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PubMed2000

Deoxyribonuclease for cystic fibrosis.

BACKGROUND: Recombinant human deoxyribonuclease is currently used to treat pulmonary disease (the major cause of morbidity and mortality) in cystic fibrosis. OBJECTIVES: To determine whether the use of recombinant human deoxyribonuclease in cystic fibrosis is associated with improved mortality and morbidity as compared to placebo and to identify any adverse events associated with its use. To compare the efficacy of recombinant human deoxyribonuclease with other mucolytics. SEARCH STRATEGY: The Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, hand searching relevant journals and abstracts from conferences. The company producing recombinant human deoxyribonuclease was also contacted. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: All randomised and quasi-randomised trials where recombinant human deoxyribonuclease was compared to either placebo, standard therapy or another mucolytic for any duration, dose regimen and age of patient with cystic fibrosis of any disease severity. DATA COLLECTION AND ANALYSIS: Trials were independently assessed for inclusion criteria, methodological quality and data extraction by the two reviewers. Comparisons were between recombinant human deoxyribonuclease and placebo and recombinant human deoxyribonuclease and other mucolytics. The following outcomes were recorded: Mean % change from baseline in forced vital capacity (FVC), forced expiratory voloume at one second (FEV1) and weight, mean number of respiratory tract exacerbations, days intravenous and oral antibiotics used, mean number of days as inpatient, number of deaths, adverse events and the cost of therapy. MAIN RESULTS: Seven primary clinical trials were identified, totalling 1710 patients. Two further studies examined the health care cost of patients from one of the clinical trials. No eligible studies compared recombinant human deoxyribonuclease to another mucolytic. Five trials presented outcomes at up to one month, one at three months and one at six months. No reduction in mortality for treated patients was identified (Relative Risk (RR) at six month 1.01, 95%Confidence Interval (CI) 0.09, 11.11). Lung function improved to a greater extent in the treated groups (at six months Weighted Mean Difference (WMD) FEV1 5.7, 95%CI 4.18, 7.23, at three months 7.3, 95%CI 4.04, 10.65). Pooled data from the five trials of up to one month gave WMD 9.2 95%CI 0.93, 17. 6 although there was significant heterogeneity). Recombinant human deoxyribonuclease was well tolerated with no excess of serious adverse events (RR haemoptysis 0.89, 95%CI 0.54, 1.45, pneumothorax 0.97 95%CI 0.19, 4.96). Voice alteration was, however, reported more frequently in the treated groups (RR 2.33 95%CI 1.38, 3.93). No study analysed our pre-defined outcome measure for respiratory exacerbations and insufficient data was available to analyse differences in antibiotic treatment, inpatient stay and quality of life. REVIEWER'S CONCLUSIONS: Studies are of insufficient duration to identify a reduction in mortality or number of respiratory exacerbations. Further trials are required to answer these important questions. Recombinant human deoxyribonuclease therapy is associated with an improvement in lung function after six months treatment, but it is not possible to assess whether this effect on lung function is sustained in the long-term. No studies were identified that compared recombinant human deoxyribonuclease to another mucolytic.

Cystic Fibrosis↗

PubMed2000

Aminosteroids for acute traumatic brain injury.

BACKGROUND: Traumatic brain injury is a leading cause of premature death and disability. Post-traumatic membrane lipid peroxidation has been proposed as one mechanism leading to secondary brain damage following head injury. Aminosteroids have been shown to inhibit lipid peroxidation in laboratory animals and have the potential to improve outcome following head injury. OBJECTIVES: To quantify the effectiveness and safety of aminosteroids in the treatment of acute traumatic brain injury. SEARCH STRATEGY: We searched the Cochrane Injuries Group trials register, The Cochrane Controlled Trials Register, MEDLINE and EMBASE. We contacted experts in the field and the company that manufactures tirilazad. SELECTION CRITERIA: We sought to identify all randomised controlled trials of aminosteroids versus placebo in the treatment of acute traumatic brain injury. Studies using a quasi random form of allocation, such as alternation, were excluded from the review. DATA COLLECTION AND ANALYSIS: One reviewer examined the electronic search results for reports of possibly relevant trials for retrieval in full. Two reviewers (IR and PA) applied the selection criteria independently to the trial report, with no disagreement. MAIN RESULTS: Two randomised controlled trials have examined the effect of the aminosteroid tirilazad mesylate on death and disability following head injury. To date, only the results of one of these trials are available for analysis. The risk of death in patients treated with tirilazad was almost identical to those given placebo RR=1.05 (95% confidence interval 0.86 to 1.29). The risk of death and severe disability in patients treated with tirilazad was again almost identical to those given placebo RR=1.07 (95% confidence interval 0.93 to 1.23). REVIEWER'S CONCLUSIONS: There is no evidence to support the routine use of aminosteroids in the management of traumatic head injury. On the basis of the existing evidence from randomised trials of aminosteroids in head injury it is not possible to refute the possibility of moderate but potentially clinically important benefits or harms. A further randomised controlled trial of tirilazad mesylate with 1156 participants has been completed, the results of which should become available in the near future.

Brain Injuries↗

PubMed2000

Psychological therapies for sickle cell disease and pain.

BACKGROUND: Sickle cell disease comprises of a group of genetic blood disorders, and occurs when the sickle cell haemoglobin gene is inherited from both parents. The effects of the condition are: varying degrees of anaemia which if severe reduce the capacity for mobility; predisposition to obstruction of small blood capillaries causing pain in muscle and bone known as "crises"; damage to major organs such as the spleen, liver, kidneys, and lungs; and increased vulnerability to severe infections. There are both medical and non-medical complications, and treatment is usually symptomatic and palliative in nature. Psychological intervention for individuals with sickle cell disease seems viable in complementing current medical treatment, and studies examining their efficacy appear to have also yielded encouraging results. OBJECTIVES: To examine the evidence that in patients with sickle cell disease, psychological treatment improves the ability to cope with the condition. SEARCH STRATEGY: The Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Also, searches on the Internet were performed. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of psychological intervention to no (psychological) intervention in patients with sickle cell disease. DATA COLLECTION AND ANALYSIS: The following outcomes were assessed: pain, mood, coping, health service utilisation, general health, quality of life, and life satisfaction. MAIN RESULTS: Four trials which reported results were all found to be unsuitable for inclusion at the present time, owing to incomplete data in the published papers. REVIEWER'S CONCLUSIONS: Psychological approaches are commonly used in an attempt to improve coping ability in patients with sickle cell disease. No conclusions can be made about the use of specific psychological therapies in sickle cell disease from the information currently available. This systematic review has clearly identified the need for well designed, adequately-powered, multicentre, RCTs assessing the effectiveness of specific interventions in sickle cell disease.

Adaptation, Psychological↗

PubMed2006

Zotepine for schizophrenia.

BACKGROUND: Zotepine is a relatively new antipsychotic often used for the treatment of people with schizophrenia. It is claimed to be particularly effective for negative symptoms. OBJECTIVES: To determine the effects of zotepine compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and related psychoses. SEARCH STRATEGY: For the 2006 update we searched the Cochrane Schizophrenia Group's register of trials. SELECTION CRITERIA: We included all randomised clinical trials comparing zotepine with other treatments for people with schizophrenia or other psychoses. DATA COLLECTION AND ANALYSIS: We independently inspected citations and abstracts, ordered papers, re-inspected these and assessed their quality. For homogenous dichotomous data we calculated the relative risk (RR), 95% confidence intervals (CI) and, where appropriate, numbers needed to treat/harm (NNT/H) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). We inspected all data for heterogeneity. MAIN RESULTS: The review currently includes 11 studies with 966 participants. Most outcomes were short term (4-12 weeks). We found no data for outcomes such as relapse, time in hospital, satisfaction with care and day-to-day functioning. Compared with placebo, mental state ratings favoured zotepine (n=106, 1 RCT, RR No 20% decrease in BPRS 0.44 CI 0.3 to 0.7, NNT 3 CI 2 to 6) using the last observation carried forward method. For the comparison with typical drugs, limited data suggest that zotepine may be as effective as these older medications. Mental state measures of 'no clinically important improvement' favour zotepine when compared with other active drugs (n=356, 4 RCTs, RR 0.77 CI 0.7 to 0.9, NNT 7 CI 4 to 22). About one third of people in both the zotepine and control groups left the studies before trial completion. Zotepine may result in less movement disorder adverse effects than typical antipsychotic drugs. Trials have not highlighted clear differences between zotepine and other atypical drugs. AUTHORS' CONCLUSIONS: Zotepine may be a valuable addition to the class of atypical antipsychotic drugs. However, more data from existing studies is urgently needed to increase confidence in the findings of this review. In addition to this, new data from well planned, conducted and reported long term pragmatic randomised trials are needed. Otherwise clinical use of zotepine will be based upon speculation of short explanatory trials for everyday practice.

Antipsychotic Agents↗

PubMed2001

Timing and volume of fluid administration for patients with bleeding following trauma.

BACKGROUND: Treatment of haemorrhagic shock involves maintaining blood pressure and tissue perfusion until bleeding is controlled. Different resuscitation strategies have been used to maintain the blood pressure in trauma patients until bleeding is controlled. However, while maintaining blood pressure may prevent shock, it may worsen bleeding. OBJECTIVES: To assess the effects of early versus delayed, and larger versus smaller volume of fluid administration in trauma patients with bleeding. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, the specialised register of the Injuries Group, MEDLINE, EMBASE, the National Research Register and the Science Citation Index. We checked reference lists of identified articles and contacted authors and experts in the field. SELECTION CRITERIA: Randomised trials of the timing and volume of intravenous fluid administration in trauma patients with bleeding. Trials in which different types of intravenous fluid were compared were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: We did not combine the results quantitatively because the interventions and patient populations were so diverse. Early versus delayed fluid administration: Three trials reported mortality and two coagulation data. In the first trial (n=598) relative risk (RR) for death with early fluid administration was 1.26 (95% confidence interval of 1.00-1.58). The weighted mean differences (WMD) for prothrombin time and partial thromboplastin time were 2.7 (95% CI 0.9-4.5) and 4.3 (95% CI 1.74-6.9) seconds respectively. In the second trial (n=50) RR for death with early blood transfusion was 5.4 (95% CI 0.3-107.1). The WMD for partial thromboplastin time was 7.0 (95% CI 6.0-8.0) seconds. In the third trial (n=1309) RR for death with early fluid administration was 1.06 (95% CI 0.77-1.47). Larger versus smaller volume of fluid administration: Three trials reported mortality and one coagulation data. In the first trial (n=36) RR for death with a larger volume of fluid resuscitation was 0.80 (95% CI 0.28-22.29). Prothrombin time and Partial thromboplastin time were 14.8 and 47.3 seconds in those who received a larger volume of fluid as compared to 13.9 and 35.1 seconds in the comparison group. In the second trial (n=99) RR for death with a high (100 mm Hg) compared to low (70 mm Hg) systolic blood pressure resuscitation target was 1.02 (95% CI 0.27-3.85). In the third trial (n=25) there were no deaths. REVIEWER'S CONCLUSIONS: We found no evidence from randomised controlled trials to support early or larger volume of intravenous fluid administration in uncontrolled haemorrhage. There is continuing uncertainty about the best fluid administration strategy in bleeding trauma patients. Further randomised controlled trials are needed to establish the most effective fluid resuscitation strategy.

Hemorrhage↗

PubMed2002

Nitrates for achalasia.

BACKGROUND: Achalasia is a disease that impairs oesophageal motility. Though nitrates have been used to treat achalasia for a long time, the effectiveness of nitrates for achalasia is still controversial. OBJECTIVES: To quantify short-term and long-term effects of nitrate therapy in patients with achalasia. SEARCH STRATEGY: Trials were identified by searching the Cochrane Controlled Trials Register (Issue 4-2001), MEDLINE (1966-2001), EMBASE (1980-2001), LILACS - Latin American and Caribbean health science literature (1982-2001) and CBM-Chinese Biomedical database(1980-2000). Additionally, all references in the identified trials were checked for further relevant trials. SELECTION CRITERIA: All randomised controlled trials involving achalasic patients given any type of nitrates were included. DATA COLLECTION AND ANALYSIS: Data were extracted by two independent observers based on the intention to treat principle. MAIN RESULTS: Two randomised cross-over studies were found, but no results are included. Due to the design of the studies and the method of reporting the results in the original paper it was not possible to extract the necessary information to examine any of the outcomes. REVIEWER'S CONCLUSIONS: We can conclude no implications for practice at this stage. Appropriately designed parallel group randomised controlled trials with long term follow-up are needed to determine the effects of nitrates.

Esophageal Achalasia↗

PubMed2004

Nitrates for achalasia.

BACKGROUND: Achalasia is a disease that impairs oesophageal motility. Though nitrates have been used to treat achalasia for a long time, the effectiveness of nitrates for achalasia is still controversial. OBJECTIVES: To quantify short-term and long-term effects of nitrate therapy in patients with achalasia. SEARCH STRATEGY: Trials were identified by searching the Cochrane Controlled Trials Register (Issue 4-2001), MEDLINE (1966-2001), EMBASE (1980-2001), LILACS - Latin American and Caribbean health science literature (1982-2001) and CBM-Chinese Biomedical database(1980-2000). Additionally, all references in the identified trials were checked for further relevant trials. An updated search was run on the Cochrane Library, MEDLINE, and EMBASE in September 2003 - no new trials were found. SELECTION CRITERIA: All randomised controlled trials involving achalasic patients given any type of nitrates were included. DATA COLLECTION AND ANALYSIS: Data were extracted by two independent observers based on the intention to treat principle. MAIN RESULTS: Two randomised cross-over studies were found, but no results are included. Due to the design of the studies and the method of reporting the results in the original paper it was not possible to extract the necessary information to examine any of the outcomes. REVIEWER'S CONCLUSIONS: We can conclude no implications for practice at this stage. Appropriately designed parallel group randomised controlled trials with long term follow-up are needed to determine the effects of nitrates.

Esophageal Achalasia↗

PubMed2003

Fibrin sealant use for minimising peri-operative allogeneic blood transfusion.

BACKGROUND: Fibrin sealants have gained increasing popularity as interventions to improve peri-operative (intra/post-operative) haemostasis and diminish the need for allogeneic red cell transfusion (blood from an unrelated donor). OBJECTIVES: To examine the efficacy of fibrin sealants in reducing peri-operative blood loss and allogeneic red blood cell (RBC) transfusion. SEARCH STRATEGY: Studies were identified by: searches of MEDLINE, EMBASE, Current Contents, the Cochrane Library (July 2002), manufacturer web sites (to July 2002), and bibliographies of published articles. SELECTION CRITERIA: Controlled trials in which adult patients, scheduled for elective surgery, were randomised to fibrin sealant treatment or to a control group who did not receive fibrin sealant treatment. Trials were eligible if they reported data on the number of patients exposed to allogeneic red cell transfusion, the volume of blood transfused, or blood loss (assessed objectively). DATA COLLECTION AND ANALYSIS: Primary outcomes measured were: the number of patients exposed to allogeneic red cells, the amount of blood transfused, and blood loss. Other outcomes measured were: re-operation due to bleeding, infection, mortality, and length of hospital stay. Treatment effects were pooled using a random effects model. MAIN RESULTS: Seven trials, including a total of 388 patients, reported data on peri-operative exposure to allogeneic RBC transfusion. Fibrin sealant treatment, on average, reduced the rate of exposure to allogeneic red cell transfusion by a relative 54% (relative risk [RR] = 0.46: 95%CI = 0.32 to 0.68). Eight trials, including a total of 442 patients, provided data for post-operative blood loss. Fibrin sealant treatment reduced blood loss on average by around 134 per patient (95%CI = 51 to 217 ). However the trials reviewed were small and of poor methodological quality (91% unblinded). REVIEWER'S CONCLUSIONS: Overall the results suggest that fibrin sealants are efficacious in reducing both post-operative blood loss and peri-operative exposure to allogeneic RBC transfusion. However, due to the lack of blinding, transfusion practices may have been influenced by knowledge of the patient's treatment status. This raises concerns about the use of blood transfusion practice as an outcome variable in trials of fibrin sealant. In the case of blood loss, the results must be interpreted with caution, in view of the statistically significant heterogeneity in treatment effect observed. Large, methodologically rigorous, randomised controlled trials of fibrin sealants are needed.

Adult↗

PubMed2006

Puerarin injection for unstable angina pectoris.

BACKGROUND: Puerarin is extracted from the Chinese herb puerariae lobata. Many users of Chinese herbal medicine believe that puerarin has positive effects in the treatment of coronary heart disease (CHD). In recent years puerarin injection has been widely used to treat CHD and angina pectoris. OBJECTIVES: To assess the benefits and harms of puerarin injection for unstable angina. SEARCH STRATEGY: The following electronic databases were searched: The Cochrane Controlled Trials Register on The Cochrane Library (Issue 3, 2004), MEDLINE (1995 to 2004), EMBASE (1995 to 2004), CBM (1995 to 2004), Chinese Cochrane Centre Controlled Trials Register (to 2004), Current Controlled Trials (www.controlled-trials.com) and The National Research Register. We also hand searched 60 Chinese traditional medicine journals. SELECTION CRITERIA: Randomised controlled trials undertaken on adults with unstable angina evaluating the following types of interventions: Puerarin injection compared to western drugs or placebo, or puerarin injection used with western drugs compared to western drugs alone. DATA COLLECTION AND ANALYSIS: Data were extracted and analysed independently by two reviewers. Differences in data extraction and analysis were resolved by consensus, referring back to the original article. Study authors were contacted for additional information. Adverse effects information was collected from the trials. MAIN RESULTS: 20 trials involving 1240 people were included. All trials identified were classified as having a high risk of bias because of poor reported methodology. The duration of treatment was 7-20 days and no information supplied suggested longer follow-ups were conducted for any trials. This limited the observation to participants who were not undertaking normal activities of daily living. The primary outcome (death) was not report in any trial. For all the secondary outcome measures, frequency of acute angina attacks, improvements in ECG, doses and incidence of nitroglycerine needed and levels of plasma endothelin, there was no evidence that puerarin had better or worse effects to other conventional treatments. There was strong evidence to suggest that puerarin injection plus western drugs was a better treatment option than western drugs alone. AUTHORS' CONCLUSIONS: Puerarin injection may be effective in unstable angina when used in addition to conventional treatments. However, these finding should be interpreted with care because of the very low methodological quality of studies and potential publication bias. In the light of the findings, a more rigorously designed, randomised double-blind placebo-controlled trial is needed.

Adult↗

PubMed2002

[Duration of oral anticoagulant therapy in deep venous thrombosis of the lower limbs].

The optimal duration of oral anticoagulant therapy is a matter of debate. It is essential to balance the desired effect of the anticoagulants in reducing recurrences against the risk of major bleeding. Recent data suggest that it is necessary to tailor the duration of anticoagulation individually according to the topography of deep vein thrombosis (DVT) and the presence of risk factors. A six-week treatment for patients with isolated calf DVT is sufficient. For proximal DVT and/or pulmonary embolism, a short anticoagulant course seems sufficient in patients with temporary risk factors (three months) and a longer anticoagulant course (six months at least) is recommended for cases with permanent risk factors or idiopathic DVT. The inherited or acquired hypercoagulable states can be divides into those that are common and associated with a modest risk of recurrence (i.e. isolated factor V Leiden or G20210A prothrombin gene) and those are uncommon but associated with a high risk of recurrence (i.e. antithrombin, protein C or S deficiencies and anticardiolipin antibodies). Thus, the presence of one of these last abnormalities favours more prolonged anticoagulant therapy. For the high-risk of recurrence patients, there is a paucity of evidence based medicine particularly for patients with biological thrombophilia, and randomised controlled trials in this population are required. An assessment of low- or fixed-dose oral anticoagulation is also necessary in order to reduce the bleeding risk.

Administration, Oral↗

PubMed2006

Botulinum toxin in the management of sialorrhoea: a systematic review.

Sialorrhoea can be a significant problem in both adults and children and can cause both physical and psychosocial problems. Botulinum toxin has enjoyed an emergence in the treatment of sialorrhoea, a systematic review of the evidence for botulinum toxin reveals two randomised controlled trials (RCTs) and four other trials that fulfilled our inclusion criteria. Both RCTs demonstrate the effectiveness of botulinum toxin in the management of sialorrhoea. There was no clear evidence for one antigenic type of botulinum toxin over another and minimal evidence for the optimal dose of botulinum toxin for each antigenic type. No advantage is conferred in using ultrasound guidance in injecting the glands. None of the RCTs or other studies directly compared submandibular versus parotid injection or directly compared botulinum toxin against surgery. Minor side effects were reported in one of the RCTs but overall botulinum toxin is a safe, minimally invasive and effective means in the treatment of sialorrhoea with the potential to become the treatment of choice. Our review demonstrates that further randomised controlled trials are required to more fully evaluate this new modality of treatment.

Animals↗

PubMed1996

Identification of randomised clinical trials in the Australian and New Zealand Journal of Psychiatry for the Cochrane Collaboration.

Biased and otherwise unsystematic reviews of the literature may result in factual errors in the conclusions reached by reviewers. The Cochrane Collaboration is an attempt to address some of these concerns. Randomised clinical trials published in the Australian and New Zealand Journal of Psychiatry are now available for inclusion in the Cochrane Collaboration reviews.

Australia↗

PubMed1999

Adjuvant and induction chemotherapy in non-small cell lung cancer.

About 25%-30% of patients with non-small cell lung cancer can be resected with curative intent. However, systemic relapses occur in up to 70% of these patients. Thus, postoperative adjuvant chemotherapy was evaluated in several randomised trials but the results of these trials were inconclusive with a survival benefit only in some trials. Shortcomings of these trials included low number of patients, poor patient compliance and inadequate chemotherapy protocols. A recent meta-analysis suggested an absolute survival benefit of 5% at five years for postoperative cisplatin-based chemotherapy as compared to surgery alone. Thus adjuvant chemotherapy with both improved chemotherapy protocols and improved anti-emetics is currently re-evaluated in several randomised trials on large patient populations.

Antineoplastic Agents↗

PubMed2002

[Randomised controlled trials: a reading guide].

This paper, first of a series devoted to evidence-based medicine, describes how to critically read an article on a randomised controlled intervention trial. This guide is applied to the common clinical question, whether or not to prescribe systemic glucocorticoids for patients with exacerbation of chronic obstructive pulmonary disease, through the analysis of two recently published series. It comprises a three-step evaluation: the assessment of the study methods to ensure that the results are valid, the analysis of the results of the larger of the two studies, and the evaluation of whether the results can be applied to a patient whose clinical case illustrates this article. Finally, a few limitations of randomised controlled trials are discussed.

Anti-Inflammatory Agents↗

PubMed2004

Evidence-based medicine and drug-eluting stents.

Successful implementation of evidence-based medicine in the development of high-risk medical devices requires a methodical scientific approach. However, even when research evidence is available from randomised controlled studies, it can be difficult to translate clinical evidence into regulatory and clinical decisions. Drug-eluting stents are used as an example to illustrate this principle.

Clinical Trials as Topic↗

PubMed2005

[Selective reporting of positive outcomes in randomised trials--secondary publication.. A comparison of protocols with published reports].

INTRODUCTION: Selective reporting of positive outcomes is associated with bias. MATERIALS AND METHODS: We conducted a cohort study of 102 protocols of randomised trials approved by the Scientific Ethics Committees for Copenhagen and Frederiksberg in 1994-1995 and the corresponding 122 reports. RESULTS: The median proportion of incompletely reported outcomes per trial was 50%. Statistically significant outcomes were more often fully reported, odds ratio 2.4. In 62% of trials, at least one primary outcome was changed. DISCUSSION: Outcomes in randomised trials are often reported selectively.

Clinical Protocols↗

PubMed2006

[Endoluminal treatment of gastro-oesophageal reflux disease: too early to determine a clear role].

Gastro-oesophageal reflux disease is a chronic disorder. The most important therapeutic measure is long-term pharmacological acid inhibition. Anti-reflux surgery plays a role in cases where pharmacological treatment fails. A new development is endoluminal treatment for reflux disorders. The various methods used are based on one of the following principles: radiofrequency ablation, gastroplication and implantation of a bulking agent. Short-term results with endoluminal treatment are not very positive and longer-term results have been disappointing so far. Results from randomised studies are still largely unavailable. Longer follow-up and controlled randomised studies are needed before a well-founded judgment can be made regarding the place of endoluminal treatment in the therapeutic armamentarium.

Antacids↗

PubMed2002

Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ.

OBJECTIVE: To assess the association between competing interests and authors' conclusions in randomised clinical trials. DESIGN: Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. STUDIES: 159 trials from 12 medical specialties. MAIN OUTCOME MEASURES: Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention. RESULTS: Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. CONCLUSIONS: Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions.

Analysis of Variance↗