EFFICACY AND SAFETY OF FLAVONOIDS IN ADULT PATIENTS WITH HEMORRHOIDS: A SYSTEMATIC REVIEW
Author(s)
Ortega Callejas G1, Soto-Molina H2, Escobar Juárez Y2, Martinez Samano E2
1HS Estudios Farmacoeconómicos S.A. de C.V., Mexico, DF, Mexico, 2HS Estudios Farmacoeconómicos S.A. de C.V., Mexico City, Mexico
OBJECTIVES: To conduct a systematic review of the efficacy and safety of flavonoids versus the treatments currently available in the Health System of Mexico, in adult patients with hemorrhoids since the true benefits are still unclear. METHODS: A systematic review by Cochrane methodology was carried out in PubMed, Cochrane, LILACs, Nieto Editores, Imbiomed and Medigraphic to identify randomized controlled trials (RCT) and meta-analysis (MA) of flavonoids, until November 27, 2019, using placebo, lidocaine hydrocortisone, indomethacin, benzonatate or mesalazine as comparators; and also applying a filter by language restricted to English or Spanish. The risk of bias was evaluated by PRISMA and CONSORT. RESULTS: Two hundred and sixty six RCT were evaluated by title out of 350 identified, then 7 were evaluated in full text and finally 2 were included. Both, the MA (N= 343) and the additional RCT (N= 134) report a statistically significant difference between flavonoids vs placebo, in the improvement of bleeding (RR 1.46; 95% CI 1.10–1.93, I2= 60%; p = 0.008 and Chi-square = 5.9; p = 0.015 respectively), in contrast to what is concluded regarding pain improvement (RR 2.38; 95% CI 0.22–25.29; p = 0.47 and Chi-square = 16.9; p <0.0001 respectively). There was also no significant difference in adverse events (RR 0.62; 95% CI 0.30–1.27; p = 0.71). With respect to the quality of evidence, it was identified a high risk of bias in the individual studies due to methodologic heterogeneity. CONCLUSIONS: The lack and low quality of evidence supporting the use of flavonoids for the routine treatment of hemorrhoid symptoms does not allow to conclude their efficacy and safety. It is necessary to conduct RCT with better design.
Conference/Value in Health Info
2020-05, ISPOR 2020, Orlando, FL, USA
Value in Health, Volume 23, Issue 5, S1 (May 2020)
Code
PDG57
Topic
Clinical Outcomes, Epidemiology & Public Health, Health Service Delivery & Process of Care
Topic Subcategory
Comparative Effectiveness or Efficacy, Disease Management, Public Health, Safety & Pharmacoepidemiology
Disease
Drugs, Gastrointestinal Disorders