Systematic mapping review of interventions to prevent blood loss, infection and relapse in orthognathic surgery.

BACKGROUND: This systematic mapping review aims to identify, describe, and organize the currently available evidence in systematic reviews (SR) and primary studies regarding orthognathic surgery (OS) co-interventions and surgical modalities, focusing on the outcomes blood loss, infection and relapse. MATERIAL AND METHODS: A comprehensive search strategy was performed to identify all SRs, randomized controlled trials and observational studies that evaluate surgical modalities and perioperative co-interventions in OS that evaluate the outcomes blood loss, infection and relapse, regardless of language or publication date. Searches were conducted in MEDLINE, EMBASE, Epistemonikos, Lilacs, Web of Science, and CENTRAL. In addition, grey literature was screened. RESULTS: 27 SRs and 150 primary studies fulfilled the inclusion criteria, 91 from SRs, and 59 from our search strategy. Overall, the quality of the SRs was graded as "Critically low," and only two SRs were rated as "High" quality. 11 PICO questions were extracted from SRs and 31 from primary studies, which focused on osteosynthesis methods, surgical cutting devices, use of antibiotics, and induced hypotension. In addition, evidence bubble maps for each outcome were created to analyze in a visual manner the existing evidence. CONCLUSIONS: Future primary and secondary high-quality research should be addressed focused on the eight knowledge gaps identified in this mapping review. We concluded that the evidence mapping approach is a practical methodology for organizing the current evidence and identifying knowledge gaps in OS, helping to reduce research waste and canalize future efforts in developing studies for unsolved questions.

Socio-economic impact on women diagnosed and treated for breast cancer: a cross-sectional study.

INTRODUCTION: The increase in breast cancer survival poses a challenge for patients to be able to rejoin their professional and social life in very similar conditions to those before diagnosis. The aim of this study is to assess short- and medium-term social, economic and professional impact of BC among women diagnosed with it. METHODS: A cross-sectional descriptive study using QLQ-C30, QLQ-BR23, and MOS-SSS instruments and a semi-structured interview in women diagnosed in years 2011, 2014, and 2016 in Hospital de la Santa Creu i Sant Pau in Barcelona (Spain). RESULTS: 175 patients were included with a mean age of 55. About 62.8% were married or coupled, 76% were living with their family unit, and 52.6% denied changes in their living situation. The mean Support Global Index was 74.7% and 78.8% before and after diagnosis, respectively. The mean global quality of life (QOL) was 67.3%, outstanding insomnia as the main symptom (X > 30%) and sexual function as the most affected dimension. At the moment of diagnosis, two-thirds of patients were working. After diagnosis, 87.5% stopped working, 39.4% were off work for 7-12 months, and only 50% returned to work. Multivariate analysis identified working as the most associated variable with a good QOL. CONCLUSIONS: QOL among women diagnosed with breast cancer is quite high and stable. Nevertheless, there are some very relevant aspects to QOL that need to be considered whilst caring for patients with BC to achieve rehabilitation as complete and comprehensive as possible.

Evidence mapping based on systematic reviews of therapeutic interventions for soft tissue sarcomas.

PURPOSE: Soft tissue sarcomas are a heterogeneous group of rare tumours of mesenchymal origin. Evidence mapping is one of the most didactic and friendly approaches to organise and summarise the range of research activity in broad topic fields. The objective of this evidence mapping is to identify, describe and organise the current available evidence about therapeutic interventions on soft tissues sarcomas. METHODS: We followed the methodology of global evidence mapping. We performed a search of the PubMed, EMBASE, The Cochrane Library and Epistemonikos to identify systematic reviews (SRs) with or without meta-analyses published between 1990 and March 2016. Two independent literature reviewers assessed eligibility and extracted data. Methodological quality of the included systematic reviews was assessed using AMSTAR. We organised the results according to identified PICO questions and used tables and a bubble plot to display the results. RESULTS: The map is based on 24 SRs that met eligibility criteria and included 66 individual studies. Three-quarters were either observational or uncontrolled clinical trials. The quality of the included SRs was in general moderate or high. We identified 64 PICO questions from them. The corresponding results mostly favoured the intervention arm. CONCLUSIONS: This evidence mapping was built on the basis of SRs, which mostly included non-experimental studies and were qualified by the AMSTAR tool as of moderate quality. The evidence mapping created from PICO questions is a useful approach to describe complex and huge clinical topics through graphical media and orientate further research to fulfil the existing gaps. However, it is important to delimitate the steps of the evidence mapping in a pre-established protocol.

Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012.

INTRODUCTION: The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor. OBJECTIVE: To assess the methodological quality of RCTs published in Spanish-language dermatology journals. METHODS: By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study. RESULTS: The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies. DISCUSSION AND CONCLUSIONS: In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results.

Identifying randomized clinical trials in Spanish-language dermatology journals.

INTRODUCTION: The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. OBJECTIVE: To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. METHODS: We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. RESULTS: Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. CONCLUSIONS: Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online.

Healthcare quality indicators of peripheral artery disease based on systematic reviews.

OBJECTIVES: Peripheral artery disease (PAD) is a major health problem whose clinical management includes multiple options regarding risk factor control, diagnosis, and medical and surgical treatment. The aim was to generate indicators based on systematic reviews to evaluate the quality of healthcare provided in PAD. METHODS: Electronic searches were run for systematic reviews in The Cochrane Library (Issue 6, 2011), MEDLINE, EMBASE, and other databases (up to June 2011). Conclusive systematic reviews of high methodological quality were selected to formulate clinical recommendations. Indicators were derived from clinical recommendations with moderate to very high strength of evidence as assessed by the GRADE system. RESULTS: From 1,804 reviews initially identified, 29 conclusive and high-quality systematic reviews were selected and nine clinical recommendations were formulated with a moderate to very high strength of recommendation. Six indicators were finally generated: four on pharmacological interventions, antiplatelet agents, naftidrofuryl, cilostazol, and statins; and two lifestyle interventions, exercise and tobacco cessation. No indicators were derived for diagnostic tests or surgical techniques. Most indicators targeted patients with intermittent claudication. CONCLUSIONS: These quality indicators will help clinicians to assess the appropriateness of healthcare provided in PAD. The development of evidence-based indicators in PAD is limited by the lack of methodological quality of the research in this disease, the inconclusiveness of the evidence on diagnostic and surgical techniques, and the dynamic nature of the vascular diseases field.

Quality of tuberculosis guidelines: urgent need for improvement.

SETTING: Clinical practice guidelines have been developed for many disorders, but their quality varies greatly and does not always reach an acceptable standard. No evaluation of clinical practice guidelines on tuberculosis (TB) has been carried out to date. OBJECTIVE: To identify and assess the quality of TB guidelines. DESIGN: We systematically searched documents published from January 1998 to May 2008 in Medline and the Turning Research into Practice (TRIP) database and in clearing houses and on websites of scientific societies. Three appraisers evaluated each guideline using the AGREE (Appraisal of Guidelines, Research and Evaluation) instrument. A standardised score was calculated separately for each of the six domains. RESULTS: A total of 36 guidelines for TB were identified, and after appraisal good overall agreement was observed among the three evaluators. Results revealed that quality was acceptable in two domains but had serious shortcomings in the other four. A slight improvement in quality was observed in documents published in 2005 or later. After global assessment, 18 documents were considered 'recommended with provisos' and only two documents 'strongly recommended' for use in clinical practice. CONCLUSION: The methodological quality of TB guidelines was disappointingly low. All guideline developers should adhere to instruments such as AGREE to produce documents of optimal quality.

Prevalence evolution and impact of cardiovascular risk factors on allograft and renal transplant patient survival.

OBJECTIVE: The prevalence of traditional cardiovascular risk factors in renal transplantation is high. Studying the evolution of cardiovascular risk factors over time may help us to design better strategies to control them. The relative impact of traditional cardiovascular risk factors on allograft survival and mortality in transplant recipients is not clear. This study was performed to determine the incidence and risk factors for allograft survival and mortality among renal transplant patients. PATIENTS AND METHODS: We enrolled 250 patients who had undergone transplantation between 1980 and 2004. They were followed for various periods, and we analyzed the impact of traditional and nontraditional risk factors on renal allograft survival. RESULTS: The prevalence of hypertension was >80% during all the follow-up periods. Blood pressure diminished, antihypertensive drug prescription increased, and 15% of patients had adequate blood pressure control during follow-up. The prevalence of pretransplant diabetes mellitus was 6.8%; the incidence of posttransplant diabetes mellitus (PTDM) was 14.2%. The prevalence of PTDM increased over the course of patient evolution. The prevalence of dyslipidemia was in all cases >70%; total cholesterol and low-density lipoprotein (LDL)-cholesterol decreased; prescription of statins increased; and the percentage of patients with good lipid control also increased. The 25% prevalence of active smoking at the time of transplantation decreased to 13.6% at 10 years posttransplantation. The mean patient follow-up was 8 +/- 4.6 years. Sixty-five patients (26%) lost their grafts and 40 (16%) died during follow-up. Donor age, exercise, diastolic blood pressure, renal function, and albumin levels were independent risk factors for graft loss. Charlson comorbidity index at transplantation, recipient and donor ages, exercise, diastolic blood pressure, and LDL-cholesterol posttransplantation were independent risk factors for mortality among renal transplant recipients. CONCLUSION: Blood pressure and lipid control improved during follow-up, however, insufficiently among renal transplant patients. The prevalence of diabetes gradually increased, and the incidence of smoking cessation was low. Diastolic blood pressure, exercise, and albuminemia were the most significant modifiable cardiovascular risk factors for renal allograft survival. Diastolic blood pressure, LDL-cholesterol level, and exercise were the most relevant modifiable cardiovascular risk factors for the survival of renal transplant patients.

Amitriptyline in the treatment of fibromyalgia: a systematic review of its efficacy.

The objective of this study was to assess the efficacy and safety of amitriptyline as a treatment of FM. A comprehensive computerized search in Medline (Pubmed), EMBASE and The Cochrane Library was performed. Randomized controlled trials (RCTs) comparing amitriptyline vs placebo in adult patients suffering from FM were identified, the methodological quality was assessed and the results of the main outcomes were evaluated. Ten RCTs were identified. Large clinical variability and statistical heterogeneity precluded quantitative meta-analysis. Overall, the study quality was moderate to high. Amitriptyline 25 mg/day (six RCTs) demonstrated a therapeutic response compared with placebo in the domains of pain, sleep, fatigue and overall patient and investigator impression. This benefit was generally seen at 6-8 weeks of treatment but no effect was noted at 12 weeks. Amitriptyline 50 mg/day (four RCTs) did not demonstrate a therapeutic effect compared with placebo. Neither dose of amitriptyline had an effect on tender points count. No clear statements on adverse events with amitriptyline can be made due to inconsistencies in data among the studies. A definitive clinical recommendation regarding the efficacy of amitriptyline for FM symptoms cannot be made. There is some evidence to support the short-term efficacy of amitriptyline 25 mg/day in FM. There is no evidence to support the efficacy of amitriptyline at higher doses or for periods >8 weeks. More stringent RCTs with longer follow-up periods are required to determine the long-term efficacy and safety of the amitriptyline and define its role in the multidisciplinary management of FM.

Ensayos clínicos en intervenciones no farmacológicas

Publicación fruto de la mesa redonda celebrada en 2000 en Bellaterra sobre los ensayos clínicos en intervenciones no farmacológicas. La monografía reúne todas las aportaciones, discusiones y conclusiones de las 11 ponencias que se realizaron durante esa jornada. La prevención del alcoholismo, ensayos clínicos en ejercicio físico y deporte, la terapia génica o la cirugía endoscópica son algunos de los temas incluidos en esta publicación.Desde esta página se permite la descarga gratuita de la obra completa en pdf o por capítulos, así como solicitar un ejemplar on-line.

A randomized, double-blind multicentre clinical trial comparing the efficacy of calcium dobesilate with placebo in the treatment of chronic venous disease.

OBJECTIVE: To assess the efficacy of calcium dobesilate on the quality-of-life (QoL) of patients with chronic venous disease (CVD). DESIGN: Randomised, parallel, double blind, placebo-controlled clinical trial. METHODS: Patients were recruited from vascular surgery clinics and randomised to 500mg capsules of calcium dobesilate twice a day for 3 months or placebo. The primary outcome measure was 'QoL after 3 months' treatment measured by the specific Chronic Insufficiency Venous International Questionnaire (CIVIQ). Secondary outcomes were QoL at 12 months and assessment of the CVD signs and symptoms. The principal analysis was undertaken on the intention-to-treat (ITT) data. RESULTS: Five hundred and nine patients were recruited (246 to calcium dobesilate and 263 to placebo). The analysis of the 'QoL after 3 months' showed no significant differences between groups (p=0.07). For secondary outcomes, oedema and symptoms of CVD, there were no significant differences between groups. In a multi-factorial analysis, the 'QoL at 12 months' was better in the calcium dobesilate group than in placebo group (p=0.02). CONCLUSIONS: Treatment with calcium dobesilate was not found to be superior to placebo on the QoL of CVD patients. The sustained effect of calcium dobesilate observed after treatment should be confirmed in future studies.

[Clinical trials published in Revista Española de Anestesiología y Reanimación: characteristics and quality of design]. / Características y calidad metodológica de los ensayos clínicos publicados en la Revista Española de Anestesiología y Reanimación.

OBJECTIVE: To identify and assess the quality of controlled clinical trials published in Revista Española de Anestesiología y Reanimación during the period 1967-2004. MATERIAL AND METHODS: We identified and classified clinical trials following the criteria adopted by the International Cochrane Collaboration. Each trial was described and its design assessed. RESULTS: We identified 640 controlled clinical trials: 233 (36.4%) were published as original articles, 398 (62.2%) were conference presentations, and 9 (1.4%) were in other publication formats. The most common type of trial design, found in 398 (62.2%) cases, was drug-to-drug comparison. The main outcome was of clinical interest in 464 (72.5%) cases. The system of randomization used was considered adequate in only 37 (5.8%) of the studies. The funding source for 432 (67.5%) trials was not specified. CONCLUSIONS: It is noteworthy that Revista Española de Anestesiología y Reanimación has published a large number of controlled clinical trials in comparison with other Spanish journals covered by Index Medicus. We observed that important information on how the trials were carried out was missing and that trial quality was low in terms of current standards. The editorial board's adoption of the CONSORT statement may help to improve the quality of trials currently being published, and that question should be analyzed after a reasonable period of time has passed.

[Clinical practice guidelines (I): elaboration, implementation and evaluation]. / Guías de práctica clínica (I): elaboración, implantación y evaluación.

Clinical practice guidelines are defined as a set of systematically developed recommendations that aim to guide the decision-making process. In the last ten years, interest in clinical practice guidelines has grown steadily as they have enabled a point of encounter between research and clinical practice. Unlike classical protocols, usually based on consensus or opinion and a narrative review of the available scientific literature, clinical practice guidelines are developed by multidisciplinary teams, review the evidence exhaustively and systematically, evaluate the quality of the information, and propose specific recommendations in line with the quality and design of the studies available. The later stages of dissemination, implementation, and posterior evaluation of their impact complete the cycle for dynamic change in clinical practice.

[Clinical practice guidelines (II): searching and critical evaluation]. / Guías de práctica clínica (II): búsqueda y valoración crítica.

Clinical practice guidelines have unique characteristics of the Internet era in which they are starting to be increasingly popular. The fact that they are often elaborated by governmental agencies and are not published in conventional journals means that they may not be accessible using the usual search methods employed for other types of scientific studies and documents (clinical trials, reviews, etc.). The Internet has become an essential tool for locating clinical practice guidelines, and meta-search engines, specific databases, directories, and elaborating institutions are of special importance. The relative lack of indexing of clinical practice guides means that Medline and Embase are not as useful in this context as in searching for original studies. With the aim of evaluating the validity, reproducibility, and reliability of clinical practice guidelines, a series of European institutions designed a tool to evaluate clinical practice guidelines at the end of the 1990s. This instrument, named AGREE, aims to offer a framework for the evaluation of the quality of clinical practice guidelines. It can also be useful in the design of new clinical practice guidelines as well as in the evaluation of the validity of guidelines to be updated or adapted. The AGREE instrument has become the reference for those that use guidelines, those that elaborate them, and for healthcare providers.

Description of controlled trials published in Methods and Findings, 1979-2002.

It is thought that the controlled trial (CT) is the most adequate research method to assess a therapeutic intervention in terms of efficacy, and it also constitutes the basis for the development of systematic reviews on health interventions. To identify and obtain the majority of published CTs is not an easy task, mainly because of limitations concerning the currently available electronic sources. The aim of the present work was to identify, describe, and assess the quality of CTs published in the journal Methods and Findings in Experimental and Clinical Pharmacology (M&F). Additionally, to assess the retrievability of both methods, a search was performed in Medline (PubMed access) through the use of an optimal search strategy for CTs. A total of 189 original studies out of a total of 2796 reviewed articles met the CT criteria according to the Jadad scale score, we could hold that only 58% of the CTs were of good quality. The present work confirms, once again, the limitations of a CT search performed exclusively through Medline (sensitivity 64% and specificity 98%). In conclusion, we suggest that the journal M&F explicitly joins the International CONSORT Statement.

Surgery versus radiosurgery for patients with a solitary brain metastasis from non-small cell lung cancer.

BACKGROUND: Non-small cell lung cancer is one of the leading causes of death in the developed countries. Patients die of local progression, disseminated disease or both. Brain metastases are often seen in non-small cell lung cancer patients and although they are frequently multiple, a subset of patients with a solitary brain metastasis (with controlled primary tumour) is regularly seen in clinical practice. Treatment of a solitary brain metastasis has usually been surgery, when possible, but the development of new stereotactic techniques of radiotherapy using a linear accelerator or the 'gamma knife' have provided new treatment options. OBJECTIVES: To compare the effectiveness of surgery with that of radiosurgery, either combined with whole brain radiotherapy or administered alone, for patients with a solitary brain metastasis from successfully treated non-small cell lung cancer. SEARCH STRATEGY: The following electronic databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL, 2004 issue 2), MEDLINE (1966 to present), EMBASE (1974 to present), CINAHL (1982 to present). Finally the Cochrane Lung Cancer Specialised Register was also searched. SELECTION CRITERIA: Randomised and controlled trials that compared surgery (with or without whole brain irradiation) with all types of radiosurgery (with or without whole brain irradiation) for solitary brain metastasis from non-small cell lung cancer. All other types of studies i.e.prospective or retrospective cohort studies were not considered appropriate.Studies including patients with multiple brain metastasis or diagnosed without the support of CT scan/MRI diagnostic imaging were also excluded. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results to identify suitable trials. MAIN RESULTS: Despite extensive searching no randomised trials were found. Electronic search identified 686 references. A total of 47 were selected for further evaluation but none was relevant to this review. AUTHORS' CONCLUSIONS: The reviewers felt that the inclusion of studies less rigorous than randomised trials would result in misleading findings. Cohort or single arm studies only provide partial information and have the risk of significant bias. From the evaluated studies, we found that a variety of different criteria were used for the definition of solitary brain metastasis. We observed that the term "single brain metastasis" was misused as synonymous with solitary brain metastasis. Some of the single arm or cohort studies come from single institutions where the availability of both techniques (radiosurgery and surgery) is not described. Therefore, a tendency to use the most accessible technique could be suspected. Finally, in order to determine which technique is superior for patients with a solitary brain metastasis from non-small cell lung cancer, an appropriate randomised trial should be designed. Based on the available evidence a meaningful conclusion cannot be drawn.

Phlebotonics for venous insufficiency.

BACKGROUND: Chronic venous insufficiency (CVI) is a common condition caused by inadequate blood flow through the veins, usually in the lower limbs. It can result in considerable discomfort with symptoms such as pain, itchiness and tiredness in the legs. Sufferers may also experience swelling and ulcers. Phlebotonics are a class of drugs that are often used to treat CVI. OBJECTIVES: To assess the efficacy of oral or topical phlebotonics. SEARCH STRATEGY: We searched the Cochrane Peripheral Vascular Diseases Group trials register (April 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2005), MEDLINE (January 1966 to April 2005), EMBASE (January 1980 to April 2005) and reference lists of articles. We also contacted pharmaceutical companies. SELECTION CRITERIA: Randomised, double blind, placebo-controlled trials (RCTs) assessing the efficacy of rutosides, hidrosmine, diosmine, calcium dobesilate, chromocarbe, centella asiatica, disodium flavodate, french maritime pine bark extract, grape seed extract and aminaftone in CVI patients at any stage of the disease. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. The effects of treatment were estimated by relative risk (RR) or by standardised mean differences (SMD) by applying a random effects statistical model. Sensitivity analyses were also performed. MAIN RESULTS: Fifty-nine RCTs of oral phlebotonics were included, but only 44 trials involving 4413 participants contained quantifiable data for the efficacy analysis: 23 of rutosides, ten of hidrosmine and diosmine, six of calcium dobesilate, two of centella asiatica, one of french maritime pine bark extract, one of aminaftone and one of grape seed extract. No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria. Outcomes included oedema, venous ulcers, trophic disorders, subjective symptoms (pain, cramps, restless legs, itching, heaviness, swelling and paraesthesias), global assessment measures and side effects. The results of many variables were heterogeneous. Phlebotonics showed some global benefit (i.e. oedema reduction) (relative risk 0.72, 95% confidence interval 0.65 to 0.81). The benefit for the remaining CVI signs and symptoms must be evaluated by phlebotonic group. There were no quantifiable data on quality of life. AUTHORS' CONCLUSIONS: There is not enough evidence to globally support the efficacy of phlebotonics for chronic venous insufficiency. There is a suggestion of some efficacy of phlebotonics on oedema but this is of uncertain clinical relevance. Due to the limitations of current evidence, there is a need for further randomised, controlled clinical trials with greater attention paid to methodological quality.

Hormone replacement therapy for preventing cardiovascular disease in post-menopausal women.

BACKGROUND: There is apparently compelling evidence, from observational studies, that hormone replacement therapy (HRT) may have benefits in reducing cardiovascular events in post-menopausal women. However, these observational data are subject to biases and confounding and require support from formally designed randomised controlled trials of the effects of HRT on cardiovascular disease risk. OBJECTIVES: To assess the effects of HRT for the primary and secondary prevention of cardiovascular diseases in post-menopausal women. SEARCH STRATEGY: We searched MEDLINE (1998 to December 2002)), EMBASE (1998 to December 2002), the Cochrane Controlled Trials Register (CCTR) (Issue 4 2002), the National Research Register (1998 to present), Clinical Trials.gov (1998 to present), and the database of Spanish Clinical Trials (1998 to present) and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials comparing HRT with controls (placebo or no treatment) with a minimum follow up of 6 months for treating or preventing cardiovascular disease in postmenopausal women with or without cardiovascular disease. DATA COLLECTION AND ANALYSIS: Three independent reviewers extracted information from the articles, solving discrepancies by consensus. All outcomes studied were dichotomous. Risk ratios and 95% confidence intervals (CI) were calculated for each study and plotted. Random effects meta-analysis was used in efficacy outcomes (cardiovascular events) and fixed-effects meta-analysis in variables regarding side effects (deep venous thrombosis). MAIN RESULTS: No protective effect of HRT was seen for any of the cardiovascular outcomes assessed: all cause mortality, cardiovascular death, non-fatal MI, venous thromboemboli or stroke. Higher risks of venous thromboembolic events (Relative risk (RR) 2.15, 95% CI 1.61 to 2.86), pulmonary embolus (RR 2.15, 95% CI 1.41 to 3.28), and stroke (RR 1.44, 95% CI 1.10 to 1.89) was found in those randomised to HRT compared with placebo. No substantial heterogeneity (p <0.1) was detected in any of the outcomes studied. AUTHORS' CONCLUSIONS: At present, a recommendation for initiating HRT for the reason of preventing cardiovascular events in post-menopausal women (with or without cardiovascular disease) should not be made. Women with other risk factors for venous thromboembolic events should be discouraged from using HRT if the sole goal is to prevent cardiovascular events.

Neuroreflexotherapy for non-specific low-back pain.

BACKGROUND: Among the wide range of therapeutic alternatives proposed for the management of low-back pain (LBP), a less widely used technique from Spain, called neuroreflexotherapy (NRT) has claimed to show very favourable results, mainly in patients with chronic low-back pain. OBJECTIVES: The aim of this review was to systematically assess the effectiveness of NRT for the treatment of non-specific LBP in adult patients, aged 16 to 65 years. A secondary objective was to compare NRT with other conventional interventions. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE to October 1, 2002. SELECTION CRITERIA: Only randomised controlled trials (RCTs) of NRT for the treatment of patients with a clinical diagnosis of non-specific LBP were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials and extracted data using pre-designed forms. Because the outcome variables were not assessed in a homogenous way, it was not possible to pool the results to obtain an estimate of global effect, as initially planned. MAIN RESULTS: Three RCT were included, with a total of 125 subjects randomised to the control groups and 148 subjects receiving active NRT. Neuroreflexotherapy was the same in all three trials, while the control groups received sham-NRT in two trials and standard care in one. Two trials studied patients with chronic LBP, the third studied patients with a mix of chronic and sub-acute LBP. Clinical outcomes were measured in the short-term (15 to 60 days) in all three trials; in one trial, resource utilization was measured after one year. Individuals who received active NRT showed statistically significantly better outcomes than the control groups for measures of pain, degree of mobility, disability, medication use, consumption of resources and costs. No significant differences were observed for quality of life measures. Side effects were more frequently reported in the control groups during short-term follow-up, with no major side effects reported by those receiving active NRT. REVIEWERS' CONCLUSIONS: NRT appears to be a safe and effective intervention for the treatment of chronic non-specific LBP. The efficacy is less clear for sub-acute LBP. However, these results are limited to three trials conducted by a small number of specifically trained and experienced clinicians, in a limited geographical location. No data are available on the ease and time-frame needed to achieve that level of expertise. RCTs by other practitioners, in other locations, that replicate the effects reported in this review are needed before recommending a broader practice.