Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol.

BACKGROUND: Acupuncture has been reported to reduce hot flashes in patients with breast cancer undergoing adjuvant hormonal therapy. Although hot flashes are common, the prevalence varies among cultures, races, and ethnicities; the efficacy of acupuncture across cultures has not been investigated. METHODS: This is a coordinated multinational study, including three parallel randomized trials with a planned analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients on adjuvant endocrine therapy. Using a standardized acupuncture protocol (total across all three studies of n = 80) versus usual care (total n = 80), symptoms are assessed using changes in the Endocrine Symptom Subscale of Functional Assessment of Cancer Therapy-Endocrine Symptoms. Secondary outcomes include hot flash severity, quality of life, and sleep quality. Differences in response to acupuncture between participants in the three countries will also be explored. DISCUSSION: Here we describe the design of a protocol for a coordinated multinational study, with attention to the complex considerations in developing a multinational research effort testing a non-pharmacologic intervention. This protocol and approach provide guidance for future efforts to evaluate and test non-pharmacologic interventions across multinational populations. TRIAL REGISTRATION: clinicaltrials.gov (Identifier: NCT00797732, registered on December 21, 2018), Chinese Clinical Trial Registry (ChiCTR2100045888), and The Clinical Research Information Service (CRIS) of Korea (Registration number: KCT0003618).

[Effect of acupuncture combined with rehabilitation training on cognitive function and amino acid metabolism in children with cerebral palsy].

OBJECTIVE: To observe the effect of acupuncture combined with rehabilitation training on cognitive function and amino acid metabolism in children with cerebral palsy. METHODS: Twenty children with cerebral palsy (cerebral palsy group) were randomly divided into an acupuncture and rehabilitation group (11 cases) and a rehabilitation group (9 cases), and 10 healthy children were included as the normal group. The rehabilitation group was treated with rehabilitation training, 30 min each time; on the basis of rehabilitation training, the acupuncture and rehabilitation group was treated with acupuncture at Sishenzhen, Zhisanzhen, Naosanzhen, Niesanzhen, Dazhui (GV 14), Shenzhu (GV 12), Mingmen (GV 4), etc. The Sishenzhen (left and right points) and the ipsilateral Niesanzhen were respectively connected with a group of electrodes, intermittent wave, frequency of 2 Hz for 30 min. Both groups were treated once every other day, three times a week, totaling for 3 months. The Gesell developmental diagnostic scale (GESELL) was used to evaluate the developmental quotient (DQ) scores before and after treatment, and the blood samples of children with cerebral palsy before and after treatment and normal children were collected for amino acid metabolomics. RESULTS: Compared before treatment, the DQ scores of adaptation, fine motor and social in the acupuncture and rehabilitation group was increased after treatment (P<0.05), and the DQ score of fine motor in the rehabilitation group was increased after treatment (P<0.05). Compared with the normal group, the serum L-glutamate, L-ornithine, L-tyrosine, L-methionine and L-arginine in the cerebral palsy group were down-regulated, and L-histidine, L-citrulline, 5-hydroxylysine and L-glutamine were up-regulated before treatment. The functional pathways mapped by different metabolites between the cerebral palsy group and the normal group included arginine biosynthesis, arginine and proline metabolism, etc. Compared with the cerebral palsy group, the serum L-histidine was decreased, and L-citrulline showed decreasing trend in the acupuncture and rehabilitation group after treatment. CONCLUSION: Acupuncture combined with rehabilitation training could improve cognitive function in children with cerebral palsy, and the effect may be related to the down-regulation of L-histidine and L-citrulline metabolism.

Inhibitory Effects of Euphorbia ebracteolata Hayata Extract ECB on Melanoma-Induced Hyperplasia of Blood Vessels in Zebrafish Embryos.

Melanoma is a serious malignant form of skin cancer. Euphorbiaceae compound B (ECB, 2,4-dihydroxy-6-methoxy-3-methylacetophenone) is an acetophenone compound that is isolated from Euphorbia ebracteolata Hayata (EEH), an herbaceous perennial, and has antitumor activity. Here, we transplanted human melanoma cells into zebrafish embryos to establish a zebrafish/melanoma model. We showed that this model can be used to evaluate the therapeutic effect of EEH and ECB and discussed its potential mechanism of action. The results showed that ECB was an active ingredient of EEH in inhibiting melanoma-induced hyperplasia of blood vessels in zebrafish embryos, similar to the angiogenic inhibitor vatalanib. ECB inhibited the number and length of subintestinal veins (p < 0.05), as well as the distribution of melanoma in zebrafish embryos (p < 0.05). More importantly, unlike vatalanib, ECB only inhibited melanoma-induced abnormal and excessive growth of blood vessels in xenografts. In addition, ECB inhibited the mRNA expression of vegfr2 and vegfr3 in zebrafish. Both vegfr2 and vegfr3 are essential genes that regulate blood vessel formation and upregulate the expression of p53 and casp3a genes in zebrafish. Together, the above-mentioned results indicate that ECB has a potential antimelanoma effect in vivo, which may be mediated by inhibiting vascular endothelial growth factor receptors.

[Professor WU Xu's experience in treatment of tic disorders in children with acupuncture from "meridian tendons"].

Professor WU Xu believes that the pathogenesis of tic disorders in children is "agitation of liver wind, lending to excessive wind and spasm of tendons" "deficiency of yin fluid, the tendons failing to be nourished" "spirit failing to govern, leading to tendons not be restrained" and advocates to treat this disease from the theory of "meridian tendons". He suggests the acupoints that related to "meridian tendons", and emphasizes the depth of needling and the procedure of acupuncture, and believes that the core of treating is to balance the yin and yang of "meridian tendons" and regulate spirit.

[Professor WU Xu's clinical experience of acupuncture for alternating hemiplegia of childhood].

Professor WU Xu's clinical experience of acupuncture for alternating hemiplegia of childhood is summarized. Based on the syndrome differentiation of meridians and the theory of zangfu, professor WU proposes that the etiology and pathogenesis is "three yin as the root causes, deficiency wind as the symptoms", and the treatment is to tonify deficiency and reinforce the vital essence, soothe the liver and relieve wind. The acupoints used is mainly in the foot three yin meridians, paying attention to tonifying the kidney; the combinations of Hegu (LI 4) and Taichong (LR 3), Fengmen (BL 12) and Fengshi (GB 31) are adopted; combined with the back-shu points and the governor vessel acupoints, professor WU emphasizes "harmonizing yin and yang" and "treating and nourishing the spirit".

Effect of "Tonifying Kidney and Invigorating Brain" acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram.

INTRODUCTION: Cerebral palsy is the most common motor disability of childhood. Spastic cerebral palsy accounts for 60% to 70% of cases. Research has shown that acupuncture can improve the quality of life of children with cerebral palsy, but the mechanism of action remains unclear. This study aims to determine the effectiveness of acupuncture for treatment of children with spastic cerebral palsy and to assess the value of multimodal magnetic resonance imaging (MRI) and ambulatory electroencephalogram (EEG) for evaluation of treatment effect. METHODS AND ANALYSIS: This randomized controlled trial will enroll a total of 72 children with CP from 2 hospitals-Jiangsu Province Hospital of Chinese Medicine and Nanjing State Hospital of Pediatric-with 36 participants from each hospital. Patients will be randomly assigned (1:1 ratio) to receive "Tonifying Kidney and Invigorating Brain" acupuncture treatment plus standardized physical rehabilitation treatment (treatment group) or only standardized physical rehabilitation (control group). All participants will receive 3 treatment sessions per week for 3 consecutive months; they will then be followed up for another 3 months. The primary outcome measures will include multimodal magnetic resonance imaging (MRI), ambulatory electroencephalogram (EEG), and Gesell Developmental Diagnostic Schedules. The secondary outcome measures will include Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM), Functional Independence Measure (WeeFIM), and Modified Ashworth Scale score. Outcome measures (including primary and secondary outcome measures) were collected at the baseline, 3 months and 6 months prior to the intervention.Ethics and dissemination PATIENTS CONSENT:: Obtained. ETHICS APPROVAL: The central independent ethics committee of Jiangsu Province Hospital of Traditional Chinese Medicine approved the protocol (2017NL-115-02). SAFETY CONSIDERATIONS: Routine blood tests and liver and kidney function tests will be conducted to exclude patients with severe heart, liver, or kidney diseases. The same examinations will be performed again at the end of the study to detect any possible side effects. Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented. Serious adverse events will be reported to the principal investigator immediately. All unexpected and unintended responses, even those not necessarily related to the acupuncture intervention, will be documented as adverse events. CASE DROPOUT MANAGEMENT: Participants have a right to withdraw from the study at any time if they feel uncomfortable upon receiving the treatments or being diagnosed with serious complications or diseases. They will then be referred to the preferred department for further treatment and management. If cases of dropout, the researcher need to contact the participant to reason the problem out, collect and record all the necessary assessments on the last visit as well as the date of last visit. All data available until the date of withdrawal will be stored for further statistical analysis. DISCUSSION: This research is being conducted to assess the value of acupuncture as an intervention for rehabilitation of children with spastic cerebral palsy and also to evaluate the usefulness of multimodal MRI and ambulatory EEG for identifying changes in brain function. TRIAL REGISTRATION: This trial is registered with Chinese Clinical Trials Register, ChiCTR 1900024546 (registered 15 July 2019; retrospective registration, http://www.chictr.org.cn/showproj.aspx?proj=35763).

[Effect of scalp acupuncture stimulation on cerebral cortex function and related mechanism].

A literature review was performed to investigate the possible mechanism of scalp acupuncture in stimulating the skin, fascia, muscle, and periosteum and thus affecting cerebral cortex function. The results of literature research show that the effect of scalp acupuncture on cerebral cortex function may be achieved by the stimulation of specific anatomical structures. Stimulation of the skin, fascia, muscle and periosteum can activate the functional areas of the cerebral cortex through the midbrain, thalamus, and brainstem. In addition, different depths of stimulation may affect the deep and shallow sensation of the brain, self-monitoring of the fascia, subcortical central compensation, and cortical discharge. Therefore, exploration of the specific rules and differences in the effect of stimulating different anatomical structures on brain function is the future focus of the clinical and basic research on scalp acupuncture.

Synergistic effect of moxibustion and rehabilitation training in functional recovery of post-stroke spastic hemiplegia.

OBJECTIVE: To evaluate the therapeutic benefit of combining moxibustion and rehabilitation training for functional recovery in post-stroke spastic hemiplegic patients. METHODS: We randomly divided 84 cases subjecting to inclusion criteria into moxibustion plus rehabilitation training group (MRT group, n=44) and rehabilitation training group (RT group, n=40). Evaluation of therapeutic effect was observed before treatment, 2 weeks during treatment and 6 months after treatment. Spasticity was evaluated using modified Ashworth scale (MAS) and Clinical Spasticity Index (CSI), recovery of motor function was assessed by Brunnstrom recovery stages and Simplified Fugl-Meyer Motor Scale, and performance of activities of daily living (ADL) was measured, and the quality of life was assessed by Patient Reported Outcomes (PRO). RESULTS: Evaluation of upper limbs, hands and lower limbs based on CSI and MAS revealed significant improvements in patients treated with MRT, compared to RT alone, both during and after therapy. CSI and MAS also showed significant improvement in patients at each time point in the MRT group, compared to RT group. Marked improvement in Fugl-Meyer Motor Scale was also observed in MRT group at each time point. Based on Brunnstrom grades of upper limbs, hands and lower limbs, significant differences between the two groups were recorded at all time points during and after therapy. Barthel index (BI) and PRO also confirmed the dramatic differences between the two therapy groups. CONCLUSIONS: Our results demonstrate that combination therapy with moxibustion and rehabilitation training offers greater clinical benefits in relieving spasticity, promoting function recovery of motion, improving the performance of ADL, and increasing quality of life in post-stroke spastic hemiplegic patients, compared to RT alone.

Sucrose fed-batch strategy enhanced biomass, polysaccharide, and ganoderic acids production in fermentation of Ganoderma lucidum 5.26.

Ganoderma, as a Chinese traditional medicine, has multiple bioactivities. However, industrial production was limited due to low yield during Ganoderma fermentation. In this work, sucrose was found to greatly enhance intracellular polysaccharide (IPS) content and specific extracellular polysaccharide (EPS) production rate. The mechanism was studied by analyzing the activities of enzymes related to polysaccharide biosynthesis. The results revealed that sucrose regulated the activities of phosphoglucomutase and phosphoglucose isomerase. When glucose and sucrose mixture was used as carbon source, biomass, polysaccharide and ganoderic acids (GAs) production was greatly enhanced. A sucrose fed-batch strategy was developed in 10-L bioreactor, and was scaled up to 300-L bioreactor. The biomass, EPS and IPS production was 25.5, 2.9 and 4.8 g/L, respectively, which was the highest biomass and IPS production in pilot scale. This study provides information for further understanding the regulation mechanism of Ganoderma polysaccharide biosynthesis. It demonstrates that sucrose fed-batch is a useful strategy for enhancing Ganoderma biomass, polysaccharide and GAs production.

[Professor WU Xu's clinical experiences on acupuncture for acute upper abdominal pain].

The clinical experiences and proven cases of distinguished doctor of TCM, professor WU Xu, on acupuncture for acute upper abdominal pain is introduced. Professor WU's manipulation characteristics of acupuncture for acute upper abdominal pain, including acute cholecystitis, kidney stone, acute stomach pain, are one-hand shape but both hands in nature, moving like Tai Chi, force on the tip of needle, movement of qi mainly. The main technique posture is one-hand holding needle with middle finger for pressing, the needle is hold by thumb and index finger, and is assisted by middle finger. The special acupuncture experience of emergency is treatment according to syndrome differentiation, combination of acupuncture and moxibustion, selecting acupoint based on experience, blood-letting acupuncture therapy and so on.

[Effect of total glucosides of paeony on Wnt/ß-catenin signal transduction pathway expression in kidney of diabetic rats].

The study is to explore the effect of total glucosides of paeony (TGP)on Wnt/ß-catenin signal transduction pathway expression in kidney of diabetic rats, and discuss the protection of TGP in diabetic nephropathy and possible mechanism. Ninety male SD rats of 8 weeks age were randomly divided into normal control group (n = 10) and model group (n = 80). Rats of the normal control group were fed with regular diet, while rats of the model group were fed with high-fat high-sugar diet and 4 weeks later were given an intraperitoneal injection of 35 mg x kg(-1) streptozotocin (STZ). The successfully induced type 2 diabetic rat models were then randomly divided into DM group, three TGP (50, 100, 200 mg x kg(-1) x d(-1)) treatment group and tripterygium wilfordii glycosides (8 mg x kg(-1) x d(-1)) control group. Rats of DM group and each treatment group were given high-fat high-sugar diet. At week 14, the levels of blood sugar, 24 hour urine protein, serum creatinine and blood urea nitrogen were tested. The rats were then sacrificed. Renal pathological changes were examined. Renal tissue Wnt-1 and ß-catenin expressions were detected by immunohistochemical assay. Wnt-1 mRNA and ß-catenin mRNA expression was semi-quantified by RT-PCR. Wnt-1 protein and ß-catenin protein expression was semi-quantified by Western blot. The Result show that Wnt-1 and ß-catenin expression increased in kidney of high-fat high-sugar induced type 2 diabetic rats. Compared with diabetic group, the level of serum creatinine, blood urea nitrogen, 24 h urine protein, mean glomerular area and mean glomerular volume were decreased, renal histopathology were improved, expression of Wnt-1 and ß-catenin mRNA and protein was reduced in TGP group. Tripterygium wilfordii glycosides had the similar effect. In conclusion, these results showed that Wnt/ß-catenin abnormal activation in kidney of type 2 diabetic rats, TGP can improve kidney damage in diabetic rats and delay the development of diabetic nephropathy by inhibit the Wnt/ß-catenin signaling pathway.

Effect of total glucosides of paeony on Wnt/β-catenin signal transduction pathway expression in kidney of diabetic rats / 中国中药杂志

The study is to explore the effect of total glucosides of paeony (TGP)on Wnt/β-catenin signal transduction pathway expression in kidney of diabetic rats, and discuss the protection of TGP in diabetic nephropathy and possible mechanism. Ninety male SD rats of 8 weeks age were randomly divided into normal control group (n = 10) and model group (n = 80). Rats of the normal control group were fed with regular diet, while rats of the model group were fed with high-fat high-sugar diet and 4 weeks later were given an intraperitoneal injection of 35 mg x kg(-1) streptozotocin (STZ). The successfully induced type 2 diabetic rat models were then randomly divided into DM group, three TGP (50, 100, 200 mg x kg(-1) x d(-1)) treatment group and tripterygium wilfordii glycosides (8 mg x kg(-1) x d(-1)) control group. Rats of DM group and each treatment group were given high-fat high-sugar diet. At week 14, the levels of blood sugar, 24 hour urine protein, serum creatinine and blood urea nitrogen were tested. The rats were then sacrificed. Renal pathological changes were examined. Renal tissue Wnt-1 and β-catenin expressions were detected by immunohistochemical assay. Wnt-1 mRNA and β-catenin mRNA expression was semi-quantified by RT-PCR. Wnt-1 protein and β-catenin protein expression was semi-quantified by Western blot. The Result show that Wnt-1 and β-catenin expression increased in kidney of high-fat high-sugar induced type 2 diabetic rats. Compared with diabetic group, the level of serum creatinine, blood urea nitrogen, 24 h urine protein, mean glomerular area and mean glomerular volume were decreased, renal histopathology were improved, expression of Wnt-1 and β-catenin mRNA and protein was reduced in TGP group. Tripterygium wilfordii glycosides had the similar effect. In conclusion, these results showed that Wnt/β-catenin abnormal activation in kidney of type 2 diabetic rats, TGP can improve kidney damage in diabetic rats and delay the development of diabetic nephropathy by inhibit the Wnt/β-catenin signaling pathway.