Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220]

BACKGROUND Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). METHODS/DESIGN Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. DISCUSSION The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.

Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine.

BACKGROUND Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment. METHODS/DESIGN The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only. Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP) is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment). Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham) groups for a brain perfusion study (by single photon emission tomography). The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups. DISCUSSION This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between the baseline period (the 4 weeks prior to the start of treatment) and the period from weeks 9 to 12. As a secondary aspect, we shall record the index of laterality and the percentage of change in the mean count per pixel in each region of interest measured by the brain perfusion tomography, performed on a subsample of the patients within the real and sham acupuncture groups. TRIAL REGISTRATION Current Controlled Trials ISRCTN98703707.

Regression of cardiac growth in kidney transplant recipients using anti-m-TOR drugs plus RAS blockers: a controlled longitudinal study.

BACKGROUND Left ventricular hypertrophy (LVH) is common in kidney transplant (KT) recipients. LVH is associated with a worse outcome, though m-TOR therapy may help to revert this complication. We therefore conducted a longitudinal study to assess morphological and functional echocardiographic changes after conversion from CNI to m-TOR inhibitor drugs in nondiabetic KT patients who had previously received RAS blockers during the follow-up. METHODS We undertook a 1-year nonrandomized controlled study in 30 non-diabetic KT patients who were converted from calcineurin inhibitor (CNI) to m-TOR therapy. A control group received immunosuppressive therapy based on CNIs. Two echocardiograms were done during the follow-up. RESULTS Nineteen patients were switched to SRL and 11 to EVL. The m-TOR group showed a significant reduction in LVMi after 1 year (from 62 ± 22 to 55 ± 20 g/m2.7; P=0.003, paired t-test). A higher proportion of patients showing LVMi reduction was observed in the m-TOR group (53.3 versus 29.3%, P=0.048) at the study end. In addition, only 56% of the m-TOR patients had LVH at the study end compared to 77% of the control group (P=0.047). A significant change from baseline in deceleration time in early diastole was observed in the m-TOR group compared with the control group (P=0.019). CONCLUSIONS Switching from CNI to m-TOR therapy in non-diabetic KT patients may regress LVH, independently of blood pressure changes and follow-up time. This suggests a direct non-hemodynamic effect of m-TOR drugs on cardiac mass.

Pacemaker therapy in patients with neurally mediated syncope and documented asystole: Third International Study on Syncope of Uncertain Etiology (ISSUE-3): a randomized trial.

BACKGROUND: The efficacy of cardiac pacing for prevention of syncopal recurrences in patients with neurally mediated syncope is controversial. We wanted to determine whether pacing therapy reduces syncopal recurrences in patients with severe asystolic neurally mediated syncope. METHODS AND RESULTS: Double-blind, randomized placebo-controlled study conducted in 29 centers in the Third International Study on Syncope of Uncertain Etiology (ISSUE-3) trial. Patients were ≥40 years, had experienced ≥3 syncopal episodes in the previous 2 years. Initially, 511 patients, received an implantable loop recorder; 89 of these had documentation of syncope with ≥3 s asystole or ≥6 s asystole without syncope within 12 ± 10 months and met criteria for pacemaker implantation; 77 of 89 patients were randomly assigned to dual-chamber pacing with rate drop response or to sensing only. The data were analyzed on intention-to-treat principle. There was syncope recurrence during follow-up in 27 patients, 19 of whom had been assigned to pacemaker OFF and 8 to pacemaker ON. The 2-year estimated syncope recurrence rate was 57% (95% CI, 40-74) with pacemaker OFF and 25% (95% CI, 13-45) with pacemaker ON (log rank: P=0.039 at the threshold of statistical significance of 0.04). The risk of recurrence was reduced by 57% (95% CI, 4-81). Five patients had procedural complications: lead dislodgment in 4 requiring correction and subclavian vein thrombosis in 1 patient. CONCLUSIONS: Dual-chamber permanent pacing is effective in reducing recurrence of syncope in patients ≥40 years with severe asystolic neurally mediated syncope. The observed 32% absolute and 57% relative reduction in syncope recurrence support this invasive treatment for the relatively benign neurally mediated syncope. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359203.

Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study).

BACKGROUND: Randomized controlled trials (RCTs) may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs) spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. METHODS/DESIGN: Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs.We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. DISCUSSION: Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials by investigators, Clinical Trial Units, RECs and funding agencies. Identification and modification of barriers to successful study completion at an early stage could help to reduce the risk of trial discontinuation, save limited resources, and enable RCTs to better meet their ethical requirements.

A randomised controlled pilot study comparing Mepitel(®) and SurfaSoft(®) on paediatric donor sites treated with Recell(®).

This randomized controlled pilot study examined the effects of a silicone net dressing (Mepitel(®)) and a monofilament polyamide woven dressing (SurfaSoft(®)) on the rate of epithelialisation and epidermal maturation, pain, and ease of dressing removal on paediatric donor sites treated with epithelial cell suspension (ReCell(®)). Fifteen children (1-15 years) admitted for acute or reconstructive burns procedures in a tertiary referral hospital in Australia were randomly assigned to the experimental group, Mepitel(®) (n=8) and to the control group, SurfaSoft(®) (n=7). All donor sites were treated with ReCell(®) and covered with the assigned dressing. Measurements of rate of epithelialisation and epidermal maturation, pain, and ease of dressing removal were recorded every two days until the wound was healed. Results showed that there was no difference in the rate of epidermal maturation between the two groups. Less pain and force to remove the dressing was shown in the Mepitel(®) group when compared to SurfaSoft(®). The rate of epithelialisation was found to be an unreliable measure. Although additional research is required to support the results of this study, these results suggest that Mepitel's(®) pliable, self-adhesive and atraumatic properties may improve healing of ReCell(®) treated donor sites with less pain at dressing changes. This pilot study provides a strong base for further research in this area.

Premature Discontinuation of Randomized Trials in Critical and Emergency Care: A Retrospective Cohort Study.

OBJECTIVES: Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials. DESIGN: Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003. SETTING: Randomized clinical trials involving patients in an acute or nonacute care setting. SUBJECTS AND INTERVENTIONS: We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators. MEASUREMENTS AND MAIN RESULTS: Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size. CONCLUSIONS: Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.

A randomized follow-up study of the general health and quality of life of an elderly edentulous population wearing either mandibular two-implant overdentures or conventional dentures

L’augmentation de la population âgée dans la société indique que les systèmes de soins de la santé font face à de nouveaux défis. Les hauts niveaux d’incapacité qui en résultent peuvent être réduits par les nouvelles technologies, la promotion de la santé ainsi que des stratégies de prévention. Les écrits scientifiques récents soulignent la supériorité des prothèses dentaires implanto-portées par rapport aux prothèses conventionnelles en termes de satisfaction et de qualité de la vie des patients. Cependant, il n'est toujours pas clair si ces avantages ont des effets positifs à long terme sur la santé orale et générale ainsi que sur la qualité de vie des populations âgées. Objectifs, Hypothèses : Notre but était de mesurer l’impact des prothèses mandibulaires retenues par 2 implants sur la qualité de vie associée à la santé bucco-dentaire et générale ainsi que sur la santé orale et la qualité du sommeil des aînés édentés. Nous avons évalué les hypothèses nulles suivantes : il n'y a aucune différence entre les individus portants des prothèses mandibulaires retenues par 2 implants (IODs) et ceux qui portent des prothèses conventionnelles (CDs), par rapport à la qualité de vie reliée à la santé bucco-dentaire et générale, la santé orale et la qualité du sommeil, un an après avoir reçu leurs nouvelles prothèses. Méthodes : Dans cette étude randomisée contrôlée, 255 aînés ont reçu au hasard IODs ou les CDs, les deux types de prothèses étant opposés à des prothèses maxillaires conventionnelles. La qualité de la vie reliée à la santé bucco-dentaire (OHRQoL) et la santé générale subjective ont été mesurées avec les questionnaires Oral Health Impact Profile (OHIP-20) et Short Form-36 (SF-36) en condition pré-traitement et après un an. La qualité du sommeil et la somnolence diurne ont été mesurées à l’aide du questionnaire Qualité de Sommeil de Pittsburg et de l'Échelle de Somnolence Epworth. La santé orale a été évaluée par un examen clinique. Les variables indépendantes étaient le sens de cohérence et le type de prosthèse, ainsi que des variables socio-démographiques. En utilisant des analyses statistiques bi et multi-factorielles, des comparaisons à l’intérieur d’un même groupe et entre deux groupes ont été effectuées. Résultats : Les différences pré et post traitement pour les cotes OHIP étaient significativement plus grandes pour le groupe IOD que le groupe CD (p<0.05). Le type de traitement et la cote pré-traitement étaient des facteurs significatifs à OHRQoL (p < 0.0001). Dans le groupe CD, il y avait une diminution significative par rapport aux cotes de «Physical Component Scores (PCS)», le fonctionnement physique, le rôle physique et la douleur physique entre les données pré-traitement et un an après le traitement, ce qui indique une diminution au niveau de la santé générale subjective. Dans le groupe IOD, une diminution statistiquement non significative a été remarquée par rapport à toutes les cotes des sous-échelles de SF-36, sauf pour la douleur physique. Le modèle final de régression a démontré qu’après ajustement pour les variables âge, sexe, statut marital et type de traitement, la cote totale finale d’OHIP et les données de bases de PCS prédisaient la cote finale de PCS (p < 0.0001). Aucune corrélation significative entre sens de cohérence et OHRQoL n'a été détectée (r =-0.1; p > 0.05). Les aînés porteurs des prothèses conventionnelles avaient presque 5 fois plus de chance d’avoir une stomatite prothétique que ceux portant des prothèses mandibulaires hybrides retenues par 2 implants (p < 0.0001). Les aînés ayant subjectivement une mauvaise santé générale avaient une qualité de sommeil moins bonne que ceux avec une meilleure santé générale subjective (p < 0.05). Les personnes qui avaient une OHRQoL moins bonne étaient presque 4 fois plus somnolentes pendant le jour que celles avec une meilleure OHRQoL (p=0.003, χ2; OR =3.8 CI 1.5 to 9.8). L'analyse de régression a montré que la santé générale subjective et OHRQoL prévoient la qualité du sommeil (p=0.022 et p=0.001, respectivement) et la somnolence diurne (p=0.017 et p=0.005, respectivement). Conclusions: Les résultats de cette étude suggèrent que, chez les aînés édentés, des prothèses mandibulaires hybrides retenues par deux implants amènent une amélioration significative de la qualité de vie reliée à la santé bucco-dentaire et maintiennent la sensation d’une meilleure santé physique. Des prothèses hybrides implanto-portées peuvent contribuer à la santé orale en réduisant les traumatismes infligés à la muqueuse orale et en contrôlant la stomatite prothétique. Les aînés édentés dont le niveau de qualité de vie reliée à la santé bucco-dentaire est bas, peuvent aussi avoir des troubles de qualité du sommeil.

Role of dietary fats in modulating cardiometabolic risk during moderate weight gain : a randomized double-blind overfeeding trial (LIPOGAIN study)

BACKGROUND: Whether the type of dietary fat could alter cardiometabolic responses to a hypercaloric diet is unknown. In addition, subclinical cardiometabolic consequences of moderate weight gain require further study. METHODS AND RESULTS: In a 7-week, double-blind, parallel-group, randomized controlled trial, 39 healthy, lean individuals (mean age of 27±4) consumed muffins (51% of energy [%E] from fat and 44%E refined carbohydrates) providing 750 kcal/day added to their habitual diets. All muffins had identical contents, except for type of fat; sunflower oil rich in polyunsaturated fatty acids (PUFA diet) or palm oil rich in saturated fatty acids (SFA diet). Despite comparable weight gain in the 2 groups, total: high-density lipoprotein (HDL) cholesterol, low-density lipoprotein:HDL cholesterol, and apolipoprotein B:AI ratios decreased during the PUFA versus the SFA diet (-0.37±0.59 versus +0.07±0.29, -0.31±0.49 versus +0.05±0.28, and -0.07±0.11 versus +0.01±0.07, P=0.003, P=0.007, and P=0.01 for between-group differences), whereas no significant differences were observed for other cardiometabolic risk markers. In the whole group (ie, independently of fat type), body weight increased (+2.2%, P<0.001) together with increased plasma proinsulin (+21%, P=0.007), insulin (+17%, P=0.003), proprotein convertase subtilisin/kexin type 9, (+9%, P=0.008) fibroblast growth factor-21 (+31%, P=0.04), endothelial markers vascular cell adhesion molecule-1, intercellular adhesion molecule-1, and E-selectin (+9, +5, and +10%, respectively, P<0.01 for all), whereas nonesterified fatty acids decreased (-28%, P=0.001). CONCLUSIONS: Excess energy from PUFA versus SFA reduces atherogenic lipoproteins. Modest weight gain in young individuals induces hyperproinsulinemia and increases biomarkers of endothelial dysfunction, effects that may be partly outweighed by the lipid-lowering effects of PUFA. CLINICAL TRIAL REGISTRATION URL: http://ClinicalTrials.gov. Unique identifier: NCT01427140.

Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of mixed urinary incontinence

Background the aim of this study was to compare effective and sham intravaginal electrical stimulation (IES) in treating mixed urinary incontinence. Methods. Between January 2001 and February 2002, 40 women were randomly distributed, in a double-blind study, into two groups: group G1 (n = 20), effective IES, and group G2 (n = 20), sham IES, with follow up at one month. Different parameters was studied: 1. clinical questionnaire, 2. body mass index; 3. 60-min pad test; 4. urodynamic study. The protocol of IES consisted of three 20-min sessions per week over a seven-week period. The Dualpex Uro 996 used a frequency of 4 Hz. Results. There was no statistically significant difference in the demographic data of both groups. The number of micturitions per 24 h after treatment was reduced significantly in both groups. Urge incontinence was reduced to 15% in G1 and 31.5% in G2; there was no significant difference between the groups. In the analog wetness and discomfort sensation evaluations were reduced significantly in both groups. The pretreatment urodynamic study showed no statistical difference in urodynamic parameters between the groups. Ten percent of the women presented involuntary detrusor contractions. In the 60-min pad test, there was a significant reduction in both groups. In regards to satisfaction level, after treatment, 80% of G1 patients and 65% of G2 patients were satisfied. There was no statistically significant difference between the groups. Conclusion. Significant improvement was provided by effective and sham electrostimulation, questioning the effectiveness of electrostimulation as a monotherapy.

A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation

Introduction Oral mucositis (OM) is a significant early complication of hematopoietic cell transplantation (HCT). This phase III randomized double-blind placebo-controlled study was designed to compare the ability of 2 different low level GaAlAs diode lasers (650 nm and 780 nm) to prevent oral mucositis in HCT patients conditioned with chemotherapy or chemoradiotherapy.Materials and methods Seventy patients were enrolled and randomized into 1 of 3 treatment groups: 650 nm laser, 780 nm laser or placebo. All active laser treatment patients received daily direct laser treatment to the lower labial mucosa, right and left buccal mucosa, lateral and ventral surfaces of the tongue, and floor of mouth with energy densities of 2 J/cm(2). Study treatment began on the first day of conditioning and continued through day +2 post HCT. Mucositis and oral pain was measured on days 0, 4, 7, 11, 14, 18, and 21 post HCT.Results the 650 nm wavelength reduced the severity of oral mucositis and pain scores. Low level laser therapy was well-tolerated and no adverse events were noted.Discussion While these results are encouraging, further study is needed to truly establish the efficacy of this mucositis prevention strategy. Future research needs to determine the effects of modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy delivery, etc.) on the effectiveness of LLE laser to prevent OM.

A randomized and controlled trial about the use of oral isotretinoin for photoaging

Topical retinoids are used to treat photoaging; oral isotretinoin is gold standard for acne; off label indications, including photoaging, have been reported with insufficient evidence of efficacy. This is a randomized controlled phase II trial with clinical and histological assessment to evaluate efficacy and safety of oral isotretinoin for photoaging. Study population was comprised of 32 menopausal or sterilized women, aged 40-55, divided in 2 groups: A (21) received 20mg isotretinoin, 3 times per week, nightly moisturizer, and daily sunscreen, for three months; B (11) just moisturizer/sunscreen. Main outcome measures were: overall clinical assessment; profilometry, corneometer and elasticity tests in periocular regions and left forearm; before/after biopsies from left forearm in patients of B and in 10 randomly selected of A. Microscopic blinded evaluation of epidermal thickness, dermal elastosis, new collagen, p53 epidermal expression was performed by quantitative digital image analysis. All data were submitted to statistical analysis. Clinical evaluation showed slight improvement; profilometry, corneometer and skin elasticity tests presented significant difference in pre/post values (P = 0.001 to 0.028), but no differences between A/B. Histological findings and p53 expression were comparable between groups before treatment (P > 0.1); microscopic analysis showed no differences between groups for most variables, after treatment. Slight but significant difference between A/B for p53 with major reduction post isotretinoin [0.66±0.31 vs. 0.94±0.34 respectively (P = 0.04) was observed. There were minor side effects and no significant laboratory test alterations. We concluded that no significant clinical, microscopic changes but p53 epidermal expression reduction were observed. The role of ultra-violet induced p53 mutation in skin carcinogenesis reinforces retinoids chemoprevention. Oral isotretinoin seemed safe but not effective to treat photoaging. Caution should be considered for women prone to pregnancy. Further controlled studies are necessary. © 2010 The International Society of Dermatology.

Erythromycin versus neomycin in the treatment of hepatic encephalopathy in cirrhosis: A randomized double-blind study

Background: Hepatic encephalopathy (HE) is a severe complication in patients with hepatic cirrhosis, which causes numerous hospital admissions and deaths. Antibiotics are the best options in HE treatment, but head-to-head comparisons between these drugs are scarce. Erythromycin combines the antimicrobial effect and prokinetic properties in the same drug, but it has never been used in HE treatment. Our aim was to evaluate the efficacy of erythromycin as an HE treatment.Methods: We achieved a randomized controlled trial of adult patients with HE and hepatic cirrhosis admitted in our hospital. After randomization, the subjects received either erythromycin 250 mg or neomycin 1 g orally QID until hospital discharge or prescription of another antibiotic. All subjects were blindly evaluated every day towards quantifying clinical, neuropsychometric, hepatic and renal exams. Statistical analysis was employed to compare the groups and correlate the variables with hospitalization duration.Results: 30 patients were evaluated (15 treated with each drug). At hospital admission, the groups were homogeneous, but the erythromycin group subjects achieved a shorter hospitalization stay (p = 0.032) and a more expressive reduction in alanine aminotranspherase levels (p = 0.026). Hospitalization duration was positively correlated with C reactive protein levels measured previous to (p = 0.015) and after treatment (p = 0.01).Conclusions: In the sample evaluated erythromycin was associated with significant reductions in hospital stay and in alanine aminotranspherase values. Hospitalization time was positive correlated with C reactive protein levels measured before and after the treatments. © 2013 Romeiro et al.; licensee BioMed Central Ltd.

Effects of soy isoflavones on mammographic density and breast parenchyma in postmenopausal women: A randomized, double-blind, placebo-controlled clinical trial

OBJECTIVE: This study aims to evaluate the effects of soy isoflavones on breast tissue in postmenopausal women. METHODS: In this randomized, double-blind, placebo-controlled study, 80 women (aged ≥45 y and with amenorrhea >12 mo) with vasomotor symptoms were randomized to receive either 250 mg of standardized soy extract corresponding to isoflavone 100 mg/day (n = 40) or placebo (n = 40) for 10 months. Breasts were evaluated through mammographic density and breast parenchyma using ultrasound (US) at baseline and 10-month follow-up. Independent t test, analysis of variance, Mann-Whitney U test, and χ2 trend test were used in statistical analysis. RESULTS: Baseline clinical characteristics showed no significant differences between the isoflavone group and the placebo group, with mean (SD) age of 55.1 (6.0) and 56.2 (7.7) years, mean (SD) menopause duration of 6.6 (4.8) and 7.1 (4.2) years, and mean (SD) body mass index of 29.7 (5.0) and 28.5 (4.9) kg/m2, respectively (P > 0.05). The study was completed by 32 women on isoflavone and 34 women on placebo. The groups did not differ in mammographic density or breast parenchyma by US (P > 0.05). Within each group, the baseline and final moments did not differ in mammography or US parameters significantly (P > 0.05). CONCLUSIONS: The use of soy isoflavone extract for 10 months does not affect breast density, as assessed by mammography and US, in postmenopausal women. © 2013 by The North American Menopause Society.

Longer immediate recovery time after anesthesia increases risk of respiratory complications after laparotomy for bariatric surgery: a randomized clinical trial and a cohort study

We compared the effects of two anesthesia protocols in both immediate recovery time (IRT) and postoperative respiratory complications (PRCs) after laparotomy for bariatric surgery, and we determined the association between the longer IRT and the increase of PRC incidence. We conducted the study in two stages: (i) in a randomized controlled trial (RCT), patients received either intervention (sevoflurane-remifentanil-rocuronium-ropivacaine) or control protocol (isoflurane-sufentanil-atracurium-levobupivacaine). All patients received general anesthesia plus continuous epidural anesthesia and analgesia. Treatment was masked for all, except the provider anesthesiologist. We defined IRT as time since anesthetics discontinuation until tracheal extubation. Primary outcomes were IRT and PRCs incidence within 15 days after surgery. We also analyzed post-anesthesia care unit (PACU) and hospital length of stays; (ii) after the end of the RCT, we used the available data in an extension cohort study to investigate IRT > 20 min as exposure factor for PRCs. Control protocol (n = 152) resulted in longer IRT (30.4 ± 7.9 vs 18.2 ± 9.6 min; p < 0.0001), higher incidence of PRCs (6.58 vs 2.5 %; p = 0.048), and longer PACU and hospital stays than intervention protocol (n = 200); PRC relative risk (RR) = 2.6. Patients with IRT > 20 min (n = 190) presented higher incidence of PRCs (7.37 vs 0.62 %; p < 0.0001); RR = 12.06. Intervention protocol, with short-acting anesthetics, was more beneficial and safe compared to control protocol, with long-acting drugs, regarding the reduction of IRT, PRCs, and PACU and hospital stays for laparotomy in bariatric patients. We identified a 4.5-fold increase in the relative risk of PRCs when morbid obese patients are exposed to an IRT > 20 min.