Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial.

BACKGROUND: Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient. OBJECTIVE: To investigate the effect of acupuncture for DLSS. DESIGN: Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729). SETTING: 5 hospitals in China. PARTICIPANTS: Patients with DLSS and predominantly neurogenic claudication pain symptoms. INTERVENTION: 18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ. RESULTS: A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; P = 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient. LIMITATION: The SA could produce physiologic effects. CONCLUSION: Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment. PRIMARY FUNDING SOURCE: 2019 National Administration of Traditional Chinese Medicine "Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM" (NO. 2019XZZX-ZJ).

Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial.

BACKGROUND: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. OBJECTIVE: To assess the long-term efficacy of acupuncture for CP/CPPS. DESIGN: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938). SETTING: Ten tertiary hospitals in China. PARTICIPANTS: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. INTERVENTION: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. RESULTS: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. LIMITATION: Sham acupuncture might have had certain physiologic effects. CONCLUSION: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. PRIMARY FUNDING SOURCE: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.

Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial.

INTRODUCTION: This multicenter, randomized, noninferiority trial compared electroacupuncture with prucalopride for the treatment of severe chronic constipation (SCC). METHODS: Participants with SCC (≤ 2 mean weekly complete spontaneous bowel movements [CSBMs]) were randomly assigned to receive either 28-session electroacupuncture over 8 weeks with follow-up without treatment over 24 weeks or prucalopride (2 mg/d before breakfast) over 32 weeks. The primary outcome was the proportion of participants with ≥3 mean weekly CSBMs over weeks 3-8, based on the modified intention-to-treat population, with -10% as the noninferior margin. RESULTS: Five hundred sixty participants were randomized, 280 in each group. Electroacupuncture was noninferior to prucalopride for the primary outcome (36.2% vs 37.8%, with a difference of -1.6% [95% confidence interval, -8% to 4.7%], P < 0.001 for noninferiority); almost the same results were found in the per-protocol population. The proportions of overall CSBM responders through weeks 1-8 were similar in the electroacupuncture and prucalopride groups (24.91% vs 25.54%, with a difference of -0.63% [95% confidence interval, -7.86% to 6.60%, P = 0.864]). Except during the first 2-week treatment, no between-group differences were found in outcomes of excessive straining, stool consistency, and quality of life. Adverse events occurred in 49 (17.69%) participants in the electroacupuncture group and 123 (44.24%) in the prucalopride group. One non-treatment-related serious adverse event was recorded in the electroacupuncture group. DISCUSSION: Electroacupuncture was noninferior to prucalopride in relieving SCC with a good safety profile. The effects of 8-week electroacupuncture could sustain for 24 weeks after treatment. Electroacupuncture is a promising noninferior alternative for SCC (see Visual Abstract, http://links.lww.com/AJG/B776).

Electroacupuncture for balanced mixed urinary incontinence: secondary analysis of a randomized non-inferiority controlled trial.

INTRODUCTION AND HYPOTHESIS: The aim was to investigate the effectiveness and safety of electroacupuncture (EA) in women with balanced mixed urinary incontinence (MUI) compared with PFMT plus solifenacin. METHODS: This is a secondary analysis of a randomized non-inferiority clinical trial. Seventy-nine patients with balanced MUI were randomly assigned to receive either 12-week EA with 24-week follow-up or 36-week PFMT and solifenacin. Primary outcome was the proportion of participants with ≥50% reduction of mean 24-h incontinence episode frequency (IFE) through weeks 1-12 from baseline. Analysis was performed in an intention-to-treat population using a generalized linear model with a binomial distribution, adjusted for imbalances in baseline variables, and a two-sided p value of less than 0.05 was considered significant. RESULTS: A total of 34 participants in the EA group and 45 participants in the PFMT plus solifenacin group were included in the intention-to-treat analysis of primary outcome. Through weeks 1-12, the proportion of participants with ≥50% reduction of mean 24-h IEF was 32.4% in the EA group, and 37.2% in the PFMT plus solifenacin group, with a mean difference of -2.82% (95%CI: -23.88 to 18.23, p=0.79), revealing non-inferiority. No significant difference held true for all the secondary outcomes. Six adverse events occurred in the EA group and 22 in the PEMT plus solifenacin group. CONCLUSIONS: The effect of EA is similar to PFMT plus solifenacin in relieving the symptoms of both SUI and UUI and increasing participants' quality of life but with better safety. The effects of EA may sustain 24 weeks after treatment.

Effect of electroacupuncture in pre- and postmenopausal women with stress urinary incontinence: A subgroup analysis of two randomised clinical trials.

OBJECTIVE: To evaluate the effect of electroacupuncture and assess the impact of menopausal status in women with stress urinary incontinence or stress-predominant mixed urinary incontinence. METHODS: This study was conducted as a subgroup analysis of the data collected from two multicentre, randomised controlled trials conducted on 1004 women; 384 of these subjects were pre- or postmenopausal women who received the same electroacupuncture treatment for stress urinary incontinence or stress-predominant mixed urinary incontinence. The primary outcome evaluated in this study was the proportion of subjects who had at least a 50% reduction in the mean 72-hour incontinence episodes frequency from baseline and the difference between pre- and postmenopausal groups, as measured at the end of 6 weeks using the 72-hour bladder dairy. RESULTS: Among the 384 women, 132 were premenopausal and 252 were postmenopausal. Compared with the baseline, measurement at the end of 6 weeks of treatment showed at least 50% reduction in the mean 72-hour incontinence episodes frequency in 61.83% and 58.85% of the women in the premenopausal and postmenopausal groups, respectively (difference 1.06%, 95% confidence interval, -13.87 to 15.99; P = .889). No statistically significant intergroup differences were noted in the changes from baseline in the International Consultation on Incontinence Questionnaire-Short Form score and the 1-hour amount of urine leakage. Electroacupuncture-related adverse events occurred in 1.52% of the premenopausal and 1.59% of the postmenopausal women. CONCLUSION: This subgroup analysis indicated that electroacupuncture can improve the symptoms of urinary incontinence in women with stress urinary incontinence or stress-predominant mixed urinary incontinence and that menopausal status may not affect the effects of electroacupuncture in subjects.

Electroacupuncture for postmenopausal women with stress urinary incontinence: secondary analysis of a randomized controlled trial.

PURPOSE: The efficacy and safety of electroacupuncture was compared to those of sham electroacupuncture for the treatment of postmenopausal women with stress urinary incontinence (SUI). METHODS: This study was a secondary analysis of a multicenter, randomized controlled trial that recruited 504 women with SUI and randomized 349 postmenopausal women to receive 18 treatment sessions of electroacupuncture or sham electroacupuncture over 6 weeks, with a 24-week follow-up assessment. Treatment response was defined as a 50% or greater reduction in urine leakage, as measured by a 1-h pad test at week 6. RESULTS: Of the 349 randomized women, 332 completed the study. The response rate was 61.0% in the electroacupuncture group compared to 18.9% in the sham electroacupuncture group (difference 42.5%; 95% confidence interval, 33.3-51.7; p < 0.001). After 6 weeks of treatment, the mean 72-h urinary incontinence episode frequency, proportion of participants with at least a 50% decrease in mean 72-h incontinence episode frequency, participant-reported SUI severity, International Consultation on Incontinence Questionnaire-Short Form scores, and participants' self-evaluation of therapeutic effects improved in both groups, with significant between-group differences. Treatment-related adverse events occurred in 2.1% of women during the 6-week treatment. CONCLUSION: Electroacupuncture may effectively and safely relieve urinary incontinence symptoms and improve quality of life in postmenopausal women with SUI.

Comparing the effect of electroacupuncture treatment on obese and non-obese women with stress urinary incontinence or stress-predominant mixed urinary incontinence: A secondary analysis of two randomised controlled trials.

OBJECTIVE: To explore whether obesity patients with a body mass index (BMI) of ≥25 kg/m2 who suffer from stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (S-MUI) show less improvement in urinary incontinence (UI) symptoms after electroacupuncture (EA) treatment compared with non-obese counterparts. METHODS: This study was a secondary analysis of existing data. About 252 SUI patients and 250 S-MUI patients treated with the same EA regimen were assigned to one of the two groups: the obesity group for BMI ≥25 kg/m2 and the non-obesity group for BMI <25 kg/ m2 . The primary outcome was the proportion of treatment responders, defined as patients exhibiting a ≥50% reduction in 72-hours incontinence episode frequency, as measured by a 72-hours bladder diary at week 6 compared with baseline. RESULTS: Of the 1004 randomised women, 129 obese women (86 SUI and 43 S-MUI) and 255 non-obese women (166 SUI and 89 S-MUI) treated with EA were included in a secondary analysis. The primary outcome was that 58.3% (74/127) of patients in the obesity group and 60.7% (150/247) of patients in the non-obesity group (difference 0.55%; 95% confidence interval, -10.01 to 11.11; P = .919) responded to treatment. CONCLUSION: This study suggests that EA treatment may safely improve UI symptoms in both obese and non-obese patients, regardless of BMI category. Additionally, obesity status may not affect the efficacy of EA treatment on SUI or S-MUI among Chinese women.

Acupuncture for symptoms in menopause transition: a randomized controlled trial.

BACKGROUND: Acupuncture has been used for women during menopause transition, but evidence is limited. OBJECTIVE: We sought to evaluate the efficacy of electroacupuncture on relieving symptoms of women during menopause transition. STUDY DESIGN: We conducted a prospective, multicenter, randomized, participant-blinded trial in China mainland. Subjects were randomized to receive 24 treatment sessions of electroacupuncture at traditional acupoints or sham electroacupuncture at nonacupoints over 8 weeks with 24 weeks' follow-up. Primary outcome was the change from baseline in the total score of Menopause Rating Scale at week 8. Secondary outcomes included the changes from baseline in the average 24-hour hot flash score, the Menopause Rating Scale subscale scores, the total score of Menopause-Specific Quality of Life Questionnaire and its subscales, and serum female hormones. All analyses were performed with a 2-sided P value of < .05 considered significant based on the intention-to-treat principle. RESULTS: A total of 360 women (180 in each group) with menopause-related symptoms during menopause transition were enrolled from June 9, 2013, through Dec 28, 2015. At week 8, the reduction from baseline in the Menopause Rating Scale total score was 6.3 (95% confidence interval, 5.0-7.7) in the electroacupuncture group and 4.5 (95% confidence interval, 3.2-5.8) in the sham electroacupuncture group with a between-group difference of 1.8 (95% confidence interval, 0.9-2.8; P = .0002), less than the minimal clinically important difference of 5 points' reduction. For secondary outcomes, the between-group differences for the decrease in the mean 24-hour hot flash score were significant at weeks 8, 20, and 32, but all were less than the minimal clinically important difference in previous reports. Interestingly, the between-group differences for the Menopause-Specific Quality of Life Questionnaire total score reduction were 5.7 at week 8, 7.1 at week 20, and 8.4 at week 32, greater than the minimal clinically important difference of 4 points. Changes from baseline in follicle-stimulating hormone, luteinizing hormone, and estradiol levels at weeks 8 and 20 (P > .05 for all), with the exception of follicle-stimulating hormone/luteinizing hormone ratios (P = .0024 at week 8 and .0499 at week 20), did not differ between groups. CONCLUSION: Among women during menopause transition, 8 weeks' electroacupuncture treatment did not seem to relieve menopausal symptoms, even though it appeared to improve their quality of life. Generalizability of the trial results may be limited by mild baseline menopausal symptoms in the included participants.

Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial.

Importance: Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited. Objective: To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI. Design, Setting, and Participants: Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015. Interventions: Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. Main Outcomes and Measures: The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes). Results: Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild. Conclusions and Relevance: Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention. Trial Registration: clinicaltrials.gov Identifier: NCT01784172.

MR molecular imaging of tumours using ferritin heavy chain reporter gene expression mediated by the hTERT promoter.

OBJECTIVES: Using the human telomerase reverse transcriptase (hTERT) promoter and the modified ferritin heavy chain (Fth) reporter gene, reporter gene expression for MRI was examined in telomerase positive and negative tumour cells and xenografts. METHODS: Activity of the reporter gene expression vector Lenti-hTERT-Fth1-3FLAG-Puro was compared to constitutive CMV-driven expression and to the untransfected parental control in five tumour cell lines: A549, SKOV3, 293T, U2OS and HPDLF. In vitro, transfected cells were evaluated for FLAG-tagged protein expression, iron accumulation and transverse relaxation. In vivo, tumours transduced by lentiviral vector injection were imaged using T2*WI. Changes in tumour signal intensity were validated by histology. RESULTS: Only telomerase positive tumour cells expressed FLAG-tagged Fth and displayed an increase in R2* above the parental control, with a corresponding change in T2*WI. In addition, only telomerase positive tumours, transduced by injection of the reporter gene expression construct, exhibited a change in signal intensity on T2*WI. Tumour histology verified the expression of FLAG-tagged Fth and iron accumulation in telomerase positive tissue. CONCLUSION: Reporter gene expression for MRI, using the Fth reporter and the hTERT promoter, may be a useful strategy for the non-invasive diagnosis of many types of cancer. KEY POINTS: • Modified heavy chain of ferritin can serve as an MR reporter gene • hTERT promoter can direct the expression of reporter gene in cancer cells • MR reporter imaging mediated by hTERT promoter can be used for cancer diagnosis.

Effect of Electroacupuncture Added to Pelvic Floor Muscle Training in Women with Stress Urinary Incontinence: A Randomized Clinical Trial.

BACKGROUND: Pelvic floor muscle training (PFMT) is a first-line conservative therapy for stress urinary incontinence (SUI). Electroacupuncture (EA) has been used to treat SUI recently. OBJECTIVE: To compare the effectiveness of PFMT + EA versus PFMT + sham EA for SUI in women. DESIGN, SETTING, AND PARTICIPANTS: A prospective, multicenter, randomized, controlled clinical trial was conducted at four hospitals in China involving 304 women with SUI from May 20, 2014 to November 21, 2017. Data were analyzed from April 20 to December 21, 2018. INTERVENTION: Participants were randomized to receive 8 wk of PFMT+ EA (n = 154) or PFMT + sham EA (n = 150). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the change in the amount of urine leakage measured on a 1-hr pad test. Student's t test, the χ2 test, and the Wilcoxon rank-sum test were used for data analysis. RESULTS AND LIMITATIONS: Among the 304 participants randomized, 286 completed the study. The mean age was 57.6 yr (standard deviation [SD] 8.9) for the PFMT + sham EA group and 57.2 yr (SD 9.1) for the PFMT + EA group. The mean urine leakage at baseline was 13.6 g for the PFMT + sham EA group and 13.9 g for the PFMT + EA group. After the 8-wk intervention, the PFMT + EA group had a greater decrease in mean urine leakage (-9.8 g) than the PFMT + sham EA group (-5.8 g) with a mean difference of 4.0 g (95% confidence interval [CI] 0.8-7.2). Significantly more patients experienced a ≥50% reduction in urine leakage and the mean number of incontinence episodes in 24 h in the PFMT + EA group than in the PFMT + sham EA group (26.3%, 95%CI 15.8-36.8%). The PFMT + EA group experienced better improvement in participant-reported SUI severity at 6 wk (p < 0.001) and 8 wk (p < 0.001) and self-evaluated therapeutic effects at 2-32 wk (p < 0.001) after the intervention. Lack of measurement of the amount of urine leakage during follow-up is a limitation. CONCLUSIONS: In this randomized clinical trial, 8-wk combined treatment with PFMT + EA led to a greater improvement in SUI symptoms and better outcomes than with PFMT + sham EA. PATIENT SUMMARY: We evaluated the effectiveness and safety of pelvic floor muscle training combined with electroacupuncture for stress urinary incontinence in women, Our results show that this is a promising therapeutic approach for the treatment of stress urinary incontinence.

Real-world tobacco cessation practice in China: findings from the prospective, nationwide multicenter China National Tobacco Cessation Cohort Study (CNTCCS).

Background: Tobacco cessation is proven to be the most effective and cost-effective strategy for smokers to reduce their risk of smoking-related disease and premature death. Providing effective, efficient, safe, and patient-centred tobacco cessation treatment to reach those who need them is a significant challenge. To date, only a few nationwide studies in China have assessed the overall clinical care practice and treatment outcome of tobacco cessation. Methods: This a prospective, nationwide, multicenter, cohort study covering all Eastern China, Northwest China, Central China, North China, Southwest China, Northeast China, and South China. Participants who were current smokers aged 18-85 years attending clinic for smoking cessation were included. All the participants were treated with 3-month cessation treatment and followed up for 3 months. Data were collected prospectively using online system. The primary outcome was 7-day point abstinence rate at 24 weeks, validated biochemically by an expired carbon monoxide level of less than 10 ppm. The participants lost to follow-up or not providing validation were included as non-abstainers. Findings: A representative sample of 3557 participants were recruited and 2943 participants were included into this analysis. These participants had mean age of 53.05 years, and 94.8% were males, with 75.8% showing symptoms of tobacco dependence. A total of 965 (32.8%) participants were treated with Bupropion + behavioural counselling, followed by 935 (31.8%) with behavioural counselling, 778 (26.4%) with Varenicline + behavioural counselling, 135 (4.6%) with alternative treatments + behavioural counselling, and 130 (4.4%) with nicotine replacement therapy (NRT) + behavioural counselling. After 3-month treatment and 3-month follow-up, 21.74% of the participants quit smoking at 24 weeks. In the multivariable-adjusted analyses, quitting smoking was significantly associated with female, higher socioeconomic status, poor health condition, different treatment received, and less smoking intensity. The tobacco cessation treatment varied widely across different areas of China. In particular, the areas with higher usage of cessation medication were associated with better cessation treatment outcome. Interpretation: The CNTCCS is the first large-scale nationwide cohort study of smoking cessation in China. Rich data collected from this prospective cohort study provided the opportunity to evaluate the clinical practice of tobacco cessation treatment in China. Funding: Chinese Academy of Medical Sciences (CAMS) Initiative for Innovative Medicine (CAMS 2021-I2M-1-010), Heilongjiang Provincial Science and Technology Key Program (2022ZXJ03C02), and National Key R&D Program of China (grant no. 2017YFC1309400).

Is There Difference between the Effects of Two-Dose Stimulation for Knee Osteoarthritis in the Treatment of Heat-Sensitive Moxibustion?

Considering that the dosage of manipulating Moxa plays an important role in obtaining good effects for heat-sensitive moxibustion, it would be valuable to know whether the use of fixed dosage is as effective as the use of an individual one. The paper carried out a rigorous multi-centre randomized controlled trial, and its result demonstrated that the effectiveness of individual eliminate-sensitive dosing regimen might more superior to the stable conventional dosing regimen in the treatment of KOA. According the record of individual moxibustion time, the dosage differed in the terms of patients' conditions and moxibustion sensation, which had been measured about 47.30 ± 6.20 minutes (28 ~ 65 minutes).

Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies.

OBJECTIVE: To compare the efficacy of electroacupuncture (EA) in elderly and non-elderly women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). METHODS: This study was a secondary analysis of two randomised controlled trials involving 252 women with SUI and 132 women with stress-predominant MUI who were treated with the same EA regimen. Elderly women were defined as those aged >60 years. The main outcome measure was the proportion of patients with ≥50% decrease in the mean 72-hour urinary incontinence episode frequency (IEF) from baseline to week 6. Overall, 1004 women were recruited in the SUI and MUI trials. In the EA group, those with urge-predominant or balanced MUI at baseline were excluded from the current study, resulting in a sample size of 384. RESULTS: Out of 384 patients with SUI or stress-predominant MUI who were treated with EA, 371 completed the study. After 6-week treatment, the proportion of women who achieved ≥50% decrease in mean 72-hour IEF from baseline was 57.3% (51/89) in the elderly group and 60.70% (173/285) in the non-elderly group; the between-group difference was not significant (3.11%, 95% CI -9.83% to 16.05%; p=0.637). Similar outcomes were observed at weeks 4, 16 and 28. Both groups showed reduction in the 72 -hour IEF, amount of urine leakage (assessed by 1-hour pad test) and International Consultation on Incontinence Questionnaire-Short Form score from baseline with no significant between-group difference. No obvious EA-related adverse events were observed during the study. CONCLUSION: EA may be an effective and safe alternative treatment for SUI or stress-predominant MUI in both elderly and non-elderly women. Age may not affect the treatment outcomes of acupuncture. TRIAL REGISTRATION NUMER: NCT01784172, NCT02047032.

The Fitting Optimization Path Analysis on Scale Missing Data: Based on the 507 Patients of Poststroke Depression Measured by SDS.

OBJECTIVE: To explore the optimal fitting path of missing data of the Scale to make the fitting data close to the real situation of patients' data. METHODS: Based on the complete data set of the SDS of 507 patients with stroke, the data simulation sets of Missing Completely at Random (MCAR), Missing at Random (MAR), and Missing Not at Random (MNAR) were constructed by R software, respectively, with missing rates of 5%, 10%, 15%, 20%, 25%, 30%, 35%, and 40% under three missing mechanisms. Mean substitution (MS), random forest regression (RFR), and predictive mean matching (PMM) were used to fit the data. Root mean square error (RMSE), the width of 95% confidence intervals (95% CI), and Spearman correlation coefficient (SCC) were used to evaluate the fitting effect and determine the optimal fitting path. RESULTS: when dealing with the problem of missing data in scales, the optimal fitting path is ① under the MCAR deletion mechanism, when the deletion proportion is less than 20%, the MS method is the most convenient; when the missing ratio is greater than 20%, RFR algorithm is the best fitting method. ② Under the Mar mechanism, when the deletion ratio is less than 35%, the MS method is the most convenient. When the deletion ratio is greater than 35%, RFR has a better correlation. ③ Under the mechanism of MNAR, RFR is the best data fitting method, especially when the missing proportion is greater than 30%. In reality, when the deletion ratio is small, the complete case deletion method is the most commonly used, but the RFR algorithm can greatly expand the application scope of samples and save the cost of clinical research when the deletion ratio is less than 30%. The best way to deal with data missing should be based on the missing mechanism and proportion of actual data, and choose the best method between the statistical analysis ability of the research team, the effectiveness of the method, and the understanding of readers.

Electroacupuncture versus solifenacin for women with urgency-predominant mixed urinary incontinence: a protocol for a three-armed non-inferiority randomized controlled trial.

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.

Effect of acupuncture on women with poor ovarian response: a study protocol for a multicenter randomized controlled trial.

BACKGROUND: Poor ovarian response (POR), a manifestation of low ovarian reserve and ovarian aging, leads to a significant reduction in the pregnancy rate after in vitro fertilization-embryo transfer. Acupuncture has increasingly been used to improve the ovarian reserve. The purpose of this study will be to evaluate the effect of acupuncture on increasing the number of retrieved oocytes after controlled ovarian hyperstimulation in women with POR. METHODS: This will be a multicenter randomized controlled trial. A total of 140 women with POR will be randomly assigned to receive acupuncture or nontreatment for 12 weeks before controlled ovarian hyperstimulation. The primary outcome will be the number of retrieved oocytes. The secondary outcomes will be antral follicle counts, serum levels of anti-Müllerian hormone, basal serum levels of follicle stimulating hormone, luteinizing hormone and estradiol levels, scores from the self-rating anxiety scale, fertilization rates, cleavage rates, available embryo rates, and high-quality embryo rates. The safety of acupuncture will also be assessed. DISCUSSION: The results of this trial will help to determine the effectiveness of acupuncture in the treatment of POR. This may provide a new treatment option for patients with POR and their physicians. TRIAL REGISTRATION: AMCTR-IPR-18000198 . Registered on 10 August 2018.

Medical, epidemiologic, and social aspects of aging urinary incontinence questionnaire: Study protocol for the translation and validation of a Chinese language version.

INTRODUCTION: Mixed urinary incontinence (MUI) is a coexistence of both urgency urinary incontinence and stress urinary incontinence. Medical, Epidemiologic, and Social aspects of Aging (MESA) questionnaire is a validated and commonly used tool to diagnose predominant components of it and assess the severity, which can offer help in clinic. However, MESA questionnaire is still not available in China. The aim of the study is to translate English MESA questionnaire into a Chinese version, adapt it in Chinese culture, and validate the measurement properties among female patients with MUI and urgency-predominant MUI. METHODS: MESA questionnaire will be translated and culturally adapted in China. The validation will be embedded in a multicentered randomized controlled trial targeted at women with urgency-predominant MUI. Apart from MESA questionnaire, 3 groups of patients are to receive clinical extended assessment, keep 3-day voiding diary, and complete International Consultation on Incontinence Questionnaire Short Form to evaluate the measurement properties of reliability and validity (internal consistence, test-retest reliability, construct validity, and responsiveness). DISCUSSION: If MESA questionnaire is of relatively high reliability and validity in diagnosing subtypes of MUI and assessing the severity, it can help to choose more appropriate therapy for patients and simplify the workload of clinicians. TRIAL REGISTRATION: ClinicalTrials.gov NCT03803878, January 11, 2019.

Electroacupuncture for Women with Chronic Severe Functional Constipation: Subgroup Analysis of a Randomized Controlled Trial.

BACKGROUND: Acupuncture has been found to be effective for treating chronic constipation. OBJECTIVE: The objective of this exploratory study was to evaluate the efficacy of electroacupuncture (EA) in the subgroup of women with chronic severe functional constipation. METHODS: This is a subgroup analysis of the multicenter, randomized, sham-acupuncture (SA) controlled trial. The efficacy of 822 (76%) female patients of the 1075 randomized patients with chronic severe functional constipation was evaluated. Patients were randomly assigned to receive 28 sessions of EA or SA over 8 weeks with 12 weeks' follow-up. This study focused on sustained complete spontaneous bowel movements (CSBMs) responders over the 8-week treatment. RESULTS: The primary outcome which was percentage of the sustained CSBMs responders for the subset of women with severe constipation was significantly higher in the EA group (24.3%) than in the SA group (8.1%) with difference of 13.1% (95%CI, 6.5% to 19.7%; P<0.001). As for the secondary outcomes, responders for ≥9 of 12 weeks of follow-up were higher in the EA group than in the SA group. Additionally, EA had significantly better improvement in mean weekly CSBMs, mean weekly spontaneous bowel movements (SBMs), and mean score changes of stool consistency and straining as well as quality of life of patients. The incidence of adverse events (AEs) related to acupuncture was rare and no statistical significance was found between two groups. CONCLUSION: EA improved the spontaneity and the completeness of the bowel movement of women with severe functional constipation during 8-week treatment and the effect sustained for 12 weeks after stopping treatment.

The duration of acupuncture effects and its associated factors in chronic severe functional constipation: secondary analysis of a randomized controlled trial.

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 < 0.001). A younger age and higher baseline CSBMs per week [regression coefficient (RC) -0.06, 95% confidence interval (CI) (-0.06 to -0.04); RC 2.43, 95% CI 1.78-3.60; respectively] were associated with longer durations of acupuncture effects. CONCLUSIONS: EA had sustained post-treatment effects for CFSC. A significant association among a younger age, higher baseline CSBMs and sustained acupuncture effects was observed. Further research is needed to confirm the association. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01726504). Registered on 26 August 2012.