Non-drug rehabilitation for gait abnormality of Parkinson's disease: a review based on ClinicalTrials.gov / 中国康复理论与实践

ObjectiveTo investigate the current trend of non-drug therapy for gait abnormality of Parkinson's disease. MethodsThe clinical trials about non-drug therapy for gait abnormality of Parkinson's disease were retrieved from the clinical trial registration platform ClinicalTrials.gov, from inception to October 25th, 2022. The records were screened by two researchers independently, and the registration time, registration count, sample sizes, interventions, primary outcome measurements and study design, etc., were summarized and analyzed, according to the PICOS principle. ResultsA total of 218 eligible records were included. The registration count increased in recently years. Almost all of the trials (93.6%) were with a relatively small sample size less than 100, mainly 21 to 30 cases. The major intervention approach was the neuromodulation technique, however, virtual reality and robot-assisted gait training were coming to use in recent years. The primary outcome measurements were the clinical scales, the questionnaires and the exercise examinations. Randomized parallel controlled trials were the most (111, 50.9%). ConclusionThe number of non-drug therapy for gait abnormality of Parkinson's disease increased year by year. The new technologies such as virtual reality and robot-assisted gait training may be used more in the future.

Effect of metformin and rosiglitazone in non-obese polycystic ovary syndrome women with insulin resistance / 中华妇产科杂志

Objective:To investigate effects of metformin and rosiglitazone in non-obese polycystic ovary syndrome (PCOS) women with insulin resistance.Methods:Totally 200 non-obese PCOS women with insulin resistance in West China Second Hospital of Sichuan University were enrolled into this study from Sep. 2013 to Jun. 2016, and were randomly divided into two treatment groups: metformin group (1 500 mg/d) and rosiglitazone group (4 mg/d). The treatment lasted for 6 months. Their clinical and biochemical parameters were collected and compared.Results:In both groups, menstrual cycles [metformin group (37±4) days, rosiglitazone group (35±4) days] were shorter after treatment for 6 months (both P<0.01). After treatment for 6 months, body mass index [metformin group (21.6±1.6) kg/m 2, rosiglitazone group (21.7±1.7) kg/m 2] decreased in both groups (both P<0.01); decreased LH/FSH ratio (metformin group 1.67±0.80, rosiglitazone group 1.70±0.83) was also observed (both P<0.05). After treatment for 6 months, fasting insulin level [metformin group (13.5±5.1) mU/L, rosiglitazone group (12.7±5.6) mU/L] and homeostasis model assessment-insulin resistance index (metformin group 3.0±1.2, rosiglitazone group 2.8±1.2) were decreased in both groups (all P<0.01). Conclusions:For non-obese PCOS insulin resistance patients, screening of anthropometric and metabolic parameters is necessary. For PCOS with insulin resistance, lifestyle plus insulin sensitizers such as metformin could improve their clinical symptoms, correct the biochemical and metabolic dysfunction.

Re-investigation after 8 years on the publication of Chinese clinical trials after registration / 中华医学科研管理杂志

Objective To investigate the publication status and quality in registration centers and journals of Chinese clinical trials after registration.Methods The Chinese clinical trials registered on the US Clinical Trial Registration website (www.clinicaltrials.gov) before July 24,2009 were searched.China Knowledge Network (CNKI),Wanfang Database,VIP Database,PubMed,and EMbase Database were searched by computer from inception to December 31,2017,to investigate the outcome publication of these clinical trials in the registration center and journals.Results A total number of 654 clinical trials were included in this study.Only 25 clinical trials,accounted for 3.8％,published trial outcome on the US Clinical Trials Register,74 clinical trials,accounted for 11.3％,were published in the journals (effective literature).Most of the trials took 2 to 3 and in both from registration to completion and study closure to outcome publication.Conclusions The proportion and quali ty of clinical trial outcome publication in China were low,which alerting us that researcher should pay more attention to the trial outcome publication.

Hypertension Prevalence in the US Population Varies with Difference in Alpha-1 Antitrypsin Genotype: A Cross Sectional Study.

Background: The prevalence of hypertension (HTN) associated with alpha-1 antitrypsin deficiency (AATD) has been studied with indeterminate results. The aim of the study was to prospectively compare the prevalence of HTN before testing in 3 groups of individuals with subsequently normal, moderately deficient, and severely deficient genotypes of AATD with adjustment for differences in demographics and clinical variables. Methods: We performed a cross sectional study using data from the Alpha-1 Coded Testing (ACT) study. The univariate demographic and clinical factors associated with HTN were further analyzed by logistic regression analysis. Results: The prevalence of HTN was 27.2%, 20.6%, and 27.9% for individuals with normal, moderate and severe AATD, respectively (p<0.02). The prevalence of HTN increased with age and an interaction between age, alpha-1 antitrypsin deficiency genotype and HTN was identified. The relative risk of HTN among young moderately deficient individuals was 0.53 (95% CI 0.37-0.76) the risk of young PiMM and PiMS (normal genotype) individuals. There was no significant difference in the risk in older moderately deficient individuals 1.02 (95% CI 0.76-1.37) and individuals with severe AATD 1.10 (95% CI 0.71-1.68) when compared to normal genotypes. Conclusion: Moderate deficiency genotypes (PiMZ, PiSS, PiMNull) have less HTN than normal or severe deficiency genotypes, particularly in young individuals. We speculate that protease inhibitor deficiency over a lifetime allows unopposed proteolysis of vascular connective tissue.Measured comorbidities do not explain these findings. Validation of this data should occur in other AATD cohorts.

Registration and Reporting Guidelines for Clinical Trials / 대한내과학회지

Selective outcome reporting is a major problem because it has a negative impact on our scientific knowledge and is unethical as it involves research on human subjects. And inadequate quality of trials may distort the results from systematic reviews and meta-analyses. Thus, Clinical medicine tries to solve the problem of trials by making public registration before patient enrollment mandatory and encouraging to report the research outcomes by a specific guidelines. In the past few years, the registration of clinical trials and the reporting system has become routine, supported by the International Committee of Medical Journal Editors. In Korea, the clinical research registry named 'Clinical Research Information Service (CRiS)' was recently established and became a data provider as a primary registry to the World Health Organization (WHO) International Clinical Trial Registry Platform search portal. To expand the registration system and to operate them successfully and comprehensively, active participations of researchers as well as the government supports are required.

Primary registry of the WHO International Clinical Trial Registry Platform: Clinical Research Information Service (CRIS)

Publication bias has a negative impact on the ability of healthcare providers and consumers to make unbiased healthcare decisions. The demand for greater transparency of clinical trials has increased and a prospective registry has been suggested by the International Committee of Medical Journal Editors. By 2008, prospective registration was considered as an ethical requirement within the Declaration of Helsinki. In Korea, the clinical research registry named 'Clinical Research Information Service (CRIS)' was recently established and became a data provider as a primary registry to the World Health Organization (WHO) International Clinical Trial Registry Platform search portal. This means that CRIS conforms to the WHO registry criteria and that registering trials with the CRIS satisfies the trial registration policies of many medical journals. To improve the comprehensiveness and completeness of registered clinical research data, it is necessary to communicate and raise awareness of the need to register clinical trials, as well as to establish national policies on clinical trial registration.

Current clinical research environment: focus on psychiatry

The introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area.

A introdução de diretrizes internacionais de Boas Práticas Clínicas, em 1996, imediatamente seguida pela publicação da Resolução do Conselho Nacional de Saúde 196/96, abriu uma grande oportunidade para a participação de centros de pesquisa brasileiros em estudos internacionais. Tais estudos devem ser estritamente monitorados, a fim de assegurar a adesão às legislações, assim como garantir a segurança dos pacientes envolvidos. A fim de evitar possíveis conflitos de interesse durante e após o estudo, todos os aspectos relacionados devem ser claramente definidos previamente entre o pesquisador, o patrocinador e a instituição. Aspectos operacionais, tais como tempo para aprovação regulatória do estudo, métodos de recrutamento e retenção de pacientes e a logística em geral, também são importantes. Em 2005, a Rede Nacional de Pesquisa Clínica foi criada no Brasil, somando a experiência de vários centros de pesquisa ligados a hospitais de ensino. Seu objetivo é reforçar a atividade de pesquisa clínica no país, com práticas atualizadas e adequado treinamento técnico-científico. O desenvolvimento de protocolos de pesquisa que foquem as prioridades de saúde do país é outro objetivo fundamental da Rede. Aspectos gerais da pesquisa clínica e algumas particularidades em Psiquiatria são discutidos no artigo. O objetivo final de todo o trabalho nesta área de pesquisa é, sem dúvida, a busca de melhores condições de saúde e qualidade de vida da população.