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PubMed2005

Strategies for managing antidepressant-induced sexual dysfunction: systematic review of randomised controlled trials.

BACKGROUND: This review was undertaken to assess the effectiveness of management strategies for sexual dysfunction caused by antidepressant medication. METHODS: Electronic databases and reference lists were searched, and pharmaceutical companies and experts contacted to identify randomised controlled trials comparing management strategies for antidepressant-induced sexual dysfunction. RESULTS: Fifteen trials involving 904 people were included. One trial involving 75 people with sexual dysfunction due to sertraline assessed changing antidepressant. Switching to nefazodone was significantly less likely to result in the re-emergence of sexual dysfunction than restarting sertraline (RR 0.34, 95% CI 0.15 to 0.6). Meta-analysis of two trials involving 113 men with erectile dysfunction found that the addition of sildenafil resulted in less sexual dysfunction at endpoint on rating scales including the International Index of Erectile Function (IIEF) (WMD 19.36, 95% CI 15.00 to 23.72). Another trial found the addition of bupropion led to improved scores on the Changes in Sexual Functioning Questionnaire desire-frequency subscale (WMD 0.88, 95% CI 0.21 to 1.55). In a further study the addition of tadalafil was associated with greater improvement in the erectile function domain of the IIEF than placebo (WMD 8.10; 95% CI 4.62 to 11.68). Other augmentation strategies failed to show statistically significant improvements in sexual dysfunction compared with placebo. DISCUSSION: The currently available evidence is rather limited, with small numbers of trials assessing each strategy. However, while further randomised data is awaited, for men with antidepressant-induced erectile dysfunction, the addition of sildenafil appears to be an effective strategy.

Antidepressive Agents↗
PubMed2001

[Laparoscopic surgery--an update of current status].

Recent developments have allowed most intra-abdominal procedures to be performed by the laparoscopic technique. Potential clinical advantages are supported by the reduced pathophysiological changes demonstrated in the surgical stress response, as compared with open surgery. However, a critical assessment of randomised, controlled studies and meta-analyses comparing laparoscopic and open surgery has not convincingly shown that laparoscopic surgery improves the outcome, except in a few operations. Because the concept of minimal invasive surgery is based on well-documented pathophysiological advantages, future randomised studies comparing laparoscopic and open surgery should include a revision of perioperative care regimens with early rehabilitation, in order to demonstrate more significant benefits of laparoscopic surgery.

Appendectomy↗
PubMed1996

Ovarian ablation in early breast cancer: overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group.

BACKGROUND: Among women with early breast cancer, the effects of ovarian ablation on recurrence and death have been assessed by several randomised trials that now have long follow-up. In this report, the Early Breast Cancer Trialists' Collaborative Group present their third 5-yearly systematic overview (meta-analysis), now with 15 years' follow-up. METHODS: In 1995, information was sought on each patient in any randomised trial of ovarian ablation or suppression versus control that began before 1990. Data were obtained for 12 of the 13 studies that assessed ovarian ablation by irradiation or surgery, all of which began before 1980, but not for the four studies that assessed ovarian suppression by drugs, all of which began after 1985. Menopausal status was not consistently defined across trials; therefore, the main analyses are limited to women aged under 50 (rather than "premenopausal") when randomised. Oestrogen receptors were measured only in the trials of ablation plus cytotoxic chemotherapy versus the same chemotherapy alone. FINDINGS: Among 2102 women aged under 50 when randomised, most of whom would have been premenopausal at diagnosis, 1130 deaths and an additional 153 recurrences were reported. 15-year survival was highly significantly improved among those allocated ovarian ablation (52.4 vs 46.1%, 6.3 [SD 2.3] fewer deaths per 100 women, logrank 2p = 0.001), as was recurrence-free survival (45.0 vs 39.0%, 2p = 0.0007). The numbers of events were too small for any subgroup analyses to be reliable. The benefit was, however, significant both for those with ("node positive") and for those without ("node negative") axillary spread when diagnosed. In the trials of ablation plus cytotoxic chemotherapy versus the same chemotherapy alone, the benefit appeared smaller (even for women with oestrogen receptors detected on the primary tumour) than in the trials of ablation in the absence of chemotherapy (where the observed survival improvements were about six per 100 node-negative women and 12 per 100 node-positive women). Among 1354 women aged 50 or over when randomised, most of whom would have been perimenopausal or postmenopausal, there was only a nonsignificant improvement in survival and recurrence-free survival. INTERPRETATION: In women aged under 50 with early breast cancer, ablation of functioning ovaries significantly improves long-term survival, at least in the absence of chemotherapy. Further randomised evidence is needed on the additional effects of ovarian ablation in the presence of other adjuvant treatments, and to assess the relevance of hormone-receptor measurements.

Breast Neoplasms↗
PubMed2000

Conservative versus operative treatment for extracapsular hip fractures.

BACKGROUND: Until operative treatment involving the use of various implants was introduced in the 1950s, hip fractures were managed using conservative methods based on traction and bed rest. OBJECTIVES: To compare conservative with operative treatment for extracapsular fractures of the proximal femur (hip) in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register and bibliographies of published papers, and contacted trialists. Date of the most recent search: August 1999. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing these two treatment methods in adults with hip fracture. Outcomes sought fell into four categories: a) fracture fixation complications, b) post-operative or clinical complications, c) final outcome measures including mortality and d) anatomical restoration. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality, by use of an eleven item scale, and extracted data. Additional information was sought from trialists. Comparable groups of trials were subgrouped by implant type (fixed nail plate or sliding hip screw) and where appropriate, data were pooled using the fixed effects model. MAIN RESULTS: The four randomised trials identified involved only 402 elderly patients. These tested a variety of surgical techniques and implant devices and only one trial involving 106 patients can be considered to test current practice. In this trial, no differences were found in medical complications, mortality and long-term pain. However, operative treatment was more likely to result in the fracture healing without leg shortening, a shorter hospital stay and a statistically non-significant increase in the return of patients back to their original residence. REVIEWER'S CONCLUSIONS: The limited available evidence from randomised trials does not suggest major differences in outcome between conservative and operative management programmes for extracapsular femoral fractures, but operative treatment appears to be associated with a reduced length of hospital stay and improved rehabilitation. However these results are derived mainly from one study. Conservative treatment will be acceptable where modern surgical facilities are unavailable, and will result in a reduction in complications associated with surgery, but rehabilitation is likely to be slower and limb deformity more common. Although further randomised trials would provide more robust data, they may be difficult to mount.

Adult↗
PubMed2006

Injectable vaccines for preventing pneumococcal infection in patients with chronic obstructive pulmonary disease.

BACKGROUND: As chronic obstructive pulmonary disease (COPD) progresses, exacerbations can occur with increasing frequency. One goal of therapy in COPD is to try and prevent these exacerbations, thereby reducing disease morbidity and associated healthcare costs. Pneumococcal vaccinations are considered to be one strategy for reducing the risk of infective exacerbations. OBJECTIVES: To determine the safety and efficacy of pneumococcal vaccination in COPD. The primary outcome assessed was acute exacerbations. Secondary outcomes of interest included episodes of pneumonia, hospital admissions, adverse events related to treatment, disability, change in lung function, mortality, and cost effectiveness. SEARCH STRATEGY: We searched the Cochrane Airways Group COPD trials register using pre-specified terms. We also conducted additional handsearches of conference abstracts. The last round of searches were performed in April 2006. SELECTION CRITERIA: Only randomised controlled trials assessing the effects of injectable pneumococcal vaccine in people with COPD were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and three review authors independently assessed trial quality. MAIN RESULTS: Although 10 studies cited in 11 publications were identified that met the inclusion criteria for this review, only four of these provided data on participants with COPD. The studies which did provide data for this review consisted of two trials using a 14-valent vaccine, and two using a 23-valent injectable vaccine. Data for the primary outcome, acute exacerbation of COPD, was available from only one of the four studies. The odds ratio of 1.43 (95% confidence interval (CI) 0.31 to 6.69) between interventions was not statistically significant. Of the secondary outcomes for which data were available and could be extracted, none reached statistical significance. Three studies provided dichotomous data for persons who developed pneumonia (OR 0.89, 95% CI 0.58 to 1.37, n = 748). Rates of hospital admissions and emergency department visits came from a single study. There was no significant reduction in the odds of all-cause mortality 1 to 48 months post-vaccination (Peto odds ratio 0.94, 95% CI 0.67 to 1.33, n = 888), or for death from cardiorespiratory causes (OR 1.07, 95% CI 0.69 to 1.66). AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials that injectable pneumococcal vaccination in persons with COPD has a significant impact on morbidity or mortality. Further large randomised controlled trials would be needed to ascertain if the small benefits suggested by individual studies are real.

Humans↗
PubMed2002

Epidural blood patching for preventing and treating post-dural puncture headache.

BACKGROUND: Dural puncture is a common procedure, but leakage of CSF from the resulting dural defect may cause postural headache after the procedure, and this can be disabling. Injecting an epidural blood patch around the site of the defect may stop this leakage, and so may have a role in preventing or treating post dural puncture headache. OBJECTIVES: To assess the possible benefits and harms of epidural blood patching in both the prevention and the treatment of post-dural puncture headache. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (Cochrane Library, Issue 4, 2000), MEDLINE (January 1994 to December 1998), and EMBASE (January 1980 to December 1998). We also searched the reference lists of relevant articles identified electronically, and asked both the authors of all included trials and colleagues with an interest in this area to let us know of any other potentially relevant studies not already identified. Date of last search: December 2000. SELECTION CRITERIA: We sought all properly randomised, unconfounded trials that compared epidural blood patch versus no epidural blood patch in the prevention or treatment of post-dural puncture headache among all types of patients undergoing dural puncture for any reason. The primary outcome of effectiveness was postural headache. DATA COLLECTION AND ANALYSIS: One reviewer extracted details of trial methodology and outcome data from the reports of all trials considered eligible for inclusion. We invited the authors of all such trials both to check the information extracted and to provide any details that were unavailable in the published reports. Intention-to-treat analyses were performed using the Peto O-E method. Information about adverse effects (post-dural puncture backache, epidural infection and lower limb paraesthesia) was also extracted. MAIN RESULTS: Three trials (77 patients) were eligible for inclusion. Methodological details were generally incomplete. Although the results of our analyses suggested that both prophylactic and therapeutic epidural blood patching may be of benefit, the very small numbers of patients and outcome events, as well as uncertainties about trial methodology, precluded reliable assessments of the potential benefits and harms of this intervention. REVIEWER'S CONCLUSIONS: Further, adequately powered, randomised trials (including at least a few hundred patients) are required before reliable conclusions can be drawn about the role of epidural blood patching in the prevention and treatment of post-dural puncture headache.

Blood Patch, Epidural↗
PubMed2004

Psychotherapeutic interventions for adults with asthma.

BACKGROUND: Many people have asthma, and for some their symptoms may be triggered by psychological factors. In addition compliance with medical therapy may have a psychological dimension. Therefore, psychological interventions aim to reduce the burden of symptoms and improve management of the disease. OBJECTIVES: To assess the effectiveness of psychological interventions for adults with asthma. SEARCH STRATEGY: The Cochrane Airways Group specialised register and PsycINFO were searched with pre-defined terms until September 2003. SELECTION CRITERIA: Randomised controlled trials published in any language assessing the effects of a psychological intervention compared with a form of control in adult participants were included in the review. DATA COLLECTION AND ANALYSIS: Two reviewers assessed the relevance of abstracts identified by electronic searching and retrieved agreed studies for further scrutiny. The studies that met the inclusion criteria were assembled and data extracted. MAIN RESULTS: Twelve studies were included in the review, however study quality was poor and sample sizes were frequently small. No meta-analysis could be performed due to the diversity of interventions and the outcomes assessed. Findings between studies were conflicting. This may have been due to the different types of interventions used and the deficiencies in trial design. REVIEWER'S CONCLUSIONS: This review was unable to draw firm conclusions for the role of psychological interventions in asthma due to the absence of an adequate evidence base. Large, well-conducted and reported randomised trials are required in this area, in order to determine the effects of these techniques in the treatment of asthma in adults.

Adult↗
PubMed2004

Systemic antifungal drugs for invasive fungal infection in preterm infants.

BACKGROUND: Invasive fungal infection is an increasingly common cause of mortality and morbidity in preterm infants. In addition to amphotericin B, a variety of newer antifungal drugs and drug preparations are available for treatment. There is a need to assess their relative merits. OBJECTIVES: In preterm infants with suspected or confirmed invasive fungal infection, does treatment with newer systemic antifungal drugs or drug preparations, versus conventional amphotericin B alone, reduce mortality and adverse neurodevelopmental outcomes? SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2003), MEDLINE (1966 - August 2003), EMBASE (1980 - August 2003), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised and quasi-randomised control trials comparing one antifungal agent or combination of agents with another in preterm infants with suspected or confirmed invasive fungal infection. DATA COLLECTION AND ANALYSIS: We extracted the data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by each author, and synthesis of data using relative risk and risk difference. The pre-specified outcomes were death prior to hospital discharge, longer term neurodevelopment, and adverse drug reactions resulting in discontinuation of therapy. MAIN RESULTS: We identified only one small trial. This study compared the use of fluconazole with amphotericin B (5-Fluorocytosine added if fungal meningitis present). Three of 11 infants who were treated with fluconazole died and four of 10 infants who were treated with amphotericin B died : Relative risk: 0.68 (95% confidence interval 0.20, 2.33), Risk Difference -0.13 (95% confidence interval -0.53, 0.27) There were not any data on longer term outcomes. REVIEWER'S CONCLUSIONS: From this one small study there are insufficient data to favour one antifungal agent or combination to reduce mortality and adverse neurodevelopmental outcomes in preterm infants with suspected or confirmed invasive fungal infection. A large randomised controlled trial is required to compare the newer antifungal preparations with conventional amphotericin B. Further research may also determine the relative convenience and cost effectiveness of the available drugs.

Amphotericin B↗
PubMed2004

Antibiotic regimens for suspected early neonatal sepsis.

BACKGROUND: Early acquired infection may cause severe illness or death in the neonatal period. Prompt treatment with antibiotics has shown to reduce mortality. It is not clear which antibiotic regimen is suitable for treatment of presumed early neonatal sepsis. OBJECTIVES: To compare effectiveness and adverse effects of antibiotic regimens for treatment of presumed early neonatal sepsis. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2003), MEDLINE (1966 to August 2003), EMBASE (1980 to September 2003) and ZETOC (1993 to August 2003) databases were searched for possible studies. Pharmaceutical companies were contacted for any unpublished data. SELECTION CRITERIA: Randomised and quasi-randomised controlled studies comparing antibiotic regimens for the treatment of early neonatal sepsis (both monotherapies and combination therapies). DATA COLLECTION AND ANALYSIS: Both reviewers screened abstracts and full reports against the inclusion criteria, appraised the quality of and extracted data from papers. For dichotomous outcomes, treatment effect was expressed as relative risk with 95% confidence interval. Meta-analysis was performed using a fixed effect model. MAIN RESULTS: Two small studies had compared monotherapy with combination therapy. There was no significant difference in mortality, treatment failure or bacteriological resistance. REVIEWERS' CONCLUSIONS: There is no evidence from randomised trials to suggest that any antibiotic regimen may be better than any other in the treatment of presumed early neonatal sepsis. More studies are needed to resolve this issue.

Anti-Bacterial Agents↗
PubMed2006

Evidence for beneficial effects of antidepressants on suicidality in depressive patients: a systematic review.

The role of antidepressants in suicide prevention is a major public health question, given the high prevalence of both depression and depression-related suicidality. Therefore all means available should be utilised to clarify the influence of antidepressants on suicidality. This paper gives a comprehensive overview of the positive effects of antidepressants on suicidality. In the first section, principal methodological issues related to suicidology in general as well as to clinical and epidemiological studies that investigate the influence of antidepressants on suicidality are discussed. In the second section, the results of controlled clinical studies on the efficacy of antidepressants in suicidality are presented. The third section reports on the results of other types of studies, especially epidemiological studies. Altogether, there seems to be reasonable evidence from different research approaches that antidepressants are able to reduce suicidal ideation and also suicidal behaviour in depressive patients. While the evidence for the beneficial effect on suicidal ideation comes from randomised control group studies, some of which used a placebo arm, the evidence for the prophylactic effect on suicidal behaviour, especially suicide, was primarily obtained from well-designed epidemiological studies.

Antidepressive Agents↗
PubMed2006

Treatment of children's nighttime fears: the need for a modern randomised controlled trial.

Children's nighttime fears are common and cause significant interference to the child's functioning as well as causing much distress for the child and family. Therefore, effective and cost-efficient interventions are urgently needed by mental health professionals and counsellors. The authors review 29 studies, which investigated the efficacy of psychosocial treatment for children's nighttime fears. Most studies employed multiple baseline across subject designs or between group designs and most employed cognitive-behavioral techniques (i.e., desensitisation, emotive imagery, cognitive self-instruction, and reinforcement procedures). Although multi-method, informant assessments were not always conducted, in most studies rapid reduction of nighttime fears was typically achieved after only a few sessions with maintenance of gains. On the basis of our review, we make recommendations about assessment and intervention issues for the effective treatment of children's nighttime fears. Finally, future research directions are discussed including the need for a modern randomised clinical trial to more fully investigate treatment efficacy and the role of non-specific treatment factors.

Adolescent↗
PubMed2004

Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials.

Randomised clinical trials have come to be regarded as the gold standard in treatment evaluation. However, many doctors see the discussion of a clinical trial as an intrusion into the doctor-patient relationship and find these discussions difficult to initiate. Detailed informed consent is now a requirement of patient participation in trials; however, it is known that patients commonly fail to understand and recall the information conveyed. These difficulties for doctors and patients raise questions about the ethical integrity of the informed consent process. In this study, we have developed a set of communication strategies underpinned by ethical, linguistic and psychological theory, designed to assist doctors in this difficult task. Initially, audiotape transcripts of 26 consultations in which 10 medical oncologists invited patients to participate in clinical trials were analysed by expert ethicists, linguists, oncologists and psychologists, using rigorous qualitative methodology. A subset of seven of these was subjected to detailed linguistic analysis. A strategies document was developed to address themes which emerged from these analyses. This document was presented to relevant expert stakeholders. Their feedback was incorporated into the final document. Four themes emerged from the analysis; (a) shared decision-making, (b) the sequence of moves in the consultation, (c) the type and clarity of the information provided and (d) disclosure of controversial information and coercion. Detailed strategies were developed to assist doctors to communicate in these areas. We have developed a set of ethical strategies which may assist health professionals in this difficult area. A training package based on these strategies is currently being evaluated in a multi-centre randomised controlled trial.

Adult↗
PubMed2002

Chemoradiotherapy for cervical cancer.

Cervical cancer remains a major health problem worldwide, despite advances in screening. For patients with locally advanced stage disease, failure to obtain local-regional control usually results in death. In an effort to improve local-regional tumour control, neoadjuvant and concurrent chemoradiation has been tested. Recently, five randomised trials performed by the Gynecologic Oncology Group (GOG), Radiation Therapy Oncology Group (RTOG) and the SouthWest Oncology Group (SWOG) studying cisplatin-based chemoradiation have demonstrated a significant survival advantage. Three of the trials compared cisplatin-based concurrent chemotherapy and radiation to radiation alone and two trials compared cisplatin-based concurrent chemotherapy and radiation to radiation with hydroxyurea. In all of the trials, cisplatin-based chemotherapy administered concurrently with radiation therapy was more effective at reducing the risk of death by 30-50%. Acute toxicities, principally neutropenia and gastrointestinal, were more common with chemoradiation, but were transient and the rates of late complications (complications that persisted or occurred for more than 60 days after the treatment) were similar. Based on the results of these five randomised trials, the National Cancer Institute (NCI) released a Clinical Announcement stating that cisplatin-based chemotherapy, as used in these trials (i.e. concurrently with radiation therapy), as the new standard of therapy for cervical cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

Barbiturates for acute neurological and neurosurgical emergencies--do they still have a role?

A number of clinical studies have reported poor clinical outcomes for patients treated with barbiturate therapy in acute neurological and neurosurgical emergencies. Barbiturate therapy, as currently practised with thiopentone and pentobarbitone at least, is also associated with a prolonged post-infusion period of clinical unresponsiveness. Hence, the popularity of barbiturate therapy for sedation of critically ill neurological and neurosurgical patients has declined over the past decade. A retrospective study of traumatic brain injury patients treated at the Royal North Shore Hospital, Sydney, with high-dose thiopentone therapy between 1987 and 1997 has found disappointing results with a 1-month mortality outcome of 50% (14 of 28 patients). Nevertheless, barbiturate therapy remains a consideration for patients with severe cranial trauma in whom preferred treatments have failed to control intracranial or cerebral perfusion pressures. More favourable results ( approximately 10% 1-month mortality rate) were encountered for patients with refractory vasospasm complicating subarachnoid haemorrhage or intracerebral haemorrhage complicating supratentorial arteriovenous malformation resection. A well designed, prospective and randomised controlled trial may be of value in further determining the role of barbiturate therapy in acute neurovascular emergencies refractory to standard therapy.

Barbiturates↗
PubMed2002

The effects of vigorous exercise during pregnancy on birth weight.

Whether or not vigorous exercise during pregnancy affects birth weight is an important issue because birth weight is the single most important determinant of neonatal mortality. A current meta-analysis of randomised trials of exercise during pregnancy did not find, although also did not exclude, a clinically important effect of exercise on birth weight. Randomised trials may miss the women exercising at the most elite levels during pregnancy. We should remain open-minded on this issue until sufficient evidence is available on which to base recommendations.

Birth Weight↗
PubMed2006

Bevacizumab: a new way of doing business?

This review highlights the history of the development of treatments for choroidal neovascularization (wct AMD). It examines how drug therapies have evolved for the management of age-related macular degeneration (AMD) and the value of randomised clinical trials in determining efficacy. Finally it examines the emerging practice of utilising bevacizumab for the treatment of choroidal neovascularization despite the lack of any phase III clinical trial data.

Angiogenesis Inhibitors↗