Evidence-based medicine and hemorrhoidal diseases: does it fit together?

L. Abramowitz1, Y. Matsuda2, C. Sobrado3, G. Weyandt4, E. OKeefe5

1. Proctological Unit, Bichat University Hospital, Paris, France 2. Colo-Proctological Institute, Matsuda Hospital, Japan 3. Rua Itapeva, Brazil 4. University Clinics Wuerzburg, Department of Dermatology, Germany 5. Global Development, Intendis GmbH, Germany

ABSTRACT

Introduction & Objectives: Hemorrhoidal disease is one of the most common conditions affecting people in developed countries. Studies evaluating the epidemiology in the USA showed that the prevalence of hemorrhoids is between 4.4% and 86%, with a peak prevalence occurring between 45 and 65 years of age. However, only few prospective randomized clinical studies have investigated medical treatments and there are substantial differences in disease management between countries. The aim of this analysis was to arrive a consensus on the value of noninvasive treatment for hemorrhoidal disease. Materials & Methods: A group of international clinical experts in proctology examined the existing clinical practice between countries and compared various national guidelines for primary care physicians on the use of topical and oral therapy in hemorrhoidal disease. Results: With a high incidence of hemorrhoids in the general population, primary care healthcare providers are more likely to encounter the disorder in everyday practice. After physical examination to confirm disease etiology, conservative treatment measures are recommended initially, avoiding a specialist referral and more invasive treatments for the patient. Also most first-line treatments have little or no evidence basis for disease management after todays requirements. Topical therapies are used for symptomatic pain relief in the early stages of hemorrhoidal disease and supportive therapy in advanced stages. Long-term prevention should be addressed with defecation regulation management and advice about diet and lifestyle changes. Surgery is only used in 10% of patients and this practice is decreasing. Various non-invasive therapies (e.g. venotonics, analgesics, astringents, antiseptics) were observed and common recommendations deflected. On this basis, a treatment algorithm for the management of hemorrhoidal disease was derived. Conclusions: Topical therapies, especially controlled therapy with combinations of topical corticosteroids and anesthetics are the cornerstone of symptomatic relief of hemorrhoidal diseases. However, further clinical studies are required to cement the empirical findings. Consensus recommendations are the first step towards improving clinical practice by providing a universal guide to clinical management of hemorrhoidal disease.

INTRODUCTION
Haemorrhoids can have a substantially negative impact on patients quality of life and social wellbeing.1 Hemorrhoidal symptoms are the most common reason for consultation in proctology. Management is essentially medical for most patients, but there are several options for self-medication. Epidemiology: The incidence of hemorrhoidal disease in the general population is largely unknown, and studies have reported a wide range of prevalence: 4.4-86%.2 However, only one third of patients with symptomatic hemorrhoids seek medical help.3 Symptoms: Generalized pain, painful defecation, severe anal itching, moist or weeping wounds and bleeding. Treatment options: Only 10% of patients undergo surgery,4 but less invasive measures are recommended initially. Topical and systemic drug therapy is possible for all hemorrhoidal pathologies and first-choice treatment is topical (corticosteroid or anesthetic). Other studies: There have been few randomized clinical studies investigating treatments for hemorrhoidal disease and there is a lack of evidence for most first-line treatments. Most therapy practices are based on clinical experience, not evidence-based medicine. Current guidelines: Although symptoms of hemorrhoidal disease overlap between countries, management strategies often differ and there are no universal guidelines. AIM OF THE PRESENT STUDY To arrive at a consensus on the effects of topical and oral treatment of hemorrhoidal disease to be used in primary care and as a first step towards the creation of evidence-based guidelines.

METHOD
A group of international experts in proctology formed a consensus panel to examine the existing clinical evidence and individual national treatment approaches for the treatment of hemorrhoidal disease in primary care, with a view to resolving existing international variations. Various topics were discussed including topical, surgical and systemic therapy, treatment options for special populations (e.g. pregnancy) and options before or after surgery.

References: 1. Johannsson H, et al. Bowel habits in haemorrhoid patients and normal subjects. Am J Gastroenterol 2005;100:401-6. 2. Abramowitz L. The management of haemorrhoidal diseases. Aliment Pharmacol Ther 2010;31(Suppl 1):211. 3. Alonso P, et al. Phlebotonics for haemorrhoids. (Protocol) Cochrane Database of Systematic Reviews 2003;1:CD004322.

RESULTS
The use of both oral and topical therapies, particularly combined topical corticosteroid-anesthetic preparations are the cornerstone of symptomatic pain relief. Long-term prevention of hemorrhoidal disease recurrence should be addressed through defecation-disorder management with diet and lifestyle changes. CLASSIFICATION AND DIFFERENTIAL DIAGNOSIS Grade1 I Symptoms and physical examination
Enlarged hemorrhoids without anal prolapse but with internal hemorrhoid bleeding Enlarged hemorrhoids on anoscopy Bleeding with prolapse on defecation that resolves spontaneously after defecation Prolapse does not reposition without manual digital reduction Hemorrhoids remain permanently prolapsed and no reduction is possible

II III IV

CONSENSUS PANEL GENERAL RECOMMENDATIONS

1. Defecation regulation is the only preventive treatment for hemorrhoid pathologies. 2. Dietary and lifestyle advice should be given as post-therapy care and patients should be advised to avoid sitting for long periods. 3. Treatment should reduce hemorrhoid-associated symptoms.

References: 1. Goligher JC. Surgery of the anus, rectum and colon, 5th edn, London: Bailliere Tindall & Cassell, 1984. 2. American Gastroenterological Association. Technical review on the diagnosis and treatment of haemorrhoids. Gastroenterology 2004;126:146373.

CONSENSUS PANEL RECOMMENDATIONS ON TOPICAL THERAPY

1. Topical local analgesics may be useful at the beginning of therapy but overall there is no indication of their general use because of their side effects. 2. Where a topical corticosteroid formulation is selected to treat pain, a fixed corticosteroidanesthetic combination is preferred. If a topical corticosteroid combination is selected to treat eczema associated with severe pain, a fixed corticosteroidanesthetic combination should be used in preference. 3. Fixed corticosteroid-anesthetic combinations reduce pain quickly and treat inflammation effectively and can be used for reducing all symptoms, especially local inflammation and swelling. Fixed corticosteroid combinations may also be used for treating anal eczema and symptomatic skin tags. 4. Topical non-combination local anesthetics are useful in cases of acute pain with hemorrhoid thrombosis when strong oral analgesics are to be avoided (e.g. pregnancy, breastfeeding) or are insufficient. Topical non-combination local anesthetics may be useful for acute fissures but they should not be used in cases of eczema or mycosis in the perianal skin. 5. Topical local antiseptics have no clinical use in the treatment of hemorrhoidal disease but they may be useful in cases associated with bacterial infection of the skin. 6. Cryptitis should not be treated with topical corticosteroids or combinations containing topical corticosteroids. 7. Topical skin protectants are useful for treating irritation or eczema exacerbated by toxins. They can also be useful after anal surgery and in cases of anal pruritis without proctological etiology. 8. Topical astringents are indicated for acute weeping eczema but should not be used in cases where folliculitis is present in the perianal skin.

CONSENSUS PANEL SPECIAL RECOMMENDATIONS

1. Acute hemorrhoid pathology requires laxatives to be prescribed in cases of (frequent) associated constipation, because a fiber diet requires several days in order to have any effect. 2. NSAIDs are considered the most effective analgesic for acute hemorrhoid thrombosis but should be avoided during pregnancy (except during the first trimester and only when used in accordance with national guidelines). NSAIDS can be prescribed for short periods during breastfeeding. 3. During pregnancy and breastfeeding, defecation regulation is important to avoid hemorrhoid disease. In case of external thrombosis (frequent during this period), local therapies such as ointment and suppositories containing corticosteroids and anesthetic seem to be particularly useful. 4. Systemic varicose therapy may be useful in persistent bleeding.

Treatment algorithm for internal hemorrhoidal disease

Patients with symptoms of internal hemorrhoidal disease

Grade I

Grade II

Grade III

Grade IV

Basic Therapy:

Fibre supplements, Defecation regulation and Topical therapy

Persistent bleeding

Prolapse (+/- bleeding)

Infrared coagulation

Infrared coagulation

+ instrumental treatment

Sclerosis

Rubber band ligation

Surgery (hemorrhoidectomy)
*If eczema is present, resolve with topical therapy prior to surgery

These consensus recommendations and algorithms provide practical diagnostic evaluation and treatment guidance for primary healthcare providers. Conservative treatments measures are recommended initially; thereafter, instrumental management in specialist care settings has a high success rate. Clinical data and further studies are needed to cement these findings in order to produce evidence-based recommendations.

CONCLUSION