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At least 595 records · Page 33Linked to original sources
PubMed2005

Efficacy of Rhizophora mangle aqueous bark extract (RMABE) in the treatment of aphthous ulcers: a pilot study.

OBJECTIVE: Rhizophora mangle aqueous bark extract (RMABE) (CIKRON-H), has been used as antiseptic and skin wound healing promoter. The present study was a randomised, single-blinded, placebo control trial conducted to asses the efficacy of RMABE in treating oral aphthous ulcers. RESEARCH DESIGN AND METHODS: Patients (n = 32) with aphthous ulcers were randomised to received placebo solution or RMABE topically, once a day, from Monday to Friday, until they healed. The efficacy of the treatment was evaluated by physician clinical observations (time to heal, change in condition), the quality of the patient's life and the tolerability through recording adverse effects. RESULTS: No demographic differences were noted between the two groups at base-line. Seven days after treatment, 12 of the 17 patients in the RMABE group (71%) were completely healed of their aphthous ulcers, with repaired mucosa and no symptoms of ulcers, compared with one in 15 patients in the placebo group (7%) (p < 0.0001). The time taken for the signs and symptoms of ulcers to diminish was also higher in the placebo than in RMABE-treatment group (erythema: placebo 10.54 +/- 1.24, RMABE 4.94 +/- 0.72 days, p = 0.0003; ardour: placebo 7.00 +/- 0.76, RMABE 2.93 +/- 0.49 days, p = 0.0001; and pain: placebo 7.43 +/- 1.21, RMABE 2.92 +/- 0.23 days, p = 0.0011). No subject showed any sign of adverse effects. CONCLUSIONS: These observations demonstrate that the R. mangle aqueous bark extract reduced the time to repair mucosal tissue, erythema, ardour and pain persistence. There was no evidence any adverse effects. This is the first time that the R. mangle extract has been reported to have mouth mucosa healing properties.

Adult↗
PubMed2000

Topical treatment for vaginal candidiasis in pregnancy.

BACKGROUND: Vaginal candidiasis (moniliasis or thrush) is a common and frequently distressing infection for many women. It is even more common in pregnancy. OBJECTIVES: The objective of this review was to assess the effects of different methods of treating vaginal candidiasis in pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register. In addition, the Cochrane Controlled Trials Register (CENTRAL/CCTR) was searched. Date of last search: April 1999. SELECTION CRITERIA: Randomised trials of any treatment for vaginal candidiasis in pregnancy. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and extracted data. MAIN RESULTS: Twelve trials were included. Based on five trials, imidazole drugs were more effective than nystatin when treating vaginal candidiasis in pregnancy (odds ratio 0.21, 95% confidence interval 0.16 to 0.29). Nystatin,in turn was more effective than hydrargaphen in one trial.A trial of clotrimazole was more effective than placebo (odds ratio 0.14, 95% confidence interval 0.06 to 0.31). Single dose treatment was less effective than three or four days treatment when assessed by culture and by symptoms in three different trials and treatment lasting for four days was less effective than treatment for seven days (odds ratio 10.6, 95% confidence interval 4.01 to 28.05). Based on two trials, treatment for seven days was no more or less effective than treatment for 14 days (odds ratio 0.41, 95% confidence interval 0.16 to 1.05). REVIEWER'S CONCLUSIONS: Topical imidazole appears to be more effective than nystatin for treating symptomatic vaginal candidiasis in pregnancy. Treatments for seven days may be necessary.

Administration, Topical↗
PubMed1990

Calcium antagonists in the management of subarachnoid haemorrhage.

The development of delayed cerebral ischaemia and hence neurological deficit remains a serious problem following subarachnoid haemorrhage. Over recent years, attention has focussed on the use of the dihydropyridine class of calcium channel blocking agents ("calcium antagonists"), in particular nimodipine, as drug therapy in the prophylaxis and treatment of this condition. The theoretical basis for this is briefly discussed and then the clinical experience of the use of calcium antagonists following subarachnoid haemorrhage reviewed. In particular, attention is focussed on the randomised controlled trials that have eventually been able to show that such treatment is beneficial, both in terms of reduction of ischaemic deficit attributable to cerebral "vasospasm" and in clinical outcome, when given prophylactically, although not apparently therapeutically once deficit has developed. The evidence of the mode of action of calcium antagonists in this situation is discussed, again with particular reference to clinical data obtained in situ in the course of such trials. Although the mechanism of action remains unclear, it appears likely that it is at least in part due to the selective cerebral vasodilation induced by these compounds. The necessity for large well-controlled, prospective, randomised clinical trials in the assessment of therapeutic efficacy is stressed.

Brain Ischemia↗
PubMed1995

Adjuvant intravesical mitoxantrone after transurethral resection of primary superficial transitional cell carcinoma of the bladder. A prospective randomised study.

A prospective randomised controlled clinical trial began in 1989 on 126 patients with superficial transitional cell carcinoma of the bladder (pTa-pT1, grades 1-3) to compare the efficacy of adjuvant topical mitoxantrone after transurethral resection versus no further treatment. 62 patients received no further treatment, 64 patients received weekly 20 mg mitoxantrone intravesically for 6 weeks after differentiated TUR of all visible tumours. The endpoint of the study was any progression of stage or grade or further recurrences. The median follow up was 29 months--the minimum follow up was 24 months. The percentage of recurrences (25.8 versus 23.4), the recurrence rate (1.2 versus 0.9), the overall disease free interval and the tumour progression rate showed no statistically significant differences (P > 0.05 Mantel-Cox test). Only the comparison of time to recurrence in tumours with recurrences showed a statistically significant difference, with a longer disease free interval for the TUR plus mitoxantrone group (P = 0.016 Mantel-Cox test).

Administration, Intravesical↗
PubMed2003

The potential of nitric oxide therapeutics in stroke.

The therapeutic modulation of the nitric oxide (NO) system has generated considerable interest as a new way for managing many disease processes. In stroke, a useful strategy is to increase NO availability and thereby exploit its beneficial antiplatelet, antiatherosclerotic, haemodynamic and neuroprotective properties. Pharmacologically, this can be achieved by providing NO substrate, using NO donors or by upregulating nitric oxide synthase. Alternatively, one can reduce NO availability by inhibiting NO synthase and thereby limiting its pro-inflammatory and neurotoxic properties. This article reviews developments in NO-related therapeutics for treatment of stroke, with a particular emphasis on compounds that are in the clinical research and development pipeline. Although the routine use of NO therapeutics for the prevention or treatment of stroke cannot currently be recommended, we are evidently at an exciting stage in their pharmacological development. Definitive randomised controlled trials in stroke patients are required as a matter of urgency.

Clinical Trials as Topic↗
PubMed2005

Poststroke aphasia : epidemiology, pathophysiology and treatment.

Aphasia, the loss or impairment of language caused by brain damage, is one of the most devastating cognitive impairments of stroke. Aphasia is present in 21-38% of acute stroke patients and is associated with high short- and long-term morbidity, mortality and expenditure. Recovery from aphasia is possible even in severe cases. While speech-language therapy remains the mainstay treatment of aphasia, the effectiveness of conventional therapies has not been conclusively proved. This has motivated attempts to integrate knowledge from several domains in an effort to plan more rational therapies and to introduce other therapeutic strategies, including the use of intensive language therapy and pharmacological agents. Several placebo-controlled trials suggest that piracetam is effective in recovery from aphasia when started soon after the stroke, but its efficacy vanishes in patients with chronic aphasia. Drugs acting on catecholamine systems (bromocriptine, dexamfetamine) have shown varying degrees of efficacy in case series, open-label studies and placebo-controlled trials. Bromocriptine is useful in acute and chronic aphasias, but its beneficial action appears restricted to nonfluent aphasias with reduced initiation of spontaneous verbal messages. Dexamfetamine improves language function in subacute aphasia and the beneficial effect is maintained in the long term, but its use is restricted to highly selected samples. Pharmacological agents operating on the cholinergic system (e.g. donepezil) have shown promise. Data from single-case studies, case series and an open-label study suggest that donepezil may have beneficial effects on chronic poststroke aphasia. Preliminary evidence suggests that donepezil is well tolerated and its efficacy is maintained in the long term. Randomised controlled trials of donepezil and other cholinergic agents in poststroke aphasia are warranted.

Adult↗
PubMedDate not supplied

[Critical assessment of articles on controlled clinical trials. I. Planning].

This is the first of two articles concerning the techniques of critical appraisal of controlled clinical trials. It presents an overview of the delicate points of the following issues: operational questions; definition of primary and secondary variables, classification of the trial as pragmatic or explanatory, selection of the population sample, study design and its appropriateness to the goals, sample size and overall statistical analysis. Particular attention is given to the value of randomisation and blinding for the prevention of bias.

Bias↗
PubMed2002

Efficacy of N-acetylcarnosine in the treatment of cataracts.

PURPOSE: To evaluate the effects of 1% N-acetylcarnosine (NAC) solution on lens clarity over 6 and 24 months in patients with cataracts. TRIAL DESIGN: Randomised, placebo-controlled study. PARTICIPANTS: 49 subjects (76 affected eyes) with an average age of 65.3 +/- 7.0 years with a diagnosis of senile cataract with minimum to advanced opacification in various lens layers. METHODS: 26 patients (41 eyes) were allocated to topical NAC 1% eyedrops twice daily. The control group consisted of 13 patients (21 eyes) who received placebo eyedrops and 10 patients (14 eyes) who did not receive eyedrops. MAIN OUTCOME MEASURES: All patients were evaluated at entry and followed up every 2 months for a 6-month period (trial 1), or at 6-month intervals for a 2-year period (trial 2), for best-corrected visual acuity and glare testing. In addition, cataract was measured using stereocinematographic slit-images and retro-illumination examination of the lens. Digital analysis of lens images displayed light scattering and absorbing centres in two- and three-dimensional scales. RESULTS: The overall intra-reader reproducibility of cataract measurements (image analysis) was 0.830, and glare testing 0.998. After 6 months, 90% of NAC-treated eyes showed improvement in best corrected visual acuity (7 to 100%) and 88.9% showed a 27 to 100% improvement in glare sensitivity. Topographic studies indicated fewer areas of posterior subcapsular lens opacity and 41.5% of treated eyes had improvement in image analysis characteristics. The overall ratios of image analysis characteristics at 6 months compared with baseline measures were 1.04 and 0.86 for the control and NAC-treated group, respectively (p < 0.001). The apparent benefits of treatment were sustained after 24 months' treatment. No treated eyes demonstrated worsening of vision. The overall visual outcome in the control group showed significant worsening after 24 months in comparison with both baseline and the 6-month follow-up examination. The overall clinical results observed in the NAC-treated group by the 24-month period of examination differed significantly (p < 0.001) from the control group in the eyes with cortical, posterior subcapsular, nuclear or combined lens opacities. Tolerability of NAC eyedrops was good in almost all patients, with no reports of ocular or systemic adverse effects. CONCLUSION: Topical NAC shows potential for the treatment and prevention of cataracts.

Aged↗
PubMed2001

Interventions for promoting smoke alarm ownership and function.

BACKGROUND: Residential fires caused at least 67 deaths and 2,500 non-fatal injuries to children aged 0-16 in the United Kingdom in 1998. Smoke alarm ownership is associated with a reduced risk of residential fire death. OBJECTIVES: We evaluated interventions to promote residential smoke alarms, to assess their effect on smoke alarm ownership, smoke alarm function, fires and burns and other fire-related injuries. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Cochrane Injuries Group database, MEDLINE, EMBASE, PsycLIT, CINAHL, ERIC, Dissertation Abstracts, International Bibliography of Social Sciences, ISTP, FIREDOC and LRC. Conference proceedings, published case studies, and bibliographies were systematically searched, and investigators and relevant organisations were contacted, to identify trials. SELECTION CRITERIA: Randomised, quasi-randomised or nonrandomised controlled trials completed or published after 1969 evaluating an intervention to promote residential smoke alarms. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: We identified 26 trials, of which 13 were randomised. Overall, counselling and educational interventions had only a modest effect on the likelihood of owning an alarm (OR=1.26; 95% CI: 0.87 to 1.82) or having a functional alarm (OR=1.19; 0.85 to 1.66). Counselling as part of primary care child health surveillance had greater effects on ownership (OR=1.96; 1.03 to 3.72) and function (OR=1.72; 0.78 to 3.80). Results were sensitive to trial quality, however, and effects on fire-related injuries were not reported. In two non randomised trials, direct provision of free alarms significantly increased functioning alarms and reduced fire-related injuries. Media and community education showed little benefit in non randomised trials. REVIEWER'S CONCLUSIONS: Counselling as part of child health surveillance may increase smoke alarm ownership and function, but its effects on injuries are unevaluated. Community smoke alarm give-away programmes apparently reduce fire-related injuries, but these trials were not randomised and results must be interpreted cautiously. Further efforts to promote smoke alarms in primary care or through give-away programmes should be evaluated by adequately designed randomised controlled trials measuring injury outcomes.

Burns↗
PubMed2005

Argon plasma coagulation therapy for acute non-variceal upper gastrointestinal bleeding.

BACKGROUND: Endoscopic treatment is recommended for initial hemostasis in non-variceal upper gastrointestinal bleeding. Many endoscopic hemostatic devices are used. Argon Plasma Coagulation (APC) is an alternative. OBJECTIVES: This study reviews all available literature to access the efficacy of APC compared to other endoscopic therapies in the control of acute non-variceal upper GI hemorrhage. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4 2003), MEDLINE 1966 to December 2003, EMBASE 1980 to December 2003, Web of Science for SCISEARCH (1980 to December 2003), BIOSIS (1985 to December 2003), and the National Research Register Issue 4 2003. We also handsearched abstracts from conference proceedings of the United European Gastroenterology Week and Digestive Disease Week. SELECTION CRITERIA: Randomized, controlled trials of APC compared with other endoscopic hemostasis interventions in the treatment of non-variceal upper gastrointestinal bleeding. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and independently extracted data. MAIN RESULTS: Two trials involving 121 people were included. There was no common intervention to pool. One trial compared APC to heat probe, another trial compared APC to injection sclerotherapy. There was no significant difference between groups in either of these trials. AUTHORS' CONCLUSIONS: On the basis of the two randomised controlled trials identified in this review, there is no evidence to suggest that APC is superior to other endoscopic therapies. Further randomised controlled trials are needed.

Argon↗
PubMed2003

Routine hospital admission versus out-patient or home care in children at diagnosis of type 1 diabetes mellitus.

BACKGROUND: In many places, children newly diagnosed with type 1 diabetes mellitus are admitted to hospital for metabolic stabilisation and training, even if they are not acutely ill. Out-patient or home based management of these children could avoid the stress associated with a hospital stay, could provide a more natural learning environment for the child and its family, and might reduce costs for both the health care system and the families. OBJECTIVES: To assess the effects of routine hospital admission compared to out-patient or home-based management in children newly diagnosed with type 1 diabetes who are not acutely ill, on metabolic control, wellbeing and self-efficacy of the patient and his/her family. SEARCH STRATEGY: We searched the Cochrane Library (including the Cochrane Controlled Trials Register), Medline, Embase, Cinahl, and the British Nursing Index. Additionally, we searched reference lists of relevant studies identified and contacted one of the trialists about further studies. Date of latest search: February 2003. SELECTION CRITERIA: Comparative studies of initial hospitalisation compared to home-based and/or out-patient management in children with newly diagnosed type 1 diabetes. DATA COLLECTION AND ANALYSIS: Studies were independently selected by two reviewers. Data extraction and quality assessment of trials were done independently by two reviewers. Any differences in opinion were resolved by discussion. Authors of included studies were contacted for missing information. Results were summarised descriptively, using tables and text. MAIN RESULTS: Six studies were included in the review, including a total of 237 children in the out-patient/home group. Two studies were randomised controlled trials, three were retrospective cohort studies, and one was a prospective cohort study. Except for one randomised controlled trial that included children in the intervention group who were initially hospitalised for a brief period, studies were of low quality. The one high quality trial identified suggested that home-based management of children with newly diagnosed type 1 diabetes may lead to slightly improved long term metabolic control (at two and three years follow-up). No differences between comparison groups were found in any of the psychosocial and behavioural variables assessed or in rates of acute diabetic complications within two years. Parental costs were found to be decreased, while health system costs were increased, leaving total social costs virtually unchanged. None of the other studies assessing metabolic control found a difference between the comparison groups. There seemed to be no differences in hospitalisations or acute diabetic complications between the out-patient/home groups and the hospital groups. Results with respect to psychosocial and behavioural variables were inconclusive, with only one study finding significant results on some selected subscales of tests used. In another study, the out-patient/home group did significantly better on the assessments of treatment adherence, familial relationship and sociability, but upon further analysis this only seemed to apply to selected socioeconomic subgroups, with no clear explanations offered. REVIEWER'S CONCLUSIONS: Due to the generally low quality or limited applicability of the studies identified, the results of this review are inconclusive. On the whole, the data seem to suggest that out-patient/home management of type 1 diabetes in children at diagnosis does not lead to any disadvantages in terms of metabolic control, acute diabetic complications and hospitalisations, psychosocial variables and behaviour, or total costs. Primary research, ideally a high quality randomised controlled trial, is required.

Adolescent↗
PubMed2006

Self-management in lower urinary tract symptoms: the next major therapeutic revolution.

The standard treatments for men with lower urinary tract symptoms (LUTS) range from watchful waiting to medical and finally surgical intervention. However, the role of self-management interventions such as education and reassurance, lifestyle modification and behavioural changes has not been formally investigated, although they are widely advocated and utilised for LUTS. Self-management interventions are well established in other chronic diseases such as diabetes, arthritis and asthma. These interventions, if successfully organised within a structured program for LUTS, could improve patient outcomes as well as reduce the economic burden of LUTS treatment, by replacing or augmenting other treatments. Recent studies showing that long-term urodynamic and symptomatic deterioration of LUTS is minimal suggest that this is a safe and valid treatment option. This is supported by a recent pilot study of a LUTS self-management program which showed significant improvements in I-PSS and frequency-volume parameters. The results of a recently completed randomised controlled trial are awaited.

Humans↗
PubMed2000

Psychoeducation for schizophrenia.

BACKGROUND: Schizophrenia can be a severe and chronic illness characterised by lack of insight and poor compliance with treatment. Psychoeducational approaches have been developed to increase patients' awareness of their illness and its treatment. OBJECTIVES: To assess the effects of psychoeducational interventions compared to standard levels of knowledge provision. SEARCH STRATEGY: Electronic searches of CINAHL (1982-1999), The Cochrane Library CENTRAL (Issue 1, 1999), The Cochrane Schizophrenia Group's Register (January 1999), EMbase (1980-1999), MEDLINE (1966-1999), PsycLit (1974-1999), and Sociofile (1974-1999) were undertaken. These were supplemented with reference searching and personal contact with authors of all included studies. SELECTION CRITERIA: All relevant randomised controlled trials focusing on psychoeducation for schizophrenia or related serious mental illnesses, involving individuals or groups. Quasi-randomised trials were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted independently by at least two reviewers from included papers. Authors of trials were contacted for additional and missing data. Relative risks (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data were calculated. A random effects model was used for heterogeneous dichotomous data. Where possible the numbers needed to treat (NNT) were also calculated. Weighted or standardised means were calculated for continuous data. MAIN RESULTS: Ten studies are included in this review. All studies of group education included family members. Compliance with medication was significantly improved in a single study using brief group intervention (at one year) but other studies produced equivocal or skewed data. Any kind of psychoeducational intervention significantly decreased relapse or readmission rates at nine to 18 months follow-up compared with standard care (RR 0.8 CI 0.7-0.9 NNT 9 CI 6-22). Several of the secondary outcomes (knowledge gains, mental state, global level of functioning, status of high expressed emotion family members) were measured using scales that are difficult to interpret. Generally, however, findings were consistent with the possibility that psychoeducation has a positive effect on a persons' well being. No impact was found on insight, medication related attitudes or on overall satisfaction with services of patients or relatives but these findings rested on very few studies. Health economic outcome was only measured in one study and data were skewed. It was not possible to analyse whether different duration or formats of psychoeducation influenced effectiveness. REVIEWER'S CONCLUSIONS: Evidence from trials suggests that psychoeducational approaches are useful as a part of the treatment programme for people with schizophrenia and related illness. That the interventions are brief and inexpensive should make them attractive to managers and policy makers. More well-designed, conducted and reported randomised studies investigating the efficacy of psychoeducation are needed.

Family↗