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

These are peer-reviewed supplementary materials for the article 'An international observational study assessing conservative management in hemorrhoidal disease: results of CHORALIS (aCute HemORrhoidal disease evALuation International Study)' published in the Journal of Comparative Effectiveness Research.Table S1: Study inclusion and exclusion criteriaAim: 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.

本数据集为发表于《比较疗效研究杂志》的论文《评估痔疮疾病保守治疗的国际观察性研究：CHORALIS（急性痔疮疾病评估国际研究）结果》的同行评审补充材料。表S1：研究纳入与排除标准。研究目标：痔疮疾病（HD）管理方面的现实世界证据有限。本研究收集了来自不同大陆的临床实践数据，以评估保守治疗急性HD对症状和生活质量（QoL）的有效性，并提供了不同治疗方式的治疗视角。患者与方法：为期四周的观察性前瞻性CHORALIS研究纳入了因痔疮（采用Goligher分级进行分级）自发就诊的成年门诊患者，并根据常规临床实践接受保守治疗。评估内容包括：肛门疼痛/不适（视觉模拟评分量表 [VAS]）、其他体征/症状（患者问卷调查）、患者总体印象变化（PGI-C）问卷以及疾病特异性生活质量（HEMO-FISS-QoL）问卷。结果：在3592名参与者中，3505名被纳入分析（男性占58.4%，平均年龄40.5±13.7岁；48.4%有HD病史；72.1%为Goligher分级I级和II级）。疼痛和不适是最常见的症状。大多数治疗方法为静脉活性药物（VADs；90.9%），特别是微细化纯化黄酮类化合物（MPFF；73.7%）和二氢黄酮（14.6%）。所有基于VADs的治疗均改善了体征/症状（疼痛、不适、出血、肿胀、瘙痒和污染次数/强度/频率）和生活质量。MPFF与症状消失比例显著更高（MPFF组48.8% vs 二氢黄酮组34.4%，p < 0.001）、疼痛消失（MPFF组69.7% vs 二氢黄酮组52.8%，p < 0.001）、在PGI-C问卷中评价为“显著改善”的比例更高（MPFF组30.5% vs 二氢黄酮组17.9%，p < 0.001）以及改善时间更短（平均±标准差3.9±1.5天 vs 二氢黄酮组4.2±1.7天）。结论：在本项针对急性HD患者的前瞻性现实世界研究中，主要由VADs组成的保守疗法，包括MPFF，改善了疾病的临床体征和症状，以及生活质量。本研究证据支持VADs，尤其是MPFF，在有效管理急性HD方面的临床优势。