Treatment of internal hemorrhoids: comparison of the efficacy and complications of endoscopic rubber band ligation and endoscopic sclerotherapy: a meta-analysis

doi:10.21203/rs.3.rs-5212335/v1

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Treatment of internal hemorrhoids: comparison of the efficacy and complications of endoscopic rubber band ligation and endoscopic sclerotherapy: a meta-analysis

https://doi.org/10.21203/rs.3.rs-5212335/v1

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Objective: Hemorrhoids are one of the most common benign anorectal diseases, and rubber band ligation is still the first-line nonsurgical treatment. Endoscopic treatment for hemorrhoidal diseases has become more popular in recent years. This paper aimed to comprehensively analyze and compare the therapeutic efficacy and prognosis of two common endoscopic treatments for hemorrhoidal diseases – ligation treatment and sclerotherapy – via a meta-analysis.

Methods: The PubMed, Cochrane Library, Web of Science, Embase, CNKI, and other databases were searched to include all eligible randomized controlled trials (RCTs) comparing endoscopic rubber band ligation (ERBL) and endoscopic sclerotherapy (EIS) since the establishment of each database. The Cochrane Risk Assessment Tool was used to evaluate the quality of all included studies.

Results: Based on the chosen inclusion and exclusion criteria, this study considered eight papers with a total of 824 cases. The combined effect sizes showed no significant difference in the overall efficacy of the two treatments. The subgroup analyses revealed that the prolapse relief/improvement was significantly higher with ERBL than with EIS. The occurrence of moderate/severe pain was significantly higher after ERBL than after EIS (OR = 4.18, 95% CI: 2.20–7.95, P < 0.0001).

Conclusion: ERBL was more effective in the improvement of prolapse and is preferable if prolapse is the main symptom. Although the incidence of pain after ERBL is relatively high, analgesics can be applied to alleviate the pain. No significant differences were noted in terms of recurrence.

hemorrhoids

endoscopy

ligation treatment

sclerotherapy

complications

recurrence

Hemorrhoids are one of the most common benign lesions of the anus and intestines. According to international epidemiological surveys, the incidence rate of hemorrhoids exceeds 50%, with China having the highest incidence globally (1–3). The main clinical symptoms of internal hemorrhoids include painless blood in the stool, prolapse, perianal skin irritation or itching, pain caused by thrombosis, and other related discomforts, seriously affecting the quality of life of patients. The mechanism of hemorrhoids has not yet been fully clarified, and the globally accepted theory is the “anal cushion sliding cushioning theory,” in which the anal cushion lies abnormally in the anal canal. Sliding is the main mechanism explaining the development of internal hemorrhoids(4, 5), and hemorrhoidectomy is the “gold standard procedure” for grade III–IV hemorrhoids (Goligher’s classification) (6). The most representative procedures are the Milligan-Morgan (open hemorrhoidectomy) and Ferguson (closed hemorrhoidectomy) procedures, and most of today’s hemorrhoidectomies are based on these two procedures. However, traditional surgical excision is associated with severe postoperative pain, higher costs, longer hospitalization, and impaired anal self-control and discrimination touch (7). Thus, more endoscopists have begun the routine use of soft endoscopy for the microinvasive treatment of hemorrhoids. Endoscopic treatment has mainly been used for ligation treatment and sclerotherapy in recent years. In sclerotherapy, sclerosants cause the occlusion of the capillaries in the hemorrhoids and fibrosis of the hemorrhoidal tissue, improving bleeding and prolapse symptoms. Currently, dodecyl alcohol, ALTA (aluminum potassium sulfate and tannic acid), saline, 50% dextrose solution, 5% almond oil with carbolic acid, and 5% ethanol solution are commonly used as sclerosants(8–12). In ligation, a rubber band is used to ligate the base of internal hemorrhoids to prevent blood supply to the hemorrhoidal nucleus, triggering tissue necrosis and detachment. However, there is a lack of relevant clinical guidelines and operational consensus to guide the microinvasive endoscopic treatment of internal hemorrhoids, and there are relatively few randomized controlled trials (RCTs) on endoscopy. Moreover, the conclusions of studies are inconsistent and need further research and analysis. Thus, this study conducted a meta-analysis to evaluate the efficacy of endoscopic rubber band ligation (ERBL) and endoscopic injection sclerotherapy (EIS) and compare the complications of the different treatments.

This study was conducted in strict accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria. We determined the correct descriptor terms via MeSH and used the descriptor terms combined with entry terms to search the PubMed, Embase, Cochrane, Web of Science, and CNKI databases. References were also screened to ensure the inclusion of relevant literature. We requested the full text and trial data from authors as necessary, with July 30, 2023, being the last date for this search.

Search formula

The search formula was as follows: (((“Sclerotherapy”[Mesh]) OR (Sclerotherapies[Title/Abstract])) AND ((((“Ligation”[Mesh]) OR (Ligations[Title/Abstract])) OR (Ligature[Title/Abstract])) OR (Ligatures[Title/Abstract]))) AND ((“Hemorrhoids”[Mesh]) OR (Hemorrhoid[Title/Abstract])).

Inclusion and exclusion criteria

Only RCTs were included. We excluded single-arm studies, studies related to multiple interventions, and studies whose full texts were unavailable. The included studies had to record statistical data on cure/improvement rates and postoperative complications. We also excluded case reports, conference abstracts, journal editorials, reviews, meta-analyses, retrospective studies, and studies related to the Cochrane Register of Controlled Trials alone. This study had no language restrictions.

Outcome measures

The outcomes of interest were the improvement of the patient’s symptoms (improved or cured) after the different treatments, and there was a separate analysis of relief or cure of several different symptoms. Data on postoperative complications were collected. Several individual complications were analyzed separately, such as pain, mainly in patients with moderate or higher severity (calculated using the visual analog scale [VAS]). Moreover, data related to hemorrhoidal recurrence were obtained.

Data extraction

All the retrieved studies were imported into Zotero, and duplicate studies were removed. The inclusion of studies was determined by two independent researchers who read the full text of the studies individually. Data were extracted from the studies that met the inclusion criteria by two researchers using a standardized data extraction form. The data included author names, year of publication, demographic characteristics, and number of patients, arms, postoperative outcomes, complications, and recurrences. Disagreements between the two researchers regarding the extracted data were resolved after discussion.

Quality assessment

Because the studies included in this meta-analysis were RCTs, the risk-of-bias table of the Cochrane Handbook for Systematic Reviews of Interventions was used for quality assessment. Seven of the eight included RCTs described a specific method of group randomization, with one study not specifying a method (13). Possible sources of risk of bias were allocation concealment and blinding sessions, with only three studies detailing the implementation of blinding and allocation concealment (14–16). No remaining risks of bias were identified. The qualities of the included studies were rated independently by the authors and another physician (Fig. 1). Publication bias could not be assessed because there were fewer than 10 included studies.

Statistical analysis

The study was statistically analyzed using RevMan 5.4. For dichotomous variables, the odds ratio (OR) was used as an indicator of joint effects. The I² test was used to assess heterogeneity. When heterogeneity was large (P < 0.1, I² > 50%), a random-effects model was selected. When the heterogeneity between studies was small (P ≥ 0.1, I² ≤ 50%), the fixed-effect model was used for analysis. Subgroup analysis was used for significant methodological or clinical heterogeneity.

The database search yielded 415 papers; 146 duplicates were removed, and 214 papers were excluded by reading the study titles and abstracts. The full texts of the remaining 42 studies were searched except for one whose text could not be obtained, and the authors did not respond when contacted. The full texts of the 41 studies were read, and we excluded 21 non-RCTs, five conference abstracts, and seven RCTs that did not include endoscopic surgery. Ultimately, eight randomized controlled studies were included in the meta-analysis (Fig. 2)(8, 13–15, 17–20). The eight studies included a total of 824 patients; 398 were treated with ERBL and 446 were treated with EIS. Seven of the included RCTs reported on hemorrhoids grading (8, 13–15, 18–20), and only one enrolled patients with grade IV hemorrhoids (20). The sclerosants used varied; four studies applied dodecyl alcohol as the hardener (14, 17–19), and one used 50% dextrose solution (16). A study applied 5% phenol (15), and two used ethanolamine oleate as the sclerosant (13, 20). The remaining characteristics of the included studies are shown in Table 1.

Treatment efficacy

Seven RCTs were included in the meta-analysis of treatment outcomes and improvement in prolapse, bleeding and other hemorrhoidal symptoms in patients was defined as effective. The final analysis showed that 273 of 365 patients in the ERBL group were treated effectively (efficiency rate of 74.8%), and 300 of 393 patients in the EIS group were treated effectively (efficiency rate of 76.3%). The final results showed no significant difference in the overall efficacy between the two treatments (OR = 1.02, 95% CI: 0.29–3.57, P = 0.98). Specificity analysis suggested a high degree of heterogeneity (Fig. 3), and subgroup analysis was performed to subdivide the study population.

Prolapse relief

Four RCTs were included in the meta-analysis of prolapse efficacy. Prolapse relief was noted in 108 of 122 cases in the ERBL group (treatment efficiency of 88.5%) and 89 of 118 cases in the EIS group (treatment efficiency of 75.4%). The results after combining effect sizes showed that prolapse relief was significantly higher in the ERBL group than in the EIS group (OR = 2.57, 95%CI: 1.28–5.17, P = 0.008), and heterogeneity was not statistically significant(Fig. 4).

Bleeding relief

Four studies were included in the meta-analysis of bleeding relief. Ninety-seven and 105 cases in the ERBL and EIS groups, respectively, achieved relief of bleeding symptoms after treatment. The combined effect size suggested that there was no significant difference between the two treatments in improving bleeding symptoms (OR = 0.89, 95% CI: 0.26–3.06, P = 0.85)(Fig. 5).

Recurrence

The difference in recurrence rate was not significantly different between the two treatment arms (OR = 0.90, 95% CI: 0.29–2.74, P = 0.46); eight studies were included in the analysis, with a recurrence rate of 14.7% in the ERBL group (53/361) and 16% in the EIS group (66/412)(Fig. 6).

Complications

Multiple complications were reported in all eight studies, and pain was the main outcome in this study. Five studies reported pain incidence and pain levels (8, 13–15, 17); three used a VAS to calculate the pain levels(14, 15, 17), and the remaining two studies used mild, moderate, or severe to describe the level of pain. Combining the effect sizes showed that the occurrence of moderate/severe pain was significantly higher after ERBL than after EIS (OR = 4.18, 95% CI: 2.20–7.95, P < 0.0001)(Fig. 7).

The most common hemorrhoid-related complaint is painless rectal bleeding or tissue prolapse during defecation (21). The treatment of hemorrhoids varies by country and grade. Conservative, instrumental, and surgical treatments have been recommended by guidelines or consensuses of various countries (5, 22–25). Conservative treatment mainly involves dietary therapy, such as increasing water and fiber intake, as well as the use of laxatives, phlebotonics, and analgesics. Alonso-Coello et al. reported in a meta-analysis that laxative application significantly improved bleeding symptoms (26). Moreover, the ESCP treatment guidelines and SICCR consensus clearly suggest that fiber laxatives reduce the risk of bleeding in patients with hemorrhoidal disease (22, 24). Phlebotonics are a heterogeneous class of drugs consisting of products derived directly from plants, such as flavonoids, or synthetic compounds, such as calcium dobesilate. The use of this class of drugs has been recognized by several national guidelines (22–25). Several high-quality meta-analyses have clearly reported that phlebotonics improve symptoms, such as bleeding, and reduce the risk of recurrence (27–29). The mechanism involved in the onset of action of phlebotonics is not fully understood and may be related to improved vascular tension, increased lymphatic drainage, and decreased capillary wall permeability. Despite the greater trauma, longer hospitalization period, and higher cost, surgical treatment is still the first choice for patients with grade III–IV hemorrhoidal disease or hemorrhoids combined with prolapse. Patients with grade II–III hemorrhoidal disease with poor results from outpatient treatment may also be considered for surgical treatment (22–25).

Outpatient treatments mainly include ligation, sclerotherapy, and infrared coagulation, which are commonly applied to failed conservative treatments for grade I–III hemorrhoids. The goal of outpatient treatment is to alleviate prolapse symptoms by reducing the size of the hemorrhoidal nucleus or the distribution of blood vessels or by increasing the fixation of hemorrhoidal tissues to the intestinal wall. Outpatient treatment has a precise therapeutic efficacy and fewer adverse effects compared with surgery (30)^,(31). Currently, ligation and sclerotherapy are the more commonly used outpatient treatments in clinical practice.

Traditional nonsurgical treatment in the outpatient setting utilizes rigid instruments, which limits visualization and introduces operative difficulty. Endoscopic treatment can combine traditional ligation with the advantages of endoscopic visualization. Moreover, with the recent advances in clinical technology and the development of microinvasive treatment, more endoscopists are attempting to treat hemorrhoids using flexible endoscopy. Trowers first reported endoscopic ligation for hemorrhoids in 1998, and the treatment was effective in more than 90% of patients(32). Charles et al. reported on ERBL for treating grade II–III hemorrhoids in a prospective study, concluding that endoscopic treatment for hemorrhoids is safe and effective (33). Wehrmann compared the safety and efficacy of rigid anoscopy and flexible endoscopy in the treatment of grade II–III hemorrhoids in a prospective RCT and concluded their efficacies and safeties were comparable; however, the frequency of treatments required for flexible endoscopy was significantly reduced (34). Su et al. studied 759 patients who underwent ERBL and followed up postoperative patients for a mean period of 55 months and concluded that endoscopic ligation has good long-term results.

Similarly, several recent studies have shown that applying EIS to hemorrhoids is efficacious, with few serious adverse effects. Xie et al. included 201 patients with a median follow-up of 33 months in a large-sample retrospective study in which they reported on the long-term effectiveness of the endoscopic treatment of hemorrhoids (35). Xia et al. designed a prospective, multicenter, large-sample clinical trial in which the convenience, safety, and efficacy of EIS were similarly demonstrated (36, 37). Ponsky et al. first reported the application of endoscopy, with 23.4% saline as a sclerosant, during sclerotherapy in 19 patients with hemorrhoidal disease in 1991; the effect of EIS on bleeding relief was very effective and had a low complication rate (38). Complications of EIS treatment are relatively few and mild, mainly due to imprecision regarding the injection site. Flexible endoscopy, with its visualization advantages, allows for more precise injections, and the possibility of reversing the endoscope allows for clearer exposure of the hemorrhoidal nucleus.

Recent studies have shown that conventional RBL has a higher efficacy rate than EIS and a relatively low recurrence rate (22, 39). In contrast, ERBL and EIS have emerged as nonsurgical treatments in recent years, and relatively few studies have compared these two treatments, with some having very different conclusions. This study analyzed articles on both treatments and concluded that both treatments have favorable outcomes; however, for the relief of prolapsed hemorrhoids, ERBL is even more advantageous. There was no significant difference between the two modalities in terms of relief in bleeding, and recurrence rates were similar for both treatments. However, the incidence of pain was significantly higher after ERBL than after EIS. This may be related to high local mucosal tension after lancing.

This paper has some limitations. First, there were few relevant RCTs, the effect sizes of the included comparisons were low and the methodological quality of some of the studies was not high; these factors may have affected the accuracy of the conclusions. Further studies on the length of surgery, hospitalization period, and cost of these two treatments, as well as a longer period of follow-up and higher-quality, larger-scale RCTs may be needed to verify our conclusions and guide clinical practice.

With the development of microinvasive technology and the gradual recognition of endoscopic treatment by patients, the endoscopic treatment of hemorrhoids may gradually become the mainstream outpatient treatment and even replace traditional rigid endoscopy. This study indicates that ERBL and EIS have satisfactory efficacy, with no significant difference in recurrence rates between the two treatments. Patients who have hemorrhoids, with prolapse as the main clinical symptom, can be prioritized for ERBL. However, the incidence of pain may be higher with ERBL than with EIS. The need for routine analgesia and the choice of analgesic may need to be confirmed by further follow-up studies.

Author Contributions

Conception and design: Weijie Wang, Geng Chen

Analysis and interpretation of data: Weijie Wang, Xiaohua Bao, Geng Chen

Drafting of the article: Weijie Wang, Xuanhan Li

Critical revision of the article for important intellectual content: Geng Chen

Final approval of the article: Weijie Wang, Xuanhan Li, Geng Chen

Acknowledgments

Declaration of funding interests: This work was supported by Jilin Provincial Finance Department (No.2021LC010)

Disclosures

Weijie Wang, Xiaohua Bao, Xuanhan Li, Geng Chenhave no conflicts of interest or financial ties to disclose.

Ethical Approval

not applicable

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Table 1 is available in the Supplementary Files section.

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Treatment of internal hemorrhoids: comparison of the efficacy and complications of endoscopic rubber band ligation and endoscopic sclerotherapy: a meta-analysis

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Abstract

Figures

INTRODUCTION

METHODS

Search formula

Inclusion and exclusion criteria

Outcome measures

Data extraction

Quality assessment

Statistical analysis

OUTCOME

Treatment efficacy

Prolapse relief

Bleeding relief

Recurrence

Complications

DISCUSSION

CONCLUSION

Declarations

References

Table

Additional Declarations

Supplementary Files

Status:

Version 1