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PubMed2006

Paraneoplastic changes of oropharyngeal mucosa in breast cancer.

BACKGROUND: Paraneoplasias in the oral cavity are uncommon and have been rarely described so far. A woman with isolated papillomatosis and keratosis of oropharyngeal epithelia is reported. CASE REPORT: In a 43-year-old woman suffering from breast cancer, extensive changes of oropharyngeal epithelia were apparent 2.5 years after primary surgery and combined radiochemotherapy (RCT) as well as relapse therapy with RCT. At that time, radiologic investigations showed no locoregional or distant metastases. Nevertheless, after removal of the upper lip changes and skin resurfacing of the upper lip, progression of the oropharyngeal and labial changes was registered. Subsequent restaging showed advanced liver metastases. After treatment of the liver metastases, a regression of the extensive oropharyngeal changes became apparent. CONCLUSION: The appearance of untypical changes of oropharyngeal epithelia is suspective of paraneoplasia. In order to diagnose tumor recurrence, a restaging should be performed.

Adult↗
PubMed2006

Concurrent radiotherapy and taxane chemotherapy in patients with locoregional recurrence of breast cancer. A retrospective analysis.

BACKGROUND AND PURPOSE: Locoregional breast cancer recurrence is characterized by a high rate of systemic and local re-recurrence. Data on concurrent radiochemotherapy (RCT) in these cases are scarce. The purpose of this study was to evaluate feasibility, toxicity and efficacy of local control of a radiotherapy combined with a chemotherapy containing a taxane. PATIENTS AND METHODS: Between May 1999 and November 2004, 36 women referred to the authors' clinic because of locoregional breast cancer recurrence that was either inoperable (n = 29) or resected (n = 7) received concurrent irradiation and taxane monotherapy weekly (TAX/RT; n = 28: paclitaxel 90 mg/m(2), n = 24, or docetaxel 35 mg/m(2), n = 4) or taxane + cisplatin therapy (TAX/CIS/RT; n = 8; paclitaxel 135 mg/m(2) d1 and cisplatin 20 mg/m(2) d1-5 q28). RESULTS: Comparing TAX/RT with TAX/CIS/RT, the complete remission rate in patients with macroscopic tumor prior to RCT was significantly higher for TAX/RT than for TAX/CIS/RT (7/19 vs. 0/8; p = 0.046), but overall remission rates were comparable, i.e., partial remission: 11/20 versus 6/8 cases, stable disease (no change): 1/20 versus 2/8 cases, and response rate: 95% versus 75%, respectively. The cumulative local recurrence-free survival rate at 1 and 2 years post-treatment was 83% and 68% and that of systemic recurrence-free survival 56% and 29%, respectively. The main toxic reactions of third-degree and higher were dermatitis in TAX/RT (57% vs. 11% for TAX/CIS/RT) and leukocytopenia in TAX/CIS/RT (62% vs. 7% for TAX/RT). CONCLUSION: Concurrent irradiation and taxane chemotherapy weekly, in particular with paclitaxel, is recommended due to response and acceptable side effects for treatment of inoperable locoregional breast cancer recurrence.

Adult↗
PubMed2005

Depressive symptoms in mothers of pre-school children--effects of deprivation, social support, stress and neighbourhood social capital.

BACKGROUND: Depressive symptoms in mothers of young children can have serious consequences for the health of the child. In particular, children whose mothers are experiencing depressive symptoms are at significantly greater risk of poisoning and accidental injury. A mother's risk of developing depressive symptoms has been shown to be related to socio-economic disadvantage, high levels of stress and a perceived lack of social support. Residents who perceive their neighbourhoods to be of low social capital are more likely to report poor mental health. The aim of this study was to investigate the relationship between maternal depressive symptoms, deprivation, social support, stress and neighbourhood social capital in a group of mothers living in deprived areas of Nottingham, United Kingdom (UK). DESIGN AND SETTING: A postal questionnaire at entry to a randomised controlled trial (RCT) assessed socio-demographic characteristics and a second questionnaire, 21 months later, assessed depressive symptoms, perceived lack of social support, self-reported stress and individual-level assessment of neighbourhood social capital. PARTICIPANTS: A total of 846 mothers of young children living in deprived areas in Nottingham, UK, enrolled in the control group of an RCT. RESULTS: One-third of mothers reported high levels of depressive symptoms. Neighbourhood-level deprivation and receiving means-tested benefits were independently associated with maternal depressive symptoms. A lack of social support and high levels of self-reported stress were also strongly associated with depressive symptoms. Individual-level assessment of neighbourhood social capital was not associated with depressive symptoms amongst mothers after adjusting for self-reported stress. CONCLUSIONS: Neighbourhood- and individual-level variables of deprivation and psychological distress are more important than mother's assessment of the social capital of the neighbourhood in which she lives in determining the risk of depressive symptoms. Interventions aimed at supporting mothers of young children may be more effective at reducing the risks of depressive symptoms and consequent risks to the child's health than interventions aimed at improving a neighbourhood's social capital.

Adult↗
PubMed2002

Pre-operative optimisation employing dopexamine or adrenaline for patients undergoing major elective surgery: a cost-effectiveness analysis.

OBJECTIVE: To compare the cost and cost-effectiveness of a policy of pre-operative optimisation of oxygen delivery (using either adrenaline or dopexamine) to reduce the risk associated with major elective surgery, in high-risk patients. METHODS: A cost-effectiveness analysis using data from a randomised controlled trial (RCT). In the RCT 138 patients undergoing major elective surgery were allocated to receive pre-operative optimisation employing either adrenaline or dopexamine (assigned randomly), or to receive routine peri-operative care. Differential health service costs were based on trial data on the number and cause of hospital in-patient days and the utilisation of health care resources. These were costed using unit costs from a UK hospital. The cost-effectiveness analysis related differential costs to differential life-years during a 2 year trial follow-up. RESULTS: The mean number of in-patient days was 16 in the pre-optimised groups (19 adrenaline; 13 dopexamine) and 22 in the standard care group. The number (%) of deaths, over a 2 year follow-up, was 24 (26%) in the pre-optimised groups and 15 (33%) in the standard care group. The mean total costs were EUR 11,310 in the pre-optimised groups and EUR 16,965 in the standard care group. Life-years were 1.68 in the pre-optimised groups and 1.46 in the standard care group. The probability that pre-operative optimisation is less costly than standard care is 98%. The probability that it dominates standard care is 93%. CONCLUSIONS: Based on resource use and effectiveness data collected in the trial, pre-operative optimisation of high-risk surgical patients undergoing major elective surgery is cost-effective compared with standard treatment.

Bayes Theorem↗
PubMed2006

Informed consent in clinical trials in critical care: experience from the PAC-Man Study.

OBJECTIVES: To identify the proportion of critically ill patients able to consent to participation in a randomised controlled trial (RCT) and to assess to what extent patient consent and relative assent processes could be conducted according to ethics committee permission. DESIGN: Descriptive study nested in an RCT. SETTING: Fifty-six UK intensive care units participating in the PAC-Man trial. PATIENTS AND PARTICIPANTS: First 500 patients consecutively enrolled into PAC-Man. MEASUREMENT AND RESULTS: The outcome measures were patient consent and/or relative assent. Of the 498 patients included, 13 (2.6%) provided consent before randomisation. Of the remaining 485 patients, relative assent was obtained for 394 patients (81.2%), and refused post-randomisation for 3 patients (0.6%). No relatives were available for 15 patients (3.1%), and it was unclear from documentation whether relative assent had been obtained for 73 patients (15.1%). Of the 482 patients who did not provide consent prior to randomisation, 188 (39%) survived. Of these, 175 (93.1%) gave retrospective informed consent, six (3.2%) refused, and seven (3.7%) did not regain mental competency. CONCLUSIONS: A very small proportion of patients were able to give consent before randomisation. Due to the high in-hospital mortality (60.6%), only around one third of the remaining patients could provide consent retrospectively. This study demonstrates difficulties experienced in obtaining consent from critically ill patients to participate in medical research and raises important issues about the ethical basis of the consent process in critical care.

Critical Care↗
PubMed2004

Randomized controlled trial of hip protectors among women living in the community.

OBJECTIVE: To assess whether hip protectors used among women living in the community in the United Kingdom and at high risk of hip fracture, lead to a reduction in hip fracture. DESIGN: Pragmatic randomized controlled trial (RCT). SETTING: Primary care with participants being recruited largely from general practitioners' patient lists. PARTICIPANTS: Women aged 70 years and over with one or more risk factors for hip fracture (i.e., low body weight, current smoker, a prior fracture, family history of hip fracture). INTERVENTION: Three pairs of hip protectors of the "shell" type mailed to participants with instructions on how to use them. MAIN OUTCOME MEASURE: Reduction in hip fractures. RESULTS: 1,388 and 2,781 women aged 70 years or over were randomized to be given three pairs of hip protectors or act as controls, respectively. We followed up both groups of women for a minimum of 24 months (maximum 42 months, median 28). Compliance was poor with only 31% of participants reporting that they wore the hip protectors on a daily basis at 12 months. Intention-to-treat analysis showed that there was no statistically significant difference in the unadjusted odds ratios (ORs) of sustaining a hip fracture between the groups (OR = 1.19; 95% confidence interval, 0.80 to 1.78, p = 0.40). Adjustment for important covariates did not materially change these findings (OR = 1.17; 95% CI, 0.78 to 1.75). Comparing the rate of hip fracture between those women who regularly wore the devices and the control group yielded an OR of 1.12 (95% CI, 0.58 to 2.03; p = 0.83). CONCLUSION: This study is the largest RCT of hip protectors to date and provides no evidence of an effect of hip protectors among women living independently and at high risk of fracture.

Accidental Falls↗
PubMed2006

High-intensity resistance training and postmenopausal bone loss: a meta-analysis.

INTRODUCTION: Conflicting evidence exists regarding the optimum exercise for postmenopausal bone loss. A systematic review and meta-analysis was undertaken to evaluate the effects of randomised controlled trials (RCTs) of progressive, high-intensity resistance training on bone mineral density (BMD) amongst postmenopausal women. METHODS: Structured electronic searching of multiple databases and hand-searching of key journals and reference lists was undertaken to locate relevant studies up to December 2004. Study quality and possible publication bias were assessed using recognised methods. Primary outcomes were absolute changes in BMD at the lumbar spine (LS), femoral neck (FN) and total hip (TH). A priori defined subgroup analyses included concurrent hormonal or antiresorptive therapy or calcium supplementation during the intervention. The weighted mean difference method (WMD) was used for combining study group estimates. Random or fixed effect models were applied according to study heterogeneity observed from the I (2) statistic. RESULTS: At the LS, 14 RCT study groups were homogenous (I (2)=25.2%) in demonstrating a significant increase (P=0.006) in BMD of 0.006 g/cm(2) (fixed effect; 95% CI 0.002-0.011) following high-intensity resistance training. In contrast, marked heterogeneity (I (2)=88.2%) was apparent within 11 RCT study groups evaluating FN. For this comparison, a random effects model showed a positive change in FN BMD of 0.010 g/cm(2) (95% CI -0.002 to 0.021; P = 0.11). Subgroup analyses showed more anatomical variability of BMD responses to resistance training according to participants' hormone therapy use. Treatment effects for study groups increasing all participants' calcium intake showed significant positive BMD changes at TH (P=0.007). Methodological quality of all included studies was low, and a reporting bias towards studies with positive BMD outcomes was evident. CONCLUSIONS: These findings are relevant to the nonpharmacological treatment of postmenopausal bone loss.

Aged↗
PubMedDate not supplied

Methodological and political issues in clinical pharmacology research by the year 2000.

Parallel groups in a large, multicenter, phase III "pivotal" randomized clinical trial (RCT) with clinically relevant end-points are seen by the medical community as the "gold standard" of clinical research. However, there are limitations, some methodological and others political. The main one is the external validity of the method because a treatment, as studied in RCTs, does not necessarily reflect how it is used in clinical practice. Also, the method, as it stands, is not really predictive of the success in a particular patient of a certain intervention studied in a trial. To overcome these methodological drawbacks, different options have been implemented. The most important ones are: (1) the performance of pragmatic RCTs intended to address effectiveness rather than efficacy; (2) meta-analysis; and (3) the use of observational studies, with or without a comparison group. Recent experience has shown that type-A adverse drug reactions (ADRs) related to a specific class of drugs have been successfully characterized throughout cohort- or population-based case-control studies, whereas the evidence linking a specific drug entity to a type-B ADR, apparently severe enough to withdraw the drug from the market, has come mainly from case reports or case series. Other limitations of the RCT are more of a political nature. These large "pivotal" trials are mostly sponsored by the pharmaceutical industry, and to guarantee the scientific and ethical integrity of data produced, they are performed following standard operating procedures (SOPs) and good clinical practice (GCP) guidelines. Sometimes industry is not interested in sponsoring trials; thus, RCTs performed are in practice highly biased because of their potential economical profits. Furthermore, applying SOPs and GCPs is expensive and difficult to implement, and it is hard to find funding in public institutions. As a result, there is an urgent need to create a network of independent, skilled groups interested in sponsoring and performing institutional RCTs following "user friendly" GCP when the profits are low, but scientific interest high.

Forecasting↗
PubMed2002

FDG PET for staging of advanced non-small cell lung cancer prior to neoadjuvant radio-chemotherapy.

The aim of this study was to evaluate positron emission tomography (PET) with fluorine-18 fluorodeoxyglucose (FDG) for the staging of non-small cell lung cancer (NSCLC) before combined neoadjuvant, i.e. preoperative, radio-chemotherapy (RCT). From November 1998 until September 2001, 101 patients with NSCLC were investigated prospectively. The inclusion criterion was a histologically proven NSCLC of stage IIIA or B according to conventional staging including biopsy. The results of PET were compared with those obtained by mediastinoscopy, computed tomography (CT), bone scan and abdominal ultrasonography. Validation of discrepant findings was achieved by biopsy or repeated CT. PET proved to be highly accurate for the detection of lymph node metastases (sensitivity 96%, specificity 73%, positive predictive value 88%, negative predictive value 89%, accuracy 88%) as well as distant metastases (in 25/101 patients, all previously unknown). PET findings changed further treatment in 29/101 patients (29%). Twenty-five were excluded from RCT due to the presence of previously unknown distant metastases. One patient was free of metastases and therefore was operated on without pre-treatment. Two patients did not receive any further treatment because a malignant tumour could be excluded after PET. In the final patient PET demonstrated a tumour pattern not typical for NSCLC which could be attributed to a seminoma after repeated biopsy. FDG PET is the most accurate non-invasive diagnostic procedure for the staging of advanced NSCLC. Therefore use of FDG PET is highly recommended in order to select patients for neoadjuvant or other stage-dependent treatment modalities.

Adult↗
PubMed2004

Response prediction by FDG-PET after neoadjuvant radiochemotherapy and combined regional hyperthermia of rectal cancer: correlation with endorectal ultrasound and histopathology.

Accurate response assessment after neoadjuvant therapy is essential in patients with rectal cancer. The aim of this study was to assess the value of fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET) in predicting response of locally advanced rectal cancer to preoperative multimodal treatment. Twenty-two consecutive patients with locally advanced (uT3/4) primary rectal cancer were entered in this prospective pilot study. FDG-PET was performed before and after neoadjuvant radiochemotherapy (RCT) with combined regional hyperthermia (RHT). Treatment consisted of external-beam radiotherapy (45 Gy), chemotherapy (folinic acid and 5-fluorouracil) and regional pelvic hyperthermia followed by curative tumour resection 6-8 weeks later. Semi-quantitative measurements (SUV) of tumour FDG uptake were made before and 2-4 weeks after completion of neoadjuvant treatment. Two patients who did not receive post-therapeutic restaging by FDG-PET were excluded from the analysis. Results were correlated with findings on endorectal ultrasound (EUS, n=17 patients) and histopathology. Histopathological evaluation of the resected tumour revealed complete response in one patient, partial response in 12 and stable disease in seven. SUV reduction in tumours was significantly greater in responders than in non-responders [60% (+/-15%) vs 30% (+/-18%), P=0.003, CI=95%). Using a minimum post-therapeutic SUV reduction of 36% to define response, FDG-PET revealed a sensitivity of 100% (EUS: 33%) and a specificity of 86% (EUS: 80%) in response prediction; the corresponding positive and negative predictive values were 93% (EUS: 80%) and 100% (EUS: 33%), respectively. FDG-PET results were statistically significant (P<0.001, CI=95%). FDG-PET has great potential in the assessment of tumour response to neoadjuvant RCT in combination with RHT and is superior to EUS for this purpose.

Adolescent↗
PubMed2006

Prophylactic antibiotics in chest trauma: a meta-analysis of high-quality studies.

BACKGROUND: Use of antibiotics in patients with isolated chest trauma is controversial. Available studies offer contradictory results because of small sample sizes. However, information provided by recent randomized controlled trials (RCT) included in a systematic review and meta-analysis could help solve the controversy. We performed a systematic review using high-quality information related to the use of antibiotics in patients with a chest tube. METHODS: We developed a systematic review to evaluate the effectiveness of prophylactic antibiotics in chest-trauma patients. Studies included were class I RCT comparing prophylactic antibiotics versus placebo in patients with isolated chest trauma. Main outcomes were posttraumatic empyema and pneumonia. RESULTS: Five Class I studies were selected. There were statistically significant differences regarding the frequency of posttraumatic empyema (RR 0.19) and pneumonia (RR 0.44) in favor of the use of prophylactic antibiotics when compared with placebo. CONCLUSIONS: The use of prophylactic antibiotics in patients with chest trauma decreases the incidence of posttraumatic empyema and pneumonia.

Anti-Bacterial Agents↗
PubMed2006

MR assessment of the repaired rotator cuff: prevalence, size, location, and clinical relevance of tendon rerupture.

The objectives of this study were to use magnetic resonance (MR) imaging to evaluate the prevalence, size, location, and clinical relevance of tendon rerupture following complete repair of full-thickness rotator cuff tear (RCT). A total of 78 surgically proven full-thickness rotator cuff tears in 74 patients were retrospectively included in the study. Clinical assessment was performed using the University of California at Los Angeles score. Postoperative MR imaging was evaluated to determine prevalence, size, and location of tendon rerupture. At a mean 48.4 months' follow-up, 62 shoulders (79.5%) had favorable outcomes and 45 shoulders (57.6%) showed rerupture on MR imaging studies. Reruptures were significantly more prevalent among patients with intermediate-to-bad outcomes (81.3%), with surgically demonstrated two-tendon tears (78.9%) or three-tendon tears (100%), and with preoperative fatty degeneration of the supraspinatus muscle greater than 1 (91.6%). Reruptures were also significantly larger in those subgroups. Complete repair of RCT of all sizes may have favorable outcomes in a significant proportion of patients in spite of a high prevalence of reruptures. Preoperative tear size and degree of muscle fatty degeneration influence the prevalence and rerupture size. After repair of supraspinatus tears, reruptures tend to invade the posterior aspect of the tendon.

Adult↗
PubMed2003

The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principles.

BACKGROUND: Although the randomized controlled trial (RCT) is a major methodological breakthrough extending the limits of objectivity in clinical medical science, clinical trials of surgery have seldom included placebo surgery as a control, for ethical reasons. Especially in clinical studies intended eventually to establish a new intervention for developmental conditions, it has been recognized that there is huge examiner bias. In addition, the many miraculous cases that have been reported in nonsurgical open trials for developmental conditions and have eventually been evaluated as nonspecific positive outcomes in RCTs suggest that empirically promising interventions must be subjected to scientific scrutiny as soon as possible in the field of developmental conditions. APPLICATION TO PEDIATRIC NEUROSURGERY: Therefore, in childhood neurosurgery, clinical studies to establish a new therapeutic measure for developmental conditions should be designed as rigorously as possible using optimized scientific methods. The worldwide ethical guideline, the Declaration of Helsinki issued by the World Medical Association, can provide principles for the establishment of a new intervention in the treatment of a patient when proven therapeutic methods do not exist or methods used thus far have been ineffective. Physicians' discretion to use unproven or new therapeutic measures for such patients is approved in the presence of efforts of an ethical and scientific approach. Even if the measure is a very promising intervention, the research aspects must completely be demonstrated for informed consent and review by the ethical committee and the trial must be regarded as a clinical research. Especially when an RCT is not possible for ethical reasons, appropriate epidemiological data or animal experiments should suggest that the new measure is effective before a clinical trial. In a clinical setting, where neither epidemiological studies nor animal experimentation can be introduced, if necessary the researcher should collaborate with experts to obtain multidisciplinary justification for clinical testing.

Animals↗
PubMed2003

Small differences in non-fatal in-hospital reinfarctions complicating acute myocardial infarction as observed in current randomised controlled trials will not essentially influence long-term mortality. Results from the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Registry.

BACKGROUND: Recent randomized controlled trials (RCT) comparing different nonmechanical reperfusion strategies in patients with acute ST elevation myocardial infarction (AMI) (The GUSTO V, the ASSENT 3 and the HERO 2 trials) reported no differences in mortality, but lower nonfatal reinfarction rates in each best treatment arm during the hospital stay. METHODS: We analyzed the prospective observational Maximal Individual The rapy in Acute Myocardial Infarction (MITRA) data base selecting AMI patients similar to the RCT patients, to determine whether the observed differences in reinfarction rates will have an influence on longterm mortality. RESULTS: Out of 6737 patients included in MITRA between 1994 and 2000, 2109 (31%) fulfilled the selection criteria simulating the RCTs and were followed up for a median of 18 (quartiles: 16/22) months. Mortality at 1-year after discharge was 6.8% (95%CI: 2.3-11.3%) in patients with versus 4.4% (95%CI: 3.5-5.3%) in patients without a non-fatal reinfarction (absolute difference 2.4%, p = 0.04 by log rank test). Transferred to the results of the RCTs, this difference would require more than 1 million patients in each treatment arm of the RCTs to show significant differences in long-term mortality. CONCLUSION: Non-fatal in-hospital reinfarctions were associated with a higher mortality during the 18 month follow-up in MITRA. However, because the observed differences in the rates of non-fatal in hospital reinfarctions between the treatment arms in the GUSTO V, the ASSENT 3 and the HERO 2 trials were very small, our data make it very improbable that they will result in lower 1-year mortality rates.

Aged↗
PubMed2004

"Real life" use of sirolimus-eluting coronary stents in Germany. Results from the prospective multi-centre German Cypher Registry.

BACKGROUND: Drugeluting stents (DES) are currently judged to be a "break-through" technology for the prevention of restenosis after percutaneous coronary interventions (PCI). However, experience is limited to randomised controlled clinical trials (RCT) in selected lesions and the currently available DES are more expensive compared to conventional "bare" stents. Therefore, actual clinical practice may be very different to RCT. METHODS: We analysed the data of the German Cypher trade mark Registry, a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher trade mark sirolimus-eluting coronary stent, in April 2002. RESULTS: From April 2002 until March 2003, 1638 procedures at 88 hospitals were included in the German Cypher trade mark Registry. The mean inclusion rate per centre and month remained low (<3 procedures/month and participating hospital) during the whole inclusion period. Most patients presented with stable angina pectoris (45.8%); however, 6.4% of patients were treated for a non-ST elevation myocardial infarction, 10.3% of patients for ST elevation myocardial infarction and 1.7% in cardiogenic shock. In patients without ST elevation myocardial infarction, a de novo stenosis was treated in 68.4% of cases, a restenosis in 4.1%, and an in-stent restenosis in 25.5% of cases. Chronic total occlusions were treated in 6.1% of patients. Predilatation was performed in 68.3% of patients and 1.05 +/- 0.35 Cypher trade mark stents were implanted per patient with a median (quartiles) stent length of 18 (13-21) mm. PCI-related death occurred in 0.1% of patients and a Q-wave myocardial infarction in 1.1%. Urgent re-PCI before hospital discharge was performed in 1.3% and urgent bypass surgery in 0.1% of cases. CONCLUSIONS: The use of the sirolimus-eluting coronary stents in this "real life" registry was found to be safe concerning acute complications. In about one half of the registry patients, the DES was implanted in lesions that were excluded from RCTs.

Blood Vessel Prosthesis↗
PubMed2005

Stent-supported angioplasty versus endarterectomy for carotid artery stenosis: evidence from current randomized trials.

BACKGROUND: Carotid artery stenting (CAS) for carotid artery stenoses is evolving as an alternative to carotid endarterectomy (CEA). However, the value of CAS is still a matter of debate. Therefore, we performed a metaanalysis of the randomized controlled clinical trials (RCT) on this issue. METHODS: RCTs were identified through searching MEDLINE, textbooks and by personal communication. RESULTS: Six finished RCTs on this issue could be identified, including 1263 patients, 628 randomized to CAS and 635 to CEA. The 30-day death or stroke rate was 8.0% (50/628) in patients treated with CAS compared to 6.1% (39/635) in CEA patients (OR=1.36, 95% CI: 0.88-2.11; p=0.17; p for heterogeneity=0.009). The rate of cranial nerve palsy was 7.1% in the CEA compared to 0% in the CAS group (p<0.0001). The rate of myocardial infarctions was reduced from 3.1 to 1% (OR=0.32, 95% CI: 0.12- 0.81; p=0.02; p for heterogeneity=0.49). The death or stroke rate during follow-up was 12.1% in patients treated with CAS compared to 12.2% in CEA patients (OR=0.99, 95% CI: 0.70-1.42; p=0.98; p for heterogeneity=0.02). CONCLUSION: The available RCT data on CAS vs. CEA suggest that both methods seem to be equally effective concerning short- and medium-term results, while CAS is associated with lower minor complications than CEA. However, because of the significant heterogeneity between the study outcomes, the results of the large RCTs underway should be awaited before it can be advised to use CAS in a broader perspective.

Angioplasty, Balloon↗
PubMed2000

[Prospective study of JCR-Oligo I of the Child and Adolescence Rheumatology Working Group].

Intra-articular injection of corticosteroids is a powerful anti-inflammatory treatment with relatively few side effects. To date no prospective RCT exists on its use in children with oligoarthritis type I. Thus, in January 2000 the Arbeitsgemeinschaft started a multicenter RCT to compare in children with this diagnosis the initial treatment recommended in the textbooks, which is NSAID plus physiotherapy, with the early use of intra-articular injection of Triamcinolonhexacetonide. In the synovial fluid the presence of cytokines and the specific reactivity of T cells will be explored, and a highly sensitive screening for infectious agents will be performed.

Adolescent↗
PubMed2006

Intravenous immunoglobulins as therapeutic option in the treatment of multiple sclerosis.

Treatment of neurological disorders with intravenous immunoglobulin (IVIG) is an increasing feature of practice for an expanding range of indications. This article reviews the current literature regarding the role of IVIG treatment in multiple sclerosis (MS) and summarizes recommendations for the use of IVIG in different courses and clinical subsets of the disease. Principally based on the results of four randomized, double-blind, placebo-controlled trials (RCTs) and a corresponding meta-analysis, the amount of evidence for the efficacy of IVIG treatment is currently most convincing for the relapsing-remitting course of MS (RRMS); nevertheless, it lags clearly behind that for beta interferon due to smaller study sizes, partial deficits in study design and not established optimal dosage. This prompted the basis for a consensus statement in some countries to recommend IVIG as second-line treatment in RRMS, when other licensed therapies (i. e., beta interferon, glatiramer acetate) are individually not tolerated due to side effects or concomitant disease. Recent evidence indicates that IVIG is also effective in clinically isolated syndrome (CIS) and should be considered as a therapeutic option, particularly when licensed immunotherapy can not be offered. During an acute relapse additional IVIG administration to established steroid treatment showed no benefit. Despite promising experimental data on promotion of remyelination, fixed chronic deficits were not reversed or improved by long-term IVIG treatment either. Currently there is no indication for IVIG treatment in the chronic progressive disease stages, since a large and well-designed RCT failed to show any beneficial effect in patients with secondary progressive MS (SPMS) and data derived from primary progressive MS (PPMS) are still pending. However, preliminary results of a so far unpublished RCT including patients with PPMS and SPMS suggest a strong trend towards a beneficial effect in PPMS. So far, IVIG is the only therapy investigated for reducing postpartum relapses, whereas immunomodulatory drugs are contraindicated during pregnancy and lactation period. Data evaluating the peripartal use of IVIG along with the positive results of the trials in RRMS justify postpartal IVIG treatment particularly for mothers, who choose to breastfeed, under consideration of the recommendations specified for the relapsing-remitting disease course. As recently shown IVIG administration right from the early weeks of pregnancy appears to be a promising strategy, but cannot be recommended from the viewpoint of evidence-based medicine.

Female↗