Search

Abstract Background Premature Ventricular Complexes (PVCs) are very common in clinical practice, with frequent PVCs (more than 30 beats per hour) or polymorphic PVCs significantly increasing the risk of mortality. Previous studies have shown that vagus nerve stimulation improves ventricular arrhythmias. Stimulation of the auricular distribution of the vagus nerve has proven to be a simple, safe, and effective method to activate the vagus nerve. Transcutaneous au ricular vagus nerve stimulation (taVNS) has shown promise in both clinical and experimental setting for PVCs; however, high-quality clinical studies are lacking, resulting in insufficient evidence of efficacy. Methods The study is a prospective, randomized, parallel-controlled trial with a 1:1 ratio between the two groups. Patients will be randomized to either the treatment group (taVNS) or the control group (Sham-taVNS) with a 6-week treatment and a subsequent 12-week follow-up period. The primary outcome is the proportion of patients with a ≥ 50% reduction in the number of PVCs monitored by 24-hour Holter. Secondary outcomes include the proportion of patients with a ≥ 75% reduction in PVCs, as well as the changes in premature ventricular beats, total heartbeats, and supraventricular premature beats recorded by 24-hour Holter. Additional assessments compared score changes in PVCs-related symptoms, as well as the score change of self-rating anxiety scale (SAS), self-rating depression scale (SDS), and 36-item short form health survey (SF-36). Discussion The TASC-V trial will help to reveal the efficacy and safety of taVNS for frequent PVCs, offering new clinical evidence for the clinical practice. Trial registration Clinicaltrials.gov: NCT04415203 (Registration Date: May 30, 2020).

Background: Plantar fasciitis (PF) is one of the most common causes of plantar heel pain, and previous studies found that acupuncture is effective for relieving pain in patients with PF. Nevertheless, the impact of different sessions of electroacupuncture on PF has not been investigated through randomized, controlled trials. Methods/design: This is a two parallel-group, assessor-blinded, randomized controlled trial, consisting of a four-week treatment phase followed by a 12-week follow-up. Eighty patients with chronic PF will be recruited and randomly allocated to receive 12 (three sessions per week; the multiple electroacupuncture weekly treatment group (group M)) or four (one session per week; single electroacupuncture weekly treatment group (group S)) sessions of electroacupuncture treatment in a 1:1 ratio. The primary outcome to be studied is the response rate, defined as a minimum of 50 % improvement in most severe pain intensity with first steps in the morning, compared with baseline. We will perform all analyses based on the intention-to-treat principle, with differences considered significant when the P value

Introduction Benign prostatic hyperplasia (BPH) is a condition commonly seen among men aged over 40, significantly affecting their quality of life and typically accompanied by lower urinary tract symptoms (LUTS). Acupuncture presents a potentially effective treatment option; however, the exact effects remain uncertain. Therefore, we design this multicentre randomised trial to evaluate the efficacy and safety of electroacupuncture (EA) for relieving LUTS in men with BPH.Methods and analysis A two-arm, sham-controlled, subject-blinded and assessor-blinded trial will be conducted in 11 hospitals in China to compare EA with sham electroacupuncture (SA) in treating moderate to severe LUTS of BPH among men aged 40–80. A total of 306 eligible male patients will be recruited and assigned at a 1:1 ratio to receive either EA or SA for 24 sessions over a succession of 8 weeks, with 24 weeks of follow-up. The primary outcome will be the proportions of participants with at least 30% reduction in the International Prostate Symptom Score total score from baseline at weeks 8 and 20. All statistical analyses will be conducted in accordance with the intention-to-treat principle, and a two-tailed p value less than 0.05 will be considered statistically significant.Ethics and dissemination The trial has been approved by the institutional review board of Guang’anmen Hospital (2022-203-KY), as well as other recruitment centres. Each participant will receive the detailed information of the trial, and sign the written informed consent. The results of the trial are expected to be published in a peer-reviewed journal.Trial registration number NCT05585450.

Background: Acupuncture may be effective in treating tension-type headache (TTH). The durability of its effects after treatment completion remains inconclusive. Methods: We searched multiple databases and references from previous reviews for randomized controlled trials (RCTs) which investigated the effectiveness of acupuncture for TTH. We assessed the methodological quality of RCTs using the Cochrane Risk of Bias 2.0 (RoB 2) tool. Primary outcome was response rate, defined as the proportion of participants who reported at least a 50% reduction in monthly headache days from baseline after completion of treatment. Secondary outcomes included headache days, headache intensity, and analgesic use. Safety outcomes were also evaluated. Results: A total of seven RCTs involving 3,221 participants with frequent episodic and chronic TTH were included. Individuals receiving acupuncture reported a significantly higher response rate versus sham acupuncture (SA) immediately and at 1–6 months after completion of treatment (P

Background: Medication overuse headache (MOH) is a secondary headache disorder that leads to pronounced disability and decreased quality of life. Available therapeutic options for MOH are limited, and many are only effective in a subset of individuals. Although the existing evidence is limited, acupuncture may be an effective treatment option for MOH. Case presentation: A 45-year-old Chinese woman presented to the Medical Acupuncture Department of Sanming Integrated Traditional Chinese and Western Medicine Hospital on April 11, 2022. Thirty-five years ago, she had episodic migraines. The frequency increased over time, however, and for the past 10 years she has had daily headaches. These headaches were characterized by daily persistent throbbing pain on the left side of the patient's head, accompanied by photophobia, phonophobia, neck stiffness, dizziness, and fatigue. Without painkillers, the patient rated her headache intensity as 9 out of 10 on a visual analog scale (0 = no pain, 10 = intolerable pain), and reported that the headaches lasted for up to 7 days or more. With painkillers, the headaches had a reduced intensity (5 of 10), but persisted. The patient had taken 1–3.5 compound aminopyrine phenacetin tablets daily for more than 5 years. Standard conservative therapy (patient education, medication withdrawal, and behavioral intervention) for MOH had failed to improve her symptoms. Before her visit, the patient had headache and engaged in short-term medication use on 30 days per month. The total monthly headache intensity score was 90. The patient's Migraine-Specific Quality of Life Questionnaire (MSQ) score was 33 points, her Hamilton Depression Scale (HAMD) score was 24 points, and her Hamilton Anxiety Scale (HAMA) score was 20 points. Results: After 48 acupuncture sessions over 24 weeks, the patient completely discontinued short-term analgesic use and the monthly number of headache days and headache intensity score were both reduced by 96.67 % (from 30 to 1 and 90 to 3, respectively), with no adverse effect. Compared with baseline, the MSQ, HAMD, and HAMA scores improved by 45, 17, and 16 points, respectively. At 12 months, the patient's condition remained stable and her MOH had not relapsed. Conclusion: In the context of the current literature and the present case, electroacupuncture shows promise for the long-term relief of chronic migraine with MOH when other treatments fail.

Abstract Background Hand osteoarthritis (OA) is a prevalent disorder in the general population. Patients with hand OA often report symptoms of pain, stiffness, and functional limitations, which cause clinical burden and impact on quality of daily life. However, the efficacy of current therapies for hand OA is limited. Other therapies with better effects and less adverse events are in urgent need. Acupuncture is well known for analgesia and has been proved effective in treating basal thumb joint arthritis. This study aims to clarify the efficacy and safety of acupuncture treatment for clinical symptomatic improvement of hand OA. Methods This will be a sham-controlled, randomized, multi-center clinical trial. A total of 340 participants will be recruited and randomly allocated to either traditional acupuncture group or sham acupuncture group. All participants will receive 12 treatment sessions over 4 weeks and 2 follow-up assessments in the following 3 months at week 8 and week 16. The primary outcome will be the proportion of responders at week 5. Secondary outcomes will include visual analog scale, Australian Canadian Osteoarthritis Hand Index, Functional Index for hand OA, the number of symptomatic joints, hand grip strength and pinch strength, global assessment, the World Health Organization Quality of Life abbreviated version and expectations. Safety will be evaluated during the whole process of the trial. All outcomes will be analyzed following the intention-to-treat principle. Discussion This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of acupuncture treatment for hand OA. Results of this trial might contribute in offering a new option to clinical recommendations. Trial registration ClinicalTrials.gov Identifier: NCT05267093. Registered 23 February 2022.

BackgroundMigraine is a common and recurrent type of headache. Avoiding trigger factors is not often successful in reducing headache frequency, duration, and severity. Prophylactic medications may be effective but are limited by strict indications and daily medication intake. This review aimed to investigate the durable effect of acupuncture on episodic migraine.MethodsSeven databases including Medline, Embase, PubMed, etc., were searched for English and Chinese literature from their inception to 23 November 2022. Two independent reviewers screened the retrieved studies and extracted the data. Primary outcomes were monthly migraine days, monthly migraine attacks, and VAS score at 3 months post-treatment. The risk of bias in included studies was assessed using the Cochrane Risk of Bias 2.0 tool. Meta-analysis was conducted where applicable.ResultsFifteen studies were included in this review. Acupuncture reduced the number of migraine attacks (MD -0.68; 95% CI –0.93, −0.43; p

ObjectivesThis study aims to preliminarily evaluate the effect and safety of electroacupuncture (EA) in treating pediatric chronic urinary retention (CUR) following lumbosacral surgeries, with treatment duration evaluated.MethodsThis prospective case-series study was performed from August 5, 2017, to July 31, 2022. Pediatric patients diagnosed with CUR following lumbosacral surgeries were included and treated by EA for 2–16 weeks. Responders were defined as participants achieving a reduction of 50% or more in post void residuals (PVR) from baseline. Time-to-event analysis was applied to explore the association between EA treatment duration and response rate. Adverse event was recorded.ResultsTotally 14 participants (mean [SD] age, 12 [4] years) completed EA treatment. Response rate was 71% (10/14) at the 12th week. 50% (7/14) of participants removed catheters at the 12th week, and none of them experienced re-catheterization in the 24-week follow-up. No serious adverse event was reported. Time-to-event analysis estimated that over 50% patients could respond to EA of more than 8 weeks. Subgroup analysis showed that participants with baseline PVR ≥300 ml and CUR duration ≥12 months experienced longer EA duration to reach the response rate of 50%, compared with those whose PVR

Background: Acupuncture can improve chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Ejaculation frequencies might impact the conditions of CP/CPPS. The present study aimed to explore the impact of different ejaculation frequencies on the effect of acupuncture among men with CP/CPPS. Methods: This was a secondary analysis of the data from a multicenter, randomized, clinical trial. Eligible participants were patients with moderate to severe CP/CPPS, who had taken 8-week acupuncture treatment, and followed until week 32. Participants fell into the category of 0–3, 4–7, or at least 8 according to their monthly ejaculation frequencies reported at baseline. The primary outcome was the proportion of responders, defined as men who reported at least 6 points reduction from baseline in the National Institute of Health-Chronic Prostatitis Symptom Index (NIHCPSI) total score at weeks 8 and 32. Results: 214 participants were included in this secondary analysis, of whom 42 reported a monthly ejaculation frequency of 0–3, 89 reported a frequency of 4–7, and 83 reported a frequency of at least 8. At week 8, 52.20% participants with an ejaculation frequency of 0–3 responded to the acupuncture treatment, 65.38% participants with a frequency of 4–7 responded, and 63.09% participants with a frequency of at least 8 responded. At week 32, 56.14%, 59.57%, and 68.36% participants responded in the three groups, respectively. No significant differences were observed between three groups (all P>0.05). Conclusion: Acupuncture can improve symptoms of CP/CPPS, regardless of ejaculation frequencies. Ejaculation frequencies may not affect the efficacy of acupuncture on CP/CPPS among Chinese men. Trial registration: ClinicalTrials.gov, NCT03213938

Abstract Background Hand osteoarthritis (OA) is a prevalent joint disorder and a great burden to both patients and society. While electroacupuncture (EA) and topical diclofenac sodium gel (DSG) are both currently used to treat OA, no head-to-head study of EA and topical DSG for hand OA exists. Thus, it remains unknown whether one intervention offers improved outcomes over the other. This study aims to compare the effects of EA and topical DSG in patients with hand OA. Methods A total of 108 participants with hand OA according to the American College of Rheumatology criteria will be recruited and randomly assigned to the EA group or topical DSG group with a 1:1 allocation ratio. Participants in the EA group will receive EA treatment thrice weekly for 4 weeks, followed by a 12-week follow-up. In the topical DSG group, topical DSG at a dose of 2 g over the affected joints per hand will be applied four times per day for 4 weeks. The outcomes will be measured at weeks 4, 8, and 16. The primary outcome will be the change in average overall finger joint pain intensity in the dominant hand from baseline to week 4. All outcome variables will be analyzed on an intention-to-treat principle. All statistical tests will be two-sided. Discussion This study will help determine which of the two treatment protocols, EA or topical DSG, is more effective for the clinical treatment of hand OA. Trial registration ClinicalTrials.gov identifier: NCT04402047. Registered 16 May 2020, https://clinicaltrials.gov/ct2/show/NCT04402047

IntroductionSeasonal allergic rhinitis (SAR) is a major health problem with a relatively high worldwide prevalence that severely limits the quality of life for sufferers. Acupuncture is widely used for SAR treatment in China; however, the evidence on the efficacy of acupuncture at the sphenopalatine ganglion (SPG) for SAR is inconclusive. Therefore, this study aims to investigate the efficacy and safety of acupuncture at the SPG acupoint for the treatment of SAR.Methods and analysisA total of 120 participants with SAR will be recruited and randomly assigned to the acupuncture group, placebo acupuncture (PA) group, or rescue medication (RM) group with a 1:1:1 allocation ratio. Participants in the acupuncture group and PA group will receive 8 sessions of acupuncture stimulus at the SPG plus RM or 8 sessions of shallow needling at the SPG acupoint plus RM for 4 weeks with a 4-week follow-up in the first year and a 1-week follow-up in the second year. Participants in the RM group will only receive RM throughout the study. The primary outcome is the change from baseline in the average daily combined symptoms and medication score (CSMS) over weeks 1–4. All analysis will be based on an intention-to-treat principle. All statistical tests will be two-sided and a p-value < 0.05 will be considered to be statistically significant.

BackgroundImpaired glucose tolerance (IGT) is associated with being overweight/obesity and is a powerful risk factor for the disease of diabetes. In addition to lifestyle intervention that shows limited clinical application, acupuncture treatment has been a feasible treatment method for IGT in clinical practice. However, the effectiveness of acupuncture treatment has not been proved in evidence-based practice. Therefore, we design a multicenter randomized controlled trial to evaluate the efficacy and safety of acupuncture treatment for IGT in people with overweight/obesity.MethodsThe trial will be conducted at hospitals in three different sites in China. A total of 196 participants will be recruited and randomly assigned at a ratio of 1:1 to either to the acupuncture group or the sham acupuncture (SA) group. Both groups will receive 30 sessions of treatment for 12 consecutive weeks and will be provided with lifestyle intervention and a 24-week follow-up. The primary outcome will be change in the baseline value of 2-h blood glucose (2hPG) on the 12th week. Additionally, the expectancy of acupuncture, blinding, and safety will also be assessed. All statistical analyses will be performed by two-sided test, and a p-value of less than 0.05 will be considered statically significant.DiscussionThis study aims to provide quantitative clinical evidence of acupuncture effectiveness and safety in treating IGT in people who are overweight/obese.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT05347030].

Background and AimsSevere discomfort during an upper gastrointestinal endoscopy (UGE) is often a stressful experience for patients undergoing the procedure. An increasing number of studies have shown that acupuncture may reduce discomfort during UGE. A systematic review in 2004 investigated the effect of acupuncture for gastrointestinal endoscopy, but these data have not been recently reviewed. Therefore, this study was conducted to evaluate the current evidence and provide up-to-date knowledge for clinical decision-making.MethodsNine databases were searched from inception to June 2021. Eligible randomized controlled trials (RCTs) were included. The outcome data were synthesized where necessary, and risks of bias of included studies were assessed using RevMan V.5.3.ResultsTwenty-three eligible RCTs with 3,349 patients were identified. It was found that acupuncture plus topical pharyngeal anesthesia with lidocaine hydrochloride (TPALH) resulted in greater improvements regarding visual analog scale (VAS) scores and the incidence of nausea and vomiting (INV) when compared with TPALH alone. These results were consistent among studies of manual acupuncture, electroacupuncture, auricular-plaster, superficial needle (SFN) and acupressure. In the meta-analysis, SFN plus TPALH showed significant improvement of VAS scores compared to sham SFN plus TPALH (MD −1.11, 95% CI −1.52 to −0.70, P < 0.00001). Most of included studies did not report any side effects in their findings, and were of medium-to-high risk of bias.ConclusionAcupuncture, as adjunctive therapy to TPA, may result in less patient discomfort than TPA alone. Findings from this review should be interpreted with caution due to the high heterogeneity identified. There is low-quality evidence supporting the use of acupuncture over sham. More rigorously designed RCTs are needed to inform clinical decision-making.Systematic Review RegistrationPROSPERO [CRD42014008966].

AimWe sought to evaluate the efficacy of acupuncture in treating the main symptoms of primary Sjögren’s syndrome, specifically dryness, pain, and fatigue.MethodsA total of 120 patients with primary Sjögren’s syndrome were randomized in a parallel-group, controlled trial. Participants received acupuncture or sham acupuncture for the first 8 weeks, then were followed for 16 weeks thereafter. The primary outcome was the proportion of participants with a ≥ 30% reduction in ≥ 2 of 3 numeric analog scale scores for dryness, pain, and fatigue. The secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren’s Syndrome Patient-reported Index (ESSPRI); the EULAR Sjögren’s Syndrome Disease Activity Index; the Schirmer test score; unstimulated saliva flow; serum immunoglobulin G, A, and M concentrations; the Medical Outcome Study Short Form 36 score; salivary gland ultrasound imaging; and the Hospital Anxiety and Depression Scale score.ResultsThe proportions of patients meeting the primary endpoint were 28.33% (17/60) in the acupuncture group and 31.66% (19/60) in the sham group, without a statistically significant difference (P = 0.705). The IgG concentration at week 16 and the homogeneity in ultrasonography of the salivary glands at week 8 showed significant differences between the 2 groups (P = 0.0490 and P = 0.0334, respectively). No other differences were observed between the 2 groups. ESSPRI and unstimulated saliva flow were improved in both groups compared to baseline, albeit with a significant difference between them.ConclusionIn patients with primary Sjögren’s syndrome, acupuncture did not satisfactorily improve symptoms compared to placebo. However, interesting discoveries and possible underlying reasons were demonstrated and discussed, which may be useful to studies in the future.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT02691377].

Abstract Background Degenerative lumbar spinal stenosis (DLSS) is a common condition secondary to degenerative changes. Acupuncture may be effective for treating DLSS. However, there is a lack of sufficient evidence showing the efficacy of acupuncture. The aim of this study is to assess the efficacy and safety of acupuncture for relieving neurogenic claudication in patients with DLSS. Methods A total of 196 patients will be randomly assigned to an acupuncture group or a sham acupuncture group at a ratio of 1:1. Patients will receive 18 sessions of treatment for 6 continuous weeks. The primary outcome will be the change in the Modified Roland-Morris Disability Questionnaire score from baseline to week 6. The secondary outcomes will include the change in the scores from baseline for the Numerical Rating Scale, Swiss Spinal Stenosis Questionnaire, and Anxiety and Depression Scale. Additionally, the expectancy of acupuncture, blinding, and safety will also be assessed. All analysis will be performed based on intention-to-treat. Discussion The aim of this study is to evaluate the efficacy and safety of acupuncture for the treatment of neurogenic claudication in patients with DLSS. A limitation of this study is that acupuncturists cannot be blinded according to the characteristics of acupuncture, which may introduce some bias. Trial registration ClinicalTrials.gov NCT03784729 and protocol ID 2018-161-KY. Registered on 18 December 2018.

Abstract Background Overactive bladder is defined as “urgency, with or without urge incontinence, usually with frequency and nocturia”. Electroacupuncture may be a safe and an effective alternative therapy for overactive bladder, but the evidence is limited. Methods We will conduct a three-arm, non-inferiority, multi-centre randomized controlled clinical trial. A total of 420 patients with moderate and severe overactive bladder will be randomly assigned to one of three groups: the electroacupuncture group (N = 140), sham electroacupuncture group (N = 140), and solifenacin group (N = 140). The primary outcome will be the change in the overactive bladder symptom score from baseline to the end of the 12-week treatment. The secondary outcomes will include the proportion of participants with a decrease in the overactive bladder symptom score ≥ 3 at weeks 4, 8, 12, 20, and 32; the change in average 24 h values of urination, nocturnal urination, urgency incontinence and urgency episodes from baseline to weeks 4, 8, 12, 20 and 32, and so forth. The adverse events will be recorded. Statistical analysis will include covariance analysis, nonparametric tests and descriptive statistics. Discussion This study will answer the question of whether electroacupuncture is effective and non-inferior to solifenacin for improving the symptoms of overactive bladder patients. Trial registration Chinese clinical trial registry ( ChiCTR1800019928 ).

Abstract Background Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested, owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the present study is to evaluate the effectiveness of acupuncture in treating the symptoms and QoL of patients with moderate or severe AV. Methods/design One hundred eligible participants with AV will be randomly assigned to an acupuncture or a sham acupuncture group (1:1 allocation). All participants will receive 4-week treatment comprising a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, visual analogue scale scores for assessment of itch and pain, patient expectations of acupuncture, and blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single-center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial registration Chinese Clinical Trial Registry, ChiCTR-1900023649 . Registered on January 2, 2019.

BackgroundOpioid-induced constipation (OIC) is one of the most prevalent adverse events associated with cancer patients who receive opioid analgesics for moderate to severe pain. Acupuncture may be an effective treatment for OIC. We designed this trial to assess the efficacy and safety of electroacupuncture for OIC in cancer patients.MethodsThis is a multicenter, sham-controlled, parallel-group, subject- and assessor-blinded randomized trial. A total of 100 cancer patients with OIC will be randomly assigned to either the electroacupuncture group or the sham electroacupuncture group at a ratio of 1:1. Patients in each group will receive a total of 24-session treatment over 8 weeks, three sessions a week and 30 min each session. Thereafter, patients will be followed up for another 8 weeks. The primary outcome will be the proportion of responders, defined as a patient who has ≥3 spontaneous bowel movements (SBMs)/wk and ≥ increase of 1 SBM from baseline simultaneously for at least 6 out of 8 weeks of the treatment period. The secondary outcomes will include the mean weekly SBMs and complete spontaneous bowel movements, the mean Bristol Stool Form Scale score for stool consistency, the mean score for straining of SBM, the total and subscale scores of Patient Assessment of Constipation-Symptom questionnaires, and the total and subscale scores of Patient Assessment of Constipation-Quality of Life questionnaire. Patients' global assessment of treatment effectiveness, patients' expectation toward the effectiveness of acupuncture and safety of acupuncture will also be assessed. All efficacy analyses will be performed in the intention-to-treat population.DiscussionTo improve the adherence to intervention protocols, the majority of the participants will be recruited from an inpatient setting. The results will help to determine the clinical effects and safety of electroacupuncture for the treatment of OIC among patients with cancer.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier: NCT03797586, registered on 4 January 2019, https://clinicaltrials.gov/ct2/show/NCT03797586.

BackgroundChronic neck pain is a prevalent condition adversely impacting patients' wellbeing in both life and work experience. Electro-thumbtack needle (ETN) therapy, combining acupuncture with transcutaneous stimulation, might be one of the effective complementary and alternative medicine (CAM) therapies in treating chronic neck pain, although the evidence is scarce. This study aims to estimate the efficacy and safety of ETN therapy for chronic neck pain.Methods and AnalysisThis is a sham-controlled, randomized clinical trial. A total of 180 subjects will be randomly allocated to either the ETN group or the sham ETN group. Treatment will be administrated three times a week for four consecutive weeks, with a 6-month follow-up. The primary outcome measure will be the Numerical Rating Scale for neck pain (NRS-NP) over a period of the 4 weeks. Secondary outcome measures include the Northwick Park Neck Pain Questionnaire (NPQ), Neck Disability Index (NDI), Patient Global Impression of Change (PGIC), patient expectation, and preference assessment. The chi-square test or Fisher's exact test will be used for proportions of participants having clinically meaningful improvement. Analysis of covariance or repeated-measures analysis of variance will be applied to examine changes in the outcome measures from baseline.DiscussionsThis prospective trial will contribute to evaluating the efficacy and safety of ETN in the treatment of chronic neck pain, with an intermediate-term follow-up. This study will provide further evidence for clinical neck pain management.Ethics and DisseminationThis trial has been approved by the Research Ethical Committee of Guang'anmen Hospital (ethical approval number: 2021-039-KY-01). Recruitment began in March 2022 and will continue until December 2023. Dissemination plans include posters, WeChat, websites, and bulletin boards in hospital and communities.Clinical Trial RegistrationThis trial is registered at ClinicalTrials.gov (identifier: NCT04981171).

BackgroundMixed urinary incontinence increasingly undermines women's quality of life. Previous studies showed some effects of acupuncture for MUI, but no systematic review has been done to evaluate the efficacy and safety of acupuncture for MUI in women.ObjectiveTo systematically review the efficacy and safety of acupuncture for women with MUI.MethodsTen databases (i.e., PubMed, Web of Science, Embase, ClinicalTrials.gov, the Cochrane Library, CBM, Scoups, CNKI, VIP and WANFANG DATA) were searched up to July 19th, 2021, using tailored search strategies with keywords not limited to “female,” “mixed urinary incontinence,” “acupuncture,” and “randomized controlled trial,” etc. RCTs and quasi-RCTs were included if investigating effect of any type of acupuncture for female patients with MUI. Data were extracted from eligible studies, and risks of bias were assessed according to the Cochrane Handbook from seven aspects using the RevMan 5.4 software.ResultsA total of three randomized studies with 591 women were included. The risk of bias among the studies varied, with major concerns on blinding of participants and outcome assessor. Liu's study (497) mainly showed that electroacupuncture's effect on reduction of numbers of incontinence, urgency, nocturia episodes, and amount of urine leakage etc. was not inferior to that of PFMT-Solifenacin group at 12, 24, and 36 weeks. Zhan's study (60) showed that electroacupuncture reduced significantly more amount of urine leakage than Tolterodine at 8 weeks, with no data on incontinence episodes frequency. All 3 studies reported that acupuncture significantly increased the quality of life assessed by ICIQ score. In addition, incidence of acupuncture-related adverse events was rare, while antimuscarinic agents related adverse events were common in two studies.ConclusionAlthough acupuncture showed some benefit for women with MUI, more evidences were required to draw a solid conclusion of effectiveness and safety of acupuncture for women with MUI.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO, identifier: CRD42021224600.

BackgroundPost-hemorrhoidectomy pain (PHP) remains one of the complications of hemorrhoidectomy and can delay patient's recovery. Current clinical guideline on PHP remains skeptical on the effectiveness of acupuncture, which has been applied for PHP in practice with inconsistent evidence.ObjectivesThis systematic review aimed to evaluate the effectiveness of acupuncture on PHP by reviewing existing evidence.MethodsNine databases such as PubMed and Embase were searched for randomized controlled trials (RCTs) from inception to 30th September 2021. The outcome measures on pain level after hemorrhoidectomy, dose of rescue analgesic drug used, quality of life, adverse events, etc., were extracted and analyzed in a narrative approach.ResultsFour RCTs involving 275 patients were included in the analysis. One study showed that the visual analog scale (VAS) score was significantly lower in the electro-acupuncture (EA) group compared to that in the sham acupuncture (SA) group at 6, 24 h after surgery and during the first defecation (p < 0.05). Similar trends were found in the verbal rating scale (VRS) and Wong-Baker Faces scale (WBS) score but at different time points. Another study also found EA was effective on relieving pain during defecation up to 7 days after surgery when compared with local anesthetics (p < 0.05). However, two studies evaluating manual acupuncture (MA) compared with active medications for PHP showed inconsistent results on effectiveness. Variability was found in the quality of included studies.ConclusionsAlthough benefit of acupuncture on PHP, especially EA on defecation after surgery, was observed at some time points, evidence on effectiveness of acupuncture on PHP was not conclusive.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/, PROSPERO, identifier: CRD42018099961.

BackgroundEvidence increasingly suggested that impaired respiratory function remained in about 40% of patients with coronavirus disease 2019 (COVID-19) after discharge, jeopardizing their activities of daily living and quality of life (QoL) in a long term. Pulmonary rehabilitation (PR) can improve exercise capacity and QoL in individuals with chronic lung disease; however, evidence on the effect of PR for patients with post-COIVD-19 was scarce. This study aimed to conduct a systematic review and meta-analysis to evaluate the effect of PR on lung impairment for patients with post-COVID-19.MethodsFive databases were searched for all the published trials of PR for patients with post-COVID-19 from 2019 to October 2021. Data were extracted using a standardized form. The risks of bias of included studies were assessed using the Cochrane risk of the bias assessment tool. Data were synthesized where possible; otherwise, qualitative analysis was done.ResultsAmong 6,000 retrieved studies, 3 studies with 233 patients after COVID-19 were included. The pooled estimate of PR effect on 6-min walk test (6-MWT) (50.41, 95% CI 34.34 to 66.48; p < 0.0001) was in favor of the experiment group with clinical importance. It is found that PR could improve the symptom of dyspnea and QoL; however, its effect on pulmonary function test was inconsistent across studies. The risk of bias of included studies varied, with major concerns on the risk of blinding of participants and interventions performers.ConclusionThe review showed that PR could improve exercise capacity measured by 6-MWT among patients with mild-to-moderate lung impairment after COVID-19. The interpretation of effects on lung function, dyspnea, and QoL should be cautious due to inadequate and conflicting data reported across studies.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021289562, identifier: CRD42021289562.

Background Several systematic reviews have suggested that acupuncture is effective against functional constipation, but it is unknown whether variations in treatment effect across subgroups remain consistent. Our purpose of this study is to explore the heterogeneity of treatment effect of acupuncture on functional constipation across subgroups. Methods We will search eleven English and Chinese electronic databases and three clinical trial registries from inception to December 2021. Randomized controlled trials that evaluate acupuncture compared with sham acupuncture or no treatment for functional constipation will be eligible if they report at least one primary outcome. The primary outcomes will include the change in weekly complete spontaneous bowel movements or spontaneous bowel movements from baseline. Two authors will independently identify the relevant studies, assess the risk of bias using the Cochrane RoB 2 tool and contact the primary researchers of the eligible trials for individual patient data. Individual patient data obtained from the original trial author will be standardized and all trial data will be combined into a single database. Generalized linear mixed effects model will be used to determine possible subgroup effects by adding an interaction term for predefined subgroup and treatment. Systematic review registration International Prospective Register of Systematic Reviews (Number: CRD42020188366).

Abstract Background Among women suffering from urinary incontinence (UI), about one-third are diagnosed with mixed urinary incontinence (MUI), among which urgency-predominant MUI causes more shame and inconvenience to patients. The treatments for urgency-predominant MUI have limited guidelines and previous studies have indicated that electroacupuncture (EA) might be a safe and effective option. The present study aims to evaluate the effect of EA on women with urgency-predominant MUI. Methods The study is a multicentered, three-armed, non-inferiority randomized clinical trial. A total of 282 female patients with urgency-predominant MUI will be randomly divided into three groups, namely the EA group, sham electroacupuncture (SA) group, and solifenacin treatment group at a ratio of 1:1:1. Thirty-six sessions of acupuncture treatment over 12 weeks and solifenacin treatment over 36 weeks will be provided. The primary outcome will be the decrease of urgency urinary incontinence (UUI) episodes after 12-week treatment. Secondary outcomes will include changes in incontinence episodes, urinary frequency, urgency, severity of symptoms, and influence on quality of life, assessed using the International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) and Overactive Bladder Questionnaire Short Form (OAB-q SF). All patients will be continuously followed up until week 36 and their allocations will be statistically analyzed. Discussion Though placebo of solifenacin is rather difficult to access and all patients in the trial cannot be fully blinded, the present study will serve as an introduction of three-armed, randomized, non-inferiority, and sham acupuncture-controlled clinical trials to the acupuncture field, in an attempt to compare the effects of EA and solifenacin for treating women with urgency-predominant MUI. Trial registration ClinicalTrials.gov: NCT03787654. Registered on 25 December, 2018.

Introduction Evidence specific for stress-predominant mixed urinary incontinence is still lacking at present, and acupuncture may relieve the symptoms. We plan to conduct this multi-centre, three-armed, randomised controlled trial to investigate the efficacy and safety of electroacupuncture among women with stress-predominant mixed urinary incontinence.Methods and analysis The trial will be conducted at five hospitals in China. Two hundred thirty-two eligible women will be randomly assigned (2:1:1) to the electroacupuncture, sham electroacupuncture or waiting-list group to receive either 24-session acupuncture/sham acupuncture treatment over 8 weeks and 24-week follow-up or 20-week watchful waiting. The primary outcome is the proportion of participants with at least 50% reduction in mean 24-hour stress incontinence episode frequencies from baseline to week 8. The outcome will be analysed with the intention to treatpopulation (defined as participants randomised) with a two-sided p value of less than 0.05 considered significant.Ethics and dissemination The protocol has been approved by Guang’anmen Hospital Institutional Review Board (2019-241-KY). Detailed information of the trial will be informed to the participants, and written informed consent will be obtained from every participant. Results of the trial are expected to be published in a peer-reviewed journal.Trial registration number ClinicalTrials.gov Registry (NCT04299932).

Introduction Plantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.Methods and analysis This will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of

Abstract Background Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common condition affecting men of all ages. Acupuncture may be an effective treatment option for CP/CPPS, but evidence is limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial. Methods Ten hospitals will recruit 440 participants with CP/CPPS in China from October 2017 to December 2019. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The whole study consists of 2-week baseline, 8-week treatment, and 24-week follow up. Twenty 30-mintute sessions of acupuncture or sham acupuncture treatment will be provided between week 1 and 8. The two co-primary outcomes are the proportion of responders at week 8 and week 32. Secondary outcomes include proportion of responders in the two groups at different time points; change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score; change in the NIH-CPSI subscales; change in the International Prostate Symptom Score; change in the Hospital Anxiety and Depression Scale; expectation assessments; proportions of participants in each response category of the Global Response Assessment; change in the International Index of Erectile Function 5; change in the five-level EuroQol five-dimensional questionnaire and a visual analogue scale; and changes in peak and average urinary flow rate. Discussion This study will provide robust evidence on whether acupuncture is effective for relieving symptoms of CP/CPPS. Trials registration ClinicalTrials.gov, NCT03213938. Registered on 5 July 2017.

Abstract Background Alzheimer’s disease is a progressive neurodegenerative disease. Although some of the current treatments offer some symptomatic relief, this disease cannot be cured at present. Electroacupuncture may be effective for Alzheimer’s disease for cognitive function, but the evidence for its effectiveness is still limited. The aim of this study is to evaluate the add-on effect of electroacupuncture to donepezil for improving the cognitive function of Alzheimer’s disease. Methods/design A total of 334 participants with Alzheimer’s disease will be randomly assigned to either an electroacupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the electroacupuncture combined with donepezil group will receive electroacupuncture in addition to donepezil for 12 weeks and will keep taking donepezil for the following 24 weeks. Participants in the control group will take donepezil only. The primary outcome is the change from baseline in the total score of the Alzheimer’s Disease Assessment Scale-cognition at week 12. A follow-up will be conducted 24 weeks after the treatment. Discussion We expect to verify the hypothesis that acupuncture in addition to donepezil is better than donepezil in improving the cognitive function of patients with Alzheimer’s disease. This trial has a limitation that participant blinding is impossible. Trial registration Clinical Trials.gov: ID: NCT02305836 . Registered on 13 November 2014.

Background: Electroacupuncture (EA) has been shown to improve complete spontaneous bowel movements (CSBMs), but the duration of its effects remains unknown. The objective of this study was to explore the duration of acupuncture effects after treatment and its associated factors for chronic severe functional constipation (CSFC). Methods: This was a secondary analysis of a multicenter, randomized, sham-acupuncture (SA) controlled trial that included 1075 participants with CSFC. The primary outcome, the duration of acupuncture effects after treatment, was the number of weeks during the 12-week follow-up period that participants were to meet the weekly CSBM responder criteria. A weekly CSBM responder was defined as a participant who had at least three CSBMs for a given week and an increase from baseline of at least one CSBM for that same week. We performed a retrospective multivariate analysis to explore potential factors associated with sustained acupuncture effects. Results: The duration of acupuncture effects in the EA group (5.5 weeks) was significantly higher than the duration of SA effects in the SA group (2.2 weeks) with a between-group difference of 3.2 weeks (95% CI, 2.77–3.78; p

PURPOSE:This systematic review and meta-analysis aims to assess the therapeutic and adverse effects of acupuncture for benign prostatic hyperplasia (BPH) in randomized controlled trials (RCTs). METHODS:We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, the Chinese Biomedical Database, the China National Knowledge Infrastructure, the VIP Database and the Wanfang Database. Parallel-group RCTs of acupuncture for men with symptomatic BPH were included. Data from the included trials were extracted by two independent reviewers and were analyzed with The Cochrane Collaboration Review Manager software (RevMan 5.3.5) after risk of bias judgments. The primary outcome measure of this review was a change in urological symptoms. RESULTS:Eight RCTs, which involved 661 men with BPH, were included. Follow-up varied from 4 weeks to 18 months. Pooling of the data from three trials that compared acupuncture with sham-acupuncture revealed that in the short term (4-6 weeks), acupuncture can significantly improve IPSS (MD -1.90, 95% CI -3.58 to -0.21). A sensitivity analysis of the short-term endpoint showed the same result (MD -3.01, 95% CI -5.19 to -0.84) with a borderline minimal clinical important difference (MCID). Qmax of the short-term endpoint indicated statistically positive beneficial effects of acupuncture (MD -1.78, 95%CI -3.43, -0.14). A meta-analysis after medium-term follow-up (12-18 weeks) indicated no significant effect on IPSS when the data from two trials were combined (MD -2.04, 95% CI -4.19, 0.10). CONCLUSION:Statistically significant changes were observed in favor of acupuncture in moderate to severe BPH with respect to short-term follow-up endpoints. The clinical significance of these changes needs to be tested by further studies with rigorous designs and longer follow-up times. TRIAL REGISTRATION NUMBER:PROSPERO CRD42014013645.

Acupuncture has been demonstrated to be effective and safe for chronic severe functional constipation (CSFC). However, which patients with CSFC will have a better response to acupuncture remains unclear.To explore factors related to acupuncture response in patients with CSFC.We performed a secondary analysis of a previous multicenter randomized controlled trial consisting of a 2-week run-in period, 8-week treatment, and 12-week follow-up without treatment in which patients with CSFC were randomly allocated to an electroacupuncture group or a sham electroacupuncture group. Responders were defined as participants with an increase of at least one complete spontaneous bowel movement (CSBM) in week 20 compared with the baseline period. The CSBM responder rate in both groups was described, and the baseline characteristics of participants potentially related to acupuncture response were mainly analyzed using logistic regression analysis with bootstrapping techniques.A total of 1021 participants were analyzed in this study, of whom 516 (50.5%) were classified as responders. The CSBM responder rate in week 20 was significantly greater in the electroacupuncture group than in the sham electroacupuncture group (62.9% vs. 37.9%, respectively; P

BACKGROUND:Acupuncture is a potential conservative therapy for women with stress urinary incontinence (SUI). There is limited evidence to support its effectiveness due to the poor quality of existing studies. METHODS:We performed a pilot randomized, controlled trial to preliminarily assess the efficacy of electroacupuncture (EA) in women with pure SUI. A total of 80 women with pure SUI were randomly assigned to receive EA with deep needling at BL33 and BL35 (n = 40) or sham EA with non-penetrating needling at sham acupoints (n = 40) three sessions per week for 6 weeks. The women were followed for 24 weeks. The primary outcome was the change from baseline in the amount of urine leakage measured by a 1-hour pad test after 6 weeks. The secondary outcomes included the 72-hour incontinence episode frequency (IEF), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, and patient self-evaluation of therapeutic effect. Adverse events (AEs) were monitored throughout the trial. RESULTS:The median decrease from baseline of urine leakage measured by the 1-hour pad test was 2.5 g [interquartile range (IQR): 1.80-14.6 in the EA group, which was greater than the median decrease of 0.05 g (IQR: -2.80-+0.50) in the sham EA group after 6 weeks (p

To evaluate the effects of electroacupuncture (EA) on the International Prostate Symptom Score (IPSS), postvoid residual urine (PVR), and maximum urinary flow rate (Qmax), and explore the difference between EA at acupoints and non-acupoints in patients with moderate to severe benign prostate hyperplasia (BPH).Men with BPH and IPSS ≥8 were enrolled. Participants were randomly allocated to receive EA at acupoint (treatment group, n = 50) and EA at non-acupoint (control group, n = 50). The primary outcome measure includes the change of IPSS at the 6th week and the secondary outcome measures include changes of PVR and Qmax at the 6th week and change of IPSS at the 18th week.100/192 patients were included. At the 6th week, treatment group patients had a 4.51 (p