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Homotoxicology--a review of randomised clinical trials.

AIM: Homotoxicology is a form of therapy that uses homoeopathically diluted remedies with a view of eliminating toxins from the body. It is not a therapeutic method based on accepted scientific principles or biological plausibility. Yet numerous clinical studies have claimed efficacy. The aim of this systematic review is to summarise and critically evaluate the evidence from rigorous clinical trials of this form of therapy. METHODS: Seven electronic databases were searched for all studies of homotoxicological medicines for any human condition. To be included, trials had to be randomised and placebo-controlled. Data from such studies were validated and extracted according to pre-defined criteria. Their methodological quality was formally assessed using the Jadad score. Key data of all included trials were tabulated and summarised in narrative form. RESULTS: Seven trials met our inclusion criteria. Their Jadad scores indicated mostly a high methodological standard. The trials tested the efficacy of seven different medicines for seven different indications. The results were positive in all but one study. Important flaws were found in all trials. These render the results of the primary studies less reliable than their high Jadad scores might suggest. CONCLUSION: Despite mostly positive findings and high ratings on the Jadad score, the placebo-controlled, randomised clinical trials of homotoxicology fail to demonstrate the efficacy of this therapeutic approach.

Complementary Therapies↗

Radical prostatectomy and prostate cancer screening: the need for national audit and research.

Public awareness of prostate cancer is increasing. Growing numbers of middle-aged men are seeking screening tests for prostate cancer and advice about its surgical treatment. Contrary to the hopes of many, the benefit of early diagnosis and by radical prostatectomy remains in doubt. Recent analyses suggest that 'watchful waiting', with no immediate treatment, may be an equally effective option. If this is true, why screen? Why operate? These questions should be a cause of concern to more than 1 million British men who are unaware that they have prostate cancer and to the providers of health care who have failed to address this dilemma. A national audit and randomised clinical trial are indicated.

Aged↗

Antiplatelet agents versus control or anticoagulation for heart failure in sinus rhythm.

BACKGROUND: Morbidity and mortality in patients with symptomatic chronic heart failure is high, it predisposes to stroke and thromboembolism which in turn contribute to high mortality in heart failure. OBJECTIVES: To determine effect of antiplatelet agents when compared to placebo or anticoagulant therapy on death and/or major thromboembolic events in adults with heart failure who are in sinus rhythm. SEARCH STRATEGY: Systematic search of electronic databases (MEDLINE, EMBASE, DARE). Abstracts from cardiology meetings and reference lists of relevant papers were searched. Authors of studies were contacted for further information. SELECTION CRITERIA: Randomised parallel group placebo or controlled trials comparing antiplatelet therapy with control or anticoagulation in adults with chronic heart failure in sinus rhythm. Treatment for at least 1 month. To assess any adverse effects cohort study & non-randomised controlled studies were assessed. Orally administered antiplatelet agents e.g. non-steroidal anti-inflammatory agents, TICLOPIDINE, CLOPIDOGREL, DIPYRIDAMOLE, ASPIRIN compared with anticoagulant agents e.g. COUMARINS, WARFARIN or placebo. DATA COLLECTION AND ANALYSIS: Data were extracted by two reviewers independently. No meta-analyses were performed as no data were available from randomised comparisons. The data extracted included data relating to the complexities of the topic area, such as patient characteristics and concomitant treatments, as well as data relating to study eligibility, quality, and outcomes. Non-randomised studies were used to identify side-effects caused by anticoagulants. MAIN RESULTS: One RCT of warfarin, aspirin versus no antithrombotic therapy was found but no definitive data have yet been published. Three retrospective, non-randomised cohort studies from the V-HeFT, SOLVD and SAVE trials examining the role of ACE inhibitors have examined the role of aspirin therapy +/- anticoagulant therapy in patients with heart failure and/or left ventricular systolic dysfunction. The results from these trials were conflicting. REVIEWER'S CONCLUSIONS: At present there is no evidence from long term RCTs to recommend use of aspirin to prevent thromboembolism in patients with heart failure in sinus rhythm. A possible interaction with ACE inhibitors may reduce the efficacy of aspirin, although this evidence is from retrospective analyses of trial cohorts. There is also no evidence to indicate superior effects from oral anticoagulation, when compared to aspirin, in patients with heart failure in sinus rhythm.

Anticoagulants↗

Activity of chemotherapy and immunotherapy on malignant mesothelioma: a systematic review of the literature with meta-analysis.

The role of chemotherapy for unresectable malignant mesothelioma is unclear. The aims of the present study were to evaluate the methodological quality of published papers relative to chemotherapy or immunotherapy in malignant mesothelioma and to aggregate, for trials having a similar methodology, the response rates in order to identify the most active chemotherapeutic drugs and regimens. The literature relative to this topic, published between 1965 and June 2001 was reviewed. A methodological qualitative evaluation was performed according to the European Lung Cancer Working Party scale, specifically designed for phase II trials. A study was considered as potentially positive if the upper limit of the 95% confidence interval (CI) of the response rate was greater than 20% and positive if the lower limit of the 95% CI was > 20%. Eighty-three studies (88 treatment arms) were eligible for the systematic review. Fifty-three arms were considered as positive or potentially positive. No statistically significant difference in the methodological quality was observed between negative and positive studies. Studies were aggregated in four groups according to the presence of cisplatin and/or doxorubicin in the treatment regimen. The combination of cisplatin and doxorubicin had the highest response rate (28.5%; P < 0.001). Cisplatin was the most active single-agent regimen. Our systematic qualitative and quantitative overview of the literature suggests that the most active chemotherapeutic regimen, in term of objective response rate, is the combination of cisplatin and doxorubicin and the best single-agent is cisplatin. The combination of these two drugs can be recommended as control arm for future randomised phase III trials.

Antineoplastic Combined Chemotherapy Protocols↗

Emerging evidence for the use of atypical antipsychotics in borderline personality disorder.

BACKGROUND: The availability of new atypical antipsychotics provides new opportunities for the treatment of borderline personality disorder (BPD). METHODS: Original papers on this topic were sought. Our study reviewed and discussed 14 papers. RESULTS: 2 RCTs, 4 non-controlled open-label studies and 8 case reports. The patient populations studied were highly diverse and the dropout rate after a long follow-up period was high. All of the articles reported positive effects of olanzapine, clozapine, quetiapine and risperidone. CONCLUSION: BPD patients with psychotic-like, impulsive or suicidal symptoms might benefit from atypical antipsychotics. Since the methodological quality of the reviewed articles is poor, further randomised placebo-controlled studies with longer follow-ups are needed before any firm conclusions can be drawn.

Antipsychotic Agents↗

A single dose of the topical carbonic anhydrase inhibitor MK-927 decreases IOP in patients.

MK-927 is a novel topical carbonic anhydrase inhibitor (CAI). We present the first single-dose clinical trial of MK-927 in 24 patients with bilateral primary open-angle glaucoma or ocular hypertension. This investigation was conducted as a two-centre, double-masked, randomised, placebo controlled study. Patients received one drop of 2% MK-927 in one eye and placebo in the other eye. Modified diurnal intraocular pressure (IOP) curves were performed before the study and on one treatment day. A single dose of 2% MK-927 induced a peak mean IOP decrease of 10.5 mmHg at 4.5 hours postdose. With compensation for diurnal variation, as determined by the prestudy diurnal pressure curve, the net peak mean reduction of IOP caused by MK-927 was 7.5 mmHg versus a corresponding net change of 1.4 mmHg in the contralateral placebo treated eye. Thus a single dose of MK-927 gave a clinically significant IOP reduction in patients.

Carbonic Anhydrase Inhibitors↗

Creams for preventing stretch marks in pregnancy.

BACKGROUND: Many women develop stretch marks (striae gravidarum) during pregnancy. A number of creams have been used to remove these stretch marks. OBJECTIVES: The objective of this review was to assess the effects of topical treatments to prevent the development of stretch marks. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register. In addition, the Cochrane Controlled Trials Register (CENTRAL/CCTR) was searched. Date of last search: April 1999. SELECTION CRITERIA: Randomised trials comparing active creams with placebo for the treatment of stretch marks in pregnant women. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. MAIN RESULTS: One study involving 100 women was included. Compared to placebo, treatment with a cream containing Centella asiatica extract, alpha tocopherol and collagen-elastin hydrolysates was associated with less women developing stretch marks (odds ratio 0.41, 95% confidence interval 0.17 to 0.99). REVIEWER'S CONCLUSIONS: One particular cream appears to help prevent the development of stretch marks in pregnancy, but only for women who had previously suffered stretch marks in pregnancy. There is no evidence of benefit for general use.

Cosmetics↗

Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer.

BACKGROUND: Postoperative air leak is a frequent complication after pulmonary resection for lung cancer. It may cause serious complications, such as empyema, or prolong the need for chest tube and hospitalisation. Surgical sealants of different types have been developed to prevent or to reduce postoperative air leaks. A systematic review was therefore undertaken to evaluate the evidence on their effectiveness. OBJECTIVES: To evaluate the effectiveness of surgical sealants in preventing or in reducing postoperative air leaks after pulmonary resection for lung cancer. SEARCH STRATEGY: The electronic databases MEDLINE (1966 to 2004), EMBASE (1974 to 2004), Cancerlit (1993 to 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3/2004) and listed references were searched, and handsearching of conference proceedings was conducted to identify published and unpublished trials. SELECTION CRITERIA: Randomised controlled clinical trials were included in which standard closure techniques plus a sealant were compared with the same intervention with no use of any sealant in patients undergoing elective pulmonary resection provided that a large proportion of the patients included in the studies had undergone pulmonary resection for lung cancer. DATA COLLECTION AND ANALYSIS: Three reviewers independently selected the trials to be included in the review, assessed methodological quality of each trial and extracted data using a standardised form. Because of several limitations, narrative synthesis was used at this stage. MAIN RESULTS: Twelve trials, with 1097 patients in total, were included. In eight trials there was a statistically significant difference between treatment and control patients in reducing postoperative air leaks. However this reduction only proved a significant reduction of hospital stay in one trial. Only in one trial reduction of time of chest drain removal and reduction of percentage of patient with persistent air leak were significantly smaller in the treatment group. AUTHORS' CONCLUSIONS: Although surgical sealants seem to reduce postoperative air leaks, length of hospitalisation is not affected and infectious complications may be increased. Therefore, systematic use of surgical sealants in clinical practice cannot be recommended at the moment. More randomised controlled clinical trials are needed.

Air↗

[Heart transplantation--state of the art today].

In spite of pharmacological progress, end stage congestive heart failure is still associated with a decrease in quality and expectation of life. Heart transplantation remains the last therapeutic option for these patients. While the one year survival rate has increased over the last few years up to 84%, a major problem remains the significant lack of donors. Therefore, the criteria for the selection of candidates for cardiac transplantation have to be kept quite tight: Evidence of poor outcome without transplantation is associated with ejection fractions below 20 to 25%, cardiac indices less than 2.01/min/m2, left ventricular filling pressure above 20 mm Hg and a enddiastolic diameter of > 80 mm. There are, however, also quite important functional parameters indicating the need for heart transplantation, e.g. the maximal oxygene uptake being less than 10 ml/kg/min or below 50% of the age-appropriate value. Elevated pulmonary vascular resistance above 4 to 5 Wood units without a significant decrease during application of prostaglandin derivatives or inhalation of NO represents a contraindication for orthotopic heart transplantation; alternatively, a heterotopic transplantation can be considered. Since there is a significant shortage of suitable donor organs, the donor criteria have been broadened, e. g. the accepted donor age was increased to 60 years. Based on these extended criteria, a careful donor evaluation including cardiac history, cardiac examination, ECG and echocardiogram has to be performed. Coronary angiography in older donors is suggested, but in many cases not possible due to circumstances. Further precondition for a good graft function is a sophisticated donor management until the time of explantation. Hypovolemia and hypocalemia, hypothermia, hypoxia and rapid lost of circulating triiodothyronine (T3) have to be detected and balanced. The cardioplegic solution used might not only have an impact on the immediate postoperative performance of the graft, but also on the long term outcome, particularly with regard to graft vessel disease. There are generally two types of solutions: Those with intracellular and those with extracellular electrolyte concentrations. In addition, the potassium concentration might be of some importance. Potassium seems to damage endothelial cells and trigger subsequent immunological reactions. Therefore, high potassium concentrations in the cardioplegic solution might correlate with the incidence of graft vessel disease during the long term follow-up. The surgical technique for orthotopic heart transplantation developed at the beginning of the sixties by Lower and Shumway has been used unchanged for the last 30 years. The only alteration recently introduced is the separate direct anastomosis of the pulmonary and systemic veins in order to improve the atrial function. Until recently the commonly employed immunosuppressive strategy after heart transplantation consisted of the standard drugs cyclosporin, azathioprin and prednisolon. Some transplant-units use additionally induction therapy with antibody preparations. Many centers, however, abolished this regimen due to significant short and long term side effects. Promising new, more specific antibodies (which are chimerized or humanised) could revive the induction concept. The most thoroughly tested novel immunosuppressive agent is tacrolimus (FK506). It has been demonstrated to be 10 to 100 times more potent than cyclosporin A in in vitro and in vivo models. It binds to a different binding protein (FK-binding-protein) than cyclosporin (cyclophilin), but has a similar mechanism of action inhibiting the expression of T-cell-activator genes for certain cytokines. First non-randomised studies after heart transplantation performed at the University of Pittsburgh revealed that significantly more tacrolimus than cyclosporin patients were free of rejection. In order to confirm these observations, we performed a prospective randomised controlled clin

Clinical Trials as Topic↗

Should beta blockers remain first choice in the treatment of primary hypertension? A meta-analysis.

BACKGROUND: Beta blockers have been used widely in the treatment of hypertension and are recommended as first-line drugs in hypertension guidelines. However, a preliminary analysis has shown that atenolol is not very effective in hypertension. We aim to substantially enlarge the data on atenolol and analyse the effect of different beta blockers. METHODS: The Cochrane Library and PubMed were searched for beta blocker treatment in patients with primary hypertension. Data were then entered into the Cochrane Collaboration Review Manager package and were summarised in meta-analyses. 13 randomised controlled trials (n=105 951) were included in a meta-analysis comparing treatment with beta blockers with other antihypertensive drugs. Seven studies (n=27 433) were included in a comparison of beta blockers and placebo or no treatment. FINDINGS: The relative risk of stroke was 16% higher for beta blockers (95% CI 4-30%) than for other drugs. There was no difference for myocardial infarction. When the effect of beta blockers was compared with that of placebo or no treatment, the relative risk of stroke was reduced by 19% for all beta blockers (7-29%), about half that expected from previous hypertension trials. There was no difference for myocardial infarction or mortality. INTERPRETATION: In comparison with other antihypertensive drugs, the effect of beta blockers is less than optimum, with a raised risk of stroke. Hence, we believe that beta blockers should not remain first choice in the treatment of primary hypertension and should not be used as reference drugs in future randomised controlled trials of hypertension.

Adrenergic beta-Antagonists↗