Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial.

INTRODUCTION: Obesity has been identified as a significant risk factor for several chronic conditions, including diabetes, tumours and cardiovascular disease, and has been associated with increased mortality rates. Despite the well-established clinical practice of electroacupuncture (EA) as a potential treatment option for obesity, its efficacy remains questionable, primarily due to the paucity of empirical evidence supporting its therapeutic benefits. METHODS AND ANALYSIS: The present study aims to investigate the efficacy and safety of EA for weight loss in obese individuals with pre-diabetes, using a randomised, placebo-controlled clinical trial design. A total of 256 eligible patients will be randomly assigned to one of two groups: EA (comprising EA treatment with health education) or superficial acupuncture (SA) (comprising SA treatment with health education). The intervention will be administered three times per week for the initial 12 weeks, two times per week for the subsequent 8 weeks and one time per week for the final 4 weeks, with a 24-week follow-up period. The primary outcome measure will be the percentage of patients who achieve a reduction of 10% or more in their body weight at week 24. Secondary outcome measures will include changes in body weight and body mass index, blood test results, data collected by the body composition analyser, size of adipose tissue scanned by MRI of the abdomen and the Impact of Weight on Quality of Life, the 21-item Three-Factor Eating Questionnaire-Revised and the Food Craving Questionnaire-Trait. The Treatment Emergent Symptom Scale will be employed to monitor every adverse reaction from baseline to follow-up. ETHICS AND DISSEMINATION: This trial has received ethical clearance from the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine under the registration number 2021SHL-KY-74. All participants will provide their written informed consent prior to their enrolment. The findings of this investigation will be disseminated through peer-reviewed publications and scholarly conferences. TRIAL REGISTRATION NUMBER: NCT05237089.

Electroacupuncture with intermittent wave stimulation as rehabilitation approach for chronic Bell's palsy: a randomized controlled trial.

PURPOSE: To evaluate the effectiveness and safety of electroacupuncture (EA) using intermittent wave stimulation in enhancing facial symmetry and nerve function in chronic Bell's palsy patients. METHODS: A 6-week assessor-blinded, randomized trial followed by an 18-week observational period was conducted. Sixty individuals with chronic Bell's palsy, showing no signs of recovery after 12 months, were equally divided to receive either 18 sessions of EA using intermittent wave stimulation or Transcutaneous Electrical Stimulation (TES), administered thrice weekly over 6 weeks. The primary outcome measure was the change in the total facial nerve index (TFNI) score from baseline to Week 6, with secondary outcomes including TFNI scores at Weeks 12 and 24, as well as the change in Sunnybrook Facial Grading System (SFG) score from baseline to Week 6, and SFG scores at Weeks 12 and 24. RESULTS: The EA group showed a significant improvement, with a mean total facial nerve index score increase of 24.35 (4.77) by Week 6 compared with 14.21 (5.12) in the Transcutaneous Electrical Stimulation group (P<.001). This superiority persisted during the 24-week follow-up. While no significant difference was observed in the Sunnybrook Facial Grading System score change from baseline to Week 6, variations were noted at Weeks 12 and 24. No major adverse effects were reported. CONCLUSION: EA with intermittent wave stimulation notably enhanced facial symmetry in chronic Bell's palsy patients over Transcutaneous Electrical Stimulation by Week 6, maintaining this edge throughout the follow-up.

The effect of Baduanjin Qigong combined with five-elements music on anxiety and quality of sleep in asymptomatic patients with COVID-19 infection: A randomised controlled trial.

Background: Infections of Coronavirus Disease-2019 (COVID-19) and the subsequent quarantine can culminate in anxious mood and sleep disturbances. The objective of this clinical trial was to investigate the effect of traditional Qigong with music therapy on relieving anxiety and improving the quality of sleep in Chinese adults with COVID-19 infection. Methods: A total of 200 asymptomatic COVID-19 infected patients were randomly assigned into two groups during their quarantine period in Chongming Island, Shanghai. The patients in the treatment group daily received Baduanjin Qigong, five-elements music therapy and routine care, while the patients in the control group only took the routine care. The primary outcome was anxiety levels measured by the 7-item Generalized Anxiety Disorder scale (GAD-7). Secondary outcomes included the quality of sleep measured by the Jenkins Sleep Scale (JSS), the degree of depression measured by the Patient Health Questionnaire (PHQ-9), as well as the self-efficacy in the Perceived Health Competence Scale (PHCS). An online questionnaire was given to all participants on the day of arrival to determine the baseline for all outcomes and then given again on the day of discharge. A one-way analysis of covariance was used to analyze the differences between the two groups after intervention. Results: At the end of the intervention, 177 (88.5%) patients finished the questionnaire. Patients in the treatment group had clearly decreased GAD-7 scores (MD = 2.7, 95% CI = 2.3, 3.2) after the daily exercise and music. Patients in the control group had little changes in the GAD-7 (MD = -0.2, 95%CI = -0.7, 0.3, P = 0.07), as well as the PHQ-9 (MD = 0.1, 95%CI = -0.5, 0.6, P = 0.66) after the routine care, when compared to their baseline scores. There were statistical between-group differences in GAD-7 (MD = 2.9, 95% CI = 2.2, 3.6, P < 0.001）and in the PHQ-9 scores (MD = 3.6, 95% CI = 2.9, 4.4, P < 0.001) at the post-treatment. Compared with the control group, patients had significantly lower scores on the JSS (MD = 2.7, 95% CI = 2.0, 3.3, P < 0.001), and higher scores on the PHCS (MD = -5.0, 95% CI = -6.1, -3.9, P < 0.001) after receiving Qigong and the music therapy. Conclusion: Traditional Baduanjin Qigong and five-elements music therapy help to relieve anxiety and depression, and improve the sleep quality in patients with COVID-19 infection. Trial registration: Chinese Clinical Trial Registry ChiCTR2200059800.

Moxibustion for medical personnel with negative emotion and insomnia during COVID-19 pandemic: A randomized, controlled trial.

Background: We conducted this randomized controlled trial (RCT) to evaluate the effectiveness and safety of moxibustion at Sanyinjiao (SP6) acupoint for treatment of negative mood and sleep quality in healthcare workers during the 2019 coronavirus disease (COVID-19). Methods: A total of 180 participants were divided in a 1:1 ratio into two groups, the treatment group (for moxibustion) and the control group (for no treatment). The treatment group had a 30-minute moxibustion therapy once a day for two weeks, followed by a two-week follow-up. The Hamilton Anxiety Scale (HAMA) was used to assess the degree of the participants' anxiety, and the Patient Health Questionnaire-9 (PHQ-9) was utilized to examine their depressed condition. The Maslach Burnout Inventory-General Survey (MBI-GS) was used to measure the level of burnout among healthcare workers. To determine the severity of insomnia, the Sleep Dysfunction Rating Scale (SDRS) was utilized. At baseline, week 2, and week 4, all scales were evaluated. Results: Compared to the control group, The treatment group improved more significantly in the HAMA at week 2 (MD = -19.01, 95% CI: -21.89 to -16.14; P<0.001) and at week 4 follow-up visits (MD = -8.96, 95% CI: -11.19 to -6.73; P<0.001). A subgroup study of HAMA scores revealed that position and education had significant impact on treatment effectiveness. During the 2-week intervention period, the treatment group showed more significant improvements in depressive symptoms measured by PHQ-9 (13.00±2.41 vs. 15.60±3.65; P<0.001), work burnout symptoms measured by MBI-GS (MD = -11.88, 95% CI, -15.73 to -8.03; P<0.001), and insomnia symptoms measured by SDRS (MD = -2.45, 95% CI, -4.24 to -0.66; P<0.01). There were no significant adverse effects reported. Conclusion: Moxibustion at SP6 may be an effective treatment to improve anxiety, depression, sleep quality, and quality of life for healthcare workers during COVID-19. Trial registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR-2200059327.

Electroacupuncture for Pain Relief After Endoscopic Sinus Surgery: A Randomized Controlled Trial.

Postoperative pain is a common problem after endoscopic sinus surgery (ESS). Electroacupuncture (EA) is proven to be effective in relieving postoperative pain. However, EA has not been studied in patients undergoing ESS. This study was designed to evaluate the efficacy and safety of EA compared to a sham control in relieving pain after ESS. A total of 62 patients were randomly allocated to receive either EA (n = 31) or sham EA (n = 31) for 5 sessions, 30 minutes per session for 4 days (2 hours before and 2 hours after surgery, and 3 sessions daily for the following 3 days). There were no significant differences between the 2 groups with regard to demographic characteristics. Compared to the sham EA group, the EA group showed a significantly greater reduction in the pain intensity of single daily scoring with a numerical rating scale at the day following surgery (postoperative day 1, POD1) (-1.35; 95% confidence interval [CI], -1.74 to -0.97; P < .001) and POD2 (-1.16; 95% CI, -1.55 to -0.77; P < .001), whereas no significant between-group difference was detected at the day of surgery (POD0), POD3 or POD6. Intraoperative heart rate and mean blood pressure in the EA group showed a more stable trend. A significant improvement was found for an actigraphy-measured average time of night wakings, recovery time from anesthesia, and quality of recovery-15 in the EA group. No severe adverse events occurred during the trial. Our results demonstrate that EA can serve as an effective adjuvant therapeutic tool for pain relief after ESS. PERSPECTIVE: This randomized sham-controlled, patient-and-assessor blinded trial provided evidence for the first time that EA can relieve postoperative pain and other symptom management in patients after ESS. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR1900024183, http://www.chictr.org.cn/showproj.aspx?proj=40573.

Effect of electroacupuncture on discomfort during gastroscopy: A randomised controlled trial.

BACKGROUND: Gastrointestinal reactions, pain and discomfort are inevitable in patients undergoing common gastroscopy. Acupuncture is an effective therapy that assists in the perioperative period; however, evidence of it relieving discomfort is limited. We conducted this trial to observe the effect of electroacupuncture (EA) on discomfort caused by gastroscopy without sedatives. METHODS: This was a single-centre, patient-assessor blind, randomised controlled trial. Sixty patients requiring gastroscopy were randomly assigned to the EA and control groups (sham acupuncture, SA, group) in a 1:1 ratio. Patients in the EA group underwent treatment at acupoints LI4 (Hegu), PC6 (Neiguan), ST36 (Zusanli), and ST34 (Liangqiu) for 30 min before gastroscopy, whereas patients in the SA group underwent superficial acupuncture at non-acupoints. The patients' nausea level, throat discomfort, bucking, and agitation were evaluated using a visual analogue scale (VAS) within 30 min after gastroscopy. The mean VAS score was the primary outcome. Secondary outcomes were the Amsterdam Preoperative Anxiety and Information Inventory Scale, used to evaluate patients' preoperative anxiety levels, and the 6-item State-Trait Anxiety Inventory (STAI-S6), used to assess anxiety before and after gastroscopy. The patients' vital signs, including heart rate, blood pressure, and pulse oxygen saturation, were recorded before, during, and after gastroscopy. RESULTS: At 30 min after gastroscopy, the mean VAS score in the EA group (4.20 ± 0.63) was lower than that in the control group (5.14 ± 0.70, mean difference (MD): - 0.94, 95% confidence interval (CI): - 1.28, - 0.59, P < 0.001). There were statistically significant between-group differences in the nausea and vomiting, throat discomfort and agitation VAS scores (all P < 0.01), whereas no difference was found in the bucking VAS score (P = 0.692). Compared with the SA group, patients in the EA group had a 6.90-point lower in STAI-S6 (95% CI: -12.98, -0.81, P = 0.027) after gastroscopy. Patients in the EA group had a slower heart rate and lower blood pressure than those in the SA group. Serious adverse events were not observed during the trial. CONCLUSION: EA can help relieve patients' anxiety, and improve their nausea and vomiting, throat discomfort, and agitation during gastroscopy. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR) ID: ChiCTR2000040726.

[Jianpi Peiyuan acupoint thread embedding therapy for perimenopausal obesity: a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy and safety of Jianpi Peiyuan acupoint thread embedding therapy on perimenopausal obesity (PMO). METHODS: Ninety-six patients of PMO were randomly divided into an observation group (48 cases) and a control group (48 cases). The control group received health education and lifestyle intervention. On the basis of the treatment in the control group, the observation group was treated with acupoint thread embedding at the main acupoints of Shangwan (CV 13), Zhongwan (CV 12), Xiawan (CV 10), Yinlingquan (SP 9) and Fenglong (ST 40), etc. as well as the supplementary acupoints in accordance with the syndrome differentiation, once every 2 weeks for 8 weeks (4 times in total). The indexes of obesity (body mass index [BMI], waist circumference, hip circumference and body mass), modified Kupperman score, insomnia severity index (ISI) score, self-rating anxiety scale (SAS) score, and self-rating depression scale (SDS) score of the two groups were observed before and after treatment, and the safety was evaluated. RESULTS: After treatment, BMI, waist circumference, hip circumference and body mass in the two groups were lower than before treatment (P<0.05), and those in the observation group were lower than the control group (P<0.05). After treatment, Kupperman, ISI and SAS scores in the observation group were lower than before treatment (P<0.05), and ISI score in the control group was lower than before treatment (P<0.05). Kupperman, ISI and SAS scores in the observation group were lower than those in the control group (P<0.05). There was no significant difference in SDS between the two groups or within groups (P>0.05). No serious adverse reactions occurred during the experiment. CONCLUSION: Jianpi Peiyuan acupoint thread embedding therapy can reduce the degree of obesity in PMO patients, and improve patients' the perimenopausal symptoms, insomnia and anxiety, with good safety.

Identification of the anti-inflammatory quality markers of Chrysanthemi Flos (Juhua) using spectrum-effect relationships combined with bioactivity re-evaluation.

Chrysanthemi Flos (Juhua), an edible herbal medicine that possesses efficacies of dispersing wind, clearing heat and detoxifying. Studies have demonstrated that the health benefits of Chrysanthemi Flos are largely attributable to its anti-inflammatory effects. However, the correlation between the compounds monitored by the current quality control methods and the anti-inflammatory effects of Chrysanthemi Flos is unclear. In order to better control the quality of Chrysanthemi Flos, the identification of anti-inflammatory quality markers (Q-markers) of Chrysanthemi Flos was performed. The chemical components of Chrysanthemi Flos were profiled by HPLC fingerprints combined with chemometrics methods. Simultaneously, the anti-inflammatory activities of 10 batches of water extracts of Chrysanthemi Flos were evaluated in lipopolysaccharide-activated RAW 264.7 macrophages cells. Gray correlation analysis was performed to assess the relationship between the anti-inflammatory activity and chemical properties. The results showed that 13 common peaks were closely correlated with the anti-inflammatory effect, and further bioactivity re-evaluation confirmed that 10 known compounds exerted a strong anti-inflammatory effect. The quantitative analysis of the 10 Q-markers showed that the 25 batches of samples could be discriminated into different zones according to their producing areas. Conclusively, the present work identified 10 anti-inflammatory Q-markers of Chrysanthemi Flos using spectrum-effect relationships combined with bioactivity re-evaluation.

Effect of Electroacupuncture on Insomnia in Patients With Depression: A Randomized Clinical Trial.

Importance: Electroacupuncture (EA) is a widely recognized therapy for depression and sleep disorders in clinical practice, but its efficacy in the treatment of comorbid insomnia and depression remains uncertain. Objective: To assess the efficacy and safety of EA as an alternative therapy in improving sleep quality and mental state for patients with insomnia and depression. Design, Setting, and Participants: A 32-week patient- and assessor-blinded, randomized, sham-controlled clinical trial (8-week intervention plus 24-week observational follow-up) was conducted from September 1, 2016, to July 30, 2019, at 3 tertiary hospitals in Shanghai, China. Patients were randomized to receive EA treatment and standard care, sham acupuncture (SA) treatment and standard care, or standard care only as control. Patients were 18 to 70 years of age, had insomnia, and met the criteria for depression as classified in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Data were analyzed from May 4 to September 13, 2020. Interventions: All patients in the 3 groups were provided with standard care guided by psychiatrists. Patients in the EA and SA groups received real or sham acupuncture treatment, 3 sessions per week for 8 weeks, for a total of 24 sessions. Main Outcomes and Measures: The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. Secondary outcomes included PSQI at 12, 20, and 32 weeks of follow-up; sleep parameters recorded in actigraphy; Insomnia Severity Index; 17-item Hamilton Depression Rating Scale score; and Self-rating Anxiety Scale score. Results: Among the 270 patients (194 women [71.9%] and 76 men [28.1%]; mean [SD] age, 50.3 [14.2] years) included in the intention-to-treat analysis, 247 (91.5%) completed all outcome measurements at week 32, and 23 (8.5%) dropped out of the trial. The mean difference in PSQI from baseline to week 8 within the EA group was -6.2 (95% CI, -6.9 to -5.6). At week 8, the difference in PSQI score was -3.6 (95% CI, -4.4 to -2.8; P < .001) between the EA and SA groups and -5.1 (95% CI, -6.0 to -4.2; P < .001) between the EA and control groups. The efficacy of EA in treating insomnia was sustained during the 24-week postintervention follow-up. Significant improvement in the 17-item Hamilton Depression Rating Scale (-10.7 [95% CI, -11.8 to -9.7]), Insomnia Severity Index (-7.6 [95% CI, -8.5 to -6.7]), and Self-rating Anxiety Scale (-2.9 [95% CI, -4.1 to -1.7]) scores and the total sleep time recorded in the actigraphy (29.1 [95% CI, 21.5-36.7] minutes) was observed in the EA group during the 8-week intervention period (P < .001 for all). No between-group differences were found in the frequency of sleep awakenings. No serious adverse events were reported. Conclusions and Relevance: In this randomized clinical trial of EA treatment for insomnia in patients with depression, quality of sleep improved significantly in the EA group compared with the SA or control group at week 8 and was sustained at week 32. Trial Registration: ClinicalTrials.gov Identifier: NCT03122080.

Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial.

BACKGROUND: Gastroscopy procedures are frequently performed under general sedation to minimize discomfort. Patients who refuse a sedative injection may experience more discomfort and adverse reactions such as pain and nausea. These instances reduce patient compliance and willingness to participate in future procedures. Acupuncture has been shown to have an anti-nausea and analgesic effect; however, there is limited data available that demonstrates the efficacy of acupuncture when applied before gastroscopy. METHODS: A total of 60 participants will be randomly assigned to the electroacupuncture (EA) group and the sham electroacupuncture (SEA) group at a ratio of 1:1. Acupuncture treatment will be performed before gastroscopy for a duration of 30 min. All patients will complete detailed questionnaires at 30 min and 7 days post-procedure to record the severity of their symptoms. The primary outcome will be the average of 4 standard visual analogue scale (VAS) scores in the categories of nausea, vomiting, throat discomfort, and agitation as reported by the patient. The secondary outcomes will be patient's anxiety level as recorded by the 6-item short form of the State-Trait Anxiety Inventory (STAI-S6) and Amsterdam Pre-Operative Anxiety and Information Scale (APAIS), preference in a future endoscopy, pulse oxygen saturation (SpO2), heart rate (HR), and blood pressure (BP). Anxiety scales will be assessed before and after acupuncture; others will be completed at 30 min and 7 days post-procedure. The duration of the gastroscopy and the number of biopsies will be recorded after operation. DISCUSSION: This randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the improvement of patient discomfort during gastroscopy without systemic sedation. TRIAL REGISTRATION: ChiCTR2000040726 . This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2020SHL-KY-11). Registration date 12 August 2020.

Acupuncture for insomnia after ischemic stroke: an assessor-participant blinded, randomized controlled trial.

BACKGROUND: To date, there has been little focus on research into acupuncture for insomnia after ischemic stroke. Insomnia is one of the most common sequelae after ischemic stroke, and it is the most unrecognized modifiable risk factor. OBJECTIVE: To evaluate the efficacy and safety of acupuncture for insomnia after ischemic stroke. METHODS: In this assessor-participant blinded, randomized, controlled trial, 144 ischemic stroke patients with insomnia meeting Diagnostic and Statistical Manual of Mental Disorders (fifth edition, DSM-5) criteria were assigned to verum or sham acupuncture treatment (n = 72 per group) for three sessions per week over 4 weeks. The outcomes were the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), stroke-specific quality of life (SSQoL), and Hospital Anxiety and Depression Scale (HADS) scores. Multiple objective sleep variables were recorded using actigraphy. Assessment was conducted at baseline, and thereafter once biweekly for the 4-week treatment and at 4 weeks of follow-up. RESULTS: The verum acupuncture group had significantly greater improvements than the sham acupuncture group in sleep quality from 2 weeks into treatment throughout the follow-up, indicated by ISI scores and actigraphic variable SE (sleep efficiency). This greater improvement was also observed in the PSQI after 4 weeks of treatment throughout follow-up, as well as actigraphic variable TST (total sleep time), SSQoL and HADS scores at the end of treatment, and SSQoL and depression scores at follow-up. There was no significant difference between groups in the actigraphic variable SA (sleep awakenings). Adverse events were mild in severity, and their incidence was not significantly different between the two groups. CONCLUSION: Acupuncture appears to be efficacious, in terms of improving insomnia, related quality of life, and affective symptoms, for patients with ischemic stroke. TRIAL REGISTRATION NUMBER: ChiCTR-IIC-16008382 (Chinese Clinical Trial Registry).

Effect of Electroacupuncture on Bladder Dysfunction via Regulation of MLC and MLCK Phosphorylation in a Rat Model of Type 2 Diabetes Mellitus.

Previous studies observed have reported that electroacupuncture (EA) is effective in relieving diabetic bladder dysfunction (DBD); however, little is known about the mechanism. Therefore, we explored the effects and mechanisms of EA on DBD in streptozotocin-high-fat diet- (STZ-HFD-) induced diabetic rats. The Sprague-Dawley male rats were divided randomly into four groups: normal group, diabetes mellitus group (DM group), DM with EA treatment group (EA group), and DM with sham EA treatment group (sham EA group). After 8 weeks of EA treatment, the body weight, serum glucose, bladder weight, and cystometrogram were evaluated. The bladder wall thickness was examined by abdominal ultrasound imaging. After the transabdominal ultrasound measurements, hematoxylin-eosin (HE) staining was used to observe the bladder mucosa layer. The bladder detrusor smooth muscle cells (SMCs) and fibroblasts were observed under transmission electron microscopy (TEM). The phospho-myosin light chain (p-MLC), phospho-myosin light chain kinase (p-MLCK), and phospho-myosin phosphatase target subunit 1 (p-MYPT1) levels in the bladder were examined using Western blot. The bladder weight, serum glucose, bladder wall thickness, volume threshold for micturition, and postvoid residual (PVR) volume in the diabetic rats were significantly higher than those in the control animals. EA treatment significantly reduced the bladder weight, bladder wall thickness, volume threshold for micturition, and PVR volume in diabetic rats. EA caused a significant increase in the MLC dephosphorylation and MLCK phosphorylation levels in the group compared to the sham EA and model groups. EA reduced the infiltration of inflammatory cells in the bladder mucosa layer of diabetic rats. In addition, EA repaired the damaged bladder detrusor muscle of diabetic rats by reducing mitochondrial damage of the SMCs and fibroblasts. Therefore, EA could reduce the bladder hypertrophy to ameliorate DBD by reversing the impairment in the mucosa layer and detrusor SMCs, which might be mainly mediated by the regulation of p-MLC and p-MLCK levels.

Effects of Acupuncture on Vascular Cognitive Impairment with No Dementia: A Randomized Controlled Trial.

BACKGROUND: Acupuncture has been used for treating vascular cognitive impairment, but evidence for its effectiveness remains limited. OBJECTIVE: This single-center, patient-accessor blinded, randomized controlled trial was designed to assess whether acupuncture could improve the cognitive function of patients with vascular cognitive impairment with no dementia (VCIND). METHODS: 120 VCIND patients were randomly assigned to the electro-acupuncture (EA) or sham acupuncture (SA) group at a 1 : 1 ratio, with treatment conducted thrice weekly for 8 weeks. The primary outcome was the changes of cognitive function measured by the Montreal Cognitive Assessment (MoCA) from baseline to week 8. The secondary outcomes included the scores of the Mini-Mental State Examination (MMSE), the Modified Barthel Index (MBI) and the Self-rating Depression Scale (SDS). Follow-up assessments were performed with MoCA and MMSE at week 16 and 32. Linear mixed-effects models were used for analysis and all statistical tests were two-sided. RESULTS: The results showed that patients in the EA group had a significantly greater improvement in MoCA score (23.85±4.18) than those in the SA group (21.48±4.44) at week 8 (95% CI = 0.80, 3.92, p = 0.04), as well as higher MoCA scores over time (p < 0.001 for interaction). Patients who received EA showed a greater increase in MMSE scores (26.41±3.47) than those who received SA (24.40±3.85) along 8 weeks (95% CI = 0.69, 3.34, p = 0.004). However, results diminished over time. No serious adverse events occurred during the trial. CONCLUSION: EA is a safe and effective technique to improve cognition over the short term of 8 weeks in VCIND patients.

The mechanism of electroacupuncture for depression on basic research: a systematic review.

BACKGROUND: Electroacupuncture (EA) is generally accepted as a safe and harmless treatment option for alleviating depression. However, there are several challenges related to the use of EA. Although EA has been shown to be effective in treating depression, the molecular mechanism is unclear. OBJECTIVE: To reveal the therapeutic effect of EA and its possible mechanism in the treatment of depression. SEARCH STRATEGY: We performed a systematic search according to PRISMA guidelines. We electronically searched PubMed, Web of Science (WOS), the China National Knowledge Infrastructure (CNKI), Wanfang Data Information Site and the VIP information database for animal studies in English published from the inception of these databases to December 31, 2019. INCLUSION CRITERIA: Electronic searches of PubMed, WOS, the CNKI, Wanfang and the VIP database were conducted using the following search terms: (depression OR depressive disorder OR antidepressive), (rat OR mouse) AND (acupuncture OR EA). DATA EXTRACTION AND ANALYSIS: The data were extracted primarily by one author, and a follow-up review was conducted by the other authors. RESULTS: Twenty-eight articles met the inclusion criteria. The most commonly used method for inducing depression in animal models was 21 days of chronic unpredictable mild stress. For the depression model, the most commonly selected EA frequency was 2 Hz. Among the 28 selected studies, 11 studies observed depression-related behaviors and used them as indicators of EA efficacy. The other 17 studies focused on mechanisms and assessed the indexes that exhibited abnormalities that were known to result from depression and then returned to a normal range after EA treatment. Treatment of depression by EA involves multiple therapeutic mechanisms, including inhibition of HPA axis hyperactivity and inflammation, regulation of neuropeptides and neurotransmitters, modulation of the expression of particular genes, restoration of hippocampal synaptic plasticity, increased expression of BDNF, and regulation of several signaling pathways. CONCLUSIONS: This review reveals that the mechanisms underlying the effect of acupuncture involve multiple pathways and targets, suggesting that acupuncture is a wholistic treatment for people rather than for diseases. Our findings also explain why acupuncture can treat various disorders in addition to depression.

The effect of acupuncture on depression and its correlation with metabolic alterations: A randomized controlled trial.

BACKGROUND: Electroacupuncture (EA) treatment has antidepressant effect and when patients were treated with EA and antidepressants, the effect could be maintained for a longer time. However, the effect of EA combined with antidepressants based on metabolism is still in the initial observation stage, which requires further research. METHODS: A total of 60 patients with moderate depression were assigned into 2 groups at a ratio of 1:1, the EA group (receiving EA and antidepressants) and the control group (taking antidepressants only) in this randomized controlled pilot trial. The EA treatment was performed 3 times a week for 8 consecutive weeks and then follow up for 4 weeks. The patients' depressive mood was measured by the Hamilton Depression scale (HAMD) at baseline, week 4, week 8 and week 12. Before and after 8-week treatment, morning urine samples from all patients were analyzed by the gas chromatography-mass spectrometry (GC-MS) to find possible metabolic markers of depression and of EA treatment related changes. RESULTS: Compared with the control group, the EA group showed more significant improvements in depressive symptoms measured by HAMD at week 4 (16.89 ±â€Š5.74 vs 25.58 ±â€Š7.03, P < .001), week 8 (9.59 ±â€Š5.13 vs 25.04 ±â€Š7.49, P < .001) and week 12 (11.07 ±â€Š6.85 vs 27.25 ±â€Š7.14, P < .001). The significant differences in urinary specific metabolites before and after EA treatment were malonic acid (fatty acid biosynthesis), cysteine (glutamate metabolism), glutathione (glutamate metabolism), tryptophan (tryptophan metabolism), proline (glutamate metabolism), and N-acetyl-5-hydroxytryptamine. These metabolites are involved in tryptophan metabolism, glutamate metabolism, and fatty acid biosynthesis. CONCLUSION: EA treatment combined with antidepressants is more effective in improving depressive symptoms than antidepressants alone. EA may treat depression by acting on tryptophan metabolism, glutamate metabolism, and fatty acid biosynthesis. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-2000030786.

Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial.

BACKGROUND: Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients' quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. METHOD: This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. DISCUSSION: This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. TRIAL REGISTRATION: ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068.

Effects of the pestle needle therapy, a type of acupoint stimulation, on post-hemorrhoidectomy pain: A randomized controlled trial.

BACKGROUND: Hemorrhoids are one of the most common conditions that lead to surgery, and until now surgical hemorrhoidectomy has been the major effective treatment. Post-operative pain from hemorrhoidectomy has been experienced by thousands of patients and remains a major inconvenience of the operation. OBJECTIVE: This study evaluates the clinical efficacy of the pestle needle therapy, an acupoint stimulation method, for relief of post-hemorrhoidectomy pain. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This was a single-center, patient-assessor-blinded and randomized controlled trial with 154 patients receiving Milligan hemorrhoidectomy surgery. Eligible patients were randomly assigned to either a treatment group or a control group at a ratio of 1:1. The treatment group received the pestle needle therapy, with manual stimulation at Yaoshu (DU2), Mingmen (DU4), Changqiang (DU1), Chengshan (BL57), Erbai (EX-UE2) and the perianal points (1, 3, 5, 7, 9, and 11o'clock around the lesion); while the control group received a sham treatment with very light pressure. Three sessions of treatment were performed at 30 min, 4 h and 12 h after the surgery, and each lasted for 15 min. MAIN OUTCOME MEASURES: The primary outcome was post-operative pain measured with the visual analogue scale (VAS) at 12 h after surgery. The secondary outcomes included the VAS scores measured at 0.5, 2, 4, 6, 8, 24 and 48 h after surgery, the analgesic dose, the time and the VAS score of the patients' first defecation after surgery, as well as the Hamilton Rating Scale for Anxiety (HAMA) evaluated before discharge. RESULTS: The mean pain score of the treatment group was significantly lower than that of the control group (3.10 ± 1.27 vs 4.82 ± 1.29; P < 0.001) at 12 h after surgery. Compared with the control group, patients in the treatment group needed a smaller dose of analgesic within the first 24 hours after surgery (P = 0.002); and their HAMA scores before discharge were lower (4.07 ± 2.40 vs 5.10 ± 2.45, P = 0.009). Compared to the treatment group, patients in the control group had a greater time to the first defecation after surgery ([52.34 ± 15.72] h vs [27.08 ± 13.68] h; P < 0.001), but there was no difference in their VAS scores at the first defecation (P = 0.092). CONCLUSION: The pestle needle therapy was effective for relieving pain, reducing anxiety and improving bowel function after hemorrhoidectomy, and it is worthy of clinical application.

Efficacy of Electroacupuncture on Treating Depression-Related Insomnia: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of electroacupuncture (EA) on treating insomnia in patients with depression. PATIENTS AND METHODS: In a patient-assessor-blind, randomized and sham controlled trial, 90 depression patients with insomnia were assigned into three different groups, receiving EA in the treatment group, superficial acupuncture at sham points in the control group A, or Streitberger non-insertion sham acupuncture in the control group B. Treatment was applied 3 times weekly for 8 consecutive weeks. The primary outcome was measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes were sleep parameters including sleep efficiency (SE), total sleep time (TST) and numbers of sleep awakenings (SA) recorded in the actigraphy, as well as applying the Hamilton Rating Scale for Depression (HAMD-17), Self-Rating Depression Scale (SDS) and Hamilton Rating Scale for Anxiety (HAMA). Assessments were performed at the baseline (week 0), week 4, week 8, and week 12. Linear mixed-effects models were used for analyses and all statistical tests were two-sided. RESULTS: Patients in the EA group had more significant improvement in PSQI scores than those in the control groups over time (respectively p<0.001 and p=0.04 for treatment and time interaction). At 8-week posttreatment, the EA group reported a reduction of -6.64 points in PSQI scores compared with -2.23 points in the control group A (95% CI= -5.74 to -2.39) and -2.94 points in the control group B (95% CI= -5.73 to -2.47). Compared with the two control groups, significant between-group differences were seen in SE (both p<0.01) and TST (both p<0.01) at week 8; similar results can be found in HAMD-17, SDS, and HAMA scores as well. However, there were no between-group differences in SA (respectively p=0.24 and p=0.08) after 8-weeks of treatment. CONCLUSION: Electroacupuncture may improve the sleep quality of patients with depression. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR); URL: http://www.chictr.org.cn/showproj.aspx?proj=12327; Trial ID: ChiCTR-IIR-16008058.

Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial.

BACKGROUND: Postoperative pain is common after nasal endoscopic surgery. It interferes with the quality of sleep and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied in a randomized controlled trial. METHODS/DESIGN: This randomized sham-controlled patient- and assessor-blind pilot trial has been designed to evaluate the efficacy and safety of electroacupuncture in managing postoperative pain following nasal endoscopic surgery to treat sinusitis due to nasal polyps. Altogether, 30 participants will be randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will occur within 2 h before the operation, immediately after the operation upon arrival in the recovery ward, and once daily for 3 days. The primary outcome is the pain numerical rating scale, which will be analyzed using the area under the curve. The secondary outcome measures include heart rate and blood pressure after the operation, sleep quality during the hospital stay (actigraph), quality of recovery, and the 36-item short form health survey. This trial will use an intention-to-treat analysis. DISCUSSION: This pilot randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the management of postoperative pain. It will inform the design of a further full-scale trial. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900024183. Registered on 29 June 2019.