Background The aim of this study is to describe the baseline characteristics of an Italian, real-world cohort of patients with symptomatic hemorrhoidal disease (HD) and to evaluate the effectiveness and safety of phlebotonic drugs, in addition to standard of care. Methods This is a prospective, multicenter, observational cohort study (VIVI2022/01/VIVALDI, ClinicalTrials.gov number: NCT07376928) on adults with symptomatic Goligher grade I-II-III HD. The primary endpoint was the improvement in the hemorrhoidal disease symptom score (HDSS). Secondary endpoints were based on the resolution of bleeding (Giamundo score), improvement in quality of life (Short Health Scale adapted for HD), Goligher grading, Single Pile Hemorrhoid Classification (SPHC), adverse events, satisfaction with treatment, and change in treatment strategy during the 30-day observational period. Patients were evaluated by visits and questionnaires at baseline and after 30 days; at day 30, the evaluation also included the assessment of surgical indication. At day 15, patients were also interviewed through a phone call in order to verify adherence and unexpected effects. Results A total of 115 patients (70% male), with a mean (SD) age of 51.4 years and HD diagnosed since an average of 4.6 (8.3) years, were enrolled. The mean HDSS decreased from 7.8 (3.6) at baseline to 3.7 (2.6) at day 30 ( p 0.001). Bleeding was reported by 94.8% of patients at baseline vs. 58.3% at day 30 ( p 0.0001). At day 30, 39.1% of patients displayed a Goligher downstaging. The mean SHS-HD score decreased from 11.29 (3.8) at baseline to 7.56 (2.8) at day 30 ( p 0.0001). The average number of piles per patient was 2.72 (1.6) at baseline and 2.51 (1.3) at day 30 mean change: −0.32 (1.42); p = 0.0026. Only one patient (1%) reported one non-serious adverse event (moderate abdominal distension), which was deemed not related to the studied drug and did not lead to treatment discontinuation during the 30-day follow-up. Treatment was deemed satisfactory by 73% of patients, with none discontinuing within day 30. Conclusion A 30-day course of conservative therapy with oral phlebotonics was found to be safe and effective in improving a variety of clinical measures in adults with symptomatic Goligher grade I-II-III HD.
Giani et al. (Tue,) studied this question.