Acupuncture for Vascular Dementia: A Pragmatic Randomized Clinical Trial.

In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group) or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group). Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily living, and quality of life were assessed by mini-mental state examination (MMSE), Activities of Daily Living Scale (ADL), and dementia quality of life questionnaire (DEMQOL), respectively. All the data were collected at baseline, after 6-week treatment, and after 4-week follow-up. No significant differences of MMSE scores were observed among the three groups but pooled-acupuncture group had significant higher score than control group. Compared to control group, ADL score significantly decreased in NR-acupuncture group and pooled-acupuncture group. For DEMQOL scores, no significant differences were observed among the three groups, as well as between pooled-acupuncture group and control group. Additional acupuncture to routine care may have beneficial effects on the improvements of cognitive status and activities of daily living but have limited efficacy on health-related quality of life in VaD patients.

A randomized controlled trial of single point acupuncture in primary dysmenorrhea.

BACKGROUND: Acupuncture is often used for primary dysmenorrhea. But there is no convincing evidence due to low methodological quality. We aim to assess immediate effect of acupuncture at specific acupoint compared with unrelated acupoint and nonacupoint on primary dysmenorrhea. METHODS: The Acupuncture Analgesia Effect in Primary Dysmenorrhoea-II is a multicenter controlled trial conducted in six large hospitals of China. Patients who met inclusion criteria were randomly assigned to classic acupoint (N = 167), unrelated acupoint (N = 167), or non-acupoint (N = 167) group on a 1:1:1 basis. They received three sessions with electro-acupuncture at a classic acupoint (Sanyinjiao, SP6), or an unrelated acupoint (Xuanzhong, GB39), or nonacupoint location, respectively. The primary outcome was subjective pain as measured by a 100-mm visual analog scale (VAS). Measurements were obtained at 0, 5, 10, 30, and 60 minutes following the first intervention. In addition, patients scored changes of general complaints using Cox retrospective symptom scales (RSS-Cox) and 7-point verbal rating scale (VRS) during three menstrual cycles. Secondary outcomes included VAS score for average pain, pain total time, additional in-bed time, and proportion of participants using analgesics during three menstrual cycles. FINDINGS: Five hundred and one people underwent random assignment. The primary comparison of VAS scores following the first intervention demonstrated that classic acupoint group was more effective both than unrelated acupoint (-4.0 mm, 95% CI -7.1 to -0.9, P = 0.010) and nonacupoint (-4.0 mm, 95% CI -7.0 to -0.9, P = 0.012) groups. However, no significant differences were detected among the three acupuncture groups for RSS-Cox or VRS outcomes. The per-protocol analysis showed similar pattern. No serious adverse events were noted. CONCLUSION: Specific acupoint acupuncture produced a statistically, but not clinically, significant effect compared with unrelated acupoint and nonacupoint acupuncture in primary dysmenorrhea patients. Future studies should focus on effects of multiple points acupuncture on primary dysmenorrhea.

Effect of acupuncture on Deqi traits and pain intensity in primary dysmenorrhea: analysis of data from a larger randomized controlled trial.

BACKGROUND: Deqi is a central concept in traditional Chinese acupuncture. We performed a secondary analysis on data from a larger randomized controlled trial (RCT) in order to assess the effect of acupuncture on deqi traits and pain intensity in primary dysmenorrhea. METHODS: A total of 60 primary dysmenorrhea patients were enrolled and randomly assigned to one of three treatment groups. Acupuncture was given at SP6, GB39 or nonacupoint. Subjective pain was measured by a 100-mm visual analogue scale (VAS) before and after acupuncture. The Massachusetts General Hospital acupuncture sensation scales (MASS) with minor modification was used to rate deqi sensations during acupuncture. RESULTS: The results showed that VAS scores of pain after acupuncture were significantly decreased comparing to before acupuncture treatment in all three groups (P = 0.000). However, no significant differences were found among three groups at the beginning or end of acupuncture treatment (P = 0.928, P = 0.419). CONCLUSIONS: There was no statistical difference among three groups in terms of intensity of deqi feeling. The types of sensation were similar across the groups with only minor differences among them. TRIAL REGISTRATION NUMBER: Controlled-Trials.com ISRCTN24863192.

Muscle hypertonia after permanent focal cerebral ischemia in rats: a qualitative and quantitative behavioral and electrophysiological study.

OBJECTIVES: To examine the level of peripheral muscle resistance after cerebral ischemia. METHODS: A total of 326 healthy male Sprague-Dawley rats were used in the present experiments. We used a modified method to establish peripheral muscle resistance in rat model of stroke, and qualified the recovery of motor functional deficits by behavioral measures and quantified the level of peripheral muscle resistance by electrophysiological test. RESULTS: Neurological score started to go up from day 0, achieved its peak on day 3 (1.49 ± 0.56) and kept at a high level within 10 days after surgery. Compared with 1 day before surgery, both the turn score in corner test and asymmetry score in cylinder test were increased significantly on day 3, day 6 and day 9 after surgery (p < 0.01). On day 6 and day 9 after surgery, the Hmax:Mmax ratio of hemiplegic side of middle cerebral artery occlusion (MCAO) rats was obviously higher than the same side in healthy rat (p < 0.01) and the ratio on the contralateral side of MCAO rats (p < 0.05). CONCLUSIONS: There is a progressive increase in peripheral muscle resistance on day 6 to day 9 after surgery in a rat model of postischemic stroke.

[Application and thinking of acupuncture therapy in comprehensive management of hypertension].

The theory of disease prevention with traditional Chinese medicine is introduced into the prevention of chronic diseases such as hypertension. In order to fully implement the advantages of acupuncture, the three-level prevention strategy is strengthened on the whole-process intervention with acupuncture for hypertension, including prevention before disease onset, starting intervention at the early phase, and prevention disease from exacerbating. Moreover, the comprehensive management scheme, multidisciplinary coordination and participation mechanism are investigated in the field of traditional Chinese medicine for preventive treatment of hypertension.

Biomarkers of oxidative stress in vascular dementia patients.

OBJECTIVE: Little is known about the role of oxidative stress in the pathogenesis of vascular dementia (VaD). The aim of this study was to investigate the biomarkers of oxidative stress in urine, as reflected by 8-hydroxydeoxyguanosine (8-OHdG), 8-isoprostaglandin F(2a) (8-isoPGF(2a)) and nitrotyrosine (NT) levels, in a group of well characterized VaD patients and in two control groups of Vascular Not Demented (VaND) patients and health y subjects. METHODS: Ninety-six subjects from the Tianjin municipality in China were recruited. Forty-six patients were in the VaD group, 24 patients with VaND and 26 persons with no signs of cognitive disorder were employed as control groups. Urinary 8-OHdG and 8-isoPGF(2a) was performed using enzyme-linked immunosorbent assay (ELISA), and urinary NT levels were measured by chemiluminescence detection. RESULTS: Significantly higher urinary 8-OHdG levels were detected in VaD patients compared to VaND patients and healthy control subjects. In contrast, urinary 8-isoPGF(2a) levels were significantly lower in VaD patients compared with two control groups. For NT levels, no statistically significant differences were observed among the three groups. CONCLUSION: Increased urinary 8-OHdG level was a potential marker of oxidative stress in VaD patients. Furthermore, it is also important to take into account potential confounders in order to improve the identification of changes in the status of oxidative stress as related to VaD.

Efficacy of acupuncture for acute migraine attack: a multicenter single blinded, randomized controlled trial.

OBJECTIVE: We aim to investigate the efficacy of acupuncture for acute migraine attacks comparing with sham acupuncture. DESIGN: The study was designed as a multicenter, single-blinded, randomized controlled clinical trial. SETTING AND PATIENTS: From March 2007 to February 2009, 150 patients were randomly allocated to verum or sham acupuncture group in a ratio of 1:1. INTERVENTIONS: Every patient received a verum or sham acupuncture treatment when having a migraine attack and, medications were allowed if the pain failed to be relieved two hours after the acupuncture. OUTCOME MEASURES: The primary outcome was visual analog scale (VAS) scores for pain, ranging from 0 (no pain) to 10 (worst pain ever). RESULTS: The mean VAS scores 24 hours after treatment decreased from 5.7 ± 1.4 to 3.3 ± 2.5 in the verum acupuncture group, and from 5.4 ± 1.3 to 4.7 ± 2.4 in the sham acupuncture group. Significant differences existed between the two groups (P = 0.001). CONCLUSIONS: This trial suggested that verum acupuncture group was superior to sham acupuncture group on relieving pain and reducing the usage of acute medication.

Sino-European Transcontinental Basic and Clinical High-Tech Acupuncture Studies-Part 4: "Fire of Life" Analysis of Heart Rate Variability during Acupuncture in Clinical Studies.

This fourth part of a series of Sino-European high-tech acupuncture studies describes the first clinical transcontinental teleacupuncture measurements in two patients (cervical spine syndrome and tachycardia; both 27 years old) from the Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, China. The electrocardiographic data were transferred to the Stronach Research Unit for Complementary and Integrative Laser Medicine and the TCM Research Center in Graz via conventional internet connections. Data analysis was performed in Graz using a new "Fire of Life" heart rate variability analysis. Analysis was performed without any technical problems in both subjects. Heart rate decreased significantly during acupuncture in the two patients from Beijing. At the same time, total HRV increased during acupuncture. The different influences of HRV (respiratory sinus arrhythmia, blood pressure waves, etc.) could be clearly documented using the new "Fire of Life" analysis.

Influence of acupuncture on cognitive function and markers of oxidative DNA damage in patients with vascular dementia.

OBJECTIVE: To test the influence of acupuncture on cognitive function and a marker of oxidative DNA damage in patients with vascular dementia (VD). METHODS: Sixteen VD patients were evaluated before and after acupuncture, using the Folstein mini-mental state examination-revised (MMSE-R) to assess cognitive function, and the ADL-R scale to assess independence in activities of daily living (ADL). Life quality was evaluated using the DEMQOL (Dementia quality of life questionnaire) questionnaire, and syndromes and expression of vascular dementia were evaluated with the Scale for the differentiation of syndromes of vascular dementia (SDSVD). In addition, the urine concentration of 8-hydroxy-2'-deoxyguanosine (8-OHdG)--a marker of oxidative damage--was quantified with enzyme-linked immunosorbent assay. RESULTS: The MMSE-R and DEMQOL scores were higher after acupuncture than before (P < 0.05), while there were no obvious differences in the ADL-R or SDSVD scores (P > 0.05). The 8-OHdG content in urine significantly decreased after acupuncture (P < 0.05). CONCLUSION: Acupuncture reduces the levels of 8-OHdG and improves cognitive function and quality of life in VD patients, suggesting that acupuncture is beneficial at least in part by preventing oxidative damage.

[Effects of electroacupuncture on ethology, microglia activation and P2X7 receptor expression in periaqueductal gray in rats with migraine].

OBJECTIVE: To observe the effects of electroacupuncture(EA) at "Fengchi"(GB20) on the ethology, microglia activation and P2X7 receptor(P2X7R) expression in the periaqueductal gray(PAG) in recurrent migraine rat model, so as to explore the underlying mechanism of EA reducing central sensitization of migraine. METHODS: Thirty-six male SD rats were randomly divided into control, model and EA groups, with 12 rats in each group. Recurrent migraine model was induced using repea-ted dural electrical stimulation once another day(the 1st, 3rd, 5th, 7th and 9th days), for a total of 5 times; rats in the EA group received EA treatment(2 Hz/15 Hz, 0.8-1 mA) at GB20 after dural electrical stimulation, for 10 min every time, once a day for 9 days; rats in the control group only received electrode placement. The facial and hindpaw mechanical withdrawal threshold was detected by using an electronic von-Frey on the 0th(baseline), 2nd, 4th, 6th, and 8th days. Microglia activation in the PAG was evaluated by using immunofluorescence staining to detect the number of ionized calcium binding adaptor molecule-1(Iba-1)-labeled microglia. Expression levels of microglia marker Iba-1, inflammatory factor interleukin(IL)-1ß and P2X7R were detected by Western blot. RESULTS: Compared with the control group, the facial and hindpaw mechanical withdrawal threshold of rats were significantly reduced on the 2nd, 4th, 6th, and 8th days(P<0.01，P<0.001); the microglia in the PAG area were significantly activated, with the number of Iba-1-positive microglia, and the expression levels of Iba-1, IL-1ß and P2X7R proteins significant increased(P<0.001, P<0.05) in the model group. Compared with the model group, the facial and hindpaw mechanical withdrawal threshold of rats were significantly increased on the 4th, 6th, and 8th days(P<0.05，P<0.001，P<0.01), and the above indicators were significantly reversed (P<0.05) in the EA group. CONCLUSION: EA at GB20 can significantly improve facial and hindpaw mechanical withdrawal threshold of migraine rats, and its possible mechanism may be related to inhibiting microglia activation mediated by P2X7R in the PAG.

[Acupuncture as adjuvant therapy for 32 cases of coronavirus disease 2019].

OBJECTIVE: To observe the clinical effect of acupuncture on coronavirus disease 2019 (COVID-19) based on the conventional treatment. METHODS: A total of 35 patients with COVID-19 of mild or ordinary type were involved (3 cases dropped off). Acupuncture was applied on the basis of western medicine and Chinese materia medica treatment. Dazhui (GV 14), Fengchi (GB 20), Kongzui (LU 6), Hegu (LI 4), etc. were selected as the main acupoints, the supplementary acupoints and the reinforcing and reducing manipulations were selected according to syndrome differentiation. Acupuncture treatment was given once a day, 5 times a week. On day 3 and day 7 of acupuncture, relief condition of the main symptoms was observed. Before acupuncture and on day 3 and day 7 of acupuncture, efficacy evaluation scale of TCM on COVID-19 (efficacy evaluation scale) score was recorded. The effects of different intervention time of acupuncture on patients' hospitalization time were compared, the understanding of acupuncture treatment of patients discharged from hospital was recorded, the clinical efficacy and safety of acupuncture treatment were evaluated. RESULTS: On day 3 and day 7 of acupuncture, the symptoms of lung system and non lung system were both relieved; the scores of efficacy evaluation scale were both decreased compared before acupuncture (P<0.05), and the efficacy evaluation scale score of day 7 of acupuncture were lower than day 3 of acupuncture (P<0.05). The average hospitalization time of patients received early acupuncture was shorter than late acupuncture (P<0.05). The total effective rate was 84.4% (27/32) on day 7 of acupuncture, which was higher than 34.4% (11/32) on day 3 of acupuncture (P<0.05). During the acupuncture treatment, there were neither adverse reactions in patients nor occupational exposures in doctors. The patients generally believed that acupuncture could promote the recovery of COVID-19 and recommended acupuncture treatment. CONCLUSION: On the basis of the conventional treatment, acupuncture can effectively relieve the clinical symptoms in patients with COVID-19, early intervention of acupuncture can accelerate the recovery process. Acupuncture has good safety, clinical compliance and recognition of patients.

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.

Acupuncture for menstruation-related migraine prophylaxis: A multicenter randomized controlled trial.

Objective: The aim of this study was to evaluate the efficacy of acupuncture, an alternative medicine therapy, as a preventive treatment for menstruation-related migraine (MRM). Patients and methods: This was a prospective, multicenter, double-dummy, participant-blinded, randomized controlled clinical trial conducted in China between 1 April 2013, and 30 April 2014. The participants were enrolled from four study centers and randomized to into either the acupuncture group, which received 24 sessions of acupuncture at traditional acupoints plus placebo, or the medication group, which received sham acupuncture plus naproxen. The primary endpoint was change from the baseline average number of migraine days per perimenstrual period over cycles 1-3. The secondary endpoints included changes from the baseline average number of migraine days outside the perimenstrual period, mean number of migraine hours during and outside the perimenstrual period, mean visual analog scale score during and outside the perimenstrual period, ≥50% migraine responder rate, and the proportion of participants who used acute pain medication over cycles 1-3 and 4-6. Results: A total of 172 women with MRM were enrolled; 170 in the intention-to-treat analyses. Our primary outcome reported a significant between-group difference that favored the acupuncture group (95% CI, 0.17-0.50; P < 0.001), with the average reduction of migraine days per perimenstrual period from the baseline was 0.94 (95% CI, 0.82-1.07) in the acupuncture group and 0.61 (95% CI, 0.50-0.71) in the medication group over cycles 1-3. Conclusion: This study showed that compared to medication, acupuncture reduces the number of migraine days experienced by patients with MRM. For patients who received the acupuncture treatment over three cycles, the preventive effect of the therapy was sustained for six cycles. Clinical trial registration: [https://www.isrctn.com/ISRCTN57133712], identifier [ISRCTN15663606].

Immediate analgesia effect of single point acupuncture in primary dysmenorrhea: a randomized controlled trial.

BACKGROUND: Acupuncture is often used for primary dysmenorrhea. OBJECTIVE: To assess the efficacy of a single point of acupuncture in the management of primary dysmenorrhea compared with sham acupuncture and no acupuncture. METHODOLOGY: Patients with primary dysmenorrhea were randomly assigned to acupoint group (n=50), unrelated acupoint group (n=50), nonacupoint group (n=46), or no acupuncture group (n=48). Acupuncture and sham acupuncture were administered once-daily for 3 days with electro-acupuncture at Sanyinjiao (SP6) that was specifically designed to treat primary dysmenorrhea, or an unrelated acupoint (Xuanzhong, GB39), or nonacupoint location. The primary outcome was pain intensity as measured by a 100-mm visual analog scale (VAS) at baseline; 5, 10, 30, and 60 minutes following the start of the first intervention. Cox retrospective symptom scale (RSS), verbal rating scale (VRS), pain total time, and proportion of participants using analgesics were also recorded during three menstrual cycles. RESULTS: The primary comparison of VAS scores demonstrated that patients receiving acupuncture (-15.56 mm, 95% CI -22.16 to -8.95, P<0.001), unrelated acupoint (-18.14 mm, 95% CI -24.81 to -11.47, P<0.001), and nonacupoint (-10.96 mm, 95% CI -17.62 to -4.30, P=0.001) treatment presented significant improvements compared with no acupuncture group. There were no significant differences among the four groups with respect to secondary outcomes. CONCLUSION: Acupuncture was better than no acupuncture for relieving the pain of dysmenorrhea following a single point of acupuncture, but no differences were detected between acupoint acupuncture and unrelated acupoint acupuncture, acupoint acupuncture and nonacupoint acupuncture.

[Application of pragmatic randomized controlled trial's design in clinical research of acupuncture].

Currently, the randomized controlled trial (RCT) becomes the generally accepted golden standard for clinical trials. It can be classified into two types based on different design, that is, the explanatory randomized controlled trial (ERCT) and the pragmatic randomized controlled trial (PRCT). In designing a clinical trial, researcher may select either of them according to the goal of research. The design feature of PRCT and its application in designing clinical trials of acupuncture were introduced in this paper. Further attention should be paid on resolvent of how to apply PRCT in combining with other design methods organically to work out clinical trial scheme with high quality and consistent with the characteristics of acupuncture as possible, for evaluating the effect of acupuncture more accurately and objectively, so as to promote the international application and development of acupuncture therapy.

Prevention of chemotherapy-induced nausea and vomiting with acupuncture: A protocol for systematic review and meta-analysis.

BACKGROUND: Nausea and vomiting are the most common complications following chemotherapy and usually lead to decreased quality of life. Acupuncture therapy is an effective method for chemotherapy-induced nausea and vomiting (CINV), the effects and safety have been observed by many clinicians and demonstrated in a systematic review, which was included in the Cochrane Library in 2014. After several years, new studies have occurred and an updated systematic evaluation is needed. This protocol describes a method for performing a systematic review and meta-analysis to further evaluate the beneficial effects and safety of acupuncture for CINV. METHODS: A searching strategy will be carried out mainly in eight databases in English and Chinese, Cochrane Central Register of Controlled Trials, PubMed, Embase, China National Knowledge Infrastructure, the Chinese Scientific Journal Database, the Wanfang database, China Doctoral Dissertations Full-text Database, and China Master's Theses Full-text Database. Only randomized controlled trials related to acupuncture for CINV will be included to enhance the effectiveness. The effective percentage will be used as primary outcome. Changes in the symptoms of nausea and vomiting, like severity, duration, and frequency as well as quality of life will be assessed as secondary outcome. Side effects and adverse events will be used as safety evaluations. To ensure the quality of the systematic evaluation, study selection, data extraction, and quality assessment will be independently performed by 2 authors, and the third author will deal with any disagreement. The Review Manager V.5.3.3 s will be used to perform the data synthesis and subgroup analysis. RESULTS: There are additional studies, further explanations and more subgroup analyses compared with the previous systematic analysis to determine the effects and safety of acupuncture for CINV. CONCLUSION: The result of this systematic review may offer clinicians stronger evidence to assist patient in relieving CINV. ETHICS AND DISSEMINATION: There is no need to acquire ethical approval for individuals come from literatures instead of recruiting directly. The findings of this review will be reported in peer-reviewed publications and/or presented at relevant conferences TRIAL REGISTRATION NUMBER:: CRD42016045223.

Effects of moxibustion on symptoms of mild cognitive impairment: protocol of a systematic review and meta-analysis.

INTRODUCTION: Mild cognitive impairment (MCI) is considered the intermediate phase between normal age-related cognitive decline and dementia. Moxibustion has gained increased popularity for the management of MCI in China.This study aimed to evaluate the effects and safety of moxibustion on symptoms of MCI. METHODS AND ANALYSIS: Four English databases and six Chinese databases will be searched from their inception to October 2019: Embase, MEDLINE, Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, China National Knowledge Infrastructure, Chongqing VIP Chinese Science and Technology Periodical Database, Wanfang Database, SinoMed, China Doctoral Dissertations Full-text Database and the China Master's Theses Full-text Database. Only clinical randomised controlled trials and the first period in randomised cross-over trial related to moxibustion for MCI will be included. The primary outcomes include the improvement of cognitive function, as measured by validated assessment tools. The secondary outcomes include changes in the activity of daily living scale, effective rate and the incidences of adverse events. The selection of studies, data extraction and risk of bias assessment will be carried out by two independent reviewers. Review Manager V.5.3 software will be used for statistical analyses. Heterogeneity test, data synthesis and subgroup analysis will be performed if necessary. The risk of bias of included studies will be assessed by the Cochrane Handbook risk of bias tool. Evidence quality will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation system. ETHICS AND DISSEMINATION: Ethics approval is not required as no private information from individuals are collected. The results will be published in a peer-reviewed journal or disseminated in relevant conferences. TRIAL REGISTRATION NUMBER: CRD42018112657.

Baseline Brain Gray Matter Volume as a Predictor of Acupuncture Outcome in Treating Migraine.

Background: The present study aimed to investigate the use of imaging biomarkers to predict the outcome of acupuncture in patients with migraine without aura (MwoA). Methods: Forty-one patients with MwoA received 4 weeks of acupuncture treatment and two brain imaging sessions at the Beijing Traditional Chinese Medicine Hospital affiliated with Capital Medical University. Patients kept a headache diary for 4 weeks before treatment and during acupuncture treatment. Responders were defined as those with at least a 50% reduction in the number of migraine days. The machine learning method was used to distinguish responders from non-responders based on pre-treatment brain gray matter (GM) volume. Longitudinal changes in GM predictive regions were also analyzed. Results: After 4 weeks of acupuncture, 19 patients were classified as responders. Based on 10-fold cross-validation for the selection of GM features, the linear support vector machine produced a classification model with 73% sensitivity, 85% specificity, and 83% accuracy. The area under the receiver operating characteristic curve was 0.7871. This classification model included 10 GM areas that were mainly distributed in the frontal, temporal, parietal, precuneus, and cuneus gyri. The reduction in the number of migraine days was correlated with baseline GM volume in the cuneus, parietal, and frontal gyri in all patients. Moreover, the left cuneus showed a longitudinal increase in GM volume in responders. Conclusion: The results suggest that pre-treatment brain structure could be a novel predictor of the outcome of acupuncture in the treatment of MwoA. Imaging features could be a useful tool for the prediction of acupuncture efficacy, which would enable the development of a personalized medicine strategy.

Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH. METHODS: The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment. DISCUSSION: The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.

Electroacupuncture exerts an anti-migraine effect via modulation of the 5-HT7 receptor in the conscious rat.

BACKGROUND: Acupuncture has been recommended as an alternative therapy for migraine. Emerging evidence suggests that the 5-HT7 receptor (5-HT7R) plays a significant facilitatory role in descending modulation in migraine pathophysiology, and that activation of 5-HT7R in the descending pathway is involved in migraine central sensitisation. OBJECTIVE: To investigate the ability of electroacupuncture (EA) to ameliorate central sensitisation via modulation of 5-HT7R in the descending pain pathways using a rat model of migraine induced by repetitive dural electrical stimulation (DES). DESIGN: 64 male Sprague-Dawley rats were randomly divided into four groups: Normal group; DES group (receiving dural electrical stimulation only); DES+GB20 group (DES model group treated with EA at GB20); and DES+Sham group (DES model group treated with EA at a non-traditional (sham) acupuncture point). The presence of cutaneous allodynia was determined by measuring facial and hind-paw withdrawal latencies to electronic von-Frey. The expression of 5-HT7R in the descending pathways (periaqueductal grey, raphe magnus nucleus, and trigeminal nucleus caudalis) was assessed using immunofluorescence and Western blotting. RESULTS: Facial and hind-paw withdrawal thresholds were significantly increased in the DES+GB20 group compared with the untreated DES group. The expression of 5-HT7R was significantly decreased in the DES+GB20 group compared with the DES group (one-way analysis of variance (ANOVA), P<0.05). No significant differences in behaviour or expression were found between the rats in the DES+Sham group and the untreated DES group (one-way ANOVA, P>0.05). CONCLUSION: EA at GB20 may ameliorate central sensitisation in migraine by inhibiting the activation of 5-HT7 receptors in the descending pain pathway in a rat model of migraine.