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PubMed2002

Treatments for secondary postpartum haemorrhage.

BACKGROUND: Secondary postpartum haemorrhage is any abnormal or excessive bleeding from the birth canal occurring between 24 hours and 12 weeks postnatally. In developed countries, two per cent of postnatal women are admitted to hospital with this condition, half of them undergoing uterine surgical evacuation; in developing countries it is a major contributor to maternal death. OBJECTIVES: To evaluate the relative effectiveness and safety of the treatments used for secondary postpartum haemorrhage. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (May 2001), the Cochrane Controlled Trials Register (The Cochrane Library, issue 2, 2001), MEDLINE (back to 1966) and EMBASE (back to 1988). The National Research Register was also searched. The reference lists of trial reports and reviews were searched by hand. Where possible, further sources were sought from the first named authors of the papers identified. SELECTION CRITERIA: All randomised or quasi randomised comparisons between drug therapies, surgical therapies and placebo or no treatment for the management of secondary postpartum haemorrhage occurring between 24 hours and three months following a pregnancy of at least 24 weeks gestation. DATA COLLECTION AND ANALYSIS: Reports of possibly eligible studies were scrutinised by two investigators. The third investigator acted as an advisor/arbitrator. MAIN RESULTS: Of the 45 papers identified, none met the inclusion criteria. REVIEWER'S CONCLUSIONS: No information is available from randomised controlled trials to inform the management of women with secondary postpartum haemorrhage. This topic may have received little attention because it is perceived as being associated with maternal morbidity rather than mortality in developed countries; it is only recently that the extent and importance of postnatal maternal morbidity has been recognised. A well designed randomised controlled trial comparing the various drug therapies for women with secondary postpartum haemorrhage against each other and against placebo or no treatment groups is needed.

Female↗
PubMed1991

How effective is topical alpha-2b interferon in preventing recurrence of superficial bladder cancer?

A total of 44 patients with low and intermediate grade superficial urothelial bladder cancer Ta and T1 were randomised into a controlled, long-term, phase III trial on topical instillation therapy with high dose alpha-2b interferon (100 x 10(6) IU versus low dose alpha-2b interferon (10 x 10(6) IU) versus ethoglucid. Thirteen patients in the low dose group, 11 in the high dose group and 10 in the ethoglucid group completing the trial were evaluable (median follow-up 36.5 months) and were followed up for 3 years. They were treated weekly for 10 weeks and then monthly for a total of 1 year. The aim of the trial was to establish the prophylactic efficacy and the toxic side effects, if any, of alpha-2b interferon in the topical treatment of superficial bladder cancer. Recurrence rate and disease-free survival were chosen as study end-points. The recurrence rate was 4.4 in the low dose interferon group, 2.76 in the high dose interferon group and 3.08 in the ethoglucid group. In the low dose interferon group the time to the first recurrence was 22.23 months versus 22.36 in the high dose group and 21.76 months in the ethoglucid group. No differences of statistical significance were noted between the 3 groups. Progression occurred in 5 patients on interferon but was not seen in those on ethoglucid. Neither systemic nor local side effects were seen in the interferon groups, but 3 patients had to be taken off ethoglucid because of severe chemocystitis. In superficial bladder cancer, topical instillation therapy with interferon is as effective as conventional chemotherapy and has no side effects.

Administration, Intravesical↗
PubMed2003

A randomised, double-blind, placebo-controlled trial of photodynamic therapy using 5-aminolaevulinic acid for the treatment of cervical intraepithelial neoplasia.

Photodynamic therapy (PDT) using topical 5-aminolaevulinic acid (ALA) has been used to treat histologically confirmed cervical intraepithelial neoplasia (CIN-I and -I/II) in a randomised, double-blind, placebo-controlled protocol. Fluorescence microscopy revealed that topical application of 3% ALA in Intrasite Gel to the cervix for 3 hr resulted in the accumulation of protoporphyrin IX in the cervical epithelium. Treatment of CIN with ALA-PDT was well tolerated, with only 3/12 patients in the PDT arm (0/13 in the placebo arm) reporting any discomfort during illumination. Histologic examination of the treated tissue following loop excision 3 months post-PDT indicated that 33% of patients had no evidence of CIN, 42% had no change in the grade of their disease, whilst 25% exhibited an apparent progression of disease. In the control group, the respective figures were 31%, 38% and 31%. There was no significant difference in response between the groups receiving ALA-PDT and those receiving placebo treatment.

Administration, Topical↗
PubMed1986

Topical anaesthesia for venepuncture.

A topical anaesthetic cream was tested in a randomised, double blind, placebo controlled trial of 15 children. The severity of pain experienced during venepuncture was assessed, using visual analogue and verbal rating scales. The topical anaesthetic cream was found to be significantly superior to placebo using each form of assessment.

Administration, Topical↗
PubMed2005

The role of decompressive craniectomy in the management of traumatic brain injury: a critical review.

Brain swelling and intracranial hypertension following severe head injury are known to contribute to secondary brain damage, and have been shown to adversely affect patient outcome. The use of unilateral craniectomy following the evacuation of a mass lesion, such as acute subdural haematoma or traumatic intracerebral haematoma, is accepted practice. The following review focuses on a bi-fronto-temporal decompressive craniectomy, used as an isolated operation for the control of intracranial hypertension, secondary to diffuse brain swelling refractory to medical management. Though the operation is being increasingly used, current opinion is still divided regarding its overall effects on outcome. This review examines the experimental and clinical evidence for and against the use of decompressive craniectomy, highlights the lack of class I evidence relevant to this topic and emphasises the necessity for well-designed prospective randomised controlled trials.

Animals↗
PubMed2006

["Knowing--enjoying--better living". A seminar for persons with psychosis to improve their quality of life and reduce their vulnerability].

UNLABELLED: As a result of a recent paradigm change in medicine the improvement of quality of life has become a central goal of treatment next to reducing symptoms. In order to address this demand we designed a new psychoeducational program for outpatients, which -- in contrast to traditional psychoeducation -- attaches as much importance to quality of life topics as it does to illness related topics. The seminar was developed especially in view of the score resources available today. First results of the evaluation are presented. METHOD: Psychiatrists in the community are encouraged to refer patients suffering from schizophrenia or schizoaffective disorders to this psychoeducational program as an additional component to regular treatment. The program is carried out in 9 group sessions at weekly intervals with 6-8 group members. At the beginning and at the end of the seminar different objective and subjective outcomes were assessed and predictors for seminar success were identified. RESULTS: 98 participants could be included in data analysis. After completing the program the seminar participants had significantly more knowledge about the illness, a significantly better quality of life and significantly more competence and control. Furthermore there were changes in the illness concept: prejudices about medication decreased, confidence in medication increased, and beliefs about susceptibility to illness and to relapse increased. CONCLUSIONS: First experiences with a psychoeducational seminar for persons with psychosis, putting equal stress on disease related and quality of life topics are encouraging, but require further confirmation through a randomised controlled trial.

Activities of Daily Living↗
PubMed1997

A randomised, prospective, double-blind, placebo-controlled trial of glyceryl trinitrate ointment in treatment of anal fissure.

BACKGROUND: Anal fissure is most commonly treated surgically by internal anal sphincterotomy. However, there is some concern over the effects of this procedure on continence. Nitric oxide donors such as glyceryl trinitrate (GTN) have been shown to cause a reversible chemical sphincterotomy capable of healing fissures in a small series of cases. This study reports a prospective, randomised, double-blind, placebo-controlled trial to test the hypothesis that topical GTN is the best first-line treatment for chronic anal fissure. METHODS: 80 consecutive patients were randomised to receive treatments with topical 0.2% GTN ointment or placebo. Maximum anal resting pressure (MARP) was measured with a constantly perfused side-hole catheter before and after the first application of trial ointment. Anodermal blood flow was measured during manometry by laser Doppler flowmetry. After initial treatments, patients were given a supply of ointment (either GTN or placebo) to be applied to the lower anal canal twice daily. Patients were reviewed 2-weekly. At the initial and follow up visits patients were asked to record pain experienced on defaecation on a linear analogue pain score. Endpoints were healing of the fissure or condition after 8 weeks of treatment. FINDINGS: After 8 weeks, healing was observed in 26/38 (68%) patients treated with GTN and in 3/39 (8%) patients treated with placebo (p < 0.0001, chi 2 test). Linear analogue pain score fell significantly in both groups after 2 weeks of treatment. This fall was maintained in those treated with GTN but pain scores returned to pre-treatment values by 4 weeks on treatment with placebo. MARP fell significantly from a mean of 115.9 (SD 31.6) to 75.9 (30.1) cm H2O (p < 0.001, Student's paired t-test) in patients treated with GTN but no change was seen in MARP after placebo. Anodermal blood flow measured by laser Doppler flowmetry significantly increased after application of GTN ointment but was unaffected by placebo. INTERPRETATION: Topical GTN provides rapid, sustained relief of pain in patients with anal fissure. Over two-thirds of patients treated in this way avoided surgery which would otherwise have been required for healing. Long-term follow up is needed to assess the risk of recurrent fissure in patients with GTN.

Administration, Topical↗
PubMed2005

A randomised, placebo controlled clinical trial of the aldose reductase inhibitor CT-112 as management of corneal epithelial disorders in diabetic patients.

AIM: To evaluate the efficacy of topical aldose reductase inhibitor CT-112 (5-[3-ethoxy-4-pentyloxyphenyl]-2,4-thiazolidinedione) on corneal epithelial barrier function in diabetic patients. METHODS: This was a prospective, randomised, double masked placebo controlled study. 34 eyes of 34 diabetic patients were randomly assigned treatment with 0.25% eye drops of CT-112 (n = 22) or a placebo (n = 12) four times a day for 8 weeks. Corneal fluorescein staining and corneal sensation were examined before treatment as well as 4 and 8 weeks after administration. Corneal epithelial permeability to fluorescence was measured with an anterior fluorophotometer. RESULTS: Average scores of superficial punctate keratopathy and corneal sensitivity did not differ significantly between the two groups at any time. Whereas average fluorescein concentrations did not differ significantly for the CT-112 and placebo groups before treatment, they did differ significantly 4 and 8 weeks after treatment (4 weeks, p = 0.0327; 8 weeks, p = 0.0143). CONCLUSION: The topical aldose reductase inhibitor, CT-112 improves the corneal epithelial barrier function in diabetic patients.

Aged↗
PubMed2001

Psychological aspects of breast reconstruction: a review of the literature.

AIM: This paper critically examines the research literature relating to the psychological aspects of breast reconstruction. Particular attention is given to the role of specialist breast care nurses in supporting women faced with the decision of whether or not to opt for reconstructive surgery. BACKGROUND: Breast reconstruction is intended to offer psychological benefits (e.g. improvements to quality of life, body image, anxiety and depression) to women treated by mastectomy following diagnosis of breast cancer. METHODS: A literature search was carried out on the PSYCHINFO, MEDLINE and CINAHL databases using the terms "breast reconstruction", "mastectomy", "reconstructive surgery", "breast surgery", "breast implants", "transverse rectus adominis myocutaneous (TRAM) flap" and "Lat-dorsi". Further relevant articles were identified from the reference lists of papers detected by this literature search. Finally, proceedings of recent psychological and surgical meetings were scrutinized to identify any conference papers on this topic. FINDINGS: A thorough search of the existing literature revealed a lack of theoretically based studies examining breast reconstruction in terms of relevant psychological constructs, especially in relation to coping and decision-making. This review highlights the methodological flaws with much of the existing research in this area, in particular the reliance upon retrospective designs and the inappropriate use of randomised controlled trials. Suggestions are given for further research in this topical area. CONCLUSIONS: Existing research into the psychological aspects of breast reconstruction is limited and not sufficiently conclusive to inform changes to policy and the provision of care. More methodologically rigorous research is needed.

Adaptation, Psychological↗
PubMed2000

Nasal decongestants for the common cold.

BACKGROUND: The common cold is a major and recurrent cause of morbidity, affecting children and adults two or more times each year. Nasal congestion is its commonest symptom, and many therapies are marketed for its relief. There is no meta-analysis of controlled clinical trials on the effects of nasal decongestants for the common cold. OBJECTIVES: To assess the efficacy of nasal decongestants at reducing the symptom of nasal congestion in adults and children with the common cold and to identify possible adverse effects associated with their use. SEARCH STRATEGY: MEDLINE, EMBASE and Current Contents were searched up to May 1999. Searching the Cochrane Acute Respiratory Infections Group's trials register, following the review citation trail from other references and contacting known principal investigators and pharmaceutical companies was also done. SELECTION CRITERIA: Randomised, placebo controlled trials of single-active oral and topical nasal decongestants in adults and children suffering from the common cold. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two reviewers (DT and LB). All outcomes variables were continuous. Subjective outcomes were normalised to a common scale and a weighted mean difference (WMD) was calculated. A standardised mean difference (SMD) was calculated for the objective outcomes. MAIN RESULTS: Four studies in adults, but none in children, fitted all inclusion criteria. There was a significant 13% decrease in subjective symptoms after decongestant compared with placebo. This was supported by a significant decrease in nasal airways resistance. Repeated doses of nasal decongestant were not significantly better than placebo at relieving symptoms of nasal congestion. REVIEWER'S CONCLUSIONS: A single dose of nasal decongestant in the common cold is moderately effective for the short term relief of congestion in adults, while there is no evidence available to show benefit after repeated use over several days. These medications are not recommended for use in young children with the common cold.

Adult↗
PubMed1985

Failure of acyclovir cream in treatment of recurrent herpes labialis.

A double blind, randomised, crossover placebo controlled trial of 5% acyclovir cream, applied topically five times a day for five days, was carried out in 45 patients with recurrent herpes labialis. These patients had a total of 72 episodes, 34 of which were treated with the 5% acyclovir cream and 38 with placebo cream. Treatment was begun by the patients as soon as possible after the onset of prodromal symptoms. There was no significant clinical benefit from treatment with acyclovir cream compared with placebo cream. The median healing times were nine days with acyclovir cream, 10 days with placebo cream, and 13 days when no treatment was given. The possibility that the 40% propylene glycol cream base alone has a therapeutic effect must therefore be considered.

Acyclovir↗
PubMed2006

Personally addressed hand-signed letters increase questionnaire response: a meta-analysis of randomised controlled trials.

BACKGROUND: Postal questionnaires are commonly used to collect data for health studies, but non-response reduces study sample sizes and can introduce bias. Finding ways to increase the proportion of questionnaires returned would improve research quality. We sought to quantify the effect on response when researchers address participants personally by name on letters that accompany questionnaires. METHODS: All randomised controlled trials in a published systematic review that evaluated the effect on response of including participants' names on letters that accompany questionnaires were included. Odds ratios for response were pooled in a random effects meta-analysis and evidence for changes in effects over time was assessed using random effects meta-regression. RESULTS: Fourteen randomised controlled trials were included covering a wide range of topics. Most topics were unrelated to health or social care. The odds of response when including participants' names on letters were increased by one-fifth (pooled OR 1.18, 95% CI 1.03 to 1.34; p = 0.015). When participants' names and hand-written signatures were used in combination, the effect was a more substantial increase in response (OR 1.45, 95% CI 1.27 to 1.66; p < 0.001), corresponding to an absolute increase in the proportion of questionnaires returned of between 4% and 10%, depending on the baseline response rate. There was no evidence that the magnitude of these effects had declined over time. CONCLUSION: This meta-analysis of the best available evidence indicates that researchers using postal questionnaires can increase response by addressing participants by name on cover letters. The effect appears to be enhanced by including hand-written signatures.

Communication↗