Efficacy and Safety of Acupuncture for Cyclic Mastalgia: Study Protocol for a Randomized, Sham-Controlled Trial.

Purpose: Cyclic mastalgia is prevalent among women and negatively impairs their daily life and work. There is still a lack of effective therapies for mastalgia, and acupuncture may be a promising method. We design this multicenter randomized trial to evaluate the efficacy and safety of acupuncture on cyclic mastalgia. Study Design and methods: Sixty participants with moderate-to-severe cyclic breast pain (with a duration of 5-21 days and the worst pain scoring 5 points or more on Numerical Rating Scale [NRS]) will be recruited at three hospitals in China. They will be randomly assigned to acupuncture group or sham-acupuncture group at 1:1 ratio to receive 16-session treatment during 3 consecutive menstrual cycles, and follow-up for 6 menstrual cycles after treatment. The primary outcome is the change from baseline in the NRS score on the worst breast pain during the third cycle of treatment period. All statistical tests will be two-sided and P value <0.05 will be considered statistically significant.

Impact of ejaculation upon effect of acupuncture on chronic prostatitis/chronic pelvic pain syndrome: Secondary analysis of a randomized controlled trial.

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.

Identification of brain-to-spinal circuits controlling the laterality and duration of mechanical allodynia in mice.

Mechanical allodynia (MA) represents one prevalent symptom of chronic pain. Previously we and others have identified spinal and brain circuits that transmit or modulate the initial establishment of MA. However, brain-derived descending pathways that control the laterality and duration of MA are still poorly understood. Here we report that the contralateral brain-to-spinal circuits, from Oprm1 neurons in the lateral parabrachial nucleus (lPBNOprm1), via Pdyn neurons in the dorsal medial regions of hypothalamus (dmHPdyn), to the spinal dorsal horn (SDH), act to prevent nerve injury from inducing contralateral MA and reduce the duration of bilateral MA induced by capsaicin. Ablating/silencing dmH-projecting lPBNOprm1 neurons or SDH-projecting dmHPdyn neurons, deleting Dyn peptide from dmH, or blocking spinal κ-opioid receptors all led to long-lasting bilateral MA. Conversely, activation of dmHPdyn neurons or their axonal terminals in SDH can suppress sustained bilateral MA induced by lPBN lesion.

Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China: A Randomized Clinical Trial.

Importance: Opioid-induced constipation (OIC) is prevalent among patients treated with opioids for cancer pain. Safe and effective therapies for OIC in patients with cancer remain an unmet need. Objective: To determine the efficacy of electroacupuncture (EA) for OIC in patients with cancer. Design, Setting, and Participants: This randomized clinical trial was conducted at 6 tertiary hospitals in China among 100 adult patients with cancer who were screened for OIC and enrolled between May 1, 2019, and December 11, 2021. Interventions: Patients were randomized to receive 24 sessions of EA or sham electroacupuncture (SA) over 8 weeks and then were followed up for 8 weeks after treatment. Main Outcomes and Measures: The primary outcome was the proportion of overall responders, defined as patients who had at least 3 spontaneous bowel movements (SBMs) per week and an increase of at least 1 SBM from baseline in the same week for at least 6 of the 8 weeks of the treatment period. All statistical analyses were based on the intention-to-treat principle. Results: A total of 100 patients (mean [SD] age, 64.4 [10.5] years; 56 men [56.0%]) underwent randomization; 50 were randomly assigned to each group. Among them, 44 of 50 patients (88.0%) in the EA group and 42 of 50 patients (84.0%) in the SA group received at least 20 (≥83.3%) sessions of treatment. The proportion of overall responders at week 8 was 40.1% (95% CI, 26.1%-54.1%) in the EA group and 9.0% (95% CI, 0.5%-17.4%) in the SA group (difference between groups, 31.1 percentage points [95% CI, 14.8-47.6 percentage points]; P < .001). Compared with SA, EA provided greater relief for most OIC symptoms and improved quality of life among patients with OIC. Electroacupuncture had no effects on cancer pain and its opioid treatment dosage. Electroacupuncture-related adverse events were rare, and, if any, all were mild and transient. Conclusions and Relevance: This randomized clinical trial found that 8-week EA treatment could increase weekly SBMs with a good safety profile and improve quality of life for the treatment of OIC. Electroacupuncture thus provided an alternative option for OIC in adult patients with cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT03797586.

Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial.

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.

Effectiveness of electroacupuncture versus prucalopride for women with severe chronic constipation: secondary analysis of a randomized controlled trial.

PURPOSE: Electroacupuncture (EA) is a component alternative therapy for severe chronic constipation (SCC). Women are more vulnerable to SCC and gender might impact the response of patients with functional gastrointestinal disorders to therapy. We performed this secondary analysis to explore the effectiveness and safety of EA compared with prucalopride among women with SCC. METHODS: Based on a multicenter, randomized, noninferiority trial, 446 female patients were randomly assigned to receive 28-session EA (n = 222) over 8 weeks with 24-week follow-up without treatment or to receive prucalopride (n = 224) over 32 consecutive weeks. The primary outcome was the proportion of overall complete spontaneous bowel movements (CSBMs) responders over weeks 1-8, defined as at least three CSBMs per week, and more than an increase of one CSBM from baseline meanwhile for at least 6 weeks during an 8-week treatment period. Secondary outcomes measure sustained CSBM responder, weekly responders, change from baseline in mean weekly CSBMs and SBMs, straining and stool consistency, quality of life, and adverse events (AEs). RESULTS: The proportion of overall responders was 25.23% in the EA group, similar to 25.89% in the prucalopride group, with a between-group difference of - 0.67% (95% CI, - 8.80 to 7.40%; P = 0.872) during an 8-week treatment. In the secondary outcomes, EA and prucalopride groups had no significant difference, except that EA was inferior to prucalopride in improving SBMs. The AEs were less in the EA group than the prucalopride group. CONCLUSION: EA may be a promising and safe treatment for women with SCC; its effect could sustain 24 weeks after treatment stopped.

Acupuncture for Impaired Glucose Tolerance in People With Obesity: A Protocol for a Multicenter Randomized Controlled Trial.

Background: Impaired 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. Methods: The 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. Discussion: This 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].

Effects of Electroacupuncture on Opioid-Induced Constipation in Patients With Cancer: Study Protocol for a Multicenter Randomized Controlled Trial.

Background: Opioid-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. Methods: This 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. Discussion: To 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 Registration: www.ClinicalTrials.gov, identifier: NCT03797586, registered on 4 January 2019, https://clinicaltrials.gov/ct2/show/NCT03797586.

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.

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.

Non-pharmacological therapies for treating chronic pelvic pain in women: A review.

Chronic pelvic pain (CPP) is an intricate condition with multiple etiologies that lead to indefinite pain mechanisms. Physicians and researchers are challenged in its treatment, and the combined therapy of pharmacologic and non-pharmacologic treatment has been recognized as a multidisciplinary approach cited by guidelines and adopted in clinical practice. As an alternative therapy for CPP, non-pharmacologic therapies benefit patients and deserve further study. This study reviews the literature published from January 1991 to April 2022 on non-pharmacologic therapies for CPP in adult women. Based on a survey, this review found that the most commonly used non-pharmacological therapies for CPP include pelvic floor physical therapy, psychotherapy, acupuncture, neuromodulation, and dietary therapy. By evaluating the efficacy and safety of each therapy, this study concluded that non-pharmacological therapies should be included in the initial treatment plan because of their high degree of safety and low rate of side effects. To fill the lack of data on non-pharmacologic therapies for CPP, this study provides evidence that may guide treatment and pain management.

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 for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial.

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).

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.

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).

Efficacy of acupuncture for treatment of intermittent claudication in patients with degenerative lumbar spinal stenosis: protocol for a randomized controlled trial.

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.

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.

Sorafenib may enhance antitumour efficacy in hepatocellular carcinoma patients by modulating the proportions and functions of natural killer cells.

Dysfunction of natural killer (NK) cells is associated with poor prognosis in hepatocellular carcinoma (HCC). We explored the phenotypic and functional characteristics of peripheral blood NK cells in HCC patients following sorafenib treatment.Peripheral blood samples were collected from 60 HCC patients in a single centre (2015~2017) and 45 healthy donors. The percentage and cytoplasmic granule production of NK cells were analysed. Subset proportions were evaluated for their associations with the modified Response Evaluation Criteria in Solid Tumors (mRECIST), time to progression, and median overall survival (OS).Compared with baseline, the percentages of total and CD56dimCD16+ NK cells increased after two months of treatment, while the percentage of CD56brightCD16- NK cells decreased, leading to a dramatically reduced ratio of CD56bright and CD56dim NK cells (ratiobri/dim). Patients with low ratiobri/dim exhibited better mRECIST responses and longer median OS than those with high ratiobri/dim. The expression levels of granzyme B and perforin in total NK cells and in both subsets of cells were increased after treatment.This study showed that sorafenib could affect the proportions and functions of peripheral CD56brightCD16- and CD56dimCD16+ NK cells, which was associated with the outcomes including OS of HCC patients.

Electroacupuncture for women with urgency-predominant mixed urinary incontinence: secondary analysis of a randomized noninferiority trial.

OBJECTIVE: To compare the effects and safety of electroacupuncture (EA) and the integration of pelvic floor muscle training (PFMT) and solifenacin in women with urgency-predominant mixed urinary incontinence (MUI). METHODS: The study was a secondary analysis of a randomized noninferiority trial which recruited 500 women with MUI and randomized 178 with urgency-predominant MUI to either receive 12-week EA treatment and 24-week follow-up or 36-week PFMT-solifenacin treatment. Clinical response was defined as at least 50% reduction in average 24-h urgency incontinence episode frequency (IEF), measured by 72-h voiding diary through weeks 1-12. RESULTS: Of the patients randomized, 173 completed the study. The clinical response was 45.78% in EA group, similar with 50.0% in PFMT-solifenacin group, with a difference of - 3.54 (95% CI - 19.08 to 12.0; P = 0.66). In both groups, the proportion of patients with at least 50% reduction of IEF and stress IEF were improved, while the score of ICIQ-SF, episodes of urination, nocturia and urgency, 1-h amount of urinary leakage (AUL), proportion of patients using pads and the number consumed were all decreased after 12-week treatment. The effects could sustain till 36 weeks. Adverse events occurred less in EA group. CONCLUSIONS: EA might reduce IEF, AUL and improve the life quality of female patients with urgency-predominant MUI. The effect may sustain till 36 weeks.