Contralateral acupuncture for migraine without aura: a randomized trial protocol with multimodal MRI.

Introduction: Migraine is a common clinical disorder, ranks as the second most disabling disease worldwide, and often manifests with unilateral onset. Contralateral acupuncture (CAT), as a classical acupuncture method, has been proven to be effective in the treatment of migraine without aura (MWoA). However, its neural mechanisms have not been investigated using multimodal magnetic resonance imaging (MRI). Methods and analysis: In this multimodal neuroimaging randomized trial, a total of 96 female MWoA participants and 30 female healthy controls (HCs) will be recruited. The 96 female MWoA participants will be randomized into three groups: Group A (CAT group), Group B [ipsilateral acupuncture (IAT) group], and Group C (sham CAT group) in a 1:1:1 allocation ratio. Each group will receive 30 min of treatment every other day, three times a week, for 8 weeks, followed by an 8-week follow-up period. The primary outcome is the intensity of the migraine attack. Data will be collected at baseline (week 0), at the end of the 8-week treatment period (weeks 1-8), and during the 8-week follow-up (weeks 9-16). Adverse events will be recorded. Multimodal MRI scans will be conducted at baseline and after 8-week treatment. Discussion: This study hypothesized that CAT may treat MWoA by restoring pathological alterations in brain neural activity, particularly by restoring cross-integrated functional connectivity with periaqueductal gray (PAG) as the core pathological brain region. The findings will provide scientific evidence for CAT in the treatment of MWoA. Ethics and dissemination: The Medical Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine has given study approval (approval no. 2022-006). This trial has been registered with the Chinese Clinical Trials Registry (registration no. ChiCTR2300069456). Peer-reviewed papers will be used to publicize the trial's findings. Clinical trial registration: https://clinicaltrials.gov/, identifier ChiCTR2300069456.

Grey matter abnormalities in major depressive disorder patients with suicide attempts: A systematic review of age-specific differences.

Background: Previous studies have reported alterations in brain structure in major depressive disorder (MDD) patients with suicide attempts. However, age-related changes in suicidal MDD patients remain unclear. Methods: We performed a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Embase, PubMed, and Web of Science were searched to identify relevant studies from inception to January 2023. All voxel-based and surface-based morphometry studies comparing suicidal MDD patients to MDD or healthy controls were included. Studies were then grouped by age range (old, middle-age, adolescent) and the commonalities and age-related structural brain alterations were summarized. The included studies were evaluated using the Newcastle-Ottawa Scale (NOS). Results: A total of 17 studies met the inclusion criteria, including 3 of late-life depression (LLD) patients, 11 of middle-aged depression (MAD) patients, and 3 of adolescent depression (AOD) patients. The majority of studies had moderate to high NOS scores, indicating good quality. Patients in all three age groups exhibited extensive alterations in the lateral, medial, and orbital regions of the frontal lobes. Furthermore, suicidal MAD patients showed a specific decrease in the gray matter volume of the dorsolateral prefrontal cortex compared to suicidal LLD patients. Cortical thickness and left angular gyrus volume were decreased in suicidal MAD and suicidal LLD patients, but increased in suicidal AOD patients. Conclusion: This systematic review summarizes structural brain changes in suicidal MDD patients at three age groups: elderly, middle-aged, and adolescent. These findings help elucidate the common circuitry of MDD related to suicide over the lifespan and highlight unique circuitry associated with different ages. These findings may help predict the risk of suicide in MDD patients at different ages.

Immediate analgesic effect of acupuncture intervention within 10 min during acute migraine attacks: protocol of a randomised controlled trial.

INTRODUCTION: Migraine is a widespread neurological disorder characterised by recurrent moderate-to-severe headaches. These headaches can seriously affect patients' daily life and work, especially during acute attacks when patients often need immediate pain relief. This study aims to assess the immediate analgesic effect of acupuncture for 10 min during acute migraine attacks. METHODS AND ANALYSIS: The study will randomly divide 80 participants into either the acupuncture group or the sham acupuncture group with an allocation ratio of 1:1. Each group will receive 10 min of treatment, and the post-treatment evaluation will be performed after 0, 0-2, 4, 6, 8 and 10 min of acupuncture. The primary outcome is the pain Visual Analogue Scale (VAS) score assessed before and after treatment at 10 min. Additionally, secondary outcomes include the pain VAS score assessed at 0-2, 4, 6 and 8 min, blinding assessment and treatment effectiveness expectations scale. Data will be collected at baseline time and the end of treatment (after 10 min). Adverse events during each treatment period will be collected and recorded. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine (2022-008). All participants will provide written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registration Center (ChiCTR2200066976).

The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial.

BACKGROUND: Obesity is an increasing problem worldwide. The effective treatments for obesity mainly include diet, physical activity, behavioral intervention, pharmacotherapy, and bariatric surgery, which all have certain limitations. As a specific type of acupuncture therapy, acupoint catgut embedding (ACE) has gained substantial attention in the management of obesity in recent years. Previous studies suggested that ACE may be an effective obesity treatment. However, the evidence for the efficacy of ACE in abdominal obesity (AO) remains inadequate due to the paucity of high-quality studies. OBJECTIVE: This study aims to investigate the difference in the effectiveness of catgut embedding at acupoints and catgut embedding at nonacupoints in patients with AO and to further validate the efficacy and safety of ACE for AO. METHODS: This is a multicenter, double-blind, 16-week randomized controlled trial. A total of 92 eligible participants with AO will be randomly divided into 2 groups (1:1 allocation ratio). The ACE group will receive catgut embedding at acupoints and the control group will receive catgut embedding at nonacupoints. The intervention will be performed every 2 weeks for a total of 6 sessions. Follow-up will be performed every 2 weeks for a total of 2 visits. The primary outcome is waist circumference. Secondary outcomes include body weight, BMI, hip circumference, and the visual analog scale of appetite. Upon the completion of the trial, we will evaluate the effect of catgut embedding at acupoints or nonacupoints on obesity indicators in patients with AO. For treatment outcomes, an intention-to-treat analysis will be performed. RESULTS: The start of recruitment began in August 2019 and is expected to end in September 2023. CONCLUSIONS: Although studies have been conducted to demonstrate the effectiveness of ACE in the treatment of obesity, the evidence for the efficacy of ACE in AO remains insufficient due to the quality of the studies. This rigorous normative randomized controlled trial will verify the effect of catgut embedding at acupoints or nonacupoints in patients with AO. The findings will provide credible evidence as to whether ACE is an effective and safe treatment for AO. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800016947; https://tinyurl.com/2p82257p. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46863.

Efficacy of transcutaneous electrical acupoint stimulation for patients with first-episode schizophrenia: An 8-week, preliminary, randomized controlled trial.

Combination therapy with antipsychotics has been investigated for treating schizophrenia, and has shown clear advantages among non-invasive therapies. Transcutaneous electrical acupoint stimulation (TEAS) is a novel non-invasive treatment with definite efficacy in treating mental disorders. The current study aimed to investigate the efficacy of TEAS in further improving the psychotic symptoms in patients with first-episode schizophrenia (FES) being treated with pharmacological drugs. This 8-week, preliminary, sham-controlled, randomized clinical trial was conducted in patients with FES to compare the efficacy of TEAS and sham TEAS in combination with aripiprazole treatment. The primary outcome was a change in the Positive and Negative Syndrome Scale (PANSS) score after ending the intervention (Week 8). A total of 49 participants completed the whole treatment cycle. The linear mixed-effects regression for PANSS indicated a significant time × group interaction (F(2, 116)=9.79, p <0.001). The PANSS score differed by 8.77 points (95% CI, -2.07 to -15.47 points; p=.01) between the TEAS group and the sham TEAS group after 8 weeks of treatment; this difference was significant. This study indicates that 8 weeks of TEAS combined with aripiprazole treatment can effectively treat FES. Thus, TEAS is an effective combination therapy to improve the psychiatric symptoms of FES.

Acupuncture Treatment for Threatened Abortion.

Background: Threatened abortion, also known as threatened miscarriage, is a common complication in pregnant women; it seriously harms their physical and mental health. However, there are only a few reports on acupuncture treatment to address threatened abortion. Case: A woman had a threatened abortion. She experienced vaginal bleeding and had an intrauterine hematoma after embryo transfer. She declined medication use because of concerns about the adverse effects to the embryo. Therefore, acupuncture treatment was performed to relieve her pain and save the fetus. Results: After the 4th treatment, her vaginal bleeding stopped, and her uterine effusion was reduced to 27 × 22 mm. After the 11th treatment, the uterine effusion decreased even more-to 40 × 7 mm-and disappeared completely after the 16th treatment. No adverse events occurred during her treatment, and her bleeding and uterine effusion did not recur. The fetus developed normally, and the child was born. This child is currently healthy and growing. Conclusions: By stimulating the body's acupoints, acupuncture can be used to adjust the Qi and Blood, and consolidate Extraordinary Vessels, mainly in Chong and Ren, to prevent miscarriage. This case report provided information about the treatment of a threatened abortion and illustrated how acupuncture was be used to stop a threatened abortion. This report can be utilized to support high-quality randomized controlled trials. Given that there is a lack of standardized and safe procedures for treating threatened abortion by using acupuncture, this research is needed.

Brain-Imaging Mechanisms on Female Abdominal Obesity Treated by "Shu-Mu" Acupoint Catgut Embedding and Compatibility Relation: Study Protocol for a 12-Week Randomized Controlled Trial.

Background: Acupoint catgut embedding (ACE) has been proven to be effective and safe in the treatment of obesity, but few studies have been conducted involving its central mechanisms. Our previous study has demonstrated the effectiveness of Shu-Mu ACE in the treatment of abdominal obesity (AO). However, the neurological mechanism of Shu-Mu ACE for weight loss has not yet been elucidated. The mechanism of the combination of the Shu and Mu acupoints may be related to the central integrative effects of the brain. This paper aims to explore the potential neural mechanisms of Shu-Mu ACE in female patients with AO. Methods and Analysis: A total of 100 eligible female AO patients and 20 healthy female subjects will be recruited for this study. 100 AO patients will be randomly allocated to five groups: Shu-Mu ACE (Group A), Shu ACE (Group B), Mu ACE (Group C), sham ACE (Group D), and waiting-list (Group E). Treatment will be administrated once every two weeks for 12 weeks. The body mass index (BMI), waist circumference (WC), Visual Analog Scales (VAS) of appetite, Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS) will be utilized to evaluate the clinical efficacy. Outcomes will be assessed at baseline and at each time point of treatment. Multimodal MRI will be performed at baseline and after 12-week treatment and the results will be used to investigate the neural mechanisms of ACE for obesity. Neurological changes and clinical data will be analysed for correlation. Discussions: This study hypothesized that Shu-Mu ACE therapy has a synergistic effect and may treat AO by modulating the neuropathological alterations in the brain. Our findings will demonstrate the neurological mechanism of AO treated by "Shu-Mu" Acupoint Catgut Embedding and compatibility relation. Trial Registration: This trial is registered at the Chinese Clinical Trial Registration Center (No. ChiCTR2100048920).

Effect of Acupoint Catgut Embedding for Abdominally Obese Female with Strong Appetite: Mixed Analysis of a Randomized Clinical Trial.

Background: Abdominal obesity (AO) is not only a health issue, but also a serious impact on women's work and life. The article of acupoint catgut embedding (ACE) on AO has already been accepted to be published and showed significant effect. However, whether ACE is effective for abdominally obese female with strong appetite is still unclear. Methods: This is a mixed analysis of a multicenter, double-blind, randomized controlled trial.Which was conducted in China between July 2018 and March 2020 (n = 101), while with the supplementary samples (n = 22) between April 2020 and June 2022. According to the appetite and intervention methods, 123 abdominally obese female were divided into ACE group with strong appetite (n = 27) and moderate appetite (n = 31), control (non-acupoint catgut embedding) group with strong appetite (n = 37) and moderate appetite (n = 28). Four subgroups were given a 12-week actual intervention period and a 4-week follow-up. Waist circumference (WC), appetite, body weight and BMI were applied and assessed at baseline and after 6, 12 and 16 weeks. Results: In this study, the mean onset age of abdominal obesity in females was 25.27 (8.19) years old. The longer duration of AO, the lower the appetite in females (p<0.05). At 12 and 16 weeks, ACE group with strong appetite showed significant decrease in WC and appetite than control group with strong appetite (p<0.01). However, ACE group with moderate appetite showed no significant decrease than control group with moderate appetite in WC, appetite, body weight and BMI (p>0.05). At 12 and 16 weeks, there was no significant difference in appetite between the ACE groups (strong and moderate appetite)(p>0.05), while there was still a difference between the control groups (p<0.05). Conclusion: Younger abdominally obese female had a stronger appetite. ACE own the remarkable therapeutic effects for younger abdominally obese female and showed the perfect effect on appetite-reduction.

Pediatric Tuina for functional constipation in children: study protocol for a randomized controlled trail.

BACKGROUND: Functional constipation (FC) is a common functional gastrointestinal disorder, which brings many negative impacts to the children's daily life. Pediatric Tuina has been proved to be a potential therapy for FC. However, the evidence for its effectiveness and safety is insufficient due to the lack of high-quality study. This study aims to evaluate the efficacy and safety of pediatric Tuina for children with FC. METHODS/DESIGN: This study is a randomized, controlled, multicentre, clinical trial. We will include 176 children with FC from five hospitals. The participants will be randomly allocated into two groups: the pediatric Tuina group and the Medilac-Vita group. This study will include a 1-week actual treatment period and a 2-week follow-up period. Primary outcomes are weekly spontaneous bowel movements and weekly complete spontaneous bowel movements. The secondary outcomes are effective rate, stool form, distress sensation, and glycerine enema rate. The assessment will be performed each week. Adverse event will be monitored in the treatment period and follow-up period. DISCUSSION: This study is designed to evaluate the efficacy and safety of pediatric Tuina for children with FC, and we hypothesize that pediatric Tuina is more effective than probiotics. It will provide reliable evidence and support for the treatment of FC by pediatric Tuina. TRIAL REGISTRATION: This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2100046485). .

Manual acupuncture as prophylaxis for migraine without aura: study protocol for a multi-center, randomized, single-blinded trial.

BACKGROUND: Migraine is a highly prevalent neurological disorder. It is the third most prevalent disorder and the seventh highest cause of disability worldwide. Acupuncture may be a viable prophylactic treatment option for frequent or uncontrolled migraine. Clinical studies comparing acupuncture and placebo acupuncture have not reached a consistent conclusion in confirming whether acupuncture is effective in migraine prophylaxis. The effect of acupuncture mainly depends on acupoints and needles operation. We found that the design of the placebo acupuncture in previous studies included shallow needling at sham acupoints, non-penetrating needling at sham acupoints, and needling at inactive acupuncture points to achieve the inert effect of control group, but the non-penetrating needling at true acupoints was ignored. This randomized controlled trial aims to use true acupoints for non-penetrating acupuncture as control to evaluate the efficacy of manual acupuncture for the prophylaxis of migraine without aura (MWoA). METHODS/DESIGN: This is a single-blinded, randomized, controlled, prospective, multi-center trial with two parallel treatment groups. A total of 198 eligible patients with MWoA will be randomly divided into two groups (1:1 allocation ratio). The intervention group will receive manual acupuncture and the control group will receive placebo acupuncture (non-penetrating). Patients will receive three acupuncture treatment sessions per week for 4 consecutive weeks. All patients will then receive a 12-week follow-up. DISCUSSION: In this study, we are evaluating the efficacy and safety of manual acupuncture in the prophylaxis of MWoA. The placebo control is using non-penetrating needling verum acupoints. It is essential to determine an appropriate control method to ensure the methodological quality of a randomized controlled trial. TRIAL REGISTRATION: The trial has been registered in the Chinese Clinical Trial Registry (approval no. ChiCTR2000032308 ) in April 2020.

Efficacy of contralateral acupuncture in women with migraine without aura: protocol for a randomised controlled trial.

INTRODUCTION: Migraine is a common neurological disorder with a higher prevalence occurring in women. Migraine without aura (MwoA) is the most common type of migraine. In recent years, the safety and effectiveness of acupuncture for migraines have been internationally recognised. Contralateral acupuncture (CAT) (Jùcì) is an ancient classic acupuncture technique from Huang Di Nei Jing that refers to the acupoints on the right side (healthy side) selected for diseases on the left (affected side) and vice versa. Some studies have shown that efficacy of CAT on the painful disorder is even better than ipsilateral acupuncture (IAT), but there remains a lack of high-quality evidence to support it. METHODS AND ANALYSIS: This is a single-centre, randomised and sham-controlled clinical trial in China with three parallel groups that aim to evaluate the efficacy of CAT in women with unilateral MwoA. 243 participants will be randomly divided into the experimental group (CAT group), control group 1 (IAT group) and control group 2 (sham acupuncture group) (1:1:1 allocation ratio). Each group will be given 30-minute treatment sessions, once every other day, approximately three times per week, for a total of 24 treatments and follow-up visits two times. The primary outcome is the changes in days of migraine attacks. The secondary outcomes are frequency of migraine attacks, intensity of migraine, migraine duration, the dose of intake of acute medication, the Migraine-Specific Quality of Life Questionnaire, the Migraine Disability Assessment Score, the Headache Impact Test-6 and the Pittsburgh Sleep Quality Index. The data will be collected at the baseline time (week 0), end of treatment (week 4-8) and the follow-up time (week 12-16). Adverse events will be collected and recorded during each treatment. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of the Sports Trauma Specialist Hospital of Yunnan Province (2021-01). All participants will provide written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registration Center (ChiCTR2100051479).

A multicenter, randomized controlled trial of massage in children with pediatric cerebral palsy: Efficacy of pediatric massage for children with spastic cerebral palsy.

BACKGROUND: Cerebral palsy is 1 of the diseases critically affecting the health of children. The spasmodic type is the most common, characterized by the increased muscular tension. It often leads to lifelong disability, bringing a heavy economic burden to families and society. As a key treatment in traditional Chinese medicine, pediatric massage has a significant clinical effect on cerebral palsy in children; however, high-quality randomized controlled studies are lacking. The main objective of this study was to evaluate the efficacy of pediatric massage for children with spastic cerebral palsy. METHODS/DESIGN: The study will be a multicenter, single-blinded, randomized-controlled pilot trial. During the period from June 2019 to December 2020, 182 children with spastic cerebral palsy will be randomly divided into experimental and control groups in a 1:1 ratio. The experimental group will undergo the modified selective spinal massage method combined with the basic rehabilitation treatment, while only the basic rehabilitation treatment would be performed for the control group. The intervention period of the study will last 12 weeks, 5 days weekly on weekdays. The primary outcomes include a modified Ashworth scale assessment and gross motor function test. The secondary outcomes include the 4-diagnostic scale of Chinese medicine and children's intelligence. The observation index will be measured during the complete 12 weeks duration after the treatment of the child, that is, before treatment, after 4 weeks of treatment, after 8 weeks, and after 12 weeks of treatment. DISCUSSION: This study aims to evaluate the efficacy of pediatric massage on children with spastic cerebral palsy; if the outcome is positive, it can provide a reference for the further promotion and application of pediatric massage in the treatment of spastic cerebral palsy. TRIAL REGISTRATION: Chinese ClinicalTrials.gov, ID: ChiCTR1900021666. Acupuncture-Moxibustion Clinical Trial Registry, AMCTR: (AMCTR-IPR-19000260) Registered on 04 March 2019.

Cerebral fractional amplitude of low-frequency fluctuations may predict headache intensity improvement following acupuncture treatment in migraine patients.

OBJECTIVE: To explore how baseline resting-state cerebral function predicts clinical outcomes of acupuncture treatment for migraine. METHODS: One hundred migraine patients and 46 healthy subjects were recruited. Patients were randomized into the acupuncture, sham acupuncture, and waiting list groups. Resting-state functional magnetic resonance imaging data were collected at baseline and after 1 month of longitudinal acupuncture treatments. Fractional amplitude of low-frequency fluctuations (fALFF) calculations were applied to explore the associations between baseline fALFF and changes in clinical variables in the acupuncture treatment group and the waiting list group. RESULTS: Compared with healthy subjects, migraine patients had lower fALFF in the left rostral ventromedial medulla, right thalamus, left amygdala, and right angular gyrus. Regression analyses revealed that baseline fALFF values in the left middle frontal gyrus, left superior temporal gyrus, and middle temporal gyrus were positively associated with headache intensity changes in the acupuncture treatment group, while baseline fALFF values in the bilateral lingual gyrus and cuneus were negatively associated with headache intensity changes in this group. CONCLUSION: The baseline fALFF values of brain regions associated with cognitive pain modulation, but not migraine severity, may predict future headache intensity improvement levels in migraine patients receiving acupuncture treatment.

Fire needle plus cupping for acute herpes zoster: study protocol for a randomized controlled trial.

BACKGROUND: Acute herpes zoster (AHZ) is a common skin disease caused by invasion of the varicella zoster virus into the ganglia and skin, and the severe pain is the most complaint, which can seriously disturb the normal life of patients. Fire needle plus cupping is a special acupuncture treatment, which is widely used to treat AHZ for its better analgesic effect in China although it has not been fully verified by rigorous randomized controlled trial (RCT). METHODS/DESIGN: To test the effect, a three-arm randomized parallel controlled trial protocol has been designed. A total of 105 AHZ patients suffering pain will be randomly divided into three groups in an equal proportion. The interventions are fire needle plus cupping (FC) in group A, famciclovir plus gabapentin (FG) in group B, and fire needle plus cupping plus famciclovir (FCF) in group C. The length for the trial is set for a week time frame. Precisely speaking, the A group (FC) is to carry out 1 treatment per day for the total of 7 treatment sessions within 1 week period. On the other hand, the B group (FG) will take drugs orally three times a day within the trial 1 week. Meanwhile, with its combination element, the C group (FCF) is due to undertake both treatments and drugs as prescribed for A and B groups within the trial week. As an intra-trial arrangement, analgesic medication will be carefully administered for temporary pain release if the sudden intolerable pain appeared. For the primary outcome, this study is due to apply visual analogue scale to identify pain intensity relief. As the secondary outcomes are concerned, this study is aiming to focus on the issues related to changes in substance P and beta-endorphin concentrations in peripheral plasma, as well as those issues of analgesic needs, side effects, symptoms, and physical signs including pain classification, local itching, burning sensation, fever, local lymphadenopathy, skin lesion area, blisters, herpes clusters, vesicular traits, ulcers, and pimples; all these are taken into account for evaluation. For the final stage, the participants are to be followed up for postherpetic neuralgia. DISCUSSION: The results of this trial aim to provide sufficient evidence on FC treatment over both FG and FCF treatments. It will then give a credible alternative treatment to cut down acute pain and to cure AHZ infection. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800015372 . Registered on 28 March 2018.

Chinese Herbal Medicines Compared with N-Acetylcysteine for the Treatment of Idiopathic Pulmonary Fibrosis: A Systematic Review of Randomized Controlled Trials.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a major global health problem. The prevalence of the disease appears to be increasing. There is no curative therapy for IPF except lung transplantation. Chinese herbal medicines (CHMs) are showing promise for treatment of IPF. However, their effectiveness and safety are still unclear and deserve further investigation. The aim of this systematic review is to access the efficacy and safety of CHMs in treating IPF. METHODS: The protocol of this review is registered at PROSPERO. We searched seven main databases for randomized clinical trials (RCTs) on CHMs for IPF from their inception to June 4, 2018. The methodological quality of RCTs was assessed using the Cochrane risk of bias tool. All trials included were analyzed according to the criteria of the Cochrane Handbook. Review Manager 5.3, R-3.5.2 software, and Grade pro GDT web solution were used for data synthesis and analysis. RESULTS: Thirteen randomized clinical trials enrolling 733 patients were included. All trials included had clear outcome indicators. The methodological quality of included trials was generally "poor." Few trials reported methods of randomization. One trial on Xuefu-zhuyu capsule assessed rate of acute exacerbation and mortality after treatment for 72 weeks and found no statistically significant difference between two groups. This meta-analysis demonstrated a significant improvement in QOL of IPF patients when CHMs was applied or combined with conventional medicine treatment. 6MWT was significantly improved in IPF patients after using CHMs or combined with conventional medicine treatment. CHMs treatment also had a certain improvement in TLC and DLCO, but the effect on FVC was not significant. Besides, CHMs failed to provide benefits in terms of PaO2. The reported adverse events were not obvious and severe. CONCLUSIONS: Some CHMs seem effective and safe as alternative remedies for patients with IPF, suggesting that further study of CHMs in the treatment of IPF is warranted. Although this systematic review suggests that CHMs may have positive effect on quality of life, 6-minute walk test distance, and lung function (TLC, DLOC%) and seem to be relatively safe during the course of treatment, the results must be treated with great caution because of the methodological flaws of the included trials. Long-term and high-quality trials are needed in the future to provide clear evidence for the use of CHMs.

Cervicogenic headache treated by acupuncture based on jin theory: study protocol for a randomized controlled trial.

BACKGROUND: Numerous randomized trials involving acupuncture treatment for cervicogenic headache (CEH) have been conducted in recent years, but the evidence for its effectiveness is not clear. Hence, we designed a randomized trial to evaluate the efficacy and advantages of acupuncture for treating CEH. DESIGN: This is a parallel-design, two-arm, patient-assessor blinded, randomized, sham-controlled clinical trial. A total of 166 patients with CEH aged from 18 to 70 will be recruited and assigned randomly into a jin acupuncture group and a pseudo acupuncture group at a 1:1 ratio; they will receive 12 sessions of real acupuncture and sham acupuncture for 4 weeks, respectively, during the study. The primary outcomes are pain degree (PD) and pain rate (PR) calculated by the PainVision analyzer, as well as parameters detected by surface electromyography (SEMG). The secondary outcomes will be measured with the short-form McGill Pain Questionnaire (SF-MPQ), range of motion (ROM) of the neck, the Northwick Park Neck Pain Questionnaire (NPQ), the 36-item short-form Health Survey (SF-36), the Self-Rating Anxiety Scale (SAS), and the Self-Rating Depression Scale (SDS). Clinical assessments will be evaluated at baseline and in the fourth week as well as in the eighth and sixteenth weeks. Adverse events will be noted and recorded for the safety evaluation. DISCUSSION: This study will provide high-quality evidence of the value of acupuncture based on jin theory for treating CEH. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800015316 . Registered on 22 March 2018. Updated version AMCTR-IOR-18000157 . Registered on 1 April 2018.

Acupuncture for perimenopausal depressive disorder: A systematic review and meta-analysis protocol.

BACKGROUND: Perimenopausal depressive disorder (PDD) is a disease that plagues many perimenopausal women. There is an urgent need for a safe way to treat the disease. With few side effects, acupuncture treatment for PDD has been gradually accepted. However, at present, the evidence is insufficient and relevant studies are not in-depth enough. The purpose of this study is to explore the efficacy and safety of acupuncture for PDD. METHODS: All randomized controlled trials articles on acupuncture treatment of PDD will be searched in databases such as MEDLINE, EBASE, Cochrane Library, Springer, World Health Organization International Clinical Trials Registry Platform, China National Knowledge Infrastructure, Wan Fang, Chinese Biomedical Literature Database, Chinese Scientific Journal Database and so on. Non-RCT articles will be screened and key information will be extracted. The primary outcome is the Hamilton depression scale. Second outcomes are the Hamilton anxiety scale, Quality of life scale, changes of symptoms in traditional Chinese medicine and hormone levels. RESULTS: This systematic review will provide the highest level of evidence and provide an evaluation of the efficacy and safety of acupuncture for PDD. CONCLUSION: This study provides evidence for evaluating the efficacy and safety of acupuncture in the treatment of PDD. PROSPERO REGISTRATION NUMBER: CRD42018115811.

Acupuncture for patients with mild hypertension: A randomized controlled trial.

Acupuncture may be beneficial for patients with mild hypertension, but the evidence is not convincing. We aimed to examine the effect of acupuncture on blood pressure (BP) reduction in patients with mild hypertension. We conducted a multicenter, single-blind, sham-controlled, randomized trial in eleven hospitals in China. The trial included 428 patients with systolic blood pressure (SBP) from 140 to 159 mm Hg and/or with diastolic blood pressure (DBP) from 90 to 99 mm Hg. The patients were randomly assigned to receive 18 sessions of affected meridian acupuncture (n = 107) or non-affected meridian acupuncture (n = 107) or sham acupuncture (n = 107) during 6 weeks, or to stay in a waiting-list control (n = 107). All patients received 24-hour ambulatory blood pressure monitoring at weeks 6, 9, and 12. We included 415 participants in the intention-to-treat analysis. The two acupuncture groups were pooled in the analysis, since they had no difference in all outcomes. SBP decreased at week 6 in acupuncture group vs sham acupuncture vs waiting-list group (7.2 ± 11.0 mm Hg vs 4.1 ± 11.5 mm Hg vs 4.1 ± 13.2 mm Hg); acupuncture was not superior to sham acupuncture (mean difference 2.7 mm Hg, 95% CI 0.4 to 5.9, adjusted P = 0.103) or waiting-list control (2.9 mm Hg, 95% CI -0.2 to 6.0, adjusted P = 0.078). However, acupuncture was superior to sham acupuncture (3.3 mm Hg, 95% CI 0.2 to 6.3, adjusted P = 0.035) and waiting-list control (4.8 mm Hg, 95% CI 1.8 to 7.8, P < 0.001) at week 9. Acupuncture had a small effect size on the reduction of BP in patients with mild hypertension.

Effect of hydrokinesitherapy on balance and walking ability in post-stroke patients: A systematic review protocol.

INTRODUCTION: Brain stroke is the second most common cause of death and major cause of disability in adults, representing a huge burden on patients and their families. Hydrokinesitherapy, a type of physical rehabilitation, may be beneficial to post-stroke recovery. We will systematically assess the clinical effectiveness and safety of hydrokinesitherapy for rehabilitation of stroke survivors in this review. METHODS: We will perform a systematic search to identify all potentially relevant published studies on this topic. Online electronic databases including MEDLINE (via PubMed), EMBASE (via embase.com), Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, CINAHL (via EBSCOhost) and SPORTDiscus (via EBSCOhost) will be searched without language restrictions from their inception to September 30, 2018. All relevant randomized controlled trails (RCTs) will be screened according to predetermined inclusion criteria. Two independent reviewers will evaluate the methodological quality of each study included. One reviewer will extract data and another reviewer will check the accuracy. Any disagreements will be discussed with a third reviewer. The posture balance and walking ability will be defined as primary outcomes. Activities of daily living (ADL), drop-out and adverse events will also be assessed as secondary outcomes. The evaluation of methodological quality, data analysis will be completed using Cochrane Review Manager 5.3 according to Cochrane Handbook for Systematic Reviews of Interventions. TRIAL REGISTRATION NUMBER: CRD42018110787.

Acupuncture for perimenopausal insomnia: A systematic review and meta-analysis protocol.

BACKGROUND: Perimenopausal insomnia (PI) is one of the most common complaints in women. Acupuncture is used to treat PI increasingly considering its less side effect. The subject of this study is to explore the effectiveness and safety of acupuncture for PI. METHODS: All the randomized controlled trials(RCT) literatures of acupuncture for PI will be searched in the databases of MEDLINE, Cochrane Library, Web of Science, EMBASE, Springer, WHO International Clinical Trials Registry Platform (ICTRP), China National Knowledge Infrastructure (CNKI), Wan fang, Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP), and other available resources using the subject terms of 'acupuncture" and "perimenopausal insomnia" and their synonyms. The languages are limited as English and Chinese. Non-RCT literatures will be screened and relative information will be extracted. Sleep quality values is considered as the primary outcome. Secondary outcomes include biochemical indicators, such as hormone levels, side effects caused by acupuncture, total scores on the insomnia severity index and traditional Chinese medicine symptom changes. RESULTS: This systematic review study will provide an evidence of acupuncture for PI. CONCLUSION: The study will give an explicit evidence to evaluate the effectiveness and side effects of acupuncture for PI. PROSPERO REGISTRATION NUMBER: CRD42018092917.