The Effect of Traditional Chinese Medicine on Postviral Olfactory Dysfunction: A Systematic Review and Meta-Analysis.

Objective: The aim of this study is to evaluate the efficacy and safety of traditional Chinese medicine (TCM) for postviral olfactory dysfunction (PVOD). Methods: PubMed, EMBASE, Cochrane Central Register of Controlled Trials, China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Chinese Biomedical and Medical (CBM) Database, and Wanfang Database were electronically searched from their inception to July 25, 2022. Two authors independently performed study selection, data extraction, and quality assessment to ensure systematic quality evaluation. Randomized controlled trials (RCTs) comparing TCM with olfactory training and/or drug therapy (OTDT) were included. The outcomes were the effective rate, QOD-P, TDI score, UPSIT score, and adverse effects. Cochrane RoB was the guideline used to evaluate the methodological quality of the included trials. RevMan 5.3 software was used for statistical analysis. Results: A total of 6 RCTs involving 467 patients with PVOD were selected. Compared with OTDT, TCM plus OTDT decreased QOD-P (MD = -1.73, 95% CI (-2.40, -1.06), P < 0.0001) but did not increase the effective rate (T&T) (RR = 1.28, 95% CI (0.86, 1.90), P=0.22, I 2 = 61%). Compared with no treatment, TCM seemed to increase the treatment success rate (UPSIT) (RR = 3.17, 95% CI (1.78, 5.65), P < 0.0001, I 2 = 0%), but there was no statistically significant difference in improving the UPSIT score (MD = 3.44, 95% CI (-1.36, 8.24), P=0.16). Compared with drug therapy, TCM plus drug therapy appeared to increase the effective rate (ΔVAS) (RR = 2.36, 95% CI (1.41, 3.94), I 2 = 0%), but there was no statistically significant difference in improving the TDI score (MD = 2.10, 95% CI (-1.99, 6.19), P=0.31). No significant differences in adverse reactions were reported between TCM and OTDT. Conclusion: TCM may be an effective treatment for PVOD. With a lack of high-quality RCTs, further large-scale and high-quality RCTs are still warranted.

Ginger Constituent 6-Shogaol Attenuates Vincristine-Induced Activation of Mouse Gastroesophageal Vagal Afferent C-Fibers.

Chemotherapeutic agent-induced nausea and vomiting are the severe adverse effects that are induced by their stimulations on the peripheral and/or central emetic nerve pathways. Even though ginger has been widely used as an herbal medicine to treat emesis, mechanisms underlying its neuronal actions are still less clear. The present study aimed to determine the chemotherapeutic agent vincristine-induced effect on gastroesophageal vagal afferent nerve endings and the potential inhibitory role of ginger constituent 6-shogaol on such response. Two-photon neuron imaging studies were performed in ex vivo gastroesophageal-vagal preparations from Pirt-GCaMP6 transgenic mice. Vincristine was applied to the gastroesophageal vagal afferent nerve endings, and the evoked calcium influxes in their intact nodose ganglion neuron somas were recorded. The responsive nodose neuron population was first characterized, and the inhibitory effects of 5-HT3 antagonist palonosetron, TRPA1 antagonist HC-030031, and ginger constituent 6-shogaol were then determined. Vincristine application at gastroesophageal vagal afferent nerve endings elicited intensive calcium influxes in a sub-population of vagal ganglion neurons. These neurons were characterized by their positive responses to P2X2/3 receptor agonist α,ß-methylene ATP and TRPA1 agonist cinnamaldehyde, suggesting their nociceptive placodal nodose C-fiber neuron lineages. Pretreatment with TRPA1 selective blocker HC-030031 inhibited vincristine-induced calcium influxes in gastroesophageal nodose C-fiber neurons, indicating that TRPA1 played a functional role in mediating vincristine-induced activation response. Such inhibitory effect was comparable to that from 5-HT3 receptor antagonist palonosetron. Alternatively, pretreatment with ginger constituent 6-shogaol significantly attenuated vincristine-induced activation response. The present study provides new evidence that chemotherapeutic agent vincristine directly activates vagal nodose nociceptive C-fiber neurons at their peripheral nerve endings in the upper gastrointestinal tract. This activation response requires both TRPA1 and 5-HT3 receptors and can be attenuated by ginger constituent 6-shogaol.

Effect of Pulmonary Rehabilitation on Postoperative Clinical Status in Patients with Lung Cancer and Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis.

Pulmonary rehabilitation (PR) has a curative effect in patients undergoing pneumonectomy for lung cancer. Nevertheless, the contribution of PR to the clinical status of patients with chronic obstructive pulmonary disease (COPD) undergoing lung resection has not been adequately elucidated. The aim of this systematic review of randomized and nonrandomized controlled trials was to appraise the impact of PR compared to conventional treatment based on postoperative clinical status in patients with lung cancer and COPD. Literature in English from PubMed, Cochrane Library, Science Citation Index, and Embase databases and in Chinese from the Chinese National Knowledge Infrastructure and the WANFANG Database was retrieved from inception to November 2021, employing the keywords "Pulmonary Neoplasms," "Chronic Obstructive Pulmonary Diseases," "Physical Therapy Modalities," and "pulmonary rehabilitation." Only studies that reported PR results were included. This review was registered in the International Prospective Register of Systematic Reviews (number: CRD42021224343). A total of nine controlled trials with 651 patients were included. Postoperative pulmonary complications (PPCs) were the primary outcome measure. PR decreased the risk of complications after surgery compared to regular treatment (odds ratio (OR) 0.21, 95% confidence interval (CI) 0.12-0.37, P < 0.01). PR reduced the risk of pneumonia after surgery compared to regular treatment (OR 0.36, 95% CI 0.15-0.86, P=0.02). There was a significant difference in the postoperative length of stay (mean difference -2.13 days, 95% CI -2.65 to -1.61 days, P < 0.05). PR was an effective intervention that decreased PPCs in patients suffering from lung cancer and COPD. However, due to the limitations of the available data, the results should be interpreted with caution.

Effectiveness of intervention for aromatase inhibitor-associated musculoskeletal symptoms: A protocol for systematic review and meta-analysis.

BACKGROUND: Aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) are among the most common prominent side effects in patients using aromatase inhibitors (AIs) for breast cancer. Muscle and joint pain, morning stiffness, arthritis, and bone loss are common clinical symptoms in individuals. Traditional Chinese medicine (TCM) has been demonstrated to be useful in the treatment of AIMSS in previous investigations, although the sample sizes were limited, and systematic reviews were inadequate. The effectiveness and safety of TCM in the treatment of AIMSS will be investigated in this study. METHODS: Randomized controlled trials from January 2010 to October 2021 were limited to English or Chinese. We searched PubMed, EMBASE, Cochrane Library, Web of Science, Medline, China Biomedical Database (CBM), China National Knowledge Infrastructure (CNKI), Wanfang database, and the VIP database. Two researchers reviewed the literature and retrieved the data independently. Review Manager V5.3.was used to conduct the statistical analysis. RESULTS: This systematic review and meta-analysis presents the most recent data on the use of TCM to treat AIMSS and offers a scientifically sound foundation for therapeutic practice. Upon completion, the findings will be submitted to a peer-reviewed journal. ETHICS AND DISSEMINATION: As the systematic review protocol did not involve human subjects, ethical approval was not required. PROSPERO REGISTRATION NUMBER: CRD42020192553.

Effects of Acupuncture and Moxibustion on Breast Cancer-Related Lymphedema: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

OBJECTIVE: The aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to evaluate the effects of acupuncture and moxibustion (AM) in women with breast cancer-related lymphedema (BCRL). METHODS: We retrieved RCTs published before January 24, 2021, from the MEDLINE, EMBASE, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Chongqing VIP (VIP), and Wanfang databases. RCTs that compared acupuncture and/or moxibustion intervention with other treatments were included. A random effects or fixed effects model was used based on the heterogeneity findings. Study quality was evaluated using the Cochrane risk of bias tool. RESULTS: We included 14 RCTs in the analyses, of which 4 RCTs adopted acupuncture, 4 RCTs used moxibustion, and the rest used both. AM significantly reduced arm circumference at the elbow crease compared to routine care (Mean deviation (MD) = -7.26, 95% confidence interval (CI) = -8.30 to -6.21, P < .00001). There was a significant difference between AM and diosmin tablets in the effective index for upper limb lymphedema (MD = 24.68, 95% CI = 24.82-30.53, P < .00001), the range of motion of the shoulder during protraction (MD = 6.77, 95% CI = 2.81-10.73, P = .0008), and adduction (MD = 4.17, 95% CI = 1.02-7.32, P = .01). There was a significant difference between moxibustion and pneumatic circulation (MD = -0.51, 95% CI = -0.85 to -0.17, P = .003) in the visual analog score (VAS) for swelling. Finally, compared to the blank control, acupuncture reduced the VAS for pain (MD = -1.33, 95% CI = -1.52 to -1.15, P < .00001; heterogeneity (I2) = 0%, P = .57). CONCLUSION: Our results suggest that AM is effective in the treatment of BCRL. AM may reduce arm circumference at the elbow crease (compared to routine care), increase effective index for upper limb lymphedema (compared to oral diosmin tablets), improve the range of motion of the shoulder during protraction and adduction (compared to oral diosmin tablets), and decrease the VAS for both swelling (compared to pneumatic circulation) and pain (compared to blank control).

Capsaicin-Sensitive Vagal Afferent Nerve-Mediated Interoceptive Signals in the Esophagus.

Heartburn and non-cardiac chest pain are the predominant symptoms in many esophageal disorders, such as gastroesophageal reflux disease (GERD), non-erosive reflux disease (NERD), functional heartburn and chest pain, and eosinophilic esophagitis (EoE). At present, neuronal mechanisms underlying the process of interoceptive signals in the esophagus are still less clear. Noxious stimuli can activate a subpopulation of primary afferent neurons at their nerve terminals in the esophagus. The evoked action potentials are transmitted through both the spinal and vagal pathways to their central terminals, which synapse with the neurons in the central nervous system to induce esophageal nociception. Over the last few decades, progress has been made in our understanding on the peripheral and central neuronal mechanisms of esophageal nociception. In this review, we focus on the roles of capsaicin-sensitive vagal primary afferent nodose and jugular C-fiber neurons in processing nociceptive signals in the esophagus. We briefly compare their distinctive phenotypic features and functional responses to mechanical and chemical stimulations in the esophagus. Then, we summarize activation and/or sensitization effects of acid, inflammatory cells (eosinophils and mast cells), and mediators (ATP, 5-HT, bradykinin, adenosine, S1P) on these two nociceptive C-fiber subtypes. Lastly, we discuss the potential roles of capsaicin-sensitive esophageal afferent nerves in processing esophageal sensation and nociception. A better knowledge of the mechanism of nociceptive signal processes in primary afferent nerves in the esophagus will help to develop novel treatment approaches to relieve esophageal nociceptive symptoms, especially those that are refractory to proton pump inhibitors.

Effects of traditional Chinese medicine combined with chemotherapy for extensive-stage small-cell lung cancer patients on improving oncologic survival: study protocol of a multicenter, randomized, single-blind, placebo-controlled trial.

BACKGROUND: Extensive-stage small-cell lung cancer (ES-SCLC) is characterized by extensive metastases, aggressive progression, and poor prognosis. Chemotherapy is applied as a preferred first-line regimen for ES-SCLC, but inadequate for improving its overall survival. Traditional Chinese medicine (TCM) is widely used in the clinical practice of ES-SCLC for its synergy with chemotherapy. However, there is still no substantial evidence to prove that TCM can effectively improve the long-term efficacy of ES-SCLC patients. The study intends to determine whether the TCM with chemotherapy can improve the overall survival (OS) in treating with ES-SCLC when compared with chemotherapy alone. METHOD/DESIGN: A multicenter, randomized, single-blind, placebo-controlled clinical trial will be conducted to determine whether the TCM granules combined with chemotherapy can improve the OS of ES-SCLC. Two hundred seventy participants will randomly receive 4-6 cycles (21 days per cycle) of chemotherapy plus TCM granules or placebo. The primary outcome measure is OS. The secondary outcome measures includes progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and tumor markers. Visits will be performed at the end of each cycle during the treatment period and then every 3 months in the follow-up period until the patients' death or study completion. DISCUSSION: The study's result will provide a high-level evidence for TCM granules using with chemotherapy on the first-line treatment of ES-SCLC. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900022991 . Registered on 6 May 2019 (prospective registration).

Clinical characteristics and prognostic analysis of Lung Cancer patients with Hypercoagulability: A single-center, retrospective, real-world study.

Objective: We explored the clinical regularity and prognosis of lung carcinoma (LC) patients with hypercoagulability, which is often associated with the occurrence and development of tumors. Methods: This retrospective study analyzed 624 LC patients diagnosed from 2010-2017 in the Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, China. Kaplan-Meier analysis was used to estimate survival and the log-rank test was used to identify differences in survival between groups. The predictive power of a hypercoagulation model was tested using receiver operating characteristic (ROC) curve analysis. Univariate and multivariate Cox regression analyses were performed to explore independent factors associated with survival. A logistic regression model was used to explore factors related to hypercoagulability. The diagnostic power of relevant influencing factors on hypercoagulability was tested using ROC curve analysis. Results: Of 624 patients in the study, 161(25.8%) had hypercoagulability and 463 did not (normal group). The overall survival (OS) of the hypercoagulability group was significantly lower than the normal group (P < 0.0001). The ROC curve showed that the predictive power of the hypercoagulability model was better than that of a single coagulation indicator (P < 0.01). Both univariate and multivariate Cox regression analyses showed that hypercoagulability was an independent factor affecting the prognosis of LC (P<0.0001). The results of the logistic regression analysis showed that clinical stage (P < 0.05), cytokeratin 19 fragment (Cyfra211) (P < 0.05), and the platelet-to-lymphocyte ratio (PLR) (P < 0.05) were positively correlated with hypercoagulability. When combining clinical stage, Cyfra211, and the PLR to predict hypercoagulability, the area under the ROC curve was 0.797 (P < 0.01). Conclusions: In LC, hypercoagulability is an independent factor associated with poor OS and could be a prognostic factor.

The effect of traditional Chinese medicine treatment for post-viral olfactory dysfunction: A protocol for systematic review and meta-analysis.

BACKGROUND: Post-viral olfactory dysfunction (PVOD) have been reported in infections caused by several respiratory viruses, especially in COVID-19 which influence severely the quality of life of affected subjects. Few study has been published on the treatment of PVOD. Traditional Chinese medicine (TCM) is an effective method for PVOD which effects and safety have been confirmed. Therefore, this study is aim to evaluate the effects of TCM on PVOD. METHODS: A searching strategy will be carried out mainly in the following databases in English and Chinese, PubMed, EMBASE, Cochrane Central Register of Controlled Trials, China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Chinese Biomedical and Medical Database (CBM), and Wanfang Database. Only randomized controlled trials related to TCM for PVOD will be included to enhance effectiveness. The primary outcome is the effective rate of PVOD. The secondary outcomes are included olfactory domain value examination, visual analogue scale (VAS), questionnaires of olfactory disorders (QOD), T&T olfactometer test, Sniffin ticks test, and any other clinical assessments. Two authors will independently perform study selection, data extraction, and quality assessment to ensure the quality of the systematic evaluation. Every disagreement will be deal with by the third author. Data synthesis and subgroup analysis will be performed in the Review Manager V 5.3.3. RESULTS: This study is aim to evaluate the efficacy and safety of TCM in PVOD. CONCLUSION: : This meta-analysis may provide more reliable evidence-based medical evidence for clinical practice to assist patient in relieving PVOD. 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. PROSPERO REGISTRATION NUMBER: CRD42021238977.

Huayu Pill () Promotes Fluorescent Doxorubicin Delivery to Tumors in Mouse Model of Lung Cancer.

OBJECTIVE: To study the effect and mechanism of Huayu Wan (, HYW) in combination of chemotherapy of tumor treatment. METHODS: HYW serum was added in Lewis cells to assess its impact on fluorescent doxorubicin delivery in vitro. Then, Lewis tumor cells was implanted in C57BL/6 mice via xenograft transplantation. Tumor growth was measured and signal intensity corresponding to blood flow was assessed by laser doppler perfusion imaging (LDPI). Finally, the effect of HYW on the effificacy of doxorubicin was studied. RESULTS: HYW can improve the transfer of fluorescent doxorubicin into cells. The blood flow signal in the tumor tissues of the HYW group was higher than that of the control group (P<0.01). Furthermore, HYW improved drug delivery of doxorubicin to tumor tissues, and this activity was associated with HYW-induced microvascular proliferation (P<0.01). CONCLUSIONS: HYW can promote microangiogenesis and increase blood supply in tumor tissues, which in turn may increase the risk of metastasis. At the same time, HYW increases drug delivery and improves the effificacy of chemotherapy drugs through vascular proliferation. Therefore, rational judgment must be exercised when considering applying HYW to an antitumor regimen.

Huayu Wan Prevents Lewis Lung Cancer Metastasis in Mice via the Platelet Pathway.

OBJECTIVE: To study the mechanism of Huayu Wan on the metastasis of Lewis lung cancer in mice via the platelet pathway. METHOD: Construction of the lung metastasis model by injection of Lewis cells through the tail vein. The next day, 72 mice were randomly divided into the Huayu Wan group (HYW), the aspirin group, the control group, and the normal group . Treatment was given for 5 days per week for a total of 16 days. The size and distribution of lung metastases were observed. Thromboelastography was used to detect platelet function, flow cytometry was used to analyze platelet activation, and ELISA was used to detect platelet tumor metastasis-related factor expression. RESULT: Lung weight in the control group was significantly higher than that in the HYW group (P < 0.05). The distribution of lung metastases in the control group was obviously more than that in the HYW group. The thromboelastogram showed that the R value of the control group was significantly lower than the normal group, while the R values of the HYW and aspirin groups were higher than the control group (P < 0.05). Flow cytometry analysis showed that the expression of CD62P in platelet-rich plasma in the control group was significantly higher than that in the normal group, while the expression of CD62P in the HYW and aspirin groups was lower than that in the control group (P < 0.05). In addition, ELISA showed that the expression of VEGF, bFGF, and CD62P in serum of the HYW group was significantly decreased than the control group (P < 0.05), and the expression of VEGF and bFGF in serum of the aspirin group was significantly decreased than the control group (P < 0.05). CONCLUSION: The mechanism of Huayu Wan inhibiting the metastasis of lung cancer in mice may be related to the improvement of blood hypercoagulability, the inhibition of platelet activation, and the expression of VEGF, bFGF, and CD62P.

Efficacy of acupuncture in the prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: a multi-center, single-blind, randomized, sham-controlled clinical research.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is a common and distressing side effect. We conducted this clinical trial to compare the effectiveness of true acupuncture vs. sham acupuncture in controlling chemotherapy-induced nausea and vomiting (CINV) among patients with advanced cancer. METHODS: A total of 134 participants were randomly allocated into true acupuncture (TA) (n = 68) and sham acupuncture (SA) (n = 66) groups. Participants in both groups received acupuncture session twice on the first day of chemotherapy, and once consecutively on the following 4 days. The primary outcome was using the Common Terminology Criteria for Adverse Events (CTCAE) to assess CINV. The secondary outcome measures were the Eastern Cooperative Oncology Group score (ECOG), Simplified Nutritional Appetite Questionnaire (SNAQ), and Hospital Anxiety and Depression scale (HADS). RESULTS: Compared to the SA group, the TA group didn't show significant improvement in complete response rates of chemotherapy-induced nausea and vomiting (all P > 0.05). However, the TA group could modestly reduce the severity of nausea (from day-3 to day-21, P < 0.05) or vomiting (from day-4 to day-21, P < 0.05), which is notably superior to the control group. Besides, TA promoted the nutritional status of patients with a significantly higher score comparing to the SA group on day 14 (21.82 vs.20.12, P = 0.003) and day 21 (22.39 vs. 20.43, P = 0.001). No apparent differences were found in anxiety and depression assessment between these groups. Participants in both groups were well tolerant of acupuncture therapy. There was no adverse event occurs in our study. CONCLUSION: Acupuncture as an adjunctive approach could alleviate the severity of chemotherapy-induced nausea and vomiting compared to the sham control, even though the effect of acupuncture in preventing CINV occurring is relatively modest.

A network pharmacology approach to explore active compounds and pharmacological mechanisms of epimedium for treatment of premature ovarian insufficiency.

BACKGROUND AND PURPOSE: Premature ovarian insufficiency (POI) refers to a hypergonadotropic hypoestrogenism and the condition of pre-onset ovarian function failure. Epimedium is a common traditional Chinese herbal medicine that is widely used to relieve POI in China. To systematically explore the pharmacological mechanism of epimedium on POI therapy, a network pharmacology approach was conducted at the molecular level. METHODS: In this study, we adopt the network pharmacology method, which mainly includes active ingredients prescreening, target prediction, gene enrichment analysis and network analysis. RESULTS: The network analysis revealed that 6 targets (ESR1, AR, ESR2, KDR, CYP19A1 and ESRRG) might be the therapeutic targets of epimedium on POI. In addition, gene-enrichment analysis suggested that epimedium appeared to play a role in POI by modulating 6 molecular functions, 5 cellular components, 15 biological processes and striking 52 potential targets involved in 13 signaling pathways. CONCLUSION: This study predicted the pharmacological and molecular mechanism of epimedium against POI from a holistic perspective, as well as provided a powerful tool for exploring pharmacological mechanisms and rational clinical application of traditional Chinese medicine.

The Effect of Ginkgo Biloba Dropping Pills on Hemorheology and Blood Lipid: A Systematic Review of Randomized Trials.

OBJECTIVE: A systematic review of randomized trials was performed to assess the effect of Ginkgo Biloba Dropping Pills (GBDP) on clinical hemorheology and blood lipid indicators. METHODS: The data of the Embase, Cochrane Library, PubMed, Clinical Trials, China National Knowledge Infrastructure, the Wanfang database, the VIP database, and the Sinomed were retrieved by computers from the establishment of the database to March 27, 2018, and screened and extracted by two researchers according to inclusion and exclusion criteria. Cochrane 5.0 recommended bias risk assessment tool was used to evaluate the methodological quality of the included literature, and Revman 5.3 software were used for meta-analysis. RESULTS: 10 literatures were finally selected in accordance with the standard. There were a total of 1201 cases, 608 cases in ginkgo biloba dropping pill group and 593 in routine treatment group. Compared with control group, GBDP significantly improved plasma viscosity [N=383, RR= - 0.45, 95%CI=(-0.86,-0.04), P=0.03], whole blood high shear [N=232, RR= - 0.92,95%CI=(-1.69, -0.16), P =0.02], whole blood low shear [N = 232, RR = - 2.22, 95% CI = (- 3.74, -0.7), P = 0.004], red blood cell specific volume [N =132, RR = - 4.55, 95% CI = (- 6.36, 2.73), P < 0.000 01], fibrinogen [N=243, RR=-0.60,95%CI=(-0.82,-0.39), P<0.00001], triglyceride [N=912, RR=-0.60,95%CI=(-1.12, -0.07), P =0.03], cholesterol [N=912, RR=-0.97,95%CI=(-1.41, -0.52), P <0.0001], low-density cholesterol [N=1100, RR=-0.72,95%CI=(-1.19, -0.25), P =0.003], and sensitivity analysis before and after of high-density cholesterol [N=1020, RR=0.08,95%CI=(-0.17,0.34), P =0.52] and [N=683, RR=0.27,95%CI=(0.13,0.42), P =0.0003]. And seven adverse reactions were reported. CONCLUSION: GBDP can improve hemorheology indexes, which is to reduce the blood viscosity, to improve blood lipid status, and to prevent and treat cardiocerebral and renal vascular diseases to a certain extent, with slight clinical adverse reactions. But our results were based on small amount of clinical studies with poor quality and insufficient evidence, which may lead to low credibility of conclusions. Therefore, more large-sample, multiple-center, randomized controlled clinical trials and related mechanisms researches are needed to obtain better clinical trial evidence in order to verify the further effectiveness and safety of GBDP on hemorheology.

Effects of ginger constituent 6-shogaol on gastroesophageal vagal afferent C-fibers.

BACKGROUND: Ginger has been used as an herbal medicine worldwide to relieve nausea/vomiting and gastrointestinal discomfort, but the cellular and molecular mechanisms of its neuronal action remain unclear. The present study aimed to determine the effects of ginger constituent 6-shogaol on gastroesophageal vagal nodose C-fibers. METHODS: Extracellular single-unit recording and two-photon nodose neuron imaging were performed, respectively, in ex vivo gastroesophageal-vagal preparations from wild type and Pirt-GCaMP6 transgenic mice. The action potential discharge or calcium influx evoked by mechanical distension and chemical perfusions applied to the gastroesophageal vagal afferent nerve endings were recorded, respectively, at their intact neuronal cell soma in vagal nodose ganglia. The effects of 6-shogaol on nodose C-fiber neurons were then compared and determined. KEY RESULTS: Gastroesophageal application of 6-shogaol-elicited intensive calcium influxes in nodose neurons and evoked robust action potential discharges in most studied nodose C-fibers. Such activation effects were followed by a desensitized response to the second application of 6-shogaol. However, action potential discharges evoked by esophageal mechanical distension, after 6-shogaol perfusion, did not significantly change. Pretreatment with TRPA1 selective blocker HC-030031 inhibited 6-shogaol-induced action potential discharges in gastric and esophageal nodose C-fiber neurons, suggesting that TRPA1 played a role in mediating 6-shogaol-induced activation response. CONCLUSION AND INFERENCES: This study provides evidence that ginger constituent 6-shogaol directly activates vagal afferent C-fiber peripheral gastrointestinal endings. This activation leads to desensitization to subsequent application of 6-shogaol but not subsequent esophageal mechanical distension. Further investigation is required to establish a possible contribution in its anti-emetic effects.

Chinese Medicine Yishen Jiangu Granules () on Aromatase Inhibitor-Associated Musculoskeletal Symptoms.

OBJECTIVE: To assess the effectiveness of Yishen Jiangu Granules (, YSJGG) on aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). METHODS: A single-arm, open-label study was conducted in 34 postmenopausal women with breast cancer who experienced AIMSS. Patients were treated with YSJGG for 12 weeks (12.4 g orally twice daily). The primary outcome was a change in the mean worst pain score of Brief Pain Inventory-Short Form (BPI-SF) over 12 weeks, and the second outcomes included changes in pain severity and pain-related interference of BPI-SF and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the Functional Assessment of Cancer Therapy-Breast (FACT-B), bone mineral density (BMD) and blood indices such as calcium (Ca), phosphate (P), and alkaline phosphatase (ALP). RESULTS: Of 37 women recruited, 30 initiated the therapy and 24 were evaluable at 12 weeks. The primary outcome (BPI-SF worst pain scores) achieved a 2.17-point reduction compared with baseline (5.75±1.87 vs 3.58±2.15, P<0.01). There were reductions in pain severity (decreased 1.65, P<0.01) and pain-related interference (decreased 2.55, P<0.01). The changes in WOMAC and M-SACRAH scores were similar to BPI-SF (P<0.05). In the FACT-B, only physical well-being and functional well-being were improved compared with baseline (P<0.05). No clinical differences were found in BMD, Ca, P and ALP. CONCLUSION: YSJGG is an effective and well-tolerated agent to reduce AIMSS.

Effects of the Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: A randomized, controlled clinical trial.

Aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) are prevalent among patients on AI therapy, which leads to a lower quality of life and poor adherence to AI treatment. We evaluated whether Yi Shen Jian Gu granules (YSJG) is effective and safe to relieve AIMSS in patients with breast cancer. Eligible participants were randomly assigned to the YSJG group or the placebo group. Both groups had a 12-week treatment period and a 12-week follow-up period. Brief Pain Inventory-Short Form (BPI-SF), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, and the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) were obtained at baseline and at 4, 8, 12 and 24 weeks. Of 146 participants enrolled, 84 were randomly assigned, and 77 were evaluable at 12 weeks. Baseline characteristics were comparable between two groups. The primary outcome was the differences in mean BPI-SF scores at 12 weeks. The worst pain scores decreased by 3.10 points (50.2%; 95% CI, 2.50 to 3.65) for YSJG group compared with a 1.63-point decrease (26.9%; 95% CI, 3.86 to 4.97) for the placebo group (P = 0.001). Significantly improvements were also observed for the WOMAC and M-SACRAH. Possibly YSJG-related side effects were grade 1 nausea (10%) and grade 2 diarrhea (2%). Serum follicle-stimulating hormone and serum estradiol were kept in the postmenopausal range before and after YSJG treatment. Patients with AIMSS treated with YSJG granules had significant improvements in musculoskeletal symptoms. YSJG is effective, safe and well-tolerated in managing AIMSS. TRIAL REGISTRATION: ISCTN: ISRCTN06129599 (assigned 14 August 2013).

Treatment of triple-negative breast cancer with Chinese herbal medicine: A prospective cohort study protocol.

INTRODUCTION: Triple-negative breast cancer (TNBC) is featured with the biological properties of strong aggressive behaviors, rapid disease progression, high risk of recurrence and metastasis, and low disease free survival. Patients with this tumor are insensitive to the endocrine therapy and target treatment for HER-2; therefore, chemotherapy is often used as routine treatment in clinical. Because of the fact that a considerable number of patients seek for Chinese herbal medicine (CHM) treatment after operation and chemotherapy and (or) radiotherapy, it is thus need to evaluate the correlation between Chinese herbal medicine treatment and prognosis. METHODS AND ANALYSIS: This is a multicenter, prospective cohort study started in March 2016 in Beijing. A simple of 220 participants diagnosed with TNBC were recruited from nine hospitals and are followed up every 3 to 6 months till March 2020. Detailed information of participants includes personal information, history of cancer, quality of life, symptoms of traditional Chinese medicine and fatigue status is taken face-to-face at baseline. ETHICS AND DISSEMINATION: The study has received ethical approval from the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (No.2016BL-014-01). Articles summarizing the primary results and ancillary analyses will be published in peer-reviewed journals. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-OOC-16008246.

Gubenyiliu II Inhibits Breast Tumor Growth and Metastasis Associated with Decreased Heparanase Expression and Phosphorylation of ERK and AKT Pathways.

Gubenyiliu II (GYII), a Traditional Chinese Medicine (TCM) formula used in our hospital, has shown beneficial effects in cancer patients. In this study, we investigated the molecular mechanisms underlying the beneficial effects of GYII on murine breast cancer models. GYII showed significant inhibitory effects on tumor growth and metastasis in the murine breast cancer model. Additionally, GYII suppressed the proliferation of 4T1 and MCF-7 cells in a dose-dependent manner. A better inhibitory effect on 4T1 cell proliferation and migration was found in the decomposed recipes (DR) of GYII. Moreover, heparanase expression and the degree of angiogenesis were reduced in tumor tissues. Western blot analysis showed decreased expression of heparanase and growth factors in the cells treated with GYII and its decomposed recipes (DR2 and DR3), and thereby a reduction in the phosphorylation of extracellular signal-regulated kinase (ERK) and serine-threonine kinase (AKT). These results suggest that GYII exerts anti-tumor growth and anti-metastatic effects in the murine breast cancer model. The anti-tumor activity of GYII and its decomposed recipes is, at least partly, associated with decreased heparanase and growth factor expression, which subsequently suppressed the activation of the ERK and AKT pathways.

Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side effects in patients with cancer. The introduction and development of antiemetic drugs have significantly improved the ability of clinicians to control CINV, but it is not easy to translate to practical application, owing to financial issues, provider-related barriers, and patient factors. Nondrug therapies are needed to alleviate the symptoms of CINV. Acupuncture is an appropriate adjunctive treatment for CINV, but additional evidence is needed. METHODS/DESIGN: This study is a multicenter, randomized, sham-controlled prospective clinical trial. A total of 136 participants will be randomly allocated into the intervention group (verum acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. All treatment will be given for 5 days. Participants in both groups will receive acupuncture sessions twice on the first day of chemotherapy and once consecutively on the following 4 days. Each session takes approximately 30 minutes. The primary outcome measure will be the Common Terminology Criteria for Adverse Events to assess CINV. The secondary outcome measures will be the Eastern Cooperative Oncology Group score, Simplified Nutritional Appetite Questionnaire, and Hospital Anxiety and Depression scale. Safety will be assessed at each visit. DISCUSSION: The results of this trial will provide clinical evidence for the effect and safety of acupuncture for CINV. TRIAL REGISTRATIONS: ISRCTN Registry identifier: ISRCTN13287728 ). Registered on 28 February 2015. ClinicalTrials.gov identifier: NCT02369107 . Registered on 17 February 2015.