دورية أكاديمية
Effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for hemorrhoidal symptoms: a prospective, observational study.
| العنوان: | Effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for hemorrhoidal symptoms: a prospective, observational study. |
|---|---|
| المؤلفون: | Marik AR; Egis Pharmaceuticals PLC, Budapest, Hungary. marik.aniko.rita@egis.hu., Miklós I; Egis Pharmaceuticals PLC, Budapest, Hungary., Csukly G; Bitrial Clinical Research Kft, Budapest, Hungary., Hársfalvi P; Bitrial Clinical Research Kft, Budapest, Hungary., Novák A; Semmelweis University, Budapest, Hungary. |
| المصدر: | International journal of colorectal disease [Int J Colorectal Dis] 2024 May 16; Vol. 39 (1), pp. 72. Date of Electronic Publication: 2024 May 16. |
| نوع المنشور: | Journal Article; Observational Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer International Country of Publication: Germany NLM ID: 8607899 Publication Model: Electronic Cited Medium: Internet ISSN: 1432-1262 (Electronic) Linking ISSN: 01791958 NLM ISO Abbreviation: Int J Colorectal Dis Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [Heidelberg] : [New York : Springer International ; Springer-Verlag, distributor], 1986- |
| مواضيع طبية MeSH: | Sucralfate*/administration & dosage , Sucralfate*/therapeutic use , Hemorrhoids*/drug therapy , Ointments*, Humans ; Female ; Suppositories ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome ; Patient Satisfaction ; Adult ; Aged ; Administration, Rectal |
| مستخلص: | Background and Aims: A high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products constitute a new treatment alternative that act as a mechanical barrier to facilitate healing. The aim of this prospective, observational study was to determine patient- and physician-assessed effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for the treatment of hemorrhoidal symptoms in routine clinical practice. Methods: Adult patients with diagnosed, mild-to-moderate, symptomatic non-bleeding hemorrhoids treated with rectal ointment or suppositories containing sucralfate were enrolled. Patients were administered treatment twice per day for at least 1 week until symptom resolution and/or for a maximum of 4 weeks. The primary endpoint was patient-assessed effectiveness on a modified Symptom Severity Score (mSSS, range 0 to 14). Physician-assessed effectiveness (9 symptoms, 0 to 5 Likert scale), hemorrhoid grade, and patient satisfaction were also determined. Results: Five investigators enrolled 60 patients; mean age was 48.4 ± 16.6 years and 72.4% were female. Pain or pressure sensitivity was reported as the most severe symptom by patients, and pressure sensitivity, discharge, soiling, and prolapse by physicians. Mean patient-assessed mSSS at baseline was 6.6 ± 1.9 and was significantly improved overall and in the ointment and suppository groups individually by -4.6 ± 2.0, -4.4 ± 1.8, and -4.8 ± 2.2, respectively (p < 0.0001). Investigator-assessed mean baseline symptom score was 18.1 ± 3.9 and improved by -7.1 ± 4.5, -6.9 ± 5.4, and -7.3 ± 3.5, respectively (p < 0.0001). Investigator-assessed symptoms of pressure sensitivity, swelling, and discharge were improved to the greatest extent. Hemorrhoid grade was improved in 38% of patients at the end of treatment. Compliance with treatment was 97.4% and patient satisfaction with application and onset of action was high (81.3% and 76.2%, respectively). Both the ointment and suppository were well tolerated. Conclusions: The effectiveness of topical ointment or suppository containing sucralfate on patient- and investigator-assessed hemorrhoidal symptoms in real-life clinical practice was demonstrated. Patient satisfaction was high and treatments were well tolerated. Larger controlled trials are warranted to confirm the results. (© 2024. The Author(s).) |
| References: | PLoS One. 2018 Oct 18;13(10):e0205952. (PMID: 30335861) Antioxidants (Basel). 2022 Jun 05;11(6):. (PMID: 35740016) Acta Biomed. 2021 Feb 04;92(1):e2021029. (PMID: 33683221) Am J Gastroenterol. 2014 Aug;109(8):1141-57; (Quiz) 1058. (PMID: 25022811) Int J Colorectal Dis. 2012 Feb;27(2):215-20. (PMID: 21932016) Tech Coloproctol. 2022 May;26(5):387-392. (PMID: 35141793) Gut. 2009 May;58(5):668-78. (PMID: 19091821) Dis Colon Rectum. 2008 Feb;51(2):231-4. (PMID: 18095028) World J Surg. 2013 Jan;37(1):233-8. (PMID: 23010700) Dis Colon Rectum. 1988 Jun;31(6):474-80. (PMID: 3378471) Can Fam Physician. 2008 Feb;54(2):189-90. (PMID: 18272631) Scand J Gastroenterol Suppl. 1990;173:1-5. (PMID: 2190304) N Engl J Med. 2012 Oct 4;367(14):1355-60. (PMID: 23034025) Transl Gastroenterol Hepatol. 2021 Jan 05;6:15. (PMID: 33409409) Int Wound J. 2023 Feb;20(2):543-553. (PMID: 35864080) Int Wound J. 2020 Aug;17(4):1047-1051. (PMID: 32319175) Tech Coloproctol. 2020 Feb;24(2):145-164. (PMID: 31993837) Dis Colon Rectum. 2011 Jun;54(6):699-704. (PMID: 21552054) Arch Dermatol. 2000 Oct;136(10):1199-200. (PMID: 11030763) J Comp Eff Res. 2020 Dec;9(17):1219-1232. (PMID: 33079605) Adv Data. 1992 Mar 24;(212):1-15. (PMID: 10119851) Front Surg. 2021 Aug 18;8:729166. (PMID: 34485376) Eur Rev Med Pharmacol Sci. 2020 Sep;24(18):9645-9649. (PMID: 33015808) Recent Pat Inflamm Allergy Drug Discov. 2010 Jan;4(1):25-36. (PMID: 19832693) J Gastroenterol Hepatol. 2020 Apr;35(4):577-585. (PMID: 31512275) World J Gastroenterol. 2012 May 7;18(17):2009-17. (PMID: 22563187) Surg Open Sci. 2023 Feb 24;12:22-28. (PMID: 36876020) J Am Coll Surg. 2007 Jan;204(1):102-17. (PMID: 17189119) Int J Mol Med. 2008 Jul;22(1):17-23. (PMID: 18575771) Life (Basel). 2023 Jan 23;13(2):. (PMID: 36836674) Acta Biomed. 2020 Mar 19;91(1):139-141. (PMID: 32191669) Gastroenterol Clin North Am. 2008 Sep;37(3):627-44, ix. (PMID: 18794000) Clin Gastroenterol Hepatol. 2013 Jun;11(6):593-603. (PMID: 23333220) J Clin Gastroenterol. 1981;3(Suppl 2):117-27. (PMID: 6798100) BMC Med Res Methodol. 2014 Nov 19;14:118. (PMID: 25407057) |
| فهرسة مساهمة: | Keywords: Hemorrhoidal disease; Sucralfate ointment; Sucralfate suppository; Symptoms; Topical medical device |
| تواريخ الأحداث: | Date Created: 20240515 Date Completed: 20240515 Latest Revision: 20240613 |
| رمز التحديث: | 20240614 |
| مُعرف محوري في PubMed: | PMC11096207 |
| DOI: | 10.1007/s00384-024-04642-7 |
| PMID: | 38750150 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder كن أول من يترك تعليقا!