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PubMed2000

The effect of oral N-acetylcysteine in chronic bronchitis: a quantitative systematic review.

The role of N-acetylcysteine (NAC) in the treatment of chronic bronchitis is unclear. Since a number of studies have been published on this topic, a systematic review of published studies seems justified. A systematic search (Medline, Embase, Cochrane Library, bibliographies, no language restriction) for published randomized trials comparing oral NAC with placebo in patients with chronic bronchitis was performed. Dichotomous data on prevention of exacerbation, improvement of symptoms and adverse effects were extracted from original reports. The relative benefit and number-needed-to-treat were calculated for both individual trials and combined data. Thirty-nine trials were retrieved; eleven (2,011 analysed patients), published 1976-1994, were regarded as relevant and valid according to preset criteria. In nine studies, 351 of 723 (48.5%) patients receiving NAC had no exacerbation compared with 229 of 733 (31.2%) patients receiving placebo (relative benefit 1.56 (95% confidence interval (CI) 1.37-1.77), number-needed-to-treat 5.8 (95% CI 4.5-8.1). There was no evidence of any effect of study period (12-24 weeks) or cumulative dose of NAC on efficacy. In five trials, 286 of 466 (61.4%) patients receiving NAC reported improvement of their symptoms compared with 160 of 462 (34.6%) patients receiving placebo (relative benefit 1.78 (95% CI 1.54-2.05), number-needed-to-treat 3.7 (95% CI 3.0-4.9)). With NAC, 68 of 666 (10.2%) patients reported gastrointestinal adverse effects compared with 73 of 671 (10.9%) taking placebo. With NAC, 79 of 1,207 (6.5%) patients withdrew from the study due to adverse effects, compared with 87 of 1,234 (7.1%) receiving placebo. In conclusion, with treatment periods of approximately 12-24 weeks, oral N-acetylcysteine reduces the risk of exacerbations and improves symptoms in patients with chronic bronchitis compared with placebo, without increasing the risk of adverse effects. Whether this benefit is sufficient to justify the routine and long-term use of N-acetylcysteine in all patients with chronic bronchitis should be addressed in further studies and cost-effectiveness analyses.

Acetylcysteine↗
PubMed2002

Systematic reviews in endocrinology. The Cochrane Metabolism and Endocrine Disorders Review Group.

The Cochrane Collaboration is an international nonprofit organization that aims to make up-to-date accurate information about the effects of health care readily available worldwide by preparing, maintaining, and disseminating systematic reviews of the effects of health care. The Cochrane Metabolism, Endocrinology, and Diabetes Review Group's primary concern is the evaluation of randomized controlled trials and other controlled comparisons of health care interventions relevant to the prevention, treatment or management, and rehabilitation of metabolic, nutritional, and endocrine disorders. This article discusses the role of systematic reviews and metaanalyses and invites interested parties to get involved and contribute.

Clinical Competence↗
PubMed2002

The mission of the cochrane anesthesia review group: preparing and disseminating systematic reviews of the effect of health care in anesthesiology.

IMPLICATIONS: This article illustrates the basic principles of evidence-based medicine and the work within the Cochrane Collaboration and the Cochrane Anesthesia Review Group. It describes how important randomized controlled trials and systematic reviews are in providing the best evidence to answer clinically relevant questions.

Anesthesiology↗
PubMed1999

In which journals will pediatricians find the best evidence for clinical practice?

OBJECTIVE: The objective of this study was to identify the journals that contain the best evidence relating to clinical pediatric practice, thus enabling general pediatricians and pediatric trainees to identify the best quality evidence more efficiently and to select journals for general reading more judiciously. METHODS: In the first of three strategies, journal citations from completed systematic reviews using topic headings of pediatric(s), child, infant(s), newborn, neonate(s), neonatology, and adolescent(s) in the Cochrane Database of Systematic Reviews (CDSR) in the 1997, Issue 4, Cochrane Library were collected. In the second strategy, journal citations from American Academy of Pediatrics' (AAP) policy statements from 1994 to 1996 found in the AAP policy reference guide were collected. In the third strategy, journal citations from the Canadian Paediatric Society (CPS) statements from 1990 to 1997 found in Pediatrics and Child Health were collected. Topics related to tertiary neonatology, nonphysician health care professionals, public health policy, ethics, and nonjournal citation sources were excluded. All statements with no references were excluded. Journal citations in CDSR with no pediatric subjects and citation of AAP policy statements cited in AAP policy statements were excluded. The number of citations from the journal cited most frequently, from journals that represented approximately 10% of all citations and from the 10 journals cited most frequently were expressed as a percent of total citations and a 95% CI was calculated. RESULTS: Using all three strategies (CDSR, AAP, and CPS), the journal cited most frequently was Pediatrics. Using the CDSR strategy (n = 234), citations from Pediatrics represented 6.0% of the total (95% CI: 3.0%, 9.0%), using the AAP strategy (n = 930), citations from Pediatrics represented 11. 4% of the total (95% CI: 9.4%, 13.4%), and using the CPS strategy (n = 873), citations from Pediatrics represented 11.9% of the total (95% CI: 9.8, 14.1). Using the CDSR strategy, citations from the 10 journals cited most frequently made up 38.9% of the total citations (95% CI: 32.7%, 45.1%), using the AAP strategy, citations from the 10 journals cited most frequently made up 42.3% of the total citations (95% CI: 39.3%, 45.3%), and using the CPS strategy, citations from the 10 journals cited most frequently made up 60.6% of the total citations (95% CI: 57.4, 63.8). In the CPS strategy, citations from the Journal of Pediatrics represented 10.2% of the total citations (95% CI: 8.2, 12.2) and citations from New England Journal of Medicine represented 9.5% of the total citations (95% CI: 7.6, 11.5). A total of 7 journals were found to be among the 10 cited most frequently using all three strategies (in alphabetical order): Archives of Diseases in Childhood, British Medical Journal, Journal of the American Medical Association, Journal of Pediatrics, Lancet, New England Journal of Medicine, and Pediatrics. CONCLUSIONS: This study provides the general pediatrician and pediatric trainee with a strategy to identify efficiently a significant proportion of the best evidence on pediatric practice by restricting searches and reading to a limited number of journals. It also highlights the fact that the best quality evidence on pediatric practice is found in a large number of medical journals.

Canada↗
PubMed2002

[Treatment of chronic anal fissure with topically applied nitroglycerin ointment. A systematic review of evidence-based results].

This study explores the evidence-based background for treating chronic anal fissure with topically applied nitroglycerin (NTG): in part the general effect of NTG and in part how its effect compares to that of surgery, which has been claimed to have long-term complications like incontinence for flatus and faeces. Ten randomised clinical trials published up to July 2001 were retrieved. In five of six studies, NTG had an effect on healing that was better than that of placebo or lignocaine. Headache is a common side effect of the treatment. Lateral internal sphincterotomy, the operation of choice for chronic anal fissure, and topical NTG were compared in four trials. Surgery had a better healing rate, but more late complications. The results suggest that in 31-65% of patients an operation could be avoided with NTG therapy. Topically applied 0.2% nitroglycerin three times a day for four weeks is therefore the primary choice in the treatment of anal fissures. But the possibility still remains that the observed effect of NTG may be the outcome of publication bias.

Administration, Topical↗
PubMed2005

Topical anesthetics for dermal instrumentation: a systematic review of randomized, controlled trials.

STUDY OBJECTIVE: We compare the analgesic efficacy of topical anesthetics for dermal instrumentation with conventional infiltrated local anesthesia and also compare topically available amide and ester agents with a eutectic mixture of local anesthetics (EMLA). METHODS: We conducted a systematic review of randomized, controlled trials. Relevant literature was identified through searches of MEDLINE, Cochrane Central Register of Controlled Trials, and the Excerpta Medica Database Drugs and Pharmacology. We limited the type of procedures to puncture of intact skin with a needle. The primary outcome was analgesic efficacy, reflected in the patient's self-report of pain intensity during dermal instrumentation. Where possible, quantitative methods were used to summarize the results. RESULTS: We identified 25 randomized controlled trials including 2,096 subjects. The results of the trials comparing the efficacy of EMLA with infiltrated local anesthetic were inconsistent. Qualitative analysis demonstrated comparable analgesic efficacy between liposome-encapsulated lidocaine and EMLA. The weighted mean difference in 100-mm visual analogue scale pain scores favored topical tetracaine over EMLA (-8.1 mm; 95% confidence interval -15.6 mm to -0.6 mm). Liposome-encapsulated tetracaine provided greater analgesia than EMLA according to the weighted mean difference in 100-mm visual analogue scale scores (-10.9 mm; 95% confidence interval -15.9 mm to -5.9 mm). CONCLUSION: EMLA may be an effective, noninvasive means of analgesia before dermal procedures. However, we identified 3 topical anesthetics that are at least as efficacious as EMLA: tetracaine, liposome-encapsulated tetracaine, and liposome-encapsulated lidocaine. Liposomal lidocaine is commercially available in the United States and offers a more rapid onset and less expensive alternative to EMLA.

Administration, Cutaneous↗
PubMed2001

A method for research programming in the field of evidence-based medicine.

OBJECTIVE: This paper presents the method we used in programming research on the efficacy of therapeutic interventions for nine chronic benign pain disorders. METHODS: We started with an inventory to identify commonly applied interventions. For these interventions we searched the literature to identify gaps in evidence. First, we searched for recent reviews, of which we assessed the methodologic quality. If only reviews of poor or moderate quality were found, a new systematic review was recommended. When we found no recent reviews, we searched for randomized controlled trials (RCTs). If there was insufficient or inconsistent evidence, the performance of a new RCT was advised. This structured procedure resulted in a list with topics for which new systematic reviews were recommended and topics for which new RCTs were needed. These lists were the starting points for priority setting by four Centers for Pain Management and Research. All members of the centers were asked to state the priority of each topic. The resulting hierarchy of topics for their own center was discussed in a meeting in each center, giving participants the opportunity to elucidate their views and considerations. RESULTS: The final result was a robust priority list for the need of research (systematic reviews and RCTs) on chronic benign pain syndromes. DISCUSSION: The strength and weaknesses of this approach are discussed. This method of priority setting is by no means restricted to treatments for chronic pain; it is also a useful approach for programming research to enable evidence-based medicine in other fields of interest.

Decision Making, Organizational↗
PubMed2004

Topical treatments for seasonal allergic conjunctivitis: systematic review and meta-analysis of efficacy and effectiveness.

BACKGROUND: Evidence for the effectiveness of topical treatments, in providing symptomatic relief from ocular allergy, remains uncertain. AIMS: To assess the effectiveness and relative efficacy of topical treatments for the management of seasonal allergic conjunctivitis. DESIGN OF STUDY: A systematic review and meta-analysis. SETTING: A literature search of the Cochrane Library, Medline, and EMBASE bibliographic databases. METHOD: Double-masked randomised controlled trials were identified, that compared the use of topical mast cell stabilisers (sodium cromoglycate, nedocromil, lodoxamide) with placebo, topical antihistamines with placebo, and topical mast cell stabilisers with topical antihistamines. RESULTS: A meta-analysis of six trials showed that patients using sodium cromoglycate were 17 times (95% confidence interval [CI] = 4 to 78) more likely to perceive benefit compared with those using a placebo, although this estimate may be partially influenced by publication bias. Five trials indicated that those patients using nedocromil were 1.8 times (95% CI = 1.3 to 2.6) more likely to perceive their allergy to be moderately or totally controlled than those using a placebo. Four trials showed that those using antihistamines were 1.3 times (95% CI = 0.8 to 2.2) more likely to perceive a 'good' treatment effect than those using mast cell stabilisers, although this beneficial effect was not statistically significant. Limited evidence suggests that antihistamines might have a faster therapeutic effect compared to mast cell stabilisers. CONCLUSION: Overall, these findings confirm the benefit of topical mast cell stabilisers and antihistamines over placebo for the treatment of allergic conjunctivitis. There is, however, insufficient evidence to recommend the use of one type of medication over another. Treatment preferences should therefore be based on convenience of use (with reduced frequency of instillation for some preparations), patient preference, and costs, especially as important side effects were not reported with any medication.

Administration, Topical↗
PubMed2006

Comparison of reports of randomized controlled trials and systematic reviews in surgical journals: literature review.

OBJECTIVES: Randomized controlled trials and systematic reviews of such trials are the gold standard for assessing the effectiveness of interventions. There have been concerns about the anecdotal evidence underpinning many of the interventions used and introduced into surgical care. The American College of Surgeons has prioritized the need for more trials and systematic reviews of trials. To investigate the assertion that the methodological quality of studies conducted in surgery is in general poor and to assess the possible impact of new policy developments in the US, we sought to compare the number and proportion of published randomized controlled trials and systematic reviews in the leading two US and UK general surgical journals. Two reviewers systematically and independently hand searched all issues of these journals over a 12-month period to identify randomised controlled trials and systematic reviews. DESIGN: Systematic searching and independent abstraction of data from all volumes of the top two general surgical journals published in the USA and the UK in 2004. SETTING: 519 original reports in UK journals and 616 original reports in USA journals. MAIN OUTCOME MEASURES: Number and proportion of randomized controlled trials and systematic reviews. RESULTS: Overall, the proportion of randomized controlled trials in all four journals was 5.6% (95% confidence interval [CI] 4.4-7.0) and 5.2% (95% CI 4.1-6.7) for systematic reviews. For journals published in the UK 29/519 (5.6%) of the publications were reports of randomized controlled trials, and for the USA journals this figure was 34/616 (5.5%); odds ratio [OR]=0.99, 95%CI 0.6-1.6; P=0.96. Systematic reviews were significantly more commonly reported in the UK journals: UK 37/519 (7.1%) versus USA 22/616 (3.6%); OR=0.48, 95%CI 0.3-0.8; P<0.01. CONCLUSIONS: The concerns expressed almost a decade ago remain valid: there are still very few reports of randomized controlled trials and systematic reviews published in leading USA and UK surgical journals, with relatively little difference between these countries in the proportion of reported studies employing these designs. The American College of Surgeons initiative has yet to make an impact.

Biomedical Research↗
PubMed2026

Anatomy and Biomechanics of the Deltoid Ligament Complex in Healthy Ankles: Protocol for a Systematic Review and Meta-Analysis.

INTRODUCTION: Up to one in two individuals who have a history of an ankle injury will develop chronic ankle instability, which subsequently increases the risk of osteoarthritis development. Although lateral ankle ligament injuries are the most common, recent research shows that concomitant injuries to the deltoid (medial collateral) ligament complex may be more prevalent than previously recognised. However, the anatomy and biomechanics of the deltoid ligament complex are reported inconsistently in the literature. This systematic review will summarise current evidence on the anatomy and biomechanics of the deltoid ligament complex in healthy adult ankles. METHODS: Searches will be conducted in Scopus, MEDLINE, Embase, CINAHL and SPORTDiscus. Our search strategy will cover terms associated with 'deltoid ligament', 'anatomy' and 'biomechanics'. We will only include dissection and imaging studies published in English that report any of the listed clinically relevant properties of the deltoid ligament in healthy adult human ankles. Two reviewers will independently perform screening and assess study quality using the anatomical quality assessment (AQUA) tool. One reviewer will extract relevant data, which will be independently verified by co-authors. Primary outcomes include band prevalence, length, width, cross-sectional area, maximum and/or failure load and elastic modulus. If three or more studies report a primary outcome, we will conduct a meta-analysis and report findings as pooled means with 95% confidence intervals. If a meta-analysis is not feasible, outcomes will be summarised as a narrative analysis. Measures will be taken during data synthesis to address anticipated methodological heterogeneity across included studies, and pooled estimates will be interpreted with caution. DISCUSSION: This protocol details a systematic review that aims to summarise the anatomy and biomechanics of the deltoid ligament complex. Our findings will inform computational modelling, clinical management and biomechanics for ankle pathologies, as well as identifying research gaps and directions for future research. TRIAL REGISTRATION: PROSPERO: CRD420251142867.

Humans↗
PubMed2002

[A Cochrane review on the umbilical cord care and prevention of infections. Antiseptic solutions are not necessary in developed countries but life-saving in developing countries].

One million newborn infants die every year by bacterial infections, which often have entered the body via the umbilicus. A Cochrane systematic review on "Topical umbilical cord care at birth" by J Zupan and P Garner is reviewed. Zupan and Garner conclude that simply to keep the umbilical cord dry and clean is sufficient for healthy, term neonates in rich countries; disinfectants do not offer any advantage. However, cleaning the umbilical cord with disinfectants may reduce the risk of serious bacterial infections in babies in poor countries or in neonatal wards. Observational studies in poor countries indicate that the life of numerous infants can be saved if pregnant women are vaccinated against tetanus and disinfectants are substituted for harmful cord care traditions. This Cochrane review is credible, but it should be updated and considered tentative since no data on sepsis are included. The search strategy should be better described and observational studies (case control and cohort studies) from poor countries should be included since there are no randomized control trials from these countries.

Anti-Infective Agents, Local↗
PubMed2003

Calcium channel blockers for inhibiting preterm labour; a systematic review of the evidence and a protocol for administration of nifedipine.

OBJECTIVE: To assess the effects on maternal, fetal and neonatal outcomes of nifedipine (and other calcium channel blockers) administered as a tocolytic agent to women in preterm labour. METHODS: Standard methods of the Cochrane Collaboration and its Pregnancy and Childbirth Review Group were used. All published and unpublished randomised trials in which calcium channel blockers were used for tocolysis for women in preterm labour between 20 and 36 weeks' gestation, were considered. MAIN RESULTS: The systematic review includes 12 randomised controlled trials with a total of 1029 participating women. No trials were identified in which calcium channel blockers were compared with a placebo or no alternative tocolytic treatment. Calcium channel blockers appear to be more effective than betamimetic agents in prolonging pregnancy for 7 days or longer, are much less likely to cause maternal side-effects and are associated with reduced neonatal morbidity. CONCLUSION: Calcium channel blockers (especially nifedipine) can be considered safer and more effective tocolytic agents than betamimetics.

Calcium Channel Blockers↗
PubMedDate not supplied

Towards ethical guidelines for dealing with unsolicited patient emails and giving teleadvice in the absence of a pre-existing patient-physician relationship systematic review and expert survey.

BACKGROUND: Many health information providers on the Internet and doctors with email accounts are confronted with the phenomenon of receiving unsolicited emails from patients asking for medical advice. Also, a growing number of websites offer "ask-the-doctor" services, where patients can ask questions to health professionals via email or other means of telecommunication. It is unclear whether these types of interactions constitute medical practice, and whether physicians have the ethical obligation to respond to unsolicited patient emails. OBJECTIVE: To improve the quality of online communication between patients and health professionals (physicians, experts) in the absence of a pre-existing patient-physician relationship or face-to-face communication, by preparing a set of guiding ethical principles applicable to this kind of interaction. METHODS: Systematic review of the literature, professional, and ethical codes; and consultation with experts. RESULTS: Two different types of patient-physician encounters have to be distinguished. "Traditional" clinical encounters or telemedicine applications are called "Type B" interactions here (Bona fide relationship). In comparison, online interactions lack many of the characteristics of bona fide interactions; most notably there is no pre-existing relationship and the information available to the physician is limited if, for example, a physician responds to the email of a patient who he has never seen before. I call these "Type A" consultations (Absence of pre-existing patient-physician relationship). While guidelines for Type B interactions on the Internet exist (Kane, 1998), this is not the case for Type A interactions. The following principles are suggested: Physicians responding to patients' requests on the Internet should act within the limitations of telecommunication services and keep the global nature of the Internet in mind; not every aspect of medicine requires face-to-face communication; requests for help, including unsolicited patient questions, should not be ignored, but dealt with in some appropriate manner; informed consent requires fair and honest labeling; health professionals and information providers must maintain confidentiality; health professionals should define internal procedures and perform quality control measures. CONCLUSIONS: Different media are appropriate at each point on the continuum between dispensing general health information and handling patient problems that would require the practice of medicine to solve. For example, email is a sufficiently capable medium for giving out general health information, while diagnosis and treatment usually requires at least advanced telemedical technology. Patients have to be educated that it is unethical to diagnose and treat over the Internet in the absence of a pre-existing patient-physician relationship, and if the interaction is limited to a single email. More research is needed to establish more evidence regarding situations in which teleadvice is beneficial and efficient.

Humans↗
PubMed1999

Effective treatment of subfertility: introducing the Cochrane Menstrual Disorders and Subfertility Group.

The last two decades have seen a rapid explosion in research surrounding subfertility treatments. This ever-increasing volume of research has made it a difficult task for health professionals involved in the management of the subfertility to be able to assimilate the information easily. There is an urgent need for the findings from research to be synthesized into simple easy to read reviews that are both of a high quality and are based on the best evidence available. The Menstrual Disorders and Subfertility Group of the Cochrane Collaboration is attempting to address these issues by collecting a register of all the randomized controlled trials in the field of reproductive medicine and preparing systematic reviews on topics that will be of interest to healthcare workers and consumers. Readers are invited to participate in this process by identifying published and unpublished data and by helping in the process of preparing protocols and systematic reviews for inclusion in the Cochrane Library.

Female↗