[Reflections on supervision strategies of new Tibetan drug registration].

Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.

Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies.

Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs.

Can Dietary Intake of Vitamin C-Oriented Foods Reduce the Risk of Osteoporosis, Fracture, and BMD Loss? Systematic Review With Meta-Analyses of Recent Studies.

Several epidemiological studies have been performed to evaluate the association of dietary intake of vitamin C-oriented foods (DIVCF) with risk of fracture and bone mineral density (BMD) loss, but the results remain controversial. Therefore, we conducted a systematic meta-analysis to assess this correlation. We searched EmBase, PubMed, Web of Science, and the Chinese database CNKI for relevant articles published up to August 2019.

Does Routine Anti-Osteoporosis Medication Lower the Risk of Fractures in Male Subjects? An Updated Systematic Review With Meta-Analysis of Clinical Trials.

Several epidemiological articles have reported the correlations between anti-osteoporosis medication and the risks of fractures in male and female subjects, but the specific efficacy of anti-osteoporosis medication for male subjects remains largely unexplored. The aim of this study was to evaluate the correlation between anti-osteoporosis medication and the risk of fracture in relation to low bone mass [including outcomes of osteoporosis, fracture, and bone mineral density (BMD) loss] in male subjects analyzed in studies within the updated literature. Randomized controlled trials (RCTs) that analyzed the effectiveness of a treating prescription for male subjects with osteoporosis (or low BMD) and that focused on the outcomes of fracture were included.

ameliorates scopolamine-induced cognitive dysfunction.

Kai Xin San (KXS, containing ginseng, hoelen, polygala, and acorus), a traditional Chinese herbal compound, has been found to regulate cognitive dysfunction; however, its mechanism of action is still unclear. In this study, 72 specific-pathogen-free male Kunming mice aged 8 weeks were randomly divided into a vehicle control group, scopolamine group, low-dose KXS group, moderate-dose KXS group, high-dose KXS group, and positive control group. Except for the vehicle control group and scopolamine groups (which received physiological saline), the doses of KXS (0.

An exploration of the role of a fish-oriented diet in cognitive decline: a systematic review of the literature.

Epidemiological studies have presented inconsistent evidence of the correlation between a fish-oriented dietary intake (FDI) and the risk of cognitive decline. To address these controversies, we performed this systematic review of prospective studies published in December 2016 and earlier using PubMed, Embase, and Web of Science. Two independent researchers conducted the eligibility assessment and data extraction; all discrepancies were solved by discussion with a third researcher.

Is adjunctive treatment with medication of liver-soothing-oriented method beneficial for depression after cerebrovascular accident?: A PRISMA-compliant meta-analysis.

Background: Adjunctive treatment with medication of liver-soothing-oriented method (MLSM) is one of the most commonly used approaches for subjects with depression after cerebrovascular accident (DCVA) in China. The purpose of this meta-analysis was to evaluate the outcome of MLSM treatment in subjects with DCVA using relevant published literature.

Methods: The PubMed, Cochrane Library, Embase, Chinese databases of China National Knowledge Infrastructure, WanFang, Sinomed, and VIP were used to collect all publications until March 2016.

Role of Medicinal Plants for Liver-Qi Regulation Adjuvant Therapy in Post-stroke Depression: A Systematic Review of Literature.

Current evidence demonstrated certain beneficial effects of medicinal herbs as an adjuvant therapy for post-stroke depression (PSD) in China; Chai-hu (Chinese Thorowax Root, Radix Bupleuri) is an example of a medicinal plant for Liver-Qi regulation (MPLR) in the treatment of PSD. Despite several narrative reports on the antidepressant properties of MPLR, it appears that there are no systematic reviews to summarize its outcome effects. Therefore, the aim of this review was to assess the effectiveness and safety of MPLR adjuvant therapy in patients with PSD.

[A review of research on the development of instruments for therapeutic efficacy evaluation of traditional Chinese medicine].

Objective: Due to the differences between Chinese and Western cultures, Chinese version of foreign research instruments may not be totally applicable for use in evaluating the therapeutic effect of traditional Chinese medicine (TCM). Great efforts have been made by Chinese researchers to develop scales for evaluation of the therapeutic effects of TCM. This study aims to understand the current situation of research in the development of evaluation instrument in TCM.

Principles of ethics review on traditional medicine and the practice of institute review board in China.

As one of the significant parts of medical science research in China, the research on Chinese medicine (CM) reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture. Therefore, in the practice of ethics review on CM research protocols, besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study, we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values. In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics, and then attempted to summarize the key points for the bioethics review to CM researches in China, so as to serve as reference for the bioethics review to traditional and alternative medicine researches.

[Randomized controlled clinical trials for acupuncture treatment of spastic cerebral palsy children by bilateral horizontal puncturing from Yuzhen (BL 9) to Tianzhu (BL 10)].

Objective: To observe the effect of acupuncture of the body surface projection region of the pyramidal decussationes on spastic cerebral palsy (CP) so as to explore an effective therapy for it.

Methods: A total of 120 CP infant patients were randomized into control group (treated with modern rehabilitation training, n = 60) and acupuncture group (treated with acupuncture combined with modern rehabilitation training, n = 60). Four acupuncture needles were penetrated subcutaneously through the region between Yuzhen (BL 9) and Tianzhu (BL 10)equidistantly (the superficial projection region of the pyramidal decussationes), once daily for 3 months.

[Influence of acupoint-catgut-implantation on blood pressure and cardiac function in chronic congestive heart failure rats].

Objective: To observe the effect of acupoint-catgut-implantation on blood pressure and cardiac function in chronic heart failure (CHF) rats.

Methods: A total of 60 SD female rats were randomly divided into sham-operation group (sham), CHF model group, catgut-implantation group, Captopril group. CHF model was established by suprarenal abdominal artery constriction.

[Evaluation of consistency of tongue and pulse signs observed by traditional Chinese medicine clinicians].

Objective: To evaluate the consistency of tongue manifestation and pulse condition observed by traditional Chinese medicine clinicians.

Methods: Field investigation and direct inquiry were performed in the study. Two physicians from the same department judged tongue manifestation and pulse condition independently.

[A prospective comparative study of three treatment options in patients with malignant gastric outlet obstruction].

Objective: To evaluate outcomes after different treatment options including endoscopic stent placement, surgical bypass, and percutaneous gastrostomy for malignant gastric outlet obstruction (GOO).

Methods: Thirty-nine patients with GOO secondary to unresectable primary or metastatic cancer were treated with endoscopic stent placement (group 1, n=13), surgical bypass (group 2, n=21), or percutaneous gastrostomy (group 3, n=5). QLQ-STO22 form was used to assess quality of life (QOL) at baseline, 1 month, and 3 months following intervention.

[A study of scale response for Health Scale of Traditional Chinese Medicine].

Objective: To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM).

Methods: A cross-sectional investigation was carried out among 28 hospital staff members by using 151 scale descriptors. This investigation involved all the descriptors from the initial version of HSTCM.

[Comparison of pragmatic clinical trials and explanatory clinical trials].

Clinical trials are often designed as either pragmatic or explanatory. The pragmatic clinical trials are generally used for measuring the effectiveness of a treatment in common clinical practice, while the explanatory trial for measuring the efficacy of a treatment under ideal conditions. Since the methods concerning pragmatic clinical trials are less introduced in China, its archetypal features, advantages and limitations were introduced in this paper.

[Reliability and validity of Health Scale of Traditional Chinese Medicine].

Objective: To test the reliability and validity of Health Scale of Traditional Chinese Medicine (HSTCM) by means of questionnaires.

Methods: A cross-sectional survey was conducted at Liwan Community of Guangzhou, Old People's Home in Guangzhou and Outpatient Department of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 652 Chinese individuals (over 18 years old) were assessed with the 88-item version of HSTCM and World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF), which were randomly delivered to them.

[Characteristics of traditional Chinese medicine syndromes in patients with acute ischemic stroke of yin or yang syndrome: a multicenter trial].

Objective: To explore the composition characteristics of traditional Chinese medicine (TCM) syndromes in patients with acute ischemic stroke of yin or yang syndrome by investigating the characteristics of TCM syndromes at different periods after onset.

Methods: One thousand two hundred and forty-six patients with acute ischemic stroke were admitted in twenty hospitals. According to the "diagnostic criteria of syndrome differentiation of stroke", the characteristics of syndromes in the patients were investigated at the periods of 1-3 days, 4-10 days and 11-30 days after they had ischemic stroke.

[Randomized multicenter control clinical study on acute ischemic stroke treatment with traditional Chinese medicine].

Objective: To observe the effect of a comprehensive protocol of integrated Chinese and Western medicine (ICWM) in treating with acute ischemic stroke.

Methods: A multi-center, prospective, random and control clinical trial was adopted with 606 patients of acute ischemic stroke. They were divided into the treatment group (274 cases) treated with ICWM protocol, and the control group (263 cases) treated with Western medicine plus placebe, and BI, mRS were assessed after treatment.

[Problems-solving strategies in clinical treatment guideline for traditional Chinese medicine and integrative medicine].

The members of guideline development of traditional Chinese medicine and integrative medicine were not chosen according to strict standards at present. The major problems in clinical guideline development include the insufficiency of evidence and the missing recommendation according to evidence reliability. In order to establish a clinical guideline for the treatment, we should abide by the principle for guideline development in this field.

[Determination of ginsenoside rd in human plasma by LC/MS/MS].

Objective: To develop a HPLC/MS/MS method for the determination of ginsenoside Rd in human plasma.

Methods: Plasma samples were pretreated by solid phase extraction (SPE). Ginsenoside Rd (m/z 964.