Efficacy and safety of bipolar energy-based therapy for hemorrhoids: a systematic review

Literature search strategy

The authors performed a thorough literature search from several databases (PubMed/Medline, Embase, CINAHL, Cochrane, Web of Science, and Google Scholar) using various keywords in the search engine, including “internal”, “external”, “mixed”, “hemorrhoid,” “bipolar therapy,” “hemorrhoid energy therapy (HET)”, “HET bipolar system,” “grade I hemorrhoid,” “grade II hemorrhoid,” “grade III hemorrhoid,” “grade IV hemorrhoid,” and “nonsurgical” in the search engine, from inception to July 18^th, 2024. The initial literature search was independently performed by 2 authors (KMT and RV), who reviewed the title and abstract of each study. Any discrepancies in the article section were reviewed by other 2 authors (BSD and DA). Full texts of the remaining articles were retrieved for additional review. The “References” sections of these articles were also examined to identify additional articles that met the inclusion criteria. The literature search and study selection were conducted in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA) criteria (Supplementary Fig. 1).

Eligibility criteria

Specific inclusion criteria were used in selecting articles. These included: 1) the use of bipolar energy therapy for the management of hemorrhoids; 2) patients 18 years of age or older; 3) a sample size of at least 10 patients; 4) patient demographic descriptions; and 5) articles and abstracts published in the English language. To avoid data duplication, included studies were also reviewed to ensure that the timeframe and location of the studies did not overlap. Exclusion criteria included: 1) case reports, case series, and surveys; 2) studies that did not use bipolar energy therapy; 3) studies that used surgical techniques; 4) studies without pertinent patient data; 5) studies with non-human subjects; 6) subjects with participants <18 years old; 7) studies with sample size < 10; and 8) studies published in languages other than English.

Data extraction and quality assessment

Data pertinent to outcomes of interest were extracted into a standardized form. The Newcastle–Ottawa Scale (NOS) was used to assess the methodological quality of the included cohort studies, with each study labeled as “low”, “moderate” or “high” quality [14]. For randomized controlled trials (RCTs), the Revised Cochrane risk-of-bias tool (RoB) was used: each individual domain was used to rate each RCT as high, low, or some concern [15]. Quality appraisal for each study was performed independently by multiple authors (KMT, KR, RV, DA). The NOS and RoB assessments are illustrated in Supplementary Tables 1 and 2, respectively.

Study outcomes and definitions

The primary endpoint of our systematic review was technical success and clinical success. Technical success was defined as successful administration of HET to the desired area, while clinical success consisted of complete resolution of symptoms directly related to hemorrhoids, such as rectal bleeding, pain and/or prolapse after HET at a 3-month follow up.

The secondary outcomes assessed were total adverse effects, as well as individual adverse effects such as bleeding and pain. Adverse effects were further stratified by severity, based on the American Society for Gastrointestinal Endoscopy (ASGE) lexicon [16].

Study selection and characteristics of included studies

Eight studies, including a total of 512 patients, were included in the final analysis [13,17-23]. These studies included 3 prospective cohort studies [17,20,22], 4 retrospective cohort studies [13,19,21,23], and 1 randomized controlled trial [18]. All studies were single-center studies and were performed in the United States, except for the study by Filgate et al [18], which was conducted in New Zealand. In 7 of the studies, 54.22% (n=270) of patients were female and 45.78% (n=228) were male; Filgate et al [18] did not report the patients’ sex (n=14). The mean patient age was 55.6 years (Table 1).

Table 1 Demographic data of included studies

The most common presenting symptom was bleeding, which was reported in 460 (89.8%) cases, followed by pain, seen in 88 (17.2%) patients. Of the total cases, 48.6% (n=249) were classified as grade I hemorrhoids, while 42.4% (n=217) were grade II, and 3.5% (n=18) were grade III. In 28 (5.5%) cases, the grade of the hemorrhoids was not reported.

Quality assessment

As determined by the NOS, 2 cohort studies were of low quality [19,20] and 5 cohort studies were determined to be of moderate quality [13,17,21,22,23] (Supplementary Table 1). The study by Filgate et al [18] was determined by the Cochrane RoB tool to have a low risk of bias (Supplementary Table 2).

Outcomes

The outcomes of our analysis showed 100% technical success (412/412), while the clinical success rate was 86.1% (404/469). Most studies reported only the number of patients with complete resolution; only Kothari [17] reported the number of patients with a partial response (Table 2). Malik et al [19] did not report technical success or failure information, but 96 of 100 patients achieved clinical success in their cohort. Regarding clinical failures, 11/100 patients in the Peng et al [23] cohort, 4/100 in the study by Malik et al [19], and 8/27 in the Studniarek et al [22] group showed persistent symptoms without improvement; no such data were available from the other 5 studies. The recurrence rates were reported in 2 studies (Kantsevoy et al [13] and Patel et al [21]), with an average of 19.3% (Table 2).

Table 2 Technical and clinical outcomes

Adverse effects

Adverse events were reported in 71 (13.9%) patients, with bleeding seen in 43 patients (8.4%). Of those, 70 (98.6%) were classified as mild adverse events based on the ASGE lexicon. In the study by Filgate et al [18], 1 patient had a severe adverse event, involving perianal thrombosis, which necessitated readmission and required 21 days of work. No deaths were reported during these procedures.