TONEFACT: Can even advanced hemorrhoids be treated without surgery? A paradigm shift in the management of hemorrhoids

Abstract

Hemorrhoids are one of the most common anorectal disorders. Early hemorrhoids are treated conservatively, but advanced hemorrhoids are usually treated with surgery. However, in the last decade, we have worked extensively in the field of conservative management of hemorrhoids. From our experience, we could manage a large proportion of advanced hemorrhoids without surgery by a treatment concept (TONEFACT) with a high satisfaction rate. Evidence for the TONEFACT approach primarily comes from observational studies and a prospective, non-randomized study of 85 patients. This has been shown to improve defecation time and reduce prolapse symptoms in early-stage hemorrhoids, leading to fewer surgical interventions. Although promising, these observations lack validation from more extensive randomized controlled trials to draw firm conclusions. In this opinion review, without using much data, we will discuss our viewpoint based on our experience as specified by the journal guidelines.

Key Words: Hemorrhoids; Fiber; Water intake; Non-surgical; Conservative management

Core Tip: Hemorrhoids are one of the most prevalent disorders. Many patients with hemorrhoids undergo surgery as treatment, especially in advanced grades (late grade II, grade III & grade IV) and hemorrhoids with uncontrolled bleeding. TONEFACT is a novel treatment that rectifies the root cause of hemorrhoids, thereby stopping the progression and causing the cessation of symptoms (bleeding and thrombosis). Thus, it removes the requirement of surgery in a good proportion of patients who were indicated for surgery. Considering the high prevalence rate of the disease, this amounts to enormous savings in hospital admissions and surgical morbidity at the global level.

INTRODUCTION

Hemorrhoids are quite prevalent, and it is estimated that about 22%-30% of the population will suffer from hemorrhoids in their lifetime[1-4]. Amongst these, many require surgical intervention[5-8]. These surgical interventions include Hemorroidectomy, Transanal Haemorrhoidal Dearterialization, non doppler hemorrhoidal artery ligation, Laser hemorrhoidoplasty, stapled hemorroidectomy, etc.[9-12]. However, various systematic reviews and meta-analyses have failed to determine the supremacy of one procedure over another[13-15]. Given the high prevalence rate of hemorrhoids, surgical intervention is carried out in hundreds of thousands of patients worldwide, and it places a huge burden on healthcare systems[13,16,17]. We have worked on the conservative management of hemorrhoids for the last 12 years and have realized that a majority of hemorrhoids, even advanced ones, can be successfully managed without surgery[18,19]. In this opinion review, we shared our viewpoint based on our experience.

In recent decades, conservative management strategies for advanced hemorrhoids have received relatively less attention, possibly due to the traditional surgical perspective[20-23]. Therefore, patients suffering from hemorrhoids usually consult surgeons and not gastrophysicians. Understandably, surgeons are not keen on working out new methods for the conservative treatment of a disease on which they usually operate.

TONEFACT

The concept and the TONEFACT management concept are summarized in Table 1. T stands for time (less than 3-5 minutes during defecation). O stands for once a day defecation (frequency of defecation). N stands for no mobile or newspaper on the toilet (as it leads to a significant increase in time). E stands for exercise (Kegels 100 times per day). F stands for fiber (20-25 g of psyllium husk with 500 mL water) and fluid intake (water intake to be more than 3.5 L/day). A stands for apply pressure (many people do not attempt to strain during defecation, thereby prolonging the defecation time) and keep a small bench below the feet while defecating (to straighten the retro anal angle). C stands for compulsive defecation to be avoided (increases the risk of hemorrhoidal rupture and thrombosis). T stands for to resist the desire to achieve 100% evacuation (many people significantly prolong defecation time just to achieve the feeling of 100% evacuation, even though they had cleared most of the rectum in the first few minutes).

Table 1 Categorized description and benefits of TONEFACT regimen.

Interventions	TONEFACT component	Description	Addresses causative factor
Behavioral	T-time during defecation	≤ 5 min during defecation	Prevents prolonged defecation time; defines objective endpoints of management[29,30]
Behavioral	O-once (frequency of defecation)	Defecation once daily, avoiding unnecessary multiple attempts	Prevents repeated straining; supports objective management endpoints[19]
Behavioral	N-no mobile or newspaper on toilet	Avoiding use of gadgets or reading material on the toilet	Prevents prolongation of defecation time[31-35]
Behavioral	C-compulsive defecation to be avoided	Avoiding defecation for non-physiological reasons (e.g., social pressure)	Prevents excessive straining and hemorrhoidal rupture/thrombosis[30]
Behavioral	T-to resist desire for 100% evacuation	Avoid unnecessary straining for complete emptying sensation	Prevents prolonged defecation and excessive straining
Exercise-based	E-exercise (Kegels)	100 daily Kegel exercises	Improves pelvic floor and anal muscle tone; reduces prolapse and mucus discharge[64,65]
Dietary	F-fiber and fluid intake	20–25 g psyllium husk + 500 mL water; total fluid ≥ 3.5 liters/day	Softens stool, reduces defecation time, improves bowel regularity[58]
Postural	A-apply pressure during defecation and keep a bench under feet	Use of a small bench under the feet to mimic the squatting position	Facilitates complete evacuation and reduces time/straining during defecation[59,60]

Three main causative factors addressed TONEFACT

The three main causative factors that initiate or worsen the hemorrhoids and are tackled by TONEFACT are: (1) Prolonged defecation time (addressed by T, N, F, A, T); (2) Excessive or repeated straining (addressed by C, E); and (3) Decreased muscle tone (worsen prolapse; addressed by E). The TONEFACT concept effectively addresses these three causative factors (Table 1, Figure 1).

Figure 1 Overview of TONEFACT treatment.

Amongst the several causative factors of hemorrhoids (Figure 1), the above three listed factors are the prominent ones responsible for the initiation of hemorrhoids, the disease progression, and the disease morbidity (hemorrhoidal rupture leading to bleeding and thrombosis of hemorrhoids)[24-27]. Although Rome IV CRITERIA does not explicitly mention defecation time, it states that prolonged defecation time is associated with an underlying bowel disorder. Defecation time should be as short as possible to avoid the risk of developing defecation disorders[28,29].

Though these factors were known to be causative for a long time and the patients were also routinely advised by their physicians to avoid them, this knowledge was not adequately helping. The reason for this was the lack of a definitive ‘endpoint’ of the treatment goal (‘endpoints’ are values that are not harmful and are considered “normal”). In all chronic diseases, objectively defining the treatment endpoint is fundamental to achieving the desired results and vice versa. To exemplify, let us assume that the endpoint of managing hypertension [blood pressure (BP) < 140/90] is not defined and is not clear to the treating physician. A patient reports with a BP of 220/100. He would be simply advised to decrease his BP without specifying any endpoint. The patient would start the medication, and his BP stabilizes at 180/90. He would then be satisfied that his BP has been reduced, would be content with the treatment, and would not report back to his physician, thereby leading to damage due to high BP. Even reporting back to the physician will not help because the physician will also be satisfied (as the BP has been lowered). After all, the treatment goal was also not clear in his mind. Therefore, without defining a definitive treatment endpoint, it is simply unthinkable to treat any chronic disease, including hypertension, high serum cholesterol in coronary artery disease, diabetes mellitus, or cancers.

In patients with chronic constipation and hemorrhoids, the treatment endpoints for defecation time and frequency were never defined. After working extensively with hundreds of patients, we analyzed that the risk of hemorrhoid prolapse, along with its progression, hemorrhoidal rupture leading to bleeding, and hemorrhoidal thrombosis, becomes much less when defecation time < 5 minutes and defecation frequency was not more than once or twice per day. Subsequently, we published the concept of TONEFACT[19]. After this, we conducted a prospective non-randomized non-controlled trial to analyze the efficacy of TONEFACT in 85 patients with advanced hemorrhoids (grade III and IV) who had been advised surgery at different centers[18]. Out of these, 79 had grade III and 6 had grade IV hemorrhoids. Prolapse was present in 100%, and bleeding was present in 71.8% (61/85) of patients[18]. They underwent TONEFACT treatment. After a median follow-up of 40 (12-96) months, hemorrhoidal prolapse improved in 56.5% (48/85), did not progress over time in 25.9% (22/85), and continued to progress in 4.7% (4/85) of patients[18]. On long-term follow-up, 12.9% (11/85) underwent surgery for hemorrhoids. Bleeding episodes decreased from 71.8% (61/85) to 29.4% (25/85; P < 0.0001)[18]. Satisfaction levels were assessed, and 68.2% (58/85) of patients were highly satisfied, 12.9% (11/85) were moderately satisfied, and 18.9% (16/85) were not satisfied with treatment[18]. This study highlighted the efficacy of the TONEFACT concept[18]. TONEFACT improved/stopped prolapse progression in 82.4% of patients and could prevent surgery in 87.1% of patients, as only 12.9% of patients underwent surgery. This, coupled with a high satisfaction rate (81.9% patients were highly or moderately satisfied with the treatment and the fact that they could avoid surgery), highlighted the efficacy of the TONEFACT concept[18].

METHODS TO DECREASE PROLONGED DEFECATION TIME

Amongst the listed three factors, the prolonged defection time has been recognized as the main causative factor. Apart from defining the treatment endpoint (3 minutes during defecation), the other components helpful in preventing prolonged defecation time follow.

No mobile or newspaper on the toilet

The habit of taking a mobile or newspaper is quite detrimental as it leads to a significant increase in time[30-34]. The habit is now being seen with increasing frequency in younger generations who play games or scan newspapers on their smartphones while sitting during defecation on the toilet[35]. We observed that most smartphone users on the toilet not only spend extra time on the toilet but also frequently underestimate the time spent there. This causes them to undermine the importance of the issue. Another common argument or explanation was that the time spent defecating was less even though they kept sitting on the toilet to finish the task on the smartphone. However, it was observed that simply sitting on the toilet commode even after completing the act of defecation also increases the venous congestion and precipitation of hemorrhoidal symptoms. We also noted that without quitting this habit, it was quite challenging to decrease the time spent during defecation.

This habit is also harmful to the neck and the spine, as the people who used smartphones in the lavatory had considerably larger cervical and spinal flexion angles than those who did not[36]. Moreover, smartphones taken to the toilet are rarely cleaned, are frequently contaminated, and increase the risk of infection from different infections[37-39]. This habit has been labelled as smartphone lavatory syndrome[40].

Taking adequate fiber and the right method of taking it

There is a lot of confusion and a lack of knowledge due to heterogeneity and the overlapping effects among different fibers. It is difficult for laypersons and even physicians to correctly identify the fiber to be consumed. Therefore, the usual recommendation is to increase fiber in the diet, which is most commonly perceived as increased intake of fruits and vegetables. Such broad, non-specific recommendations are more like a cliché and are generally met with poor compliance, especially on a long-term basis[41]. Therefore, a fiber supplement is required as the dietary intake of fiber is below par in the majority of patients. The average fiber requirement for an adult is 35-40 g/day, whereas the daily fiber intake is usually less than 15 g/day[42,43]. The fiber supplement, which would be near optimal, possesses almost all the benefits of different fibers and is easy to consume with minimal side effects, and deserves to be recommended for this purpose. The identification of this type of fiber would make it convenient for physicians to recommend, easy for laypersons and patients to understand, and increase long-term compliance.

It is difficult to define a particular fiber as an optimum fiber, as none of the fibers possesses all the beneficial characteristics. However, the fiber that comes closest to being optimum is psyllium husk (ispaghula husk)[18,42,44]. Psyllium is soluble, has a high water-holding capacity, and has a good viscous/gel-forming capacity[45]. The unique property of psyllium is that it is partially fermenting. Due to this, it possesses the benefits of fermentation, like the production of short-chain fatty acids, but does not cause much bloating or abdominal cramps as the gas production is less (partially fermenting). Unlike other fibers like oats, which lose viscosity (gel-forming capacity) and water-holding capacity due to fermentation, psyllium does not lose its viscosity and water-holding capacity after partial fermentation. This leads to good bowel-regulatory action (soft, bulky stools in constipated patients and well-formed stools in diarrhea patients). These characteristics make psyllium a unique fiber, as this single fiber possesses almost all the benefits of different fibers with minimal side effects. Moreover, it is cheap, readily available, and easy to consume[18,42].

Optimal dose of psyllium supplementation

Previously published studies analyzed the psyllium supplementation at much lower doses (5-10 g/day) in various clinical conditions like chronic constipation and irritable bowel syndrome (IBS)[46]. Though these studies demonstrated a beneficial effect of psyllium on IBS symptoms, the resultant benefit was perhaps just a proportion of the potential achievable benefits[46]. As mentioned above, the average fiber requirement for an adult is 35-40 g/day, whereas the daily fiber intake is usually less than 15 g/day[42,43]. There is an approximate deficiency of 20-25 g of fiber per day, which needs to be supplemented. When the fiber supplement was increased from 10 to 20-25 g/day, there was a significant increase in relief in conditions like constipation and IBS[35].

Optimal method of psyllium supplementation

The second aspect is the amount of water taken along with the fiber. Psyllium, being a soluble fiber, absorbs water and swells, and it takes the absorbed water to the rectum, thereby making stools softer and bulkier. However, for this to happen optimally, adequate water must be taken along with the fiber (25 mL water/g fiber, 500 mL water with 25 g fiber/day)[18,42]. These aspects markedly increase the efficacy of fiber supplements but were ignored by the previous studies[47,48].

Importance of daily fluid/water intake and primary idiopathic constipation mediated by the lack of thirst concept

Chronic idiopathic constipation (CIC) affects 10%-17% of the world’s population[49,50]. CIC can be primary or secondary (because of metabolic, organic, neurologic, drug, or systemic disorders)[50-52]. CIC is frequently hereditary, which suggests a genetic predisposition[52]. CIC is often presumed to be mediated by problems in the small and large intestines, including increased absorption of water, slow transit, or any kind of evacuation disorder[53,54]. Usually, lifestyle modifications, which include increasing dietary fiber, are the first step in managing CIC[53]. If patients do not respond to these simple changes, then treatment with osmotic and stimulant laxatives is attempted[53].

However, it was found that in many patients, the decreased water intake played a significant role in CIC, and the genetic component in CIC is likely to be mediated by a lack of thirst (LOT)[55]. This concept was labelled as primary idiopathic constipation mediated by LOT (PICLOT)[55]. These patients hardly feel the need to drink water throughout the day[55]. Interestingly, in these patients, along with constipation, the LOT could be traced for generations almost with the same propensity, thereby suggesting that CIC could perhaps be mediated by LOT and transmitted through the same mechanism[55].

It was observed that increasing water intake decreased the intensity and symptoms of CIC[55]. Primary idiopathic constipation mediated by LOT has clinical relevance because significant relief can be obtained by simply increasing the water intake rather than targeting the gut (laxative use and even surgery) in this subset of patients[55]. Therefore, recommending a minimum of 3.5 L of water intake per day to these patients helped ameliorate the symptoms of constipation and significantly decrease the prolonged defecation time.

However, drinking 3.5 L of water can be an uphill task for patients, a majority of whom are used to drinking minimal amounts of water (half to 1 L per day). These patients were recommended to fix time slots to drink water. These time slots may be 30 minutes before and 60 minutes after meals as drinking too much water is not recommended with meals[56]. The time slots for drinking 750-1000 mL of water can be morning (before breakfast), between breakfast and lunch, between lunch and evening tea, and between evening tea and dinner. Drinking a good amount of water in the morning, preferably on an empty stomach, also activates the gastrocolic reflex, which further facilitates the early passage of bowel movements[57]. The recommendation of > 3.5 L/day fluid intake may not be suitable for all individuals, especially those with comorbidities such as liver, kidney, or heart disease. Therefore, it is pertinent that any comorbidity that needs limitation of water intake must be taken into account before recommending intake of 3.5 L of water per day.

APPLY PRESSURE AND KEEP A BENCH BELOW THE FEET

Many people do not attempt to strain at all during defecation due to a prevailing belief in many cultures that straining while defecating is harmful. Though it is correct that excessive straining during defecation is harmful, no/minimal straining also prolongs the defecation time significantly. The key lies in maintaining the optimum balance. Recommending that patients apply pressure while defecating helped to decrease defecation time in most patients.

Increasing the hip flexion by sitting in a squatting position or raising the legs in the sitting position straightens the rectoanal canal[58]. This makes the defecation process easier and faster with less straining[58]. Raising the legs by keeping a small bench (of 12-16 inches height) below the feet also increases the hip flexion. This flexion makes defecation much easier by straightening the rectoanal canal[58,59].

TO RESIST THE DESIRE TO ACHIEVE 100% EVACUATION

It was observed that many people significantly prolong defecation time just to achieve the feeling of 100% evacuation, even though they had cleared most of the rectum in the first few minutes. This led to a significant prolongation of defecation time. They need to be counselled that to avoid sitting for a long time, it is not harmful if they apply proper pressure to evacuate a major part of the rectum in 3-5 minutes and then finish. This helps to decrease the defecation time. The urge for a complete 100% evacuation can be ignored and will pass after a few minutes. This works well as the body gets accustomed to less time during defecation, and gradually, such patients can clear their complete bowels in 3-5 minutes. Though this habit is not present in every patient, it is seen in a good proportion of patients, and proper counselling goes a long way in reducing the defecation time.

METHODS TO DECREASE EXCESSIVE STRAINING DURING DEFECATION

Once or twice a day defecation

Many patients develop a habit of defecating multiple times, especially in South Asian countries where the diet is high in fiber and the stools are bulkier. This habit of going multiple times puts excessive strain on hemorrhoids, leading to their rupture and even progression. However, this habit can be corrected without much difficulty by advising patients to properly evacuate the rectum by applying adequate pressure (as discussed above) and then ignoring subsequent urges for clearing the bowels. The reason behind this is a cultural belief that if a person has an urge to defecate, then it should not be curbed. The patients need to be counselled that holding the urge to defecate until the next day after already defecating is not harmful. Hence, the subsequent urges can be ignored. This counselling works well, and most patients can decrease frequency from several times to once or twice a day.

COMPULSIVE DEFECATION TO BE AVOIDED

It happens, not infrequently, that a patient with existing hemorrhoids tries to attempt defecation out of their schedule for social reasons. It leads to excessive straining, leading to hemorrhoidal rupture (bleeding) and even thrombosed hemorrhoids[19]. For example, if a patient defecates every day at 8 am but has an early morning long trip planned, then they may fear the availability of a toilet and will try to clear their bowels early in the morning that day. In such a scenario, the patient will have to put excessive strain to clear the bowel. This is an example of compulsive defecation and was seen more commonly in female patients[19]. Patients suffering from hemorrhoids should be advised to plan things in a way so that the compulsive defecation can be avoided[19].

METHODS TO IMPROVE ANAL TONE AND PELVIC FLOOR MUSCLE STRENGTH

Exercise

The strength of pelvic floor muscles and anal tone play an important role in delaying and recovering from the hemorrhoidal prolapse. Therefore, recommending Kegel exercises (KE) to patients with prolapsing hemorrhoids (grade II, III, and IV) helps to decrease the prolapse and stop/slow the progression of prolapse when coupled with other components of TONEFACT.

KE, also known as pelvic floor muscle training or pelvic floor muscle exercises, is a non-invasive and safe behavioral treatment method shown to be effective in increasing pelvic floor muscle strength[60,61]. KE entails repeated, selective, and voluntary contraction and relaxation of the external anal sphincter, pubococcygeus and levator ani muscles[62]. The contraction and relaxation phases must last at least 3-5 seconds each for the exercises to be effective[60,61]. KE strengthens the pelvic floor muscle group and enhances the pelvic floor muscle tone, thereby helping in maintaining the suspension of urinary and intestinal pelvic organs[63]. Toned muscles can hold the anatomy in place, which may minimize the descent of hemorrhoidal tissue during a bowel movement. In addition, these exercises improve local blood flow and reduce venous congestion and swelling, which is essential in forming hemorrhoids. KE, which strengthen muscle coordination and control, also reduce strain on the toilet, one of the leading factors contributing to prolapse[63,64]. Although not a treatment in its own right, KE are beneficial for these patients and are particularly useful in combination with dietary and behavioral changes in the treatment of early-stage prolapsed hemorrhoids.

DISCUSSION

A visual flowchart depicting the clinical application pathway of TONEFACT is depicted in Figure 2.

Figure 2 Flow chart to implement TONEFACT.

Multiple physiological mechanisms explain how behavioral modifications lead to the regression of hemorrhoidal symptoms. Dietary and defecation habit changes help alleviate inflammation in the hemorrhoidal plexus, contributing to the mechanism of symptom development[65,66]. Normalization of the vascular tone (which is often dysregulated in the hemorrhoidal disease) takes place with improved bowel habits and reduced straining[66]. Increased fiber intake may also preserve the integrity of connective tissue by decreasing mechanical tension on the anal cushions, thereby potentially delaying the degenerative processes of collagen and elastic fibers[66]. These physiological effects offer logical justification for the inclusion of behavioral strategies into conservative management protocols.

Various outpatient procedures, such as sclerotherapy, infrared coagulation, rubber band ligation, etc., also help TONEFACT to prevent surgery in grades I-III hemorrhoids[67-69]. Hemorrhoidal sclerotherapy is enjoying a new age of interest due to the use of polidocanol foam, which is more effective than the liquid[70,71]. Various articles have already shown promising results. Also, the combination of polidocanol foam with rubber-band ligation has been used effectively in a technique called sclerobanding[23,72].

Implementing the TONEFACT regimen successfully requires a level of motivation and self-discipline in the patient and persistent effort from the treating physician to guide his patient. TONEFACT helps to prevent surgery in a good proportion of such patients.

An individualized approach is essential as not all causative factors may be present in all patients. This requires the real-world application of TONEFACT, including data collection practices, follow-up strategies, and the role of structured counseling in enhancing compliance. Precisely the same protocol is followed at our institute, the Garg Fistula Research Institute. Though tremendous efforts are required, the results are equally gratifying when the patients who had been recommended for surgery (late grade II, grade III, thrombosed hemorrhoids patients, and early grade patients with excessive bleeding) no longer need surgery. In our experience implementing TONEFACT in early hemorrhoids is even more gratifying, as it prevents progression in most patients. Therefore, the reduction in disease burden (of advanced hemorrhoids) would be huge, as the patient load in early hemorrhoids is even larger. There are a few centers where the conservative management of hemorrhoids (even advanced ones) is done. However, our experience can help to highlight that the TONEFACT concept is effective in preventing surgery in a large number, if not all, patients with hemorrhoids with excessive bleeding and advanced hemorrhoids.

As TONEFACT is a lifestyle modification, the associated costs are negligible, primarily limited to purchasing fiber supplements. In contrast, surgical interventions entail substantial expenses due to hospital admission, operative procedures, anesthesia, and postoperative recovery. This stark cost differential underscores the potential cost-effectiveness of TONEFACT in alleviating the global healthcare burden, particularly in patients who can avoid surgery altogether.

Limitations of this opinion review are a small sample size and studies included in this review are non-comparative and non-randomized as no comparative study is available for advanced-grade hemorrhoids and nonsurgical measures. Though we took the utmost care, selection bias is still possible. We also understand the skepticism about the ability of behavioral modifications alone to reduce prolapsed hemorrhoids. While we do not claim complete reversal in all cases, our experience, supported by long-term follow-up data, indicates significant symptomatic improvement and avoidance of surgery in a substantial proportion of patients. However, we acknowledge the need for future studies to incorporate larger, stratified cohorts and ideally include randomized controlled trials for more definitive conclusions and to validate these findings. The main strength was that it represents the first review of conservative management for advanced-grade hemorrhoids and has promising results.

CONCLUSION

TONEFACT is a promising and potentially transformative approach to treat early and advanced hemorrhoids without surgery. However, prospective randomized controlled trials are required to authenticate and validate the findings of TONEFACT treatment in patients with hemorrhoids.