Cognitive and Hippocampal Changes in Older Adults With Subjective Cognitive Decline After Acupuncture Intervention.

OBJECTIVE: Converging evidence indicates that subjective cognitive decline (SCD) could be an early indicator of dementia. The hippocampus is the earliest affected region during the progression of cognitive impairment. However, little is known about whether and how acupuncture change the hippocampal structure and function of SCD individuals. METHODS: Here, we used multi-modal MRI to reveal the mechanism of acupuncture in treating SCD. Seventy-two older participants were randomized into acupuncture or sham acupuncture group and treated for 12 weeks. RESULTS: At the end of the intervention, compared to sham acupuncture, participants with acupuncture treatment showed improvement in composite Z score from multi-domain neuropsychological tests, as well as increased hippocampal volume and functional connectivity. Moreover, the greater white matter integrity of the fornix, which is the major output tract of the hippocampus, was shown in the acupuncture group. CONCLUSION: These findings suggest that acupuncture may improve the cognitive function of SCD individuals, and increase hippocampal volume on the regional level and enhance the structural and functional connectivity of hippocampus on the connective level.

PolyphyllinVI alleviates the spared nerve injury-induced neuropathic pain based on P2X3 receptor-mediated the release of inflammatory mediators.

ETHNOPHARMACOLOGICAL RELEVANCE: PolyphyllinVI (PPⅥ) is the main bioactive component of Chonglou which is a traditional Chinese herbal with various effects, including antitumor, anti-inflammatory, and analgesia. AIM OF THE STUDY: This study aimed to investigate the properties and mechanisms of the analgesia of PPⅥ by using neuropathic pain (NPP) mice. MATERIALS AND METHODS: The potential targets and mechanisms of PPⅥ in alleviating NPP were excavated based on the network pharmacology. Subsequently, the construction of a spared nerve injury (SNI) mice model was used to evaluate the effect of PPⅥ on NPP and the expression of the P2X3 receptor. We identified the signaling pathways of PPⅥ analgesia by RNA sequencing. RESULTS: The results of network pharmacology showed that BCL2, CASP3, JUN, STAT3, and TNF were the key targets of the analgesic effect of PPⅥ. PPⅥ increased the MWT and TWL of SNI mice and decreased the level of P2X3 receptors in the dorsal root ganglion (DRG) and spinal cord (SC). Additionally, PPⅥ reduced the release of pro-inflammatory mediators (TNF-α, IL-1ß, and IL-6) in the DRG, SC, and serum. Based on the KEGG enrichment of differentially expressed genes (DEGs) identified by RNA-Seq, PPVI may relieve NPP by regulating the AMPK/NF-κB signaling pathway. Western blotting results showed that the AMPK signaling pathway was activated, followed by inhibition of the NF-κB signaling pathway. CONCLUSION: PPⅥ increased the MWT and TWL of SNI mice maybe by inhibiting the expression of the P2X3 receptor and the release of inflammatory mediators. The properties of the analgesia of PPⅥ may be based on the AMPK/NF-κB pathway.

Acupuncture for response and complete pain relief time of acute renal colic: Secondary analysis of a randomized controlled trial.

Background: The integration of acupuncture with intramuscular injection of diclofenac sodium can expedite the onset of analgesia in treating acute renal colic caused by urolithiasis. However, it remains unclear whether acupuncture can accelerate pain relief constantly until complete remission. This study aimed to explore the extent to which acupuncture can expedite the onset time of response or complete pain relief in treating acute renal colic, and the predictive value of patient characteristics for treatment efficacy. Methods: This secondary analysis utilized data from a prior randomized controlled trial. Eighty patients with acute renal colic were randomly assigned 1:1 to the acupuncture group or the sham acupuncture group. After intramuscular injection of diclofenac sodium, acupuncture or sham acupuncture was delivered to patients. The outcomes included time to response (at least a 50 % reduction in pain) and complete pain relief. Between-group comparison under the 2 events was estimated by Kaplan-Meier methodology. Subgroup analysis was performed utilizing the Cox proportional hazards model. Results: The median response time and complete pain relief time in the acupuncture group were lower than those in the sham acupuncture group (5 vs 30 min, Log Rank P < 0.001; 20 min vs not observed, Log Rank P < 0.001, respectively). Hazard Ratios (HRs) for response across all subgroups favored the acupuncture group. All HRs for complete pain relief favored acupuncture, expect large stone and moderate pain at baseline. No interaction was found in either event. Conclusion: Acupuncture can accelerate the response time and complete pain relief time for patients with acute renal colic, with the efficacy universally. Trial registration: This study has been registered at Chinese Clinical Trial Registry: ChiCTR1900025202.

Didymin alleviates metabolic dysfunction-associated fatty liver disease (MAFLD) via the stimulation of Sirt1-mediated lipophagy and mitochondrial biogenesis.

BACKGROUND: Metabolic dysfunction-associated fatty liver disease (MAFLD) is one of the most prevalent metabolic syndromes worldwide. However, no approved pharmacological treatments are available for MAFLD. Chenpi, one kind of dried peel of citrus fruits, has traditionally been utilized as a medicinal herb for liver diseases. Didymin is a newly identified oral bioactive dietary flavonoid glycoside derived from Chenpi. In this study, we investigated the therapeutic potential of Didymin as an anti-MAFLD drug and elucidated its underlying mechanisms. METHODS: High-fat diet (HFD)-induced MAFLD mice and alpha mouse liver 12 (AML12) cells were utilized to evaluate the effects and mechanisms of Didymin in the treatment of MAFLD. Liver weight, serum biochemical parameters, and liver morphology were examined to demonstrate the therapeutic efficacy of Didymin in MAFLD treatment. RNA-seq analysis was performed to identify potential pathways that could be affected by Didymin. The impact of Didymin on Sirt1 was corroborated through western blot, molecular docking analysis, microscale thermophoresis (MST), and deacetylase activity assay. Then, a Sirt1 inhibitor (EX-527) was utilized to confirm that Didymin alleviates MAFLD via Sirt1. Western blot and additional assays were used to investigate the underlying mechanisms. RESULTS: Our results suggested that Didymin may possess therapeutic potential against MAFLD in vitro and in vivo. By promoting Sirt1 expression as well as directly binding to and activating Sirt1, Didymin triggers downstream pathways that enhance mitochondrial biogenesis and function while reducing apoptosis and enhancing lipophagy. CONCLUSIONS: These suggest that Didymin could be a promising medication for MAFLD treatment. Furthermore, its therapeutic effects are mediated by Sirt1.

[Research progress and thinking of acupuncture in anti-inflammation by regulating autonomic nerve system].

The nervous system is the necessary condition for inducing the curative effect of acupuncture. Both the sympathetic and vagal nerve systems are widely distributed throughout the body and organically connect various systems and organs of the human body. In maintaining the coordination and unity of human physiological activities, it is in line with the holistic view and bidirectional regulation of acupuncture, and fits in with the meridian theory of "internally belonging to the Zang-fu organs and externally connecting with the limbs and joints". Acupuncture, one of the body surface stimulation therapies, can inhibit the inflammatory response via activating sympathetic/vagus nerve mediated anti-inflammatory pathways. The peripheral nerve innervating diffe-rent acupoints determines the different anti-inflammatory pathways of the autonomic nerve, and different acupuncture methods (stimulation form and stimulation amount) are important factors affecting the anti-inflammatory mechanism of the autonomic nerve. In the future, we should analyze the central integration mechanism between sympathetic nerve and vagus nerve regulated by acupuncture at the level of brain neural circuits, and clarify the "multi-target" advantage of acupuncture, so as to provide inspiration and reference for the study of neuroimmunological effects of acupuncture.

Acupuncture combined with ondansetron for prevention of postoperative nausea and vomiting in high-risk patients undergoing laparoscopic gynaecological surgery: A randomised controlled trial.

BACKGROUND: Consensus guidelines recommend the use of multiple antiemetics as prophylaxis in patients at high risk of postoperative nausea and vomiting (PONV), but the evidence regarding combining acupuncture and antiemetics as a multimodal approach was of very low quality. OBJECTIVE: This study aimed to assess the effect of combinations of acupuncture with ondansetron versus ondansetron alone for PONV prophylaxis in women at a high risk. METHODS: This parallel, randomised controlled trial was conducted in a tertiary hospital in China. Patients who had three or four PONV risk factors on the Apfel simplified risk score, undergoing elective laparoscopic gynaecological surgery for benign pathology, were recruited. Patients in the combination group received two sessions of acupuncture treatment and 8 mg intravenous ondansetron, whereas those in the ondansetron group received ondansetron alone. The primary outcome was the incidence of PONV within 24 h postoperatively. Secondary outcomes included the incidence of postoperative nausea, postoperative vomiting, adverse events etc. RESULTS: Between January and July 2021, a total of 212 women were recruited, 91 patients in the combination group and 93 patients in the ondansetron group were included in the modified intention-to-treat analysis. In the first 24 h postoperatively, 44.0% of the patients in the combination group and 60.2% of the patients in the ondansetron group experienced nausea, vomiting, or both (difference, -16.3% [95% CI, -30.5 to -2.0]; risk ratio, 0.73 [95% CI, 0.55-0.97]; p = 0.03). However, the results of the secondary outcomes showed that compared to ondansetron alone, acupuncture together with ondansetron was only effective in reducing nausea but did not have a significant impact on vomiting. The incidence of adverse events was similar between the groups. CONCLUSION: Acupuncture combined with ondansetron as a multimodal prophylaxis approach is more effective than ondansetron alone in preventing postoperative nausea in high-risk patients.

Thermographic evaluation of acupoints in lower limb region of individuals with osteoarthritis: A cross-sectional case-control study protocol.

PURPOSE: Acupuncture has been widely used in the treatment of knee osteoarthritis (KOA), but the selection of acupoints is indeterminate and lacks biological basis. The skin temperature of acupoints can reflect the state of local tissue and may be a potential factor for guiding acupoint selection. This study aims to compare the skin temperature of acupoints between KOA patients and the healthy population. STUDY DESIGN AND METHODS: This is a protocol for a cross-sectional case-control study with 170 KOA patients and 170 age- and gender-matched healthy individuals. Diagnosed patients aged 45 to 70 will be recruited in the KOA group. Participants in the healthy group will be matched with the KOA group based on mean age and gender distribution. Skin temperature of 11 acupoints (ST35, EX-LE5, GB33, GB34, EX-LE2, ST34, ST36, GB39, BL40, SP9, SP10) will be extracted from infrared thermography (IRT) images of the lower limbs. Other measurements will include demographic data (gender, age, ethnicity, education, height, weight, BMI) and disease-related data (numerical rating scale, pain sites, duration of pain, pain descriptors, pain activities). DISCUSSION: The results of this study will provide biological evidence for acupoint selection. This study is a precondition for follow-up studies, in which the value of optimized acupoint selection will be verified. TRIAL REGISTRATION: ChiCTR2200058867.

Psychological and neurological predictors of acupuncture effect in patients with chronic pain: a randomized controlled neuroimaging trial.

ABSTRACT: Chronic pain has been one of the leading causes of disability. Acupuncture is globally used in chronic pain management. However, the efficacy of acupuncture treatment varies across patients. Identifying individual factors and developing approaches that predict medical benefits may promise important scientific and clinical applications. Here, we investigated the psychological and neurological factors collected before treatment that would determine acupuncture efficacy in knee osteoarthritis. In this neuroimaging-based randomized controlled trial, 52 patients completed a baseline assessment, 4-week acupuncture or sham-acupuncture treatment, and an assessment after treatment. The patients, magnetic resonance imaging operators, and outcome evaluators were blinded to treatment group assignment. First, we found that patients receiving acupuncture treatment showed larger pain intensity improvements compared with patients in the sham-acupuncture arm. Second, positive expectation, extraversion, and emotional attention were correlated with the magnitude of clinical improvements in the acupuncture group. Third, the identified neurological metrics encompassed striatal volumes, posterior cingulate cortex (PCC) cortical thickness, PCC/precuneus fractional amplitude of low-frequency fluctuation (fALFF), striatal fALFF, and graph-based small-worldness of the default mode network and striatum. Specifically, functional metrics predisposing patients to acupuncture improvement changed as a consequence of acupuncture treatment, whereas structural metrics remained stable. Furthermore, support vector machine models applied to the questionnaire and brain features could jointly predict acupuncture improvement with an accuracy of 81.48%. Besides, the correlations and models were not significant in the sham-acupuncture group. These results demonstrate the specific psychological, brain functional, and structural predictors of acupuncture improvement and may offer opportunities to aid clinical practices.

Electroacupuncture vs Sham Electroacupuncture in the Treatment of Postoperative Ileus After Laparoscopic Surgery for Colorectal Cancer: A Multicenter, Randomized Clinical Trial.

Importance: Despite the adoption of the optimized Enhanced Recovery After Surgery (ERAS) protocol, postoperative ileus (POI) severely impairs recovery after colorectal resection and increases the burden on the health care system. Objective: To assess the efficacy of electroacupuncture (EA) in reducing the duration of POI with the ERAS protocol. Design, Setting, and Participants: This multicenter, randomized, sham-controlled trial was conducted in China from October 12, 2020, through October 17, 2021. There was a 1:1 allocation using the dynamic block random method, and analyses were by intention to treat. Patients 18 years or older undergoing laparoscopic resection of colorectal cancer for the first time were randomly assigned to treatment group by a central system. Interventions: Patients were randomly assigned to 4 sessions of EA or sham electroacupuncture (SA) after surgery. All patients were treated within the ERAS protocol. Main Outcomes and Measures: The primary outcome was the time to first defecation. Secondary outcomes included other patient-reported outcome measures, length of postoperative hospital stay, readmission rate within 30 days, and incidence of postoperative complications and adverse events. Results: A total of 249 patients were randomly assigned to treatment groups. After the exclusion of 1 patient because of a diagnosis of intestinal tuberculosis, 248 patients (mean [SD] age, 60.2 [11.4] years; 153 men [61.7%]) were included in the analyses. The median (IQR) time to first defecation was 76.4 (67.6-96.8) hours in the EA group and 90.0 (73.6-100.3) hours in the SA group (mean difference, -8.76; 95% CI, -15.80 to -1.73; P = .003). In the EA group compared with the SA group, the time to first flatus (median [IQR], 44.3 [37.0-58.2] hours vs 58.9 [48.2-67.4] hours; P < .001) and the tolerability of semiliquid diet (median [IQR], 105.8 [87.0-120.3] hours vs 116.5 [92.0-137.0] hours; P = .01) and solid food (median [IQR], 181.8 [149.5-211.4] hours vs 190.3 [165.0-228.5] hours; P = .01) were significantly decreased. Prolonged POI occurred in 13 of 125 patients (10%) in the EA group vs 25 of 123 patients (20%) in the SA group (risk ratio [RR], 0.51; 95% CI, 0.27-0.95; P = .03). Other secondary outcomes were not different between groups. There were no severe adverse events. Conclusions and Relevance: Results of this randomized clinical trial demonstrated that in patients undergoing laparoscopic surgery for colorectal cancer with the ERAS protocol, EA shortened the duration of POI and decreased the risk for prolonged POI compared with SA. EA may be considered as an adjunct to the ERAS protocol to promote gastrointestinal function recovery and prevent prolonged POI after surgery. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2000038444.

Acupuncture for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Pilot Randomized Clinical Trial.

Importance: Acupuncture is a promising therapy for irritable bowel syndrome (IBS), but the use of subjective scales as an assessment is accompanied by high placebo response rates. Objectives: To preliminarily test the feasibility of using US Food and Drug Administration (FDA)-recommended end points to evaluate the efficacy of acupuncture in the treatment of IBS. Design, Setting, and Participants: This pilot, multicenter randomized clinical trial was conducted in 4 tertiary hospitals in China from July 1, 2020, to March 31, 2021, and 14-week data collection was completed in March 2021. Individuals with a diagnosis of IBS with diarrhea (IBS-D) were randomized to 1 of 3 groups, including 2 acupuncture groups (specific acupoints [SA] and nonspecific acupoints [NSA]) and a sham acupuncture group (non-acupoints [NA]) with a 1:1:1 ratio. Interventions: Patients in all groups received twelve 30-minute sessions over 4 consecutive weeks at 3 sessions per week (ideally every other day). Main Outcomes and Measures: The primary outcome was the response rate at week 4, which was defined as the proportion of patients whose worst abdominal pain score (score range, 0-10, with 0 indicating no pain and 10 indicating unbearable severe pain) decreased by at least 30% and the number of type 6 or 7 stool days decreased by 50% or greater. Results: Ninety patients (54 male [60.0%]; mean [SD] age, 34.5 [11.3] years) were enrolled, with 30 patients in each group. There were substantial improvements in the primary outcomes for all groups (composite response rates of 46.7% [95% CI, 28.8%-65.4%] in the SA group, 46.7% [95% CI, 28.8%-65.4%] in the NSA group, and 26.7% [95% CI, 13.0%-46.2%] in the NA group), although the difference between them was not statistically significant (P = .18). The response rates of adequate relief at week 4 were 64.3% (95% CI, 44.1%-80.7%) in the SA group, 62.1% (95% CI, 42.4%-78.7%) in the NSA group, and 55.2% (95% CI, 36.0%-73.0%) in the NA group (P = .76). Adverse events were reported in 2 patients (6.7%) in the SA group and 3 patients (10%) in NSA or NA group. Conclusions and Relevance: In this pilot randomized clinical trial, acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms, although there were no significant differences among the 3 groups. These findings suggest that acupuncture is feasible and safe; a larger, sufficiently powered trial is needed to accurately assess efficacy. Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000030670.

Potential mechanisms of acupuncture in enhancing cerebral perfusion of ischemic stroke.

Ischemic stroke is the predominant cause of long-term disability and death worldwide. It is attributable to the sudden interruption of regional cerebral blood flow, resulting in brain cell death and neurological impairment. Acupuncture is a widely used adjuvant treatment for ischemic stroke in China and shows promising efficacy in clinical practice. This review mainly focused on the evidence to illustrate several possible mechanisms of acupuncture therapy on cerebral perfusion in ischemic stroke. Studies have shown that acupuncture is probably effective in the enhancement of cerebral perfusion after ischemic stroke. It promotes the improvement of hemodynamics, the release of vasoactive substances, the formation of new blood vessels, as well as the restitution of microcirculation. Multiple factors may contribute to the variability in acupuncture's therapeutic effects, including the acupoint selection, stimulation frequency and intensity, and retaining needle time. Acupuncture has the potential to become a non-pharmacological adjuvant approach to enhance cerebral perfusion in ischemic stroke. Future studies are required to gain our insight into acupuncture as well as accelerate its clinical translation.

Edge-enhanced dual discriminator generative adversarial network for fast MRI with parallel imaging using multi-view information.

In clinical medicine, magnetic resonance imaging (MRI) is one of the most important tools for diagnosis, triage, prognosis, and treatment planning. However, MRI suffers from an inherent slow data acquisition process because data is collected sequentially in k-space. In recent years, most MRI reconstruction methods proposed in the literature focus on holistic image reconstruction rather than enhancing the edge information. This work steps aside this general trend by elaborating on the enhancement of edge information. Specifically, we introduce a novel parallel imaging coupled dual discriminator generative adversarial network (PIDD-GAN) for fast multi-channel MRI reconstruction by incorporating multi-view information. The dual discriminator design aims to improve the edge information in MRI reconstruction. One discriminator is used for holistic image reconstruction, whereas the other one is responsible for enhancing edge information. An improved U-Net with local and global residual learning is proposed for the generator. Frequency channel attention blocks (FCA Blocks) are embedded in the generator for incorporating attention mechanisms. Content loss is introduced to train the generator for better reconstruction quality. We performed comprehensive experiments on Calgary-Campinas public brain MR dataset and compared our method with state-of-the-art MRI reconstruction methods. Ablation studies of residual learning were conducted on the MICCAI13 dataset to validate the proposed modules. Results show that our PIDD-GAN provides high-quality reconstructed MR images, with well-preserved edge information. The time of single-image reconstruction is below 5ms, which meets the demand of faster processing.

[Research progress of acupuncture for peripheral inflammatory response].

Acupuncture can regulate peripheral inflammatory response mainly through somatosensory-vagal/sympathetic nerve-splenic/adrenal/local reflex pathway. Besides, acupuncture may also play an anti-inflammatory role through gut microbiota and neuro-endocrine pathway. The effects of acupuncture have acupoint specificity and time window effect, and are influenced by voltage, current and frequency of electroacupuncture. Future research should focus on the connection and interaction of multiple targets, pathways and mechanisms in the brain, and clarify the multi-target advantages of acupuncture anti-inflammatory.

Effect of acupuncture for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized clinical trial.

BACKGROUND: Diarrhea-predominant irritable bowel syndrome (IBS-D) is the most common subtype of IBS. Acupuncture is commonly used to treat IBS-D, but its effect is uncertain because of the poor quality of prior studies. This trial aims to evaluate the efficacy and safety of acupuncture treatment for IBS-D through comparisons with sham acupuncture. METHODS/DESIGN: This is a large-scale, multi-center, randomized, two-arm interventional clinical trial. Participants will take part in a total of 20 weeks of study, which contained 3 phases: 2-week screening, 6-week treatment, and 12-week follow-up. Based on the composite response rate of the primary endpoint in our pilot study (a sham acupuncture response rate of 27% and a true acupuncture of approximately 45%), 280 randomly allocated participants were planned. Eligible participants will be randomly assigned to the true acupuncture group and sham acupuncture group according to a ratio of 1:1, and a total of 15 sessions of treatment overall 6-week treatment period will be brought. The primary endpoint is a composite response rate at week 6, and the responder is defined as who responses in both abdominal pain intensity and stool consistency. Furthermore, composite response rates at other weeks, IBS Symptom Severity Scale, IBS Quality of Life, Adequate Relief scale, and individual IBS symptoms (abdominal pain, bloating, stool frequency) are chosen as secondary endpoints. DISCUSSION: This trial may provide high-quality evidence for the efficacy and safety of acupuncture in the treatment of IBS-D. The results of this study will be published in peer-reviewed journals. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2100044762. Registered on 26 March 2021.

The impact of expectancy on the efficacy of acupuncture treatment for postprandial distress syndrome: Secondary analysis of a randomized clinical trial.

BACKGROUND: Expectancy is an important source of the placebo effect. However, it is unclear whether this has an effect on the efficacy of acupuncture and sham acupuncture in the treatment of postprandial distress syndrome (PDS). AIM: To evaluate the effects of high expectancy (HE) and low expectancy (LE) on the efficacy of acupuncture and sham acupuncture in the treatment of PDS. METHODS: This post hoc secondary analysis used data from our previous randomized controlled trial. Patients were, respectively, enrolled in the HE group and LE group according to expectancy assessments. The composite primary outcomes were the response rate and the elimination rate after 4 weeks of treatment. Expectancy was considered a factor affecting the efficacy of acupuncture treatment only if both primary outcomes achieved significance. RESULTS: For the acupuncture group, the response rate was 84.5% in the HE group and 78.8% in the LE group (p = 0.458), and the elimination rate was 32.1% in the HE group and 21.2% in the LE group (p = 0.241). For the sham acupuncture group, the response rate at week 4 was 52.3% in the HE group and 53.1% in the LE group (p = 0.936), and the elimination rate at week 4 was 23.1% in the HE group and 10.6% in the LE group (p = 0.090). CONCLUSION: In this study, the response rate and elimination rate were higher in the high-expectancy group, but no conclusive evidence was found for an association between expectancy and the efficacy of acupuncture and sham acupuncture.

Effect of Adjunctive Acupuncture on Pain Relief Among Emergency Department Patients With Acute Renal Colic Due to Urolithiasis: A Randomized Clinical Trial.

Importance: Renal colic is described as one of the worst types of pain, and effective analgesia in the shortest possible time is of paramount importance. Objectives: To examine whether acupuncture, as an adjunctive therapy to analgesics, could accelerate pain relief in patients with acute renal colic. Design, Setting, and Participants: This single-center, sham-controlled, randomized clinical trial was conducted in an emergency department in China between March 2020 and September 2020. Participants with acute renal colic (visual analog scale [VAS] score ≥4) due to urolithiasis were recruited. Data were analyzed from October 2020 to January 2022. Interventions: After diagnosis and randomization, all patients received 50 mg/2 mL of diclofenac sodium intramuscular injection immediately followed by 30-minute acupuncture or sham acupuncture. Main Outcomes and Measures: The primary outcome was the response rate at 10 minutes after needle manipulation, which was defined as the proportion of participants whose VAS score decreased by at least 50% from baseline. Secondary outcomes included response rates at 0, 5, 15, 20, 30, 45, and 60 minutes, rescue analgesia, and adverse events. Results: A total of 115 participants were screened and 80 participants (66 men [82.5%]; mean [SD] age, 45.8 [13.8] years) were enrolled, consisting of 40 per group. The response rates at 10 minutes were 77.5% (31 of 40) and 10.0% (4 of 40) in the acupuncture and sham acupuncture groups, respectively. The between-group differences were 67.5% (95% CI, 51.5% to 83.4%; P < .001). The response rates of acupuncture were also significantly higher than sham acupuncture at 0, 5, 15, 20 and 30 minutes, whereas no significant difference was detected at 45 and 60 minutes. However, there was no difference between the 2 groups in rescue analgesia rate (difference 2.5%; 95% CI -8.8% to 13.2%; P > .99). No adverse events occurred during the trial. Conclusions and Relevance: These findings suggest that acupuncture plus intramuscular injection of diclofenac is safe and provides fast and substantial pain relief for patients with renal colic compared with sham acupuncture in the emergency setting. However, no difference in rescue analgesia was found, possibly because of the ceiling effect caused by subsequent but robust analgesia of diclofenac. Acupuncture can be considered an optional adjunctive therapy in relieving acute renal colic. Trial Registration: Chinese Clinical Trial Registry: ChiCTR1900025202.

Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial.

INTRODUCTION: Hypertension is a common risk factor for cardiovascular disease. Transcutaneous electrical acupoint stimulation (TEAS) may be effective for hypertension, but the evidence remains limited. The aim of this study is to evaluate the effectiveness and safety of the smart phone-based TEAS as adjunctive therapy for hypertension. METHODS AND ANALYSIS: This study is a 52-week cluster randomised controlled trial with 1600 hypertension patients in 32 community health service centres. Patients who meet the inclusion criteria will be randomised into usual care group or TEAS group in a 1:1 ratio. All patients will be provided with usual care as recommended by the guidelines. In addition to this, patients in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at home, 4 times weekly for 12 weeks. The primary outcome will be the mean difference in the changes in office systolic blood pressure from baseline to 12 weeks between TEAS and usual care groups. Secondary outcomes will include the change of mean diastolic blood pressure, proportion of patients with controlled blood pressure (blood pressure <140/90 mm Hg), proportion of patients taking antihypertensive drugs, change in number of antihypertensive drugs and changes in 12-item Short-Form. Tertiary outcomes will include change in body mass index, change in waist circumference, physical activity and medication adherence. Safety outcomes will be any serious adverse events and clinical events. ETHICS AND DISSEMINATION: This study has been approved by ethics committee of Beijing University of Chinese Medicine (No. 2020BZHYLL0104). Written informed consent will be obtained from all patients before randomisation. Trial results will be disseminated in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ChiCTR2000039400.

Home-based transcutaneous electrical acupoint stimulation for high-normal blood pressure: A randomized controlled trial.

The authors investigated the effectiveness of home-based transcutaneous electrical acupoint stimulation (TEAS) combined with lifestyle modification on blood pressure (BP) control and explored the feasibility of the trial design in this prospective, randomized controlled trial. The authors recruited individuals with high-normal BP who had a systolic blood pressure (SBP) of 120-139 mm Hg and a diastolic blood pressure (DBP) of 80-89 mm Hg, or both. Participants were randomly assigned to receive either lifestyle modification combined with TEAS four times weekly for 12 weeks at home (intervention group) or solely lifestyle modification (control group). The primary outcome was the change in mean SBP at week 12 from the baseline measurement. A total of 60 participants were randomized in a 1:1 ratio, and an intention-to-treat analysis was performed on all of the outcomes. The mean difference in the change in SBP for the intervention group (compared to the control) at week 12 was -3.85 mm Hg (95% CI: -7.58 to -.12; p = .043); for the DBP, the change was -2.27 mm Hg (95% CI: -5.76 to 1.23; p = .199). There was no difference in the proportion of progression to hypertension, quality of life, body mass index (BMI) or waist circumference. In addition, two participants reported TEAS-related adverse events. The authors found a reduction in SBP control in the pragmatic, home-based intervention by using TEAS combined with lifestyle modification in adults with high-normal BP. Trial Registration: The study was registered in the Chinese Clinical Trial Registry (ChiCTR 1900024982) on August 6, 2019.