Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial

Author(s): Alessandro Sturiale*, Gaetano Gallo, Luigi Brusciano, Concetta Cacace, Danilo Cafaro, Felipe Celedon Porzio, Gabriele Naldini

Journal Name: Reviews on Recent Clinical Trials

Volume 15 , Issue 2 , 2020

Become EABM
Become Reviewer

Graphical Abstract:


Abstract:

Introduction: Hemorrhoidal Disease (HD) is a very common anorectal disorder that affects millions of people around the world and represents a major medical and socioeconomic problem. The aim of the present study was to assess the safety and efficacy of Proctosoll Allevia® in patients affected by symptomatic HD in comparison with the results obtained from a control group.

Materials and Methods: From January to February 2019, all the patients referred to the outpatient clinic of Rajalakshmi Hospital, who were complaining of first or second degree hemorrhoidal symptoms, were enrolled in the study. They were randomly assigned to either of the 2 arms. Group 1: patients were treated with the Proctosoll Allevia® and were under a controlled diet. Group 2: patients were only under a controlled diet without any treatment - control group.

Results: A total of 51 subjects were screened and 45 (13 F- 32 M) enrolled in the study. All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet. No major adverse events associated with the use of the new product were recorded.

Conclusion: The treatment of I-II degree symptomatic HD with Proctosoll Allevia® has demonstrated to be promising with a good profile of tolerability, safety and efficacy.

Keywords: Cortisone-free cream, hemorrhoidal prolapse, hemorrhoids, Proctosoll Allevia®, safety and efficacy, randomized clinical trial.

[1]
Abramowitz L, Benabderrahmane M, Pospait D, Philip J, Laouénan C. The prevalence of proctological symptoms amongst patients who see general practitioners in France. Eur J Gen Pract 2014; 20(4): 301-6.
[http://dx.doi.org/10.3109/13814788.2014.899578] [PMID: 24702041]
[2]
Gallo G, Sacco R, Sammarco G. Epidemiology of hemorrhoidal disease. Coloproctology 2018; 2: 3-7.
[http://dx.doi.org/10.1007/978-3-319-53357-5_1]
[3]
Pata F, Sgrò A, Ferrara F, Vigorita V, Gallo G, Pellino G. Anatomy, physiology and pathophysiology of haemorrhoids. Rev Recent Clin Trials 2020. (E-pub Ahead of Print)
[http://dx.doi.org/10.2174/1574887115666200406115150] [PMID: 32250229]
[4]
Lohsiriwat V. Hemorrhoids: From basic pathophysiology to clinical management. World J Gastroenterol 2012; 18(17): 2009-17.
[http://dx.doi.org/10.3748/wjg.v18.i17.2009] [PMID: 22563187]
[5]
Mehanna D, Platell C. Investigating chronic, bright red, rectal bleeding. ANZ J Surg 2001; 71(12): 720-2.
[http://dx.doi.org/10.1046/j.1445-1433.2001.02277.x] [PMID: 11906386]
[6]
Gralnek IM, Ron-Tal Fisher O, Holub JL, Eisen GM. The role of colonoscopy in evaluating hematochezia: a population-based study in a large consortium of endoscopy practices. Gastrointest Endosc 2013; 77(3): 410-8.
[http://dx.doi.org/10.1016/j.gie.2012.10.025] [PMID: 23294756]
[7]
Newman J, Fitzgerald JEF, Gupta S, von Roon AC, Sigurdsson HH, Allen-Mersh TG. Outcome predictors in acute surgical admissions for lower gastrointestinal bleeding. Colorectal Dis 2012; 14(8): 1020-6.
[http://dx.doi.org/10.1111/j.1463-1318.2011.02824.x] [PMID: 21910819]
[8]
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.
[http://dx.doi.org/10.1007/s10151-020-02149-1] [PMID: 31993837]
[9]
Sturiale A, Fabiani B, Menconi C, et al. Long-term results after stapled hemorrhoidopexy: A survey study with mean follow-up of 12 years. Tech Coloproctol 2018; 22(9): 689-96.
[http://dx.doi.org/10.1007/s10151-018-1860-8] [PMID: 30288629]
[10]
Margetis N. Pathophysiology of internal hemorrhoids. Ann Gastroenterol 2019; 32(3): 264-72.
[http://dx.doi.org/10.20524/aog.2019.0355] [PMID: 31040623]
[11]
Loder PB, Kamm MA, Nicholls RJ, Phillips RKS. Haemorrhoids: pathology, pathophysiology and aetiology. Br J Surg 1994; 81(7): 946-54.
[http://dx.doi.org/10.1002/bjs.1800810707] [PMID: 7922085]
[12]
Surjushe A, Vasani R, Saple DG. Aloe vera: A short review. Indian J Dermatol 2008; 53(4): 163-6.
[http://dx.doi.org/10.4103/0019-5154.44785] [PMID: 19882025]
[13]
Khubchandani ITH-C. Lin, D.-L. Ren, Q.-L. He, H. Peng, S.-K. Xie, D. Su, X.-X. Wang: Partial stapled hemorrhoidopexy versus circular stapled hemorrhoidopexy for grade III-IV prolapsing hemorrhoids: a two-year prospective controlled study. Tech Coloproctol 2012; 16(5): 345.
[http://dx.doi.org/10.1007/s10151-012-0866-x] [PMID: 22936580]
[14]
Sturiale A, Fabiani B, Menconi C, Cafaro D, Porzio FC, Naldini G. Stapled surgery for hemorrhoidal prolapse: From the beginning to the modern times. Rev Recent Clin Trials 2020. (E-pub Ahead of Print)
[http://dx.doi.org/10.2174/1574887115666200310164519] [PMID: 32156241]
[15]
Cafaro D, Sturiale A, Fortuna V, et al. Clinical effect of the bergamot- derived gel ( Benebeo gel ® ) associated with mesalazine for the treatment of anitis and proctitis 2018; 1: 1-3.
[http://dx.doi.org/10.15761/TGP.1000110]
[16]
Sammarco G, Trompetto M, Gallo G. Thrombosed External Haemorrhoids: A Clinician’s Dilemma. Rev Recent Clin Trials 2019; 14(4): 232-4.
[http://dx.doi.org/10.2174/1574887114666190927163646] [PMID: 31560294]
[17]
Efficacy of a standardized herbal preparation ( Roidosanal ® ) in the treatment of hemorrhoids : A randomized, controlled, open-label multicentre 2014; 5: 117-24.
[http://dx.doi.org/10.4103/0975-9476.131732]
[18]
Gan T, Liu Y-D, Wang Y, Yang J. Traditional Chinese Medicine herbs for stopping bleeding from haemorrhoids. Cochrane Database Syst Rev 2010; 10 CD006791
[http://dx.doi.org/10.1002/14651858.CD006791.pub2] [PMID: 20927750]
[19]
Rahimi R, Abdollahi M. Evidence-based review of medicinal plants used for the treatment of hemorrhoids. Int J Pharmacol 2013; 9: 1-11.
[http://dx.doi.org/10.3923/ijp.2013.1.11]
[20]
Dehdari S, Hajimehdipoor H, Esmaeili S, Choopani R, Mortazavi SA. Traditional and modern aspects of hemorrhoid treatment in Iran: A review. J Integr Med 2018; 16(2): 90-8.
[http://dx.doi.org/10.1016/j.joim.2018.01.002] [PMID: 29526242]
[21]
Rahman S, Carter P, Bhattarai N. aloe vera for tissue engineering applications. J Funct Biomater 2017; 8(1): 6.
[http://dx.doi.org/10.3390/jfb8010006] [PMID: 28216559]
[22]
Lin T-K, Zhong L, Santiago JL. Anti-Inflammatory and skin barrier repair effects of topical application of some plant oils. Int J Mol Sci 2017; 19(1): 70.
[http://dx.doi.org/10.3390/ijms19010070] [PMID: 29280987]


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 15
ISSUE: 2
Year: 2020
Page: [152 - 159]
Pages: 8
DOI: 10.2174/1574887115666200421110107
Price: $65

Article Metrics

PDF: 12
HTML: 1