Current Status and Consensus on the Use of Injectable Treatment for Hemorrhoids in China: A Cross-sectional Study

HUO Xingxiao, SUN Songpeng*, LONG Junhong, LIANG Longyu, CHU Hongchuan, ZHOU Yangyang, LIU Yan, LIU Jiaxin

Department of Anorectology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China

*Corresponding author: SUN Songpeng, Chief physician; E-mail: sspbeijing@126.com

Abstract

Background: Hemorrhoids are among the most common anorectal diseases, and injection therapy represents a widely used treatment modality. However, national data regarding the depth of application and standardized usage of injection therapy remain scarce, necessitating this investigative study.

Objective: To explore the current depth and breadth of hemorrhoid injection therapy implementation in China, its standardized application, effectiveness and safety, and the reasons for its non-adoption.

Methods: An online questionnaire was distributed to members of the Professional Committee of Anorectal Diseases of the Chinese Association for Medical Education between July and November 2022. The self-designed instrument comprised 37 questions covering demographic information, hemorrhoid treatment methods, injection therapy utilization, and complications. Statistical analysis was performed using SPSS 21.0 software.

Results: A total of 335 questionnaires were collected, with 312 valid responses (93.1% response rate). Among respondents, 293 doctors (93.9%) used sclerotherapy, and 153 (54.2%) had performed over 500 injection procedures. No statistically significant differences were observed in the number of injection therapies performed across different hospital levels, ownership types, or categories (P>0.05). A total of 293 (93.9%) and 263 (84.3%) physicians considered injection therapy appropriate for internal hemorrhoids and the internal component of mixed hemorrhoids, respectively. For Grade I and II internal hemorrhoids, sclerotherapy accounted for 55.4% (173/312) and 79.2% (247/312) of treatments, respectively. Regarding anesthesia, local anesthesia was used in 229 cases (73.4%) and spinal anesthesia in 145 cases (46.5%). Xiaozhiling injection was used by 280 physicians (89.7%), making it the most commonly employed sclerosing agent. A total of 201 doctors (64.4%) treated three hemorrhoids in a single session. For anterior anal hemorrhoids, 140 physicians (44.9%) believed injection was appropriate, while 172 (55.1%) considered it contraindicated. Dosage analysis revealed that Xiaozhiling single-site injections concentrated at 1–5 mL (80.7%, 92 respondents), with low-dose (0–3 mL) regimens comprising 56.7% (59/104). Although 233 physicians (74.7%) endorsed the curative potential of injection monotherapy, 227 (88.8%) combined it with other procedures in clinical practice, with hemorrhoidectomy accounting for 64.7% (202/312). The estimated 1-year recurrence rate of <10% for injection monotherapy was reported by 90.3% (233/258) of doctors, decreasing to 58.9% (146/248) at the 5-year assessment. Complication rates included anal pain (134 cases, 42.9%), urinary retention (90 cases, 28.8%), and injection site induration (182 cases, 58.3%) as common adverse reactions. Serious complications included perianal abscess (5.1%, 16 cases), sepsis (1.3%, 4 cases), and rectal perforation (1.6%, 5 cases). Among reasons for not performing injection therapy, 15 physicians (35.7%) cited hospital management factors, 9 (21.4%) mentioned pricing issues, 8 (19.0%) questioned efficacy, and 6 (14.3%) reported drug shortages.

Conclusion: Hemorrhoid injection therapy has gained widespread recognition and adoption among anorectal physicians in China, with 93.9% of doctors performing this therapy and over 54.2% having conducted more than 500 cases, with no significant differences across hospital levels and types. At least 55.4% of physicians appropriately mastered the indications, with Grades I–II internal hemorrhoids more likely to receive injection therapy. Xiaozhiling is the most commonly used sclerosing agent, with three hemorrhoids typically treated per session. Injection therapy demonstrates confirmed efficacy, with 90% of physicians reporting 1-year recurrence rates <10%, and long-term recurrence data supporting its reliability. However, nearly 90% of physicians prefer combining injection with other procedures, reflecting insufficient confidence in monotherapy and highlighting the need to clarify the symptom-relief goal of device-based therapy and strengthen physician-patient communication. As a safe and effective hemorrhoid management modality, injection therapy is suitable for nationwide promotion, though standardized operation training and complication prevention systems require strengthening.

Keywords: Hemorrhoids; Injection therapy; Current application status; Sclerosing agents; Complications

Introduction

Hemorrhoidal disease (HD) is a common and highly prevalent anorectal condition, with a morbidity rate of 49.14% among Chinese urban and rural residents [1], and similar prevalence rates among urban residents aged 25–64 years [2]. Studies indicate that 23.7% of patients receiving conservative treatment ultimately require non-conservative interventions [3]. Contemporary patients, particularly younger individuals, increasingly prefer minimally invasive, less painful treatments with rapid recovery [4]. Injection therapy offers simple operation, favorable safety profiles [5-6], minimal postoperative anal pain and discomfort [7], and can be performed in outpatient settings [5,7-8], meeting current patient demands. Most guidelines highly recommend this approach for Goligher Grades I–III internal hemorrhoids [4,7-8].

Injection therapy for hemorrhoids began in 1869 when Morgan [9] first reported successful cases using iron persulfate injection. In 1979, Andrews [10] documented 3,000 cases treated with phenol in olive oil or glycerin mixtures. During the 1920s–1930s, injection therapy became a common treatment modality [11], with 5% phenol being the most widely used sclerosing agent, though quinine and other agents were also reported [12]. The emergence of modified traditional techniques and new technologies—including rubber band ligation [13], hemorrhoidal artery ligation [14], and procedure for prolapse and hemorrhoids (PPH) [15]—with their favorable efficacy and reduced postoperative pain, gradually decreased the use of injection therapy. In the 21st century, hemorrhoid surgery has evolved in two directions: traditional techniques enhanced by new devices, and minimally painful, minimally invasive procedures [16]. The application of polidocanol foam as a sclerosing agent in 2007 injected new vitality into injection therapy [16].

China has also achieved remarkable success in hemorrhoid injection therapy based on traditional Chinese medicine theory. Xiaozhiling injection was successfully developed between 1975–1977, and its novel therapy for internal hemorrhoids passed expert evaluation in 1979 [17], with one study demonstrating 99% efficacy in 21,148 cases and a 3-year recurrence rate of 1% [18]. In the early 1990s, Shaobei injection gained widespread application [19], and Fantengzhi injection was successfully developed in 2006 [20], contributing to the substantial development of hemorrhoid injection therapy in China. However, in the early 21st century, the adoption of PPH and rubber band ligation techniques temporarily reduced the prominence of injection therapy. In recent years, with increasing patient demand for minimal pain and rapid recovery, injection therapy has regained attention, with new guidelines and consensus statements being issued successively [5-6,17,21-22].

This study conducted a questionnaire survey among members of the Professional Committee of Anorectal Diseases of the Chinese Association for Medical Education to investigate the current application status of hemorrhoid injection therapy in China and anorectal physicians' attitudes toward this treatment modality.

Methods

Study Subjects

Between July and November 2022, an online questionnaire was distributed to committee members of the Professional Committee of Anorectal Diseases of the Chinese Association for Medical Education. Inclusion criteria were: (1) anorectal specialists; (2) currently practicing; (3) able to complete the questionnaire independently. Exclusion criteria were: (1) no surgical practice within the past five years; (2) unwillingness to participate; (3) psychiatric disorders.

Study Design

This cross-sectional study employed a self-designed questionnaire comprising 37 questions covering demographic information, hemorrhoid treatment methods, combination with other modalities, sclerotherapy utilization rates, and adverse reactions. Specific questions are detailed in the appendix. The questionnaire was distributed online via Wenjuanxing software to committee members of the Professional Committee of Anorectal Diseases of the Chinese Association for Medical Education.

Internal hemorrhoid grading followed the Goligher classification system [7], dividing internal hemorrhoids into four grades: Grade I: bleeding without prolapse; Grade II: prolapse with spontaneous reduction; Grade III: prolapse requiring manual reduction; Grade IV: irreducible prolapse.

This study was approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine (Ethics approval number: 2022DZMEC-302-01) and adhered to the Declaration of Helsinki.

Statistical Analysis

Data were processed using SPSS 21.0 software. Normally distributed continuous variables were expressed as (x̄±s), while non-normally distributed continuous variables were expressed as M(P25, P75). Categorical data were expressed as frequency (percentage), with inter-group comparisons performed using χ² tests. Statistical significance was defined as P<0.05.

Results

Demographic Characteristics

A total of 335 questionnaires were collected, yielding 312 valid responses after excluding duplicates, for an effective response rate of 93.1%. Questionnaire completion times ranged from 225 to 3,860 seconds. All participants were anorectal specialists currently practicing or still engaged in anorectal work, representing 32 provinces, autonomous regions, and municipalities directly under the central government (excluding Hong Kong, Macao, and Taiwan). Demographic characteristics are presented in [TABLE:1].

Depth and Breadth of Hemorrhoid Injection Therapy Application in China

Regarding hemorrhoid treatment, 101 physicians (32.4%) reported that approximately 1/10 of their patients received injection therapy, while 40 (12.8%), 36 (11.5%), and 67 (21.5%) reported treatment rates of 1/5, 1/3, and 1/2, respectively. Forty-nine physicians (15.7%) applied injection therapy to all hemorrhoid patients, while 19 (6.1%) reported not currently performing injection therapy.

Among 282 physicians who responded regarding injection therapy case volumes, 51 (18.1%) had performed fewer than 100 cases, 78 (27.7%) had performed 100–500 cases, 28 (9.9%) had performed 500–1,000 cases, 95 (33.7%) had performed over 1,000 cases, and 30 (10.6%) had performed over 10,000 cases. No statistically significant differences were observed in injection therapy volumes across hospital levels, ownership types, or categories (P>0.05), as shown in [TABLE:2].

Standardization of Hemorrhoid Injection Therapy

According to Goligher grading, physicians' treatment selections for each hemorrhoid grade are detailed in [TABLE:3]. For Grade I internal hemorrhoids, conservative treatment was most common (281/312, 90.1%), followed by injection therapy (173/312, 55.4%). For Grade II internal hemorrhoids, sclerotherapy was most prevalent (247/312, 79.2%), followed by conservative treatment (217/312, 69.6%). For Grade III internal hemorrhoids, excisional hemorrhoidectomy was most common (275/312, 88.1%), followed by rubber band ligation (235/312, 75.3%) and injection therapy (222/312, 71.2%). For Grade IV internal hemorrhoids, excisional hemorrhoidectomy predominated (290/312, 92.9%), followed by rubber band ligation (208/312, 66.7%).

Regarding sclerosing agents, Xiaozhiling injection was used by 280 physicians (89.7%), making it the most commonly employed agent, followed by Shaobei injection (70 physicians, 22.4%), Fantengzhi injection (14 physicians, 4.5%), polidocanol (46 physicians, 14.7%), and lauromacrogol (62 physicians, 19.9%). Seven physicians (2.2%) reported using other sclerosing agents, while none reported using phenol.

For the number of hemorrhoids treated per session, 3 physicians (1.0%) reported treating one hemorrhoid, 26 (8.3%) treated two, 201 (64.4%) treated three, 46 (14.7%) treated four, and 36 (11.5%) treated five. Regarding anterior anal hemorrhoids, 140 physicians (44.9%) considered injection appropriate, while 172 (55.1%) deemed it contraindicated.

Among 114 physicians who reported Xiaozhiling injection dosage per hemorrhoid, 2 (1.8%) injected 0.5 mL, 92 (80.7%) injected 1–5 mL, 13 (11.4%) injected 5–10 mL, 1 (0.9%) injected 15–20 mL, and 6 (5.3%) injected 20–60 mL. Among 104 physicians using Xiaozhiling, 59 (56.7%) selected 0–3 mL per site, 20 (19.2%) chose 3–5 mL, 19 (18.2%) chose 6–10 mL, and 6 (5.7%) chose 10–30 mL. For Shaobei injection (14 physicians), 10 (71.4%) injected 1–5 mL per hemorrhoid, 1 (7.1%) injected 10 mL, and 3 (21.4%) injected 20 mL. For polidocanol (10 physicians), 2 (20.0%) injected 0.2–1 mL, and 4 (40.0%) injected 1–4 mL. For lauromacrogol (13 physicians), 1 (7.7%) injected 0.5 mL, 8 (61.5%) injected 1–2 mL, and 4 (30.7%) injected 2–4 mL. One physician reported using sodium morrhuate at 2 mL per site, and another reported using Fantengzhi at 0.5–1 mL per site.

Regarding treatment setting, 97 physicians (31.1%) performed injection therapy in outpatient clinics, while others required hospitalization. For anesthesia selection, 75 physicians (24%) believed no anesthesia was necessary, 229 (73.4%) used local anesthesia, 88 (28.2%) used epidural anesthesia, 145 (46.5%) used spinal anesthesia, 122 (39.1%) used sacral anesthesia, 48 (15.4%) used intravenous general anesthesia, and 9 (2.9%) used endotracheal general anesthesia.

Effectiveness and Safety of Hemorrhoid Injection Therapy

A total of 233 physicians (74.7%) believed that sclerotherapy alone could cure hemorrhoids, while 54 (17.3%) disagreed and 25 (8.0%) were uncertain. Only 35 physicians (11.2%) frequently used injection therapy alone, while 277 (88.8%) primarily combined injection with other procedures. The main combined procedures included rubber band ligation (85 physicians, 27.2%), hemorrhoidectomy (202 physicians, 64.7%), PPH (14 physicians, 4.5%), and other procedures (11 physicians, 3.5%).

[TABLE:4] presents physicians' assessments of 1-, 3-, and 5-year recurrence rates following injection monotherapy. The proportion reporting recurrence rates <10% was 90.3% (233/258) at 1 year, 69.8% (176/252) at 3 years, and 58.9% (146/248) at 5 years.

Among patients receiving injection therapy alone, physicians reported the following complications: anal pain (134 physicians, 42.9%), urinary retention (90 physicians, 28.8%), fever (55 physicians, 17.6%), allergic reactions (11 physicians, 3.5%), injection site ulceration (46 physicians, 14.7%), injection site induration (182 physicians, 58.3%), perianal abscess (16 physicians, 5.1%), anal fistula (4 physicians, 1.3%), necrotizing fasciitis (3 physicians, 1.0%), prostatic infection or abscess (2 physicians, 0.6%), pelvic/abdominal infection (5 physicians, 1.6%), sepsis (4 physicians, 1.3%), rectal perforation (5 physicians, 1.6%), rectovaginal fistula (1 physician, 0.3%), rectourethral fistula (1 physician, 0.3%), and other complications (43 physicians, 13.8%). Among the 5 physicians reporting pelvic/abdominal infection, 4 (80.0%) also reported rectal perforation, 3 (60.0%) reported necrotizing fasciitis, 3 (60.0%) reported sepsis, and 1 (20.0%) reported prostatic infection or abscess, rectovaginal fistula, and rectourethral fistula.

Reasons for Not Performing Injection Therapy

Forty-two physicians analyzed reasons for not performing hemorrhoid injection therapy. Eight (19.0%) cited poor efficacy, 15 (35.7%) identified hospital management issues, 9 (21.4%) mentioned pricing problems, and 6 (14.3%) reported drug shortages. Additionally, 6 physicians (14.3%) considered it a technical issue preventing sclerotherapy implementation.

Discussion

This research group conducted a nationwide survey with support from the Professional Committee of Anorectal Diseases of the Chinese Association for Medical Education. The study included participants from 32 provinces, autonomous regions, and municipalities (excluding Hong Kong, Macao, and Taiwan), representing hospitals at all levels (from primary to tertiary Grade A) and various types (public and private, traditional Chinese medicine and Western medicine), indicating that our data reflect the national status of hemorrhoid injection therapy.

This study investigated four aspects of hemorrhoid injection therapy nationwide: (1) depth and breadth of implementation; (2) standardized application; (3) effectiveness and safety; and (4) specific reasons for non-adoption.

Our results show that only 6.1% of anorectal specialists do not perform injection therapy, while over 54.2% have conducted more than 500 cases, with no significant differences across hospital levels or types. This demonstrates widespread acceptance of injection therapy among physicians nationwide. The indications for injection therapy include conservative treatment-refractory Goligher Grades I–III internal hemorrhoids and Grade IV internal hemorrhoids in patients unwilling or unsuitable for surgery [4,6-8]. Our findings indicate that the vast majority of anorectal physicians understand these indication principles, though a small minority inappropriately consider it for external hemorrhoids, highlighting the need for enhanced education to standardize practice and protect patient interests.

The Goligher grading system is the primary tool for assessing internal hemorrhoid severity, with most guidelines [4,6-8] using it to direct treatment. One survey found that 63% of physicians base treatment decisions on Goligher grading [24]. Hemorrhoid treatment options include conservative therapy, device-based treatments such as injection and rubber band ligation [4] or office-based procedures [7-8], and surgical interventions like hemorrhoidectomy or PPH [4,7-8], with increasing invasiveness. Current guidelines recommend conservative therapy as first-line for all internal hemorrhoid patients [4,7-8], followed by device-based (office) treatments. Device and surgical treatments show similar efficacy for Grade II hemorrhoids, but device therapy carries lower complication rates, while surgery demonstrates superior efficacy for Grade III hemorrhoids [25]. Studies show comparable efficacy between rubber band ligation and PPH for Grade III and mild Grade IV hemorrhoid prolapse, though ligation has higher recurrent bleeding rates but lower pain and procedure-related complications [26]. Higher Goligher grades correlate with poorer device therapy outcomes compared to surgery, but with milder complications such as anal pain. Therefore, the American Society of Colon and Rectal Surgeons Clinical Practice Guidelines [7] and the Chinese Guidelines for Hemorrhoid Diagnosis and Treatment [4] explicitly state that surgical treatment may be selected after failed device therapy.

Both injection and ligation are minimally invasive, minimally painful, effective, office-based procedures. Although Western countries prefer rubber band ligation [27], studies [28-29] demonstrate similar efficacy and safety between the two modalities, with injection therapy causing less postoperative anal pain, making it a more logical first choice. The Chinese Expert Consensus on Hemorrhoid Injection Therapy (2023 Edition) [6] recommends injection therapy as first-line for conservative treatment-refractory Grades I–III internal hemorrhoids, with Grade IV hemorrhoids also being eligible. Given patients' demands for rapid recovery, 96.7% of experts consider injection therapy suitable for day surgery [30]. Our findings reflect Chinese anorectal physicians' consensus on hemorrhoid treatment strategies: conservative therapy as the foundation, with device-based treatments as secondary options, showing preference for injection therapy in Grades I–II and surgical excision in Grades III–IV.

At the operational level, this study demonstrates that injection therapy can be performed in outpatient settings without anesthesia, making it particularly suitable for day surgery. China offers more sclerosing agent options than Western countries, with Xiaozhiling being the most widely used, followed by Shaobei, and with Fantengzhi, lauromacrogol, and polidocanol also in use. Phenol, once widely used, is no longer employed by any surveyed physicians. Most practitioners treat three hemorrhoids per session, while over half consider anterior anal hemorrhoids unsuitable for injection.

The efficacy reported by our participants supports the Chinese Expert Consensus on Hemorrhoid Injection Therapy (2023 Edition) [6]. Over 90% of physicians reported 1-year recurrence rates below 10%, nearly 70% reported 3-year rates below 10%, and nearly 60% reported 5-year rates below 10%, consistent with current research findings [6].

However, injection therapy-related complications require continued attention. Injection site induration remains the most common complication, with massage at the injection site to distribute the medication evenly being key to prevention [17]. Additionally, many patients experience acute post-procedure complications such as anal pain, urinary retention, and allergic reactions, requiring physicians performing day-surgery injections to have appropriate management protocols. Although injection therapy is very safe, rare severe complications including rectal perforation, pelvic/abdominal infection, sepsis, rectovaginal fistula, and rectourethral fistula do occur, with international case reports documenting similar events [31-33], underscoring the need for cautious, standardized technique.

While injection therapy is generally safe and effective, this study found that although over 70% of physicians believe monotherapy is effective, nearly 90% still combine injection with other procedures. This may reflect insufficient confidence in injection therapy alone or Chinese physicians' pursuit of definitive cure. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines [7] explicitly state that device therapy aims to reduce hemorrhoid size and alleviate symptoms. Therefore, thorough communication with patients to clarify treatment goals is essential before performing independent injection therapy. Additionally, consensus on the definition of post-hemorrhoidectomy recurrence has not yet been established and requires future clarification.

Limitations

This study has several limitations. First, as a cross-sectional survey, it has inherent temporal constraints, with recurrence and complication rates relying on respondents' subjective assessments, potentially introducing recall bias or subjective error. Second, the comprehensive questionnaire may have caused fatigue among some participants, affecting response accuracy and introducing information bias that could compromise data validity.

Conclusion

Injection therapy represents a common and widely accepted hemorrhoid treatment modality among anorectal physicians, with low recurrence rates and minimal adverse reactions. It can be used independently or in combination with other procedures, causes fewer complications than surgical methods, and warrants implementation across all hospital levels. However, standardized operation training and complication prevention and control systems require strengthening.

Author Contributions

HUO Xingxiao: conceptualization, design, data collection, data curation, statistical analysis, interpretation of results, figure/table preparation, manuscript writing. SUN Songpeng: data curation, overall responsibility, supervision, review and revision. LONG Junhong: content oversight. LIANG Longyu, CHU Hongchuan, ZHOU Yangyang, LIU Yan, LIU Jiaxin: data collection and curation.

Conflicts of Interest: None declared.

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Received: March 8, 2025; Revised: May 24, 2025

Edited by JIA Mengmeng