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

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.

Recurrence Rates and Pharmacological Treatment for Hemorrhoidal Disease: A Systematic Review.

INTRODUCTION: Hemorrhoidal disease (HD) is characterized by prolapse of the inflamed and bleeding vascular tissues of the anal canal. Although HD is associated with a high recurrence rate, there is a lack of understanding around interventions that can reduce recurrence and improve outcomes for patients. As such, a systematic literature review (SLR) was conducted to summarize evidence on epidemiology, recurrence, and efficacy of interventions in HD. METHODS: Real-world evidence (RWE) studies evaluating the incidence, prevalence, or recurrence of HD, as well as SLRs including a meta-analytic component reporting on the efficacy of systemic or topical pharmacological treatments for adults with HD, were included. Systematic searches were conducted in MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Database of Systematic Reviews. RESULTS: The SLR identified 44 eligible publications. Consistent data were limited on the epidemiology of HD or HD recurrence. Specifically, incidence and prevalence reported across geographies were impacted by differences in data collection. Reported risk factors for HD were sedentary behavior, constipation, male gender, and age. Twenty-three RWE studies and one meta-analysis reported HD recurrence rates ranging from 0 to 56.5% following surgery or phlebotonics, with most (n = 19) reporting rates of 20% or less. In addition to time since treatment, risk factors for recurring disease were similar to those for HD in general. With respect to treatment, micronized purified flavonoid fractions significantly improved the main symptoms of HD compared to other pharmacological treatments. CONCLUSION: The SLRs did not identify any RWE studies reporting recurrence in patients receiving systemic or topical treatments, highlighting the need for future research in this area. Further, more studies are needed to understand the optimum duration of medical treatment to prevent recurrence.

Patients with hemorrhoidal disease (HD) can experience recurring disease following a period of improvement or remission. It is not well established how often this might happen, who is at greatest risk, or which treatments can reduce this risk. In this study, a systematic literature review (SLR) was conducted to summarize evidence on the occurrence and recurrence of HD, as well as treatment effectiveness. Several literature databases were searched for articles that described real-world evidence (RWE) studies reporting the epidemiology or recurrence of HD as well as published SLRs that combined the results of multiple studies (meta-analyses) on treatment for adults with HD. Forty of 2037 articles identified by the search were considered relevant, and four others identified by clinicians were also included (total = 44; 39 RWE, 5 meta-analyses). Review of the RWE articles revealed that HD epidemiology was determined differently between studies. Only 23 reported recurrence rates (up to 56.5%) after surgery or treatment with phlebotonic drugs (drugs that improve blood flow in veins). Most (19/23) reported recurrence rates of 20% or less. Risk factors for recurrence were similar to usual HD risk factors (e.g., constipation, male gender, age) in addition to time since treatment. Phlebotonic agents, including those made from plant extracts (micronized purified flavonoid fractions, MPFFs) improved hemorrhoidal symptoms compared with placebo or no treatment. In one meta-analysis, MPFF was the only phlebotonic to significantly reduce recurrence risk versus no treatment or placebo. Overall, more research is needed to compare treatments and determine optimal treatment duration to prevent recurrence. Author-narrated video abstract.

Micronized purified flavonoid fraction in the treatment of hemorrhoidal disease.

Hemorrhoidal disease (HD) is common in adults. Treatment is largely conservative, although more invasive procedures may be required. Venoactive drugs such as micronized purified flavonoid fraction (MPFF) are widely used, but a recent and comprehensive review of supporting evidence is lacking. In acute HD, MPFF can reduce HD symptoms such as bleeding, pain, anal discomfort, anal discharge and pruritus. In patients undergoing surgery, postoperative adjunct MPFF consistently reduces pain, bleeding duration and use of analgesia. MPFF treatment is appropriate and effective both as a first-line conservative treatment and as a postoperative adjunct treatment. MPFF reduces the duration of hospital stay following surgery, facilitating a return to normal activity and improving quality of life. MPFF may also prevent HD recurrence.

Hemorrhoidal disease and chronic venous insufficiency: Concomitance or coincidence; results of the CHORUS study (Chronic venous and HemORrhoidal diseases evalUation and Scientific research).

BACKGROUND AND AIM: The CHORUS study (Chronic venous and HemORrhoidal diseases evalUation and Scientific research) was conducted to provide data on patients presenting with hemorrhoidal disease (HD) in clinical practice and to explore the frequency with which it coexists with chronic venous disease (CVD) and shared risk factors. METHODS: This international, noninterventional study enrolled adult patients attending a consultation for hemorrhoidal complaints. The questionnaire completed by physicians established the subjects' demographic and lifestyle characteristics and collected information on HD grade and symptoms and signs of CVD. RESULTS: A total of 5617 patients were analyzed. Symptoms commonly reported were bleeding (71.8%), pain (67.4%), swelling (55.0%), itching (44.1%), and prolapse (36.2%). Multivariate analysis revealed the variables with the strongest association with HD severity were older age, higher CVD CEAP (Clinical manifestations, Etiologic factors, Anatomic distribution of disease, and underlying Pathophysiology) class, constipation, and male gender (all P < 0.0001). Elevated BMI was a risk factor for HD recurrence. Among women, number of births had a significant association with both HD grade and recurrence. The presence of CVD, reported in approximately half the patients (51.2%), was strongly associated with advanced grade of HD (P < 0.0001). Treatments most commonly prescribed were venoactive drugs (94.3%), dietary fiber (71.4%), topical treatment (70.3%), analgesics (26.3%), and surgery (23.5%). CONCLUSIONS: CHORUS provides a snap shot of current profiles, risk factors, and treatments of patients with HD across the globe. The coexistence of HD and CVD in more than half the study population highlights the importance of examining for CVD among patients with a hemorrhoid diagnosis, particularly when shared risk factors are present.

A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy.

PURPOSE: Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. METHODS: In the DGHAL arm (N = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm (N = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. RESULTS: Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group (p < 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group (p = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation. CONCLUSION: Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results. TRIAL REGISTRATION: clinicaltrials.gov -Identifier NCT01240772.

Perineal retraining improves conservative treatment for faecal incontinence: a multicentre randomized study.

BACKGROUND: Anal incontinence is a frequent complaint that profoundly affects quality of life. Our aim was to determine whether perineal retraining gives additional benefits to standard medical treatment. METHODS: Patients with anal incontinence and a Wexner score >4 were randomly assigned to standard conservative treatment (control) or perineal retraining, including biofeedback, in addition to standard treatments (biofeedback). Diaries, self-administered questionnaires and satisfaction scores quantified the benefits. Self-evaluated improvement was the primary outcome measure. A score ≥3 (in an improvement scale from -5 to +5) defined success. RESULTS: Overall, 157 patients were included; 80 in the control group (75% females, mean age 60.1 ± 13.2 years) and 77 in the biofeedback group (79% females, mean age 61.9 ± 10.2 years). After a 4-month follow-up, the success rate was significantly higher in the biofeedback group (57% versus 37%; p<0.021). In the biofeedback group, daily stool frequency, leakage, and faecal urgency significantly decreased, and daily non-urgent perception of stool increased. Conversely, symptomatic scores and quality of life scales did not significantly differ between groups. In a multivariate model, the adjusted odds ratio showed that perineal retraining was significantly associated with a higher chance of self-rated improvement (adjusted Odd Ratio [95%CI]: 2.34 [1.14-4.80]; p=0.021). CONCLUSIONS: Perineal retraining offers a moderate but significant benefit for patients suffering from anal incontinence.

Increased risk for nonmelanoma skin cancers in patients who receive thiopurines for inflammatory bowel disease.

BACKGROUND & AIMS: Patients with inflammatory bowel disease (IBD) who have been exposed to thiopurines might have an increased risk of skin cancer. We assessed this risk among patients in France. METHODS: We performed a prospective observational cohort study of 19,486 patients with IBD, enrolled from May 2004 to June 2005, who were followed up until December 31, 2007. The incidence of nonmelanoma skin cancer (NMSC) in the general population, used for reference, was determined from the French Network of Cancer Registries. RESULTS: Before the age of 50 years, the crude incidence rates of NMSC among patients currently receiving or who previously received thiopurines were 0.66/1000 and 0.38/1000 patient-years, respectively; these values were 2.59/1000 and 1.96/1000 patient-years for the age group of 50 to 65 years and 4.04/1000 and 5.70/1000 patient-years for patients older than 65 years. Among patients who had never received thiopurines, the incidence of NMSC was zero before the age of 50 years, 0.60/1000 for the ages of 50 to 65 years, and 0.84/1000 for those older than 65 years. A multivariate Cox regression model stratified by propensity score quintiles showed that ongoing thiopurine treatment (hazard ratio [HR], 5.9; 95% confidence interval [CI], 2.1-16.4; P = .0006) and past thiopurine exposure (HR, 3.9; 95% CI, 1.3-12.1; P = .02) were risk factors for NMSC. They also identified age per 1-year increase as a risk factor for NMSC (HR, 1.08; 95% CI, 1.05-1.11; P < .0001). CONCLUSIONS: Ongoing and past exposure to thiopurines significantly increases the risk of NMSC in patients with IBD, even before the age of 50 years. These patients should be protected against UV radiation and receive lifelong dermatologic screening.

Defecation disorders: a French population survey.

PURPOSE: Despite frequent occurrence, functional defecation disorders and related conditions have been infrequently reported in population studies. This study was designed to assess symptoms, lifestyle-behavioral changes, and medical care seeking related to functional defecation disorders in a large household community survey. METHODS: A large household community survey was conducted in 10,000 individuals aged 15 years or older. A mailed questionnaire was used to assess ten common anorectal complaints; frequency, association, impact on quality of life, and medical care seeking were quantified. RESULTS: Evaluation was obtained in 7,196 patients (3,455 males). During the previous 12-month period, 2,097 patients (29.1 percent) experienced functional defecation disorders: outlet constipation and fecal incontinence were reported in 22.4 and 16.8 percent respectively. Compared with patients with no anorectal complaint, patients with functional defecation disorders had a different gender status (females, 63.3 vs. 47.6 percent; P<0.01). Based on symptom severity, functional defecation disorders were perceived as the main anorectal complaint in 1,192 patients. In this group, emptying difficulties, unsatisfied defecation, gas, and fecal incontinence occurred at least once per month in 71.6, 56.1, 77.9, and 49 percent respectively: 66.6 percent with outlet constipation and 85.6 percent with incontinence revealed impairment in quality of life. Incontinent patients more frequently avoided medical care than those complaining of outlet constipation (67.4 vs. 46.4 percent; P<0.01). CONCLUSIONS: Functional defecation disorders concerns at least one of four French individuals. Outlet constipation and fecal incontinence frequently occur in association. Despite a low rate of patients seeking care, symptoms often are severe and related to quality of life impairment.