The effect of sucralfate-containing ointment on quality of life in people with symptoms associated with haemorrhoidal disease and its complications: the results of the EMOCARE survey

Main Article Content

Corrado Giua
Luigi Minerba
Antonio Piras
Nicolina Floris
Flora Romano
Group SIFAC

Keywords

clinical pharmacist, community pharmacy, haemorrhoidal disease, minor disease, quality of life, sucralfate ointment

Abstract

Background and aim: A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the treatment of symptoms associated with haemorrhoidal disease. This survey evaluated the effect of the mentioned sucralfate ointment, on quality of life (QoL) and symptom frequency in participants seeking treatment for haemorrhoidal disease from community pharmacies in Italy.


Methods: EMOCARE was a multicentre prospective survey conducted at community pharmacies in Italy. Eligible participants (≥18 years) were those with haemorrhoidal symptoms in the last 7 days and were willing to initiate a treatment with the sucralfate ointment and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile). A survey was administered by the investigating pharmacists at the beginning and end (~14 days) of treatment. The primary endpoint was the change in HEMO-FISS-QoL scores.


Results: Of the 290 (mean age 53.1 years old; 58.3% female) enrolled, 287 attended the follow-up visit. After a mean duration of 13 days, the sucralfate ointment significantly improved total HEMO-FISS-QoL scores (mean change from baseline: –10.41; 95%CI –11.95, –8.86; P<0.001) and mean scores for all domains of the HEMO-FISS-QoL scale (–11.13 [95%CI –12.95, –9.30] for physical disorders, –6.14 [95%CI –7.42, –4.85] for psychology, –18.79 [95% CI –21.67, –15.90] for defaecation, and –6.46 [95%CI –8.40, –4.51] for sexuality; all P<0.001 versus baseline). At the end of treatment, 39.4% of participants reported that they no longer had haemorrhoidal symptoms and the frequency of all assessed symptoms were reduced significantly from baseline (all P<0.05).


Conclusions: After a mean 13 days of treatment  the sucralfate ointment with herbal extracts improved HEMO-FISS-QoL scores and reduced symptoms in people with haemorrhoidal disease.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...
Abstract 423 | pdf Downloads 115

References

1. Godeberge P, Sheikh P, Zagriadskiĭ E, et al. 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): 577–85.
2. Sheikh P, Régnier C, Goron F, Salmat G. The prevalence, characteristics and treatment of hemorrhoidal disease: results of an international web-based survey. J Comp Eff Res. 2020; 9 (17): 1219–32.
3. 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): 145–64.
4. Altomare DF, Giannini I. Pharmacological treatment of hemorrhoids: a narrative review. Expert Opin Pharmacother. 2013; 14 (17): 2343–9.
5. Alonso-Coello P, Zhou Q, Martinez-Zapata MJ, et al. Meta-analysis of flavonoids for the treatment of haemorrhoids. Br J Surg. 2006; 93 (8): 909–20.
6. Perera N, Liolitsa D, Iype S, et al. Phlebotonics for haemorrhoids. Cochrane Database Syst Rev. 2012; (8): CD004322.
7. Sheikh P, Lohsiriwat V, Shelygin Y. Micronized Purified Flavonoid Fraction in Hemorrhoid Disease: A Systematic Review and Meta-Analysis. Adv Ther. 2020; 37 (6): 2792–812.
8. Amaturo A, Meucci M, Mari FS. Treatment of haemorrhoidal disease with micronized purified flavonoid fraction and sucralfate ointment. Acta Biomed. 2020; 91 (1): 139–41.
9. Servier Italia S.p.A. Emoflon™ pomata rettale - Istruzioni per l'Uso [in Italian]. https://emoflon.it/Content/documents/emoflon-foglietto-illustrativo.pdf. Accessed 26 November 2020.
10. Abramowitz L, Bouchard D, Siproudhis L, et al. Psychometric properties of a questionnaire (HEMO-FISS-QoL) to evaluate the burden associated with haemorrhoidal disease and anal fissures. Colorectal Dis. 2019; 21 (1): 48–58.
11. Vejdan AK, Khosravi M, Amirian Z, et al. Evaluation of the efficacy of topical sucralfate on healing haemorrhoidectomy incision wounds and reducing pain severity: a randomised clinical trial. Int Wound J. 2020; 17 (4): 1047–51.
12. Gupta PJ, Heda PS, Kalaskar S, Tamaskar VP. Topical sucralfate decreases pain after hemorrhoidectomy and improves healing: a randomized, blinded, controlled study. Dis Colon Rectum. 2008; 51 (2): 231–4.
13. Ala S, Saeedi M, Eshghi F, et al. Efficacy of 10% sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy: a prospective, double-blind, randomized, placebo-controlled trial. World J Surg. 2013; 37 (1): 233–8.
14. DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002; 40 (9): 794–811.
15. Zschocke I, Mrowietz U, Lotzin A, Karakasili E, Reich K. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ). Arch Dermatol Res. 2014; 306 (3): 287–97.
16. Tournu G, Abramowitz L, Couffignal C, et al. Prevalence of anal symptoms in general practice: a prospective study. BMC Fam Pract. 2017; 18 (1): 78.