An international observational study assessing conservative management in hemorrhoidal disease: results of CHORALIS (aCute HemORrhoidal disease evALuation International Study)
Publication: Journal of Comparative Effectiveness Research
Abstract
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.
Plain language summary of the results of the CHORALIS study, an international observational study assessing non-surgical treatments in hemorrhoidal disease
What is this article about?
Hemorrhoids, also called piles, are vessels located in the anus. They can cause symptoms like pain, bleeding, swelling and itching and soiling and can affect a person's quality of life. The treatment given for hemorrhoids depends on how bad they are. This study looked at how well non-surgical hemorrhoid treatments prescribed in medical practice work, by asking nearly 3600 people with hemorrhoids.
What were the results?
Most of the people who took part in the study were treated with venoactive drugs (medicines that act on the blood vessels), which were mostly micronized purified flavonoid fraction (MPFF). The results showed that the venoactive drug treatments helped to improve the symptoms of hemorrhoids and quality of life and that the treatment based on MPFF seemed to work better than another type of treatment based on a medicine called diosmin. People who took MPFF said that they felt “very much better” and their symptoms got better faster than people taking other treatments. Both the people being treated and their doctors were satisfied with the effectiveness of the hemorrhoid treatments.
What do the results mean?
Overall, the results of the study suggest that using treatments that include venoactive drugs, especially MPFF, can make a positive difference for people with hemorrhoids by reducing their symptoms and improving their quality of life.
Supplementary Material
References
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Received: 25 April 2024
Accepted: 26 July 2024
Published online: 12 August 2024
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An international observational study assessing conservative management in hemorrhoidal disease: results of CHORALIS (aCute HemORrhoidal disease evALuation International Study). (2024) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2024-0070
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