The Efficacy and Safety of <italic>Jeoryeong-tang</italic> (Zhu Ling Tang) for Postoperative Benign Prostatic Hyperplasia Patients: A Protocol for a Systematic Review and Meta-analysis

Seokyung Park; Jisoo Baek; Seonmi Shin; Sojung Park; Chungsik Cho

doi:10.22246/jikm.2025.46.6.1572

The Journal of Internal Korean Medicine > Volume 46(6); 2025 > Article

Park, Baek, Shin, Park, and Cho: The Efficacy and Safety of Jeoryeong-tang (Zhu Ling Tang) for Postoperative Benign Prostatic Hyperplasia Patients: A Protocol for a Systematic Review and Meta-analysis

Original Article

The Journal of Internal Korean Medicine 2025; 46(6): 1572-1585.

Published online: December 30, 2025

DOI: https://doi.org/10.22246/jikm.2025.46.6.1572

The Efficacy and Safety of Jeoryeong-tang (Zhu Ling Tang) for Postoperative Benign Prostatic Hyperplasia Patients: A Protocol for a Systematic Review and Meta-analysis

Seokyung Park¹, Jisoo Baek², Seonmi Shin³, Sojung Park⁴, Chungsik Cho²

¹ Dept. of Education & Research, Seoul Korean Medicine Hospital of Daejeon University

² Dept. of Internal Korean Medicine, College of Korean Medicine, Dae-Jeon University

³ Dept. of Internal Medicine, College of Korean Medicine, Se-Myung University

⁴ Pusan National University, School of Korean Medicine, Korean Medicine Hospital of Pusan University

·Corresponding author: Chungsik Cho Dept. of Internal Korean Medicine, College of Korean Medicine, Dae-Jeon University, 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea TEL: 02-2222-8201 FAX: 02-2222-8111 E-mail: choo1o2@dju.kr

·This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea. (RS-2022-KH127462)

·The authors have no conflicts of interests to disclose.

·Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.

Received December 15, 2025 Revised December 18, 2025 Accepted December 18, 2025

This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background:

This study will conduct a systematic review and meta-analysis to evaluate the efficacy and safety of Jeoryeong-tang for postoperative benign prostatic hyperplasia (BPH) patients.

Methods:

The following electronic databases will be searched: MEDLINE (PubMed), EMBASE, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Citation Information by NII, Korean Information Service System, Korean Medical Database, Oriental Medicine Advanced Searching Integrated System, ScienceON, and Research Information Sharing Service. Randomized controlled trials (RCTs) assessing Jeoryeong-tang with or without conventional treatment will be included. Primary outcomes will include the International Prostate Symptom Score (IPSS), while secondary outcomes will assess quality of life (QoL), urinary function, and adverse effects. Data synthesis will be performed according to Cochrane methodology.

Results:

This review will evaluate the therapeutic effects and safety of Jeoryeong-tang by analyzing reported outcomes and adverse effects.

Conclusion:

This systematic review will provide evidence regarding the efficacy and safety of Jeoryeong-tang in postoperative BPH patients.

Keywords: benign prostatic hyperplasia, postoperative care, Jeoryeong-tang, East Asian herbal medicine, protocol, systematic review, meta-analysis

1. Introduction

Benign prostatic hyperplasia (BPH) is a prevalent condition among aging men, characterized by lower urinary tract symptoms (LUTS), including residual urine, urinary urgency, weak urinary stream, abdominal straining during urination, and delayed urination. BPH is diagnosed based on the presence of prostate enlargement, urinary obstruction, and LUTS¹. Globally, reported cases of BPH have increased from 51.1 million in 2000 to 94 million in 2019². Histological studies indicate a prevalence of 8% in men in their 40s, 50% in their 60s, and 80% in their 90s. Prostate size increases with age, serving as a risk factor for LUTS and BPH progression³. LUTS in BPH can result from both direct obstruction due to prostate enlargement and secondary bladder changes caused by bladder outlet obstruction (BOO). Bladder decompensation involves alterations in microcirculation, extracellular matrix composition, neural function, and smooth muscle dynamics, often due to ischemia and increased intravesical pressure. Over time, elevated intravesical pressure raises oxygen demand, contributing to bladder dysfunction⁴. The evaluation and diagnosis of BPH begin with a comprehensive initial assessment, including a detailed medical history, physical examination, the International Prostate Symptom Score (IPSS) to quantify symptom severity, and urinalysis to rule out other conditions. Patients should be counseled on available management options, ranging from lifestyle modifications and medical therapy to procedural interventions. Follow-up evaluations are recommended 4 to 12 weeks after initiating treatment to assess therapeutic response. These evaluations include re-assessment with IPSS and, if necessary, additional tests such as post-void residual (PVR) measurement and uroflowmetry. In cases where symptoms persist or worsen despite medical management, further diagnostic workup and alternative treatments, including surgery, should be considered. Before surgical or minimally invasive interventions, preoperative assessments such as prostate imaging (via ultrasound, MRI, or CT), cystoscopy, PVR measurement, uroflowmetry, and pressure flow studies may be performed when diagnostic uncertainty exists. Clinicians should also discuss the possibility of treatment failure and the need for additional interventions with patients considering procedural options⁴. The primary goals of BPH treatment are to improve the quality of life by managing LUTS, reduce the risk of acute urinary retention, and prevent or slow deterioration of bladder function. Treatment strategies are determined based on symptom severity, measured by the IPSS, and diagnostic test results. Available options include lifestyle modifications, watchful waiting, pharmacotherapy, and surgical interventions⁵. Medical treatment of BPH focuses on alleviating LUTS and preventing disease progression. Common pharmacological options include alpha-blockers to relax the prostate and bladder neck muscles, 5-alpha reductase inhibitors (5-ARIs) to reduce prostate size, and phosphodiesterase-5 inhibitors (PDE5) for symptom relief. In severe cases, combination therapy is used to enhance treatment outcomes, and alpha-blockers are recommended before catheter removal in acute urinary retention cases⁴^,5. Surgical treatment is recommended for patients with severe symptoms, complications such as urinary retention or recurrent infections, or cases where medical therapy proves ineffective. The most common surgical procedure is transurethral resection of the prostate (TURP), which removes excess prostate tissue to improve urine flow. For larger prostates, simple prostatectomy (open, laparoscopic, or robotic-assisted) may be performed. Less invasive options include transurethral incision of the prostate (TUIP) for smaller prostates, transurethral vaporization (TUVP), and photoselective vaporization of the prostate (PVP). Recent advancements have introduced minimally invasive procedures, such as prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), laser enucleation (HoLEP, ThuLEP), robotic waterjet treatment (RWT), and prostate artery embolization (PAE), which offer shorter recovery times and fewer side effects. The selection of these surgical approaches depends on prostate size, patient health, and treatment goals⁴^,5. Despite the effectiveness of conventional treatments for BPH, both pharmacological and surgical interventions have notable limitations. While alpha-blockers improve urinary flow, they do not reduce prostate size or halt disease progression. 5-alpha reductase inhibitors require long-term administration and are associated with significant sexual and mood-related side effects. Anticholinergic agents may exacerbate urinary retention, while PDE5 inhibitors have multiple contraindications and a delayed onset of action. Surgical interventions, though often effective, carry risks such as bleeding, infection, urinary incontinence, and a high incidence of retrograde ejaculation, with some patients requiring reoperation due to symptom recurrence^4-⁶.

Given these drawbacks, East Asian Herbal Medicine (EAHM) offers a complementary and potentially beneficial approach, particularly for postoperative BPH patients who continue to experience symptoms. Establishing its efficacy and safety as an evidence-based therapeutic strategy for postoperative BPH management is crucial⁷. Studies on East Asian Traditional Medicine (EATM) approaches for BPH have been conducted, particularly regarding the efficacy of Jeoryeong-tang (JR) and its main components. One study on Polyporus umbellatus polysaccharide, a major bioactive component in Polyporus umbellatus—the primary herbal ingredient in JR—demonstrated that high doses significantly reduce prostate wet weight and the prostate index in BPH. Polyporus umbellatus polysaccharide combined with terazosin has been shown to increase superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities, decrease malondialdehyde (MDA) levels, and effectively slow BPH progression⁸. The combined use of modified JR and Danggui Shaoyao Powder alongside conventional Western medicine has demonstrated significant clinical improvements in BPH symptoms and quality of life (QoL), with superior efficacy compared to Western medicine alone⁹. Another study reported that Cinnamon Twig and Poria Decoction, in combination with Polyporus Decoction and tamsulosin, improved BPH symptoms, reduced IPSS scores, and enhanced overall patient quality of life¹⁰.

Although multiple studies have reported the therapeutic effects of JR in BPH patients, there is currently no systematic review evaluating its effects specifically in postoperative BPH patients. Therefore, this study aims to conduct a systematic review and meta-analysis to assess the efficacy and safety of JR in postoperative BPH patients.

2. Materials and methods

1) Study registration

This protocol is registered in the Open Science Framework (OSF), with the registration doi. The protocol will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

2) Inclusion/exclusion criteria

We will compose the clinical question following the Population, Intervention, Comparison, and Outcomes form to conduct a systematic review following the National Evidence-based Healthcare Collaborating Agency (NECA) guidelines¹¹.

(1) Type of studies

We will only include randomized controlled trials (RCTs) regarding postoperative BPH treatment using JR, regardless of the language or publication restriction. We will exclude other studies such as case reports, case series, nonhuman studies, nonRCTs, protocols, uncontrolled trials, cross-sectional studies, pilot studies, feasibility studies, reviews, and experimental studies.

(2) Type of participants

We will include male patients over the age of 18 who have undergone surgery for BPH. Diagnosis of BPH must have been confirmed prior to surgery through assessments such as the International Prostate Symptom Score (IPSS), voiding diary, uroflowmetry, Digital Rectal Examination (DRE), post-void residual (PVR) evaluation, Transrectal Ultrasonography (TRUS), Prostate-Specific Antigen (PSA) testing, serum creatinine levels, and urinalysis. There will be no restrictions regarding race, disease duration, or severity. However, patients with acute urinary retention will be excluded. There will be no limitations regarding race, disease duration, and disease severity of the participants. We will exclude patients with acute urinary retention.

(3) Types of interventions

① Experimental intervention

We will include studies where the experimental intervention is JR as monotherapy with or without conventional treatment including alpha-blockers, 5-alpha reductase inhibitors (5ARI), anticholinergic agents, antidiuretic agents, and phosphodiesterase 5 inhibitors (PDE5). We will include studies using JR with or without antibiotics or antibacterial. Any JR composition or fusion will be allowed. We will exclude studies using JR as an adjuvant treatment to other herbal medicines and those involving acupuncture, acupressure, moxibustion, warm needling, and Qigong therapy as experimental adjuvant treatments.

② Control intervention

We will include studies where the control intervention is conventional treatment, including alpha-blockers, 5-alpha reductase inhibitors (5ARI), anticholinergic agents, antidiuretic agents, and phosphodiesterase 5 inhibitors (PDE5). We will include studies using postoperative care including counseling, massage, antibiotics or antibacterial, and health education nursing.

(4) Types of outcome measurements

① Primary outcomes

The primary outcome measures will include the International Prostate Symptom Score (IPSS).

② Secondary outcomes

The secondary outcome measurements will include Quality of Life score (QoL), Maximum Flow Rate (Qmax), Postvoidal residue (PVR), coagulation time, and the number of adverse effects.

3) Searching methods for included studies

(1) Electronic searches. We will search the following databases from their inception until October 31, 2025: the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Citation Information by NII, EMBASE, Oriental Medicine Advanced Searching Integrated System, Korean Medical Database, Korean Studies Information Service System, Medline via PubMed, ScienceON, and Research Information Sharing Service. The search terms included “benign prostatic hyperplasia,” “postoperative” for participants; “Jeoryeong-tang,” “zhuling-tang,” or “choreitō” for interventions; and “randomized clinical trial” for study design. (Tables 1-4)

Table 1

Search Strategy for the PubMed.

No.	Search Items
#1	“Prostatic Hyperplasia"[Mesh]

#2	(Prostatic Hyperplasia[Mesh] OR “Prostatic Hyperplasia"[TIAB] OR “Prostatic Hypertrophy"[TIAB] OR “Benign Prostatic Hyperplasia"[TIAB] OR “Benign Prostatic Hypertrophy"[TIAB] OR “Prostatic Enlargement"[TIAB] OR “Prostatism"[TIAB] OR “Bladder Outlet Obstruction"[TIAB] OR BOO[TIAB] OR “Bladder Neck Obstruction"[TIAB] OR “Urinary Bladder Neck Obstruction"[Mesh] OR “Urinary Bladder Neck Obstruction"[TIAB] OR “Urinary Retention"[Mesh] OR “Urinary Retention"[TIAB] OR “Uroschesis"[TIAB] OR “Acute Urinary Retention"[TIAB] OR “Chronic Urinary Retention"[TIAB] OR “Lower Urinary Tract Symptoms"[Mesh] OR “Lower Urinary Tract Symptom"[TIAB] OR LUTS[TIAB] OR “Lower Urinary Tract Obstruction"[TIAB] OR “Prostate Enlargement"[TIAB] OR “Secondary Upper Urinary Tract Hydrop"[TIAB] OR “Upper Urinary Tract Infection"[TIAB] OR “Bladder Infection"[TIAB])

#3	#1 OR #2

#4	(Prostatectomy[Mesh] OR “Prostatectomy"[TIAB] OR “Transurethral Resection of the Prostate"[Mesh] OR TURP[TIAB] OR “Transurethral Incision of the Prostate"[TIAB] OR TUIP[TIAB] OR “Transurethral Vaporization of the Prostate"[TIAB] OR TUVP[TIAB] OR “Photoselective Vaporization of the Prostate"[TIAB] OR PVP[TIAB] OR “Prostatic Urethral Lift"[TIAB] OR PUL[TIAB] OR “Water Vapor Thermal Therapy"[TIAB] OR WVTT[TIAB] OR “Laser Enucleation"[TIAB] OR “Holmium Laser Enucleation of the Prostate"[TIAB] OR HoLEP[TIAB] OR “Thulium Laser Enucleation of the Prostate"[TIAB] OR ThuLEP[TIAB] OR “Robotic Waterjet Treatment"[TIAB] OR RWT[TIAB] OR “Prostate Artery Embolization"[TIAB] OR PAE[TIAB] OR “Temporary Implanted Prostatic Devices"[TIAB] OR TIPD[TIAB]

#5	“Surgery"[TIAB] OR “Surgical"[TIAB] OR “Operation"[TIAB] OR “Operative"[TIAB] OR “Postoperative"[TIAB] OR “Post-Surgery"[TIAB] OR “Post-Surgical"[TIAB] OR “Post-Treatment"[TIAB])

#6	#4 OR #5

#7	“Jeoryeong-tang”[Title/Abstract] OR “Jeoryeong”[Title/Abstract]

#8	“Zhuling-tang” [Title/Abstract] OR “Zhuling” [Title/Abstract]

#9	“Choreitō” [Title/Abstract] OR “Choreito” [Title/Abstract]

#10	#7 OR #8 OR #9

#11	#3 AND #6 AND #10

Table 2

Search Strategy for the EMBASE.

No.	Search Items
#1	Prostatic hyperplasia’/exp

#2	(‘prostatic hyperplasia’ OR ‘prostatic hypertrophy’ OR ‘benign prostatic hyperplasia’ OR ‘benign prostatic hypertrophy’ OR ‘prostatic enlargement’ OR ‘prostatism’ OR ‘bladder outlet obstruction’ OR ‘BOO’ OR ‘bladder neck obstruction’ OR ‘urinary bladder neck obstruction’/exp OR ‘urinary bladder neck obstruction’ OR ‘urinary retention’/exp OR ‘urinary retention’ OR ‘uroschesis’ OR ‘acute urinary retention’ OR ‘chronic urinary retention’ OR ‘lower urinary tract symptoms’/exp OR ‘lower urinary tract symptom’ OR ‘LUTS’ OR ‘lower urinary tract obstruction’ OR ‘prostate enlargement’ OR ‘secondary upper urinary tract hydrop’ OR ‘upper urinary tract infection’ OR ‘bladder infection):ab, ti

#3	#1 OR #2

#4	(’prostatectomy’/exp OR ‘prostatectomy’ OR ‘transurethral resection of the prostate’/exp OR ‘TURP’ OR ‘transurethral incision of the prostate’ OR ‘TUIP’ OR ‘transurethral vaporization of the prostate’ OR ‘TUVP’ OR ‘photoselective vaporization of the prostate’ OR ‘PVP’ OR ‘prostatic urethral lift’ OR ‘PUL’ OR ‘water vapor thermal therapy’ OR ‘WVTT’ OR ‘laser enucleation’ OR ‘holmium laser enucleation of the prostate’ OR ‘HoLEP’ OR ‘thulium laser enucleation of the prostate’ OR ‘ThuLEP’ OR ‘robotic waterjet treatment’ OR ‘RWT’ OR ‘prostate artery embolization’ OR ‘PAE’ OR ‘temporary implanted prostatic devices’ OR ‘TIPD’):ab, ti

#5	(’surgery’ OR ‘surgical’ OR ‘operation’ OR ‘operative’ OR ‘postoperative’ OR ‘post-surgery’ OR ‘post-surgical’ OR ‘post-treatment’):ab, ti

#6	#4 OR #5

#7	(‘Jeoryeong-tang’ OR ‘Jeoryeong’):ab, ti

#8	(‘Zhuling-tang’ OR ‘Zhuling’):ab, ti

#9	(‘Choreitō’ OR ‘Choreito’):ab, ti

#10	#7 OR #8 OR #9

#11	#3 AND #6 AND #10

Table 3

Search Strategy for the CENTRAL

No.	Search Items
#1	MeSH descriptor: [Prostatic Hyperplasia] explode all trees

#2	(‘prostatic hyperplasia’ OR ‘prostatic hypertrophy’ OR ‘benign prostatic hyperplasia’ OR ‘benign prostatic hypertrophy’ OR ‘prostatic enlargement’ OR ‘prostatism’ OR ‘bladder outlet obstruction’ OR ‘BOO’ OR ‘bladder neck obstruction’ OR ‘urinary bladder neck obstruction’ OR ‘urinary retention’ OR ‘uroschesis’ OR ‘acute urinary retention’ OR ‘chronic urinary retention’ OR ‘lower urinary tract symptoms’ OR ‘lower urinary tract symptom’ OR ‘LUTS’ OR ‘lower urinary tract obstruction’ OR ‘prostate enlargement’ OR ‘secondary upper urinary tract hydrop’ OR ‘upper urinary tract infection’ OR ‘bladder infection’):ti,ab,kw

#3	#1 OR #2

#4	(’prostatectomy’ OR ‘transurethral resection of the prostate’ OR ‘TURP’ OR ‘transurethral incision of the prostate’ OR ‘TUIP’ OR ‘transurethral vaporization of the prostate’ OR ‘TUVP’ OR ‘photoselective vaporization of the prostate’ OR ‘PVP’ OR ‘prostatic urethral lift’ OR ‘PUL’ OR ‘water vapor thermal therapy’ OR ‘WVTT’ OR ‘laser enucleation’ OR ‘holmium laser enucleation of the prostate’ OR ‘HoLEP’ OR ‘thulium laser enucleation of the prostate’ OR ‘ThuLEP’ OR ‘robotic waterjet treatment’ OR ‘RWT’ OR ‘prostate artery embolization’ OR ’PAE’ OR ’temporary implanted prostatic devices’ OR ’TIPD’):ti,ab,kw

#5	(’surgery’ OR ’surgical’ OR ’operation’ OR ’operative’ OR ’postoperative’ OR ’post-surgery’ OR ’post-surgical’ OR ’post-treatment’):ti,ab,kw

#6	#4 OR #5

#7	(’Jeoryeong-tang’ OR ’Jeoryeong’):ti,ab,kw

#8	(’Zhuling-tang’ OR ’Zhuling’):ti,ab,kw

#9	(’Choreito’ OR ’Choreitō’):ti,ab,kw

#10	#7 OR #8 OR #9

#11	#3 AND #6 AND #10

Table 4

Search strategy for the CNKI.

No.	Search Items
#1	(SU=‘前列腺增生’+‘前列腺良性增生’+ 良性增生前列腺’+‘良性前列腺增生’ +‘良性前列腺肥大’+‘良性前列腺增生症’+‘良性前列腺肥大症’)
#2	(SU=‘豬苓湯’+‘猪苓汤’+‘豬苓湯’)
#3	#1 AND #2
#4	(SU=‘前列腺增生’+‘前列腺良性增生’+‘良性增生前列腺’+‘良性前列腺增生’+‘良性前列腺肥大’+‘良性前列腺增生症’+‘良性前列腺肥大症’)
#5	(TKA=‘豬苓湯’+ ‘猪苓汤’+‘豬苓湯’)
#6	#4 AND #5
#7	(TKA=‘前列腺增生’+‘前列腺良性增生’+‘良性增生前列腺’+‘良性前列腺增生’+‘良性前列腺肥大’+‘良性前列腺增生症’+‘良性前列腺肥大症’)
#8	(SU=‘豬苓湯’+‘猪苓汤’+‘豬苓湯’)
#9	#7 AND #8
#10	(TKA=‘前列腺增生’+‘前列腺良性增生’+‘良性增生前列腺’+‘良性前列腺增生’+‘良性前列腺肥大’+‘良性前列腺增生症’+‘良性前列腺肥大症’)
#11	(TKA=‘豬苓湯’+‘猪苓汤’+‘豬苓湯’)
#12	#10 AND #11
#13	#3 OR #6 OR #9 OR #12

(2) Searching other resources

We will review the reference lists of the included studies to identify additional studies.

4) Data collection and analysis

(1) Literature selection

All collected studies will be imported into the literature management software Endnote 20.0.1 software (Clarivate Analytics, Boston, MA). After removing duplicate studies, 2 independent researchers will screen the titles and/or abstracts to identify studies that meet the inclusion criteria. Subsequently, both researchers will perform full-text reviews of the studies retrieved from the first screening. Disagreements will be resolved by consulting a third researcher. Fig. 1. shows the selection process for eligible studies.

Fig. 1

PRISMA flow chart of selection process.

(2) Data extraction

After retrieving eligible studies, we will extract the following data using a pre-specified data extraction form: first author, publication year, study design, intervention, comparison, duration, follow-up, outcome measures, results, and adverse events. The extracted information will be summarized and organized using Microsoft Excel 2020. In case of missing data, the original authors will be contacted.

(3) Risk of bias assessment

To assess the risk of bias in the included studies, we will use the Cochrane Risk of Bias 2 (RoB 2) tool, which evaluates five domains: randomization process, deviations from intended interventions, missing outcome data, measurement of outcomes, and selection of reported results. Each domain will be categorized as Low risk, High risk, or Unclear risk, as shown in Table 5. Two independent reviewers will conduct the assessment, and disagreements will be resolved through discussion with a third reviewer. To ensure consistency in interpretation, we will use a RoB tool translated into Korean, following the NECA guidelines¹¹.

Table 5

Risk of Bias (RoB) 2 Assessment Criteria

Bias Domain	Description	Judgment Criteria (Low/High/Unclear)
Randomization Process	Were the participants randomly assigned to groups?	Low: Adequate random sequence generation and allocation concealment High: Inadequate randomization or allocation Unclear: Insufficient information

Deviations from Intended Interventions	Were the interventions implemented as planned?	Low: No deviations due to trial context High: Deviations likely affected outcomes Unclear: Lack of details

Missing Outcome Data	Was the loss of participants adequately addressed?	Low: Minimal missing data or proper handling High: High dropout rates or biased missing data Unclear: Insufficient information

Measurement of the Outcome	Were outcome assessors blinded?	Low: Proper blinding or objective outcome measures High: No blinding and subjective outcomes Unclear: Lack of details

Selection of the Reported Result	Was the reported result pre-specified?	Low: Outcome measures pre-specified and reported High: Selective reporting suspected Unclear: No protocol available

(4) Measurement of intervention effect

Continuous data will be presented as the mean difference or standardized mean difference with a 95% confidence interval (CI). Dichotomous data will be presented as the risk ratio with a 95% CI.

(5) Heterogeneity measurement

Among-study heterogeneity will be evaluated using the Chi-Squared test and I² statistic. We will grade the heterogeneity as follows:

① I² < 25%: low grade

② 25% ≤ I² ≤ 50%: moderate grade

③ I² ≥ 75%: high grade

(6) Data synthesis

We will perform a meta-analysis to evaluate the clinical effect of JR. For binary outcomes, risk ratios (RRs) or odds ratios (ORs) with 95% confidence intervals (CIs) will be used to estimate effect sizes, applying the Mantel-Haenszel method. For continuous outcomes, mean differences (MDs) or standardized mean differences (SMDs) with 95% CIs will be used, depending on measurement consistency across studies. The heterogeneity of the studies will be assessed using the Chi-square test and I² statistic. If I² < 50% or there are ≤4 included studies, a fixed-effects model will be applied; otherwise, a random-effects model will be used. We will conduct all analyses using RevMan version 5.4 (Copenhagen, The Nordic Cochrane Center, the Cochrane Collaboration, 2020) and consider a p-value of less than 0.05 as statistically significant.

(7) Subgroup analysis

If significant heterogeneity is detected in the meta-analysis, we will conduct a subgroup analysis to explore potential sources of variability. Subgroup comparisons will be performed based on the sole use of Jeoryeong-tang (JR) and conventional medicine, including alpha-blockers, 5-alpha reductase inhibitors (5ARIs), anticholinergic agents, antidiuretic agents, and phosphodiesterase-5 inhibitors (PDE5). This analysis aims to determine whether differences in treatment effects are influenced by the type of intervention.

5) Ethics and dissemination

No ethical approval is required for this protocol since we will not use individual patient data. The results will be published in a peer-reviewed journal and presented at a relevant conference.

3. Discussion

Recent systematic reviews have suggested the therapeutic effects of EAHM on patients with BPH. The effect of JR alone or with postoperative BPH treatment remains unclear. Therefore, the proposed study will present updated evidence regarding the efficacy and safety of JR for postoperative BPH in terms of improving IPSS, QoL, Qmax, PVR, and coagulation time.

This study may present several potential limitations. Firstly, the quality of the included randomized controlled trials may be evaluated as low due to performance bias, as studies with nonplacebo control groups are considered. Secondly, the lack of standardization in the JR formulations across different studies might result in considerable heterogeneity. Nonetheless, the study could still offer valuable evidence for the recommendation of JR in postoperative BPH patients, as well as potential directions for future research.

References

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2. GBD, 2019 Benign Prostatic Hyperplasia Collaborators. The global, regional, and national burden of benign prostatic hyperplasia in 204 countries and territories from, 2000 to 2019:a systematic analysis for the Global Burden of Disease Study 2019. Lancet Healthy Longev 2022:3(11):e754–76. doi:10.1016/S2666-7568(22)00213-6.

3. Lim KB. Epidemiology of clinical benign prostatic hyperplasia. Asian J Urol 2017:4(3):148–51. doi:10.1016/j.ajur.2017.06.004.

4. Sandhu JS, Bixler BR, Dahm P, Goueli R, Kirkby E, Stoffel JT, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH):AUA Guideline amendment 2023. J Urol 2023:10:1097/JU.0000000000003698https://doi.org/10.1097/JU.0000000000003698.

5. Miernik A, Gratzke C. Current Treatment for Benign Prostatic Hyperplasia. Dtsch Arztebl Int 2020:117(49):843–854. doi:10.3238/arztebl.2020.0843.

6. Halawani A, Paterson R, Zhong T, Du K, Ren R, Forbes CM. Risks and side effects in the medical management of benign prostatic hyperplasia. Prostate Int 2024:12(2):57–64. doi:10.1016/j.prnil.2023.11.004.

7. Ma CH, Lin WL, Lui SL, Cai XY, Wong VT, Ziea E, et al. Efficacy and safety of Chinese herbal medicine for benign prostatic hyperplasia:systematic review of randomized controlled trials. Asian J Androl 2013:15(4):471–82. doi:10.1038/aja.2012.173.

8. Liu XM, Jin ZG, Yin XY, Hao TJ, Jin LK, Niu ML. Effect of Polyporus Umbellatus Polysaccharide on Oxidative Stress Level in BPH Rat Model. Journal of Huanghe S&T College 2022:24(11):30–4. DOI:10.19576/j.issn.2096-790X.2022.11.006.

9. Liu CS, Liu QX, Liang BQ, Cai ZF, Zhao D. Study on the Clinical Efficacy of Zhuling Decoction Combined with Danggui Shaoyao Powder for the Treatment of Benign Prostatic Hyperplasia. Journal of Guangzhou University of Traditional Chinese Medicine 2022:39(11):2534–8. DOI:10.13359/j.cnki.gzxbtcm.2022.11.011.

10. Zhang GQ. Forty-One Cases of Benign Prostatic Hyperplasia Treated with Cinnamon Twig and Poria Decoction in Combination with Polyporus Decoction Together with Tamsulosin. Henan Traditional Chinese Medicine 2017:37(08):1338–40. DOI:10.16367/j.issn.1003-5028.2017.08.0471.

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Appendices

【Supplemental Material 1】 PRISMA 2020 Checklist

Section and Topic	Item #	Checklist item	Location where item is reported
TITLE

Title	1	Identify the report as a systematic review.	#1

ABSTRACT

Abstract	2	See the PRISMA 2020 for Abstracts checklist.	#2

INTRODUCTION

Rationale	3	Describe the rationale for the review in the context of existing knowledge.	#3-5

Objectives	4	Provide an explicit statement of the objective(s) or question(s) the review addresses.	#3-5

METHODS

Eligibility criteria	5	Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses.	#5-8

Information sources	6	Specify all databases, registers, websites, organisations, reference lists and other sources searched or consulted to identify studies. Specify the date when each source was last searched or consulted.	#5

Search strategy	7	Present the full search strategies for all databases, registers and websites, including any filters and limits used.	Table1-3

Selection process	8	Specify the methods used to decide whether a study met the inclusion criteria of the review, including how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process.	#5

Data collection process	9	Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools used in the process.	#5-6

Data items	10a	List and define all outcomes for which data were sought. Specify whether all results that were compatible with each outcome domain in each study were sought (e.g. for all measures, time points, analyses), and if not, the methods used to decide which results to collect.	N/A

	10b	List and define all other variables for which data were sought (e.g. participant and intervention characteristics, funding sources). Describe any assumptions made about any missing or unclear information.	N/A

Study risk of bias assessment	11	Specify the methods used to assess risk of bias in the included studies, including details of the tool(s) used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process.	#7

Effect measures	12	Specify for each outcome the effect measure(s) (e.g. risk ratio, mean difference) used in the synthesis or presentation of results.	#7

Synthesis methods	13a	Describe the processes used to decide which studies were eligible for each synthesis (e.g. tabulating the study intervention characteristics and comparing against the planned groups for each synthesis (item #5)).	#7-8

	13b	Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or data conversions.	#7-8

	13c	Describe any methods used to tabulate or visually display results of individual studies and syntheses.	N/A

	13d	Describe any methods used to synthesize results and provide a rationale for the choice(s). If meta-analysis was performed, describe the model(s), method(s) to identify the presence and extent of statistical heterogeneity, and software package(s) used.	#7-8

	13e	Describe any methods used to explore possible causes of heterogeneity among study results (e.g. subgroup analysis, meta-regression).	#7-8

	13f	Describe any sensitivity analyses conducted to assess robustness of the synthesized results.	#7-8

Reporting bias assessment	14	Describe any methods used to assess risk of bias due to missing results in a synthesis (arising from reporting biases).	#7

Certainty assessment	15	Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome.	#7-8

RESULTS

Study selection	16a	Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram.	N/A

	16b	Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded.	N/A

Study characteristics	17	Cite each included study and present its characteristics.	N/A

Risk of bias in studies	18	Present assessments of risk of bias for each included study.	N/A

Results of individual studies	19	For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimate and its precision (e.g. confidence/credible interval), ideally using structured tables or plots.	N/A

Results of syntheses	20a	For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies.	N/A

	20b	Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its precision (e.g. confidence/credible interval) and measures of statistical heterogeneity. If comparing groups, describe the direction of the effect.	N/A

	20c	Present results of all investigations of possible causes of heterogeneity among study results.	N/A

	20d	Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results.	N/A

Reporting biases	21	Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed.	N/A

Certainty of evidence	22	Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed.	N/A

DISCUSSION
Discussion	23a	Provide a general interpretation of the results in the context of other evidence.	#8

	23b	Discuss any limitations of the evidence included in the review.	#8

	23c	Discuss any limitations of the review processes used.	#8

	23d	Discuss implications of the results for practice, policy, and future research.	#8

OTHER INFORMATION

Registration and protocol	24a	Provide registration information for the review, including register name and registration number, or state that the review was not registered.	#5

	24b	Indicate where the review protocol can be accessed, or state that a protocol was not prepared.	#5

	24c	Describe and explain any amendments to information provided at registration or in the protocol.	#5

Support	25	Describe sources of financial or non-financial support for the review, and the role of the funders or sponsors in the review.	#1

Competing interests	26	Declare any competing interests of review authors.	#1

Availability of data, code and other materials	27	Report which of the following are publicly available and where they can be found: template data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review.	#1

From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71

For more information, visit: http://www.prisma-statement.org/