Abstract
Purpose
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).
Conclusion
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.
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References
Johanson JF, Sonnenberg A (1990) The prevalence of haemorrhoids and chronic constipation. Gastroenterology 98:380–386
Corman ML (2005) Haemorrhoids. In: Corman ML (ed) Colon and rectal surgery, 5th edn. Williams & Wilkins, Philadelphia, pp 177–253
Madoff RD, Fleshman JW (2004) American Gastroenterological Association technical review on the diagnosis and treatment of haemorrhoids. Gastroenterology 126:1463–1473
Khoury GA, Lake SP, Lewis MC, Lewis AA (1985) A randomised trial to compare single with multiple phenol injection treatment for haemorrhoids. Br J Surg 72:741–742
Al-Ghnaniem R, Leather AJ, Rennie JA (2001) Survey of methods of treatment of haemorrhoids and complications of injection sclerotherapy. Ann R Coll Surg Engl 83:325–328
Sim AJW, Murie JA, Mackenzie I (1981) Comparison of rubber band ligation and sclerosant injection for first and second degree haemorrhoids: a prospective clinical trial. Acta Chir Scand 147:717–720
Akerud L (1995) Sclerotherapy of haemorrhoids: a prospective randomised trial of polidocanol and phenol in oil. Coloproctology 17:73–86
Namasivayam J, Payne D, Maguire D (2000) Prostatic abscess following injection of internal haemorrhoids. Clin Radiol 55:67–68
Barwell J, Watkins RM, Lloyd-Davies E, Wilkins DC (1999) Life-threatening retroperitoneal sepsis after haemorrhoid injection sclerotherapy: report of a case. Dis Colon Rectum 42:421–423
Kaman L, Aggarwal S, Kumar R, Behera A, Katariya RN (1999) Necrotizing fasciitis after injection sclerotherapy for haemorrhoids: report of a case. Dis Colon Rectum 42:419–420
Palit V, Biyani CS, Kay CL, Shah T (2001) Prostatocutaneous fistula following injection of internal haemorrhoids with oily phenol. Int Urol Nephrol 33:509–510
Bullock N (1997) Impotence after sclerotherapy of haemorrhoids: case reports. BMJ 314:419
Rashid MM, Murtaza B, Gondal ZI, Mehmood A, Shah SS, Abbasi MH, Tamimy MS, Kazmi ST (2006) Injection sclerotherapy for haemorrhoids causing adult respiratory distress syndrome. J Coll Physicians Surg Pak 16:373–375
Wollmann JC (2004) The history of sclerosing foams. Dermatol Surg 30:694–703
Yamaki T, Nozaki M, Iwasaka S (2004) Comparative study of duplex-guided foam sclerotherapy and duplex-guided liquid sclerotherapy for the treatment of superficial venous insufficiency. Dermatol Surg 30:718–722
Rabe E, Otto J, Schliephake D, Pannier F (2008) Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg 35:238–245
Moser KH (2007) Evaluation of the efficacy and safety of polidocanol foam in the sclerotherapy of first degree bleeding haemorrhoids. Phlebol Rev (Przeglad Flebologiczny) 15:103–106
Benin P, D'Amico C (2007) Foam sclerotherapy with Fibro-vein (STD) for the treatment of haemorrhoids, using a flexible endoscope. Minerva Chir 62:235–240
Blanchard CE (1928) A textbook of ambulant proctology. Medical Success Press, Youngstown, Ohio
Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340:c332
Ambrose NS, Morris D, Alexander-Williams J, Keighley MR (1985) A randomised trial of photocoagulation or injection sclerotherapy for the treatment of first- and second-degree haemorrhoids. Dis Colon Rectum 28:238–240
Gartell PC, Sheridan RJ, McGinn FP (1985) Out-patient treatment of haemorrhoids: a randomised clinical trial to compare rubber band ligation with phenol injection. Br J Surg 72:478–479
Mann CV, Motson R, Clifton M (1988) The immediate response to injection therapy for first-degree haemorrhoids. J R Soc Med 81:146–148
Varma JS, Chung SCS, Li AKC (1991) Prospective randomised comparison of current coagulation and injection sclerotherapy for the outpatient treatment of haemorrhoids. Int J Colorect Dis 6:43–45
Santos G, Novell JR, Khoury G, Winslet MC, Lewis AA (1993) Long-term results of large-dose single-session phenol injection sclerotherapy for haemorrhoids. Dis Colon Rectum 36:958–961
Yuksel BC, Armagan H, Berkem H, Yildiz Y, Ozel H, Hengirmen S (2008) Conservative management of haemorrhoids: a comparison of venotonic flavonoid micronized purified flavonoid fraction (MPFF) and sclerotherapy. Surg Today 38:123–129
Acknowledgments
We gratefully acknowledge the study nurses in each study site whose support was very important for the success of this study. The authors would like to thank Catherine Vangierdegom (Centre for Clinical Trials at the University of Cologne) and Antje Weyh for their help in preparing and executing the trial.
We gratefully acknowledge the support of the scientific advisor Jens Kirsch (Centre for Colorectal Disease, Bismarckplatz 1, 68165 Mannheim, Germany) for this trial. This clinical trial was supported by a research grant from Chemische Fabrik Kreussler & Co. GmbH and the German Ministry of Education and Research (CHIR-Net, grant 01GH0605).
Conflict of interest
The following authors declare that they have no conflict of interest: Karl-Heinz Moser, Christoph Mosch, Maren Walgenbach, Dieter G. Bussen, Jan Kirsch, Andreas K. Joos and Stefan Sauerland
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Moser, KH., Mosch, C., Walgenbach, M. et al. 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. Int J Colorectal Dis 28, 1439–1447 (2013). https://doi.org/10.1007/s00384-013-1729-2
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DOI: https://doi.org/10.1007/s00384-013-1729-2