Clinical efficacy of polidocanol foam sclerotherapy for hemorrhoids: a systematic review and meta-analysis_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

LIU Shuang ¹ , TAN Shufa ¹ , PENG Chuanyue ¹ , LI Yuwei ² ,  XU Chen ²

1. Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China;
2. Department of Colorectal Surgery, Tianjin Union Medical Center, Tianjin 300121, P. R. China;

Corresponding author：

XU Chen, Email: xc198129@163.com

Keywords：

hemorrhoidal disease; polydocanol; sclerotherapy; clinical efficacy; systematic review; meta-analysis

DOI：

10.7507/1007-9424.202504160

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To evaluate the clinical efficacy of polidocanol foam sclerotherapy and to establish a reliable evidence base for its application in the treatment of hemorrhoids. Methods A systematic literature search was conducted in PubMed, Embase, Web of Science, the Cochrane Library, China National Knowledge Infrastructure, Wanfang Data, Chongqing VIP, and the Chinese Medical Journal Full-text Database for randomized controlled trials published from January 1, 2000 to December 1, 2024. Included patients were assigned to either an intervention group group (treated with polidocanol foam sclerotherapy) or a control group (receiving other interventions). Data from the included studies were pooled and analyzed using a meta-analysis model in Review Manager (RevMan) software, version 5.4. The primary outcomes were the clinical cure rate, postoperative recurrence rate, and incidence of postoperative bleeding. The secondary outcomes were the pain visual analogue scale (VAS) score and the incidence of severe postoperative pain. Results A total of 12 RCTs involving 1 380 patients with hemorrhoids were included. The pooled results demonstrated that, compared to the control group, the intervention group showed a significantly higher clinical cure rate [RR(95%CI)=1.36(1.26, 1.47)], as well as lower postoperative recurrence rate [RR(95%CI)=0.43 (0.29, 0.65)] and postoperative bleeding rate [RR(95%CI)=0.75(0.60, 0.93)]. However, there were no statistically significant differences between the groups in terms of postoperative pain VAS score [WMD(95%CI) =–0.53(–1.15, 0.09)] or the incidence of severe postoperative pain [RR(95%CI)=0.81(0.34, 1.94)]. Conclusions Polidocanol foam sclerotherapy demonstrates superior clinical efficacy in terms of clinical cure rate, postoperative recurrence rate, and postoperative bleeding rate, confirming its effectiveness as a treatment for hemorrhoids.

1.	Pata F, Sgró A, Ferrara F, et al. Anatomy, physiology and pathophysiology of haemorrhoids. Rev Recent Clin Trials, 2021, 16(1): 75-80.
2.	Guttenplan M. The evaluation and office management of hemorrhoids for the gastroenterologist. Curr Gastroenterol Rep, 2017, 19(7): 30. doi: 10.1007/s11894-017-0574-9.
3.	Krammer H, Herold A, Schmidt-Lauber M. Proctology. Dtsch Med Wochenschr, 2023, 148(8): 483-496.
4.	Hawkins AT, Davis BR, Bhama AR, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the management of hemorrhoids. Dis Colon Rectum, 2024, 67(5): 614-623.
5.	Gallo G, Martellucci J, Sturiale A, et al. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol, 2020, 24(2): 145-164.
6.	Yang F, Lan Z, Chen H, et al. Causal associations between human gut microbiota and hemorrhoidal disease: a two-sample Mendelian randomization study. Medicine (Baltimore), 2024, 103(13): e37599. doi: 10.1097/MD.0000000000037599.
7.	De Schepper H, Coremans G, Denis MA, et al. Belgian consensus guideline on the management of hemorrhoidal disease. Acta Gastroenterol Belg, 2021, 84(1): 101-120.
8.	Ray-Offor E, Amadi S. Hemorrhoidal disease: predilection sites, pattern of presentation, and treatment. Ann Afr Med, 2019, 18(1): 12-16.
9.	He A, Chen M. Sclerotherapy in hemorrhoids. Indian J Surg, 2023, 85(2): 228-232.
10.	Akinmoladun O, Oh W. Management of hemorrhoids and anal fissures. Surg Clin North Am, 2024, 104(3): 473-490.
11.	Qu CY, Zhang FY, Wang W, et al. Endoscopic polidocanol foam sclerobanding for the treatment of grade Ⅱ–Ⅲ internal hemorrhoids: a prospective, multi-center, randomized study. World J Gastroenterol, 2024, 30(27): 3326-3335.
12.	方振军, 王林学, 金法. 聚多卡醇泡沫硬化剂对于进展期内痔患者术后恢复的疗效. 世界华人消化杂志, 2024, 32(5): 361-367.
13.	刘丽, 顾建华. 聚多卡醇泡沫硬化剂注射治疗各期内痔的临床效果. 智慧健康, 2024, 10(24): 40-42.
14.	张瑶洁, 张飞宇, 沈峰, 等. 内镜下泡沫硬化剂治疗Ⅰ~Ⅲ度内痔的随机对照试验. 中国内镜杂志, 2023, 29(7): 48-55.
15.	Salgueiro P, Garrido M, Santos RG, et al. Polidocanol foam sclerotherapy versus rubber band ligation in hemorrhoidal disease grades Ⅰ/Ⅱ/Ⅲ: randomized trial. Dis Colon Rectum, 2022, 65(7): e718-e727. doi: 10.1097/DCR.0000000000002117.
16.	Neves S, Falcão D, Povo A, et al. 3% polidocanol foam sclerotherapy versus hemorrhoidal artery ligation with recto anal repair in hemorrhoidal disease grades Ⅱ–Ⅲ: a randomized, pilot trial. Rev Esp Enferm Dig, 2023, 115(3): 115-120.
17.	钟婷, 庞文璟, 王磊, 等. 内镜下微创治疗内痔53例疗效分析. 国际消化病杂志, 2022, 42(6): 378-382.
18.	沈峰, 张飞宇, 瞿春莹, 等. 内镜下泡沫硬化剂注射联合橡皮圈套扎治疗Ⅱ~Ⅲ度内痔的前瞻性临床研究. 中华消化内镜杂志, 2021, 38(9): 696-701.
19.	Makanjuola A, Balogun OS, Osinowo AO, et al. Comparison of rubber band ligation with 3% polidocanol injection sclerotherapy for the treatment of internal haemorrhoids at a Nigerian tertiary hospital. Niger Postgrad Med J, 2020, 27(4): 311-316.
20.	Mishra S, Sahoo AK, Elamurugan TP, et al. Polidocanol versus phenol in oil injection sclerotherapy in treatment of internal hemorrhoids: a randomized controlled trial. Turk J Gastroenterol, 2020, 31(5): 378-383.
21.	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, 2013, 28(10): 1439-1447.
22.	Yuksel BC, Armagan H, Berkem H, et al. Conservative management of hemorrhoids: a comparison of venotonic flavonoid micronized purified flavonoid fraction (MPFF) and sclerotherapy. Surg Today, 2008, 38(2): 123-129.
23.	Pata F, Bracchitta LM, Nardo B, et al. Sclerobanding in the treatment of second and third degree hemorrhoidal disease in high risk patients on antiplatelet/anticoagulant therapy without suspension: a pilot study. Front Surg, 2023, 10: 1290706. doi: 10.3389/fsurg.2023.1290706.
24.	Kodilinye SM, Kalloo AN. Endoscopic approaches to the management of hemorrhoids. Curr Opin Gastroenterol, 2023, 39(5): 375-380.
25.	Jiang YD, Liu Y, Wu JD, et al. Massive gastrointestinal bleeding after endoscopic rubber band ligation of internal hemorrhoids: a case report. World J Clin Cases, 2022, 10(19): 6656-6663.
26.	Xiong K, Zhao Q, Li W, et al. Comparison of the long-term efficacy and safety of multiple endoscopic rubber band ligations in a single session for varying grades of internal hemorrhoids. Ir J Med Sci, 2023, 192(6): 2747-2753.
27.	Fraissenon A, Fortin F, Durous V, et al. Percutaneous sclerotherapy of large venous malformations using consecutive polidocanol and bleomycin foam: MR imaging volumetric and quality-of-life assessment. J Vasc Interv Radiol, 2024, 35(1): 127-136.
28.	de Aguiar ET, Dos Santos JB, Carvalho DD. Venous thromboembolism after ultrasound guided foam sclerotherapy. Phlebology, 2021, 36(3): 233-239.
29.	Lucio Filho CEP, Bertanha M, Prata MP, et al. Efficacy and safety of glucose, glucose and polidocanol combination, liquid polidocanol and polidocanol foam in the treatment of reticular veins: a randomized study in rabbits. Phlebology, 2021, 36(4): 303-312.
30.	Mou AN, Wang YT. Endoscopic polidocanol foam sclerobanding for treatment of internal hemorrhoids: a novel outpatient procedure. World J Gastroenterol, 2024, 30(42): 4583-4586.
31.	Yang C, Li M, Li X, et al. Foam sclerotherapy in the treatment of hemangiomas and venous malformations. Dermatol Surg, 2023, 49(9): 855-861.
32.	Kahle B. Anatomic challenges of foam sclerotherapy for varicose veins. Hautarzt, 2020, 71(1): 20-23.
33.	Zhang YY, Hu B. Endoscopic polidocanol foam sclerobanding for the treatment of Grade Ⅱ–Ⅲ internal hemorrhoids: the focus of clinical practice. World J Gastroenterol, 2024, 30(38): 4246-4248.
34.	Tutino R, Massani M, Jospin Kamdem Mambou L, et al. A stepwise proposal for low-grade hemorrhoidal disease: injection sclerotherapy as a first-line treatment and rubber band ligation for persistent relapses. Front Surg, 2022, 8: 782800. doi: 10.3389/fsurg.2021.782800.
35.	Gallo G, Pietroletti R, Novelli E, et al. A multicentre, open-label, single-arm phase Ⅱ trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM). Tech Coloproctol, 2022, 26(8): 627-636.
36.	Lobascio P, Laforgia R, Novelli E, et al. Short-term results of sclerotherapy with 3% polidocanol foam for symptomatic second- and third-degree hemorrhoidal disease. J Invest Surg, 2021, 34(10): 1059-1065.
37.	Rao AG, Nashwan AJ. Redefining hemorrhoid therapy with endoscopic polidocanol foam sclerobanding. World J Gastroenterol, 2024, 30(36): 4021-4024.
38.	Gallo G, Laforgia R, Goglia M, et al. Sclerotherapy with 3% polidocanol foam for the treatment of mucocutaneous bridges and/or residual piles after open excisional hemorrhoidectomy. Updates Surg, 2024, 76(5): 2087-2090.

1. Pata F, Sgró A, Ferrara F, et al. Anatomy, physiology and pathophysiology of haemorrhoids. Rev Recent Clin Trials, 2021, 16(1): 75-80.
2. Guttenplan M. The evaluation and office management of hemorrhoids for the gastroenterologist. Curr Gastroenterol Rep, 2017, 19(7): 30. doi: 10.1007/s11894-017-0574-9.
3. Krammer H, Herold A, Schmidt-Lauber M. Proctology. Dtsch Med Wochenschr, 2023, 148(8): 483-496.
4. Hawkins AT, Davis BR, Bhama AR, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the management of hemorrhoids. Dis Colon Rectum, 2024, 67(5): 614-623.
5. Gallo G, Martellucci J, Sturiale A, et al. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol, 2020, 24(2): 145-164.
6. Yang F, Lan Z, Chen H, et al. Causal associations between human gut microbiota and hemorrhoidal disease: a two-sample Mendelian randomization study. Medicine (Baltimore), 2024, 103(13): e37599. doi: 10.1097/MD.0000000000037599.
7. De Schepper H, Coremans G, Denis MA, et al. Belgian consensus guideline on the management of hemorrhoidal disease. Acta Gastroenterol Belg, 2021, 84(1): 101-120.
8. Ray-Offor E, Amadi S. Hemorrhoidal disease: predilection sites, pattern of presentation, and treatment. Ann Afr Med, 2019, 18(1): 12-16.
9. He A, Chen M. Sclerotherapy in hemorrhoids. Indian J Surg, 2023, 85(2): 228-232.
10. Akinmoladun O, Oh W. Management of hemorrhoids and anal fissures. Surg Clin North Am, 2024, 104(3): 473-490.
11. Qu CY, Zhang FY, Wang W, et al. Endoscopic polidocanol foam sclerobanding for the treatment of grade Ⅱ–Ⅲ internal hemorrhoids: a prospective, multi-center, randomized study. World J Gastroenterol, 2024, 30(27): 3326-3335.
12. 方振军, 王林学, 金法. 聚多卡醇泡沫硬化剂对于进展期内痔患者术后恢复的疗效. 世界华人消化杂志, 2024, 32(5): 361-367.
13. 刘丽, 顾建华. 聚多卡醇泡沫硬化剂注射治疗各期内痔的临床效果. 智慧健康, 2024, 10(24): 40-42.
14. 张瑶洁, 张飞宇, 沈峰, 等. 内镜下泡沫硬化剂治疗Ⅰ~Ⅲ度内痔的随机对照试验. 中国内镜杂志, 2023, 29(7): 48-55.
15. Salgueiro P, Garrido M, Santos RG, et al. Polidocanol foam sclerotherapy versus rubber band ligation in hemorrhoidal disease grades Ⅰ/Ⅱ/Ⅲ: randomized trial. Dis Colon Rectum, 2022, 65(7): e718-e727. doi: 10.1097/DCR.0000000000002117.
16. Neves S, Falcão D, Povo A, et al. 3% polidocanol foam sclerotherapy versus hemorrhoidal artery ligation with recto anal repair in hemorrhoidal disease grades Ⅱ–Ⅲ: a randomized, pilot trial. Rev Esp Enferm Dig, 2023, 115(3): 115-120.
17. 钟婷, 庞文璟, 王磊, 等. 内镜下微创治疗内痔53例疗效分析. 国际消化病杂志, 2022, 42(6): 378-382.
18. 沈峰, 张飞宇, 瞿春莹, 等. 内镜下泡沫硬化剂注射联合橡皮圈套扎治疗Ⅱ~Ⅲ度内痔的前瞻性临床研究. 中华消化内镜杂志, 2021, 38(9): 696-701.
19. Makanjuola A, Balogun OS, Osinowo AO, et al. Comparison of rubber band ligation with 3% polidocanol injection sclerotherapy for the treatment of internal haemorrhoids at a Nigerian tertiary hospital. Niger Postgrad Med J, 2020, 27(4): 311-316.
20. Mishra S, Sahoo AK, Elamurugan TP, et al. Polidocanol versus phenol in oil injection sclerotherapy in treatment of internal hemorrhoids: a randomized controlled trial. Turk J Gastroenterol, 2020, 31(5): 378-383.
21. 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, 2013, 28(10): 1439-1447.
22. Yuksel BC, Armagan H, Berkem H, et al. Conservative management of hemorrhoids: a comparison of venotonic flavonoid micronized purified flavonoid fraction (MPFF) and sclerotherapy. Surg Today, 2008, 38(2): 123-129.
23. Pata F, Bracchitta LM, Nardo B, et al. Sclerobanding in the treatment of second and third degree hemorrhoidal disease in high risk patients on antiplatelet/anticoagulant therapy without suspension: a pilot study. Front Surg, 2023, 10: 1290706. doi: 10.3389/fsurg.2023.1290706.
24. Kodilinye SM, Kalloo AN. Endoscopic approaches to the management of hemorrhoids. Curr Opin Gastroenterol, 2023, 39(5): 375-380.
25. Jiang YD, Liu Y, Wu JD, et al. Massive gastrointestinal bleeding after endoscopic rubber band ligation of internal hemorrhoids: a case report. World J Clin Cases, 2022, 10(19): 6656-6663.
26. Xiong K, Zhao Q, Li W, et al. Comparison of the long-term efficacy and safety of multiple endoscopic rubber band ligations in a single session for varying grades of internal hemorrhoids. Ir J Med Sci, 2023, 192(6): 2747-2753.
27. Fraissenon A, Fortin F, Durous V, et al. Percutaneous sclerotherapy of large venous malformations using consecutive polidocanol and bleomycin foam: MR imaging volumetric and quality-of-life assessment. J Vasc Interv Radiol, 2024, 35(1): 127-136.
28. de Aguiar ET, Dos Santos JB, Carvalho DD. Venous thromboembolism after ultrasound guided foam sclerotherapy. Phlebology, 2021, 36(3): 233-239.
29. Lucio Filho CEP, Bertanha M, Prata MP, et al. Efficacy and safety of glucose, glucose and polidocanol combination, liquid polidocanol and polidocanol foam in the treatment of reticular veins: a randomized study in rabbits. Phlebology, 2021, 36(4): 303-312.
30. Mou AN, Wang YT. Endoscopic polidocanol foam sclerobanding for treatment of internal hemorrhoids: a novel outpatient procedure. World J Gastroenterol, 2024, 30(42): 4583-4586.
31. Yang C, Li M, Li X, et al. Foam sclerotherapy in the treatment of hemangiomas and venous malformations. Dermatol Surg, 2023, 49(9): 855-861.
32. Kahle B. Anatomic challenges of foam sclerotherapy for varicose veins. Hautarzt, 2020, 71(1): 20-23.
33. Zhang YY, Hu B. Endoscopic polidocanol foam sclerobanding for the treatment of Grade Ⅱ–Ⅲ internal hemorrhoids: the focus of clinical practice. World J Gastroenterol, 2024, 30(38): 4246-4248.
34. Tutino R, Massani M, Jospin Kamdem Mambou L, et al. A stepwise proposal for low-grade hemorrhoidal disease: injection sclerotherapy as a first-line treatment and rubber band ligation for persistent relapses. Front Surg, 2022, 8: 782800. doi: 10.3389/fsurg.2021.782800.
35. Gallo G, Pietroletti R, Novelli E, et al. A multicentre, open-label, single-arm phase Ⅱ trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM). Tech Coloproctol, 2022, 26(8): 627-636.
36. Lobascio P, Laforgia R, Novelli E, et al. Short-term results of sclerotherapy with 3% polidocanol foam for symptomatic second- and third-degree hemorrhoidal disease. J Invest Surg, 2021, 34(10): 1059-1065.
37. Rao AG, Nashwan AJ. Redefining hemorrhoid therapy with endoscopic polidocanol foam sclerobanding. World J Gastroenterol, 2024, 30(36): 4021-4024.
38. Gallo G, Laforgia R, Goglia M, et al. Sclerotherapy with 3% polidocanol foam for the treatment of mucocutaneous bridges and/or residual piles after open excisional hemorrhoidectomy. Updates Surg, 2024, 76(5): 2087-2090.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Latest ArticlesClinical efficacy of polidocanol foam sclerotherapy for hemorrhoids: a systematic review and meta-analysis

Abstract Full text Figures/Tables Video References Cited by

Format

Content