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Results for “Randomised Controlled Trial”

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At least 1,621 records · Page 90Linked to original sources

PubMed2002

Plasmapheresis in severe sepsis and septic shock: a prospective, randomised, controlled trial.

OBJECTIVE: To determine the therapeutic efficacy and safety of plasmapheresis in the treatment of patients with severe sepsis and septic shock. DESIGN: Prospective, randomised, clinical trial with a planned, midstudy, interim analysis. SETTING: Intensive care unit in a university hospital in Archangels, Russia. PATIENTS: Consecutive patients with severe sepsis or septic shock. INTERVENTIONS: One hundred and six patients were randomised to receive either standard therapy or an add-on treatment with plasmapheresis. MEASUREMENTS AND RESULTS: The primary endpoint was 28-day survival. Septic shock was diagnosed in 57% of the plasmapheresis-treated patients and 54% of the control patients. Mean APACHE III score at entry was 56.4 in the plasmapheresis group and 53.5 in the control group. The 28-day, all-cause mortality rate was 33.3% (18/54) in the plasmapheresis group and 53.8% (28/52) in the control group. This represents a relative risk for fatal outcome in the plasmapheresis group of 0.61, an absolute risk reduction of 20.5% and a number of patients needed to treat of 4.9. Apart from six transient episodes of hypotension and one allergic reaction to fresh frozen plasma, no adverse reactions were attributable to the plasmapheresis treatment in this study. CONCLUSIONS: Plasmapheresis may be an important adjuvant to conventional treatment to reduce mortality in patients with severe sepsis or septic shock. Plasmapheresis is a safe procedure in the treatment of septic patients. A prospective randomised multicentre trial is warranted to confirm our results and to determine which subgroups of septic patients will benefit most from this treatment modality.

APACHE↗

PubMed1999

Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Bangkok Collaborative Perinatal HIV Transmission Study Group.

BACKGROUND: Many developing countries have not implemented the AIDS Clinical Trials Group 076 zidovudine regimen for prevention of perinatal HIV-1 transmission because of its complexity and cost. We investigated the safety and efficacy of short-course oral zidovudine administered during late pregnancy and labour. METHODS: In a randomised, double-blind, placebo-controlled trial, HIV-1-infected pregnant women at two Bangkok hospitals were randomly assigned placebo or one zidovudine 300 mg tablet twice daily from 36 weeks' gestation and every 3 h from onset of labour until delivery. Mothers were given infant formula and asked not to breastfeed. The main endpoint was babies' HIV-1-infection status, tested with HIV-1-DNA PCR at birth, 2 months, and 6 months. We measured maternal plasma viral concentrations by RNA PCR. FINDINGS: Between May, 1996, and December, 1997, 397 women were randomised; 393 gave birth to 395 live-born babies. Median duration of antenatal treatment was 25 days, and median number of doses during labour was three. 99% of women took at least 90% of scheduled antenatal doses. Adverse events were similar in the study groups. Of 392 babies with at least one PCR test, 55 tested positive: 18 in the zidovudine group and 37 in the placebo group. The estimated transmission risks were 9.4% (95% CI 5.2-13.5) on zidovudine and 18.9% (13.2-24.2) on placebo (p=0.006; efficacy 50.1% [15.4-70.6]). Between enrolment and delivery, women in the zidovudine group had a mean decrease in viral load of 0.56 log. About 80% of the treatment effect was explained by lowered maternal viral concentrations at delivery. INTERPRETATION: A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child HIV-1 transmission by half. This regimen could prevent many HIV-1 infections during late pregnancy and labour in less-developed countries unable to implement the full 076 regimen.

Administration, Oral↗

PubMed1997

Randomised controlled trial assessing the effectiveness of a booklet on the duration of breast feeding.

OBJECTIVE: To test the efficacy of an information booklet to increase the duration of breast feeding. RESEARCH DESIGN: Randomised design, stratifying by maternal residence and working activity. Two hundred women were recruited, 103 received the booklet and verbal counselling and 97 verbal counselling only. POPULATION: Infants observed from 15 September 1993 to 15 June 1994 in the well baby outpatient clinic of the Paediatric Institute of the Catholic University of Rome, Italy. MAIN RESULTS: No statistically significant difference was found between the two groups in the prevalence of exclusive or complementary breast feeding at 6 months of age: 48.5% and 59.2% in the intervention group, 43.7% and 51.5% in the control group. The median duration of exclusive or complementary breast feeding was 24 and 27 weeks in the treated group, 22 and 25 in the control group. CONCLUSIONS: The information booklet alone does not seem to increase the duration and the prevalence of breast feeding at 6 months of age. The use of written material with a more individualised support and more extensive use of randomised clinical trials in the evaluation of health promoting programmes is recommended.

Adult↗

PubMed2005

Insight into schizophrenia: the effects of cognitive behavioural therapy on the components of insight and association with sociodemographics--data on a previously published randomised controlled trial.

Insight in schizophrenia is an evolving concept with widespread use in clinical practice. Results are presented from a multicentre randomised trial in which patients with schizophrenia and carers received a short insight-focused Cognitive Behaviour Therapy (CBT) intervention from trained nurses in the community. The CBT group demonstrated significantly greater improvement in insight into compliance with treatment and the ability to re-label their psychotic symptoms as pathological compared with the control group at post-therapy assessment. Those participants who demonstrated improved insight into having a mental illness tended to become depressed. At the end of therapy and at 1-year follow-up, there was a statistically significantly increased dropout rate in African-Caribbean and Black African participants. The Black Caribbean group showed a significantly smaller change in insight compared to the white group. At 1-year follow-up, the result on total insight and compliance was durable. The change in insight in the Black African group was significantly lower compared to the white group. The study emphasizes the role of a short insight-focused CBT intervention in improving patients' insight into compliance and its implications. The results confirm previous findings of difficulties in engaging patients of Afro-Caribbean origin and their poor response to psychological therapies as currently delivered.

Adult↗

PubMed2000

Oral artemether for prevention of Schistosoma mansoni infection: randomised controlled trial.

BACKGROUND: Chemotherapy with praziquantel is the current strategy of choice to control schistosomiasis. However, in view of concern about praziquantel tolerance or resistance, new drugs are needed. Artemether, a derivative of the antimalarial drug artemisinin, kills immature schistosomes of Schistosoma japonicum, and reduces the incidence of infection in field trials. Laboratory studies have also showed activity by this drug against S. mansoni. We report a randomised double-blind placebo-controlled clinical trial of artemether to prevent S. mansoni infection. METHODS: The trial was done in an area of western Côte d'Ivoire endemic for S. mansoni. 354 schoolchildren were enrolled. Stool specimens were screened over four consecutive days, followed by two mass treatments with praziquantel 4 weeks apart. All S. mansoni negative children were randomly assigned to placebo (n=151) or artemether 6 mg/kg (n=138) orally six times once every 3 weeks. Adverse events were assessed 24 h after treatment. Perceived illness episodes were recorded once a week by interviewing the children with a standardised questionnaire. 3 weeks after the final medication S. mansoni infections were assessed by screening stool samples. Blood samples were examined for Plasmodium falciparum before the first and after the last artemether treatment. FINDINGS: Oral artemether showed no adverse reactions. The group that received artemether had a significantly lower incidence of S. mansoni infection (31/128 versus 68/140, relative risk: 0.50 [95% CI 0.35-0.71], p=0.00006). The geometric mean egg output among positive children in the artemether group was significantly lower than in placebo recipients (19 vs 32 eggs/g stool, p=0.017). There was also a significant reduction in the prevalence of P. falciparum. INTERPRETATION: Oral artemether is safe and shows a prophylatic effect against S. mansoni. The use of artemether may be recommended in appropriated situations as an additional tool for more effective schistosomiasis control measures. However the application needs to be carefully assessed especially in view of the concern that it could select for resistant plasmodia.

Administration, Oral↗

PubMed2006

A randomised controlled trial investigating the effect of n-3 long-chain polyunsaturated fatty acid supplementation on cognitive and retinal function in cognitively healthy older people: the Older People And n-3 Long-chain polyunsaturated fatty acids (OPAL) study protocol [ISRCTN72331636].

The number of individuals with age-related cognitive impairment is rising dramatically in the UK and globally. There is considerable interest in the general hypothesis that improving the diet of older people may slow the progression of cognitive decline. To date, there has been little attention given to the possible protective role of n-3 long-chain polyunsaturated fatty acids (n-3 LCPs) most commonly found in oily fish, in age-related loss of cognitive function. The main research hypothesis of this study is that an increased dietary intake of n-3 LCPs will have a positive effect on cognitive performance in older people in the UK. To test this hypothesis, a double-blind randomised placebo-controlled trial will be carried out among adults aged 70-79 years in which the intervention arm will receive daily capsules containing n-3 LCP (0.5 g/day docosahexaenoic acid and 0.2 g/day eicosapentaenoic acid) while the placebo arm will receive daily capsules containing olive oil. The main outcome variable assessed at 24 months will be cognitive performance and a second major outcome variable will be retinal function. Retinal function tests are included as the retina is a specifically differentiated neural tissue and therefore represents an accessible window into the functioning of the brain. The overall purpose of this public-health research is to help define a simple and effective dietary intervention aimed at maintaining cognitive and retinal function in later life. This will be the first trial of its kind aiming to slow the decline of cognitive and retinal function in older people by increasing daily dietary intake of n-3 LCPs. The link between cognitive ability, visual function and quality of life among older people suggests that this novel line of research may have considerable public health importance.

Aged↗

PubMed1999

Randomised controlled trial of trophic feeding and gut motility.

OBJECTIVES: To determine the effect of trophic feeding on gastric emptying and whole gut transit time in sick preterm infants. METHODS: A randomised, controlled, prospective study of 70 infants weighing less than 1750 g at birth, who were receiving ventilatory support, was performed. Group TF (33 infants) received trophic feeding from day 3 (0.5 ml/h if birthweight less than 1 kg, 1 ml/h if greater or equal to 1 kg) in addition to parenteral nutrition until ventilatory support finished. Group C (37 infants) received parenteral nutrition alone until ventilatory support finished. Expressed breast milk or a preterm formula were given according to maternal preference. Gastric emptying was assessed within 24 hours of nutritive milk feeding equal to 90 ml/kg/day, using ultrasound scans to measure the reduction in the gastric antral cross sectional area after a feed. Whole gut motility was assessed at both 3 and 6 weeks of age by measuring the whole gut transit time (WGTT) of the marker carmine red. RESULTS: There was no significant difference between groups in their gastric half emptying time, median difference (95% confidence interval) 2.6 (-5.9, 13.9) minutes. The WGTT was significantly faster (p < 0.05) in group TF at both 3 and 6 weeks; median difference -13 (-47, -0.1) and -12.5 (-44, -0.5) hours, respectively. CONCLUSIONS: Trophic feeding enhances whole gut motility but not gastric emptying. This effect could subsequently improve milk tolerance in sick preterm infants.

Enteral Nutrition↗

PubMed2003

Stepping down inhaled corticosteroids in asthma: randomised controlled trial.

OBJECTIVES: To determine whether the dose of inhaled corticosteroids can be stepped down in patients with chronic stable asthma while maintaining control. DESIGN: One year, randomised controlled, double blind, parallel group trial. SETTING: General practices throughout western and central Scotland. PARTICIPANTS: 259 adult patients with asthma receiving regular treatment with inhaled corticosteroids at high dose (mean dose 1430 microg beclomethasone dipropionate). INTERVENTIONS: Participants were allocated to receive either no alteration to their dose of inhaled corticosteroid (control) or a 50% reduction in their dose if they met criteria for stable asthma (stepdown). MAIN OUTCOME MEASURES: Comparison of asthma exacerbation rates, asthma related visits to general practice and hospital, health status measures, and corticosteroid dosage between the two groups. RESULTS: The proportions of subjects with asthma exacerbations were not significantly different (stepdown 31%, control 26%, P=0.354). Similarly, the numbers of visits to general practice or hospital and the disease specific and generic measures of health status over the one year period were not significantly different. On average the stepdown group received 348 microg (95% confidence interval 202 microg to 494 microg) of beclomethasone dipropionate less per day than the controls (a difference of 25%), with no difference in the annual dose of oral corticosteroids between the two treatment regimens. CONCLUSIONS: By adopting a stepdown approach to the use of inhaled steroids at high doses in asthma a reduction in the dose can be achieved without compromising asthma control.

Administration, Inhalation↗

PubMed1996

Treatment with a gonadotrophin releasing hormone agonist before endometrial resection: a multicentre, randomised controlled trial.

OBJECTIVES: To ascertain whether treatment with a gonadotrophin releasing hormone agonist before endometrial resection reduces absorption of distension fluid and operating time and facilitates the procedure. DESIGN: A multicentre, prospective, randomised controlled study. PARTICIPANTS: Seventy-one premenopausal women with established menorrhagia. INTERVENTIONS: Eight weeks of goserelin depot treatment before endometrial resection of immediate surgery in the early proliferative phase of the cycle. MAIN OUTCOME MEASURES: Irrigation fluid deficit, operating time and degree or difficulty of the procedure. RESULTS: After randomisation eight women withdrew from the study, leaving 33 women in the goserelin arm and 30 in the immediate surgery arm. Mean (SD) operating time was 15.1 (9.0) min in the goserelin group versus 16.9 (9.5) min in the controls; mean difference + 1.8 min, 95% CI, -2.9 to + 6.4. Mean (SD) distension medium deficit was, respectively, 422 (287) ml versus 564 (291 ml); mean difference + 142 ml, 95% CI -4 to + 288. The goserelin effect was restricted to the 29 women with adenomyosis as the mean (SD) fluid deficit was considerably less in the 19 treated women than in the 10 controls (299 (206) ml versus 597 (135) ml; mean difference + 298 ml, 95% CI + 149 to + 447). The surgeons classified the intraoperative difficulties as none in 6, minimal in 20, moderate in 7, and severe in no cases in the goserelin group; corresponding figures in the group without pretreatment were 2, 14, 13, and 1. CONCLUSIONS: Goserelin administration before endometrial resection may reduce absorption of fluid at surgery in women with adenomyosis and may facilitate intrauterine operating conditions.

Absorption↗

PubMed2000

Cost effectiveness analysis of intravenous ketorolac and morphine for treating pain after limb injury: double blind randomised controlled trial.

OBJECTIVES: To investigate the cost effectiveness of intravenous ketorolac compared with intravenous morphine in relieving pain after blunt limb injury in an accident and emergency department. DESIGN: Double blind, randomised, controlled study and cost consequences analysis. SETTING: Emergency department of a university hospital in the New Territories of Hong Kong. PARTICIPANTS: 148 adult patients with painful isolated limb injuries (limb injuries without other injuries). MAIN OUTCOME MEASURES: Primary outcome measure was a cost consequences analysis comparing the use of ketorolac with morphine; secondary outcome measures were pain relief at rest and with limb movement, adverse events, patients' satisfaction, and time spent in the emergency department. RESULTS: No difference was found in the median time taken to achieve pain relief at rest between the group receiving ketorolac and the group receiving morphine, but with movement the median reduction in pain score in the ketorolac group was 1.09 per hour (95% confidence interval 1.05 to 2.02) compared with 0.87 (0.84 to 1.06) in the morphine group (P=0.003). The odds of experiencing adverse events was 144.2 (41.5 to 501.6) times more likely with morphine than with ketorolac. The median time from the initial delivery of analgesia to the participant leaving the department was 20 (4.0 to 39.0) minutes shorter in the ketorolac group than in the morphine group (P=0.02). The mean cost per person was $HK44 ( pound4; $5.6) in the ketorolac group and $HK229 in the morphine group (P<0.0001). The median score for patients' satisfaction was 6.0 for ketorolac and 5.0 for morphine (P<0.0001). CONCLUSION: Intravenous ketorolac is a more cost effective analgesic than intravenous morphine in the management of isolated limb injury in an emergency department in Hong Kong, and its use may be considered as the dominant strategy.

Adolescent↗

PubMed2006

Effect of a structured course involving goal management training in older adults: A randomised controlled trial.

OBJECTIVE: The objective of this study was to investigate the effects of a structured 6-week neuropsychological course on the executive functioning of older adults with cognitive complaints. METHODS: A randomised controlled design was used involving 69 community dwelling individuals aged 55 years and older. Both objective and subjective measures were included to assess executive functioning. General linear model with repeated measures analysis of variance was used to examine the intervention effects. RESULTS: After the intervention, the participants in the intervention group were significantly less annoyed by their cognitive failures, were better able to manage their executive failures and reported less anxiety symptoms than those in the waiting list control group. CONCLUSION: These findings indicate that a combination of psycho-education and training has the potential to change the attitude of older individuals towards their cognitive functioning. PRACTICE IMPLICATIONS: Because this training focussed on cognitive functions that are among the first to decline in older adults and the subjective evaluation of the people after training was quite favourable, the proposed intervention may be considered a valuable contribution to cognitive interventions for older adults.

Activities of Daily Living↗

PubMed1997

Randomised controlled trial of hydroquinine in muscle cramps.

BACKGROUND: Although quinine and hydroquinine are commonly prescribed for muscle cramps, controlled clinical trials of these drugs have reported mixed findings about efficacy. We investigated hydroquinine therapy in otherwise healthy adults who had frequent, ordinary muscle cramps. METHODS: This randomised, double-blind, placebo-controlled, parallel-group trial consisted of three consecutive 2-week periods: qualification, treatment, and washout, 68 women and 44 men who had at least three muscle cramps per week were enrolled. During the treatment period, participants were randomly assigned 300 mg daily dose of hydroquinine hydrobromide dihydrate (54 participants) or placebo (58). The frequency, severity (1-10), duration, and location of muscle cramps, as well as any side-effects, were recorded by participant in daily diaries. The primary outcome measures were the number of muscle cramps and the number of days during which the participants had muscle cramps (cramp-days). FINDINGS: We excluded five participants from both groups from the analysis. Thus, data from 49 hydroquinine-group participants and 53 placebo-group participants were analysed. In both groups the total number of muscle cramps and the number of cramp-days decreased during the treatment period compared with the qualification period. However, these improvements were greater in the hydroquinine group than in the placebo group. The hydroquinine-group participants reported a median of 8 (95% CI 7-12) fewer cramps and median of 3 (1-4) fewer cramp-days, whereas those on placebo reported only 3 (0-5) fewer cramps and 1 (0-5) fewer cramp-days. 32 (65%) of participants in the hydroquinine group had a 50% or greater reduction in the number of muscle cramps. After the onset of cramps, hydroquinine did not reduce the severity or duration of cramps. We also found a sustained effect after treatment had stopped. Hydroquinine was well tolerated, and resulted in only mild side-effects. INTERPRETATION: In our study, 300 mg hydroquinine was safe to take in the short-term and significantly more effective than placebo in the prevention of frequent, ordinary muscle cramps. This therapeutic effect outlasted the duration of treatment.

Administration, Oral↗

PubMed1995

EMLA cream on the ears--is it effective? A prospective, randomised controlled trial of the efficacy of topical anaesthetic cream in reducing the pain of local anaesthetic infiltration for prominent ear correction.

A prospective, randomised, double blind trial was carried out to test whether or not the application of topical anaesthetic cream (EMLA cream) before infiltration of local anaesthetic would decrease the discomfort of correction of prominent ears under local anaesthetic. 23 patients were entered into the trial. They acted as their own controls, one ear having EMLA cream applied approximately 2 h prior to surgery, and the other Aqueous cream. Immediately after surgery, the patients were asked to complete two scales describing the amount of pain they had felt in each ear, both at the time of injection of local anaesthetic and during the surgery. They were also asked whether they thought the inconvenience associated with the use of the EMLA cream was worth any improvement they felt. The results showed that, compared to the placebo cream, EMLA cream significantly decreased the pain felt both at the time of injection (p < 0.005) and during the surgery (p < 0.01). However, only 62% of patients asked felt that the inconvenience associated with the use of EMLA cream was worth the benefits that it conveyed.

Administration, Topical↗

PubMed2002

Interventions to reduce unintended pregnancies among adolescents: systematic review of randomised controlled trials.

OBJECTIVE: To review the effectiveness of primary prevention strategies aimed at delaying sexual intercourse, improving use of birth control, and reducing incidence of unintended pregnancy in adolescents. DATA SOURCES: 12 electronic bibliographic databases, 10 key journals, citations of relevant articles, and contact with authors. STUDY SELECTION: 26 trials described in 22 published and unpublished reports that randomised adolescents to an intervention or a control group (alternate intervention or nothing). DATA EXTRACTION: Two independent reviewers assessed methodological quality and abstracted data. DATA SYNTHESIS: The interventions did not delay initiation of sexual intercourse in young women (pooled odds ratio 1.12; 95% confidence interval 0.96 to 1.30) or young men (0.99; 0.84 to 1.16); did not improve use of birth control by young women at every intercourse (0.95; 0.69 to 1.30) or at last intercourse (1.05; 0.50 to 2.19) or by young men at every intercourse (0.90; 0.70 to 1.16) or at last intercourse (1.25; 0.99 to 1.59); and did not reduce pregnancy rates in young women (1.04; 0.78 to 1.40). Four abstinence programmes and one school based sex education programme were associated with an increase in number of pregnancies among partners of young male participants (1.54; 1.03 to 2.29). There were significantly fewer pregnancies in young women who received a multifaceted programme (0.41; 0.20 to 0.83), though baseline differences in this study favoured the intervention. CONCLUSIONS: Primary prevention strategies evaluated to date do not delay the initiation of sexual intercourse, improve use of birth control among young men and women, or reduce the number of pregnancies in young women.

Adolescent↗

PubMed1993

Meta-analysis of randomised controlled trials of selective decontamination of the digestive tract. Selective Decontamination of the Digestive Tract Trialists' Collaborative Group.

OBJECTIVE: To determine the clinical benefits of selective decontamination of the digestive tract in patients treated in intensive care units. DESIGN: Meta-analysis of 22 randomised trials that compared different combinations of oral non-absorbable antibiotics, with or without a systemic component, with no treatment in controls. SUBJECTS: 4142 patients seen in general and specialised intensive care units around the world. 2047 received some form of antibiotic treatment, the remainder no prophylaxis. DATA ANALYSIS: Each trial was reviewed through direct contact with study investigators. Data collected were: the randomisation procedure, number of patients, number excluded from the analysis, and numbers of respiratory tract infections and deaths. Data were combined according to an intention to treat analysis with the Mantel-Haenszel-Peto method. MAIN OUTCOME MEASURES: Respiratory tract infections and total mortality. RESULTS: Selective decontamination of the digestive tract significantly reduced respiratory tract infections (odds ratio 0.37; 95% confidence interval 0.31 to 0.43). The value of the common odds ratio for total mortality (0.90; 0.79 to 1.04) suggested at best a moderate treatment effect, reaching statistical significance only when the subgroup of trials of topical and systemic treatment combined was considered separately (odds ratio 0.80; 0.67 to 0.97). No firm conclusions could be drawn owing to large variations in patient mix and severity within and between trials. CONCLUSIONS: The findings strongly indicate that selective decontamination significantly reduces infection related morbidity in patients receiving intensive care. They also highlight why definite conclusions about the effect of prophylaxis on mortality cannot be drawn despite the large number of trials available. Based on the most favourable results obtained by pooling data from trials in which combined topical and systemic treatment was used it may be estimated that 6 (range 5-9) and 23 (13-139) patients would need to be treated to prevent one respiratory tract infection and one death respectively.

Administration, Oral↗

PubMed2004

The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults.

CONTEXT: Chitosan, a deacetylated chitin, is a widely available dietary supplement purported to decrease body weight and serum lipids through gastrointestinal fat binding. Although evaluated in a number of trials, its efficacy remains in dispute. OBJECTIVE: To evaluate the efficacy of chitosan for weight loss in overweight and obese adults. DESIGN AND SETTING: A 24-week randomised, double-blind, placebo-controlled trial, conducted at the University of Auckland between November 2001 and December 2002. PARTICIPANTS: A total of 250 participants (82% women; mean (s.d.) body mass index, 35.5 (5.1) kg/m(2); mean age, 48 (12) y) INTERVENTIONS: Participants were randomly assigned to receive 3 g chitosan/day (n=125) or placebo (n=125). All participants received standardised dietary and lifestyle advice for weight loss. Adherence was monitored by capsule counts. MAIN OUTCOME MEASURES: The primary outcome measure was change in body weight. Secondary outcomes included changes in body mass index, waist circumference, body fat percentage, blood pressure, serum lipids, plasma glucose, fat-soluble vitamins, faecal fat, and health-related quality of life. RESULTS: In an intention-to-treat analysis with the last observation carried forward, the chitosan group lost more body weight than the placebo group (mean (s.e.), -0.4 (0.2) kg (0.4% loss) vs +0.2 (0.2) kg (0.2% gain), P=0.03) during the 24-week intervention, but effects were small. Similar small changes occurred in circulating total and LDL cholesterol, and glucose (P<0.01). There were no significant differences between groups for any of the other measured outcomes. CONCLUSION: In this 24-week trial, chitosan treatment did not result in a clinically significant loss of body weight compared with placebo.

Adult↗

PubMed2005

Indirect reduction and percutaneous fixation versus open reduction and internal fixation for displaced intra-articular fractures of the distal radius: a randomised, controlled trial.

A total of 179 adult patients with displaced intra-articular fractures of the distal radius was randomised to receive indirect percutaneous reduction and external fixation (n = 88) or open reduction and internal fixation (n = 91). Patients were followed up for two years. During the first year the upper limb musculoskeletal function assessment score, the SF-36 bodily pain sub-scale score, the overall Jebsen score, pinch strength and grip strength improved significantly in all patients. There was no statistically significant difference in the radiological restoration of anatomical features or the range of movement between the groups. During the period of two years, patients who underwent indirect reduction and percutaneous fixation had a more rapid return of function and a better functional outcome than those who underwent open reduction and internal fixation, provided that the intra-articular step and gap deformity were minimised.

Adolescent↗

PubMed1997

Antenatal perineal massage and subsequent perineal outcomes: a randomised controlled trial.

OBJECTIVE: To study the effects of antenatal perineal massage on subsequent perineal outcomes at delivery. DESIGN: A randomised, single-blind prospective study. SETTING: Department of Obstetrics and Gynaecology, Watford General Hospital. PARTICIPANTS: Eight hundred and sixty-one nulliparous women with singleton pregnancy and fulfilling criteria for entry to the trial between June 1994 and October 1995. RESULTS: Comparison of the group assigned to massage with the group assigned to no massage showed a reduction of 6.1% in second or third degree tears or episiotomies. This corresponded to tear rates of 75.1% in the no-massage group and 69.0% in the massage group (P = 0.073). There was a corresponding reduction in instrumental deliveries from 40.9% to 34.6% (P = 0.094). After adjustment for mother's age and infant's birthweight these reductions achieved statistical significance (P = 0.024 and P = 0.034, respectively). Analysis by mother's age showed a much larger benefit due to massage in those aged 30 and over and a smaller benefit in those under 30. CONCLUSION: Antenatal perineal massage appears to have some benefit in reducing second or third degree tears or episiotomies and instrumental deliveries. This effect was stronger in the age group 30 years and above.

Adult↗