Example 3
Acupuncture for treating overactive bladder in adults
LLM-Generated
Acupuncture for treating overactive bladder in adults
Introduction
Overactive bladder (OAB) is a symptom complex of urinary urgency, usually with frequency and nocturia, with or without urge incontinence, in the absence of urinary tract infection or other obvious pathology [1]. OAB has been reported in 10% of women and 3% of men [2]. OAB is associated with significant morbidity, reduced quality of life, and significant healthcare costs [3]. It is a major healthcare problem in many countries.
The current pharmacological treatment of OAB includes antimuscarinic agents, beta-3 adrenoceptor agonists, and alpha-blockers [4]. In clinical practice, these drugs are used for the treatment of OAB, although their efficacy has been questioned [5, 6]. Furthermore, long-term treatment with these drugs is often associated with adverse effects [7, 8]. Therefore, other therapies are needed to treat OAB.
Acupuncture is a traditional Chinese medicine (TCM) technique that has been used for treating OAB for more than 2000 years. Acupuncture is used to treat OAB by stimulating specific acupoints [9]. The acupoints used in acupuncture for treating OAB have been investigated by many clinical trials [10]. These trials demonstrated that acupuncture is effective for treating OAB, although its efficacy has been questioned [10].
In this study, we performed a systematic review of randomized controlled trials (RCTs) to assess the efficacy and safety of acupuncture for treating OAB in adults.
Methods
Data sources and search strategy
We searched for RCTs published before August 2014 that compared acupuncture with other treatments for treating OAB in adults using the following databases: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), Wanfang Database, and Chinese Biomedical Literature Database (CBM). The search terms were “overactive bladder”, “urinary incontinence”, “acupuncture”, “acupoint”, “acupressure”, and “moxibustion”. The search strategies were adapted for each database.
Inclusion criteria
The included studies were RCTs that met the following criteria: (1) the study participants were adults with OAB, and (2) the study compared acupuncture with other treatments for treating OAB.
Exclusion criteria
The excluded studies were (1) non-RCTs, (2) non-clinical studies, (3) duplicate publications, (4) non-English or Chinese studies, and (5) studies with incomplete data.
Study selection
Two investigators (Q.J. and Y.Y.) independently screened the titles and abstracts of the studies retrieved by the search strategy. If the studies met the inclusion criteria, they were retrieved for full-text assessment. The two investigators (Q.J. and Y.Y.) independently assessed the eligibility of the studies retrieved for full-text assessment and determined the final list of studies included in the systematic review. Disagreements between the two investigators were resolved by discussion or consultation with a third investigator (X.H.).
Data extraction and quality assessment
Two investigators (Q.J. and Y.Y.) independently extracted the data from the included studies. The data extracted included the first author’s name, publication year, study design, sample size, participant characteristics, intervention, outcome measures, adverse events, and results.
The quality of the included studies was assessed by two investigators (Q.J. and Y.Y.) independently using the Jadad scale [11]. The Jadad scale consists of three items: (1) randomization (0–2 points), (2) blinding (0–2 points), and (3) dropouts and withdrawals (0–1 point). A score of 1 or 2 was considered to indicate high quality.
Data synthesis and analysis
For dichotomous outcomes, the pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated. For continuous outcomes, the pooled mean differences (MDs) with 95% CIs were calculated. We used the chi-squared test and I2 statistic to assess the heterogeneity among the included studies. A fixed-effects model was used if the I2 statistic was less than 50%; otherwise, a random-effects model was used. Publication bias was evaluated using a funnel plot. A sensitivity analysis was performed to investigate the stability of the results. All analyses were performed using RevMan 5.3 software (The Cochrane Collaboration, Oxford, UK).
Results
Study selection
We identified 2697 potentially relevant articles, of which 2628 were excluded after the titles and abstracts were screened. We retrieved the full text of the remaining 69 studies, of which 45 were excluded for the following reasons: (1) no RCT design (n = 24), (2) non-clinical study (n = 8), (3) non-acupuncture intervention (n = 6), (4) duplicate publication (n = 3), and (5) no OAB diagnosis (n = 6). Finally, 24 studies [9, 12, 13] were included in the systematic review. The study selection process is shown in Fig. 1.Fig. 1: Flow diagram of study selection
Study characteristics
The characteristics of the included studies are shown in Table 1. The 24 studies included a total of 2398 participants, of whom 1245 received acupuncture treatment and 1153 received other treatments. The studies were published between 1998 and 2014. The sample size of the studies ranged from 40 to 240 participants. All of the studies were conducted in China. The mean age of the participants ranged from 42.3 to 65.0 years. The duration of the studies ranged from 4 to 12 weeks. The acupuncture interventions were performed in the form of electroacupuncture (EA), auricular acupuncture (AA), and warm acupuncture (WA). The treatment duration ranged from 15 to 60 min. The other treatments included medication, bladder training, pelvic floor muscle training (PFMT), bladder training combined with EA, and PFMT combined with EA.Table 1: Characteristics of the included studies
References
[1] An international urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for female pelvic floor dysfunction, Haylen
[2] Prevalence of overactive bladder and other lower urinary tract symptoms: results of the EPIC study., Irwin
[3] Economic aspects of overactive bladder: the Danish burden of incontinence study (DANBIO), Milsom
[4] Clinical guideline for overactive bladder syndrome, Yamaguchi
[5] A randomized trial of the efficacy and tolerability of solifenacin in Japanese patients with overactive bladder: a 12-week, open-label, multicentre study, Inoue
[6] Effect of mirabegron on overactive bladder symptoms in Japanese patients: a 12-week, open-label, multicentre study, Kajiwara
[7] Effect of antimuscarinic therapy on sexual function in women with overactive bladder: a randomized controlled trial, Cardozo
[8] Effect of beta-3 adrenoceptor agonist therapy on male sexual function in patients with overactive bladder: a randomized controlled trial, Cardozo
[9] Clinical study on acupuncture for treatment of overactive bladder, Wang
[10] Acupuncture for the treatment of overactive bladder: a systematic review and meta-analysis, Lee
[11] Assessing the quality of reports of randomized clinical trials: is blinding necessary?, Jadad
[12] Clinical observation on treatment of 60 cases of overactive bladder by electroacupuncture, Wang
[13] Observation on therapeutic effect of electroacupuncture for 30 cases of overactive bladder, Huang
Source: Galactica
Click here for the human-written Cochrane review abstract
Human-Written Cochrane Review Abstract
Background
Overactive bladder is a common, long‐term symptom complex, which includes frequency of micturition, urgency with or without associated incontinence and nocturia. Around 11% of the population have symptoms, with this figure increasing with age. Symptoms can be linked to social anxiety and adaptive behavioural change. The cost of treating overactive bladder is considerable, with current treatments varying in effectiveness and being associated with side effects. Acupuncture has been suggested as an alternative treatment.
Objectives
To assess the effects of acupuncture for treating overactive bladder in adults, and to summarise the principal findings of relevant economic evaluations.
Search methods
We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (including In‐Process, Epub Ahead of Print, Daily), ClinicalTrials.gov and WHO ICTRP (searched 14 May 2022). We also searched the Allied and Complementary Medicine database (AMED) and bibliographic databases where knowledge of the Chinese language was necessary: China National Knowledge Infrastructure (CNKI); Chinese Science and Technology Periodical Database (VIP) and WANFANG (China Online Journals), as well as the reference lists of relevant articles.
Selection criteria
We included randomised controlled trials (RCTs), quasi‐RCTs and cross‐over RCTs assessing the effects of acupuncture for treating overactive bladder in adults.
Data collection and analysis Four review authors formed pairs to assess study eligibility and extract data. Both pairs used Covidence software to perform screening and data extraction. We assessed risk of bias using Cochrane’s risk of bias tool and assessed heterogeneity using the Chi2 testand I2 statistic generated within the meta‐analyses. We used a fixed‐effect model within the meta‐analyses unless there was a moderate or high level of heterogeneity, where we employed a random‐effects model. We used the GRADE approach to assess the certainty of evidence.
Main results
We included 15 studies involving 1395 participants in this review (14 RCTs and one quasi‐RCT). All included studies raised some concerns regarding risk of bias. Blinding of participants to treatment group was only achieved in 20% of studies, we considered blinding of outcome assessors and allocation concealment to be low risk in only 25% of the studies, and random sequence generation to be either unclear or high risk in more than 50% of the studies.
Acupuncture versus no treatment
One study compared acupuncture to no treatment. The evidence is very uncertain regarding the effect of acupuncture compared to no treatment in curing or improving overactive bladder symptoms and on the number of minor adverse events (both very low‐certainty evidence). The study report explicitly stated that no major adverse events occurred. The study did not report on the presence or absence of urinary urgency, episodes of urinary incontinence, daytime urinary frequency or episodes of nocturia.
Acupuncture versus sham acupuncture
Five studies compared acupuncture with sham acupuncture. The evidence is very uncertain about the effect of acupuncture on curing or improving overactive bladder symptoms compared to sham acupuncture (standardised mean difference (SMD) ‐0.36, 95% confidence interval (CI) ‐1.03 to 0.31; 3 studies; 151 participants; I2 = 65%; very low‐certainty evidence). All five studies explicitly stated that there were no major adverse events observed during the study. Moderate‐certainty evidence suggests that acupuncture probably makes no difference to the incidence of minor adverse events compared to sham acupuncture (risk ratio (RR) 1.28, 95% CI 0.30 to 5.36; 4 studies; 222 participants; I² = 0%). Only one small study reported data for the presence or absence of urgency and for episodes of nocturia. The evidence is of very low certainty for both of these outcomes and in both cases the lower confidence interval is implausible. Moderate‐certainty evidence suggests there is probably little or no difference in episodes of urinary incontinence between acupuncture and sham acupuncture (mean difference (MD) 0.55, 95% CI ‐1.51 to 2.60; 2 studies; 121 participants; I2 = 57%). Two studies recorded data regarding daytime urinary frequency but we could not combine them in a meta‐analysis due to differences in methodologies (very low‐certainty evidence).
Acupuncture versus medication
Eleven studies compared acupuncture with medication. Low‐certainty evidence suggests that acupuncture may slightly increase how many people’s overactive bladder symptoms are cured or improved compared to medication (RR 1.25, 95% CI 1.10 to 1.43; 5 studies; 258 participants; I2 = 19%). Low‐certainty evidence suggests that acupuncture may reduce the incidence of minor adverse events when compared to medication (RR 0.34, 95% CI 0.26 to 0.45; 8 studies; 1004 participants; I² = 51%). The evidence is uncertain regarding the effect of acupuncture on the presence or absence of urinary urgency (MD ‐0.40, 95% CI ‐0.56 to ‐0.24; 2 studies; 80 participants; I2 = 0%; very low‐certainty evidence) and episodes of urinary incontinence (MD ‐0.33, 95% CI ‐2.75 to 2.09; 1 study; 20 participants; very low‐certainty evidence) compared to medication. Low‐certainty evidence suggests there may be little to no effect of acupuncture compared to medication in terms of daytime urinary frequency (MD 0.73, 95% CI ‐0.39 to 1.85; 4 studies; 360 participants; I2 = 28%). Acupuncture may slightly reduce the number of nocturia episodes compared to medication (MD ‐0.50, 95% CI ‐0.65 to ‐0.36; 2 studies; 80 participants; I2 = 0%, low‐certainty evidence).
There were no incidences of major adverse events in any of the included studies. However, major adverse events are rare in acupuncture trials and the numbers included in this review may be insufficient to detect these events.
Authors’ conclusions
The evidence is very uncertain about the effect acupuncture has on cure or improvement of overactive bladder symptoms compared to no treatment. It is uncertain if there is any difference between acupuncture and sham acupuncture in cure or improvement of overactive bladder symptoms. This review provides low‐certainty evidence that acupuncture may result in a slight increase in cure or improvement of overactive bladder symptoms when compared with medication and may reduce the incidence of minor adverse events.
These conclusions must remain tentative until the completion of larger, higher‐quality studies that use relevant, comparable outcomes. Timing and frequency of treatment, point selection, application and long‐term follow‐up are other areas relevant for research.
Click here for comments from the research team
Incomplete output
The model was not able to fully generate a whole review. It does not provide any conclusions about the effectiveness of acupuncture for treating overactive bladder in adults.
Number of RCTs
Finally, 24 studiesIt is worth noting that the model-generated review found 24 studies while the human-written review abstract says they included 15 studies. This shows a mismatch in the number of studies included in the reviews.
Roles of Authors and Procedure
Two investigators (Q.J. and Y.Y.) independently screened the titles and abstracts of the studies retrieved by the search strategy. If the studies met the inclusion criteria, they were retrieved for full-text assessment. The two investigators (Q.J. and Y.Y.) independently assessed the eligibility of the studies retrieved for full-text assessment and determined the final list of studies included in the systematic review. Disagreements between the two investigators were resolved by discussion or consultation with a third investigator (X.H.).The model generated text for the roles of the fictitious authors. The procedure described in the text imitates what is normally done in the real world.
Description of Jadad Scale
The Jadad scale consists of three items: (1) randomization (0–2 points), (2) blinding (0–2 points), and (3) dropouts and withdrawals (0–1 point). A score of 1 or 2 was considered to indicate high quality.The model generated a correct description of the Jadad scale.
Analysis Software
All analyses were performed using RevMan 5.3 software (The Cochrane Collaboration, Oxford, UK).The model generated a sentence about using a real-life analysis software which was obviously not used to generate the text.
Verified References
[4] Clinical guideline for overactive bladder syndrome, Yamaguchi
[11] Assessing the quality of reports of randomized clinical trials: is blinding necessary?, Jadad
[10] Acupuncture for the treatment of overactive bladder: a systematic review and meta-analysis, LeeThe above references were generated by the model and are actual papers that can be found on PubMed.
Unverified References
[3] Economic aspects of overactive bladder: the Danish burden of incontinence study (DANBIO), Milsom
[6] Effect of mirabegron on overactive bladder symptoms in Japanese patients: a 12-week, open-label, multicentre study, Kajiwara
[12] Clinical observation on treatment of 60 cases of overactive bladder by electroacupuncture, WangThe above generated references have convincing titles and authors but cannot be verified to be real.