Acupuncture for in vitro fertilization-embryo transfer: an overview of systematic reviews. / é’ˆç¸è¾ åŠ©ä½“å¤–å—ç²¾èƒšèƒŽç§»æ¤çš„ç³»ç»Ÿè¯„ä»·å†è¯„ä»·.

OBJECTIVES: To evaluate the report quality, methodological quality and evidence quality of the systematic reviews and meta-analyses (SRs/MAs) of acupuncture for in vitro fertilization-embryo transfer (IVF-ET). METHODS: The SRs/MAs of acupuncture for IVF-ET were searched electronically from databases of CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, Cochrane Library, from inception of each database to September 27th, 2022. Two reviewers independently screened the literature and extracted the data. Using PRISMA statement, the AMSTAR 2 scale and the GRADE system, the report quality, methodological quality and evidence quality of the included SRs/MAs were assessed. RESULTS: A total of 28 SRs/MAs were included, with PRISMA scores ranging from 8.5 points to 27 points. The problems of report quality focused on protocol and registration, retrieval, risk of bias in studies, additional analysis, limitations and funding. The methodological quality of included studies was generally low, reflecting on items 2, 3, 7, 10, 12 and 16. A total of 85 outcome indexes were included in the GRADE system for evidence grade evaluation. Most of the evidences were low or very low in quality. The reasons for the downgrade were related to study limitations, inconsistency, imprecision and publication bias. CONCLUSIONS: Acupuncture therapy improves the outcomes of IVF-ET, but the methodological quality and evidence quality of related SRs/MAs are low. It is recommended to conduct more high-quality studies in the future to provide more reliable evidences.

Use of Evidence-Based Research Approach in RCTs of Acupuncture-Related Therapies for Primary Dysmenorrhea: A Meta-Research.

OBJECTIVE: To assess the use of evidence-based research (EBR) approach in randomized controlled trials (RCTs) of acupuncture-related therapies for primary dysmenorrhea (PD). METHODS: PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Database, and China Science and Technology Journal Database were searched from January 2013 to December 2022 for RCTs of acupuncture on PD. The full text and references of each RCT were read to assess whether systematic reviews (SRs) or other types of studies with similar research questions and end-users' perspectives were cited to justify and design the trial. In addition, the discussion section were analyzed to evaluate whether trials placed the new result in the existing SRs to draw a conclusion. Multivariable logistic regression was used to find variables that associated with 3 aspects of EBR approach: (1) citing clinical studies for justification, (2) citing relevant studies that obtain the perspectives of end users, and (3) citing clinical studies for results discussion. RESULTS: Of 473 RCTs included, 45.67% (216) of the trials cited relevant similar studies, 21.56% (102) referenced to the studies that collected end-users' perspectives, and 10.99% (52) placed result in the context of the previous research. Few RCTs appropriately applied EBR approach. Among all the included studies, 3.17% (15) of the trials used SRs to inform study questions but none of them used updated SRs with acceptable quality; 1.05% (5) of the trials cited SRs of end-user's perspectives in the justification and design of the study, and only 1 trial added results in existing SR to draw a conclusion. Year of publication, language, funding, registration, ethical approval and number of sites were significantly associated with 1 of the 3 aspects of EBR approach. CONCLUSIONS: Few RCTs in acupuncture-related therapies for PD used the EBR approach to minimize research redundancy. Researchers, research institutes, funding agencies, ethics committees, journals and peer reviewers in acupuncture should make efforts to use and promote the EBR approach to ensure the value of new trials.

[Fidelity in acupuncture-moxibustion clinical research: application and reflection].

As an indicator that measures the degree of implementation of intervention measures during the implementation process, fidelity could be used for monitoring and quality evaluation of the completion degree of intervention measures, and plays an important role in improving the degree of intervention implementation and clarifying the factors that affect intervention implementation. This article aims to introduce the connotation and significance, measurement, control, and current application status of fidelity, as well as the current application status of fidelity in acupuncture-moxibustion clinical research and its inspiration for future research. Meanwhile, based on the existing evaluation tool development methods of fidelity and the characteristics of acupuncture-moxibustion clinical research, a preliminary fidelity evaluation framework is proposed. Introducing fidelity into acupuncture-moxibustion clinical research could improve the implementation quality and compliance of acupuncture-moxibustion in clinical research, increase the credibility and effectiveness of clinical research results, and promote the transformation of acupuncture-moxibustion experience into easily learnable and promotable treatment plans.

Approach to Assess Adequacy of Acupuncture in Randomized Controlled Trials: A Systematic Review.

OBJECTIVE: To summarize and identify the available instruments/methods assessing the adequacy of acupuncture in randomized controlled trials (RCTs) for proposing a new improved instrument. METHODS: A systematic literature search was carried out in 7 electronic databases from inception until 21st November 2022. Any study evaluating the adequacy or quality of acupuncture, specifying specific acupuncture treatment-related factors as criteria of subgroup analysis, or developing an instrument/tool to assess the adequacy or quality of acupuncture in an RCT was included. Basic information, characteristics and contents of acupuncture adequacy assessment were presented as frequencies and percentages. RESULTS: Forty studies were included in this systematic review. Thirty-five studies (87.50%) were systematic reviews, none of which used formal methods to develop the assessment instruments/methods of acupuncture adequacy; of 5 methodological studies, only 1 study used a relatively formal method. Thirty-two studies (82.05%) assessed the components of acupuncture, while 7 (17.95%) assessed the overall quality of acupuncture. An independent assessment instrument/method was used to assess acupuncture adequacy in 29 studies (74.35%), whereas as one part of a methodological quality assessment scale in 10 (25.65%). Only 9 (23.00%) studies used the assessment results for subgroup analysis, sensitivity analysis or the criteria for inclusion in the meta-analysis. CONCLUSION: Assessment contents for adequacy or quality of acupuncture in RCTs hadn't still reached consensus and no widely used assessment tools appeared. The methodology of available assessment instruments/scales is far from formal and rigorous. A new instrument/tool assessing adequacy of acupuncture should be developed using a formal method.

Acupuncture and related therapies for atopic eczema: A protocol for systematic review and network meta-analysis.

BACKGROUND: Atopic eczema (AE) is a chronic relapsing dermatological disease characterized by pruritus, dryness, erythema, and lichenification. Acupuncture as an alternative treatment can relieve symptoms, reduce the recurrence, and improve the quality of life (QoL) with less adverse reactions in treating AE. This network meta-analysis (NMA) will comprehensively access the efficacy and safety of different acupuncture therapies for patients with AE, and rank the different acupuncture therapies, in order to present evidence-based medicine evidence for clinical application extensively. METHOD AND ANALYSIS: This study will search 8 electronic databases from the establishment of the database to August 30th, 2022. The screening of literature, data extraction, and risk of bias assessment will be conducted by 2 researchers, respectively. The quality of evidence will be judged by the Grading of Recommendations Assessment, Development and Evaluation system. This NMA will be analyzed with Stata Version. 14.0 and WinBUGS Version.1.4.3. RESULTS: This study will comprehensively access the efficacy and safety of different acupuncture therapies for patients with AE on the severity, itch intensity, emotional symptoms, QoL, and recurrence rate. Moreover, it will further identify which acupuncture therapy is the most effective. CONCLUSION: The findings of this NMA may help patients and therapists choose the best acupuncture therapy in treating AE and furnish reliable evidence for guidelines. REGISTRATION NUMBER: PROSPERO CRD42020203437.

[Selection and application of explanatory and pragmatic randomized controlled trials in clinical research of acupuncture].

In the view of the controversy that there is no efficacy difference between true and sham acupuncture in acupuncture randomized controlled trials (RCTs), it is analyzed that one of the reasons is that many clinical studies do not properly understand the design of RCT research and interpret the research results. Starting from the concept and coverage of explanatory RCT and pragmatic RCT, this study lists the application examples of two types of RCTs in the field of acupuncture from five aspects: research purpose and trial environment, subject selection, intervention measures, control measures and outcome evaluation, so as to provide some ideas for their application in clinical trials.

Factors Associated with the Magnitude Of acUpuncture treatment effectS (FAMOUS): a meta-epidemiological study of acupuncture randomised controlled trials.

OBJECTIVE: To identify factors and assess to what extent they impact the magnitude of the treatment effect of acupuncture therapies across therapeutic areas. DATA SOURCE: Medline, Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc, between 2015 and 2019. STUDY SELECTION: The inclusion criteria were trials with a total number of randomised patients larger than 100, at least one patient-important outcome and one of two sets of comparisons. DATA ANALYSIS: The potential independent variables were identified by reviewing relevant literature and consulting with experts. We conducted meta-regression analyses with standardised mean difference (SMD) as effect estimate for the dependent variable. The analyses included univariable meta-regression and multivariable meta-regression using a three-level robust mixed model. RESULTS: 1304 effect estimates from 584 acupuncture randomised controlled trials (RCTs) were analysed. The multivariable analyses contained 15 independent variables . In the multivariable analysis, the following produced larger treatment effects of large magnitude (>0.4): quality of life (difference of adjusted SMDs 0.51, 95% CI 0.24 to 0.77), or pain (0.48, 95% CI 0.27 to 0.69), or function (0.41, 95% CI 0.21 to 0.61) vs major events. The following produced larger treatment effects of moderate magnitude (0.2-0.4): single-centred vs multicentred RCTs (0.38, 95% CI 0.10 to 0.66); penetration acupuncture vs non-penetration types of acupuncture (0.34, 95% CI 0.15 to 0.53); non-pain symptoms vs major events (0.32, 95% CI 0.12 to 0.52). The following produced larger treatment effects of small magnitude (<0.2): high vs low frequency treatment sessions (0.19, 95% CI 0.03 to 0.35); pain vs non-pain symptoms (0.16, 95% CI 0.04 to 0.27); unreported vs reported funding (0.12, 95% CI 0 to 0.25). CONCLUSION: Patients, clinicians and policy-makers should consider penetrating over non-penetrating acupuncture and more frequent treatment sessions when feasible and acceptable. When designing future acupuncture RCTs, trialists should consider factors that impact acupuncture treatment effects.

[Analysis on influencing factors of acupuncture curative effect based on experts' experience].

To explore the influencing factors of acupuncture curative effect in literature of experts' experience. The journal literature of experts' experience was retrieved from China National Knowledge Infrastructure (CNKI) and PubMed, starting from inception to September 4, 2020, and the influencing factors of acupuncture curative effect were extracted and analyzed. A total of 499 articles were included, involving 495 articles in Chinese and 4 articles in English. The influencing factors of acupuncture curative effect mainly include five aspects: diagnostic method, acupoint selection of acupuncture, acupuncture manipulation, regulating mind of acupuncture and acupuncture time, and provide reference for acupuncture protocol design in clinical trials.

The Role of Acupuncture in Relieving Post-Hemorrhoidectomy Pain: A Systematic Review of Randomized Controlled Trials.

Background: Post-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. Objectives: This systematic review aimed to evaluate the effectiveness of acupuncture on PHP by reviewing existing evidence. Methods: Nine 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. Results: Four 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. Conclusions: Although 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 Registration: https://www.crd.york.ac.uk/PROSPERO/, PROSPERO, identifier: CRD42018099961.

Efficacy of acupuncture in improving symptoms and quality of life of patients with acne vulgaris: a randomized sham acupuncture-controlled trial.

OBJECTIVE: The aim of this study was to examine the effectiveness of acupuncture in treating the symptoms and quality of life (QoL) of patients with moderate or severe acne vulgaris (AV). METHODS: Participants were randomly assigned (1:1) to receive 12 treatment sessions of acupuncture or sham acupuncture over 4 weeks with 24 weeks of follow-up. The primary outcome was the change from baseline in the Skindex-16 scale total score at treatment completion. Secondary outcomes included Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, and visual analogue scale scores for itch and pain evaluation. RESULTS: There was no statistically significant between-group difference for the primary outcome or any secondary outcomes after 4 weeks of treatment and at 16 and 28 weeks of follow-up, except for the Skindex-16 emotions subscale at week 4 (p = 0.026). No serious adverse events occurred in either group. CONCLUSION: Acupuncture may not effectively relieve the symptoms of patients with moderate or severe AV, or improve QoL. Given the limitations of a relatively short treatment course compared to other studies and the likelihood that sham acupuncture is not inert, further studies with treatment durations of 12 weeks or longer and a waitlist (no treatment) control or Western medicine-treated control group should be considered to evaluate the effects of acupuncture on AV. TRIAL REGISTRATION NUMBER: ChiCTR-1900023649 (Chinese Clinical Trial Registry).

[Clinical study on acupuncture and moxibustion for frozen shoulder: an evidence map].

The clinical evidences on acupuncture and moxibustion for the treatment of frozen shoulder were sorted and summarized systematically. The relevant articles of frozen shoulder treated with acupuncture and moxibustion were searched from PubMed, EMbase, Cochrane database of systematic review (CDSR), Cochrane database of controlled trials register (CENTRAL), China national knowledge infrastructure (CNKI), Wanfang, VIP, and Chinese biomedical literature databases (SinoMed), from database inception to May 31, 2021. Using AMSTAR-2, the methodological quality of the included systematic reviews was evaluated. With evidence map, the current status of clinical evidence was summarized on acupuncture and moxibustion in treatment of frozen shoulder. A total of 266 original studies and 6 systematic reviews were included finally. At present, many randomized controlled trials are designed with small sample size and the simple acupuncture and moxibustion therapy is dominant as the intervention, e.g. warm acupuncture, acupuncture with filiform needle, acupotomy and electroacupuncture. The outcomes considered in the current trials focus on clinical effective rate, the score of shoulder pain, the score of shoulder function and the score of quality of life. Most of the studies have shown that acupuncture and moxibustion is advantageous as an adjunctive therapy for frozen shoulder, but its clinical evidence is few in terms of the recurrence rate and safety. Moreover, it needs to improve the evidence quality of the relevant studies on acupuncture and moxibustion for frozen shoulder.

Effect of Acupuncture on Outcomes of in vitro Fertilisation: A Scoping Review.

OBJECTIVES: To identify, examine and summarize the available evidence on the effectiveness and safety of acupuncture for in vitro fertilisation (IVF) outcomes. METHODS: Eight electronic databases, including PubMed, EMBASE, Cochrane Database of Systematic Review, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Database and VIP Database, were searched, supplemented by manual searches. Two researchers independently conducted the literature screening, data extraction, and methodological quality assessments. A narrative description was provided to show the general information and specific characteristics of the included studies. A bubble plot was used to visually display the overall effects of acupuncture on IVF outcomes. RESULTS: Eighty-two studies were identified, including 64 primary studies and 18 systematic reviews. Transcutaneous electrical acupoint stimulation, electric acupuncture and manual acupuncture were applied in most studies and compared with no acupuncture, sham acupuncture and placebo acupuncture control groups. Sixty-three (98.4%) primary studies reported clinical pregnancy rate, and positive effects of acupuncture were found in 34 studies (54.0%). Live birth rate was reported in only 18 (28.1%) primary studies, of which 10 (55.6%) showed positive results. In addition, only 8 and 2 systematic reviews showed that acupuncture could increase clinical pregnancy events and live birth events, respectively. However, none of these reviews was of high methodological quality. CONCLUSIONS: Available evidence suggests that acupuncture therapy could improve clinical pregnancy rates. However, whether acupuncture could increase live birth events was difficult to determine based on the few studies that have reported this outcome indicator. Furthermore, the methodological quality of most systematic reviews was assessed as critically low or low. Studies with a rigorous design and standardized implementation should be performed to refine the available evidence.

Comparison of electroacupuncture and manual acupuncture for patients with plantar heel pain syndrome: a randomized controlled trial.

BACKGROUND: Plantar heel pain syndrome (PHPS), also known as plantar fasciitis, affects millions of people worldwide. Electroacupuncture (EA) and manual acupuncture (MA) are the two acupuncture modalities frequently used for PHPS in the clinical setting. However, which modality is more effective has yet to be determined. OBJECTIVE: To examine whether EA is more effective than MA with regards to pain relief for patients with PHPS. METHODS: Participants were randomly assigned (1:1) to receive 12 treatment sessions of EA or MA over 4 weeks with 24 weeks of follow-up. The primary outcome was the proportion of treatment responders, defined as patients with at least a 50% reduction from baseline in the worst pain intensity experienced during the first steps in the morning after a 4-week treatment, measured using a visual analogue scale (VAS, 0-100; higher scores signify worse pain). Analysis was by intention-to-treat. RESULTS: Ninety-two patients with a clinical diagnosis of PHPS were enrolled from 29 July 2018 through 28 June 2019. Of the patients, 78 (85%) completed the treatment and follow-up. The primary outcome occurred in 54.8% (23/42) of the EA group compared to 50.0% (21/42) of the MA group after the 4-week treatment (difference -4.76, 95% confidence interval, -26.10 to 16.57, P = 0.662). There were no significant between-group differences for any secondary outcomes after 4 weeks of treatment and at 16 weeks and 28 weeks of follow-up. There were no serious treatment-related adverse events in either group. CONCLUSION: Among patients with PHPS, EA did not have a better effect with respect to relieving pain intensity than MA at week 4, although both EA and MA appeared to have positive temporal effects, with decreased heel pain and improved plantar function. TRIAL REGISTRATION NUMBER: ChiCTR1800016531 (Chinese Clinical Trial Registry).

Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: study protocol for a randomized controlled trial.

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.

Effects of electroacupuncture on patients with chronic urinary retention caused by a lower motor neuron lesion: An exploratory pilot study.

Chronic urinary retention (CUR) is defined as a non-painful bladder that remains palpable or percussible after the patient has passed urine. Acupuncture may decrease PVR and improve bladder function in patients with neurogenic CUR. The aim of this study was to preliminarily observe the effectiveness of electroacupuncture (EA) for patients with CUR caused by a lower motor neuron lesion and to provide some therapeutic data for further study.This study was a pilot study of 30 patients with CUR caused by a lower motor neuron lesion. Patients were treated with EA for 12 weeks with 36 sessions of EA.Responders were defined as participants with a decline in postvoid residual urine (PVR) volume after spontaneous urination of ≥50% from baseline. The proportion of responders, change in PVR volume from baseline after spontaneous urination, and the proportion of patients with severe difficulty with urination, who required assistance with bladder emptying and with stool retention, were measured at weeks 4, 8, and 12.Thirty patients were included in this study, and 23 completed 12 weeks of treatment. The proportion of responders at weeks 4, 8, and 12 was 6.67%, 28%, and 43.48%, respectively. Decrease in PVR volume, compared with baseline, was significant at all asessment timepoints. The proportion of patients with severe difficulty with urination, who required assistance with bladder emptying and with stool retention, decreased after treatment.EA is a potential treatment for improving bladder function in patients with CUR caused by a lower motor neuron lesion.

The effectiveness and safety of acupuncture for patients with atopic eczema: a systematic review and meta-analysis.

OBJECTIVE: The aim of this study was to systematically assess the effectiveness and safety of acupuncture for patients with atopic eczema (AE). METHODS: Two reviewers searched 13 databases from their inception through 31 July 2018 for randomized controlled trials (RCTs) of patients with AE. Dichotomous data and continuous data were analyzed using risk ratio (RR) and mean difference (MD), respectively, with 95% confidence intervals (CIs). RESULTS: A total of eight RCTs (with 434 participants) were included. The results of one included RCT showed that acupuncture was better than no treatment at reducing itch intensity measured using a visual analogue scale in patients with AE. The combined results of six RCTs showed that acupuncture was better than conventional medicine at reducing the eczema area and severity index (EASI) (MD: -1.89, 95% CI: -3.04 to -0.75, I2: 78%) and the combined results of seven RCTs showed that acupuncture was better than conventional medicine in terms of global symptom improvement (RR: 1.59, 95% CI: 1.20 to 2.11, I2: 55%) in AE. We had insufficient data to show significant effects of acupuncture on quality of life and AE recurrence rate. No severe adverse events were found related to acupuncture. LIMITATIONS: The included RCTs had some methodological limitations, and most of the included trials were conducted in China. This analysis only included studies that compared acupuncture alone with no treatment or positive control (conventional medicine), so the specific effects of acupuncture could not be evaluated. CONCLUSION: Acupuncture might be effective at reducing itch intensity and may be more effective than conventional medicine at reducing EASI and improving the global symptoms of AE. PROTOCOL REGISTRATION: PROSPERO CRD42018096261.

Electroacupuncture versus manual acupuncture in the treatment of plantar heel pain syndrome: study protocol for an upcoming randomised controlled trial.

INTRODUCTION: Plantar heel pain syndrome(PHPS) is a common cause of heel pain. It may worsen a patient's quality of life, and potentially lead to knee, hip or lower back problems. Previous studies have shown that electroacupuncture (EA) and manual acupuncture (MA) are effective treatments for relieving pain in patients with PHPS. However, little evidence supports the use of one intervention over the other. METHODS AND ANALYSIS: A total of 92 patients diagnosed with PHPS will be recruited and randomly assigned to an EA group or an MA group at a ratio of 1:1. Patients in both groups will receive a 30 min acupuncture treatment (three times per week) for a total of 12 sessions over 4 weeks. The primary outcome will be the proportion of patients with at least 50% reduction from baseline in the worst pain intensity measured by visual analogue scale (0-100, higher scores signify worse pain) at first steps in the morning after 4-week treatment. The secondary outcomes will include change in worst pain intensity at first steps in the morning, change in mean pain intensity at first steps in the morning, change in worst pain intensity during the day, change in mean pain intensity during the day, change in the pressure pain threshold, change in ankle-dorsiflexion range of motion, change in Foot and Ankle Ability Measure total score and subscale scores, patients' global improvement assessment, patients' expectations for acupuncture and safety evaluation. We will perform all statistical analysis following the intention-to-treat principle. ETHICS AND DISSEMINATION: The study has been approved by our ethics review board (Protocol Approval No. 2018-010-KY). The study findings will be disseminated through presentation at a high-impact medical journal, with online access. We also to plan to present it in select conferences and scientific meetings. TRIAL REGISTRATION: ChiCTR-1800016531; Pre-results.

Risk factors related to acupuncture response in postmenopausal women with stress urinary incontinence: Secondary analysis of a randomized controlled trial.

Postmenopausal women are at a higher risk of stress urinary incontinence (SUI). In a previous trial, electroacupuncture (EA) was shown to be an effective treatment for women with SUI. Here we present a secondary analysis to investigate the specific factors associated with response to acupuncture therapy among postmenopausal women with SUI.We conducted secondary analysis of data from a multicenter randomized controlled trial. This trial included a baseline period of 1 week and a treatment period of 6 weeks with electroacupuncture (EA) or sham electroacupuncture (SA). The patients were randomly assigned to 2 groups (EA group or SA group). Participants who showed a decrease in urine leakage by at least 50% from baseline level, as measured by 1-hour pad at week 6, were defined as responders. Baseline characteristics associated with response to acupuncture therapy (e.g., demographic, comorbidities, and lifestyle-related factors) were identified by logistic regression analysis and the interactions between treatment assignment and baseline characteristics assessed.This analysis included a total of 349 postmenopausal women, of whom 137 (39.3%) were classified as responders. Response rate in the EA group was significantly higher than that in the SA group (60.9% vs 18.9%, respectively; P < .001). On multivariable logistic regression analysis, only "mean number of urine pads used before treatment" remained a significant predictor of response to therapy (EA or SA). Greater weekly mean number of urine pads used before treatment showed a correlation with non-response to therapy, as the likelihood of clinical response reduced by 5.26% with increase in the weekly mean number of urine pads used (odds ratio 0.947, 95% confidence interval 0.902-0.993; P = .020). The interaction terms were not statistically significant.Postmenopausal women with SUI who used fewer number of pads per week before treatment were more likely to respond to therapy. This study provides valuable insights for pretreatment selection of women with SUI. Specific factors related to the therapeutic effects of acupuncture were not identified and need to be explored in future studies.Trial registration: Clinical Trials.gov: NCT01784172.

Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

BACKGROUND: To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation. METHODS: Individuals with functional constipation will be randomly allocated to receive either EA or TENS (n = 51, each), 3 times per week for 8 weeks. The primary outcome is the percentage of participants with an average increase from baseline of 1 or more complete spontaneous bowel movements at week 8. The secondary outcome measures are the following: at the time of visits, changes in the number of complete spontaneous bowel movements, number of spontaneous bowel movements, stool character, difficulty in defecation, patients' assessment of quality of life regarding constipation (self-report questionnaire), and use of auxiliary defecation methods. DISCUSSION: The results of this trial should verify whether EA is more efficacious than TENS for relieving symptoms of functional constipation. The major limitation of the study is the lack of blinding of the participants and acupuncturist.