A Critical Overview of Systematic Reviews and Meta-Analyses of Acupuncture for Female Stress Urinary Incontinence

Objectives As a urinary dysfunction disorder, stress urinary incontinence (SUI) is more common in women than in men. Acupuncture, a traditional minimally invasive technique, has potential efficacy in the treatment of SUI. The purpose of this overview is to critically assess the available evidence on acupuncture for the treatment of SUI in women. Methods Two researchers searched seven databases for systematic reviews (SRs)/meta-analyses (MAs) of randomized controlled trials (RCTs) on acupuncture for SUI. Two researchers assessed the included SRs/MAs using the Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the Risk of Bias in Systematic (ROBIS) scale, the list of Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Results Eight published SRs/MAs were included in our overview. According to the results of the AMSTAR-2 assessment, all SRs/MAs were of very low quality. According to the ROBIS evaluation results, no SR/MA was assessed as low risk of bias. According to the results of the PRISMA checklist assessment, no SR/MA was fully reported on the checklist. According to GRADE, a total of 27 outcomes extracted from the included SRs/MAs were evaluated, and only 1 was rated as high quality. Conclusions Acupuncture may be an effective and safe complementary treatment for SUI in women. However, further standard and comprehensive SRs/MAs and RCTs are needed to provide an evidence-based medical rationale for this.


Introduction
As a form of dysfunction disorder, stress urinary incontinence (SUI) is the most common type of urinary incontinence. It is defined as the involuntary flow of urine due to physical exertion or effort, coughing, or sneezing [1]. SUI has a prevalence of up to 49% in physically active women and up to 15% in women aged 30-60 [2]. SUI can cause psychological burden, affect relationships, decrease physical productivity, and reduce a woman's quality of life [3], and its harm is even greater than that of major chronic diseases such as diabetes, hyperlipidemia, and chronic kidney diseases [4]. However, more than 80 percent of women received no treatment at all [5]. e main treatment modalities for SUI include lifestyle interventions, electrical stimulation, pelvic floor muscle training (PFMT), medication, and surgery [6]. e American Urological Association (AUA) currently recommends conservative treatment, such as PFMT, for patients with mild and moderate SUI [7]. However, this method has shortcomings such as poor compliance and difficulty in mastering training skills. Surgical treatment is effective in patients with severe SUI, but it can cause potential complications, including pain, infection, and dysuria [8].
erefore, there remains an urgent need for an effective and safe complementary treatment for SUI.
As a minimally invasive treatment method, acupuncture has a history of more than 2,500 years in China and is gaining more and more international attention in the field of healthcare [9]. With its unique advantages, acupuncture plays an irreplaceable role in the treatment of SUI. With the extensive use of acupuncture in the treatment of SUI, related systematic reviews (SRs) and meta-analyses (MAs) have also been published. Since the evidence provided by these SRs/ MAs for acupuncture for SUI in women is sometimes inconsistent and varies in quality, a reevaluation is needed. An overview of SRs/MAs is a new method to comprehensively assess the methodological quality and certainty of quality across multiple SRs/MAs. erefore, our research aimed to critically evaluate the quality of SRs/MAs regarding the acupuncture for female SUI through a comprehensive overview.

Materials and Methods
e methodology of this study follows the Cochrane manual, as well as the study methods of some high-quality SRs/MAs overviews [10][11][12].

Inclusion and Exclusion Criteria.
e criteria for inclusion of SRs/MAs in this overview are as follows: (1) Study design: is overview includes SRs/MAs of randomized controlled trials (RCTs) of the acupuncture on SUI; (2) Type of participants: Female subjects diagnosed with SUI based on any authoritative national or international diagnostic criteria regardless of race, age, gender, time of onset, and source of cases; (3) Intervention: e control group received the following treatments: Conventional medication (CM), rehabilitation training (RT), sham acupuncture (SA), and placebo. e intervention group received acupuncture treatment, including plum blossom acupuncture, fire acupuncture, electro-acupuncture, body acupuncture, manual acupuncture, warm acupuncture, or acupuncture therapy in combination with the treatments received by the control group; (4) Outcome indicators: Outcomes assessed in this overview include: Effective rate, 1-hour pad test, international consultation on incontinence questionnaire short form (ICIQ-SF) score, visual analog scale (VAS) score, and adverse reactions. e criteria for exclusion of SRs/MAs in this overview are as follows: (1) Animal studies; (2) Network MAs, research protocols, narrative reviews, overviews, dissertation, and conference abstracts.

Search Strategy.
Literatures were retrieved from PubMed, Cochrane Library, EMBASE, Chongqing VIP, Wanfang Database, CNKI, and SinoMed on 1 January 2022. We adopted a search strategy combining keywords with free words, and the keywords include acupuncture, urinary incontinence, systematic review, and meta-analysis. e literature search strategy (shown in Table 1) of the PubMed database was reasonably tuned for each database. We also reviewed the references of the all retrieved literature to avoid missing topic-related SRs/MAs.

Literature Screening and Data
Extraction. e literature screening (HS-S and LZ-Z) and information extraction (WB-L and ZC-W) were performed independently by two researchers. We firstly input the retrieved documents into Endnote X9 document management software, and then removed the duplicates. e literatures that potentially met the inclusion and exclusion criteria were then obtained by reading the titles and abstracts. Eventually, we finalized the included SRs/MAs by reading the full text. A standardized data extraction form was adopted to extract relevant information for the inclusion of SRs/MAs. e following information was extracted from each SR/MA: First author, year of publication, author nationality, number of RCTs included, sample size, intervention group measures, control group measures, tools used to assess the risk of bias, and main findings.

Quality Assessment for Inclusion in SRs/MAs
. Two researchers (PL-L and D-W) independently assessed the methodological quality and certainty of quality of the included SRs/MAs.

Assessment of Methodological Quality.
e methodological quality of the included SRs/MAs was assessed by the Assessment System for Evaluating Methodological Quality 2 (AMSTAR-2) [13]. Seven (2, 4, 7, 9, 11, 13, and 15) of the 16 items in the tool are critical areas.

Assessment of Risk of Bias.
e Risk of Bias in Systematic Review (ROBIS) [14] scale was used in this overview to evaluate the risk of bias in the inclusion of SRs/MAs and the evaluation was carried out in three stages.

Assessment of Reporting Quality.
e quality of each SR/MA report of the included SRs/MAs was evaluated by the list of PRISMA [15] which consists of 27 items focusing on the reporting methods and results that were incorporated into SRs/MAs.

Assessment of Certainty of Quality.
e certainty of quality for each SR/MA outcome was evaluated by e Grading of Recommendations Assessment, Development, and Evaluation (GRADE) [16], and five aspects will lead to the degradation of certainty of quality, including limitations, inconsistencies, indirectness, imprecision, and publication bias.

Literature Search and Screening Results.
A total of 166 publications were retrieved from seven electronic databases. Nine publications were retrieved for full-text evaluation after the duplicates removal and title/abstract screening. One paper [17] was excluded because it didn't focus on RCTs, and the remaining 8 SRs/MAs [18][19][20][21][22][23][24][25] were included in this overview. e flowchart of the screening process is shown in Figure 1. e exclusion list for the literature is in Table 2.

Inclusion of Characteristics of SRs/MAs.
e characteristics of the 8 SRs/MAs included in our final evaluation were summarized, as shown in Table 3.
ese SRs/MAs were published between 2014 and 2021, with 6 [18][19][20][21][22][23] published after 2017. ree of the SRs/MAs [18][19][20] were in English, and the remaining five [21][22][23][24][25] were in Chinese. e number of RCTs included in the SRs/MAs ranged from 9 to 15, and the total number of subjects included in each SR/MA ranged from 579 to 1,577. e interventions for the control group were CM, SA, RT, and placebo, and the treatments for the intervention group were electroacupuncture (EA) and manual acupuncture (MA) or EA or MA in combination with the treatments received by the control group. In terms of the quality assessment for inclusion in RCTs, the Cochrane criteria was used for four SRs/MAs [18][19][20]23] and the Jadad scale was used for four SRs/MAs [21,22,24,25].

Results of the Methodological Quality.
Regarding the methodological quality of the included SRs/MAs, all were considered to be of very low quality because more than one key item was missing from the SRs/MAs included in the quality assessment. Methodological quality limitations come from the following items: Items 2 (Only 2 SRs/MAs [19,20] Table 4.

Results of the Risk of Bias Assessment.
Regarding the results of the ROBIS assessment, Phase 1 assessed the relevance of the study topic and Domain 1, with all SRs/MAs rated as low risk of bias in both items. Domain 2 assessed the identification and selection of studies, and none of the SR/ MAs had a low risk of bias. In Domain 3, 6 SRs/MAs [18][19][20][21][22]25] were rated as low risk of bias. Domain 4 assessed the synthesis and findings, and only 2 SRs/MAs [19,23] were rated as low risk of bias. Phase 3 considered the overall risk of bias in the reviews, and none of the SR/MA had a low risk of bias. e evaluation details of the included SRs/MAs on the ROBIS scale are shown in Table 5.

Report Quality of the Included SRs/MAs.
e results of the PRISMA inventory evaluation were shown in Table 6. 22 out of 27 items have a "yes OR partially yes" response rate of more than 60%, and this shows that the report is relatively complete. However, there are some reporting deficiencies in other items. e reports of Items 7 (search strategy), Item 15 (certainty assessment), Item 22 (competing interests), Item 23 (certainty of evidence), and Item 24 (registration and protocol) are incomplete (the "yes OR partially yes" response rate is less than 50%).

Results of the Certainty of Quality.
e 8 SRs/MAs included 27 outcomes related to the effectiveness of acupuncture for SUI. For all the outcome indicators, 1 was rated as high quality, 10 moderate, 6 low and 10 very low by means of the GRADE evaluation. Publication bias (n � 24) was the most common downgrading factor, followed by risk of bias (n � 13), inconsistency (n � 13), imprecision (n � 9), and indirectness (n � 0). GRADE specific assessment details are shown in Table 7. Table 8, and 2 SRs/MAs [19,20] provide narrative reviews that regard acupuncture as a safe treatment option. It can be seen that acupuncture is effective and safe for the treatment of female SUI.

Discussion
SUI can severely impair a patient's ability to perform daily activities, leading to embarrassment, insomnia, and social isolation [26], and acupuncture is a minimally invasive technique with the potential treatment of SUI. is research aimed to systematically and comprehensively collate, evaluate and summarize the published evidence on acupuncture for SUI in recent years.

Summary of the Main Findings.
is overview incorporated 8 SRs/MAs on acupuncture for SUI. ese publications were based on the RCT and were published from 2014 to 2021. Six (6/8, 75%) SRs/MAs were published in the last five years, indicating that acupuncture had received increasing attention as an important intervention modality for SUI in women.
Based on the results of the AMSTAR-2, ROBIS, and PRISMA evaluation in this overview, the methodological   In conclusion, the analysis results show that the acupuncture prescription has some advantages in treating female SUI, but the limitations of inclusion in the study reduce the reliability of the above results. Author, year (Country) Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13 Q14 Q15 Q16 Quality Na Yang, 2021 (China) [18] Y Information sources Data collection process Study risk of bias assessment Pain Research and Management 7 Reporting bias assessment Certainty assessment

Study selection
Risk of bias in studies Results of individual studies

Results of syntheses
Reporting biases Certainty of evidence Pain Research and Management Competing interests Availability of data, code, and other materials Note: Y, yes; N, no; PY, partially yes.  Note: ① e included studies have a large bias in methodology such as randomization, allocation concealment, and blinding. ② e confidence interval overlaps less or the I2 value of the combined results was larger. ③ e sample size from the included studies does not meet the optimal sample size or the 95% confidence interval crosses the invalid line. ④ e funnel chart is asymmetry. ⑤ Fewer studies were included, and their results were all positive, which may result in a large publication bias. blinded whenever possible to minimize the risk of bias. A well-designed and rigorously executed RCT is believed to be the gold standard for evaluating interventions to minimize or avoid bias [28]. Acupuncture has its origins in TCM theory, and there exist a diverse and individualized selection of acupuncture points, and future research protocols on acupuncture should be fully standardized to improve the quality of research. In addition, the currently published SRs/MAs neglect the assessment of indicators related to urodynamic indices, and it is expected that future studies should help us to better understand the potential mechanism of acupuncture for SUI by increasing the assessment of related indicators.

Strength and Limitations.
Our overview is the first to use AMSTAR2, ROBIS, PRISMA, and GRADE to evaluate SRs/ MAs regarding acupuncture for the treatment of female SUI. e evaluation process revealed clear limitations of the current relevant SRs/MAs and RCTs, which may help boost the quality of future clinical studies. However, the overview may have some limitations due to the subjectivity of the evaluation. Although our evaluation had been assessed and reviewed by two independent reviewers, different reviewers may have their own judgments about each factor, so the results may vary. In addition, for different SRs/MAs included in this overview, the definition of effective rate is not mentioned.

Conclusion
In conclusion, acupuncture is a beneficial and safe way to treat SUI in women. However, due to the generally low methodological quality and certainty of quality in the included SRs/MAs, clinicians should approach these findings with caution in their practice.
Data Availability e datasets analyzed during the current study are available from the corresponding author upon reasonable request.

Disclosure
Hongshuo Shi and Leizuo Zhao are the co-first authors.

Conflicts of Interest
e authors declare that they have no conflicts of interest.