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At least 1,387 records · Page 77Linked to original sources
PubMed1993

[Prevention and treatment of pressure sores--a neglected research subject? An overview of clinically controlled studies in the period 1987-91].

Pressure sores are frequently seen in elderly hospitalized patients and leads to prolonged hospitalization and increased morbidity and mortality. The object of this paper was to retrieve the last five years literature regarding prevention and treatment of pressure sores. During the period 1987-1991, 751 papers on this topic were published and indexed in Medline. Only 9 of these papers represented controlled clinical trials. Three of them dealt with prevention, and the remaining 6 with treatment. Although 4 of 9 studies showed statistically significant differences between the actively treated group and the placebo group, none of the studies showed convincing clinical differences. Serious methodological flaws with respect to design, blinding, randomisation, sample size and statistical analysis were found in 8 of 9 studies. None of the clinical controlled studies on prevention of pressure sores showed any statistically significant differences between the control group and treatment with, respectively Prevasore lotion, Foam cushion and Silicore mattress. In the 6 trials on treatment of pressure sores, respectively mucopolysaccharide polysulphate creme, ketanserin creme and air-fluidized beds showed statistically better results than control treatment. We conclude that well-designed controlled clinical trials are needed to establish rational routines for prevention and treatment of pressure sores.

Clinical Nursing Research↗
PubMed2005

A review of the medical management of chronic inflammatory demyelinating polyradiculoneuropathy.

Chronic idiopathic demyelinating polyradiculoneuropathy (CIDP) is a rare condition, but merits consideration due to its disabling consequences for patients and the growing existence of efficacious therapies during the last few decades. The first step is to characterise this neuropathy among the chronic dysimmune polyneuropathies, according to clinical, electrophysiologicalal and sometimes pathologicalal and immunochemical criteria. Typical CIDP is currently defined by criteria which have progressively improved since the first attempt made by an Ad Hoc Subcommittee of the American Academy of Neurology in 1991. However, CIDP may be associated with several concurrent diseases, and other chronic demyelinating polyneuropathies may be considered as either subtypes of CIDP, such as sensory CIDP and multifocal acquired sensory and motor neuropathy, or frontiers of CIDP, such as multi-focal motor neuropathy and polyneuropathy associated with monoclonal gammopathy. These considerations are helpful in the choice of treatments, as the response to immunomodulatory agents is different according to the type of the dysimmune neuropathy. CIDP is considered to be an immune-mediated disorder and may respond dramatically to numerous short-term therapies, such as corticosteroids, plasma exchanges, or intravenous immunoglobulin. The aim of this review is both to summarise the main results of the published open and randomised controlled trials for CIDP, and to provide some information about randomised controlled trials currently in progress. The objectives of the current and future trials are firstly, to choose the best regimen for short-term treatments, and secondly, to test new immunosuppressants in long-term therapy, if the neurological condition requires it.

Clinical Trials as Topic↗
PubMed2006

The overactive bladder: review of current pharmacotherapy in adults. Part 2: treatment options in cases refractory to anticholinergics.

In the first part of this review the potential pathophysiological factors involved in the overactive bladder were outlined, and the wide range of first-line anticholinergic pharmacotherapies available for such patients were reviewed. The second part will focus on the intravesical instillation of resiniferatoxin and injections of botulinum toxin into the bladder to treat overactive bladder and detrusor overactivity. Resiniferatoxin has been shown to increase bladder capacity and improve incontinence in patients with neurogenic and non-neurogenic detrusor overactivity. Botulinum toxin has successfully been used to treat neurogenic and idiopathic detrusor overactivity, with improvements observed in bladder capacity, decreases in detrusor pressures on filling and voiding, and increased volumes at first contraction. Further validation is required for both treatments, in the form of large randomised controlled trials, before their use can be considered routine, with particular focus on dosing required.

Administration, Intravesical↗
PubMed2002

Ambulatory blood pressure monitoring.

End-organ damage associated with hypertension is more closely related to ambulatory blood pressure (ABP) than clinic or casual blood pressure measurements. ABP measurements give better prediction of clinical outcome than clinic or casual blood pressure measurements. The technique of ABP monitoring (ABPM) is specialised; validated monitors and appropriate quality control measures should be used. Interpretation of ABP profile should include mean daytime, night-time (sleep) and 24-hour measurements, and consideration of diary information and time of drug treatment. Reports may also include ABP "loads" (percentage area under the blood pressure curve above set limits) for daytime and night-time periods. Normal blood pressure values for adults are < 135/85 mmHg for daytime, < 120/75 mmHg for night-time, and < 130/80 mmHg for 24 hours. ABPM is indicated to exclude "white coat" hypertension and has a role in assessing apparent drug-resistant hypertension, symptomatic hypotension or hypertension, in the elderly, in hypertension in pregnancy, and to assess adequacy of control in patients at high risk of cardiovascular disease. White coat hypertension requires continued surveillance; patients who display this phenomenon may, in time, develop established hypertension. Appropriate use of ABPM may result in cost savings. Randomised controlled trials comparing management based on clinic or casual versus ABP measurements are needed.

Blood Pressure Monitoring, Ambulatory↗
PubMed2003

[Too early to recommend universal screening for colorectal cancer].

Randomised controlled trials have shown that screening may significantly reduce mortality in colorectal cancer. In the present evaluation it is shown that the reported reduction of 15 per cent, or higher, is given in relative figures. With absolute figures the reduction is only 0.15 per cent or lower. The number of individuals needed to screen (NNT) biannually for 10 years to prevent one death in colorectal cancer is 1,173 (confidence interval 741-2,807). Side-effects, costs and ethical issues are seldom, or never, discussed. Postoperative follow-up may be regarded as the screening of a high-risk group. The reduced mortality seen in the meta-analysis of randomised controlled trials is here regarded as small and should also be weighed against the drawbacks of follow-up before any recommendation for more active surveillance is given.

Colorectal Neoplasms↗
PubMed1977

[The idiopathic tetany syndrome in general practice (author's transl)].

The relevance, to general practice, of the various views on the idiopathic tetany syndrome is discussed. The effect of a drug (Frubiase Calcium forte), which largely metts the requirements stemming from the above, on all important symptome and diagnostic signs was found to be statistically superior to placebo on the basis of a randomised double blind trial in 80 patients.

Adolescent↗
PubMed2001

Antibiotics versus placebo for prevention of postoperative infection after appendicectomy.

BACKGROUND: Appendicitis is the most common cause of acute abdominal pain requiring surgical intervention. The cause of appendicitis is unclear and the mechanism of pathogenesis continues to be debated. Despite improved asepsis and surgical techniques, postoperative complications, such as wound infection and intraabdominal abscess, still account for a significant morbidity. Several studies implicate that postoperative infections are reduced by administration of antimicrobial regimes. OBJECTIVES: The objective of this review is to compare the use of antibiotics with placebo or no treatment in patients undergoing appendectomy. Will these patients benefit from antimicrobial prophylaxis? The outcomes are described according to the nature of the appendix, as either simple appendicitis (including the non-infectious stage) and complicated appendicitis. This review do not attempt to compare the effect of different regimens, a clinical question that is addressed in another review undertaken by this Group (CCCG). SEARCH STRATEGY: We searched The Cochrane Controlled Trials Register (Cochrane Library 2000 issue 4), Medline (January 1966 to September 2000), Embase and the Cochrane Colorectal Cancer Group specialised register (September 2000). In addition we manually searched the reference lists of the primary identified trials. SELECTION CRITERIA: Randomised Controlled Trials (RCT) and Controlled Clinical Trials (CCT) in which any antibiotic regime were compared to placebo in patients suspected of having appendicitis undergoing appendectomy were evaluated. Both studies on children and adults were reviewed. The outcome measures of the studies were either wound infection, intraabdominal abscess, length of stay in hospital or mortality. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality were assessed, recorded and cross-checked by to reviewers. MAIN RESULTS: Forty-four studies including 9298 patients were included in this review. The overall result is that use of antibiotics is superior to placebo for the outcome wound infection and intraabdominal abscess, with no apparent difference in the nature of the removed appendix. Studies exclusively on children and studies examining topical application reported results in favour to the above although the results were not significant. REVIEWER'S CONCLUSIONS: Antibiotic prophylaxis is effective in the prevention of postoperative complications in appendectomised patients, whether the administration are given pre-, per- and post-operatively and could be considered for routine in emergency appendectomies.

Abdominal Abscess↗
PubMed2006

Controlled clinical trials in cancer pain. How controlled should they be? A qualitative systematic review.

This qualitative systematic review of the clinical methodology used in randomised, controlled trials of oral opioids (morphine, hydromorphone, oxycodone) for cancer pain underlines the difficulties of good pain research in palliative care. The current literature lacks placebo-controlled superiority trials. Recommendations for future research are discussed.

Controlled Clinical Trials as Topic↗
PubMedDate not supplied

Topical treatment of acute sprains.

In a randomised, placebo-controlled, double-blind study with parallel group comparison, the efficacy and tolerability of topical treatment with a mucopolysaccharide polysulphate/salicylic acid cream was investigated in 156 patients with acute sprains of the knee or ankle joint. There was a more rapid reduction in pain on movement (the main parameter) in the active drug group compared with the placebo group. On day 9 after randomisation the difference was highly significant. There were no adverse events in the active drug group.

Administration, Topical↗
PubMed1988

Controlled trial of tamoxifen as a single adjuvant agent in the management of early breast cancer. 'Nolvadex' Adjuvant Trial Organisation.

At a maximum follow up of 8 years (median 5 years 6 months) in a randomised trial of adjuvant tamoxifen versus no treatment as therapy for early breast cancer, a significant advantage persists for patients receiving 20 mg of tamoxifen daily for 2 years. This advantage is independent of menopausal status, stage, grade and ER status. Log hazard rate analysis fails to demonstrate a rebound effect on stopping the drug and suggests that more prolonged treatment might further improve results.

Breast Neoplasms↗
PubMed1999

A systematic review of vinpocetine therapy in acute ischaemic stroke.

OBJECTIVES: To determine whether vinpocetine decreases short- and long-term case fatality and proportion of dependent survivors if administered within 2 weeks of stroke onset. METHODS: All published and unpublished trials were attempted to be identified using the standard search strategy of the Cochrane Collaboration Stroke Review Group, using MEDLINE searches performed with all known manufacturer code names and trade names of vinpocetine and by contacting manufacturers of vinpocetine to give information of all randomised controlled trials on vinpocetine in stroke. Researchers who participated in trials on vinpocetine in Hungary were asked for further information. Only truly randomised, unconfounded clinical trials that compared the effect of vinpocetine to either placebo or another reference treatment for acute stroke where treatment started no later than 14 days after stroke onset were eligible for inclusion. Data synthesis and analysis was performed using the Cochrane Review Manager software (RevMan version 3.0). RESULTS: Among the identified studies on vinpocetine in stroke, only one fulfilled the selection criteria for inclusion in the review. No death occurred in the study groups and no statistically significant difference was found in dependency between the treatment and the placebo groups. No adverse effects were reported. CONCLUSIONS: Based on only one small randomised controlled unconfounded study, presently there is not enough evidence to decide whether the administration of vinpocetine does or does not decrease case fatality and dependency in acute stroke.

Cerebrovascular Disorders↗
PubMed1999

Actual standards and controversies on operative technique and lymph-node dissection in colorectal cancer.

BACKGROUND: Radical lymphadenectomy for colorectal cancer according to its arterial supply seems to remove potentially metastatic lymph nodes and highlights the impact on prognosis. STANDARDS AND CONTROVERSIES: Systematic lymph-node dissection in colorectal cancer requires knowledge of normal anatomy of lymphatic drainage and spreading of lymph-node metastases. Oncological standards of curative surgery for colorectal cancer include en bloc resection, no-touch isolation technique, primary ligation of the vessels and systematic lymphadenectomy. In rectal cancer, total mesorectal excision and irrigation of the rectal stump is mandatory. Potential improvements in prognosis achieved by extended lymph-node dissection have to compete with procedure-related morbidity. High-tie ligation of the inferior mesenteric artery is a controversial issue. Prediction of prognosis is essential for planning a treatment schedule for patients. CONCLUSIONS: At present, clinicopathological stage is the single most reliable factor in prediction of outcome. New encouraging methods for detecting micrometastases of lymph nodes and new surgical technologies such as immune corrective surgery are challenging and have to be critically assessed. The results of laparoscopic surgery for the cure of colorectal cancer have to be proven within prospective randomised trials.

Colonic Neoplasms↗
PubMed2006

Chronic pelvic pain: aetiology and therapy.

Chronic pelvic pain (CPP) is a common condition in women and rates of consultation for CPP in general practice are similar to those for asthma and migraine. US and UK population-based studies, together with data from UK hospital settings demonstrate a substantial impact of CPP on health-related quality of life. In this review, we will examine the current evidence on the aetiology and management of CPP, focussing on the randomised controlled trials (RCTs) that are available to date. CPP is a heterogeneous condition and causation is often unclear. There are associations with specific pathological processes but a barrier to understanding is that many studies have data that are not comparable. In the community setting, as many as 60% of women with CPP have not received a specific diagnosis and up to 20% have not undergone any investigation. The factor most commonly associated with CPP in the community is irritable bowel syndrome, although in a tertiary setting with laparoscopy, pathology associated with CPP in ascending order of frequency is endometriosis (33%), adhesions (24%) and 'no pathology' (35%). Current RCT evidence provides some support for the use of ultrasound scanning as an aid to counselling and reassurance, progestogen (medroxyprogesterone acetate) or goserelin for pelvic congestion and a multidisciplinary approach to assessment and treatment. Adhesiolysis is not shown to be of benefit other than in women with extensive adhesions. While studied in relation to dysmenorrhoea rather than CPP, the short term results for presacral neurectomy (PSN) and laparoscopic utero-sacral nerve ablation (LUNA) seem to be similar, although PSN has better results in the long term. Selective serotonin reuptake inhibitor (SSRI) antidepressants have not been shown to be of benefit in CPP. Most of these conclusions are based on the outcome of single randomised trials and therefore need replication.

Adolescent↗
PubMed2002

Current practice for the treatment of benign intrauterine polyps: a national questionnaire survey of consultant gynaecologists in UK.

OBJECTIVE: To determine current practice regarding removal of endometrial polyps. STUDY DESIGN: A self-administered questionnaire to all 1509 UK consultant gynaecologists to enquire about their current practice and potential willingness to participate in a randomised trial. RESULTS: Treatment methods varied considerably. Inpatient polypectomy was used by 91% and the favoured method was blind removal of polyp following hysteroscopic localisation (53%). Direct hysteroscopic polypectomy was more commonly performed by 46% members of endoscopic societies compared to 33% of non-members. Outpatient polypectomy was performed by 19% of users of outpatient diagnostic hysteroscopy compared to 2.5% of non-users. One-third of respondents were willing to enter patients into a randomised controlled trial to determine the optimal intrauterine polyp removal technique. CONCLUSION: Opinion regarding the relative roles of inpatient or outpatient, and blind or hysteroscopic methods, is divided and a randomised trial comparing the efficacy and safety of these methods is practicable.

Ambulatory Surgical Procedures↗
PubMed1993

The impact of interleukin-2 on survival in renal cancer: a multivariate analysis.

The purpose of this analysis was to compare the survival of patients with advanced renal carcinoma treated with intravenous recombinant interleukin-2 to the survival of matched patients taken from the large and well characterised database of the Eastern Cooperative Oncology Group (ECOG). Recombinant interleukin-2 (rIL-2) given by continuous intravenous infusion was used to treat 387 patients with advanced adenocarcinoma of the kidney in five multi-centre studies and 327 of these patients fulfilled the study eligibility criteria and were evaluable for response, toxicity and survival. The survival of patients treated with rIL-2 was compared in a multi-variate survival analysis taking account of all identified prognostic factors to 390 control patients receiving chemotherapy derived from the database. Thirteen patients treated with rIL-2 achieved a complete remission of their disease and 32 a partial remission giving an overall response rate of 14%. Remissions were durable with a median duration of 357 days for partial remissions and a median duration in excess of 926 days for complete remissions. Most patients experienced fever or mild to moderate hypotension and other toxicities are described. However, only 11 patients required admission to intensive care and in only five cases was this judged to be due to treatment toxicity. There were three deaths judged to be probably due to treatment toxicity. rIL-2 treatment was associated with significantly prolonged survival compared to the ECOG control patients. Patients with good prognostic features appeared to have a greater survival benefit from rIL-2 than those with poor prognostic features. This analysis provides the first evidence that rIL-2 prolongs survival in patients with advanced renal cancer but cannot provide proof which should be sought in randomised prospective trials drawing on the hypotheses generated herein.

Adult↗
PubMed2001

Meta-analytical studies on new antidepressants.

A systematic search found 108 meta-analyses of the use of antidepressants in depressive disorders. Defining newer antidepressants as those introduced since the early 1980s, 18 meta-analyses were selected as being informative about their relative efficacy and tolerability in comparative randomised controlled studies (RCTs). Findings with higher confidence include: little difference in efficacy between most new and old antidepressants; superior efficacy of serotonin and noradrenaline re-uptake inhibitors (SNRIs) over selective serotonin re-uptake inhibitors (SSRIs); a slower onset of therapeutic action of fluoxetine over other SSRIs; a different side effect profile of SSRIs to TCAs with superior general tolerability of SSRIs over TCAs; poorer tolerability of fluvoxamine than other SSRIs in a within group comparison; no increased the risk of suicidal acts or ideation in fluoxetine compared with TCAs (or placebo) in low-risk patients. Findings with a lower level of confidence include: greater efficacy of TCAs than SSRIs in in-patients; greater efficacy of amitriptyline than SSRIs; better tolerability of moclobemide than TCAs; no demonstrable difference in tolerability between SSRIs and TCAs in the elderly; no better tolerability of fluvoxamine than TCAs; better tolerability of dothiepin (dosulepin) than SSRIs; better tolerability of sertraline and greater frequency of agitation on fluoxetine than other SSRIs in a within group comparison. In general, the meta-analyses were of uneven quality, as were the studies included, which limits the confidence in many of the results. Generalising from mostly short-term randomised controlled studies to clinical practice requires caution.

Adult↗
PubMed1996

Screening and early detection of prostate cancer will decrease morbidity and mortality from prostate cancer: the argument against.

The ability of prostate specific antigen, digital rectal examination and transurethral ultrasound, either individually or in combination, to detect unsuspected prostate cancer is beyond doubt. Early detection programmes have revealed prostate cancer in 6% of men over 50 years of age. Most are stage T1c, or confined to the prostate but, protagonists claim that, on the basis of size, they are 'clinically significant'. Mortality from this disease should be reduced by their treatment. Available statistics suggest that the lifetime incidence of 'screen-detected' cancers will far exceed the likelihood of dying from prostate cancer. Given the current operative mortality of total prostatectomy and the physical and psychological morbidity of screening, biopsy and treatment, it is far from certain that mortality or morbidity from prostate cancer will be decreased. Long-term outcome data for T1c prostate cancer do not exist. Is the likelihood of prostate cancer death the same for prostate-specific antigen thresholds of 2, 3 or 4 ng/ml, or from tumours found in 1 of 6, or 1 of 12 needle biopsies? None of this is known. European men deserve the benefit of scientifically based information before being exposed to another North American fashion. Prospective randomised trials investigating mortality, quality of life and cost benefit are the only solution.

Aged↗