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Treatment of Hemorrhoids - What Meta-Analysis says
Hemorrhoidal disease (HD) is one of the most common anorectal conditions affecting over 50% of adults worldwide [1]. The majority of patients with HD are successfully treated with medical treatment. Micronized Purified Flavonoid Fraction (MPFF) with its significant anti-inflammatory, antioxidant, and venoprotective actions have been reported as a significant treatment for acute HD [2].
Hemorrhoidal disease occurs when hemorrhoids become swollen with venous blood due to several risk factors like straining to attain complete evacuation, inadequate fiber intake, or prolonged lavatory sitting [3]. External HD occurs due to swelling of the external perianal vasculature and is therefore mostly associated with symptoms of pain and pruritus, and occasionally bleeding or thrombosis. Internal HD occurs when the internal hemorrhoids swell and slide toward the anus, causing chronic symptoms of Internal Hemorrhoids that classically include anal bleeding during defecation, which is painless and stops naturally at the end of straining to defecate.
In this article, we discuss a 2020 published meta-analysis, its review on Hemorrhoidal Disease as well as the effective treatment options available. This systematic review and meta-analysis sought to evaluate the efficacy of micronized purified flavonoid fraction(MPFF) in comparison with placebo or no treatment in patients with hemorrhoidal disease (HD).
META-ANALYSIS CHARACTERISTICS
Out of 497 records, the researchers included 11 articles for systematic reviews and only 4 for meta-analysis. The included studies reported bleeding, pain, pruritus, and anal discharge or leakage as endpoints. Overall patient improvement, hospitalization duration after a surgery, anal discomfort, tenesmus, edema, and relapse of HD were some other included endpoints in the study.
The study population included patients with all grades of hemorrhoidal disease of all ages and both males and females with their mean age being 33 and 57 years. It also included pregnant or postpartum women and also patients who have undergone surgery for hemorrhoidal disease.
The meta-analysis study included only published randomized controlled trials (RCTs) that reported the effect of MPFF in alleviating the signs and symptoms of patients with acute HD or after hemorrhoidectomy.
INTERVENTION EFFECTS: WHAT DOES DATA CONVEY?
Bleeding
All four studies included in the meta-analysis reported significant effects of MPFF on reducing bleeding in acute HD patients.
● Reduced Bleeding on the 7th day in the MPFF-treated group of patients compared to the placebo group [4,6,7,11].
● Improved bleeding after hemorrhoid surgery with MPFF treatment in all four studies.
● MPFF treatment lead to a complete cessation of bleeding after hemorrhoid surgeries
Two previous meta-analyses reported similar effects of MPFF on bleeding[4, 11, 13]. The findings suggest MPFF be efficient and quick in reducing bleeding in acute HD patients.
PAIN
● Pain improved significantly with MPFF treatment at day 7 compared to placebo [6,7]
● MPFF treatment compared to placebo provided more relief from pain on the 7th day as reported by a pooled meta-analysis of two studies.
● Significant improvement in pain following hemorrhoidectomy was reported by three studies [5, 10, 15].
Pruritus
● Pruritus significantly improved with MPFF as reported by two studies [8,9]
● Pruritus improved on the 60th day in 86% of patients who received MPFF compared to 58% of patients who received placebo [8, 9].
Anal Discomfort
● One study confirmed significant improvement in anal discomfort with MPFF compared to placebo at day 7 [6, 7]
Tenesmus
● In acute HD, tenesmus was improved on the 60th day in 98% of the patients treated with MPFF compared to 50% of the placebo patients [8, 9].
● Tenesmus scores were significantly lower with MPFF than with no treatment over days 1–3 and at day 60 following hemorrhoidectomy[10].
Anal Discharge or Leakage
● Three studies reported that anal discharge in acute HD significantly improved with MPFF compared to placebo.
● The proportion of improved patients was significantly greater with MPFF (97%) than with placebo (54%) at day 60 [8, 9].
● A pooled meta-analysis of two studies for the presence or absence of anal discharge or leakage after treatment for acute HD was reported in favor of MPFF [4, 6, 7].
● The results indicate that MPFF treatment is beneficial in reducing discharge and leakage.
Edema
● Significant improvement in edema with MPFF treatment in acute HD was reported by two studies.
● Edema improved significantly in 94% of the patients treated with MPFF as compared to only 58% treated with placebo after 7 days of treatment [7].
Overall Improvement
● More patients were satisfied with MPFF than with placebo after treatment [8, 9] [12].
● Overall efficacy of MPFF treatment was reported as good or excellent by a significant number of patients treated with MPFF (75.6%) than with placebo (39%) [4].
Other Outcomes
● The use of topical and systemic analgesics provided statistically significant beneficial effects with MPFF treatment in two out of three studies.
● MPFF treatment significantly reduced the use of topical and systemic analgesics in acute HD[6, 7].
● Hospital length-of-stay after hemorrhoidectomy was significantly shorter with MPFF[5].
● Two studies out of three reported statistically significant beneficial effects of MPFF treatment in recurrent acute HD. MPFF taken as preventive treatment reduced episodes of bleeding relapse in acute HD by 24% over 90 days compared to placebo treatment[11].
MPFF was well tolerated and no serious side effects were reported in any of the studies. Only in a few cases, mild secondary effects like gastralgia, diarrhea, and abdominal pain were reported.
Analyzing the beneficial effects of MPFF in managing HD
1. Consistent benefits were reported for MPFF treatment in patient-assessed overall improvement and satisfaction either in acute HD or after hemorrhoidectomy.
2. In general, qualitative analysis of the studies indicated that MPFF treatment was beneficial for the most important signs and symptoms of acute HD and for post-hemorrhoidectomy patients.
3. The results strongly suggest that patients consider MPFF to be an effective treatment providing quick relief for acute HD and improving the quality of the recovery period after hemorrhoidectomy.
4. Reduction in the need for concomitant analgesic use, shorter hospital stays after hemorrhoidectomy, and prevention of relapses have been identified as indirect benefits of treatment with MPFF in some studies.
CONCLUSION
The published results strongly suggest that patients consider MPFF as an effective treatment option providing quick relief for acute HD and improving the quality of the recovery period after hemorrhoidectomy. Lesser need for simultaneous analgesic use, shorter hospital stays after hemorrhoidectomy, and prevention of relapses have been identified as indirect benefits of treatment with MPFF. Overall, qualitative and quantitative analyses report MPFF treatment to improve the most important signs and symptoms of the hemorrhoidal disease including bleeding, pain, pruritus, tenesmus, and anal discharge.
This Piles Day, Let's Vouch to strike the Core of Hemorrhoidal Disease. To get more information about Piles / Hemorrhoids ranging from Diagnosis to Management click on the Link Below.
https://medicaldialogues.in/world-piles-day
References:
1. Júnior, C. W. S., de Almeida Obregon, C., & e Sousa, A. H. D. S. (2020). A New Classification for Hemorrhoidal Disease: The Creation of the "BPRST" Staging and Its Application in Clinical Practice. Annals of Coloproctology, 36(4), 249.
2. Sheikh P, Lohsiriwat V, Shelygin Y. Micronized Purified Flavonoid Fraction in Hemorrhoid Disease: A Systematic Review and Meta-Analysis. AdvTher. 2020;37(6):2792-2812. doi:10.1007/s12325-020-01353-7
3. Kaidar-Person, O., Person, B., &Wexner, S. D. (2007). Hemorrhoidal disease: a comprehensive review. Journal of the American College of Surgeons, 204(1), 102-117.
4. Jiang ZM, Cao JD. The impact of micronized purified flavonoid fraction on the treatment of acute haemorrhoidal episodes. Curr Med Res Opin. 2006;22(6):1141–1147. doi: 10.1185/030079906X104803.
5. Colak T, Akca T, Dirlik M, Kanik A, Dag A, Aydin S. Micronized flavonoids in pain control after hemorrhoidectomy: a prospective randomized controlled study. Surg Today. 2003;33(11):828–832. doi: 10.1007/s00595-003-2604-5.
6. Cospite M. Double-blind, placebo-controlled evaluation of clinical activity and safety of Daflon 500 mg in the treatment of acute hemorrhoids. Angiology. 1994;45(6 Pt 2):566–573.
7. Cospite M. Double blind placebo controlled evaluation of clinical activity and safety of Daflon 500 mg in the treatment of acute haemorrhoids. Phlebology. 1994
8. Godeberge P. Daflon 500 mg is significantly more effective than placebo in the treatment of haemorrhoids. Phlebology. 1992;7(Suppl. 2):61–63.
9. Godeberge P. Daflon 500 mg in the treatment of hemorrhoidal disease: a demonstrated efficacy in comparison with placebo. Angiology. 1994;45(6 Pt 2):574–578.
10. La Torre F, Nicolai AP. Clinical use of micronized purified flavonoid fraction for treatment of symptoms after hemorrhoidectomy: results of a randomized, controlled, clinical trial. Dis Colon Rectum. 2004;47(5):704–710. doi: 10.1007/s10350-003-0119-1.
11. 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. doi: 10.1046/j.1365-2168.2000.01448.x.
12. Vajrabukka T, Rojanasakul A, Vathanophas V, et al. Therapeutic activity of Daflon 500 mg® in acute episodes of hemorrhoids. Chula Med J. 1994;38(2):77–83.
13. Aziz Z, Huin WK, BadrulHisham MD, Tang WL, Yaacob S. Efficacy and tolerability of micronized purified flavonoid fractions (MPFF) for haemorrhoids: a systematic review and meta-analysis. Complement Ther Med. 2018;39:49–55. doi: 10.1016/j.ctim.2018.05.011.
14. Dimitroulopoulos D, Tsamakidis K, Xinopoulos D, Karaitianos I, Fotopoulou A, Paraskevas E. Prospective, randomized, controlled, observer-blinded trial of combined infrared photocoagulation and micronized purified flavonoid fraction versus each alone for the treatment of hemorrhoidal disease. ClinTher. 2005;27(6):746–54.
15. Lee HW, Lee WY, Chun HK. Clinical effects of Venitol on complications after hemorrhoidectomy prospective randomized and placebo-controlled trial. J Korean SocColoproctol. 1998;14(4):761–6.
Dr. Parvez Sheikh MBBS, MS, FACRSI, is the head of the Colorectal Department - Saifee Hospital, Mumbai. He is also Consultant Colorectal Surgeon at Apollo Spectra Hospital, Mumbai. Earlier he was the President of the Asia Pacific Federation of Coloproctology.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751