Effect of Acupuncture on Artery Elasticity for Atherosclerosis: A Randomized Controlled Trial

Background Atherosclerosis (AS) is a chronic arterial disease. Atherosclerosis related diseases, like myocardial infarctions (MI) and strokes have the highest mortality and disability rate. However, limited evidence verified the effects of acupuncture on arterial stiffness for subclinical atherosclerosis. We hypothesized that acupuncture could improve arterial stiffness in subclinical atherosclerosis and resist plaque progression. The aim of this study is to assess the effect of acupuncture on arterial elasticity via ultrafast pulse wave velocity (ufPWV) and explore the effect of acupuncture on lipid level and platelet function for subclinical atherosclerosis patients.MethodsThis was a randomized parallel controlled trial included 44 patients. Patients were assigned in a 1:1 ratio to acupuncture group and sham acupuncture group. Patients completed 24 treatments in total within 12 weeks of intervention. The primary outcome was ultrafast pulse wave velocity (ufPWV) assessed after every 4-weeks treatment; the secondary outcomes were carotid intima-media thickness (cIMT), blood lipid levels, fibrinogen (FIB) and blood platelet. Intention-to-treat (ITT) principle was applied and data sets were analyzed using SPSS 20.0 software.ResultsAmong the 44 randomly assigned patients, changes of right-side BS value in TA group (0.841) at week 12 were greater than SA group (-0.189), with a mean difference of 1.030 (95% CI, 0.320, 1.739; P=0.006). Similar results were observed in right-side ES, left-side BS, left-side ES at week 12. As to secondary outcomes, compared with SA group(1.08mm), the TA group(0.98mm) showed a significant decline in mean of left-side IMT at week 12. (Z= -2.118; P=0.034). There were no serious adverse events.ConclusionsAmong patients with Carotid intima-media thickening, both-side carotids arterial elasticity is significantly improved after 12-week acupuncture compared with sham acupuncture. The effects of acupuncture are more noticeable at week 12 during end-systole.Trial registrationThe trial was registered at http://www.chictr.org.cn (NO. ChiCTR1900025551, 31/08/2019)

Ma's Bamboo-Based Medicinal Moxibustion Therapy of Low Back Pain in Lumbar Disc Herniation: Study Protocol for a Randomized Controlled Trial

Background Lumbar disc herniation (LDH) is a common and frequently-occurring disease in clinic. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma's bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. Methods/design: The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma's bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156).Patients in each group will receive treatment every day,6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analogue scale(VAS)at baseline, after 6 times of treatment,the end of treatment, and follow-up. the secondary outcomes will include Oswestry disability indexes (ODI) ,modified Japanese Orthopaedic Association low back pain (M-JOA) score,serum β-endorphin (β-EP) and serum substance P (SP). β-EP and SP as well as safety evaluation indexes (routine blood test, liver and kidney function, and ECG) will be measure at baseline and after the end of treatment. Discussion The results of the trial will compare the efficacy on low back pain in LDH between Ma's bamboo-based medicinal moxibustion group and acupuncture group and will be expected to make a systematic and objective evaluation on the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy. Trial registration: ChiCTR, ChiCTR2000038725. Registered on 29 September 2020.

Acupuncture Relieves Stress-Induced Depressive Behavior by Reducing Oxidative Stress and Neuroapoptosis in Rats

Oxidative stress is closely related to the occurrence of depression. Acupuncture has been proved to be an effective method for treating depression. In order to explore the mechanism of the antidepressant effect of acupuncture, this study performed acupuncture prevention on chronic unpredictable mild stress (CUMS) depression model rats, and observed the effect of acupuncture on hippocampal oxidative stress and Nrf2 signaling pathway. Male SD rats were randomly divided into control group, CUMS group, acupuncture group, and fluoxetine group (n = 10/group). Fluoxetine, a common antidepressant, was used as a positive control drug in this study. In the fluoxetine group, rats were given fluoxetine (2.1 mg/kg) intragastrically once a day for 28 days. The acupoints of Shangxing (GV23) and Fengfu (GV16) were applied in acupuncture group, once every other day for 14 times in total. Behavioral tests and biological detections were used to evaluate the effects of the interventions and the changes of factors related to oxidative stress, Nrf2 pathway, and neuronal apoptosis. The results showed that both acupuncture and fluoxetine could increase sugar preference rate in SPT and decrease immobility time in FST in depression model rats. It also significantly decreased oxidative stress products such as ROS and H2O2, and elevated the protein and mRNA expressions of Nrf2 and HO-1. From Nissl’s staining, there were more abundant nerve cells in two intervention groups compared with CUMS group. Plus, acupuncture down-regulated the expression levels of Bax and caspase-3 and up-regulated the expression of Bcl-2. Our findings indicate that acupuncture improved depression-like behaviors of CUMS rats. And CUMS-induced depression-like behaviors in rats were related to oxidative stress and neuronal apoptosis in hippocampus. Acupuncture showed antidepressant effects in reducing oxidative stress products via regulating the Nrf2/HO-1 signaling pathway so that prevented neuronal apoptosis.

Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial

IntroductionAs the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented with significance to lead to pain relief, the immediate analgesia of acupuncture for BC still needs to be verified, and the underlying mechanism has yet to be covered. Therefore, this trial aims first to verify the immediate pain-alleviation characteristic of acupuncture for BC, then to explore its influence on the peripheral sensitised acupoint and central brain activity.Methods and analysisThis is a randomised controlled, paralleled clinical trial, with patients and outcome assessors blinded. Seventy-two patients with gallbladder stone disease presenting with BC will be randomised into a verum acupuncture group and the sham acupuncture group. Both groups will receive one session of immediate acupuncture treatment. Improvements in patients’ BC will be evaluated by the Numeric Rating Scale, and the pain threshold of acupoints will also be detected before and after treatment. During treatment, brain neural activity will be monitored with functional near-infrared spectroscopy (fNIRS), and the needle sensation will be rated. Clinical and fNIRS data will be analysed, respectively, to validate the acupuncture effect, and correlation analysis will be conducted to investigate the relationship between pain relief and peripheral–cerebral functional changes.Ethics and disseminationThis trial has been approved by the institutional review boards and ethics committees of the First Teaching Hospital of Chengdu University of Traditional Chinese Medicine, with the ethical approval identifier 2019 KL-029, and the institutional review boards and ethics committees of the First People’s Hospital of Longquanyi District, with the ethical approval identifier AF-KY-2020071. The results of this trial will be disseminated through peer-reviewed publications and conference abstracts or posters.Trial registration numberCTR2000034432.

Effects of Acupuncture on Cardiac Remodeling in Patients with Persistent Atrial Fibrillation: Results of a Randomized, Placebo-Controlled, Patient- and Assessor-Blinded Pilot Trial and Its Implications for Future Research

Background and Objectives: In this study, we attempted to determine the effects of acupuncture on cardiac remodeling and atrial fibrillation (AF) recurrence rates in patients with AF after electrical cardioversion (EC). Materials and Methods: We randomly assigned 44 patients with persistent AF to an acupuncture group or a sham acupuncture group. An electroacupuncture treatment session was administered once weekly for 12 weeks at four acupuncture points (left PC5, PC6, ST36, and ST37). Results: Among the 44 recruited participants, 16 (treatment group) and 15 (control group) completed the trial. The three-month AF recurrence rate (primary outcome) was not significantly different between the two groups. Following the completion of treatment, patients who had been treated with acupuncture had a significant reduction in left atrial volume index (42.2 ± 13.9 to 36.1 ± 9.7 mL/m2; p = 0.028), whereas no change in atrial size was observed in the sham acupuncture group. No serious adverse events were observed. The AF recurrence rate and cardiac function did not differ significantly between the two groups. At three months, the acupuncture treatment group showed more favorable atrial structural remodeling compared to the sham acupuncture group. Conclusion: In future research on acupuncture in AF management, it is recommended that the inclusion criteria be amended to include only symptomatic AF, that an appropriate control group is designed, and that the acupuncture treatment frequency is increased to several times per week.

Efficacy of Acupuncture in Post-partum With Diastasis Recti Abdominis: A Randomized Controlled Clinical Trial Study Protocol

Background: Diastasis rectus abdominis (DRA) is one of the common complications during pregnancy and post-partum, which has psychological and physical effects on post-partum women. Acupuncture, a worldwide alternative therapy, has attracted wide attention in preventing and treating diseases related to pregnancy and childbirth. This study aims to evaluate the efficacy of acupuncture combined with physical training in treating post-partum rectus muscle dissociation.Methods: This is a randomized, controlled trial of DRA in post-partum conducted at Hangzhou Hospital of Traditional Chinese Medicine Affiliated with Zhejiang University of Chinese Medicine. The primary purpose is to evaluate the effectiveness of acupuncture and physical training on DRA in post-partum women. The study will be conducted from March 2022 to March 2023. The acupuncture group received acupuncture and physical training (n = 48), the sham acupuncture group received sham acupuncture and physical training (n = 48), and the physical training group received physical training (n = 48). These experiments perform once/day, five times a week for 2 weeks, followed up for half a year after the end of the course of treatment. Our tests perform a course of treatment, which includes a total of 10 consecutive treatments. Furthermore, the patient will be followed up for half a year after the treatment. Primary and secondary indicators, including inter recti distance (IRD), linea alba (LA) tension, the MOS item short-form health survey (SF-36), short-form McGill pain questionnaire-2 (SF-MPQ-2), body mass index (BMI), waist-to-hip ratio (WHR), leeds dyspepsia questionnaire (LDQ), menstrual distress questionnaire (MDQ), 10 items of edinburgh post-natal depression scale (EPDS-10), the modified body self-image scale (MBIS), international consultation incontinence questionnaire short-form (ICIQ-SF) and hernia-related quality-of-life survey (HerQles), which will be evaluated before and after treatment and half a year after treatment. Adverse events and side effects during each treatment will be collected and recorded.Discussion: There is evidence that acupuncture and physical training can treat DRA in post-partum. In this study, we evaluate the effectiveness of acupuncture in post-partum with DRA.

A randomized controlled clinical trial comparing different numbers of acupuncture sessions for migraine

Background: Acupuncture has shown benefit in preventing migraine attacks, but there has been no clear recommendation about the number of treatment sessions that should be provided. Objectives: The aim of this study was to examine whether 5 sessions of acupuncture treatment is non-inferior to 10 sessions for migraine. Methods: We performed a multicenter, open-label, randomized, controlled clinical trial across five hospitals in Thailand. Migraine patients were randomly assigned into two groups: treatment with 5 sessions of acupuncture (group A) or 10 sessions of acupuncture (group B). Acupuncture was performed twice a week. We measured the number of migraine days, average pain severity according to a 0–10 numeric pain rating scale (NPRS) and quality of life using the EQ-5D-5L questionnaire, comparing 4 weeks after treatment versus baseline. Results: Of 156 patients, 83 and 73 patients were assigned to groups A and B, respectively. Comparing 4 weeks after treatment with baseline, the mean reduction in the number of headache days in groups A and B was 6.4 (95% confidence interval [CI] 4.8 to 7.9) days and 6.4 (95% CI 4.5 to 8.4) days, respectively (p = 0.97). The mean difference between the reduction in headache days of the two groups was −0.1 (95% CI −2.5 to 2.4) days, which included the pre-specified non-inferiority limit of −1. The mean reduction of NPRS scores in groups A and B was 4.5 (95% CI 3.8 to 5.1) and 3.8 (95% CI 3.1 to 4.5), respectively (p = 0.17). Both groups showed an improvement in quality of life. Conclusion: Both 5 and 10 sessions of acupuncture were associated with apparent benefits in terms of preventing migraine attacks, reducing the severity of the headache and improving quality of life, based on comparisons between baseline and follow-up in both study groups. Although we were unable to demonstrate non-inferiority of 5 sessions versus 10 sessions of acupuncture, the effects in the two groups were not significantly different and the temporal effects appeared to last for at least 1 month. Trial registration number: TCTR20170612002 (Thai Clinical Trials Registry).

Efficacy and Safety of Deep Acupuncture at Qugu Point (CV2) for Benign Prostatic Hyperplasia: Study Protocol for a Randomized Controlled Trial

Background: Benign prostatic hyperplasia (BPH) is one of the most common urological disease and often associated with lower urinary tract symptoms (LUTS) in elderly men. Chinese acupuncturists found that deep acupuncture at Qugu point (CV2) can effectively relieve urination difficulties and improve quality of life of patients with troublesome BPH/LUTS. However, there are currently insufficient scientific evidence and well-designed trials to support its effect as well as safety in the treatment of BPH/LUTS. Therefore, this study protocol is designed to evaluate the effectiveness and safety of deep acupuncture at CV2 for men with BPH/LUTS.Methods: A single-center, randomized, subject-and assessor-blinded, placebo-controlled trial will be conducted in an outpatient acupuncture department in Beijing, China. A total of 120 subjects (50-80 yr) will be randomized to one of three balanced groups: deep acupuncture group 1 (deep acupuncture at CV2 with needle tip reaching the prostate capsule), deep acupuncture group 2 (deep acupuncture at CV2 with needle tip 10mm away from the prostate capsule), and sham acupuncture group (sham acupuncture with non-penetrating needle) in a ratio of 1:1:1. The study period for each subject will be 4 months, including 4 weeks baseline observation period, 4 weeks intervention period, and 8 weeks follow-up period. All subjects will receive 10 treatments during the intervention period. Subjects in deep acupuncture groups will be measured the needle depth and angle by computerized tomography (CT) in their first treatment. The primary outcome is the change in International Prostate Symptom Score. Secondary outcomes include quality of life, maximum urinary flow rate, and post-void residual.Discussion: The objectives of this study include: 1) to assess the efficacy of deep acupuncture at CV2 in the treatment of BPH; 2) to evaluate the safety of acupuncture at CV2 by measure the needle depth and angle under CT. This study will provide an evidence-based recommendation for acupuncture at CV2 in the treatment of BPH.Trial registration: Registered on 18 January 2020. Chinese Clinical Trials Register, ChiCTR2000029203.

Effect of acupuncture at Zusanli (ST36) point on antral contraction function under ultrasound guidance: study protocol of a randomized controlled trial

Background Although the relationship between deqi sensations and curative effect has always been controversial, deqi sensations has been regarded as the key indicator of clinical efficacy of acupuncture therapy. There is little evidence for standardization or visualization of the mechanism of acupuncture’s therapeutic effect. This trial aims to evaluate the effect of needling at Zusanli (ST36) on antral contraction function as visualized by ultrasound. Methods This is a two-arm, single-blind, randomized, controlled trial. A total of 116 acupuncture-naïve healthy subjects will be randomly allocated to the acupuncture group or sham acupuncture group in a 1:1 ratio. Participants in the acupuncture group will receive manual acupuncture at Zusanli (ST36) with the needling depth at crural interosseous membrane. Those in the sham acupuncture group will be given penetrating needling depth at the superficial fascia layer. The primary outcome will be the changes in antral contraction frequency (ACF) before and after acupuncture. The secondary outcomes will be the changes in the thermal infrared spectrum of gastric area skin, the antral contraction amplitude (ACA), the antral movement index (AMI), and the scores on the Chinese version of Massachusetts General Hospital Acupuncture Sensation Scale (C-MASS). The adverse events will be evaluated and recorded in detail. Discussion This study may provide visual and objective evidence regarding the safety and efficacy of manual acupuncture at Zusanli (ST36). In addition, the results of this study will help to identify the role of Zusanli (ST36)in the inducing deqi. Trial registration Chinese Clinical Trial Registry ChiCTR2000040686. Registered on 8 December 2020

Acupuncture combined with opioids for cancer pain: a pilot pragmatic randomized controlled trial

Objective: Given the existing evidence for the analgesic effect of acupuncture, the current study aimed to assess whether acupuncture could be feasible and manageable as an adjunctive therapy for cancer pain in a real-world hospital setting. Methods: Thirty patients in an Oncology department with moderate or severe pain were recruited and randomized to an adjunctive acupuncture group or control group, who received pharmacotherapy for pain management without acupuncture. The duration of the treatment course was 1 week with a 2-week follow-up. In total, four acupuncture sessions were administered, on days 1/2/4/6 of the trial. Pain intensity was measured using a numerical rating scale (NRS) and the daily opioid dose was recorded. Results: The overall trends favored acupuncture for both pain intensity and daily opioid consumption. The proportion of participants experiencing at least a 2-point reduction in the NRS at the end of the treatment was 93% (n = 14/15) for the acupuncture group and 57% (n = 8/14) for the control group (risk difference (RD) 36.1%, 95% confidence interval (CI) [7.4%–65.0%]; relative risk (RR) 1.63, 95% CI [1.02–2.62]; p = 0.04). There were no serious adverse events and no dropouts during the treatment. Conclusion: This pilot study showed that adding acupuncture to routine analgesia for patients with cancer pain was feasible and acceptable to patients. The clinical effects of adding acupuncture as an adjunctive therapy need to be further evaluated. Clinical trial registration number: ChiCTR1800017023 (Chinese Clinical Trial Registry)