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PubMed1990

[How to evaluate the long-term course of osteoarthritis. Tests for trials of fundamental treatments (spine excluded)].

The best assessment tests for long term trials on osteoarthritis (OA) of the hip and knee are the following, in order of relevance value (consensus of french experts): 1) the loss of joint space thickness on successive radiographies; 2, 3) the indices of the severity for OA of the hip and knee; the investigator's overall opinion; 4) the patient's overall opinion (visual analogue scale of handicap); 5, 6, 7) the pain level (visual analogue scale); the time for going up and down a standard flight of stairs and the time of pain in this distance; the limitation of two articular movements; 8) the increase of either analgesics or NSAIDs consumption; 9) concerning OA of fingers, the number of joints newly involved on successive radiographies. At present, only the radiological tests 1 and 9 are validated. The clinical tests 2 to 8, valuable for short term trials, have yet to be validated for long term follow-up. Recommended duration of trials is three years. A rigorous organisation is necessary to avoid erroneous inclusions: all data recorded in the pre-inclusion visit have to be checked by the principal investigator. Since we have not yet a validated chondroprotective agent as a reference drug, the trial must be randomised, double blind, placebo controlled, parallel group study.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2004

Red clover isoflavones and menopausal health.

Menopausal symptoms such as hot flushes and night sweats can be very disrupting. While hormone replacement therapy is an effective therapy, concerns about side effects and breast cancer risk have stimulated interest into alternative therapies such as phytoestrogens. These are oestrogen-like compounds made by plants. Two major sources of phytoestrogens are soy and red clover. Data on randomised controlled trials of red clover for the control of menopausal symptoms are presented. The conflicting data are encouraging and suggest that phytoestrogens are a treatment modality that needs pursuing.

Female↗
PubMed2006

Women's experience of decision making about mode of delivery after a previous caesarean section: the role of health professionals and information about health risks.

OBJECTIVE: To explore women's experiences of decision making about mode of delivery after previous caesarean section. DESIGN: A qualitative interview study. SETTING: Two city maternity units in southwest England and Eastern Scotland. SAMPLE: Twenty-one women who had recently delivered a baby and whose previous child was delivered by caesarean section. METHODS: Semi-structured interviews analysed using the framework approach. MAIN OUTCOME MEASURES: Women's views on the influence of uncertainty on decision making, issues concerning information provision and decision-making roles. RESULTS: Experiences of decision making varied considerably. Some women were certain about choosing either vaginal birth after caesarean or repeat elective caesarean section, others were very uncertain and for some this uncertainty persisted after the birth. Information was most commonly provided by hospital doctors (mainly consultants) and more often related to procedural issues rather than possible health risks and benefits. Women felt they had to actively seek information rather than it being provided routinely. Most women were able to make their own decision about mode of delivery. Health professionals generally took a supportive role whichever mode of delivery was chosen. Although many women were comfortable with this approach, some felt they would have liked more guidance. CONCLUSION: On the whole, women experienced having control over the decision about planned mode of delivery. For many, making this decision was difficult and for some it was the cause of prolonged anxiety. Women were often making the decision without being provided with comprehensive and specific information about possible health risks and benefits. We are currently conducting a randomised controlled trial to investigate whether access to a decision aid is beneficial to women in this situation.

Adult↗
PubMed1995

Detecting differences in quality of care: the sensitivity of measures of process and outcome in treating acute myocardial infarction.

The merits or otherwise of publishing hospital specific death rates are much debated. This article compares the relative sensitivity of measures of process and outcome to differences in quality of care for the hospital treatment of myocardial infarction. Aspects of hospital care that have a proved impact on mortality from myocardial infarction are identified, and the results from meta-analysis and large randomised controlled trials are used to estimate the impact that optimal use of these interventions would have on mortality in a typical district general hospital. Sample size calculations are then performed to determine how many years of data would be needed to detect significant differences between hospitals. A comparison is then made with the amount of data that would be needed to detect significant differences if information about process of care was being collected. Process measures based on the results of randomised controlled trials were found to be able to detect relevant differences between hospitals that would not be identified by comparing hospital specific mortality, which is an insensitive indicator of the quality of care.

Hospital Mortality↗
PubMed2006

Aiming to increase birth weight: a randomised trial of pre-pregnancy information, advice and counselling in inner-urban Melbourne.

BACKGROUND: In the 1980s there was substantial interest in early pregnancy and pre-pregnancy interventions to increase birth weight and reduce preterm birth. We developed an inter-pregnancy intervention, implemented in a randomised controlled trial, to be provided by midwives at home soon after women's first birth. METHODS: MCH nurses invited women to take part during their home visit to new mothers. Women's contact details, with their permission, were passed to the study midwife. She had a randomisation schedule to which women's names were added before she met the women or their partners. All women recruited had a home visit from the study midwife with a discussion of their first pregnancy, labour and birth and the postpartum experience. Women in the intervention arm received in addition a pre-pregnancy intervention with discussion of social, health or lifestyle problems, preparation and timing for pregnancy, family history, rubella immunisation, referrals for health problems, and a reminder card. The primary outcome was defined as a birth weight difference in the second birth of 100 g (one-sided) in favour of the intervention. Additional data collected were gestational age, perinatal deaths and birth defects. Analyses used EPI-INFO and STATA. RESULTS: Intervention and comparison groups were comparable on socioeconomic factors, prior reproductive history and first birth outcomes. Infant birth weight in the second birth was lower (-97.4 g,)) among infants in the intervention arm. There were no significant differences between intervention and comparison arms in the proportion of women having a preterm birth, an infant with low birthweight, or an infant with a birth weight <10th percentile. There were more adverse outcomes in the intervention arm: ten births <32 weeks), compared with one in standard care, and more infants with a birth weight <2000 g, 16 compared with two in standard care CONCLUSION: As the primary outcome was envisaged to be either improved birth weight or no effect, the study was not designed to identify the alternative outcome with confidence. Despite widespread support for pre-pregnancy interventions to improve maternal and perinatal health, this first randomised controlled trial of a multi-component intervention provided at home, did not have a beneficial outcome.

Adult↗
PubMed1999

Topical imiquimod: a review of its use in genital warts.

UNLABELLED: Imiquimod is a topically active immunomodulatory agent that is formulated as a 5% cream for application by the patient. It is the first agent of its class, the immune response modifiers, to be used in the treatment of genital warts. In immunocompetent patients with genital warts, imiquimod stimulates the production of interferon-alpha and various other cytokines, and has indirect antiviral activity. In randomised, double-blind, vehicle-controlled clinical trials, complete clearance of warts occurred in 37 to 50% of immunocompetent patients with genital warts treated with imiquimod 5% cream 3 times a week for up to 16 weeks; partial clearance of warts (defined as a reduction in wart area of > or = 50%) was observed in 76% of recipients of imiquimod 5% cream. Rates of complete or partial clearance of warts were significantly higher in patients who applied imiquimod 5% cream 3 times a week than in recipients of imiquimod 1% or vehicle cream, each applied 3 times a week. A between-gender difference in clinical response to imiquimod 5% cream has been reported, with female patients experiencing higher rates of complete clearance of warts than males. Recurrence(s) of > or = 1 wart occurred in 13 to 19% of immunocompetent patients in whom complete clearance of warts had been achieved with imiquimod 5% cream. Imiquimod 5% cream also shows some clearance of warts in immunosuppressed HIV-infected patients with genital warts. Preliminary results of a vehicle-controlled study showed that the rate of partial clearance of warts (defined as a reduction in baseline wart area of >50%) [38%] was significantly higher with imiquimod 5% cream than with vehicle cream; however, the rate of complete clearance was not significantly higher than with vehicle cream. Imiquimod 5% cream is generally well tolerated by immunocompetent and HIV-infected patients. Local skin reactions (mainly mild or moderate), including erythema, itching and burning, are the most commonly reported adverse events, occurring in < or = 67% of patients applying imiquimod 5% cream 3 times a week. The incidence of adverse events is lower in patients applying the cream 3 times a week than with daily application. The incidence of systemic adverse events with imiquimod 5% cream (applied daily or 3 times a week) is similar to that of vehicle cream. The tolerability profile of imiquimod cream appears favourable compared with that of podophyllotoxin. CONCLUSION: Imiquimod 5% cream is a new therapeutic option for patients with genital warts. It produces clearance rates broadly similar to those of other treatment approaches and rates of wart recurrence compare favourably with those reported for established treatments. In contrast to most alternative treatment strategies. which are administered in the physician's office, imiquimod cream is a self-administered therapy for outpatient use.

Adjuvants, Immunologic↗
PubMed2004

Pregabalin: in the treatment of painful diabetic peripheral neuropathy.

Pregabalin, the pharmacologically active S-enantiomer of 3-aminomethyl-5-methyl-hexanoic acid, has a similar pharmacological profile to that of its developmental predecessor gabapentin, but showed greater analgesic activity in rodent models of neuropathic pain. The exact mechanism of action of pregabalin is unclear, although it may reduce excitatory neurotransmitter release by binding to the alpha2-delta protein subunit of voltage-gated calcium channels. Oral pregabalin at fixed dosages of 300 and 600 mg/day, administered three times daily, was superior to placebo in relieving pain and improving pain-related sleep interference in three randomised, double-blind, multicentre studies of 5-8 weeks' duration in a total of 724 evaluable patients with painful diabetic peripheral neuropathy (DPN). Significant reductions in weekly mean pain scores (primary endpoint) and sleep interference scores were observed at 1 week and sustained thereafter. A significant reduction in pain was apparent on the first day of treatment with pregabalin 300 mg/day. Twice daily fixed (600 mg/day) or flexible (150-600 mg/day) pregabalin was also effective in reducing pain and sleep interference in two 12-week placebo-controlled trials in a total of 733 randomised DPN patients. Pregabalin was well tolerated in DPN patients; mild-to-moderate dizziness, somnolence and peripheral oedema were the most common adverse events.

Analgesics, Non-Narcotic↗
PubMed2001

The CRASH trial: the first large-scale, randomised, controlled trial in head injury.

The global epidemic of head injuries is just beginning. Many are caused by road traffic crashes. It is estimated that, by 2020, road traffic crashes will have moved from its present position of ninth to third in the world disease burden ranking, as measured in disability adjusted life years. In developing countries, it will have moved to second. The Corticosteroid Randomisation After Significant Head Injury (CRASH) trial is a large-scale, randomised, controlled trial, among adults with head injury and impaired consciousness, of the effects of a short-term infusion of corticosteroids on death and on neurological disability. Following a successful pilot phase, which included over 1000 randomised participants, the main phase of the trial is now underway. Over the next 5 years, the trial aims to recruit a total of 20,000 patients. Such large numbers will only be possible if hundreds of doctors and nurses can collaborate in emergency departments all over the world. The trial is currently recruiting, and new collaborators are welcome to join the trial (see www.crash.lshtm.ac.uk).

Accidents, Traffic↗
PubMed2004

Advanced trauma life support training for hospital staff.

BACKGROUND: Injury is responsible for an increasing global burden of death and disability. As a result, new models of trauma care have been developed. Many of these, though initially developed in high-income countries, are now being adopted in low and middle-income countries (LMICs). One such trauma care model is advanced trauma life support (ATLS) training in hospitals, which is being promoted in LMICs as a strategy for improving outcomes for victims of trauma. However, the evidence of effectiveness for this health service intervention, in either HIC or LMIC settings, has not been rigorously tested using methodology such as a systematic review. OBJECTIVES: To quantify the effectiveness of hospitals with an ATLS-trained trauma response system versus hospitals without such a response system in reducing mortality and morbidity following trauma. SEARCH STRATEGY: We searched the Cochrane Injuries Group Specialised Register (CIGSR), the Cochrane Controlled Trials Register (CCTR), MEDLINE & PubMed, EMBASE, CINAHL, Science Citation Index, National Research Register, and web-based trials databases such as Current Controlled Trials. We checked references of background papers and contacted authors to identify additional published or unpublished data. SELECTION CRITERIA: Randomised controlled trials, controlled trials, controlled before- and- after studies comparing effectiveness of hospitals with an ATLS-trained trauma response system versus hospitals without such a response system in reducing mortality and morbidity following trauma. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied eligibility criteria to trial reports for inclusion and to extract data. MAIN RESULTS: There is a limited literature relating to this topic but none of the studies identified met the inclusion criteria for this review. REVIEWERS' CONCLUSIONS: There is no clear evidence that ATLS training (or similar) impacts on the outcome for victims of trauma, although there is some evidence that educational initiatives improve knowledge of what to do in emergency situations. Further, there is no evidence that trauma management systems incorporating ATLS training impact positively on outcome. Future research should concentrate on the evaluation of trauma systems incorporating ATLS, both within hospitals and at the health system level, by using rigorous research designs.

Emergency Medical Services↗
PubMed2005

Comparative study of the efficacy of eprinomectin versus ivermectin, and field efficacy of eprinomectin only, for the treatment of chorioptic mange in alpacas.

The efficacy of eprinomectin versus ivermectin (Study 1: a single-centre, randomised, treatment-controlled, blinded field trial), and the field efficacy of eprinomectin (Study 2: a single-centre, open, un-controlled field trial) for the treatment of chorioptic infestation in naturally infested alpacas were assessed in two studies. Thirty alpacas, all positive for Chorioptes sp. mite, were randomly allocated to two treatment groups in Study 1. Group A received a single topical administration of a 0.5% formulation of eprinomectin at the dose rate of 500mug/kg. Group B received three subcutaneous administrations at 14 days interval of a 1% formulation of ivermectin at the dose rate of 400mug/kg. Response to treatment was assessed by periodic mite count, and skin lesions scored. In Study 2, one group of 19 alpacas received four administrations at weekly interval of topical eprinomectin at the dose rate of 500mug/kg, and response to treatment was monitored by mite counts. No localised or systemic side effects were observed in either trial. There was a statistically significant decrease in mite counts on day 7 (P<0.001) within treatment Groups A and B of Study 1, but mite counts increased again on day 14 and remained high for the duration of the trial in both treatment groups. On day 14 of Study 2, there was a statistically significant reduction in mite counts (P<0.008) and the mite counts remained very low throughout the remainder of the study. The eprinomectin protocol employed in Study 2, consisting of four weekly topical administrations at the dose rate of 500mug/kg of body weight, proved highly effective at reducing the Chorioptes mite burden in alpacas.

Administration, Cutaneous↗
PubMed1988

Randomized clinical trial with alpha 2b-interferon in 26 stage A untreated B-chronic lymphocytic leukemia patients.

In a previous study we obtained a 50% response rate with alpha 2b Interferon in the first stages of chronic lymphocytic leukaemia. We have performed a second study randomizing 34 stage A patients, who were receiving no other treatment (8 non-treated controls and 26 patients who had been treated with 3 modalities). We obtained 17 responses (67%) with one complete haematological response (4%), 9 incomplete (34%) and 7 minor (37%). No bone marrow changes were noted after this treatment but there was a decrease in the lymph nodes or the spleen seen on three occasions. In a new randomised study we have studied the effects of the small doses of Interferon associated with chemotherapy.

Adult↗
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↗
PubMed2005

[Chemoradiotherapy and anal canal cancer].

Local control and sphincter preservation are the two challenges of anal canal cancer treatment. These tumors are radio- and chemo-sensitive and treatment moved from surgical approach, with abdominoperineal resection, to definitive radiation therapy with or without concurrent chemotherapy. Randomised trials proved the benefit of combined modality with chemoradiotherapy and of mitomycine C (MMC) compared with radiotherapy alone, with a toxic death rate of about 2%. Indications of chemoradiotherapy are locally advanced tumor T2 > or = 4 cm, T3-4 or N1-3 but the best modalities of combined treatment are still under debate. Standard chemotherapy is 5 flurouracile (5FU) + MMC, but cisplatinum (CDDP) is an effective and well tolerated substitute for MMC. Favourable results with CDDP-containing regimen in term of toxicity and carcinologic control have been reported in phase II and retrospective studies. Total radiation dose, overall duration of radiation therapy, duration of the gap and indications of additional boost are not clear, but it is demonstrated that overall duration of treatment should be as short as possible to improve the therapeutic radio. Phase II and III studies are ongoing, to evaluate the best chemotherapy regimen between 5FU+MMC and 5FU+CDDP, the benefit of neoadjuvant or maintenance chemotherapy and the interest of increased total dose. Next future could be the utilisation of oral 5FU. This article is a review of past randomised trials, phases II and retrospective study on radiochemotherapy of anal canal carcinoma.

Antineoplastic Combined Chemotherapy Protocols↗