Perspectives on hemorrhoids and their management among gastroenterologists across India: findings from in-clinic questionnaire-based survey studies

INTRODUCTION

Hemorrhoids or piles, are clusters of muscle, elastic fibers and enlarged blood vessels in the anal canal, often causing pain and bleeding. Managing hemorrhoids clinically is challenging due to their potential for long-term development and recurrence. The treatments range from lifestyle changes and over-the-counter remedies to surgical procedures, but they often have limited success in preventing recurrence. Delays in seeking specialized care from gastroenterologists due to stigma and logistical barriers usually result in disease progression and complications by the time patients receive advanced treatment.¹ Hemorrhoids can affect all ages and both sexes equally, with an estimated prevalence of 75% in India.^2,3 Symptomatic hemorrhoids are of interest to coloproctologists and are also encountered in gynecology, gastroenterology, urology and family medicine. It remains one of the most frequently encountered ailments in the general population in routine clinical settings across India. Hemorrhoid symptoms are often initiated by painless, bright red blood covering the stool and the sensation of impacted stool. Patients may also experience perineal itching due to the presence of mucus discharge and fecal soiling. Veins generally have a thin wall that expands or enlarges in response to elevated pressure. Therefore, any increase in abdominal pressure that puts more strain on the rectal veins due to pregnancy, obesity or repetitive straining at the defecation causes inappropriate blood collection and outflow.⁴

In the acute bleeding of internal hemorrhoids, one of the pathogenic processes implicated is the stagnation and stasis of blood in the vascular plexuses of the prolapsed anal cushions. Stasis has also been demonstrated to activate white blood cells to release inflammatory mediators and cause an inflammatory response, leading to increased permeability, fragility and vessel wall necrosis. The anal cushions are, therefore, easily injured by the passage of stool and bleeding. Other contributory factors are the edema and subsequent hyperplasia of underlying structures. Prominent among the symptoms complex of hemorrhoids are bleeding, prolapse during defecation, occasional pain, excessive mucus discharge and pruritus around the anus.⁴

The initial goal of managing bleeding hemorrhoids is to lessen the symptoms, which include bleeding, pain, itching and discomfort in the anus. If the symptoms are mild, first or second-degree hemorrhoids can typically be managed conservatively. Referral is necessary if symptoms, particularly bleeding or discomfort, are severe. Surgery is generally needed for hemorrhoids that are third or fourth-degree.¹

The treatment options for bleeding hemorrhoids range from pharmacological drugs like Euphorbia prostrata, flavonoids (such as diosmin and hesperidin), calcium dobesilate and herbal remedies like witch hazel and aloe vera, to non-surgical and surgical interventions such as infrared photocoagulation, rubber band ligation, injection sclerotherapy, laser treatment, cryotherapy and hemorrhoidectomy.^5,6 However, these treatments have varying effectiveness levels and carry the risk of symptom recurrence. Therefore, combination therapy is often favored to address multiple symptoms simultaneously, thereby improving overall efficacy while minimizing the limitations of individual treatments. This results in comprehensive symptom relief and better patient outcomes.

Additionally, considering the importance of the route of administration, oral medications target systemic inflammation, while topical applications offer direct relief to affected areas, emphasizing the necessity for further research to develop more effective treatment options.⁷ Euphorbia prostrata dry extract under brand name Sitcom is known as the “first in the world innovations” launched in India in 2008 after receiving approval from the Drug Controller General of India (DCGI).⁸ It is an annual herb traditionally used to address various ailments such as asthma, diabetes mellitus, bloody dysentery and sores for ages. Its positive effects on hemorrhoids stem from multiple mechanisms, including enhancing venous tone, promoting lymphatic drainage, safeguarding capillary bed microcirculation, suppressing inflammatory responses and decreasing capillary permeability.⁹

It is speculated that the analgesic, anti-inflammatory and antioxidant activity of various flavonoid components of EP extract may contribute to the healing of inflammatory tissue damage in hemorrhoidal conditions.¹⁰ A standardized extract of EP has undergone preclinical safety assessments, revealing no adverse effects on cardiovascular, respiratory, central nervous or gastrointestinal systems.⁸

In the present questionnaire-based "GUTWIN" Survey, we aim to assess the real-world perspectives of demographic characteristics and practical approaches utilized by gastroenterologists in managing hemorrhoid patients (Survey 1 study) and treating patients with bleeding hemorrhoids (Survey 2 study) with current understandings of in-clinic usage of EP.

METHODS

Survey design and participants

Two cross-sectional, questionnaire-based, real-world surveys were conducted between January and March 2023 and July and September 2023 that involved 325 gastroenterologists from various regions of India. The first survey focused on the demographic characteristics and in-clinic management of hemorrhoid patients, while the second survey focused on patients specifically dealing with bleeding hemorrhoids with the view of gastroenterologists on EP usage. Both the surveys were conducted at various locations in India, by reaching out to various gastroenterologist. The inclusion criteria for participating gastroentrologist were age in the range of 40-60 years, having more than 5 years of clinical experience, practicing in private clinics, nursing homes and hospitals.

Gastroentrologist were furthers chosen based on their qualifications and clinical experience in the management of hemorrhoids. The exclusion criteria were gastroenterologist with less than 5 years of experience, those outside the specified age range or without relevant qualifications in gastroenterology and who did not practice hemorrhoids management were excluded. Surveys were in-clinic observational research, which utilized digitally enabled questionnaires, with well-designed 18 questions in Survey 1, 17 questions in survey 2 for data collection and the data was represented in percentages. The methodology for data analysis remained consistent across all centers in India. The surveys did not involve any intervention or patients; therefore, no ethics committee approval was required.

Survey outcomes

The questions in both surveys aimed to gather information on the following.

Percentage of patients visiting out-patient department (OPD) per month. Signs, symptoms and complications of hemorrhoids. Reasons behind bleeding hemorrhoids. Complications and co-morbidities associated with bleeding hemorrhoids. Preferences of gastroenterologists regarding pharmacological interventions for internal hemorrhoid management. Preferences of gastroenterologists for oral medications, as well as medications containing flavonoids. Effectiveness of combination therapy containing Euphorbia prostrata+Calcium Dobesilate in managing bleeding haemorrhoids.

Data analysis

The data was analyzed and expressed as a percentage for all the parameters using the Microsoft Excel program 2016.

RESULTS

The survey utilized a thorough and well-structured questionnaires, conducting individual interviews with 325 gastroenterologists. The proportion of participant gastroenterologist were 325 (100%), with a distribution almost similar across the north 57 (17.54%), central 60 (18.46%) and east 60 (18.46%) zones. The maximum participation was from the south 74 (22.77%) and west 74 (22.77%) zones.

Results revealed that 85% of individuals seeking treatment for hemorrhoids belonged to the age group of 40 to 60 years.

Percentage of patients with bleeding hemorrhoids visiting out-patient department per month

Approximately 40% of gastroenterologists manage 10 to 20 cases of bleeding hemorrhoids each month in the outpatient department (Figure 1). Figure 2 illustrates the common grades of internal hemorrhoids seen in patients. 25% of the patients suffers from Grade-1 hemorrhoids. 45% of the patients suffers from Grade-2 hemorrhoids20% of the patients suffers from Grade-3 hemorrhoids. 10% of the patients suffers from Grade-4 hemorrhoids.

Signs, symptoms and complications observed in hemorrhoids patients during OPD visits

Based on epidemiological trends, an estimated 39% of gastroenterologists agreed that increased abdominal pressure accounted for bleeding hemorrhoids. Bleeding, pain, swelling and itching were the predominant signs and symptoms observed in patients with hemorrhoids (Table 1).

The three most prevalent co-morbidities identified among hemorrhoid patients were hypertension (33%), diabetes (21%) and varicose veins (20%). According to gastroenterologists, thrombosed hemorrhoids were 10% of hemorrhoid patients, while it emerged as the most prevalent complication associated with bleeding hemorrhoids. Rectal prolapse followed next as a notable complication, while fissures were observed in almost 15% of the patients.

On the other hand, Fistula was not frequently associated with bleeding hemorrhoids, with only a small percentage of gastroenterologists acknowledging its occurrence (refer to Figure 3). As for the challenges in managing patients with bleeding hemorrhoids, the majority of gastroenterologists expressed facing difficulties in their management.

Efficacy of EP in Hemorrhoids

The efficacy of EP in treating patients with hemorrhoids was notable in various aspects. Almost 67% of patients experienced cessation of bleeding in less than a week, while 57% reported resolution of pain within the same time frame. Further, 78% of patients witnessed wound healing within two weeks and almost half the population reported a resolution of swelling in under a week. Additionally, 62% found relief from burning and itching in less than a week (Table 2).

Drug medications for patients with bleeding hemorrhoids

The gastroenterologists preferred a combination of topical and oral medications for patients with bleeding hemorrhoids. Regarding oral medications, the combination of flavonoids and Calcium Dobesilate emerged as the preferred choice, as indicated in Figure 4. The majority of gastroenterologists preferred a combination of flavonoids plus local anesthetics as topical drugs for managing bleeding hemorrhoids. Among oral medications containing flavonoids, Euphorbia prostrata+Calcium Dobesilate (EP+CaDb) was the preferred choice, with MPFF (Diosmin+Hesperidin) being less commonly prescribed (Table 3). In clinical practice, the preferred medications for managing excessive bleeding were EP combined with Calcium Dobesilate and plain calcium Dobesilate (CaDb) (Table 4). The primary reasons for prescribing EP included stoppage of bleeding, to reduce pain and swelling and facilitate faster recovery.

Effectiveness of Euphorbia prostrata+calcium dobesilate in managing bleeding hemorrhoids

Regarding prescription patterns, 46.44% of gastroenterologists preferred prescribing Euphorbia prostrata+Calcium Dobesilate combination in more than 70% of cases of bleeding hemorrhoids, indicating its effectiveness in stopping bleeding (Figure 5). The study showed that the gastroenterologists expressed satisfaction and favored the Euphorbia prostrata+Calcium Dobesilate combination as highly effective in managing bleeding hemorrhoids (Figure 6).

DISCUSSION

This in-clinic survey study involved 325 gastroenterologists across India to understand their real-world perspectives in managing patients with hemorrhoids, those with bleeding hemorrhoids and in-clinic prescriptions of EP. At the end of the study, it was found that EP administration for a short period of two weeks led to improvement in symptoms such as bleeding, pain, wound healing, swelling, itching and burning.

Furthermore, the study also concluded that most gastroenterologists preferred prescribing EP along with calcium dobesilate to treat bleeding hemorrhoids. The management of bleeding hemorrhoids is complicated by their tendency to recur and the often-delayed pursuit of specialized care due to stigma and logistical challenges. These delays frequently lead to disease progression and complications by the time patients consult gastroenterologists, highlighting the need for earlier intervention and more effective treatment strategies. Based on positive results from previous preclinical and clinical studies demonstrating its efficacy and safety in treating symptomatic hemorrhoids. EP is sanctioned for use in managing patients with hemorrhoids.⁸ However, to date, only a limited number of studies have assessed the effectiveness and safety of this drug. Out of all, this survey study marks a pioneering effort to assess the knowledge, attitude and perception of gastroenterologists across India for the management of bleeding hemorrhoids.

A study conducted in West Bengal, India, which involved 30 patients with hemorrhoids, examined the usefulness of an oral fixed drug combination containing EP at a dose of 100 mg and Calcium Dobesilate at a dose of 500 mg, as well as a topical FDC made up of EP extract at a concentration of 1% w/w and lidocaine at a concentration of 3% w/w. The optimal relief from symptoms was observed within the first four days of treatment. After two weeks of treatment, the majority of symptoms, including bleeding, pain and swelling, showed substantial improvement (91.66% each) and itching and exudation ceased altogether.¹³ An observational study with over 1,850 participants revealed that the greatest improvement in hemorrhoidal symptoms occurred within the first three days of treatment with EP dry extract, suggesting a swift recovery during the early stages of treatment.¹⁴ These observations highlighted the significance of employing a multimodal targeted strategy for managing patients with hemorrhoids.

According to the clinical trials mentioned above, our study also observed the significant effectiveness of EP in treating internal hemorrhoids across several parameters. The present survey study shows that more than half of the patient population reported cessation of bleeding, resolution from pain and relief from burning and itching while almost 50% of the population reported resolution of swelling when on EP treatment for two weeks indicating the efficacy of EP in relieving signs and symptoms presented by the patients.

The major constituents identified in Euphorbia prostrata are flavonoids (Apigenin, Apigenin-7 glucoside, Luteolin and Luteolin-7 glucoside), phenolic compounds (Ellagic and Gallic acids) and tannins. EP has a proven hemostatic, anti-inflammatory, analgesic, antioxidant, anti-thrombotic, vasoprotective and astringent activities. Oral administration of EP inhibits carrageenan-induced and histamine-induced edema.² Ellagic acid, a major component, suppresses histamine release. Several clinical trials confirm that flavonoids reduce symptom duration and intensity in acute hemorrhoid attacks. Flavonoids also resolve bleeding from non-prolapsed internal hemorrhoids more quickly and are considered “edema-protective” in treating acute hemorrhoids, likely due to their effect on reducing anal mucosal edema.^11,12

This phytochemical analysis and molecular mechanism of EP are well-documented in the literature, leading physicians to prefer prescribing EP. To the best of our knowledge, this is the first survey study conducted to understand the preferences of gastroenterologists for EP over other available drugs for managing bleeding hemorrhoids. The survey results indicated that close to 75% of gastroenterologists consider drugs containing a combination of flavonoids and Calcium Dobesilate to be highly effective in managing bleeding hemorrhoids and associated healing complications, as a result majority of the gastroenterologists preferred this combination. Thus, flavonoid-containing EP could be an appropriate and compelling candidate for the treatment of hemorrhoids. Although this study had certain limitations. It is a cross-sectional, questionnaire-based survey relying on self-reported data, which may introduce recall and response biases. Voluntary participation could lead to selection bias, limiting generalizability to all gastroenterology practitioners.

CONCLUSION

The survey provides valuable insights into the present state of hemorrhoid management and treatment choices in India. It reveals that internal hemorrhoids are prevalent, often accompanied by substantial bleeding. The data emphasizes the effectiveness of flavonoids in managing all hemorrhoid symptoms. Additionally, it highlights the complementary actions of Euphorbia prostrata and Calcium Dobesilate, which contribute to a quicker reduction in symptoms, particularly in reducing bleeding within 3 to 7 days of therapy.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

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