Showing papers in "Journal of Evidence-based Medicine in 2010"

Effects of martial arts on health status: A systematic review

Abstract: Objective To systematically summarize the evidence for the effects of martial arts on health and fitness, to show the strengths of different types of martial arts, and to get a more complete picture of the impacts of martial arts on health, and also to provide a basis for future research on martial arts as an exercise prescription in exercise therapy. Method We searched for "martial arts"health" and "random" in eight databases (n= 5432). Randomized controlled trials and controlled clinical trials on the health effects of martial arts were included in the study. Results The final analysis included 28 papers (one general martial arts, one kung fu, sixteen tai chi, six judo, three karate, and one taekwondo). Among the disciplines of martial arts, tai chi was the most well-studied, followed by judo, karate, and taekwondo. Research topics varied widely, and included health, injuries, competition, morals and psychology, and herbal medicine. Most found positive effects on health. Tai chi is no-contact, low-impact, soft body and mindfulness exercise, which has been widely adopted by elderly people and proven to be a beneficial health promotion exercise. Research on judo, karate, and taekwondo mainly focused on improvements to athletes' competitive abilities, rather than on health effects. We did not find any published randomized controlled trials or controlled clinical trials on aikido, kendo, sumo, kyudo, qi gong, or other disciplines. Discussion and Conclusion Since martial arts are widely practiced, their effects on physiology, morphology, immunology, and neurology should be further studied in order to help people to select the best discipline or style to accomplish their purposes. This necessitates categorizing and classifying the disciplines and styles according to their effects on different body systems and levels of contact, as well as standardizing evaluation criteria for martial arts. Martial arts as an exercise prescription can then move from an experience-based to an evidence-based treatment. Language: en

Conducting research in the aftermath of disasters: ethical considerations.

Abstract: Disaster research focuses on the impact disasters have on people and social structures. Planning for and responding to disasters require evidence to guide decision-makers. The need for such evidence provides an ethical mandate for the conduct of sound disaster research. Disaster research ethics draws attention to ethical issues common to all research involving human subjects. However, disaster research involves a number of distinctive factors, including the degree of devastation affecting participants and the urgency often involved in initiating research projects. Such factors generate ethical issues not usually encountered with other types of research, and create tensions that must be taken into account in designing and conducting disaster research so that it attains the highest ethical standards. An overview of general research ethics issues is presented here in the context of disaster research. As with all research involving humans, protection of participants and minimizing harm is the highest ethical priority. Other ethical issues include formal ethical approval, informed consent, balancing burdens and benefits, participant recruitment, coercion, the role of compensation, and conflicts of interest. Using examples from specific studies, some of the distinctive features of disaster research ethics are discussed. These include cross-cultural collaboration and communication, vulnerability of participants arising from the degree of devastation, avoiding exploitation of disaster victims, and protecting researchers. The article concludes with some of the major challenges facing disaster research ethics and how they might be addressed.

Adverse drug reactions and adverse events of 33 varieties of traditional Chinese medicine injections on National Essential medicines List (2004 edition) of China: an overview on published literatures

Abstract: Objectives We conducted a literature review of 33 kinds of Traditional Chinese medicine injections(CMIs) on the national essential medicine list(2004 edition) of China in ADR articles to retrieve basic ADR information and research trends related to CMIs and to provide evidence for the research and development as well as the rational use of CMIs,particularly pharmacovigilance and risk management of CMIs.Methods We electronically searched Chinese Biomedical Literature Database(CBM,Jan.1978-April 2009),the China National Knowledge Infrastructure Database(CNKI,Jan.1979-April 2009),Chinese Science and Technology Periodical Database(VIP,Jan.1989-April 2009) and the Traditional Chinese Medicine Database(Jan.1984 April 2009).We also retrieved the websites of Ministry of Health and State Food and Drug Administration,to collect data about CMIs ADRs reports and regulations from "Newsletter of Adverse Drug Reactions"(Issue 1 to 22).Then we descriptively analyzed all the results on the year published,periodicals and types of study design of included ADR literatures,the major CMIs as well as the regulations about their ADRs.Results(1) There were 5 405 citations found in total and 2160 were removed because of duplication.After screening the title,abstract and full text of the selected papers,1 010 studies nally met the eligible criteria.(2) The total and cumulative amount of research articles published about CMIs ADRs significantly increases over time.(3) The included 1,010 articles were scattered among 297 periodicals.A total of 55 journals on pharmaceutical medicine,containing 399 articles,accounted for 39.50% of total;64 journals on traditional Chinese medicine and pharmaceutical medicine,containing only 197 articles,amounted for 19.50% of total.Only 22 periodicals were included on the core journals of the Beijing University List(2008 edition)(8.94% of the total journals in the list),which published 129 articles(12.77% of the total articles published).(4) We categorized the articles included into eight categories based on their content and study methodology.There were:348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles,119 overviews(11.78%),116 randomized controlled trials(11.49%),78 cross-sectional studies(7.72%),61 ADR literature analyses(6.04%),and 28 non-randomized controlled clinical studies(2.77%).(5) In the three of top ten journals,"Adverse Drug Reactions Journal","China Medical Herald",and "Chinese Pharmaceuticals" published literature accounted for 5.84%,3.76% and 2.67% of the total respectively.(6) The reports of ADRs to Shuanghuanglian,Qingkailing and Yuxingcao injections were the most in all reports for CMIs(All the three injections had more than 200 articles,accounting for 41.95% of the total).The Ministry of Health and the State Food and Drug Administration took measures to supervise them.(7) The four kinds of CMIs(Shuanghuanglian,Ciwujia,Yuxingcao,and Yinzhihuang injections) among the top 5 reported ADR literatures were removed from the market or were suspended for sale.The varieties and numbers of reports for CMIs ADRs have relationship with the supervision to them.Conclusions(1) Articles published on CMIs ADRs increased year by year,but overall the research is of low quality and is scattered in a large number of sources.(2) It is very urgent to create a clear standard to grade ADRs of CMIs for the risk management.(3) It is necessary to enforce safety re-evaluation work for CMIs and to promote the clinical rational use.

Improving reporting of adverse events and adverse drug reactions following injections of Chinese materia medica

Abstract: Background While reporting of adverse drug events (AE) and adverse drug reactions (ADR) following Chinese materia medica (CM) injection is becoming more common, the reporting quality is of concern. Methods A checklist about the reporting quality of AE/ADR was set up, and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example. Electronic databases Chinese Journal Net (1994–2009) and Chinese Science and Technological Journal Net (VIP) (1989–2009) were searched for target literature. Results Based on our search strategy, 210 articles were included, with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection (type I report). There were seven reports from regional or national ADR monitoring centers (type II report), and 28 summary reports from a single hospital or medical center (type III report). All 210 papers mentioned “adverse effect,”“safety” or related meaning words in their titles, but 199 articles did not have abstract. Patient demographic characteristics were not fully reported in these articles. In type I articles, only 97 cases (43.11%) mentioned whether patients had or did not have a history of allergies, whereas 128 cases (56.89%) in type II papers and 14 (50%) type III papers, did not mention allergic history of patients. Only three articles (3/210, 1.43%), all of them type I, mentioned the syndrome type in Chinese medicine. None of the papers gave clear indications of the type and grade of ADR/AE of patients. Most papers did not report details of the CM injection procedure, such as the drug company, product serial number, or the drug's validity period. Data about the occurrence time and management of ADR/AE was also inadequately reported. Conclusion and recommendations The current reporting format of ADR/AE in clinical CM injections is not standardized. Much fundamental information of ADR/AE following CM injection is therefore missing. A standard reporting format for ADR should be developed, and should include the following: (1) a title mentioning adverse effects and safety; (2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; (3) demographic characteristic of the patients (gender, age, etc.); (4) clinical characteristics of patients (disease, syndrome, etc); (5) allergic history of patients; (6) diagnosis and syndrome based on Chinese medicine theory; (7) detailed information about the CM intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); (8) concomitant drug use; (9) time and symptoms of ADR/AE; (10) type and grading of ADR/AE; (11) physiological systems affected by ADR/AE; (12) specific treatment and prognosis for ADR/AE; (13) evidence of the cause and effect of ADR/AE; and (14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.

Adverse drug reactions of Shuanghuanglian injection: A systematic review of public literatures

Abstract: Objectives To systematically evaluate the clinical characteristics of ADRs caused by Shuanghuanglian Injection (SHLI) and to provide reference for post-market evaluation and clinical application of SHLI Methods We searched electronic databases such as the Chinese National Knowledge Infrastructure (CNKI, 1979–20099), the Chinese Science and Technology Journal Full-text Database (VIP, 1989–20099), and the Chinese Biomedical Disc (CBMdisc, 1978–20099) ADR cases were analyzed according to occurrences categorized Available data was assessed using the Chi-square test including relative ratios (RR) with 95% confidence intervals (95%CI) Different medicine combinations and comparisons between SHL powder injection and SHL injection were calculated using the statistical software Stata 91 Results (1) A total of 452 articles were included with a total of 2,799 ADR cases reported Case reports were the main design type of included literature, which account for 8451% According to 31,165 cases of SHLI treatment and 1,013 corresponding ADRs, the incidence of SHLI ADR was calculated as 325% (2) The ratio of male to female in the reported ADR cases was 113:1 (3) Allergy to Penicillin, which account for 1338% of the total cases, was at the top for past allergic history, followed by sulfonamides and asthma (268%) (4) In terms of disease treated respiratory disease accounted for 9175% of all cases of SHLI ADRs, followed by digestive diseases (517%), and urinary diseases (111%) (5) Penicillins were the most common combination choice with SHLI, and such combination showed higher ADR risk than SHLI used alone (RR = 314, 95%CI 258 to 381) (6) Multiple systems/organs were involved in SHLI ADRs, and were ranked downwards according to proportion as: skin, digestive system, general reactions, respiratory system, nervous system, cardiovascular system, local reactions, urinary system, hematologic system and others (7) According to the WHO ADR Classification Criteria, ADR cases were divided into four grades There were 636%, 548%, 4562%, and 212% cases of Grade I, II, III, and IV respectively And the prognoses of the rest 5242% cases were reported unclearly (8) All cases of death were caused by allergic shock, except for one, which was caused by myocardial infarction induced by pain at the injection site The fastest ADR case occurred 1 minute after being injected (9) There was a remarkable difference (P < 005) in the rate of ADR caused by SHLI in power form (225%) and as a solution (414%) Conclusion The clinical manifestations of ADRs caused by SHLI mainly include skin allergic reactions and gastrointestinal reactions There is an increased risk of ADR induced by combined uses of SHLI and other drugs, especially antibiotics Compared to the solution, the powder has lower ADR occurrence and higher safety with statistical significance We propose strengthening management and surveillance on SHLI from manufacturing to application, and improving the level of the risk management for post-market drugs

Evidence-based medicine knowledge, attitudes, and practices among doctors in Sri Lanka.

Abstract: Objective To assess knowledge, attitudes, and practices on evidence-based medicine (EBM) among doctors in selected hospitals in Sri Lanka. Methods A cross-sectional descriptive study was conducted among 315 doctors in five government hospitals in Sri Lanka between December 2007 and January 2008. A pre-tested self-administered questionnaire was used to gather information on knowledge, attitudes, and practices. Results Of the 407 invited, 315 doctors participated, among whom, 87% (271) had heard the term EBM, 30% (n= 94) were aware of the Cochrane Library, and 8.5% (n= 27) were current users of it. Forty-seven per cent (n= 148) claimed to understand the terms systematic review and 37% (n= 115) meta-analysis. Twenty-four per cent (n= 77) had been exposed to some form of EBM training. All three components of EBM were known by 18% (n= 56) of participants. Attitudes toward EBM were positive among 76% (n= 239), 80% (n= 251) believed the practice of EBM would lead to improved patient care, and 77% (n= 243) considered EBM to be fundamental to professional practice. Just 3% (n= 13) considered it unimportant. EBM was used in clinical practice by 54% (n= 169) of participants. Thirty-six per cent (n= 114) referred to EBM sources when relevant. Available clinical guidelines were referred to by 56% (n= 176), and 34% (n= 107) thought that available guidelines provide sufficient support for the practice of EBM. The main barriers to practicing EBM were insufficient resources, overwork, lack of exposure to EBM, and lack of time and lack of endorsement of the need to practice EBM. Conclusions Knowledge and practices of EBM among Sri Lanka doctors were poor. However, attitudes toward EBM were relatively good.

Structured telephone support or telemonitoring programmes for patients with chronic heart failure: Cochrane reviews - in their own words

Abstract: Chronic heart failure is a debilitating condition, which can lead to frequent stays in hospital and shortened life expectancy. In recent years, a variety of ways to strengthen self-management and education interventions have been researched and developed. The most successful strategies involve specialist multidisciplinary disease management programs but many patients with heart failure don’t have access to these specialist services. This is either because of limited healthcare resources and services, or difficulty in attending the management programmes because of distance or disability. Structured telephone support may be defined as monitoring, self-care management or both. It is delivered using simple telephone technology, with data sometimes being collected and stored by a computer. An alternative, telemonitoring, may be defined as the transmission of physiologic data, such as an ECG, blood pressure, weight, respiratory rate, and other information, such as self-care, education, lifestyle modification and medicine administration; using other technology like broadband, satellite, wireless or blue-tooth. Both models of care have the potential to provide access to specialist care for a much larger number of patients across a much greater geographical area, while at the same time reducing the costs of care. These systems can also support patient self-management, transferring some of the burden of care from health professionals. Our Cochrane review included studies of both technologies compared to usual care for patients with chronic heart failure (1). We excluded studies that also provided intensified specialist follow-up to patients in either the intervention or the control group, because those additional resources might have confounded the effects of the interventions. We found that both structured telephone support and telemonitoring had benefits for patients. We also found that most patients reported a positive experience and little difficulty with this technology, despite the fact that the majority were over 65 years of age. More than 9500 patients had taken part in the thirty studies that we included and we were able to analyse details on deaths and hospitalisations for 25 peer-reviewed studies. The patients in these studies had been followed for three to 18 months, with many studies reporting outcomes after one year. The other five studies are currently available as abstracts only, with insufficient information and, although, we included them in a sensitivity analysis, we have kept them out of our main results of mortality and hospitalisation rates. In the trials of telemonitoring, there were fewer deaths in the patients allocated to telemonitoring compared to those in the control group. The number of deaths fell from about 150 per 1000, to 100 per 1000. No significant benefit was seen on mortality with structured telephone support. Both interventions produced statistically significant falls in the number of patients who needed to be admitted to hospital for heart failure. In the telemonitoring trials, it fell from 285 per 1000 in the control group, to 225 per 1000. The drop was similar for structured telephone support: 164 per 1000, down from 213 per 1000. Patients also found that their quality of life improved and we did detect some positive impact on healthcare costs, where this was reported. But, some of the studies didn’t report these outcomes and more detailed data are needed in order to evaluate the potential cost-savings of these interventions. In summary, telemonitoring and structured telephone support appear to lead to benefits for patients with chronic heart failure; although there are still several important issues to consider. For example, only very limited details are available on the cost-benefits and appropriate business models for these interventions; the impact of these interventions on patient quality of life has only been reported by a few studies; and the optimal duration of these interventions is unclear. We hope that these issues will be tackled in future research, which we will add to updates of this review.

Adverse drug reactions of Shenmai injection: a systematic review

Abstract: Objective To analyze adverse drug reactions (ADRs) associated with Shenmai injection and possible contributing factors. Methods We searched all clinical studies and ADR reports of Shenmai injection from the China National Knowledge Infrastructure (CNKI) database, the Data Bank of Chinese Scientific Journals (VIP), and Chinese Biomedical (CBM) database. We collected relevant information such as gender, age, allergic history, and diseases treated in ADR cases; types, occurrence times, and severity of ADRs; and menstruum and compatibility of Shenmai injection. Results Of the 1828 clinical studies of Shenmai injection, 146 (7.99%) mentioned 576 ADR cases; 181 ADR reports mentioned 246 ADR cases. The most commonly affected age group was 40 to 69 (57.32%). In 36 (14.63%) cases, patients were described as having an allergic history. The diseases treated in ADR cases were principally heart failure and coronary artery heart disease. Thirty-eight (15.45%) of the 246 ADR cases in ADR reports described anaphylactic shock, while the most common ADR reported in clinical studies was headache/dizziness. Of the 822 total reported ADR cases, 99 (12.04%) were class III, and 637 (77.50%) were class IV, and there were no fatalities. The menstruum of most Shenmai injections was 5% glucose. Incompatible drugs were given in 68 ADR cases. In ADR cases, the most common dosage of Shenmai injection was 40 to 60 ml; 215 (80.90%) ADR cases occurred in first time medication, mainly in the first 30 minutes after injection. Conclusions Current evidence shows that Shenmai injection had lower ADR occurrence, but some potential factors such as irrational compatibility, dosages may lead to a high risk of ADR. In future, clinicians should follow indications or functions to promote rational use of Chinese Medicine Injections .

Recommendations for reporting adverse drug reactions and adverse events of traditional Chinese medicine.

Abstract: Clearly report adverse effect or adverse event occurred in the clinical practice is very important for understanding the potential risk of using a drug for treatment of diseases, and with other advantages. This document aims to help healthcare providers to organize, report, and publish information on ADR/AE occurrences and to identify the nature of the ADR/AE in TCM and integrative medicine practice. This document provides recommendations on constructing a title, basic factors of writing an abstract and the text of ADR/AE reporting. In each part, there are some samples could be references for the development of a report and ADR/AE. We welcome any comments for improving this recommendation.

The effects of immunosuppressive drugs on CD4+CD25+ regulatory T cells: a systematic review of clinical and basic research

Abstract: Objective To assess the effects of different immunosuppressive drugs on proliferation and function of regulatory T cells(Tregs).Methods We searched MEDLINE(1966 to November 2009),EMbase(from inception to September 2009),and The Cochrane Library(Issue 4,2009) for clinical and basic research about the effects of various immunosuppressive drugs on Tregs.Data were extracted and methodological quality was assessed by two independent reviewers.Outcome measures for clinical research included blood Tregs levels,acute rejection episodes,and graft function.Outcome measures for basic research included percentage of Tregs proliferation,function,Tregs phenotype,and evidence for possible mechanisms.We analyzed data qualitatively.Results Forty-two studies,including 19 clinical trials and 23 basic studies,were included.The immunosuppressive drugs studied were calcineurin inhibitors(CNIs),Rapa,anti-metabolism drugs,IL-2 receptor-blocking antibodies,T-cell depleting antibodies,and co-stimulation blockade antibodies.Most of the studies were on Rapa and CNIs.Eight basic studies on Rapa and CNIs showed that Rapa could promote the proliferation and function of Tregs,while CNIs could not.Five clinical trials involving a total of 158 patients showed that patients taking Rapa had higher blood concentration of Tregs than those taking CNIs,but no differences were found in graft function(6-42-month follow-up).Conclusion There is substantial evidence that Rapa favors Tregs survival and function.However,the larger number of the blood Tregs in the patients treated with Rapa does not show any correlation with better graft function.Large-sample and high-quality clinical studies with longer follow-up are needed to thoroughly assess the efficacy of immunosuppressive drugs on Tregs and to reveal whether a relationship exists between Tregs and graft function.

Systematic review on the compatibility of Shuanghuanglian injection combined with western medical injections.

Abstract: Objectives Shuanghuanglian injection (SHLI) is a typical Chinese herbal injection which has been used for more than 20 years. This study aims to investigate the compatibility of SHLI with western intravenous agents. Methods An extensive literature search was executed to identify all experimental tests and clinical reports on the topics. Data on the types of infusion solutions and western medical injections, usage and dosage, outcome measures for physical and chemical properties, and changes of drug effect were searched for. The included data was analyzed and described by the category of included western drugs. Compatibility was tested through integrating the evaluations of physical properties, chemical composition, drug metabolism, and safety. Results Sixty articles (38 experimental tests and 22 clinical reports) were included after screening. Fifty–three western medical injections were identified from all the included articles. Most of the research was about the compatibility of SHLI with different types of antibiotics, including β-lactam, aminoglycoside, and quinolone etc. Thirty-one western medical injections were not recommended to be combined with SHLI. The quality of the experimental test design was low because of unbalanced evaluation indicators: more attention to physical changes than drug metabolism, effect, and safety. Conclusions A broad incompatibility existed in the combination of SHLI with western medical injections. Some results were still uncertain, but the combinations should still be avoided until researched clearly. The compatibility and interaction of Chinese herbal injections and western medicines is still a weak area. The pharmaceutical sector should strengthen post-market research to update evidence and improve its distribution.

Avoiding adverse drug reactions to Chinese medicine injections.

Abstract: A total of 109 varieties of Chinese medicine injections (CMI) have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs) Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders Contributing factors of ADRs include healthcare workers' inadequate attention to ADRs of CMI, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged To decrease ADRs resulting from CMI, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs

Adverse events to Houttuynia injection: A systematic review

Abstract: Objective To systematically assess the main clinical features of Houttuynia injection-associated adverse drug reactions (ADRs), as described in published reports, and to contribute to the post-marketing re-evaluation and clinical practices of Houttuynia injection. Method We searched the electronic databases- PubMed, EMBASE, the Chinese National Knowledge Infrastructure (CNKI), the Chinese Science and Technology Journal Full-text Database (VIP) and the Chinese Biomedical Disc (CBMdisc), for articles published through June 2010. We then extracted and analyzed the data. Results A total of 645 articles were included, with a total of 1232 ADR cases reported. Respiratory diseases accounted for 52.44% of all cases of Houttuynia injection ADRs, followed by reproductive system diseases (4.30%) and urinary system diseases (3.73%). Multiple systems or organs were involved in the ADRs, the top five were: respiratory system (37.42%), skin (34.66%), digestive system (25.49%), circulatory system (25.41%), and nervous system (23.96%). Serious systemic adverse reactions accounted for 22.56% of total ADRs. Of the reported 1,232 ADR cases, 286 ADR cases reported previous allergies in detail; allergy to penicillin accounted for 15.03% of the total cases with the allergic history, followed by unknown drugs (8.05%), and sulfonamides (3.15%). Among the ADR cases, Houttuynia injection was commonly used together with cephalosporins, penicillins, and macrolides. Macrolides combined with Houttuynia injection showed higher ADR risk than Houttuynia injection used alone (RR = 8.80, 95% CI 6.12 to 12.65, P < 0.0001). The ADR risk for intravenous injection of Houttuynia injection was higher than that of intramuscular injection (OR = 6.86, 95% CI 1.88 to 56.95, P= 0.0016). We used the WHO ADR Classification Criteria to divide the ADR cases into four grades. There were 22.56%, 36.28%, 16.48%, and 24.68% cases of Grade I, II, III, and IV, respectively. Anaphylactic shock accounted for 58.99% of the most serious ADRs (Grade I). All cases of death were caused by allergic shock, except one, who died of multiple organ failure caused by anaphylactic purpura. The fastest-onset three ADR cases occurred in one minute after injection. Conclusion The respiratory system was the most common system treated in Houttuynia injection ADR cases. It was also the most common site of ADR symptoms. The ADRs of Houttuynia injection were serious. The precautions should be taken to prevent the anaphylactic shock. Intravenous injection and the combination with with cephalosporins, penicillins, and macrolides increased the ADR risk of Houttuynia injection.

Selective serotonin reuptake inhibitors for autism spectrum disorders

Abstract: Autism affects approximately 1 person in every 150. People with autism have problems with social interaction and communication and can become preoccupied with objects and routines or rituals in a way that interferes with their day to day life. Many individuals with autism have intellectual impairment, but among these people some have islets of normal or even above normal ability. Autism causes problems for the individuals and for their families and carers; and intensive services such as special education, multidisciplinary health care and community support services are often needed. Because autism is such a profound problem, parents and carers can be drawn to a wide variety of therapies. That said, the mainstay of treatment in early life is behavioural, educational and specific (such as speech) therapies. Drug treatment has a smaller, but nevertheless important, role and our Cochrane review examines the evidence for one class of these, the selective serotonin reuptake inhibitors or SSRIs (1). In recent years, prescribing of serotonin enhancing drugs has increased more than any other medication class for autism, with the rationale being that serotonin is thought to mediate some of the brain processes that are likely to occur in autism. However, the SSRIs have gained a negative reputation among children and adolescents, because they have been associated with an increased risk for suiciderelated behaviours. Amidst these doubts about the safety of the drugs, our review was needed to find out whether there is sufficient evidence on their potential benefits and harms to be able to recommend the use of serotonin enhancing drugs in autism. We found that there were few trials, most of which were small, of uncertain quality and had used a wide variety measure to measure a wide range of outcomes. From the studies available, we couldn’t find any evidence of a positive effect for children, and the results for adults were equivocal. Only one study in adults assessed depression and anxiety outcomes, and one other study assessed improvements in aggression. All the trials were short term, typically giving the drugs for a matter of weeks, even though we know that long term therapy over months and years would be required if serotonin enhancing drugs did reduce the problems created by autism. Regarding safety, a child taking citalopram in one of the trials experienced a prolonged seizure but we found no information suggesting an increase in suicide-related behaviours. After doing the review, it is clear that gaps remain in the evidence base. These gaps would be resolved by the conduct of one or two large studies with a low risk of bias to investigate the serotonin drugs that have already been studied in small trials, as well as the serotonin enhancing drugs that have yet to feature in autism research. At the moment, though, and on the basis of the available data, we cannot advise the universal use of serotonin enhancing drugs for children who have autism and no other conditions. Where someone with autism does have other problems, such as obsessive compulsive disorder, depression, or anxiety, for which serotonin enhancing drugs might also be used, decisions about the use of the drugs should be made on an individual basis.

Adverse drug reactions linked to Ciwujia injection: A systematic review of 521 cases

Abstract: Objective To analyze adverse drug reactions (ADRs) associated with Ciwujia injection and possible contributing factors. Methods We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. Relevant information such as disease treated; menstruum and compatibility of the Ciwujia injection; age, gender, and allergic history of ADR cases; and the types, occurrence time and severity of the ADRs were collected and analyzed. Results In the 800 clinical studies of Ciwujia injection's efficacy and safety, 97 (12.1%) reported 285 ADR cases. There were 144 ADR reports for the drug describing a total of 236 ADR cases. Most of the ADR reports described cases of anaphylactic shock, while the most common ADR reported in clinical studies was local pain; 27.7% of ADR cases were I to II class in all 521 cases, and four anaphylactic shock cases died. Conclusion The relevant information of ADRs for Ciwujia injection was insufficiently reported in included studies. The ADR type distribution between clinical studies and ADR reports was inconsistency. Most of the reported ADRs were mild, and were treated successfully by slowing down the drip velocity or by withdrawing the drug and treating the symptoms. As Ciwujia injection was one of the highest numbers of ADR reports of traditional Chinese medicine injections, high quality ADR monitoring, standardized ADR reporting, and timely analysis risk factors of ADRs are extremely urgent.

Risk factors for drug resistance in pulmonary tuberculosis inpatients.

Abstract: Objective To analyze risk factors for drug resistance in pulmonary tuberculosis (PTB) inpatients. Methods Medical records of PTB inpatients in Chengdu Tuberculosis Hospital (CTH) from 2005 to 2007 were investigated retrospectively. A logistic regression model was used to analyze data. Results A total of 330 records were included in the analysis. A history of tuberculosis treatment was associated with drug resistance with odds ratio (OR) 16.79 and 95% confidence interval (95% CI) [10.14, 27.80] for all patients. Among new patients, the significant risk factor was duration of illness (OR 0.27, 95% CI [0.16, 0.46]), and for previously treated patients, risk factors included age (OR 0.96, 95% CI [0.93, 0.99]), improper initial chemotherapy (OR 3.85, 95% CI [1.59, 10.00]), and improper handling by medical staff (OR 3.44, 95% CI [1.32, 8.96]). Conclusions A history of drug treatment is associated with drug resistance among PTB inpatients. Initial resistance becomes increasingly serious till 2007. To minimize the development of resistance, more personalized treatment and supervision should be used, and better training for medical staff is needed.

Emergency Management of Yushu Earthquake Tests the Wenchuan Experience

Abstract: Objective In order to verify Wenchuan experience and argue the progress and defects of national emergency management system, the emergency management of Yushu earthquake was compared with that of Wenchuan earthquake.It will provide evidences for further improving the emergency management system in China.Methods The information and data of Yushu earthquake and Wenchuan earthquake were collected from the official website and media network.Based on the information and data of Yushu earthquake, it was compared with Wenchuan experience.Descriptive analysis methods were used to demonstrate the emergency management of earthquake disaster.Results With the experience gained from Wenchuan earthquake , the emergency rescue, emergency response and reconstruction, the emergency management of Yushu earthquake were more rapid , orderly and effective.However, there were no significant improvement of the prevention and early warning in the emergency management of Yushu earthquake.Conclusions Wenchuan experience played an important role in Yushu emergency rescue and it was verified in Yushu emergency response.Comparing the four phases of emergency management between Yushu earthquake and Wenchuan earthquake, we think that prevention and early warning still need to be developed and strengthened, while response and reconstruction have been greatly improved although they are still insufficient.

The Pan African Clinical Trials Registry: year one data analysis of the only African member of the World Health Organization Network of Primary Registries.

Abstract: Background Prospective registration in a clinical trial registry is mandatory for all clinical trial research intended for publication in any International Committee of Medical Journal Editors member journal. With the launch of the Pan African Clinical Trial Registry (PACTR) in September 2009, the first African member of the World Health Organization (WHO) Network of Primary Registers came into being as the only registry dedicated specifically to trials on the African continent. Objective To examine the usefulness of PACTR as a resource for information on clinical trial activity in Africa, and to provide data on the African clinical trial landscape after the first year of a dedicated registry. Methods Data was extracted from PACTR on 18 August 2010 on diseases investigated, intervention types, trial locations, principal investigator locations, and registration dates. Results Clinical trial registration is steadily increasing throughout the region, and there is evidence that the dedicated assistance of staff can facilitate further trial registration. An analysis of the country of origin of principal investigators shows that clinical trial work is increasingly being generated within the continent. Conclusions Although the registry is in a nascent stage, its value as a resource can already be seen; by extracting data from the registry we can identify what trial work is being conducted in the region, where, and by whom, shedding light on the present trial landscape on the continent. PACTR is committed to increasing trial registration and awareness of the importance of registration, while also helping to harmonize national registry efforts across the African continent.

Effect of conventional interferon‐α in patients with HBeAg‐positive chronic hepatitis B: a systematic review and meta‐analysis

Abstract: Background Although a few studies have tested the effect of interferon-α on chronic hepatitis B, its treatment effect remains uncertain, and the association of treatment effect with intervention characteristics has not been thoroughly explored. This study examined the effect of IFN-α in patients with HBeAg-positive chronic hepatitis B, and investigated the characteristics associated with treatment effect. Methods We searched MEDLINE, Scientific Citation Index, Current Content Connect, Cochrane Controlled Trial Register, and Chinese Biomedical Database, all up to 15 September 2009. We included randomized trials comparing IFN-α to placebo, no treatment, or standard care (SC) in patients with HBeAg-positive chronic hepatitis B. Two reviewers assessed the risk of bias and extracted data, independently and in duplicate. We conducted meta-analyses of the included studies, and subgroup analyses to examine the association of pre-specified characteristics (eg, dose, treatment duration) with treatment effect. Results A total of 31 randomized controlled trials, involving 2164 patients, were included. The risk of bias varied across studies. Compared with placebo, no treatment, or SC, IFN-α improved loss of HBeAg (OR 2.36, 95% CI 1.83 to 3.04), HBV DNA undetectability (OR 2.04, 95% CI 1.28 to 3.32), HBeAg seroconversion (OR 1.82, 95% CI 1.26 to 2.62), ALT normalization (OR 1.24, 95% CI 1.01 to 1.56), and loss of HBsAg (OR 2.45, 95% CI 1.22 to 4.91). Treatment effects differed in high versus low dose, and long versus short duration of IFN-α. The effect of high dose IFN-α (OR 3.28, 95% CI 2.31 to 4.66) is statistically larger than that of low dose IFN-α (OR 1.58, 95% CI 1.10 to 2.28) on loss of HBeAg (interaction P = 0.017), and longer IFN-α treatment durations produce greater effects (OR 3.28, 95% CI 2.16 to 5.00) than do shorter durations (OR 1.94, 95% CI 0.42 to 2.66, interaction P = 0.038). High dose IFN-α had a significant effect on HBV DNA undetectability (OR 2.80, 95% CI 2.03 to 3.86), while low dose IFN-α did not (OR 0.93, 95% CI 0.61 to 1.41, interaction P = 0.01); longer treatments significantly improved HBV DNA undetectability (OR 2.58, 95% CI 1.62 to 4.12), but shorter durations did not (OR 1.28, 95% CI 0.83 to 1.97, interaction P = 0.024). Conclusions IFN-α can improve serological, biomedical, and virological response. Higher doses and prolonged treatments appear to have larger treatment benefits than lower doses and shorter treatments. However, the increased adverse reactions and costs associated with higher doses and prolonged treatment warrant caution in applying these results.

Applying lessons from China's Wenchuan earthquake to medical rescue following the Yushu earthquake

Abstract: A 7.1-magnitude earthquake hit China's Qinghai province-4000 meters above sea level, on April 14, 2010, just 702 days after Wenchuan Earthquake. As of 12:00 on April 19, the death toll stood at 1706, with 256 missing and 12,128 injured. West China Hospital (WCH), a regional state-level hospital of the Ministry of Health, sent a medical team with relief supplies within the first hour after Yushu earthquake and the team rushed to Yushu in the first day participating golden seventy-two hours rescue effort. The second day after Yushu earthquake, medical apparatuses and drugs valued at 5 million RMB were delivered to the rescue site and the second batch of medical team were positioned. Within 33 hours of the earthquake, 102 people, including 93 with earthquake-related injuries and 9 armed police with severe altitude sickness, were send to WCH by air in four batches. WCH organized its medical rescue efforts based on first-hand experience with medical rescue following Wenchuan earthquake, a series of evidence-based diagnosis and treatment standards, and "four concentration principles," namely concentrating the wounded, experts, resources, and treatments. Of the 93 cases with earthquake-related injuries, 54 were seriously wounded, and in the five days immediately following the earthquake, 58 underwent operations and none died. The experience learned from Wenchuan earthquake have been used, improved and sublimated more rapidly, appropriately, and effectively in the Yushu earthquake medical rescue. Language: en

Assessment of the safety of Qin Kai Ling injection: a systematic review.

Abstract: Objective Qin Kai Ling (QKL) injection, which is based upon the traditional Chinese medicine formulation ‘An Gong Niu Huang Wan’, is widely used in treatment of many diseases. This review aims to assess the safety of QKL. Methods We searched Chinese databases CNKI and VIP for articles published between January 1987 and April 2009. Results A total of 1486 cases were included in this review. We were unable to determine the frequency of ADR/AE induced by QKL due to the lack of complete production and market information. We estimate, based on the limited data, that the risk of ADR/AE from QKL use should be low. We found some ADR/AE may have been induced by incorrect use of QKL, such as use in infants, or use with incompatible drugs, and some places may not suite for use of QKL, for example, four of seven patients died in private clinics or patient's home. We unable to distinguish whether incidents were ADRs or AEs because the poor reports. Conclusion Current evidence, while weak, indicates that QKL carries a low risk of ADR/AE, and some adverse events that do occur may be ascribed to improper use of the drug. Reporting of ADR/AEs needs to be greatly improved, and should follow the ‘Recommendations for reporting traditional Chinese medicine adverse drug reaction”.

Methodological issues in cost-effectiveness studies: a brief overview.

Abstract: This article discussed two methodological issues around cost-effectiveness studies, including validity and transferability of results. In an economic analysis study, methods to costing, health utility measurement, and economic modeling represent three important sources that may threaten the validity. Variations in health systems and clinical practice, and differential resource use and unit prices across regions and countries may have potentially large influence on transferability. The limitations of piggybacked design may also have implications for transferability. Caution is warranted in the design, conduct, and interpretation of cost-effectiveness studies regarding their validity and transferability.

Acupuncture Versus Western Medicine for Post Stroke Depression:A Systematic Review

Abstract: Objective To assess the efficacy and safety of acupuncture versus western medicine in the treatment of post stroke depression.Methods Randomized controlled trials (RCTs) involving acupuncture versus western medicine in the treatment of post stroke depression were identified from CBMdisc (from 1978 to 2009), VIP (from 1989 to 2009), WANFANG Database (from 1998 to 2009), CNKI (from 1979 to 2009), PubMed (from 1966 to 2009), EMBASE(from 1980 to 2009) and Cochrane Library (Issue 4,2008).We also hand searched relevant journals.Data were extracted and evaluated by two reviewers independently with a specially designed extraction form.The Cochrane Collaboration's RevMan5.0.20 software was used for data analyses.Results A total of 20 trials involving 2 031 patients were included.Meta-analyses showed that the total effective according with 24 HAMD score rate in the acupuncture group was different when compared with fluoxetine (RR=1.15, 95%CI 1.07 to 1.24) at week 8, but showing similar results between acupuncture and fluoxetine at weeks 4 and 6.The total effective according with 17 HAMD score rate in the acupuncture group was similar when compared with fluoxetine or amitriptyline.As for the 24 HAMD score, no significant difference was noted between acupuncture and fluoxetine at weeks 2, 6, 8, and 24; difference between acupuncture and fluoxetine observed at week 1 (WMD =-3.80, 95%CI-7.64 to 0.04) and week 4 (WMD=-1.34, 95%CI-2.67 to-0.02); no difference between acupuncture and amitriptylin/diapazem.As for the 24 HAMD score, significant difference was noted between acupuncture and fluoxetine at week 4 (WMD=-1.15, 95%CI-2.01 to-0.30), but showing similar results at weeks 2 and 6, as well as acupuncture and amitriptyline.In terms of the SDS scores, significant differences were noted between acupuncture and fluoxetine or amitriptyline.12 trials reported adverse events, of which two trials were measured by TESS or SERS score separately.Any report of adverse events showed acupuncture was less than drugs.Conclusion Acupuncture is not inferior to western medicine, and it is worth noting that acupuncture is associated with few adverse reactions.Further large-scale trials are required to define the role of acupuncture in the treatment of post stroke depression.