Is surgical debridement necessary in the diabetic foot treated with photodynamic therapy?

Background: Diabetic patients are susceptible to developing foot ulcerswith serious complications such as osteomyelitis and amputations. Treatment approaches are still empirical and the benefit of usual procedures such as surgical debridement has not been properly evaluated. Photodynamic Therapy (PDT) is a non-invasive and highly efficient method for the treatment of the diabetic foot, being able to eradicate the infection and to stimulate healing, decreasing considerably the amputation risk. In the day-to-day practice of our service, we have been faced with the question whether debridement is necessary before PDT. In here, we designed a study to answer that question. Methods: Patients were divided in two groups: In one of the groups (n = 17), debridement was performed before PDT and in the other (n = 40) only PDT treatment was performed. PDT sessions were performed once a week in all patients until healing was achieved, as indicated by visual inspection as well as by radiographic and laboratory exams. At the start of the study, the two groups had no statistical differences concerning their clinical features: average age, gender, insulin use, diabetes mellitus onset time and previous amputations. Results: PDT was effective in the treatment of 100% of the patients showing no relapses after one year of follow up. The group submitted to PDT without previous debridement had a statistically significant (p = 0.036, Mann-Whitney) shorter cure time (29 days, similar to 27%). Conclusion: Our data indicates that debridement is not necessary in the treatment of diabetic foot in patients that have enough peripheral arterial perfusion. In addition, we reproduced previous studies confirming that PDT is an efficient, safe, simple and affordable treatment method for the diabetic foot.Fundacao de Amparo a Pesquisa do Estado de Sao PauloCNPqHosp Anchieta, Fac Med ABC, Sao Bernardo Do Campo, BrazilFac Med ABC, Dept Bioquim, Santo Andre, BrazilUniv Sao Paulo, Dept Bioquim, Sao Paulo, BrazilUniv Fed Sao Paulo, Dept Med, Sao Paulo, BrazilUniv Fed Sao Paulo, Dept Med, Sao Paulo, BrazilFAPESP: 12/50680-5FAPESP: 13/07937-8Web of Scienc

Treatment of reducible unstable fractures of the distal radius in adults: a randomised controlled trial of De Palma percutaneous pinning versus bridging external fixation

Background: At present, there is no conclusive evidence regarding the best treatment method for reducible unstable fractures of the distal radius. This study compared the effectiveness of two methods used in surgical treatment of such fractures: percutaneous pinning and external fixation.Methods: We randomly allocated 100 patients into two groups treated surgically with modified de Palma percutaneous pinning and bridging external fixation. Independent but not blinded evaluators administered the DASH quality-of-life questionnaire at postoperative months 6 and 24, performed functional assessment of pain, range of motion, and palm grip strength, and radiographic examinations (volar and radial angle, and height of the radius) before the operation, immediately afterwards, and at 6 and 24 months postoperative. Modified de Palma percutaneous pinning patients used an above-elbow cast whereas external fixation group had unrestricted elbow motion after surgery. Patients who for any reason demonstrated treatment failure or required additional interventions were followed up and their results were included in the group into which these patients had initially been randomised according to the intention-to-treat principle. A significance level of 5% (alpha = 0.05). was used for all statistical tests, such that tests presenting a p-value less than 0.05 were considered statistically significant.Results: Ninety one (58.8 mean age and 66 participants were female) were included in the final assessment at 24 months. the DASH questionnaire evaluation showed a statistically significant result favouring the de Palma group (mean difference = -7.1 p = 0.044) after six months, but this was not maintained at 24 months. There were no statistically differences between the groups with respect to palm grip strength. Analysis of the range-of-motion limitation index (uninjured side minus affected side motion of) showed a statistical difference (mean difference = 2.4 p = 0.043) favoring the external fixator group with regard to the supination movement 6 months after the operation; however, this was not maintained at 24 months. the final results of the radiographic evaluation were similar for the two groups. Overall, five patients developed complications: two with de Palma pinning and three with external fixation.Conclusion: There was a small statistically significant difference favouring the de Palma method in early functional at 6 months according to the DASH questionnaire, and for supination movement favouring the fixator group. However, both were not clinical relevant. By 24 months the groups were similar for all outcome

Physical Activity Interventions in Faith-Based Organizations: A Systematic Review

Objective: To review and assess the effectiveness of physical activity interventions delivered in faith-based organizations. Data Source: We searched the Cochrane Library, DoPHER, EMBASE, LILACS, MEDLINE, PsycINFO, WHO ICTRP, and Clinicaltrials.gov databases until January 2016, without restriction of language or publication date. Study Inclusion and Exclusion Criteria: Randomized and nonrandomized controlled trials investigating physical activity interventions for adults delivered in faith-based organizations. Data Extraction: Two independent reviewers extracted data and assessed study methodological quality. Data Synthesis: We used relative risk and mean difference with 95% confidence interval to estimate the effect of the interventions on measures of physical activity, physical fitness, and health. Results: The review included 18 studies. Study participants were predominantly female, and the majority of trials were conducted in the United States. Study heterogeneity did not allow us to conduct meta-analyses. Although interventions delivered in faith-based organizations increased physical activity and positively influenced measures of health and fitness in participants, the quality of the evidence was very low. Conclusion: Faith-based organizations are promising settings to promote physical activity, consequently addressing health disparities. However, high-quality randomized clinical trials are needed to adequately assess the effectiveness of interventions delivered in faith-based organizations.CAPES Foundation, Ministry of Education of Brazil, BrazilUniv Fed Sao Paulo, Grad Program Evidence Based Hlth, Rua Botucatu 740, BR-04023062 Sao Paulo, SP, BrazilUniv Fed Sao Paulo, Postgrad Program Evidence Based Hlth, Sao Paulo, BrazilCochrane Brazil, Ctr Estudos Saude Baseada Evidencias & Avaliacao, Rua Borges Lagoa, Sao Paulo, SP, BrazilUniv Fed Sao Paulo, Grad Program Evidence Based Hlth, Rua Botucatu 740, BR-04023062 Sao Paulo, SP, BrazilUniv Fed Sao Paulo, Postgrad Program Evidence Based Hlth, Sao Paulo, BrazilWeb of Scienc

Dipyrone for acute primary headaches

Brazilian Cochrane Centre, BrazilCoordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)International Headache SocietyBrazilian Cochrane Ctr, São Paulo, BrazilUniversidade Federal de São Paulo, Brazilian Cochrane Ctr, São Paulo, BrazilBrazilian Cochrane Ctr, Ctr Estudos Med Baseada Evidencias & Avaliacao Te, São Paulo, BrazilUniversidade Federal de São Paulo, Brazilian Cochrane Ctr, São Paulo, BrazilWeb of Scienc

Mapping the Cochrane evidence for decision making in health care

Rationale and aim Over the past 12 years, thousands of authors working with the Cochrane Collaboration around the world have produced systematic reviews to reduce uncertainty in health care decision making. We evaluated the conclusions from Cochrane systematic reviews of randomized controlled trials in terms of their recommendations for clinical practice and research.Methods in our cross-sectional study of systematic reviews published in the Cochrane Library, we randomly selected and analysed completed systematic reviews published across all 50 Cochrane Collaborative Review Groups.Results We analysed 1016 completed systematic reviews. of these, 44% concluded that the interventions studied were likely to be beneficial, of which 1% recommended no further research and 43% recommended additional research. Also, 7% of the reviews concluded that the interventions were likely to be harmful, of which 2% did not recommend further studies and 5% recommended additional studies. in total, 49% of the reviews reported that the evidence did not support either benefit or harm, of which 1% did not recommend further studies and 48% recommended additional studies. Overall, 96% of the reviews recornmended further research.Conclusions Cochrane systematic reviews were about evenly split between those in which the authors concluded that at least one of the interventions was beneficial and those ill which the evidence neither supported nor refuted the intervention tested. the Cochrane Collaboration needs to include clinical trial protocol summaries with a study design optimized to answer the relevant research questions.Universidade Federal de São Paulo, Brazilian Cochrane Ctr, BR-04039001 São Paulo, BrazilUniversidade Federal de São Paulo, Brazilian Cochrane Ctr, BR-04039001 São Paulo, BrazilWeb of Scienc

Zinc supplementation for the prevention of type 2 diabetes mellitus

The chronic hyperglycaemia of diabetes is associated with long-term damage, dysfunction, and failure of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels. the risk of developing type 2 diabetes increases with age, obesity, and lack of physical activity. Insulin resistance is a fundamental aspect of the aetiology of type 2 diabetes. Insulin resistance has been shown to be associated with atherosclerosis, hypertriglyceridaemia, glucose intolerance, dyslipidaemia, hyperuricaemia, hypertension and polycystic ovary syndrome. the mineral zinc plays a key role in the synthesis and action of insulin, both physiologically and in diabetes mellitus. Zinc seems to stimulate insulin action and insulin receptor tyrosine kinase activity.To assess the effects of the zinc supplementation in the prevention of type 2 diabetes mellitus.Studies were obtained from computerised searches of MEDLINE, EMBASE, LILACS and the Cochrane Library.Studies were included if they had a randomised or quasi-randomised design and if they investigated zinc supplementation in adults living in the community, 18 years or older with insulin resistance (compared to placebo or no intervention).Two authors selected relevant trials, assessed methodological quality and extracted data.Only one study met the inclusion criteria of this review. There were 56 normal glucose tolerant obese women (aged 25 to 45 years, body mass index 36.2 +/- 2.3 kg/m(2)). Follow-up was four weeks. the outcomes measured were decrease of insulin resistance, anthropometric and diet parameters, leptin and insulin concentration, zinc concentration in the plasma and urine, lipid metabolism and fasting plasma glucose. There were no statistically significant differences favouring participants receiving zinc supplementation compared to placebo concerning any outcome measured by the study.There is currently no evidence to suggest the use of zinc supplementation in the prevention of type 2 diabetes mellitus. Future trials will have to standardise outcomes measures such as incidence of type 2 diabetes mellitus, decrease of the insulin resistance, quality of life, diabetic complications, all-cause mortality and costs.Universidade Federal de São Paulo, Programa Grad Med Interna & Terapeut, Piracicaba, BrazilUniversidade Federal de São Paulo, Programa Grad Med Interna & Terapeut, Piracicaba, BrazilBrazilian Cochrane Centre, Universidade Federal de São Paulo / Escola Paulista de Medicina, São Paulo, BrazilWeb of Scienc

5-FU for genital warts in non-immunocompromised individuals

BackgroundGenital warts are common and usually are harmless but can be painful and psychologically burdensome. Several local treatments can be used, including topical 5-Fluorouracil (5-FU).ObjectivesTo determine the effectiveness and safety of 5-FU topical treatment for genital warts in nonimmunocompromised individuals.Search strategyDatabases searched were Cochrane Central Register of Controlled Trials (The Cochrane Library 2009 Issue 3), MEDLINE (1966 to August 2009), EMBASE (until August 2009), LILACS (1982 to August 2009). the search had no language or publication restrictions.Selection criteriaThe review included randomised controlled trials (RCTs) among women, men, or both sexes, aged 18 years and older, comparing: 5-FU versus placebo or no treatment; 5-FU in any dose versus other isolated treatment, topical or systemic; 5-FU in any dose associated with other treatment versus placebo; 5-FU in any dose associated with other treatment versus other isolated treatment, topical or systemic; 5-FU in any dose associated with other treatment versus other associated treatment, topical or systemic.Data collection and analysisTwo authors independently assessed trial quality and extracted data from the original publications.Main resultsSix trials involving 988 patients (645 women and 343 men) and reporting eight comparisons were found. Two studies reported withdrawals and dropouts, but none mentioned analysis by intention to treat (ITT). 5-FU presented better results for cure than placebo or no treatment (relative risk (RR) 0.39, 95% confidence interval (CI) 0.23 to 0.67), meta-cresol-sulfonic acid (MCSA) (RR 2.11, 95% CI 0.83 to 5.37), Podophylin 2%, 4% or 25% (RR 1.26, 95% CI 0.86 to 1.82). There were no statistical differences for treatment failure for 5-FU versus CO2 Laser (RR 0.69, 95% CI 0.43 to 1.11) versus 5-FU + INF alpha-2a (low dose) (RR 1.02, 95% CI 0.87 to 1.119). Worse results were found for 5-FU versus 5-FU + INF alpha-2a (high dose) (RR 10.78, 95% CI 1.50 to 77.36), and 5-FU + CO2 Laser INF alpha-2a (high dose) (RR 7.97, 95% CI 2.87 to 22.13).Authors' conclusionsThe reviewed trials were highly variable in methods and quality, and the evidence provided by these studies was weak. Cure rates with several treatments were variable, and although 5-FU presents therapeutic results that are inferior to those seen with 5-FU + Inf alpha-2a (high dose) and 5-FU + CO2 Laser + Inf alpha-2a (high dose), the treatment should not be abandoned. Topical treatment with 5-FU has a therapeutic effect; however, the benefits and risks have not been determined clearly and further studies are needed.Universidade Federal de São Paulo, Dept Med, Escola Paulista Med, São Paulo, BrazilUniversidade Federal de São Paulo, Brazilian Cochrane Ctr, Escola Paulista Med, São Paulo, BrazilUniv Fed Rio Grande do Norte, Dept Med, São Paulo, BrazilUniversidade Federal de São Paulo, Dept Med, Escola Paulista Med, São Paulo, BrazilUniversidade Federal de São Paulo, Brazilian Cochrane Ctr, Escola Paulista Med, São Paulo, BrazilWeb of Scienc

Botulinum toxin for myofascial pain syndromes in adults

BackgroundThis is an updated version of the original Cochrane review published in Issue 4, 2012. Myofascial pain syndrome (MPS) is a regional muscular pain syndrome characterised by the presence of trigger points, which are painful points in one or more muscles. the pain can be felt at the site where the trigger point is located or it can be felt away from that place when the muscle is pressed (referred pain). Botulinum toxin is a protein produced by the bacterium Clostridium botulinum and is a potent neurotoxin that eventually inhibits muscle contractions. It is capable of selectively weakening painful muscles and interrupting the pain cycle.ObjectivesTo assess the effectiveness and safety of botulinum toxin A (BTXA) in the treatment of myofascial pain syndrome (MPS), excluding MPS in neck and head muscles.Search methodsThis is an updated version of the original Cochrane review published in Issue 4, 2012. the search strategy for the update was the same as in the original review and we searched CENTRAL in the Cochrane Library (2013, Issue 11 of 12), MEDLINE (Ovid) (2012 to 29 November 2013) and EMBASE (Ovid) (2012 to 27 November 2013). the search strategy was composed of terms for myofascial pain and botulinum toxin. for the original review, we also searched the Cochrane Pain, Palliative and Supportive Care (PaPaS) Review Group Specialised Register until December 2011, PubMed (from 1966 to 2011) and LILACS (from 1982 to 2011). There was no language restriction.Selection criteriaWe included randomised controlled trials (RCTs) involving botulinum toxin for treating participants with MPS. We excluded studies with MPS of the neck and head from this review as they have already been assessed in existing systematic reviews. We considered a diagnosis of MPS to be based on the identification of trigger points in the taut band through palpation of sensitive nodules, local twitch response and specific patterns of referred pain associated with each trigger point.Data collection and analysisTwo review authors independently screened identified studies, extracted data, assessed trial quality and analysed results using the Cochrane PaPaS Review Group criteria.Main resultsFour studies with a total of 233 participants, comparing BTXA with placebo, met the inclusion criteria. in one study with 145 participants, significant improvement rates of pain intensity scores and duration of daily pain were demonstrated when comparing BTXA with placebo. the three other studies showed that there was no statistically significant difference between BTXA and placebo in pain intensity.Authors' conclusionsSince the first publication of this review, no new studies were found. There is inconclusive evidence to support the use of botulinum toxin in the treatment of MPS based on data from four studies with a total of 233 participants, which we considered were of sufficient quality to be included in this review. Meta-analyses were not possible due to the heterogeneity between studies. We suggest that in future studies the same methodology to assess pain, a standardised dose of treatment, follow-up of at least four months (to observe the maximum and minimum curve of the drug effect) and appropriate data presentation should be used. More high-quality RCTs of botulinum toxin for treating MPS need to be conducted before firm conclusions on its effectiveness and safety can be drawn.Universidade Federal de São Paulo, Dept Med, BR-30150341 Belo Horizonte, MG, BrazilUniv Estado Para, Dept Publ Hlth, Belem, Para, BrazilBrazilian Cochrane Ctr, Ctr Estudos Saude Baseada Evidencias & Avaliacao, São Paulo, BrazilUniversidade Federal de São Paulo, São Paulo, BrazilUniversidade Federal de São Paulo, Dept Med, BR-30150341 Belo Horizonte, MG, BrazilUniversidade Federal de São Paulo, São Paulo, BrazilWeb of Scienc

Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery

BackgroundIncontinence after prostatectomy for benign or malignant disease is a well-known and often a feared outcome. Although small degrees of incidental incontinence may go virtually unnoticed, larger degrees of incontinence can have a major impact on a man's quality of life.Conceptually, post-prostatectomy incontinence may be caused by sphincter malfunction or bladder dysfunction, or both. Most men with post-prostatectomy incontinence (60% to 100%) have stress urinary incontinence, which is involuntary urinary leakage on effort or exertion, or on sneezing or coughing. This may be due to intrinsic sphincter deficiency and may be treated with surgery for optimal management of incontinence. Detrusor dysfunction is more common after surgery for benign prostatic disease.ObjectivesTo determine the effects of surgical treatment for urinary incontinence related to presumed sphincter deficiency after prostate surgery for:-men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) - transurethral resection of prostate (TURP), photo vaporisation of the prostate, laser enucleation of the prostate or open prostatectomy - and-men with prostate cancer -radical prostatectomy (retropubic, perineal, laparoscopic, or robotic).Search methodsWe searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, and handsearching of journals and conference proceedings (searched 31 March 2014); MEDLINE (January 1966 to April 2014); EMBASE (January 1988 to April 2014); and LILACS (January 1982 to April 2014). We handsearched the reference lists of relevant articles and conference proceedings. We contacted investigators to locate studies.Selection criteriaRandomised or quasi-randomised trials that include surgical treatments of urinary incontinence after prostate surgery.Data collection and analysisTwo authors independently screened the trials identified, appraised quality of papers, and extracted data.Main resultsOnly one study with 45 participants met the inclusion criteria. Men were divided in two sub-groups (minimal or total incontinence) and each group was randomised to artificial urethral sphincter (AUS) implantation or Macroplastique injection. Follow-up ranged from six to 120 months. in the trial as a whole, the men treated with AUS were more likely to be dry (18/20, 82%) than those who had the injectable treatment (11/23, 46%) (odds ratio (OR) 5.67, 95% confidence interval (CI) 1.28 to 25.10). However, this effect was only statistically significant for the men with more severe ('total') incontinence (OR 8.89, 95% CI 1.40 to 56.57) and the CIs were wide. There were more severe complications in the group undergoing AUS, and the costs were higher. AUS implantation was complicated in 5/22 (23%) men: the implant had to be removed from one man because of infection and in one man due to the erosion of the cuff, in one man the pump was changed due to mechanical failure, in one man there was migration to the intraperitoneal region, and one man experienced scrotal erosion. in the injectable group, 3/23 (13%) men had a complication: one man treated with Macroplastique injection had to be catheterised because of urinary retention and two men developed urinary tract infections.Authors' conclusionsThe evidence available at present was of very low quality because we identified only one small randomised clinical trial. Although the result was favourable for the implantation of AUS in the group with severe incontinence, this result should be considered with caution due to the small sample size and uncertain methodological quality of the study found.National Institute for Health Research, UKNational Institute for Health Research (NIHR)Universidade Federal de São Paulo, Dept Urol, BR-04105002 São Paulo, BrazilUniv Estado Para, Dept Publ Hlth, Belem, Para, BrazilBrazilian Cochrane Ctr, Ctr Estudos Saude Baseada Evidencias & Avaliacao, São Paulo, BrazilUniversidade Federal de São Paulo, BR-04105002 São Paulo, BrazilUniversidade Federal de São Paulo, Dept Urol, BR-04105002 São Paulo, BrazilUniversidade Federal de São Paulo, BR-04105002 São Paulo, BrazilWeb of Scienc

Beta-blockers for preventing stroke recurrence

BackgroundStroke affects 15 million people per year worldwide. Despite recent developments in acute stroke treatment, prevention remains very important. Stroke has a high rate of recurrence; therefore secondary prevention is also important. Many clinical approaches to control risk factors have been proposed. One of these approaches is the prescription of beta-blockers that have effects beyond the reduction of blood pressure, which can reduce the recurrence of stroke.ObjectivesTo evaluate the efficacy of beta-blockers for preventing stroke recurrence and for reducing death and major vascular events in people with a previous stroke or transient ischaemic attack (TIA), and to determine their safety, particularly with regard to the development of diabetes mellitus.Search methodsWe searched the Cochrane Stroke Group Trials Register (May 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Database of Systematic Reviews (CDSR) (The Cochrane Library 2014, Issue 5), the Database of Abstracts of Reviews of Effects (DARE) (May 2014), MEDLINE (1966 to May 2014), EMBASE (1980 to May 2014), and Latin American and Caribbean Health Sciences Literature (LILACS) (1982 to May 2014). We also searched ongoing trials registers and reference lists.Selection criteriaRandomised controlled trials (RCTs) that included participants with previous stroke or TIA due to arterial thrombosis or embolism. the intervention was any beta-blocker versus control, or beta-blocker plus other treatment versus other treatment.Data collection and analysisTwo review authors independently screened the trials identified, appraised quality, and extracted data.Main resultsWe included two RCTs involving 2193 participants in the review. Both studies randomised participants to either beta-blocker (atenolol 5 mg) or placebo and were of a high methodological quality. We noted no statistical differences among the groups in risks of fatal and non-fatal stroke (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.76 to 1.18). for other outcomes analysed (major vascular events, death from all causes, death from cardiovascular causes), we observed no significant differences between the groups. There were minor blood pressure reductions in the intervention group. Neither of the included studies reported the occurrence of diabetes among their outcomes or assessed quality of life. Adverse events were significantly more frequent in participants taking atenolol than in those given placebo, and were the most common reason given for discontinuing treatment (RR 1.85, 95% CI 1.45 to 2.35).Authors' conclusionsTo date, no available evidence supports the routine use of beta-blockers for secondary prevention after stroke or TIA. More studies with larger samples are needed.Brazilian Cochrane Centre, BrazilCoordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)Comissao de Aperfeicoamento de Pessoal de Ensino SuperiorUniversidade Federal de São Paulo, Brazilian Cochrane Ctr, BR-04038000 São Paulo, SP, BrazilSanta Casa Campo Mourao, Dept Med, São Paulo, BrazilCtr Estudos Saude Baseada Evidencias & Avaliacao, Brazilian Cochrane Ctr, São Paulo, BrazilUniversidade Federal de São Paulo, BR-04038000 São Paulo, SP, BrazilUniversidade Federal de São Paulo, Brazilian Cochrane Ctr, BR-04038000 São Paulo, SP, BrazilUniversidade Federal de São Paulo, BR-04038000 São Paulo, SP, BrazilWeb of Scienc