follow-up was 12 weeks after the last sclerotherapy session.
  
  
  RESULTS
  In the foam group, significantly more patients (88%) were treated successfully after one sclerotherapy session compared to the liquid group (69%; p = 0.01). There was high patient satisfaction in both groups, but significantly more patients were satisfied with their treatment in the foam group than in the liquid group (99 vs. 84%; p = 0.009). Additionally, in the foam group, significantly less treatment sessions were required (p < 0.001), and the total amount of injected polidocanol was reduced (p < 0.001).
  
  
  CONCLUSIONS
  In the therapy of first-grade haemorrhoidal disease, polidocanol 3 % foam is more effective and equally safe compared to liquid polidocanol. The results of this trial show that foam sclerotherapy is a new, innovative, effective and safe non-surgical treatment option for haemorrhoidal disease.
authors.affiliation: "Suedstadt" Surgical Group Practise, Karolingerring 31, 50678, Cologne, Germany.
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Moser
authors.forename: Christoph
authors.initials: C
authors.lastname: Mosch
authors.forename: Maren
authors.initials: M
authors.lastname: Walgenbach
authors.forename: Dieter G
authors.initials: DG
authors.lastname: Bussen
authors.forename: Jan
authors.initials: J
authors.lastname: Kirsch
authors.forename: Andreas K
authors.initials: AK
authors.lastname: Joos
authors.forename: Petra
authors.initials: P
authors.lastname: Gliem
authors.forename: Stefan
authors.initials: S
authors.lastname: Sauerland
mesh_terms: D000328:Adult; D003710:Demography; D005260:Female; D006484:Hemorrhoids / Q000628:therapy*; D006801:Humans; D008297:Male; D010146:Pain / Q000209:etiology; D017060:Patient Satisfaction; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012597:Sclerosing Solutions / Q000627:therapeutic use*; D015911:Sclerotherapy / Q000009:adverse effects*; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols