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PubMed2005

Practice costs of implementing guidelines for asthma and angina: findings from a randomised controlled trial.

We collected information about the costs of three interventions (dissemination of full guidelines or prioritised review criteria or criteria plus feedback) to improve care of adults with stable angina or asthma within the context of a randomised controlled trial. The cost of criteria with feedback was pound180 per practice compared to pound9.60-31.45 for the other interventions. Total mean costs borne by practices varied between pound838 and pound2127 per practice depending upon disease and intervention type.

Adult↗
PubMed2005

[Concomitant chemoradiation in patients with cervix cancer].

Cervical cancer is the 2nd most common cancer among women, behind breast cancer. Concomitant chemoradiation has been assessed in more than 15 randomised clinical trials. A meta-analysis for overall survival showed a statistically significant difference in favour of chemoradiotherapy: relative risk (RR) = 1.20, 95% confidence interval (CI) = 1.14-1.26, p < 0.001, p hetero = 0.21). Disease-free survival was also statistically significantly higher in favour of chemoradiotherapy: RR = 1.26, 95%CI = 1.17-1.35, p < 0.001). The benefit was more pronounced in trials including a higher proportion of stage I and II patients. Concomitant chemoradiotherapy showed a significant benefit for both local control and distant metastasis. Gastrointestinal and haematological toxicities were significantly more frequent in the chemoradiotherapy group. Details of late toxicity were sparse and therefore it was not possible to conclude on an increase of late complication rate with concomitant chemoradiotherapy. The inclusion criteria were not the same in all the trials, resulting in populations with varying distributions in disease stages. In addition, the treatment schemas for both radiotherapy and chemotherapy used in these trials were different. These results were obtained with chemotherapy based on various molecules, including cisplatin, either alone or with other cytotoxic drugs, such as 5-fluorouracil. For a similar level of benefit, the combination of cisplatin, 5-fluorouracil and hydroxyurea was more toxic than cisplatin alone in one trial in which the two protocols were compared. Future randomised trials should also aim to establish optimal chemotherapy regimens for combination with radiotherapy.

Antineoplastic Agents↗
PubMed2004

The present and future role of photodynamic therapy in cancer treatment.

It is more than 25 years since photodynamic therapy (PDT) was proposed as a useful tool in oncology, but the approach is only now being used more widely in the clinic. The understanding of the biology of PDT has advanced, and efficient, convenient, and inexpensive systems of light delivery are now available. Results from well-controlled, randomised phase III trials are also becoming available, especially for treatment of non-melanoma skin cancer and Barrett's oesophagus, and improved photosensitising drugs are in development. PDT has several potential advantages over surgery and radiotherapy: it is comparatively non-invasive, it can be targeted accurately, repeated doses can be given without the total-dose limitations associated with radiotherapy, and the healing process results in little or no scarring. PDT can usually be done in an outpatient or day-case setting, is convenient for the patient, and has no side-effects. Two photosensitising drugs, porfirmer sodium and temoporfin, have now been approved for systemic administration, and aminolevulinic acid and methyl aminolevulinate have been approved for topical use. Here, we review current use of PDT in oncology and look at its future potential as more selective photosensitising drugs become available.

Clinical Trials, Phase III as Topic↗
PubMed1980

Corynebacterium vaginale and vaginitis: a controlled trial of treatment.

In a study of the diagnosis and treatment of Corynebacterium vaginale (Haemophilus vaginalis) vaginitis in 30 patients, clinical and microscopical findings were compared with laboratory cultures. The study also included a double-blind randomised trial of treatment regimens including placebo therapy. Laboratory cultures of C. vaginale corresponded well with clinical findings, and we suggest that C. vaginale vaginitis can be reliably diagnosed with clinical and microscopical findings. Tetracycline was effective in half the patients treated, whereas all but 1 of the 17 patients eventually treated with metronidazole were cured. The apparent discrepancy between in-vitro sensitivity and in-vitro efficacy of metronidazole in this condition is discussed.

Adolescent↗
PubMed2006

[Interactions between radiation and hormonal therapy in breast cancer: simultaneous or sequential treatment].

BACKGROUND: Combining radiation and hormone therapy (administration of selective estrogen receptor modulators) has become common clinical practice in recent years for receptor positive breast cancer. Little is known about a possible interaction of both treatment modalities if they are given simultaneously. Tamoxifen (antiestrogen molecule, triphenylethylene derivative) may theoretically render cancer cells less responsive to radiotherapy arresting hormone-receptor-positive cells in G0/G1 phase and increase the risk of breast and lung fibrosis stimulating the secretion of transforming growth factor beta in human fibroblasts. PURPOSE: This article reviews the published data to assess the impact of sequencing of hormonal and radiation therapy on outcomes in breast cancer. METHODS: Computerised searches for publications debating the sequencing of hormonal therapy relative to radiation therapy were done using MEDLINE data. RESULTS: Results of tamoxifen experiments with cell culture regarding radioprotection of tumour clonogens are conflicting. In contrast to in vitro results, in animal studies no protective effect of tamoxifen was observed. In one in vitro study, letrozole (non-steroid selective aromatase inhibitor) had a radiosensitizing effect on breast-cancer lines. No randomised clinical trials to date have studied sequencing of tamoxifen or other selective estrogen receptor modulators and radiotherapy. Results from retrospective clinical studies which included treatment arms with and without tamoxifen showed reduction in tumour recurrence with tamoxifen. Some of these studies have noted increased risk of lung and breast fibrosis with tamoxifen with radiotherapy. Results of three articles examined the effect of tamoxifen sequence showed no adverse effect on local control or survival in sequential versus concurrent tamoxifen and radiation patients. One of the three studies also assessed the risk of complications with respect to the timing of tamoxifen with radiotherapy. There was no difference in the rates of complications between the two groups. The association of radiation and selective aromatase inhibitors or aromatase inactivators has not been addressed in clinical studies. CONCLUSIONS: Combined application of tamoxifen and radiotherapy improves survival and local control in breast cancer. Available clinical studies do not indicate that the simultaneous application of tamoxifen and radiotherapy is disadvantageous, as was suggested by some of the in vitro studies. The risk of subcutaneous breast and lung fibrosis might be slightly increased if tamoxifen is given simultaneously with radiotherapy. Both treatment modalities should be started early after surgery. There is no sufficient evidence to withhold tamoxifen administration during irradiation of breast cancer. The issue of optimal sequencing of hormonal and radiotherapy should be addressed in randomised clinical trials.

Animals↗
PubMed2001

[Hormonal supplements for postmenopausal women: no evidence of protection against cardiovascular disease].

Atherothrombotic cardiovascular disease is a leading cause of death in women, especially in the postmenopause. It is controversial whether postmenopausal hormone replacement therapy is protective with regard to cardiovascular disease. On the one hand, observational studies consistently show that the risk of cardiovascular disease is 35 to 50% lower among users of hormonal replacement than among non-users. In addition, hormonal replacement is associated with an improvement of the lipid profile and several other potentially beneficial effects. On the other hand, two recent placebo-controlled randomised trials did not find evidence in favour of cardiovascular protection by hormonal replacement. This discrepancy may be explained by insufficient adjustment for lifestyle factors in observational studies and insufficient consideration of methodological flaws in experimental studies, both of which lead to an overestimation of the protective effect of hormonal replacement. Hormonal replacement may affect the pathophysiology of atherothrombosis in several ways, both positive and negative. Progress in this field requires the isolation of the positive effects.

Aged↗
PubMed2001

Field efficacy of a 10 per cent pyriproxyfen spot-on for the prevention of flea infestations on cats.

The clinical application of a new method for using the insect growth regulator, pyriproxyfen, for controlling flea populations in cat-owning homes is evaluated for the first time. In a multicentric, controlled and randomised trial, 107 flea-infested cats were treated with a minimum dose of 10 mg/kg bodyweight pyriproxyfen as a 10 per cent spot-on application on two occasions, with a three-month interval between doses. For comparison, 99 cats received lufenuron suspension orally, once a month, for six months. Flea counts decreased significantly over time in each group and were significantly lower in the pyriproxyfen group than in cats treated with the reference product. The percentage of 'zero-flea' cats increased from 49 per cent on day 30 to 88 per cent on day 180 in the pyriproxyfen group and from 30 to 71 per cent in the lufenuron group at the same time points (P<0.05). Appropriately timed topical applications of pyriproxyfen, therefore, offer a method of flea control in the domestic environment.

Administration, Cutaneous↗
PubMed2005

[Chemoradiotherapy and anal canal cancer].

Local control and sphincter preservation are the two challenges of anal canal cancer treatment. These tumors are radio- and chemo-sensitive and treatment moved from surgical approach, with abdominoperineal resection, to definitive radiation therapy with or without concurrent chemotherapy. Randomised trials proved the benefit of combined modality with chemoradiotherapy and of mitomycine C (MMC) compared with radiotherapy alone, with a toxic death rate of about 2%. Indications of chemoradiotherapy are locally advanced tumor T2 > or = 4 cm, T3-4 or N1-3 but the best modalities of combined treatment are still under debate. Standard chemotherapy is 5 flurouracile (5FU) + MMC, but cisplatinum (CDDP) is an effective and well tolerated substitute for MMC. Favourable results with CDDP-containing regimen in term of toxicity and carcinologic control have been reported in phase II and retrospective studies. Total radiation dose, overall duration of radiation therapy, duration of the gap and indications of additional boost are not clear, but it is demonstrated that overall duration of treatment should be as short as possible to improve the therapeutic radio. Phase II and III studies are ongoing, to evaluate the best chemotherapy regimen between 5FU+MMC and 5FU+CDDP, the benefit of neoadjuvant or maintenance chemotherapy and the interest of increased total dose. Next future could be the utilisation of oral 5FU. This article is a review of past randomised trials, phases II and retrospective study on radiochemotherapy of anal canal carcinoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2004

New strategies in anaemia management: ACORD (Anaemia CORrection in Diabetes) trial.

Anaemia is a key component of diabetic nephropathy, but its importance has only recently been recognised. Recombinant human erythropoietin (epoetin) is an established treatment for renal anaemia, and may help to reduce complications associated with diabetic nephropathy, such as cardiovascular disease. The limited experience with the use of epoetin in this patient group prompts the urgent need for clinical data on anaemia correction in early diabetic nephropathy, particularly with regard to benefits on cardiovascular risk reduction. The Anaemia CORrection in Diabetes (ACORD) study will investigate the effects of anaemia correction on cardiac structure and function in patients with early diabetic nephropathy. This 15-month multicentre study will recruit 160 adult patients with diabetes, mild or moderate chronic kidney disease (with creatinine clearance >or=30 ml/min at screening) and moderate anaemia (haemoglobin [Hb], 10.5-13.0 g/dl). Patients will be randomised to one of two groups: the early treatment group will receive subcutaneous epoetin beta (NeoRecormon) at study entry to maintain target Hb levels of 13-15 g/dl, while the control group will reflect current practice and will not receive epoetin therapy until Hb levels decline below 10.5 g/dl. The primary efficacy variable, change in left ventricular mass index, will be evaluated at 15 months following randomisation; secondary efficacy variables will include changes in cardiac structure and function over the study period. The ACORD study should provide valuable information on the benefits of anaemia correction in patients with early diabetic nephropathy. The study will also increase awareness of the importance of treating anaemia associated with diabetes.

Anemia↗
PubMed2004

[Calcaneal fractures--the most frequent tarsal fractures].

Operative treatment of intra-articular calcaneal fractures with anatomical reduction and early mobilisation has lead to a considerable improvement of the functional results of these severe injuries over the recent two decades. New tendencies like modified approaches tailored according to the vascular anatomy, arthroscopic control of joint reduction in conjunction with open or percutaneous procedures, early flap coverage for severe open fractures or closed fractures with full thickness skin necrosis, the use of interlocking plates that further minimises the need of bone grafting and subtalar arthrolysis at the time of hardware removal for fibrous overgrowth have the potential for further improvement of the outcome. The observation from several comparative studies that operative treatment leads to superior results in displaced intra-articular calcaneal fractures has been qualified in a recent prospective, randomised multicentre trial. This paper presents and the authors' experience with the demanding operative treatment of these fractures together with new developments aiming at improving the clinical results.

Arthroscopy↗
PubMed2001

Evidence-based medicine: how good is the evidence?

The "evidence" in EBM must be of high quality in order to be useful, but this is not always the case. Even the "gold standard" of evidence-based medicine, the randomised clinical trial, is bedevilled by low inclusion rates and potentially important recruitment biases. "Real world" trials often do not give the same results as these highly artificial controlled clinical studies. Meta-analysis, the next most important level of evidence in EBM, may be unreliable, sometimes giving different results to subsequent large randomised trials. There is a bias in the hypotheses tested in large clinical trials, as the costs involved are usually covered by commercially interested companies. For this reason, trials of non-patentable compounds or therapies of no commercial interest may not be performed. The process of journal review and publication is capricious, slow and may have a selection bias towards positive studies, meaning that communication channels for the "evidence" are often unsatisfactory. For many rarer conditions and situations, there is simply no "high level" evidence, such as in paediatrics and subspecialty surgery.

Bias↗
PubMed2000

[Minimally invasive surgery in malignant tumors? A concept of quality assurance by phased evaluation exemplifed by colorectal carcinoma resection].

The concept of phased clinical scientific evaluation new surgical procedures in oncology is introduced. The principles of this concept are illustrated with the example of laparoscopic resection of colorectal carcinoma. In Phase I animal studies and anatomical studies on human cadavers it has been shown that the anatomical extent of laparoscopic and conventional colorectal resections is comparable. Uncontrolled clinical trials and registries of laparoscopic operations with a low level of evidence did not detect any severe disadvantages of laparoscopic resection of colorectal carcinoma. Controlled randomised phase III a-studies with a a high level of evidence have proven that laparoscopic colorectal resection has important short-term patient benefits when compared to conventional surgery. Controlled randomised Phase III b-Muticentertrials to compare the long-term results of laparoscopic and conventional resections or colorectal cancer are currently on their way worldwide. These multicenter trials will evaluate with the highest level of evidence wether the results of laparoscopic colorectal cancer resection are as good as those for conventional surgery. Patients scheduled for minimal-invasive resection of colorectal carcinoma should be included in one of these multicenter trials. Only after the phased clinical evaluation of the new procedure has been completed, the risk or benefit of minimal-invasive surgery for colorectal cancer can be assessed.

Colorectal Neoplasms↗
PubMed2002

[MUSTIC trial].

The atrio-bi-ventricular pacing has been used for hemodynamic improvement since 1994, and the MUSTIC trial is the first controlled study assessing this concept. It collected 67 patients with severe and stable heart failure with optimised medical therapy, with sinus rhythm and without any traditional indication for pacing. After two periods of three months with blinded randomisation and cross-over, the bi-ventricular pacing mode showed its superiority to the inactive mode concerning all study endpoints, for example with an improvement of the functional capacity of 23% assessed by the 6-minutes-walk test. Thus the MUSTIC trial opens up the way for morbidity and mortality studies.

Aged↗
PubMed1998

Epidemiological factors in clinical trial design.

Randomised, double-blind, placebo-controlled clinical trials are human experiments in which the process of randomisation and blinded observation greatly simplify the interpretation of the results. However, epidemiological issues when properly addressed allow the optimal preparation of the study with anticipation of factors to be included in the analysis which are independent of the randomisation process but can affect the results, for example, the effect of age, dose, time since vaccination and exposure to other diseases. Alternative methods of estimating vaccine efficacy may be necessary in some settings, and such methods may have limitations which must be acknowledged in interpretation. This paper reviews some recently published studies of vaccine efficacy for the application of epidemiological principles in design and analysis.

Clinical Trials as Topic↗
PubMedDate not supplied

One-year angiotensin-converting enzyme inhibition plus mycophenolate mofetil immunosuppression in the course of early IgA nephropathy: a multicenter, randomised, controlled study.

Angiotensin converting-enzyme inhibition (ACEI) is a widely accepted treatment during established renal diseases and beneficial effects have also been reported in IgA nephropathy (IgAN). Immunosuppression with myco-phenolate mofetil (MMF) has recently been introduced in the treatment of immune-mediated renal diseases showing promising results. Preliminary clinical reports are also suggestive that MMF is effective in severe forms of IgAN. We propose a randomised prospective trial aimed to compare long-term renal survival of early IgAN in the course of ACEI therapy with or without MMF immunosuppression.

Adolescent↗
PubMed1994

Treatment of Langerhans cell histiocytosis--evolution and current approaches.

Optimal treatment of Langerhans cell histiocytosis remains problematic. The absence of controlled studies and the lack of standard diagnostic and evaluation criteria have impeded therapeutic progress even though knowledge of basic aspects of LCH have advanced. Historical analysis of outcome suggests little improvement until very recently, but marked differences in outcome according to extent of disease. Consequently, major and now successful efforts have been made to stratify LCH patients into different 'risk groups'. Recent findings suggest that combination chemotherapy for multisystem disease is beneficial and that VP-16 is a useful new agent for treating LCH, despite controversies regarding its side effects. The first randomised international treatment study, LCH-1, being conducted by the Histiocyte Society, should resolve some of these controversies. Other experimental therapies may be considered for children with severe, unresponsive LCH.

Biological Factors↗

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