Systemic and local therapy of chronic hemorrhoids: Results of the prospective comparative study “VITA”

Introduction. Conservative therapy for hemorrhoids is one of the most discussed and controversial in coloproctology. Considering the high prevalence of this disease, the use of effective pathogenetical and symptoms relieve pharmacotherapy remains especially relevant.
Aim. To compare the effectiveness of complex therapy and monotherapy for chronic hemorrhoids.
Materials and methods. A prospective observational study was conducted on the effects of different approaches with the use of the Venarus and Venaproct Alium to the treatment of patients with hemorrhoids (“VITA”). The complex therapy group was treated with standardized dosages of systemic bioflavonoids hesperidin 100 mg and diosmin 900 mg, and sodium alginate rectal suppositories for topical use. The monotherapy control group received only therapy with Venarus. The study was conducted from June 20, 2023 to May 31, 2024 and included 80 patients with chronic hemorrhoids. The dynamics of hemorrhoids symptoms, the quality oflife, adherence to the therapy, the frequency of repeated disease exacerbations was compared depending on treatment approaches.
Results. Conservative pharmacotherapy was effective in both groups, however, in the complex therapy group, the effect of decreased symptoms of “blood discharge during defecation” and “presence of enlarged external hemorrhoids” was more pronounced. Statistically significant differences between groups recorded at 14 days (p = 0.009) for the symptom “blood discharge during bowel movements” and 85% of patients receiving complex therapy had no complaints about the presence of enlarged external hemorrhoids by the 14th day (p < 0.001) and 87% by the 30th day of treatment (p < 0.001).
Discussion. Pharmacotherapy of hemorrhoids, given the prevalence of symptoms of bleeding and prolapse of nodes, should be aimed at their effective elimination. The combination of systemic and topical therapy for hemorrhoids offers an integrative approach that can significantly improve the treatment effect.
Conclusion. Considering the absence of differences in patient adherence to the treatment, the effect of complex therapy compared to monotherapy of hemorrhoids symptoms decrease, indicates the advisability of using complex treatment with the Venarus and Venaproct Alium.

1. Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World J Gastrenterol. 2012;18(17):2009–2017. https://doi.org/10.3748/wjg.v18.i17.2009.

2. Shelygin YuA, Frolov SA, Titov AYu, Blagodarny LA, Vasilyev SV, Veselov AV et al. The Russian Association of Coloproctology clinical guidelines for the diagnosis and treatment of hemorrhoids. Koloproktologiya. 2019;18(1):7–38. (In Russ.) https://doi.org/10.33878/2073-7556-2019-18-1-7-38.

3. Altomare DF, Giannini I. Pharmacological treatment of hemorrhoids: a narrative review. Expert Opin Pharmacother. 2013;14(17):2343–2349. https://doi.org/10.1517/14656566.2013.836181.

4. Lohsiriwat V. Treatment of hemorrhoids: A coloproctologist’s view. World J Gastroenterol. 2015;21(31):9245–9252. https://doi.org/10.3748/wjg.v21.i31.9245.

5. Mott T, Latimer K, Edwards C. Hemorrhoids: Diagnosis and Treatment Options. Am Fam Physician. 2018;97(3):172–179. Available at: https://www.aafp.org/pubs/afp/issues/2018/0201/p172.html.

6. https://cr.minzdrav.gov.ru/recomend/178_1.

7. Godeberge P, Sheikh P, Zagriadskiĭ E, Lohsiriwat V, Montaño AJ, Košorok P, De Schepper H. Hemorrhoidal disease and chronic venous insufficiency: Concomitance or coincidence; results of the CHORUS study (Chronic venous and HemORrhoidal diseases evaluation and Scientific research). J Gastroenterol Hepatol. 2020;35(4):577–585. https://doi.org/10.1111/jgh.14857.

8. Stratta E, Gallo G, Trompetto M. Conservative Treatment of Hemorrhoidal Disease. Rev Recent Clin Trials. 2021;16(1):87–90. https://doi.org/10.2174/1574887115666201021150144.

9. Ng KS, Holzgang M, Young C. Still a Case of “No Pain, No Gain”? An Updated and Critical Review of the Pathogenesis, Diagnosis, and Management Options for Hemorrhoids in 2020. Ann Coloproctol. 2020;36(3):133–147. https://doi.org/10.3393/ac.2020.05.04.

10. Ratto C, Orefice R, Tiso D, Martinisi GB, Pietroletti R. Management of hemorrhoidal disease: new generation of oral and topical treatments. Eur Rev Med Pharmacol Sci. 2020;24(18):9645–9649. https://doi.org/10.26355/eurrev_202009_23053.

11. Alonso-Coello P, Zhou Q, Martinez-Zapata MJ, Mills E, Heels-Ansdell D, Johanson JF, Guyatt G. Meta-analysis of flavonoids for the treatment of haemorrhoids. Br J Surg. 2006;93(8):909–920. https://doi.org/10.1002/bjs.5378.

12. Misra MC, Parshad R. Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids. Br J Surg. 2000;87(7):868–872. https://doi.org/10.1046/j.1365-2168.2000.01448.x.

13. Perera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P et al. Phlebotonics for haemorrhoids. Cochrane Database Syst Rev. 2012;(8):CD004322. https://doi.org/10.1002/14651858.CD004322.pub3.

14. Petrikov AS. Diosmin and hesperidin: do we know all the effects? Lechebnoe Delo. 2023;(1):18–34. (In Russ.) https://doi.org/10.24412/2071-5315-2023-12949.

15. Titov AYu, Nekhrikova SV, Veselov AV. Medicamental therapy in the treatment of postoperative wounds perineum and anal canal. Koloproktologia. 2018;(1):7–12. (In Russ.) https://doi.org/10.33878/2073-7556-2018-0-1-7-12.

16. Shikh EV, Khaytovich ED. Own clinical and pharmacological effects of hesperidin in the treatment of chronic venous diseases. Lechebnoe Delo. 2023;(4):17–31. (In Russ.) https://doi.org/10.24412/2071-5315-2023-13018.

17. Belousov DYu. Non-interventional studies. Kachestvennaya Klinicheskaya Praktika. 2017;(1):24–33. (In Russ.) Available at: https://www.clinvest.ru/jour/article/view/75.

18. Kostarev IV, Blagodarny LA, Frolov SA. Results of sclerosing treatment of hemorrhoids in patients with high surgical risk. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2010;20(1):82–87. (In Russ.) Available at: http://old-gastro-j.ru/files/s12_1269031691.pdf.

19. Titov AYu, Mudrov AA, Kostarev IV, Kucherenko OV. Desarterization of internal hemorrhoids with sclerotherapy in the treatment of patients with chronic hemorrhoids. Meditsinskiy Sovet. 2012;(9):94–96. (In Russ.) Available at: https://cyberleninka.ru/article/n/dezarterizatsiya-vnutrennih-gemorroidalnyh-uzlov-so-skleroterapiey-pri-lechenii-bolnyh-hronicheskim-gemorroem.

20. Frolov SA, Blagodarny LA, Kostarev IV. Sclerotherapy by detergent-type sclerosants – method of choice of treatment patients suffering from bleeding hemorrhoids complicated by anemia. Koloproktologia. 2011;(2):23–27. (In Russ.) Available at: https://gnck.ru/specialists/zhurnal-koloproktologiya/journal_2_36_2011.pdf.

21. Brazier JE, Roberts J. The Estimation of a Preference-Based Measure of Health From the SF-12. Med Care. 2004;42(9):851–859. https://doi.org/10.1097/01.mlr.0000135827.18610.0d.

22. Rørvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH et al. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019;62(3):333–342. https://doi.org/10.1097/DCR.0000000000001234.

23. Indrayan A, Malhotra RK. Medical Biostatistics. 4th ed. New York: Chapman and Hall/CRC; 2017. 1032 p. https://doi.org/10.4324/9781315100265.

24. Riss S, Weiser FA, Schwameis K, Riss T, Mittlböck M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012:7(2):215–220. https://doi.org/10.1007/s00384-011-1316-3.

25. Bogomazov AM, Golovko EB, Zgryadsky EA. Incidence of hemorrhoid occurrence risk factors and definition of the relationship between hemorrhoids and chronic vein diseases. Results of the russian part of the international program CHORUS. Ambulatornaya Khirurgiya. 2017;(3-4):94–104. (In Russ.) Available at: https://www.a-surgeon.ru/jour/article/view/97/98?locale=ru_RU.

26. Knorring GYu. Rationale and effectiveness of combination therapy of chronic anal fissures and hemorrhoids. Ambulatornaya Khirurgiya. 2022;19(2):106–110. (In Russ.) https://doi.org/10.21518/1995-1477-2022-19-2-106-110.

27. Lohsiriwat V. Approach to hemorrhoids. Curr Gastroenterol Rep. 2013;15(7):332. https://doi.org/10.1007/s11894-013-0332-6.

28. Picciariello A, Tsarkov PV, Papagni V, Efetov S, Markaryan DR, Tulina I, Altomare DF. Classifications and Clinical Assessment of Haemorrhoids: The Proctologist’s Corner. Rev Recent Clin Trials. 2021;16(1):10–16. https://doi.org/10.2174/1574887115666200312163940.

29. De Marco S, Tiso D. Lifestyle and Risk Factors in Hemorrhoidal Disease. Front Surg. 2021;8:729166. https://doi.org/10.3389/fsurg.2021.729166.