Real Acupuncture Group Research Articles

The neural plasticity and efficacy of acupuncture for post-stroke dysphagia: protocol for a randomized controlled trial with fMRI and DTI

BackgroundDysphagia, a common complication of acute stroke, is associated with increased mortality and morbidity. Acupuncture, a widely used swallowing therapy in China, has been suggested as an effective therapy for treating Post-Stroke Dysphagia (PSD) by recent meta-analyses and guidelines. The use of resting-state functional Magnetic Resonance Imaging (rs-fMRI) and Diffusion Tensor Imaging (DTI) could explore the change of regional spontaneous neural activity, functional relationships between brain regions, and white matter connectivity patterns after acupuncture intervention for PSD. This trial aims to evaluate the efficacy of acupuncture treatment for PSD and explore its central mechanism by neuroimaging.Methods/designThis randomized controlled trial will recruit 40 PSD patients. All patients will be randomized to either the Real Acupuncture (RA) or Sham Acupuncture (SA) group by a ratio of 1:1. All patients will receive immediate acupuncture treatment in the MRI scanning room, followed by four weeks of long-term acupuncture treatment. The primary outcomes are the rs-fMRI and DTI indicators, which will be evaluated after the immediate and long-term acupuncture treatment. The secondary outcomes are the scales that assess the efficacy, including the Functional Oral Intake Scale (FOIS), Water Swallowing Test (WST), Swallowing Quality Of Life Questionnaire (SWAL-QOL), and National Institute of Health Stroke Scale (NIHSS). The modified version of the Massachusetts General Hospital Acupuncture Sensation Scale (M-MASS) and fMRI sensation record table will also be evaluated.DiscussionThis protocol presents the design of a randomized, single-blind trial that will evaluate the efficacy and explore the neural plasticity of acupuncture treatment for PSD. This trial will deepen our insight into the clinical value of acupuncture for PSD and initially probe into the time-dosage-effect mechanism of acupuncture.Trial registration numbersChinese Clinical Trial Registry (www.chictr.org.cn) ChiCTR2300067480. This study was registered on 9th January 2023.

Integration patterns of functional brain networks can predict the response to abdominal acupuncture in patients with major depressive disorder

Abdominal acupuncture has definite efficacy for major depressive disorder (MDD). Our study examined how abdominal acupuncture regulates the integration within and between brain networks of MDD patients by neuroimaging and whether this functional integration can predict the efficacy. Forty-six female MDD patients were randomly divided into a fluoxetine + real acupuncture group (n = 22) and a fluoxetine + sham acupuncture group (n = 24). The differences in functional magnetic resonance imaging data in the intra- and inter-network functional connectivity (FC) of the default mode network (DMN), affective network (AN), salience network (SN), and cognitive control network (CCN) between the two groups were analyzed. The FCs in brain regions with the inter-group differences and support vector regression were used to predict the efficacy of abdominal acupuncture. Our results showed: that the intra- and inter-network FCs of DMN, AN, SN, and CCN could be changed by abdominal acupuncture. Using the baseline FCs within AN and DMN or AN–DMN as characteristics, combined with support vector regression, could better predict the efficacy of acupuncture. Our study suggests that abdominal acupuncture could treat MDD by regulating the integration of the functional networks DMN, AN, SN, and CCN. The baseline FCs within the DMN and AN or between them could be used as neural markers for predicting the efficacy of abdominal acupuncture.

Efficacy of acupuncture in patients with carotid atherosclerosis: a randomized controlled clinical trial

BackgroundThe current clinical management of carotid atherosclerosis is based on the control of risk factors and medicine. However, the risk of adverse events associated with the medicine resulting in concerns and low medication compliance makes it necessary to seek a safer alternative therapy. This study assessed the effectiveness and safety of acupuncture as a treatment for carotid atherosclerosis.MethodsIn this randomized controlled trial, patients with carotid atherosclerotic plaques were included and randomly assigned (1:1) to receive real acupuncture or sham acupuncture for 12 weeks. The follow-up period was 12 weeks. The primary outcome included carotid intima-media thickness (cIMT), plaque score (PS), plaque volume (PV) and grey-scale median (GSM). Secondary outcome was pulse wave velocity (PWV). Adverse events results were recorded as safety outcomes.ResultsFrom January 2021 to February 2022, 60 eligible patients were included. 55 patients (91.7%) completed the intervention and the 12-week follow-up and there was no statistical difference in demographics between the groups. At the end of treatment, the real acupuncture group had significantly reduced PS (P = 0.002), PV (P = 0.000), and improved GSM (P = 0.044). There was no significant difference in the reduction in cIMT (Left cIMT: P = 0.338, Right cIMT: P = 0.204) and PWV between the groups (the left BS: P = 0.429; the left ES: P = 0.701; the right BS: P = 0.211; the right ES: P = 0.083). Three mild adverse reactions occurred during the study.ConclusionThis study found that acupuncture had a certain effect on reducing the thickness and volume of carotid plaque and improving the stability of plaque with minor side effects. These findings suggest that acupuncture may be a potential alternative therapy for carotid atherosclerosis.Trial registrationThis trial has been registered at ClinicalTrials.gov (ChiCTR2100041762). Submitted 30 December 2020, Registered 4 January 2021 Prospectively registered.

Acupuncture modulates emotional network resting-state functional connectivity in patients with insomnia disorder: a randomized controlled trial and fMRI study

BackgroundInsomnia disorder (ID) is one of the most common sleep problems, usually accompanied by anxiety and depression symptoms. Functional magnetic resonance imaging (fMRI) study suggests that both poor sleep quality and negative emotion are linked to the dysregulation of brain network related to emotion processing in ID patients. Acupuncture therapy has been proven effective in improving sleep quality and mood of ID patients, but the involved neurobiological mechanism remains unclear. We aimed to investigate the modulation effect of acupuncture on resting-state functional connectivity (rsFC) of the emotional network (EN) in patients experiencing insomnia.MethodsA total of 30 healthy controls (HCs) and 60 ID patients were enrolled in this study. Sixty ID patients were randomly assigned to real and sham acupuncture groups and attended resting-state fMRI scans before and after 4 weeks of acupuncture treatment. HCs completed an MRI/fMRI scan at baseline. The rsFC values within EN were calculated, and Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), Pittsburgh Sleep Quality Index (PSQI), Hyperarousal Scale (HAS), and actigraphy data were collected for clinical efficacy evaluation.ResultsResting-state FC analysis showed abnormalities in rsFC centered on the thalamus and dorsolateral prefrontal cortex within EN of ID patients compared to HCs. After real acupuncture treatment, rsFC of the anterior cingulate cortex, hippocampus, and amygdala were increased compared with the sham acupuncture group (p < 0.05, FDR corrected). In real acupuncture group, the rsFC value was decreased between left amygdala and left thalamus after 4 weeks of treatment compared with baseline. A trend of correlation was found that the increased rsFC value between the right amygdala and left hippocampus was positively correlated with the decreased HAMA scores across all ID patients, and the decreased left amygdala rsFC value with the left thalamus was negatively correlated with the increased sleep efficiency in the real acupuncture group.ConclusionOur findings showed that real acupuncture could produce a positive effect on modulating rsFC within network related to emotion processing in ID patients, which may illustrate the central mechanism underlying acupuncture for insomnia in improving sleep quality and emotion regulation.Trial registrationhttp://www.chictr.org.cn., ChiCTR1800015282, 20/03/2018.

Acupuncture for the treatment of painful diabetic peripheral neuropathy: A systematic review and meta-analysis

Background and purposeA growing number of studies have investigated the efficacy of acupuncture in the treatment of painful diabetic peripheral neuropathy (PDPN), but the findings of these studies have generated conflicting results. This study therefore aimed to assess the efficacy of acupuncture for treating PDPN so as to offer more conclusive results. MethodsSeven databases were systematically searched for studies published up until December 1, 2023. All randomized controlled trials (RCTs) of acupuncture for PDPN with visual analog scale (VAS) for pain score were included. Study selection, data extraction, and evaluation were conducted independently by researchers. The Risk of Bias 2 (RoB2) tool was employed to assess the risk of bias. From this sample, the mean difference (MD), 95 % confidence intervals (CI), publication bias, and heterogeneity were then computed. ResultsThe manual acupuncture group exhibited a significant decrease in the VAS for pain score compared with the routine care group (p < 0.0001; MD = −1.45 [95 % CI, −1.97 to −0.93], I2 = 84 %). The real acupuncture group demonstrated a greater reduction in VAS scores than the sham acupuncture group (p = 0.004; MD = −0.97 [95 % CI, −1.63 to −0.31], I2 = 65 %). Additionally, the acupuncture group showed improvements in sensory nerve conduction velocity (SNCV, p < 0.0001; MD = 2.29 [95 % CI, 1.79 to 2.78], I2 = 14 %) as well as motor nerve conduction velocity (MNCV, p < 0.0001; MD = 2.87 [95 % CI, 2.46 to 3.27], I2 = 0). Different durations of acupuncture treatment, including 6–10 weeks and 3–4 weeks, demonstrated a significant reduction in VAS scores compared with the routine care group. ConclusionThis meta-analysis provides preliminary evidence for the claim that acupuncture has the potential to alleviate PDPN symptoms and improve SNCV and MNCV. However, high-quality RCTs are needed to offer further evidence and thus better substantiate such a contention.

Acupuncture and Sleep Quality Among Patients With Parkinson Disease

Poor sleep quality greatly impairs quality of life and accelerates deterioration in patients with Parkinson disease (PD), but current remedies remain limited. Acupuncture, used as an adjunctive therapy with anti-Parkinson medications, has shown positive effects in patients with PD. However, high-quality clinical evidence to support the effectiveness of acupuncture for patients with PD and poor sleep quality is lacking. To assess the safety and efficacy of real acupuncture (RA) vs sham acupuncture (SA) as an adjunctive therapy for patients with PD who have poor sleep quality. This single-center randomized clinical trial was performed at The First Affiliated Hospital of Guangzhou University of Chinese Medicine in China from February 18, 2022, to February 18, 2023. Patients with PD and sleep complaints were recruited and randomized (1:1) to receive RA or SA treatment for 4 weeks. Data analysis was performed from April 12 to August 17, 2023. Treatment with RA or SA for 4 weeks. The main outcome was the change in Parkinson Disease Sleep Scale (PDSS) scores measured at baseline, after 4 weeks of treatment, and at 8 weeks of follow-up. Of the 83 participants enrolled, 78 (94.0%) completed the intervention and were included in the analysis. Their mean (SD) age was 64.1 (7.9) years; 41 (52.6%) were men and 37 (47.4%) were women. A significant increase in PDSS scores from baseline was observed for both the RA group (29.65 [95% CI, 24.65-34.65]; P < .001) and the SA group (10.47 [95% CI, 5.35-15.60]; P < .001). Compared with the SA group, the RA group had a significant increase in PDSS scores after 4 weeks of treatment (19.75 [95% CI, 11.02-28.49]; P < .001) and at 8 weeks of follow-up (20.24 [95% CI, 11.51-28.98]; P < .001). In this randomized clinical trial, acupuncture proved beneficial in improving sleep quality and quality of life among patients with PD. These findings suggest that the therapeutic effects of acupuncture could continue for up to 4 weeks. Chinese Clinical Trial Registry Identifier: ChiCTR2200060655.

Effects of Acupuncture on Autonomic Nervous System Parameters and Salivary Cortisol Level Among Mental Stress University Students: A Pilot Randomized Controlled Trial

Stress is a common and often unavoidable aspect of daily life that can negatively impact the autonomic nervous system, which controls the functions of internal organs and glands. Chronic stress has been associated with an imbalance in autonomic nervous system function, leading to a range of health conditions. Acupuncture is a medical treatment modality that has been applied to health care in different dimensions including physical, mental, and spiritual. This study aimed to investigate the effect of acupuncture on blood pressure, heart rate, and salivary cortisol level in mild stress university students, a population particularly vulnerable to stress. Twenty-eight university students were recruited and divided into two groups, a real acupuncture group and a sham acupuncture group. Heart rate, blood pressure, and salivary cortisol level were evaluated before and after a 30-minute acupuncture session on the ST36 acupoint. The results showed that the real acupuncture group had a significant decrease in blood pressure and heart rate, whereas the sham acupuncture group showed no change. Both groups had a slightly decrease in salivary cortisol level with no statistically significant. There was a statistically significant difference in the decrease of systolic blood pressure and heart rate after acupuncture between the two groups, but there was no significant difference between the groups in salivary cortisol level after acupuncture. The findings suggest that the acupuncture can be a valuable treatment for restoring balance to the symptoms of the autonomic nervous system in university students experiencing stress. A larger sample size, a non-intervention control, as well as different sources and times of cortisol collection, could contribute to the validation of the findings in this study.

The increased functional connectivity between the locus coeruleus and supramarginal gyrus in insomnia disorder with acupuncture modulation.

Insomnia disorder (ID) seriously affects the quality of people's daily life, and acupuncture is an effective therapy for it. As an essential component of the upward activation system, the locus coeruleus (LC) plays a crucial role in sleep-wake regulation, its aberrant functional connectivity (FC) is found to be involved in ID. The purpose of this study was to explore the modulation effect of acupuncture on the resting state FC of LC in ID patients. 60 ID patients were recruited and randomly assigned to real acupuncture (RA) or sham acupuncture (SA) treatment. Resting-state functional magnetic resonance imaging (fMRI) data were collected before and after the treatment. With LC as the region of interest, the FC method was adopted to examine acupuncture-related modulation of intrinsic connectivity in ID patients. The Pittsburgh Sleep Quality Index (PSQI), Hyperarousal Scale (HAS), and actigraphy were used to assess sleep quality and cortical hyperarousal states. Associations between clinical outcomes and FC features were calculated using Pearson's correlation analysis. The improvement in sleep quality and hyperarousal in the RA group was greater than that in the SA group. After treatment, the FC between the LC and left inferior frontal gyrus (IFG) decreased in the RA group. The FC between the LC and left insula and supramarginal gyrus (SMG) was higher in the RA group. The change of LC FC values with the SMG was negatively associated with the change in PSQI scores. Acupuncture can modulate FC between the LC and IFG, insular gyrus, and SMG. This may imply the potential mechanism of acupuncture treatment for insomnia.

Study on the Regulating Effect of Acupoint Electroacupuncture on the Depression Level of Drug Addicts

In order to study the regulating effect of electroacupuncture at specific acupoints on the depression level of drug addicts, we randomly selected 42 drug addicts from Sichuan drug rehabilitation center of women and divided them into treatment group (13), comfort group (10) and control group (19) from April to August 2019. Venous blood was taken before and after treatment, and the serum samples such as Noradrenalin (NA) and brain-derived neurotrophic factor (BDNF) were systematically detected. At the same time, Beck Depression Scale was used to detect the level of depression before and after treatment. Results showed that the level of depression in the real acupuncture group decreased significantly after treatment (p < 0.05). The contents of NA and BDNF in the serum of the real acupuncture group increased after treatment, but did not reach a significant level. In a word, the combination therapy of electroacupuncture can improve the levels of BDNF and NA in drug addicts and adjust their depression level, which is worthy of clinical promotion.

Effectiveness of Acupuncture for Anxiety Among Patients With Parkinson Disease

One of the ordinary manifestations of Parkinson disease (PD) is anxiety, which remains untreated. Anxiety is closely associated with the accelerated progression of PD. Efficacy of acupuncture for anxiety has been reported. However, to date, there are no data on acupuncture's effectiveness on anxiety for patients with PD. To investigate the effect of acupuncture vs sham acupuncture for treating anxiety in patients with PD. This is randomized, double-blinded, clinical trial enrolled patients between June 20, 2021, and February 26, 2022. Final follow-up was April 15, 2022. Patients with Parkinson disease and anxiety were allocated randomly (1:1) to receive acupuncture or sham acupuncture for 8 weeks. Acupuncture operators, outcome measures evaluators, and statistical analysts were blinded to the grouping of patients. Patients were blinded to their own grouping during the study. This study took place in the Parkinson clinic of a hospital in China. Real acupuncture or sham acupuncture for 8 weeks. Primary outcome was Hamilton Anxiety Scale (HAM-A) score. Secondary outcomes were scores on the Unified Parkinson Disease Rating Scale (UPDRS), 39-item Parkinson Disease Questionnaire (PDQ-39), and serum levels of the adrenocorticotropic hormone (ACTH) and cortisol (CORT). Seventy eligible patients were enrolled, including 34 women (48.5%) and 36 men (51.4%). Sixty-four patients (91%) completed the intervention and the 8-week follow-up, including 30 women (46.9%) and 34 men (53.1%) with a mean (SD) age of 61.84 (8.47) years. At the end of treatment, the variation of HAM-A score was 0.22 (95% CI, -0.63 to 1.07; P = .62) between the real acupuncture and sham acupuncture groups. At the end of follow-up, the real acupuncture group had a significant 7.03-point greater (95% CI, 6.18 to 7.88; P < .001) reduction in HAM-A score compared with the sham acupuncture group. Four mild adverse reactions occurred during the study. This study found acupuncture to be an effective treatment for anxiety in patients with PD. These findings suggest that acupuncture may enhance the wellbeing of patients who have Parkinson disease and anxiety. Chinese Clinical Trial Registry: ChiCTR2100047253.

Effect of acupuncture in patients with chronic non-specific low back pain: a blind randomized clinical trial

The study aimed to evaluate the effect of acupuncture in the treatment of chronic non-specific low back pain (NSLBP). MethodsIt is a randomized, double-blind, placebo-controlled clinical trial. It was developed at the outpatient clinic of the physiotherapy department at the Federal University of Sergipe. 36 individuals were selected and allocated into 2 groups, but finalized 18 subjects in the Real Acupuncture group (RA) and 17 in the Placebo Acupuncture group (PA), due to an individual not completing the treatment with acupuncture or Placebo Acupuncture, being evaluated the intensity and characterization of pain. Subjects were treated three times a week, on alternate days, totaling 10 sessions. ResultsAfter each of session, pain intensity was significantly lower at rest (p<0.028) and movement (p<0.035) in the RA group. In the PA group, pain intensity at rest (p=0.008) and movement (p=0.038) were significantly lower after 10 sessions. There was a significant reduction in the number of words selected (NWC; Br-MPQ) in the RA group when comparing sessions 1 and 10 (p=0.004). And there was a significant decrease in NWC between 1st and 10th session in the PA group (p=0.017). Regarding the pain classification index (PCI), there was a significant reduction (p=0.001) when comparing the 1st and 10th session in the RA group. When comparing RA and PA groups, the only significant difference was that CST of the right lower back was significantly lower in the AP group after the 1st and 10th sessions (p=0.028). ConclusionIt was concluded that acupuncture on NSLBP patients in the RA group decreased intensity of pain after each session, the NWC and the PCI in the measurement of pain. However, there was no evidence of improvement in sensory tests, psychoemotional aspects and quality of life.

Effect of Acupuncture on Time-Dependent of Muscle Endurance in Female Elbow Joint: A Randomized Controlled Trial.

Immediate characteristics of acupuncture have been confirmed by relevant studies; however, the current study on the time effect of acupuncture in improving upper limb forearm muscle endurance is still limited. The aims of this study are to explore: (1) whether real acupuncture (RA) can improve female forearm muscle endurance compared to sham acupuncture (SA) and (2) whether the changes in forearm muscle endurance after RA are time-dependent. Thirty-six healthy female students were recruited to participate in isokinetic tests of elbow flexion/extension (Flex/Ext) from maximum flexion to maximum extension as much as possible using an isokinetic dynamometer at a speed rate of 60°/sec. Participants in the RA group were stimulated at Quchi (LI11), Shousanli (LI10), Hegu (LI4), Xiaohai (SI8), Tianjing (SJ10), and Waiguan (SJ5) acupoints for 20 min, while the SA group needling was near at these acupoints. The values of the isokinetic parameters and surface electromyography (sEMG) signals were recorded before and after acupuncture. After RA, the isokinetic parameters values (average torque, work, power, and speed), the sEMG values at four major muscles, and the joint stiffness of elbow Flex/Ext were significantly increased (p < 0.05). The enhancement of forearm muscle endurance lasted approximately 7–21 min (from post1 to post3/post4), indicating that the effect of RA to improve elbow Flex/Ext muscle endurance is time-dependent. Therefore, this study found that RA can immediately improve the forearm muscle endurance of healthy women compared with SA, and this effect can last approximately 7–21 min until the acupuncture efficacy decreased or disappeared.

Changes in brain connectivity linked to multisensory processing of pain modulation in migraine with acupuncture treatment

Migraine without aura (MWoA) is a major neurological disorder with unsatisfactory adherence to current medications. Acupuncture has emerged as a promising method for treating MWoA. However, the brain mechanism underlying acupuncture is yet unclear. The present study aimed to examine the effects of acupuncture in regulating brain connectivity of the key regions in pain modulation. In this study, MWoA patients were recruited and randomly assigned to 4 weeks of real or sham acupuncture. Resting-state functional magnetic resonance imaging (fMRI) data were collected before and after the treatment. A modern neuroimaging literature meta-analysis of 515 fMRI studies was conducted to identify pain modulation-related key regions as regions of interest (ROIs). Seed-to-voxel resting state-functional connectivity (rsFC) method and repeated-measures two-way analysis of variance were conducted to determine the interaction effects between the two groups and time (baseline and post-treatment). The changes in rsFC were evaluated between baseline and post-treatment in real and sham acupuncture groups, respectively. Clinical data at baseline and post-treatment were also recorded in order to determine between-group differences in clinical outcomes as well as correlations between rsFC changes and clinical effects. 40 subjects were involved in the final analysis. The current study demonstrated significant improvement in real acupuncture vs sham acupuncture on headache severity (monthly migraine days), headache impact (6-item Headache Impact Test), and health-related quality of life (Migraine-Specific Quality of Life Questionnaire). Five pain modulation-related key regions, including the right amygdala (AMYG), left insula (INS), left medial orbital superior frontal gyrus (PFCventmed), left middle occipital gyrus (MOG), and right middle cingulate cortex (MCC), were selected based on the meta-analysis on brain imaging studies. This study found that 1) after acupuncture treatment, migraine patients of the real acupuncture group showed significantly enhanced connectivity in the right AMYG/MCC-left MTG and the right MCC-right superior temporal gyrus (STG) compared to that of the sham acupuncture group; 2) negative correlations were established between clinical effects and increased rsFC in the right AMYG/MCC-left MTG; 3) baseline right AMYG-left MTG rsFC predicts monthly migraine days reduction after treatment. The current results suggested that acupuncture may concurrently regulate the rsFC of two pain modulation regions in the AMYG and MCC. MTG and STG may be the key nodes linked to multisensory processing of pain modulation in migraine with acupuncture treatment. These findings highlighted the potential of acupuncture for migraine management and the mechanisms underlying the modulation effects.

Occupational therapy with or without combined acupuncture on upper limb pain and hand functions in children with spastic hemiplegic cerebral palsy: A three-arm randomized, placebo-controlled trial: 作业疗法合并或不合并针刺对痉挛型偏瘫脑瘫患儿上肢疼痛及手功能的干预研究:一个三臂随机安慰剂对照临床试验

ObjectiveThis study is conducted to investigate the effects of occupational therapy (OT) with or without combined acupuncture for upper limb pain and hand functions among children with spastic hemiplegic cerebral palsy. MethodsA total of 90 patients who met the inclusion criteria were enrolled in a three-arm randomized, placebo-controlled trial, and were allocated to mono-occupational therapy (OT) group (patients= 30), OT combined with real-acupuncture (ORA) group (patients= 30), and OT combined with placebo-acupuncture (OPA) group (patients= 30), respectively. In addition to receiving the conventional OT program as the basic treatment for total 8 weeks, patients in ORA and OPA group also received corresponding acupuncture treatment 5 days per week for the first two weeks, 3 days per week for the next two weeks, 2 days per week for another two weeks, and 1 day per week for the last two weeks. Non-communicating children's pain checklist-revised scale (NCCPC-R) was used for assessing the upper limb pain among patients. Squeeze dynamometry, modified Ashworth scale (MAS), manual muscle testing (MMT), Jebsen-Taylor hand function test (JTHFT) and box and block test (BBT) were used for assessing various aspects of upper limb and hand functions among patients. Meanwhile, adverse effects were monitored and recorded. ResultsAfter 8-week treatment, NCCPC-R global scores witnessed a dramatic decline in ORA group (P < 0.05), but not in either OPA (P > 0.05) or OT group (P > 0.05). Dramatic increases were identified in both squeeze dynamometry scores and MMT scores in all three groups (all P < 0.05). Furthermore, the increases of ORA group were more significant than those of another two groups (both P < 0.05). There were no significant changes in MAS global scores in each group (all P > 0.05). The BBT global scores of all three groups significantly increased (all P < 0.05) after treatment. Among them, the increase of the ORA group was more than that of the other two groups (P < 0.05). The 8-week treatment also had a significant impact on several sub-tests of JTFHT in each group. No significant adverse event was reported. ConclusionORA is a potential and promising alternative therapy for mitigating upper limb pain as well as improving both upper limb and hand functions among children with spastic hemiplegic cerebral palsy.

Effect of Acupuncture on Cytokine Levels in Persons with Multiple Sclerosis: A Randomized Controlled Trial.

Background: Cytokines have been found to play a role in the disease activity of multiple sclerosis (MS). Previous studies indicate that acupuncture can affect cytokine levels in persons with other inflammatory diseases. Objectives: The aim of this study is to investigate the effect of acupuncture on cytokine levels and health-related quality of life (HRQoL) in persons with MS. Materials and Methods: A single-blind, randomized controlled trial was performed. Participants (n = 66) were randomized into three groups (real acupuncture, sham acupuncture, and reference). Participants in the real acupuncture and sham groups received six treatments during a period of 4 weeks. The serum levels of 11 pro- and anti-inflammatory cytokines (IFNγ, IL-1β, IL-6, IL-8, IL-12p70, IL-13, TNFα, IL-10, IL-4, IL-2, and IL-17A) were assessed at baseline, after 2 and 4 weeks of treatment, and 4 weeks after the final treatment. Changes in HRQoL were assessed using the Functional Assessment of Multiple Sclerosis questionnaire. Results: No statistically significant differences in plasma levels between the three groups were seen for either of the cytokines, nor were there any differences between the groups for HRQoL. Conclusions: In this study, the authors could not demonstrate that a 4-week acupuncture treatment had a measurable effect on the plasma levels of seven selected cytokines or on HRQoL among people with MS. The trial was registered with the ISRCTN registry as ISRCTN34352011.

The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial

BackgroundMany patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID and GI disorder and is receiving increasing attention. Recent studies indicate that both CID and GI diseases may cause abnormal brain activity. However, the neurological mechanism underlying the effect of acupuncture on such diseases is still unclear. The aim of this study is to explore the pathological mechanisms of CID with GI discomfort, as well as the main response characteristics of acupuncture treatment from multiple perspectives using multimodal magnetic resonance imaging (MRI).MethodsA total of 60 participants with CID and GI disorders will be randomly divided into two groups (real acupuncture group and sham acupuncture group; ratio of 1:1). Patients will receive 20 sessions (five sessions per week) of real acupuncture treatment or sham acupuncture treatment. The primary outcome is the aggregate score on the Pittsburgh Sleep Quality Index. Secondary outcomes are scores on the Gastrointestinal Symptom Rating Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale. Multimodal MRI scans and clinical assessments will be performed both at baseline and post-treatment. Another 30 age-, sex-, and education-matched healthy subjects will be recruited as controls and will receive MRI scans and clinical evaluations.DiscussionThis study aims to provide scientific evidence for the mechanism of acupuncture in treating CID with GI disorder using multimodal MRI imaging data on brain structure, function, and metabolism.Trial registrationChinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173). Registered on July 11, 2018.

Immediate Analgesic Effect of Acupuncture in Patients With Primary Dysmenorrhea: A fMRI Study.

Primary dysmenorrhea (PDM) is a common gynecological disease characterized by lower abdominal pain. Acupuncture is considered a good alternative therapy for PDM. However, the central mechanism of the analgesic effect of acupuncture is largely unknown. In this study, eligible patients were randomized into the real and sham acupuncture groups using a computer-generated, permuted block randomization method. The study cohort comprised 34 patients: 19 in the real acupuncture group and 15 in the sham acupuncture group. The clinical characteristics of the patients during their menstrual period were collected, and imaging scans were performed during the first 3 days of the patients’ menstrual period. We analyzed task and resting functional magnetic resonance imaging (fMRI) data to investigate the potential central mechanism of the immediate effect of acupuncture intervention on the intensity of PDM pain. The task fMRI study found that the rostral anterior cingulate cortex (rACC) and right supplemental motor area were activated during real acupuncture. Using the resting-state functional connectivity (FC) method, we found a post- versus pre-treatment change in the FC of the rACC and left precentral gyrus in the comparison of real acupuncture versus sham acupuncture. In addition, the FC of the rACC–left precentral gyrus at baseline was negatively correlated with short-term analgesia, while the change in the FC of the rACC–left precentral gyrus was positively correlated with short-term analgesia after acupuncture treatment. These findings support the importance of rACC–left precentral gyrus resting-state FC in the modulation of the intensity of PDM pain through acupuncture, which may shed light on the central mechanism of acupuncture in the treatment of PDM.

Acupuncture for comorbid mild-moderate depression and chronic musculoskeletal pain: study protocol for a randomized controlled trial

BackgroundDepression and chronic musculoskeletal pain (CMSP) are the leading causes of years lived with disabling diseases worldwide. Moreover, they often commonly coexist, which makes diagnosis and treatment difficult. A safe and effective treatment is urgently needed. Previous studies have shown that acupuncture is a cost-effective treatment for simple depression or CMSP. However, there is limited evidence that acupuncture is effective for depression comorbid with CMSP.MethodsThis is a randomized, sham acupuncture-controlled trial with three arms: real acupuncture (RA), sham acupuncture (SA), and healthy control (HC). Forty-eight depression combined CMSP participants and 12 healthy people will be recruited from GDTCM hospital and randomized 2:2:1 to the RA, SA, and HC groups. The patients will receive RA or SA intervention for 8 weeks, and HC will not receive any intervention. Upon completion of the intervention, there will be a 4-week follow-up. The primary outcome measures will be the severity of depression and pain, which will be assessed by the Hamilton Depression Rating Scale (HAMD-17) and Brief Pain Inventory (BPI), respectively. The secondary outcome measures will be cognitive function and quality of life, which will be measured by the Montreal Cognitive Assessment (MoCA), P300, and World Health Organization Quality of Life (WHOQOL-BREF). In addition, the correlation between brain-derived neurotrophic factor (BDNF) and symptoms will also be determined.DiscussionThe aim of this study is to evaluate the clinical efficacy and underlying mechanism of acupuncture in depression comorbid with CMSP. This study could provide evidence for a convenient and cost-effective means of future prevention and treatment of combined depression and CMSP.Trial registrationChinese Clinical Trial Registry ChiCTR1800014754. Preregistered on 2 February 2018. The study is currently recruiting.

Electroacupuncture versus Sham Acupuncture for Perimenopausal Insomnia: A Randomized Controlled Clinical Trial.

ObjectiveTo evaluate the short- and long-term effects of acupuncture on perimenopausal insomnia (PMI) and quality of life.Patients and MethodsWe designed a semi-standardized, patient-blinded, randomized placebo-controlled trial. A total of 84 patients were recruited, all of whom met the criteria for diagnosis of PMI. Either acupuncture therapy or a noninvasive placebo acupuncture therapy designed to treat insomnia was implemented 18 times over the course of 8 weeks (3 times per week for 4 weeks, twice per week for 2 weeks, once per week for 2 weeks). The primary outcome was the change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to the end of treatment, week 8. Secondary outcomes included climacteric symptoms and quality of life measured by the Menopause Quality of Life (Men-QoL), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), sleep parameters recorded in the actigraphy and adverse events. The PSQI and Men-QoL were assessed at weeks 0, 4, 8, 12 and 20. Other assessments were performed at week 0 and week 8.ResultsThe participants were randomly assigned to either acupuncture (n=42) or sham acupuncture (n=42) groups. The mean difference from baseline of PSQI score at the end of treatment between real acupuncture and sham acupuncture group was −2.38 (95% CI, −3.46 to −1.30; P<0.001). The acupuncture group was associated with significantly lower scores than the sham acupuncture group at week 12 and during the 20-week follow-up visits (all P <0.001). Acupuncture was also associated with significantly higher quality of life in vasomotor and other physical dimensions (all P <0.001). At the end of treatment, researchers found a significantly higher total sleep time (TST), sleep efficiency (SE) and lower number of average awakenings (AA) (P =0.007 0.023 and 0.011, respectively) in the acupuncture group than in the sham acupuncture group. No severe adverse events were reported.ConclusionThe findings suggest that acupuncture may be a safe and effective treatment for PMI and improving quality of sleep in patients with menopause and could have a long-lasting effect.Trial RegistrationChinese Clinical Trial Registry (ChiCTR); Trial ID: ChiCTR1800018645. URL: http://www.chictr.org.cn/showproj.aspx?proj=31482.

Acupuncture for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial

BackgroundInsomnia is among the most prevalent of the sleep-related disorders. Insomnia disorder is associated with a brain hyperarousal state manifested by abnormal regional brain activity and resting state functional connectivity. Acupuncture improves sleep quality and modulates the hyperarousal state; however, the underlying neurobiological basis for improved sleep quality is poorly understood. The purpose of this clinical trial is to study the efficacy of acupuncture in the treatment of insomnia disorder. In addition, the neural mechanism by which acupuncture affects insomnia disorder will be explored using resting-state functional magnetic resonance imaging (rs-fMRI) and neuropsychological parameters.Methods and designA randomized, patient- and assessor-blinded trial will be conducted. We will randomize (in a 1:1 ratio) 60 eligible patients with insomnia disorder into a real acupuncture group or a sham acupuncture group. Interventions will be administered three times per week over a 4-week period, with an 8-week follow-up period. The healthy control group will consist of 30 age- and sex-matched healthy individuals who sleep well without any treatment intervention.All participants will undergo neuropsychological and rs-fMRI evaluations. The change in Pittsburgh Sleep Quality Index (PSQI) scores is the primary outcome parameter. The secondary outcome parameters include the Hyperarousal scale (HAS), rs-fMRI measurements, the Fatigue scale-14 (FS-14), the Hamilton depression scale (HAMD), the Hamilton anxiety scale (HAMA), a sleep diary, and an actigraph.Assessment of all parameters will be performed at baseline, post-treatment, and during follow-up. Analyses will be implemented based on intention-to-treat.DiscussionThe study results will be used to clarify the effectiveness and elucidate the mechanism by which acupuncture improves sleep quality in patients with insomnia disorder.Trial registrationChinese Clinical Trials Register, ChiCTR1800015282. Registered on 20 March 2018.