Quality assessment of reporting items in randomized controlled trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer / 国际生物医学工程杂志

Objective To evaluate the reporting item quality of randomized controlled trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer. Methods The terms including Chinese medicine, Chinese herbal medicine, randomized controlled trials, and non-small cell lung cancer were searched in Chinese and English databases by computer systems to collect relevant literatures. Based on the CONSORT 2010 (consolidated standards of reporting trials 2010), the reporting item quality of the abstracts and main text in eligible papers was evaluated. Results Ninety-five eligible studies were identified from 692 potential eligible articles. None reported all of abstract and main text items in CONSORT 2010. Only 4.12％could be identified as the randomized trial in the title. More than 40％of reports showed the scientific background or rationale in the abstract but not in the main text. Three (3.16％) eligible reports defined the primary or secondary outcome measures. None reported complete information of subjects throughout the clinical trial process. Results A total of 95 eligible papers were collected, of which 0 papers reported complete abstracts and text entries according to the CONSORT. The titles of 4.12％papers were identified as randomized trials. More than 40％of the papers only reported the study purpose or hypothesis in the abstract. 3.16％of the papers reported primary and secondary efficacy index entries, and 0 papers reported complete information of subjects from enrollment to included data analysis sets. Conclusion There is a serious problem of items shortage in the literatures of randomized controlled clinical trials on Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer. The randomized controlled clinical trials of Chinese herbal medicine as an adjunctive therapy for advanced non-small cell lung cancer should be reported based on the CONSORT to improve the quality of trials.

Changes in dental esthetic perceptions of patients subjected to inoffice tooth bleaching / Mudanças nas percepções estéticas odontológicas de pacientes submetidos a clareamento dental de consultório

Objective: This study evaluated changes in the esthetic perceptions of patients subjected to inoffice tooth bleaching. Material and Methods: Fifty participants included in a clinical trial evaluating the in-office tooth bleaching answered two questionnaires about their dental esthetic perceptions. The participants answered the Orofacial Esthetic Scale (OES) questionnaire and the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) before and after treatment. The average scores observed at baseline were compared with those recorded after tooth bleaching using the paired t-test or the Wilcoxon signed rank test (α = 0.05). Results: Improvement in tooth color (reduction of 5.1 shade guide units) had a positive impact on patients' perceptions. According to PIDAQ, tooth bleaching significantly increased the psychological impact and dental selfconfidence; and reduced esthetic concerns. The OES demonstrated improvements in participants' satisfaction for all questions, except for the one on "facial appearance". However, higher effect size was observed for the question related to tooth color, as expected. Conclusion: Tooth bleaching was associated with an overall improvement in dental esthetic perception, even when only tooth color was affected. (AU)

Objetivo: Este estudo avaliou mudanças nas percepções estéticas de pacientes submetidos a clareamento dental de consultório. Material e Métodos: Cinquenta pacientes incluídos em um ensaio clínico avaliando clareamento dental de consultório responderam a dois questionários sobre suas percepções estética odontológicas. Os participantes responderam ao questionário de escala estética orofacial (EEO) e o questionário de impacto psicossocial da estética orofacial (PIDAQ) antes e após o tratamento. As médias dos escores no início do tratamento foram comparados com aqueles mensurados após o clareamento usando o teste-T pareado ou de Wilcoxon (α = 0,05). Resultados: Melhora na cor dental (redução de 5,1 unidades da escala de cor) teve um impacto positivo nas percepções dos pacientes. De acordo com PIDAQ, o clareamento dental significativamente aumentou o impacto psicossocial e autoconfiança dental, e reduziu as preocupações estéticas. O EEO demonstrou melhora na satisfação dos participantes para todas as questões, exceto para a de "aparência facial". Entretanto, maior efeito foi observado para a questão relacionada à cor dos dentes, como esperado. Conclusão: O clareamento dental foi associado com um aumento geral na percepção estética odontológica, mesmo que apenas a cor dos dentes foi afetada. (AU)

Endorsing and enhancing ophthalmological clinical research in China / 中华实验眼科杂志

Although there are numerous case resource,there still exist a relatively long distance in clinical research in China in comparison with developing countries because of inadequate recognition and funding,which has greatly affected the development of standardization of clinical medical in China for the past few decades.With the deepening of recognition and increasing of special support to clinical medical research in China,the development based on clinic research will face new opportunities.As a result,it is necessary for ophthalmologists to explore clinical issues,leverage from the mega trend of clinical research and deliver high-quality results.To achieve this goal,ophthalmologists will have to constantly update their knowledge base,standardize clinical practice and improve diagnosis methods.So far,challenges persist in clinical research in ophthalmology as follows:It is difficult to get funding for clinical research project;It is difficult to get ethnics approval for clinical research project;The research design for forward-looking projects is yet to be standardized;Cross-disciplinary collaboration needs to be enhanced.This review was expected to inspire more attention from clinical research specialists and consequently more highquality clinical studies.

A Meta-Analysis Comparing Open-Label versus Placebo- Controlled Clinical Trials for Aripiprazole Augmentation in the Treatment of Major Depressive Disorder: Lessons and Promises

OBJECTIVE: The present study is to provide whether open-label studies (OLS) may properly foresee the efficacy of randomized, placebo-controlled trials (RCTs) using OLSs and RCTs data for aripiprazole in the treatment of MDD, with the use of meta-analysis approach. METHODS: A search of the studies used the key terms "depression and aripiprazole" from the databases of PubMed/PsychInfo from Jan 2005 through July 2013. The data were selected and verified for publication in English-based peer-reviewed journals based on rigorous inclusion criteria. Extracted data were delivered into and run by the Comprehensive Meta Analysis program v2. RESULTS: The pooled SMDs for the primary efficacy measure was statistically significant, pointing out the significant reduction of depressive symptoms after aripiprazole augmentation (AA) to current antidepressant treatment in OLSs (pooled SMD=-2.114, z=-9.625, p<0.001); similar results were also found in RCTs (pooled SMD=-2.202, z=-6.862, p<0.001). The meta-regression analysis revealed no influence of the study design for treatment outcome. CONCLUSION: There was no difference in the treatment effects of aripiprazole as an augmentation therapy in both OLSs and RCTs, indicating that open-label design may be a potentially useful predictor for treatment outcomes of controlled-clinical trials. The proper conduction of OLSs may provide informative, useful and preliminary clinical data and factors to be involved in controlled-clinical trials, by which we may have better understanding on the role of AA (e.g., dosing issues, proper duration of treatment, specific population for AA) implicated in the treatment of MDD in clinical practice.

Understanding noninferiority trials / 소아과

Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

A multi-center, randomized, controlled, double blind and double dummy clinical trial of antofloxacin hydrochloride tablet versus levofloxacin tablet for the treatment of acute bacterial infections / 中华内科杂志

Objective To evaluate the clinical efficacy and safety of antofloxacin hydrochloride tablet for the treatment of acute bacterial infections. Methods A multi-center randomized control, double blind and double dummy clinical trial was conducted; levofloxacin tablet was chosed as controlled drug. The duration of treatment was 7-14 days in both groups. Results A total of 719 patients were enrolled in the study, in which 359 patients treated with antofloxacin and 360 patients treated with levofloxacin were included. Three hundred and thirty and 337 patients completed the study and met with all the criteria for perprotocol analysis, respectively. By the end of chemotherapy, the cured rates in per protocol set (PPS)population were 79.7% and 77.4%, the effective rates were 95.2% and 96. 7%, and the bacterial clearance were 96. 7% and 97. 5% for the treating and control group, respectively. The clinical and bacterial efficacy of antofloxacin and levofloxacin was comparable by the analysis of infectious sites. Three hundred and fifty-seven and 356 patients in antofloxacin and levofloxacin groups were evaluated the safety.The drug adverse events occurred both in 10. 1%, and drug adverse reactions accurred in 7. 8% and 7.9%patients in the two groups. The most common drug adverse reactions were mild gastroenteric symptoms. No QTc prologation was detected in all the patients. One patient in each group had mild blood glucose increase at the end of therapy, but the glucose returned to normal level without any intervention. No statistic significant difference between the two groups in clinical efficacy and safety was detected (P＞0.05).Conclusions Antofloxacin hydrochloride tablet was effective and safe for the treatment of acute bacterial infections.

Terapias cognitivo-comportamentais, terapias cognitivas e técnicas comportamentais para o transtorno de ansiedade social / Cognitive behavioral-therapies, cognitive therapies and behavioral strategies for the treatment of social anxiety disorder

CONTEXTO: Pacientes com transtorno de ansiedade social respondem de forma distinta a diferentes tipos de terapias cognitivas e/ou comportamentais, o que motiva a avaliação das melhores técnicas para o tratamento desse transtorno. OBJETIVO: Realizar uma revisão sistemática de estudos controlados que avaliaram a eficácia das técnicas cognitivo e/ ou comportamentais na redução do transtorno de ansiedade social. MÉTODO: Análise sistemática de ensaios clínicos randomizados indexados nas seguintes bases de dados: PubMed/MedLine, PsycINFO, Registro Cochrane de Ensaios Controlados, LILACS, ISI/Web of Science e em artigos relacionados. RESULTADOS: Não se encontrou consenso sobre a eficácia da associação da terapia cognitiva com técnicas comportamentais. Novas técnicas (tratamento por realidade virtual, tarefa de casa via computador e autoterapia com assistência terapêutica) demonstraram ser tão eficazes quanto aquelas utilizadas na terapia cognitivo-comportamental (TCC) padrão. A associação da TCC com evitação de comportamentos de segurança e com o treino de habilidades sociais apresentou vantagem adicional em relação ao modelo convencional. Entre as técnicas comportamentais, o treino em tarefa de concentração e a exposição foram as estratégias mais eficazes. O tratamento individual foi mais efetivo do que em grupo e o modelo de sessões semanais foi mais eficaz do que sessões no mínimo quinzenais. CONCLUSÃO: Os estudos avaliados confirmaram que tanto técnicas cognitivas quanto comportamentais (convencionais e inovadoras) são eficazes no tratamento do transtorno de ansiedade social.

BACKGROUND: Patients with social anxiety disorder (SAD) exhibit distinctive patterns of response to different types of cognitive and/or behavioral treatment. Therefore, it is imperative to assess the best techniques used for the treatment of this disorder. OBJECTIVE: The aim of this paper is to perform a systematic review of controlled studies that evaluated the efficacy of cognitive and/or behavioral techniques on the treatment of SAD. METHOD: A systematic analysis of randomized clinical trials indexed in the following databases was made: PubMed/MedLine, PsycINFO, Cochrane Controlled Trials Register, LILACS, ISI Web of Science, and related articles. RESULTS: No consensus on the efficacy of associating cognitive and behavioral therapies was found. Novel techniques (such as virtual reality, bycomputerhomework,and self therapy with therapeuticassistance) werefoundto be as effectiveasstandardcognitivebehavioral therapy (CBT). The association of CBT with the avoidance of safety behaviors, as well as with social skills training was associated with an additional advantage. As for behavioral therapy, focus training and exposure therapy were considered to be the most effective techniques. Further, individual treatment was more effective than group therapy, and weekly sessions were associated with better results than those occurring at least every other week. DISCUSSION: Both cognitive and behavioral (standard and innovative) therapies are effective for treating social phobia.