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.

Effect of acupuncture on mild cognitive impairment in the elderly: A randomized controlled trial.

Background and objective: Mild cognitive impairment (MCI) is a cognitive dysfunction syndrome defined mostly by memory or other cognitive impairments, and may serve as a precursor to Alzheimer's disease (AD). In recent years, acupuncture has gained recognition as a potential intervention for MCI, attracting significant attention as a promising and well-established therapy. In this study, we critically evaluate the clinical efficacy and safety of an innovative acupuncture approach, termed "Kidney Nourishment and Spirit Regulation", as a therapeutic modality for MCI in geriatric populations. Methods: A prospective, randomized, single-blind, placebo-controlled, single-center clinical trial design where patients will be allocated in acupuncture, placebo (sham acupuncture sessions), or blank for eight weeks. The blank group will receive health education over the same eight-week period and will be offered compensatory acupuncture therapy after this period. The selected acupoints for this investigation include GV20, EX-HN1, GV24, GV29, CV6, CV4, PC6, KI3, LI4, LR3, HT7 and SP6. The primary outcome measure will be the Montreal Cognitive Assessment (MoCA), while secondary outcomes include the Mini Mental State Examination (MMSE), Activity of Daily Living (ADL), and Electroencephalogram (EEG). Discussion: This study seeks to provide an optimum regimen for acupuncture therapy in elderly MCI patients and to provide considerable theoretical evidence for its popularization and future broad adoption. We thus postulate that the current trial data might enlighten and potentially guide future research in terms of study design refinement.

Retinoic Acid-PPARα Mediates ß-Carotene Resistance to Placental Dysfunction Induced by Deoxynivalenol.

Deoxynivalenol (DON), one of the most polluted mycotoxins in the environment and food, has been proven to have strong embryonic and reproductive toxicities. However, the effects of DON on placental impairment and effective interventions are still unclear. This study investigated the effect of ß-carotene on placental functional impairment and its underlying molecular mechanism under DON exposure. Adverse pregnancy outcomes were caused by intraperitoneal injection of DON from 13.5 to 15.5 days of gestation in mice, resulting in higher enrichment of DON in placenta than in other tissue samples. Interestingly, 0.1% ß-carotene dietary supplementation could significantly alleviate DON-induced pregnancy outcomes. Additionally, in vivo and in vitro placental barrier models demonstrated the association of DON-induced placental function impairment with placental permeability barrier disruption, angiogenesis impairment, and oxidative stress induction. Moreover, ß-carotene regulated DON-induced placental toxicity by activating the expressions of claudin 1, zonula occludens-1, and vascular endothelial growth factor-A through retinoic acid-peroxisome proliferator-activated receptor α signaling.

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.

Peripheral Blood T Cell Gene Expression Responses to Exercise and HMB in Sarcopenia.

BACKGROUND: Sarcopenia is a major health problem in older adults. Exercise and nutrient supplementation have been shown to be effective interventions but there are limited studies to investigate their effects on the management of sarcopenia and its possible underlying mechanisms. Here, we studied T cell gene expression responses to interventions in sarcopenia. METHODS: The results of this study were part of a completed trial examining the effectiveness of a 12-week intervention with exercise and nutrition supplementation in community-dwelling Chinese older adults with sarcopenia, based on the available blood samples at baseline and 12 weeks from 46 randomized participants from three study groups, namely: exercise program alone (n = 11), combined-exercise program and nutrition supplement (n = 23), and waitlist control group (n = 12). T cell gene expression was evaluated, with emphasis on inflammation-related genes. Real-time PCR (RT-PCR) was performed on CD3 T cells in 38 selected genes. Correlation analysis was performed to relate the results of gene expression analysis with lower limb muscle strength performance, measured using leg extension tests. RESULTS: Our results showed a significant improvement in leg extension for both the exercise program alone and the combined groups (p < 0.001). Nine genes showed significant pre- and post-difference in gene expression over 12 weeks of intervention in the combined group. Seven genes (RASGRP1, BIN1, LEF1, ANXA6, IL-7R, LRRN3, and PRKCQ) showed an interaction effect between intervention and gene expression levels on leg extension in the confirmatory analysis, with confounder variables controlled and FDR correction. CONCLUSIONS: Our findings showed that T cell-specific inflammatory gene expression was changed significantly after 12 weeks of intervention with combined exercise and HMB supplementation in sarcopenia, and that this was associated with lower limb muscle strength performance.

[Effect of combined acupuncture-medicine anesthesia in thyroid nodule ablation and its effect on serum ß-endorphin].

OBJECTIVE: To investigate the anesthetic effect of combined acupuncture-medicine anesthesia in microwave ablation of benign thyroid nodules and its effect on serum ß-endorphin. METHODS: A total of 60 patients who met the inclusion criteria and received microwave ablation of benign thyroid nodules were randomly divided into the treatment group and the control group, with 30 patients in each. The patients in the treatment group were given combined acupuncture-medicine anesthesia, and those in the control group were given intravenous anesthesia. The two groups were compared in terms of the sedative and analgesic effects of anesthesia, amount of anesthetics used, incidence rate of intraoperative snore and respiratory depression, and change in serum ß-endorphin level before anesthesia, before surgery, and after the surgery. RESULTS: Both groups obtained satisfactory anesthetic effects. Compared with the control group, the sedation score, the amounts of fentanyl and propofol used, the incidence rates of intraoperative snore and respiratory depression in the treatment group were obviously lower (P<0.05, P<0.01). The treatment group had an increase in serum ß-endorphin level before surgery and at the end of surgery (P<0.05), while the control group showed no significant change in serum ß-endorphin level at each time point. CONCLUSION: In microwave ablation of benign thyroid nodules, combined acupuncture-medicine anesthesia has good sedative and analgesic effects and can reduce the amounts of anesthetics used as well as the incidence rates of intraoperative snore and respiratory depression. The analgesic effect of acupuncture anesthesia is associated with increased ß-endorphin secretion.

Effect of acupuncture on post-hemorrhoidectomy pain: a randomized controlled trial.

OBJECTIVES: To observe the clinical efficacy and safety of electroacupuncture (EA) in relieving pain after hemorrhoidectomy treatment for mixed hemorrhoids. DESIGN: This was a randomized controlled trial. METHODS: We conducted a single-center, single-blind, and randomized controlled clinical trial. Seventy-two patients with mixed hemorrhoids who had undergone hemorrhoidectomy were randomly assigned to the following 2 groups: the EA treatment group (EA) received surround needling with EA (n=36), and the control group received sham acupuncture (SA) treatment (n=36). The treatment was conducted within 15 min after the completion of the surgery and lasted for 30 min. The pain intensity was recorded by using the visual analog scale as the primary outcome. Secondary outcomes were verbal rating scale and Wong-Baker Faces Pain Rating. These measurements were evaluated at 11 time points: once every hour in the first 8 h after the treatment, 24 and 48 h after the treatment, and at the first defecation. Besides, quality of life was measured by Symptom Checklist-90 Scale at 24 and 48 h follow-ups. RESULTS: The EA group had significantly lower visual analog scale scores at the 3 time points of 6, 24 h, and during the defecation (p<0.05). Verbal rating scale showed a significantly lower score in the treatment group compared to the SA group at 4 h after the treatment as well as during defecation (p<0.05). The Wong-Baker Faces Pain Rating scores of EA group were significantly lower at 5, 7, and 8 h after treatment and during defecation (p<0.05) compared with those of SA group. CONCLUSION: Acupuncture is effective in alleviating postoperative pain in patients who have undergone hemorrhoidectomy.

Efficacy and safety of acupuncture treatment on primary insomnia: a randomized controlled trial.

OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of acupuncture treatment for primary insomnia. METHODS: We conducted a single-center, single-blinded, and randomized controlled clinical trial. Seventy-two patients with primary insomnia were randomly assigned into two groups - the acupuncture group, who received acupuncture treatment, and the control group, who received sham acupuncture treatment. The treatment was given three times a week for four weeks. Patients were asked to wear sleep monitors and complete questionnaires every two weeks for a total of eight weeks. The primary outcome was the Insomnia Severity Index (ISI). The secondary outcomes were sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the Actigraphy, as well as scores of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). RESULTS: Compared with pretreatment baseline, patients in both groups had varying degrees of improvements in their sleep conditions. Paired t-test showed that there was a significant difference in all indicators in the acupuncture group before and after acupuncture treatment. One-way analysis of covariance adjusted for baseline scores indicated that the ISI improved dramatically in the acupuncture group at two weeks post-treatment (F = 11.3, p = 0.001), four weeks post-treatment (F = 33.6, p < 0.001), 2 weeks follow-up (F = 39.4, p < 0.001) and four weeks follow-up (F = 34.1, p < 0.001). Similar significant improvements can also be observed in the SE, TST and SDS scores. Although no differences in SA and SAS were shown between the two groups until the end of the treatment, remarkable decrements in SA and SAS were found in the acupuncture treatment group after the two-week and four-week follow-ups. CONCLUSION: Acupuncture treatment is more effective than sham acupuncture treatment in increasing insomnia patients' sleep quality and improving their psychological health. TRIAL REGISTRATION: Chinese Clinical Trial Registry: Chi CTR-TRC-14004859.

Acupuncture therapy in the management of the clinical outcomes for temporomandibular disorders: A PRISMA-compliant meta-analysis.

PURPOSE: The purpose of this study was to evaluate conventional acupuncture therapy in the management of clinical outcomes for temporomandibular disorders (TMD) in adults. METHODS: The electronic databases PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Clinical Trails.gov were searched for reports published until March 31, 2016. RESULTS: Nine eligible studies from 8 publications involving 231 patients were included in the meta-analysis. A comparison of the main outcome of visual analog scale (VAS) values of pain between the acupuncture group and control group showed a significant decrease (MD = -0.98, 95% CI [-1.62, -0.34], I=54%, P = 0.003) in the VAS following acupuncture treatment. However, subgroup analysis according to the type of sham control group indicated that there were significant differences in the results when sham acupuncture was used as the control group (MD = -1.54, 95% CI [-2.63, -0.45], I=58%, P = 0.006) as well as when sham laser treatment was used as the control group (MD = -1.29, 95% CI [-2.32, -0.27], I = 0%, P = 0.01). However, there was no significant difference when the splint treatment group was used as the control group (MD = -0.09, 95% CI [-0.69, 0.50], I = 0%, P = 0.76). Subgroup analyses of VAS for pain by the classification of diseases indicated that the myogenous TMD subgroup demonstrated a significant difference (MD = -1.49, 95% CI [-2.45, -0.53], I = 47%, P = 0.002), and TMD showed no statistically significant difference (MD = -0.42, 95% CI [-1.14, 0.30], I = 46%, P = 0.25). Subgroup analysis according to whether the subgroup penetrated the skin showed that nonpenetrating sham acupuncture as the control group showed a significant difference (MD = -1.56, 95% CI [-2.70, -0.41], I = 58%, P = 0.008) compared with the conventional acupuncture as the treatment modality, while penetrating sham acupuncture as the control group showed no significant difference (MD = -1.29, 95% CI [-3.40, 0.82], I = not applicable, P = 0.23). No publication bias was observed considering the symmetry of the funnel plots. CONCLUSIONS: Our results indicate that conventional acupuncture therapy is effective in reducing the degree of pain in patients with TMD, especially those with myofascial pain symptoms.

Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

BACKGROUND: The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. METHODS: This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up. DISCUSSION: This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke. TRIAL REGISTRATION: Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

Comparative efficacy of nonhormonal drugs on menopausal hot flashes.

PURPOSE: The effects of nonhormonal drugs on menopausal hot flashes are still not well quantified. We therefore did a model-based meta-analysis (MBMA) to quantitate and compare the efficacy features of nonhormonal drugs on menopausal hot flashes. METHODS: Literature was searched in the public databases to extract data of clinical trials on nonhormonal drugs, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), gabapentin, clonidine, and soy isoflavones. Pharmacodynamic models were used for the quantitative analysis of each drug. RESULTS: Thirty-nine studies were included in the analysis. The results revealed a classic pharmacodynamic maximal effect (Emax) model could describe the time course of hot-flash reduction by nonhormonal drugs. After deducting placebo effects, the Emax of SSRIs/SNRIs, gabapentin, clonidine, and soy isoflavones was 13.9 %, 14.8 %, 18.5 %, and 25.0 %, respectively. The time to achieve half of the maximal effect (ET50) of SSRIs/SNRIs, gabapentin, clonidine, and soy isoflavones was 0.18 weeks, 0 weeks, 0 weeks, and 11.6 weeks, respectively. The results showed that SSRIs/SNRIs, gabapentin, and clonidine had a rapid onset, which could reach the maximum effect immediately. However, the onset of soy isoflavones was very slow, and a duration of 16.6 weeks was needed to surpass the efficacy of paroxetine (a type of SSRIs). CONCLUSIONS: The information provided in this study can be used as valuable supplementary information for treatment guidelines of nonhormonal drugs on menopausal hot flashes.

Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial.

Background. Depression is frequently accompanied by sleep disturbances including insomnia. Insomnia may persist even after mood symptoms have been adequately treated. Acupuncture is considered to be beneficial to adjust the state of body and mind and restore the normal sleep-awake cycle. This trial is aimed at evaluating the efficacy and safety of electroacupuncture on treating insomnia in patients with depression. Methods. We describe a protocol for a randomized, single-blinded, sham controlled trial. Ninety eligible patients will be randomly assigned to one of 3 treatment groups: treatment group (acupuncture), control A group (superficial acupuncture at sham points), and control B group (sham acupuncture). All treatment will be given 3 times per week for 8 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD), and Self-Rating Depression Scale (SDS). All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks after treatment, 8 weeks after treatment, and 4 weeks of follow-up. Ethics. This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2015SHL-KY-21) and is registered with ChiCTR-IIR-16008058.

Systematic Review of Adverse Effects: A Further Step towards Modernization of Acupuncture in China.

As a further step towards the modernization of acupuncture, the objective of this review was to figure out the frequency and severity of adverse complications and events in acupuncture treatment reported from 1980 to 2013 in China. All first-hand case reports of acupuncture-related complications and adverse events that could be identified in the scientific literature were reviewed and classified according to the type of complication and adverse event, circumstance of the event, and long-term patient outcome. The selected case reports were published between 1980 and 2013 in 3 databases. Relevant papers were collected and analyzed by 2 reviewers. Over the 33 years, 182 incidents were identified in 133 relevant papers. Internal organ, tissue, or nerve injury is the main complications of acupuncture especially for pneumothorax and central nervous system injury. Adverse effects also included syncope, infections, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence, and broken needles. Qualifying training of acupuncturists should be systemized and the clinical acupuncture operations should be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world.

Adverse events of massage therapy in pain-related conditions: a systematic review.

Pain-related massage, important in traditional Eastern medicine, is increasingly used in the Western world. So the widening acceptance demands continual safety assessment. This review is an evaluation of the frequency and severity of adverse events (AEs) reported mainly for pain-related massage between 2003 and 2013. Relevant all-languages reports in 6 databases were identified and assessed by two coauthors. During the 11-year period, 40 reports of 138 AEs were associated with massage. Author, year of publication, country of occurrence, participant related (age, sex) or number of patients affected, the details of manual therapy, and clinician type were extracted. Disc herniation, soft tissue trauma, neurologic compromise, spinal cord injury, dissection of the vertebral arteries, and others were the main complications of massage. Spinal manipulation in massage has repeatedly been associated with serious AEs especially. Clearly, massage therapies are not totally devoid of risks. But the incidence of such events is low.