Background: Fire needle which is an integral part of the acupuncture therapy. Periarthritis of shoulder (PAS) is a common disease, which brings lots of pain for patients. The clinical practice indicates that fire needle has a therapeutic effect on the PAS. Here, we will provide a protocol to explore the effectiveness and safety of fire needle for the PAS. Methods: We will search the randomized controlled trails (RCT) literatures of fire needle for the PAS in 9 electronic databases, including 5 English databases (PubMed, Web of Science, EMBASE, the Cochrane Central Register of Controlled Trials [Cochrane Library], and WHO International Clinical Trials Registry Platform [TCTRP]) and 4 Chinese databases (Chinese National Knowledge Infrastructure [CNKI], Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database [CBM]). We will consider the Ability assessment of daily living activities (ADL) as the primary outcome and the secondary outcome will include visual analogue scale (VAS), shoulder range of motion (ROM) and adverse events incidence caused by fire needle, such as dizziness, nausea, vomiting, weariness, etc. The selection of the studies will be performed by EndnoteX7 software. All analyses will be conducted by using RevMan software V5.3. Result: This study will provide a rational synthesis of current evidences for fire needle on PAS. Conclusion: The conclusion of this study will provide evidence to judge the effectiveness and safety of fire needle on PAS. Registration: PROS-PERO CRD42019119686.

Background:Characterized by diffuse hepatic fibrosis and nodule formation, hepatitis B cirrhosis (HBC), an important result of chronic hepatitis B development, mainly contains compensated and decompensated stage. Compensated cirrhosis can further develop into decompensated stage and hepatocellular carcinoma with serious complications and high mortality. Antiviral therapy using interferon (IFN) or nucleos(t)ide analogs (NUCs) is essential for improving the prognosis of the disease but IFN has large side effects while NUCs often develop drug resistance. Antifibrosis is also an important strategy, but currently there is no effective antifibrosis drug. Pharmacologic studies have demonstrated that oxymatrine (OM) exhibits anti-hepatitis B virus (HBV) and antifibrosis effects. An increasing number of clinical controlled studies also have found that OM combined with conventional therapy could improve the curative effect and reduce adverse events incidence in treating HBC but there is no systematic review of it. Based on the extensive collection of literature, we will use meta-analysis to assess the efficacy and safety of OM for HBC.Methods:PubMed, MEDLINE, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang data, Chinese Scientific Journals Database (VIP), and China biomedical literature database will be searched to obtain the eligible studies published up to July 15, 2018. The primary outcome will be liver function indexes, liver fibrosis indexes, and Child–Pugh score. The secondary outcome will be hepatitis B virus DNA quantification, HBV DNA seroconversion rate, hepatitis B e antigen (HBeAg) seroconversion rate, and adverse events incidence. Data analysis will be conducted using RevMan 5.3 and Stata V.9.0 software. Trial sequential analysis (TSA) will be performed to assess the risk of random error and the validity of conclusion using TSA program version 0.9 beta.Results:This systematic review will provide a high quality synthesis of OM for HBC from various evaluation aspects including liver function indexes, liver fibrosis indexes and Child-Pugh score, HBV DNA quantification, HBV DNA seroconversion rate, HBeAg seroconversion rate and adverse events incidence.Conclusion:The systematic review will provide evidence to assess the efficacy and safety of OM in the treatment of HBC.PROSPERO registration number:PROSPERO CRD42018095275.

Background. HeChan tablet (HCT) is a traditional Chinese medicine preparation extensively prescribed to treat lung cancer in China. However, the pharmacological mechanisms of HCT on lung cancer remain to be elucidated. Methods. A comprehensive network pharmacology-based strategy was conducted to explore underlying mechanisms of HCT on lung cancer. Putative targets and compounds of HCT were retrieved from TCMSP and BATMAN-TCM databases; related genes of lung cancer were retrieved from OMIM and DisGeNET databases; known therapeutic target genes of lung cancer were retrieved from TTD and DrugBank databases; PPI networks among target genes were constructed to filter hub genes by STRING. Furthermore, the pathway and GO enrichment analysis of hub genes was performed by clusterProfiler, and the clinical significance of hub genes was identified by The Cancer Genome Atlas. Result. A total of 206 compounds and 2,433 target genes of HCT were obtained. 5,317 related genes of lung cancer and 77 known therapeutic target genes of lung cancer were identified. 507 unique target genes were identified among HCT-related genes of lung cancer and 34 unique target genes were identified among HCT-known therapeutic target genes of lung cancer. By PPI networks, 11 target genes AKT1, TP53, MAPK8, JUN, EGFR, TNF, INS, IL-6, MYC, VEGFA, and MAPK1 were identified as major hub genes. IL-6, JUN, EGFR, and MYC were shown to associate with the survival of lung cancer patients. Five compounds of HCT， quercetin, luteolin, kaempferol, beta-sitosterol, and baicalein were recognized as key compounds of HCT on lung cancer. The gene enrichment analysis implied that HCT probably benefitted patients with lung cancer by modulating the MAPK and PI3K-Akt pathways. Conclusion. This study predicted pharmacological and molecular mechanisms of HCT against lung cancer and could pave the way for further experimental research and clinical application of HCT.

Background Symptomatic knee osteoarthritis (KOA) is common in China. Pharmacological therapy is not the first recommendation because of its safety issues. Nonpharmacological therapy, such as lifestyle adjustments, weight loss, muscle strengthening, and aerobic exercise programs, is strongly recommended for KOA. However, these approaches may fail due to poor patient compliance. There is a lack of high-quality randomized controlled trials of acupotomy, an effective treatment for KOA. This study was designed to investigate the efficacy of acupotomy in patients with KOA. Methods A total of 136 patients will be enrolled at the First Affiliated Hospital of Guangzhou University of Chinese Medicine and assigned to the acupotomy group or sham acupotomy group according to the block randomization scheme. Patients in the acupotomy group will receive 2 sessions of acupotomy for 2 weeks (once a week). Patients in the sham group will receive 2 sessions of sham stimulation for 2 weeks (once a week). All patients will use indomethacin cream externally. The primary outcome will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the secondary outcomes will be the visual analog scale (VAS) score, plantar pressure distribution test result, X-ray examination findings, musculoskeletal ultrasound findings, maximum knee circumference, joint mobility, and quality of life. Measurements will be taken at baseline, 1 week after the end of treatment, and at the 3- and 6-month follow-ups. Discussion To the best of our knowledge, this will be the first single-blind, sham-controlled study of acupotomy. The outcome assessors will also be blinded. The aim of this work is to demonstrate the efficacy of acupotomy in treating KOA. Trial registration Chinese Clinical Trial Registry ChiCTR2000033047. Registered on 18 May 2020.

Objective To assess the effects and safety of berberine combined with triple therapy on Helicobacter pylori (H. pylori) eradication in adults. Methods PubMed, MEDLINE, EMBASE, Cochrane Library, and Chinese databases including China National Knowledge Infrastructure (CNKI), Wanfang data, Chinese Technology Journal Full-text Database (VIP), and China biomedical literature database (CBM) were searched to obtain the eligible studies published up to October 10, 2017. The primary outcome was eradication rate of H. pylori. The secondary outcome was incidence of adverse effects. Data analysis was conducted by RevMan5.2 and Stata V.9.0 software. Trial sequential analysis (TSA) was performed to assess the risk of random error and the validity of conclusion with TSA program version 0.9 beta. Results The meta-analysis results indicated berberine combined with triple therapy could improve the eradication rates of H. pylori (urea breath test subgroup: RR=1.18, 95%CI=(1.12,1.24), P < 0.00001, biopsy subgroup: RR=1.23, 95%CI=(1.13,1.34), P < 0.00001) and reduce the total occurrence of adverse effects (OR=0.59, 95%CI(0.46, 0.75), P < 0.0001) when compared with only using triple therapy. Besides, the incidence of nausea (OR=0.59, 95%CI(0.41, 0.86), P < 0.05) and diarrhea (OR=0.41, 95%CI(0.24, 0.71) was remarkably lower in experimental group while that of abdominal distention (OR=0.64, 95%CI(0.40,1.04), P > 0.05) and vomiting (OR=0.65, 95%CI(0.37, 1.15), P > 0.05) had no significant change. TSA of H. pylori eradication rates and adverse effects incidence illustrated that the cumulative value of Z-curve went across the conventional boundary value, trial sequential monitoring boundary for benefit, and required information size, suggesting the results were stable. Conclusion Evidence from meta-analysis suggested that berberine combined with triple therapy can be an option for increasing H. pylori eradication rates and reducing overall therapy-related adverse effects incidence, particularly nausea and diarrhea, whereas more randomized controlled trials designed according to CONSORT statement are demanded to support the efficacy in further studies.

Background: Warm needle acupuncture (WNA) is an integral part of the acupuncture therapy, which combines acupuncture and moxibustion. Children with cerebral palsy (CP) is a common disease in children, which seriously affects children's growing development, physical and mental health. The clinical practice indicates that WNA has a therapeutic effect on children with CP. Here we will provide a protocol to explore the effectiveness and safety of WNA for children with CP. Methods: We will search the randomized controlled trails (RCT) literatures of WNA for children with CP in 5 English databases [PubMed, Web of Science, EMBASE, the Cochrane Central Register of Controlled Trials (Cochrane Library), and WHO International Clinical Trials Registry Platform (ICTRP)] and 4 Chinese databases [Chinese National Knowledge Infrastructure (CNKI), Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database (CBM)]. Activity of Daily Living Scales (ADL) of the patient will be considered as the primary outcome and the secondary outcome will include 88 items of gross motor function scale (GMFM-88), Gesell Growth Table (GGT), Criteria for judging efficacy and adverse events caused by WNA such as dizziness, nausea, vomiting, weariness, etc. The selection of the studies will be performed by EndnoteX7 software. And we will conduct all analyses with RevMan software V5.3. Result: This study will provide a rational synthesis of current evidences for WNA on children with CP. Conclusion: The conclusion of this study will provide evidence to judge the effectiveness and safety of WNA on children with CP. Registration PROS-PERO CRD42019122034

BackgroundSymptomatic knee osteoarthritis patients are common in China. Pharmacologic therapy is not the first recommendation because of its safety issues. Non-pharmacologic therapy, such as lifestyle adjustments, weight loss, and proper exercise is strongly recommended to use in knee osteoarthritis. But the adherance rate is very poor. Acupotomy therapy, as an effective treatment for knee osteoarthritis, is lack of high quality randomized controlled trials. This study set out to investigate the efficacy of acupotomy in patients with knee osteoarthritis.Methods136 patients will be enrolled in the First Affiliated Hospital of Guangzhou University of Chinese Medicine, and assigned into acupotomy group or sham acupotomy group according to the block randomization number. The acupotomy group will receive 2 sessions of acupotomy for 2 weeks(once a week). The sham group will receive 2 sessions of sham stimulation for 2 weeks༈once 2 week. All the patients will use indomethacin cream externally. The primary outcome is the WOMAC index and the secondary outcomes are VAS, plantar pressure distribution test, X-ray examination, musculoskeletal ultrasound, maximum knee circumference, and joint mobility. We will measure them at baseline, one week after the end of treatments, the third month and sixth month follow up.DiscussionAs we know, this is the first single-blinding and sham controlled design in acupotomy research. We aim to prove the efficacy of acupotomy in treating knee osteoarthritis.Trial registrationChinese Clinical Trial Registry: ChiCTR2000033047(2020-5-18).

Background: Warm needle acupuncture (WNA) is an integral part of the acupuncture therapy. Chronic renal failure (CRF) is a common disease, which is a type of kidney disease characterized by a slow and progressive decline in renal function. The clinical practice indicates that WNA has a therapeutic effect on CRF. Therefore, we will provide a protocol to explore the effectiveness and safety of WNA for CRF. Methods: We will search the randomized controlled trials literatures of WNA for CRF in 5 English databases (PubMed, Web of Science, EMBASE, the Cochrane Central Register of Controlled Trials [Cochrane Library], and World Health Organization International Clinical Trials Registry Platform) and 4 Chinese databases (Chinese national knowledge infrastructure, Chinese Scientific Journal Database Information, Wanfang Database, and Chinese biomedical literature database). The renal function will be considered as the primary outcome and the secondary outcome will include curative effect, security, syndrome according to standards for assessing traditional Chinese medicine, adverse events caused by WNA, such as dizziness, nausea, vomiting, weariness, and so on. We will use EndnoteX7 software to perform the selection of the studies. And all analyses will be conducted by using RevMan software V5.3. Result: This study will provide a rational synthesis of current evidences for WNM on CRF. Conclusion: The conclusion of this study will provide evidence to judge the effectiveness and safety of WNA on CRF. Registration: PROS-PERO CRD42019144530