Original Articles Nonsurgical Treatment of Hemorrhoids

John F. Johanson, M.D., M.Sc.

Hemorrhoids begin as localized cushions of specialized submucosal vascular tissue located in the anal canal adjacent to the junction of the squamous and columnar epithelium. These cushions are present at birth and represent a normal anatomic feature of the anal canal. The existence of hemorrhoidal cushions alone, therefore, does not constitute disease. Hemorrhoidal disease requires the presence of pathologic changes leading to bleeding, prolapse, or thrombosis. Rectal bleeding is the most common manifestation of hemorrhoidal disease.1 The bleeding typically appears as a bright red spot or streak on the toilet tissue or stool but may also be seen dripping into the toilet water. If prolapse is the predominant symptom, a mass may be sensed protruding through the anus with defecation. Early in its course, prolapse reduces spontaneously. In time, chronic prolapse results in persistent mucoid discharge, which may cause perianal irritation and/or pruritis. Pain is not typically a symptom of internal hemorrhoid disease unless the hemorrhoids are acutely prolapsed, which requires immediate surgical intervention. Pain may also be associated with thrombosed external hemorrhoids. Hemorrhoids are one of the most common gastrointestinal disorders affecting nearly 5% of the United States population. More than 10 million persons annually admit to symptoms of hemorrhoidal disease. However, only one third of them are ever seen by a physician for evaluation or treatment of this condition.2 Therapy can be broadly categorized into oral therapy such as fiber, topical treatments, nonsurgical destructive techniques, and surgical intervention. The decision to treat is based on the frequency and severity of symptoms. Those without symptoms of bleeding or prolapse or with infrequent symptoms often do not require any therapy, particularly since the definition of hemorrhoidal disease is based on the presence of symptoms. The specific treatment also depends to a great extent on the nature of the patients symptoms. There is no disagreement, for example, that acutely prolapsed hemorrhoids require surgical intervention. However, the overwhelming majority of patients with symptomatic hemorrhoids do not present in this manner. It is the population of patients with intermittent but bothersome symptoms that requires elucidation of the optimal therapy.

CONSERVATIVE TREATMENT In routine clinical practice, the initial choice for treatment of hemorrhoidal disease is generally conservative, including both oral and topical therapies. This approach is recommended for persons with minor symptoms that do not interrupt normal daily activities. The goal of medical treatment is to relieve symptoms as quickly as possible. A secondary goal is to maintain remission of symptoms. Treatment of the underlying pathophysiologic cause of symptoms is not possible nor is it intended with these modalities. Options for oral therapy include fiber supplements and oral diosmin (Daflon). Although fiber is widely recommended in this situation, the data supporting this option are inconsistent. One controlled trial has been published comparing fiber (psyllium seed) with placebo in 52 nonselected patients with symptomatic hemorrhoidal disease.3 In this trial, fiber supplements were given for 6 weeks and resulted in significantly reduced bleeding when compared with placebo; 92% vs. 56%, respectively. This provided an absolute risk reduction in bleeding associated with treatment of 36% and a number needed to treat (NNT) of 2.8. This means that nearly three patients will need to be treated to achieve one symptomatic response. Pain with defecation was likewise reduced with fiber supplements demonstrating response rates of 96% vs. 68%. This corresponded to a risk reduction of 28% with an NNT of 3.6. A less impressive reduction in pruritis and prolapse was noted, which failed to reach statistical significance. By contrast, another clinical trial comparing a different form of fiber supplementation demonstrated no initial difference between fiber and placebo with regard to bleeding during the first 15 days of treatment.4 In the subsequent 3 weeks, a small difference was observed between treatment and control groups,

From the University of Illinois College of Medicine at Rockford (J.F.J.) and Rockford Gastroenterology Associates (J.F.J.), Rockford, Illinois. Address correspondence to: Dr. John F. Johanson, Rockford Gastroenterology Associates, 401 Roxbury Rd., Rockford, IL 61107. e-mail: johnfj@uic.edu

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but the magnitude of treatment effect was less than what was observed in the study described above. Furthermore, there was no difference in prolapse among the two groups. Finally, two additional clinical trials examining other forms of fiber have shown no clear proof of efficacy.5,6 The data supporting the efficacy of oral Daflon is even less convincing. Two controlled trials of Daflon observed improvement in the treatment group when compared to placebo.7,8 These trials included 120 and 100 patients, respectively. Improvement was noted in subjective symptom scores for pain and anal discharge. In the first study, prolapse was likewise reduced. However, a third trial of 100 patients conducted in Thailand showed no added improvement with Daflon vs. placebo when added to a conservative regimen of fiber supplementation.9 In the latter study there was no significant difference in the number of patients with subjective improvement of symptoms. Overall response rates were 94% and 98% (NS) for fiber alone compared to fiber and Daflon, respectively. These results, in fact, seem to support the efficacy of fiber therapy and suggest that Daflon adds little. Unlike the other clinical trials of fiber supplements described earlier, however, this trial did not have a true placebo control group. The evidence supporting the beneficial effect of fiber supplements in eliminating the acute symptoms of hemorrhoidal disease is not conclusive because of the small numbers of patients examined and the seemingly conflicting results. Nevertheless, fiber is safe and inexpensive. Fiber therapy in all likelihood, therefore, will remain an integral part of the initial treatment of hemorrhoidal disease, even in the absence of undeniable proof. Topical therapy is the other first-line therapeutic alternative to treating the acute symptoms of hemorrhoidal disease. A large number of options are available, although the evidence supporting their efficacy is weak. Topical therapies reduce symptoms by exerting a local anesthetic effect, which eliminates the burning and itching associated with hemorrhoid prolapse. They have less of an effect on bleeding, although they are frequently used for this indication. A number of topical preparations are available and are listed in Table 1. There have been no clinical trials supporting the efficacy of any of these products. The only compound in which a randomized clinical trial was performed was 5-ASA suppositories.10 In this case, a double-blind placebo-controlled trial demonstrated significant reductions in hemorrhoidal symptoms among patients treated with 5-ASA suppositories compared with placebo. Analogous to fiber supplements, topical therapy has few side effects and is generally safe. Long-term use of topical steroids, however, has the potential to cause chronic perianal dermatitis.

NONSURGICAL TREATMENT OPTIONS Bleeding or other symptoms that persist despite conservative management require more aggressive therapy aimed at eliminating the underlying pathophysiologic abnormality. It is in this group that the most controversy arises when attempts are made to identify the best type of treatment, that is, nonsurgical options or surgical hemorrhoidectomy. The remainder of this discussion will focus on the question of which of these treatment modalities should be the optimal choice for chronically symptomatic hemorrhoid disease. The underlying goal of nonsurgical therapy is fixation of the hemorrhoidal cushion. The most common methods currently being employed are injection sclerotherapy, rubber band ligation (RBL), and infrared photocoagulation (IRC).11 Injection sclerotherapy for this purpose has been in use the longest; it was first employed more than 100 years ago in Europe. In this method, a small amount of sclerosant is injected into the submucosa above the hemorrhoid cushion, leading to fibrosis and ultimate fixation of the hemorrhoid cushion. RBL is probably the most commonly used nonsurgical treatment for hemorrhoidal disease. A special applicator is used to place one or more rubber bands at the base of each hemorrhoid cushion, strangulating a small amount of mucosa with the cushion. This technique has recently been adapted to allow placement of rubber bands endoscopically. The underlying mode of action, however, remains the same. The most recent advance in nonsurgical treatment of hemorrhoidal disease is the use of heat delivered in a variety of forms including infrared light or electrocautery. IRC is the best known and most widely studied technique, which causes tissue destruction by a rapid increase in heat delivered by an infrared light source. Despite the widespread application of these methods, there have been no placebo-controlled trials to establish their efficacy. Most of the studies assessing the benefits of these techniques have been descriptive studies or case series, which have detailed the effects of patients undergoing the specific treatment being described. None of these methods, however, has been compared with conservative therapy or placebo in randomized, controlled clinical trials. Without such comparisons, it is impossible to know whether the observed response was truly the result of treatment or simply related to the natural history of hemorrhoidal disease. Notwithstanding the absence of placebo-controlled trials, there have been a number of randomized trials comparing these various modalities with each other.12 19 Despite the abundance of nonsurgical options for the

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Table 1. Topical therapies for treatment of hemorrhoidal disease

Agent Mechanism of action Dosage Benefits Side effects Comments

Pramoxine HCl 1% (Anusol ointment)

Rapidly acting local anesthetic

Apply topically up to 5 times daily

Local symptom relief; no crossreactivity with other local anesthetics such as procaine or dibucaine

Local allergic reaction

Hydrocortisone acetate 1% (Anusol HC suppositories)

Topical antiinflammatory agent

Use up to b.i.d.

Useful in treatment of internal hemorrhoids

Local allergic reaction

Indicated for temporary relief of soreness, burning, or itching; forms a temporary protective coating over the inflamed tissues Unlike topical creams, suppositories provide therapy further up into the anal canal for treatment of bleeding or prolapsing internal hemorrhoids

Hydrocortisone acetate 1% (Cortaid cream)

Topical antiinflammatory agent

Use topically up to q.i.d.

Phenylephrine HCl 0.25% (Preparation H, cream, gel, or suppositories)

Local vasoconstriction leading to temporary relief of burning and itching

Use topically or per rectum up to q.i.d.

5-amino salicyclic acid suppositories

Local antiinflammatory effect

Local symptom relief; steroid provides antiinflammatory properties Works by different mechanism than other topical creams; may be effective if other local anesthetics are not effective Reduces pain and bleeding of hemorrhoids

Local allergic reaction

Local allergic reaction

Fewer side effects than topical steroid therapy

treatment of hemorrhoidal disease, none has consistently been shown to be better than the others. The absence of a clear advantage may indicate that they are equally effective. A more likely explanation, however, is that no clear choice has emerged because of the lack of statistical power among the various small clinical trials to demonstrate a significant difference among treatment options. To address this problem, we performed a meta-analysis comparing the three most common nonsurgical techniques: IRC, RBL, and injection sclerotherapy.20 Seven clinical trials were found comparing the three techniques, but two were eliminated because of serious problems with their methodology. Thus five random-

ized, controlled clinical trials were considered in the meta-analysis: two comparing RBL with IRC, two comparing sclerotherapy with RBL, and one study that compared all three treatments. When the studies were combined, pooled analyses revealed similar efficacy between RBL and IRC, whereas sclerotherapy was not as efficacious. Although initial efficacy between RBL and IRC was similar, significantly fewer patients undergoing RBL required additional treatments for symptom recurrence. This therapeutic advantage, however, occurs in the presence of a fivefold greater incidence of treatment-related pain compared with IRC. The results of the meta-analysis have subsequently been confirmed by a randomized controlled

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trial of 133 consecutive patients.21 In this trial 97% of patients treated with RBL and 92% of patients treated with IRC were symptom free or had improved to a satisfactory degree by the end of treatment (not significant [NS]). Similar to what was observed in our meta-analysis, RBL was associated with significantly more pain. In contrast to the meta-analysis, no differences in the long-term effects of IRC and RBL were observed. Given comparable efficacy and a significantly higher risk of pain, IRC was recommended as the preferred choice for nonsurgical therapy of hemorrhoidal disease. A second meta-analysis was performed in 1995 by MacRae and McLeod22 that used many of the same clinical trials. Not surprisingly, this meta-analysis showed nearly identical results, although the authors of this study came to a different conclusion. In this study RBL and IRC again demonstrated similar efficacy and were more efficacious than sclerotherapy. Patients treated with IRC were more likely to require repeat treatment, whereas RBL was significantly more painful. RBL, however, was recommended as the optimal therapy presumably because of its increased efficacy (less need for retreatment), even though it was associated with significantly more patient discomfort. It is undeniable that the difference in efficacy between RBL and IRC is limited, and therefore the choice of the optimal therapy should be individualized when possible. That is, patients should be asked whether they are willing to endure more discomfort with the initial therapy or opt for the treatment that causes less pain but may require repeat therapy in the future. I suspect most patients will choose the latter.

domized controlled trials were examined and included in the meta-analysis. Of these, three directly compared hemorrhoidectomy with RBL, the only nonsurgical technique to be tested. Of these individual trials, one demonstrated hemorrhoidectomy to be more effective,24 whereas the other two were inconclusive.25,26 When the results of the individual trials were pooled, hemorrhoidectomy was found to be significantly more effective than RBL but was also associated with a significantly greater risk of complications and pain. Although hemorrhoidectomy was clearly more efficacious, the authors believed that RBL should be the initial choice for treatment of hemorrhoidal disease. Surgery, in their opinion, should be reserved for those patients in whom nonoperative procedures are unsuccessful.

SUMMARY Although symptomatic hemorrhoidal disease affects nearly 5% of the United States population, it is disappointing that only a relatively few well-designed, randomized, placebo-controlled clinical trials have been performed. Despite the absence of unequivocal evidence, I believe a number of conclusions can be reliably drawn. First, the preponderance of evidence supports the efficacy of fiber supplements in eliminating the acute symptoms of hemorrhoidal disease. Second, despite their widespread use, there is little to support the efficacy of topical therapy. Third, IRC and RBL demonstrate comparable efficacy, although RBL is probably slightly better for treatment of prolapsed hemorrhoids. The choice of nonsurgical therapy, however, should be tailored to the individual patient because RBL is associated with more pain whereas IRC may require additional treatment sessions for recurrence of symptoms. If possible, the patient should be allowed to choose between the two. Finally, direct comparison between hemorrhoidectomy and RBL indicates that hemorrhoidectomy is clearly more efficacious but is associated with significantly more pain and complications than RBL. Based on a comprehensive review of the available evidence, therefore, it is my opinion that the optimal therapy for hemorrhoidal disease begins with fiber supplements. Short-term topical therapy to relieve symptoms has not been shown to be effective but carries little associated risk. If symptoms do not respond to conservative treatment, then either RBL or IRC is warranted. The choice of which treatment to pursue should be individualized, based on patient preference, once the risks and benefits of each have been explained. In either case, hemorrhoidectomy should be reserved for patients who fail nonoperative

COMPARISON OF SURGICAL HEMORRHOIDECTOMY WITH NONSURGICAL TREATMENT Unfortunately, there is little evidence from clinical trials to guide us in answering this question as well. The majority of the clinical trials comparing surgical with nonsurgical treatment options were performed in the early 1980s. The applicability of these trials to current practice is unclear, given the improvements in surgical techniques and the emergence of thermal fixation methods such as infrared coagulation, which were not widely available at the time these direct comparative trials were being performed. The best evidence available examining the efficacy of surgical vs. nonoperative treatment comes from the meta-analysis performed by MacRae et al.22,23 as described earlier in this report. Overall, 18 ran-

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therapy because of the greater risk of complications and postprocedure pain.

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