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

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.

Keywords: hemorrhoidal disease; micronized purified flavonoid fraction; patient satisfaction; quality of life; venoactive drugs.

Figure 1.. Symptoms in the overall population at visit 0.

Figure 2.. Proportion of participants with symptom and severity of pain and discomfort by grade of hemorrhoidal disease in the overall population at visit 0.

VAS: Visual analog scale.

Figure 3.. Prescribed treatments at visit 0, presented as proportion of individuals receiving each treatment.

VAD: Venoactive drug.

Figure 4.. Effect of venoactive drugs on different catergories.

(A) Number of symptoms. (B) Severity of pain. (C) Severity of discomfort. (D) Quality of life. HEMO-FISS-QoL: HEMOrrhoid and FISSure Quality of Life scale, SD: Standard deviation; V: Visit; VAS: Visual analog scale.

Figure 5.. Effectiveness of micronized purified flavonoid fraction-based treatment versus diosmin-based treatment.

(A) Percentage of participants ‘very much improved’ according to the PGI-C at V1 and V2. (B) Percentage of participants with pain and discomfort resolution at V2. (C) Percentage of participants with no symptoms at V2. (D) Participant satisfaction with treatment. MPFF: Micronized purified flavonoid fraction; PGI-C: Patient Global Impression of Change; V: Visit; VAS: Visual analog scale.