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PubMed2004

[Still no proof of the efficacy of acupuncture in the prevention of migraine].

Besides pharmacological treatments for migraine, alternative non-pharmacological treatment strategies might be effective. In 2001, a Cochrane review concluded that acupuncture might be effective in migraine. The authors of a recent large trial also claimed that acupuncture might reduce the frequency of migraine attacks. However, this study failed to provide a clear answer due to serious methodological short-comings, for example with respect to randomisation and the clinical relevance of the main findings. In another recent, large, randomised controlled trial, the efficacy of acupuncture was not significantly different from that of the sham procedure. In conclusion, acupuncture is probably not effective in the prevention of migraine.

Acupuncture Therapy↗
PubMed1996

Cardiovascular adverse effects of antimicrobials in complex surgical cases.

Previously undescribed adverse effects of antibiotics on the cardiovascular system were described in complex surgical cases. Hypotension, bradycardia and tachycardia were seen in a randomised clinical trial, and confirmed in a randomised experiment with piglets, and in a study with isolated vascular tissue that was exposed simultaneously to antibiotics, endotoxin, and later on histamine at histamine H1-receptors. These findings may influence indications and duration for antimicrobial therapy, and support the concept of "minimal" postoperative antibiotic therapy in emergency abdominal operations.

Animals↗
PubMed2005

Art therapy for schizophrenia or schizophrenia-like illnesses.

BACKGROUND: Many people with schizophrenia or schizophrenia-like illnesses continue to experience symptoms in spite of medication. In addition to medication, creative therapies, such as art therapy, may be helpful. Art therapy allows exploration of the patient's inner world in a non-threatening way through a therapeutic relationship and the use of art materials. It was mainly developed in adult psychiatric inpatient units and was designed for use with people for whom verbal psychotherapy would be impossible. OBJECTIVES: To review the effects of art therapy as an adjunctive treatment for schizophrenia compared with standard care and other psychosocial interventions. SEARCH STRATEGY: We updated the search of the Cochrane Schizophrenia Group's Register (February 2005), hand searched reference lists and 'Inscape' (the Journal of the British Association of Art Therapists), and contacted relevant authors. SELECTION CRITERIA: We included all randomised controlled trials that compared art therapy with standard care or other psychosocial interventions for schizophrenia. DATA COLLECTION AND ANALYSIS: We reliably selected, quality assessed and extracted data from the studies. We excluded data where more than 50% of participants in any group were lost to follow up. For continuous outcomes we calculated a weighted mean difference and its 95% confidence interval. For binary outcomes we calculated a fixed effects risk ratio (RR), its 95% confidence interval (CI) and a number needed to treat (NNT). MAIN RESULTS: The search identified 61 reports but only two studies (total n=137) met the inclusion criteria. Both compared art therapy plus standard care with standard care alone. More people completed the therapy if allocated to the art therapy group compared with standard care in the short (n=90, 1 RCT, RR 0.97 CI 0.41 to 2.29), medium (n=47, 1 RCT, RR 0.34 CI 0.15 to 0.80) and long term (n=47, 1 RCT, RR 0.96 CI 0.57 to 1.60). Data from one mental state measure (SANS) showed a small but significant difference favouring the art-therapy group (n=73, 1 RCT, WMD -2.3 CI -4.10 to -0.5). In the short term, a measure of social functioning (SFS) showed no clear difference between groups in endpoint scores (n=70, 1 RCT, WMD 7.20 CI -2.53 to 16.93) and quality of life, as measured by the PerQoL, did not indicate effects of art therapy (n=74, 1 RCT, WMD 0.1 CI -2.7 to 0.47). AUTHORS' CONCLUSIONS: Randomised studies are possible in this field. Further evaluation of the use of art therapy for serious mental illnesses is needed as its benefits or harms remain unclear.

Art Therapy↗
PubMed2000

[Status of surgical studies in oncology. I].

Advances in surgery, anesthesiology and in critical care remarkably elevated safety of surgical therapy of cancer. However, prognosis of most cancer types as esophageal and gastric carcinoma--as discussed in this part of the survey--did not improve, even not after adjuvant therapy. To enhance curative resection rate chemotherapy and radiation or a combination of both have been performed preoperatively. The weakness of radiotherapy is control of distant metastases, chemotherapy failed in local tumor control. Multimodal preoperative strategies offered enhanced survival in responders, but overall there was no significant survival advantage. Until now neither in esophageal nor in gastric cancer randomised studies could demonstrate a substantial overall survival benefit after extended lymphadenectomy.

Chemotherapy, Adjuvant↗
PubMed1997

Progress in complete androgen blockade.

Complete androgen blockade (CAB) has been shown to increase the survival of patients with symptomatic advanced prostate cancer in three large well-conducted trials compared with castration alone. However, several smaller trials found no survival advantage with CAB. A recent meta-analysis of 22 trials of CAB involving over 5,000 patients showed a non-significant improvement in survival with CAB over castration, but had a number of methodological weaknesses, whereas a sensitivity analysis of published data showed a clear survival benefit. It is hoped that the results of a very large well-designed trial by the National Cancer Institute Intergroup (NCI INT-0105), in which 1,347 men have been randomised to orchidectomy plus flutamide (Eulexin, Schering-Plough International) or orchidectomy plus placebo will provide the definitive answer to this continuing controversy.

Androgen Antagonists↗
PubMed1988

A study of bleeding time in 120 long-term aspirin trial patients.

The bleeding time was measured in 120 patients participating in a longterm randomised double-blind trial of aspirin in thromboembolic prophylaxis (UK-TIA aspirin Study). In 70 patients taking aspirin 300 mg or 1,200 mg daily for a mean duration of 35 months the bleeding time averaged 228 seconds. In comparison with 30 patients randomised to placebo and not taking aspirin whose bleeding time averaged 217 seconds, there was no significant difference. Stratification of bleeding time estimation by duration of treatment suggested no significant trend in either placebo or aspirin groups over several years. These results suggest that the longterm trials of aspirin should be looked at again from the point of view of efficacy of treatment by time from randomisation.

Aged↗
PubMed1983

Variation in the use of angiography and carotid endarterectomy by neurologists in the UK-TIA aspirin trial.

Of 959 patients with complete records at entry to the UK-TIA Aspirin Trial 32% underwent angiography; for the 27 neurologists with 10 or more patients in the trial this rate varied from 3% to 100%. Seven per cent of the patients had carotid surgery; similarly the rate varied from 0% to 25% depending on the policy of the neurologist. These differences may be partly due to different perceptions of the safety and usefulness of carotid surgery. Ten of 41 (24%) patients undergoing carotid surgery after randomisation had a perioperative stroke, and four of them died.

Aged↗
PubMed2005

Intracameral tissue plasminogen activator to prevent severe fibrinous effusion after congenital cataract surgery.

BACKGROUND/AIMS: To evaluate the efficacy of intracameral recombinant tissue plasminogen activator (r-TPA) in prevention of fibrinous effusion after lensectomy, anterior vitrectomy, and posterior chamber intraocular lens (PCIOL) implantation in patients with congenital cataract. METHODS: The study was done as a double masked randomised clinical trial between April 2002 and November 2003 in Farabi Eye Hospital. 34 eyes of 26 patients with congenital cataract were included in the study and randomised into two groups (18 cases and 16 controls). Mean age was 8.1 years (3--14 years). Each eye underwent lensectomy and anterior vitrectomy with PCIOL implantation. At the end of surgery 20 microg r-TPA was injected intra-camerally in the case group. The control group received only balanced salt solution. All patients received periocular, systemic, and topical steroids after surgery. Patients underwent follow up examinations for 3 months. RESULTS: The incidence of intraocular fibrin membrane formation was significantly lower in the case group on days 1, 3, 7, 14 (p=0.02, p=0.01, p=0.01, and p=0.01, respectively, chi(2) test), but there was no significant difference on days 30 and 90. The frequency of pigmented intraocular lens precipitates was significantly lower in the case group at the end of the third month (p<0.001, chi(2) test). No gross ocular side effects were noted after r-TPA injection. CONCLUSION: It seems that prophylactic intracameral r-TPA is effective in prevention of fibrinous effusion at least in the first 2 weeks after cataract extraction in the paediatric age group and decreases the incidence of pigmented IOL precipitates.

Adolescent↗
PubMed2001

Local treatments for cutaneous warts.

BACKGROUND: Viral warts caused by the human papilloma virus represent one of the most common diseases of the skin. Any area of skin can be affected although the hands and feet are by far the commonest sites. A very wide range of local treatments are available. OBJECTIVES: To assess the effects of different local treatments for cutaneous, non-genital warts in healthy people. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (March 1999), the Skin Group trials register (March 1999), MEDLINE (1966 to August 2000), EMBASE (1980 to August 2000) and a number of other key biomedical and health economics databases. In addition the cited references of all trials identified and key review articles were searched. Pharmaceutical companies involved in local treatments for warts and experts in the field were contacted. SELECTION CRITERIA: Randomized controlled trials of local treatments for cutaneous non-genital viral warts in immunocompetent human hosts were included. DATA COLLECTION AND ANALYSIS: Study selection and assessment of methodological quality were carried out by two independent reviewers. MAIN RESULTS: Forty-nine trials were identified which fulfilled the criteria for inclusion in the review. The evidence provided by these studies was generally weak because of poor methodology and reporting. In 17 trials with placebo groups that used participants as the unit of analysis the average cure rate of placebo preparations was 30% (range 0 to 73%) after an average period of 10 weeks (range 4 to 24 weeks). The best available evidence was for simple topical treatments containing salicylic acid, which are clearly better than placebo. Data pooled from six placebo-controlled trials show a cure rate of 144/191 (75%) compared with 89/185 (48%) in controls, odds ratio 3.91 (95% confidence interval 2.40 to 6.36), random effects model. Most of the bigger trials of cryotherapy studied different regimens rather than comparing cryotherapy with other treatments or placebo. Pooled data from two small trials that included cryotherapy and placebo or no treatment, showed no significant difference in cure rates. In two other trials comparing cryotherapy with salicylic acid no significant difference in efficacy was demonstrated. There was no consistent evidence for the effectiveness of intralesional bleomycin. Four studies, using warts rather than individuals as the unit of analysis, had widely varying results which could not be meaningfully pooled. There was some evidence for the efficacy of dinitrochlorobenzene, a potent contact sensitizer. Pooled data from two small studies comparing dinitrochlorobenzene with placebo showed cure rates of 32/40 (80%) and 17/40 (43%) respectively, odds ratio 5.42 (95% confidence interval 1.99 to 14.75), random effects model. Only limited evidence was found for the efficacy of topical 5-fluorouracil, intralesional interferons and photodynamic therapy. Bleomycin, dinitrochlorobenzene, 5-fluorouracil, interferons and photodynamic therapy are potentially hazardous or toxic treatments. REVIEWER'S CONCLUSIONS: There is a considerable lack of evidence on which to base the rational use of the local treatments for common warts. The reviewed trials are highly variable in method and quality. Cure rates with placebo preparations are variable but nevertheless considerable. There is certainly evidence that simple topical treatments containing salicylic acid have a therapeutic effect. There is less evidence for the efficacy of cryotherapy and no convincing evidence that it is any more effective than simple topical treatments. Dinitrochlorobenzene appears to be effective but no more so than the safer, simpler and cheaper topical treatments containing salicylic acid. The benefits and risks of 5-fluorouracil, bleomycin, interferons and photodynamic therapy remain to be determined.

Administration, Topical↗
PubMed2002

"Why don't they just tell me straight, why allocate it?" The struggle to make sense of participating in a randomised controlled trial.

Randomised controlled trials are the acknowledged 'gold standard' method of evaluating the effectiveness of treatments, but little is known about how and why patients decide to participate in trials nor how much they understand about trial design. In this study, in-depth, semi-structured interviews were carried out with 33 middle aged and older men with lower urinary tract symptoms related to benign prostatic disease, 22 of whom had consented to participate and 11 refused to take part in a randomised trial. The trial was evaluating the effectiveness of a new technology (laser therapy) compared with standard surgery (transurethral resection of the prostate ) and conservative management (monitoring without active intervention) (the CLasP study). Purposive sampling was used to include participants from different centres, each treatment arm, and at different stages in participation, as well as those indicated to have refused participation. Interviews explored their recall and understanding of trial information, and their reasoning about how they were allocated to a treatment. Data were analysed thematically according to the methods of constant comparison, and by examining each participant's narrative of their experiences. Most participants recalled major aspects of trial design, including the involvement of chance, but the case studies showed that most also held other co-existing (and sometimes contradictory) views about their treatment allocation. The key to understanding their experiences was their engagement in a struggle to understand the trial in the context of their own beliefs, their recall of the study information and their actual experiences of the trial. The outcome of the struggle was the placing of trust in clinicians or the development of distrust. Non-participants made sense of their experiences in similar ways, but gave different reasons for non-participation than indicated by recruiters. This study shows that most eligible patients, whatever their level of knowledge, will struggle to make sense of their participation in randomised trials. The provision of clearer written information or time to discuss the trial with particular individuals might be beneficial, although greater public understanding of trials is also needed.

Aged↗
PubMed2005

Non-steroidal anti-inflammatory agents for cystoid macular oedema following cataract surgery: a systematic review.

AIM: To examine the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of cystoid macular oedema (CMO) following cataract surgery. METHODS: Systematic literature review of randomised controlled trials (RCTs) that evaluated the effects of NSAIDs in the treatment of CMO following cataract surgery was done according to the Cochrane Collaboration methodology. RESULTS: Seven trials involving a total of 266 participants were included. Four trials studied the effects of NSAIDs in chronic CMO while the other three trials examined the effect of NSAIDs in acute CMO. Little evidence of effectiveness was found for oral indomethacin and topical fenoprofen for chronic CMO in two small trials. Treatment with topical 0.5% ketorolac for chronic CMO was found to be effective in two trials. Three trials examined the effect of topical NSAIDs on acute CMO. The comparisons among these studies were of a NSAID to placebo, prednisolone or another NSAID. Because of considerable heterogeneity between these study designs, their results were not combined in a meta-analysis. CONCLUSION: A positive effect of topical NSAID (0.5% ketorolac tromethamine ophthalmic solution) on chronic CMO was noted. However, there is not enough evidence to show the effectiveness of NSAIDs in acute CMO following cataract surgery.

Acute Disease↗
PubMed2001

The Stanley Foundation Bipolar Network. I. Rationale and methods.

BACKGROUND: The Stanley Foundation Bipolar Network (SFBN) was created to address the paucity of help studies in bipolar illness. AIMS: To describe the rationale and methods of the SFBN. METHOD: The SFBN includes five core sites and a number of affiliated sites that have adopted consistent methodology for continuous longitudinal monitoring of patients. Open and controlled studies are performed as patients' symptomatology dictates. RESULTS: The reliability of SFBN raters and the validity of the rating instruments have been established. More than 500 patients are in continuous daily longitudinal follow-up. More than 125 have been randomised to one of three of the newer antidepressants (bupropion, sertraline and venlafaxine) as adjuncts in a study of mood stabilizers and 93 to omega-3 fatty acids. A number of open clinical case series have been published. CONCLUSIONS: Well-characterised patients are followed in a detailed continuous longitudinal fashion in both opportunistic case series and double-blind, randomised controlled trials with reliable and validated measures.

Antimanic Agents↗
PubMedDate not supplied

Implementing research in nurse-led care.

In response to research showing that people waiting for cardiac surgery had a high prevalence of uncorrected coronary heart disease risk factors, a nurse-led shared care scheme was developed. A randomised controlled trial of the service demonstrated significant improvements in risk factors among the intervention group. The study is used as an example of how research findings have been used to identify an area for practice development.

Cardiac Surgical Procedures↗
PubMed2006

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

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

Animals↗
PubMed2001

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

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

Administration, Cutaneous↗