An international observational study assessing conservative management in hemorrhoidal disease: results of CHORALIS (aCute HemORrhoidal disease evALuation International Study).

Autor: Godeberge P; Department of Gastroenterology, Institut Mutualiste Montsouris, Paris Descartes University, 42 Bd Jourdan, 75014, Paris, France., Csiki Z; University of Debreceni, Faculty of Medicine, Nagyerdei krt. 94, 4032, Debrecen, Hungary.; Debreceni Clinic, Nagyerdei krt. 98, 4032, Debrecen, Hungary., Zakharash M; Department of Surgery, No.1 Bogomolets National Medical University, Tarasa Shevchenko Blvd, 13, Kyiv, Ukraine., Opot EN; University of Nairobi, Faculty of Health Sciences, Department of Surgery, Kenyatta National Hospital, PO Box 19676-00202, Nairobi, Kenya., Shelygin YA; Ryzhikh National Medical Research Centre of Coloproctology, Ulitsa Salyama Adilya, 2, Moscow, 123423, Russia., Nguyen TT; University Medical Center, 215 Hong Bang Street, Ward 11, District 5, Ho Chi Minh, Vietnam., Amir A; International Medical Center Hospital, Hail Street, Al-Ruwais, PO Box 2172 Jeddah 21451, Saudi Arabia., Konaté I; Faculty of Health Sciences University Gaston Berger, PO Box 234, Saint-Louis, Senegal., Momoh M; Department of Surgery, University of Benin, PMB1111 Ugbowo Lagos Express Road, Benin, Nigeria., Chirol J; Servier Medical Affairs, 35 rue de Verdun, 92284 Suresnes Cedex, France., Blanc-Guillemaud V; Servier Medical Affairs, 35 rue de Verdun, 92284 Suresnes Cedex, France., Donglin R; The Sixth Affiliated Hospital of Sun Yat-Sen University, 17 Shougouling Rd, Tianhe District, Guangzhou, Guangdong Province, 510507, China.
Jazyk: angličtina
Zdroj: Journal of comparative effectiveness research [J Comp Eff Res] 2024 Oct; Vol. 13 (10), pp. e240070. Date of Electronic Publication: 2024 Aug 12.
DOI: 10.57264/cer-2024-0070
Abstrakt: Aim: Real-world evidence on the management of hemorrhoidal disease (HD) is limited. This international study collected clinical practice data on the effectiveness of conservative treatments for acute HD on symptoms and quality of life (QoL), providing perspectives of treatment modalities from different continents. Patients & methods: The 4-week observational prospective CHORALIS study involved adult outpatients consulting for spontaneous complaints of hemorrhoids (graded using Goligher classification) and prescribed conservative treatments according to usual clinical practice. Assessments were: anal pain/discomfort (visual analog scale [VAS]), other signs/symptoms (patient questionnaire), Patient Global Impression of Change (PGI-C) questionnaire and disease-specific QoL (HEMO-FISS-QoL questionnaire). Results: Of 3592 participants, 3505 were analyzed (58.4% male; age 40.5 ± 13.7 years; history of HD in 48.4%; 72.1% Goligher grade I and II). Pain and discomfort were the most common symptoms. Most treatments were venoactive drugs (VADs; 90.9%), particularly micronized purified flavonoid fraction (MPFF; 73.7%) and diosmin (14.6%). All VAD-based therapies improved signs/symptoms (number/intensity/frequency of pain, discomfort, bleeding, swelling, itching and soiling) and QoL. MPFF was associated with a significantly greater proportion of patients with no symptoms (48.8 vs diosmin 34.4%, p < 0.001), pain disappearance (69.7 vs diosmin 52.8%, p < 0.001), treatment impact at 1 week rated on PGI-C as 'very much better' (30.5 vs diosmin 17.9%, p < 0.001) and shorter times to improvement (mean ± SD 3.9 ± 1.5 days vs diosmin 4.2 ± 1.7 days). Conclusion: In this prospective real-world study of patients with acute HD, conservative therapies consisting mainly of VADs, including MPFF, improved the clinical signs and symptoms of disease, as well as QoL. This study evidence supports clinical advantages associated with VADs, mostly MPFF, for effectively managing acute HD.
Databáze: MEDLINE