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At least 1,423 records · Page 79Linked to original sources
PubMed2006

Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial.

OBJECTIVE: To compare the behavioural side effects associated with two commonly used antiepilepsy drugs-phenobarbital and carbamazepine-in children in Bangladesh. DESIGN: Prospective randomised controlled single centre trial. SETTING: Specialist children's hospital in Dhaka, Bangladesh. PARTICIPANTS: 108 children aged 2-15 with generalised tonic-clonic (n=51) or partial and secondary generalised seizures (n=57). MAIN OUTCOME MEASURES: Seizure control and behavioural side effects. RESULTS: 91 children were followed up for 12 months. Six required a change of antiepilepsy drug. Side effects were compared in 85 children. In the last quarter of the 12 month follow-up, 71 children were seizure free after one year's treatment. Thirty two in the phenobarbital group and 39 in the carbamazepine group had no seizures in 74 and 102 days after randomisation, respectively. Ten children had increased behavioural problems, which were unacceptable in four (one in the phenobarbital group and three in the carbamazepine group). Independent t tests, however, showed no difference between the two trial drugs. CONCLUSION: There was no excess in behavioural side effects with phenobarbital in children with epilepsy in a country with limited resources. Trial registration NCT00381537.

Adolescent↗
PubMed2005

No difference between two splint and exercise regimens for people with osteoarthritis of the thumb: a randomised controlled trial.

The purpose of this study was to compare the effects of two 6-week splint and exercise regimens for patients with trapeziometacarpal osteoarthritis. Forty participants were enrolled in a randomised, controlled clinical trial. The experimental group received a newly designed thumb strap splint and an abduction exercise regimen, whereas the control group received current clinical practice consisting of a short opponens splint and a pinch exercise regimen. Outcome measures included pain (VAS at rest in cm), strength (tip pinch in kg), and hand function (Sollerman Test of Hand Function scored out of 80), measured by a blinded assessor at Weeks 0, 2, and 6. By Week 6 there was no significant difference in the extent of mean improvement between the groups in: pain, 0.5 cm (95% CI -1.1 to 2.1); strength, 0.1 kg (95% CI -0.8 to 0.9); or hand function, 0.7 points (95% CI -3.6 to 5.0). While both groups improved, neither regimen is superior to the other in patients with trapeziometacarpal osteoarthritis.

Exercise Therapy↗
PubMed2006

Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess.

The purpose of the trial was to determine whether a sustained release preparation of prostaglandin E2 (Propess) is better in inducing labour when compared with the more widely used short-acting (instant-release) preparation (Prostin). A randomised controlled clinical trial involving 100 pregnant women at term with an indication for induction of labour was conducted in a district general hospital in the UK over a 1-year period. Women were randomised to receive one of the two preparations. The study revealed that there was no statistically significant difference in time to onset of labour, duration of labour, total time from induction to delivery, method of delivery, and analgesia requirements. The number of preparations required to induce labour were significantly less in the Propess group. Our data suggest that both Propess and Prostin are safe and effective in induction of labour, for either primips or multips. However, Prostin use is more cost-effective.

Adolescent↗
PubMed2002

Effect of routine zinc supplementation on pneumonia in children aged 6 months to 3 years: randomised controlled trial in an urban slum.

OBJECTIVES: To evaluate the effect of daily zinc supplementation in children on the incidence of acute lower respiratory tract infections and pneumonia. DESIGN: Double masked, randomised placebo controlled trial. SETTING: A slum community in New Delhi, India. PARTICIPANTS: 2482 children aged 6 to 30 months. INTERVENTIONS: Daily elemental zinc, 10 mg to infants and 20 mg to older children or placebo for four months. Both groups received single massive dose of vitamin A (100 000 IU for infants and 200 000 IU for older children) at enrollment. MAIN OUTCOME MEASURES: All households were visited weekly. Any children with cough and lower chest indrawing or respiratory rate 5 breaths per minute less than the World Health Organization criteria for fast breathing were brought to study physicians. RESULTS: At four months the mean plasma zinc concentration was higher in the zinc group (19.8 (SD 10.1) v 9.3 (2.1) micromol/l, P<0.001). The proportion of children who had acute lower respiratory tract infection during follow up was no different in the two groups (absolute risk reduction -0.2%, 95% confidence interval -3.9% to 3.6%). Zinc supplementation resulted in a lower incidence of pneumonia than placebo (absolute risk reduction 2.5%, 95% confidence interval 0.4% to 4.6%). After correction for multiple episodes in the same child by generalised estimating equations analysis the odds ratio was 0.74, 95% confidence interval 0.56 to 0.99. CONCLUSIONS: Zinc supplementation substantially reduced the incidence of pneumonia in children who had received vitamin A.

Acute Disease↗
PubMed2004

Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial.

OBJECTIVE: To test whether oral or vaginal lactobacillus can prevent vulvovaginitis after antibiotic treatment. DESIGN: Randomised, placebo controlled, double blind, factorial 2x2 trial. SETTING: Fifty general practices and 16 pharmacies in Melbourne, Australia. PARTICIPANTS: Non-pregnant women aged 18-50 years who required a short course of oral antibiotics for a non-gynaecological infection: 278 were enrolled in the study, and results were available for 235. INTERVENTIONS: Lactobacillus preparations taken orally or vaginally, or both, from enrollment until four days after completion of their antibiotic course. MAIN OUTCOME MEASURES: Participants' reports of symptoms of post-antibiotic vulvovaginitis, with microbiological evidence of candidiasis provided by a self obtained vaginal swab. RESULTS: Overall, 55/235 (23% (95% confidence interval 18% to 29%)) women developed post-antibiotic vulvovaginitis. Compared with placebo, the odds ratio for developing post-antibiotic vulvovaginitis with oral lactobacillus was 1.06 (95% confidence interval 0.58 to 1.94) and with vaginal lactobacillus 1.38 (0.75 to 2.54). Compliance with antibiotics and interventions was high. The trial was terminated after the second interim analysis because of lack of effect of the interventions. Given the data at this time, the chances of detecting a significant reduction in vulvovaginitis with oral or vaginal lactobacillus treatment were less than 0.032 and 0.0006 respectively if the trial proceeded to full enrollment. CONCLUSIONS: The use of oral or vaginal forms of lactobacillus to prevent post-antibiotic vulvovaginitis is not supported by these results. Further research on this subject is unlikely to be fruitful, unless new understandings about the pathogenesis of post-antibiotic vulvovaginitis indicate a possible role for lactobacillus.

Administration, Intravaginal↗
PubMed2003

Effect of a ginger extract on pregnancy-induced nausea: a randomised controlled trial.

OBJECTIVE: To investigate the effect of a ginger extract (EV.EXT35) on the symptoms of morning sickness. DESIGN: Double-blind randomised placebo-controlled trial. SETTING: A tertiary metropolitan teaching hospital, March 1999-November 1999. PARTICIPANTS: The participants included 120 women less than 20 weeks pregnant, who had experienced morning sickness daily for at least a week and had had no relief of symptoms through dietary changes. INTERVENTION: Random allocation of 125 mg ginger extract (EV.EXT35; equivalent to 1.5 g of dried ginger) or placebo given four times per day for 4 days. MAIN OUTCOME MEASURES: Nausea, vomiting and retching as measured by the Rhodes Index of Nausea, Vomiting and Retching. RESULTS: The nausea experience score was significantly less for the ginger extract group relative to the placebo group after the first day of treatment and this difference was present for each treatment day. Retching was also reduced by the ginger extract although to a lesser extent. No significant effect was observed on vomiting. Follow-up of the pregnancies revealed normal ranges of birthweight, gestational age, Apgar scores and frequencies of congenital abnormalities when the study group infants were compared to the general population of infants born at the Royal Hospital for Women for the year 1999-2000. CONCLUSION: Ginger can be considered as a useful treatment option for women suffering from morning sickness.

Adult↗
PubMed1986

A randomised controlled trial of prophylactic neuroleptic treatment.

Out of 253 patients fulfilling criteria for a first episode of schizophrenic illness, 120 entered a randomised placebo-controlled trial of maintenance neuroleptic medication on discharge; they were followed to relapse or loss to follow-up, for two years or to the end of the study. Of those on active medication, 46% relapsed, as did 62% of those on placebo; the most important determinant of relapse was duration of illness prior to starting neuroleptic medication. This finding might be because extended duration of symptoms before admission is more likely to be present in illnesses which in any case will have poor prognosis, or because susceptibility to relapse is reduced by early institution of treatment. The study provides no data on which a decision between these alternative explanations can be based.

Adolescent↗
PubMed1998

Pragmatic Randomised Controlled Trials for Complex Therapies.

In order to be able to 'predict' the extent or likelihood of success of an intervention, it is essential to know that exposure and effect are causally related. The randomised controlled clinical trial (RCT) is commonly referred to as the golden standard to establish causality. Apart from ethical constraints or rare diseases it is rarely impossible to do an RCT. Sometimes, however, RCTs may not be feasible (at least at first glance) due to e. g. patients' or therapists' reluctance to participate, lack of funding, organisational limitations, or because technical skills to deliver a therapy are not available. A variety of design alternatives have been proposed to overcome these problems, e. g. clinician-preferred treatment, single consent design, double consent randomised design, prerandomisation, cluster randomisation, and response-adaptive designs ('play the winner'). For complex ('combined modality') therapies it seems reasonable to study the effect of the whole treatment package on the patient rather than the value of individual components. Change to open label or optional cross-over allow 'individualized treatment' as well as 'individualized outcome' within the framework of the RCT. For clinicians and researchers it seems wise to put more emphasis on the search for a suitable and appropriate de-sign for their current problem rather than to artificially tailor their study to an awkward standard design (or even abandon the idea to seek an answer to an open question): Much more alternatives exist than one would imagine.

Journal Article↗
PubMed1991

Development of thrombophlebitis in peripheral veins with Vialon and PTFE-Teflon cannulas: a double-blind, randomised, controlled trial.

A series of 54 normal subjects were randomised to have either a Vialon or a PTFE-Teflon peripheral vein cannula inserted in a vein in each forearm to observe the development of thrombophlebitis. Cannulas were inspected twice daily for up to 5 days to observe the development of three signs, erythema, oedema or hardness and one symptom, pain. Each sign and symptom was recorded twice daily at three points, the cannula insertion site, the mid-point of the cannula and the cannula tip. The degree of change was recorded as less than 1, 1-2 and greater than 2 cm. Any cannula causing any sign greater than 2 cm was removed. By the end of the study over 40% of both types of cannula had been removed. There were no significant differences between the numbers of each type of cannula removed at any time point throughout the duration of the study. There were no significant differences in the amounts of erythema or hardness, but minimally increased swelling was observed at the mid-point of the PTFE-Teflon cannulas (P = 0.022). Despite the theoretical superiority of Vialon as a cannula material, under controlled conditions there appears to be little difference in its inherent capacity to cause the thrombophlebitis.

Adult↗
PubMed2002

Vitamin E supplementation and macular degeneration: randomised controlled trial.

OBJECTIVE: To determine whether vitamin E supplementation influences the incidence or rate of progression of age related maculopathy (AMD). DESIGN: Prospective randomised placebo controlled clinical trial. SETTING: An urban study centre in a residential area supervised by university research staff. PARTICIPANTS: 1193 healthy volunteers aged between 55 and 80 years; 73% completed the trial on full protocol. INTERVENTIONS: Vitamin E 500 IU or placebo daily for four years. MAIN OUTCOME MEASURES PRIMARY OUTCOME: development of early age related macular degeneration in retinal photographs. Other measures included alternative definitions of age related macular degeneration, progression, changes in component features, visual acuity, and visual function RESULTS: The incidence of early age related macular degeneration (early AMD 3) was 8.6% in those receiving vitamin E versus 8.1% in those on placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61). For late disease the incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Further analysis showed no consistent differences in secondary outcomes. CONCLUSION: Daily supplement with vitamin E supplement does not prevent the development or progression of early or later stages of age related macular degeneration.

Aged↗
PubMed1998

Does sweeping of the membranes reduce the need for formal induction of labour? A randomised controlled trial.

OBJECTIVE: 1. To evaluate the effectiveness of sweeping of the membranes to reduce the need for a formal induction of labour; 2. to evaluate the side effects of this intervention. DESIGN: A randomised controlled clinical trial. SETTING: Three tertiary care hospitals of the province of Quebec, Canada. POPULATION: Two hundred women for whom non-urgent induction of labour was medically indicated. METHODS: Women were randomly allocated to sweeping of membranes, or vaginal examination for Bishop scoring only. MAIN OUTCOME MEASURES: 1. Cumulative incidence and relative risk of induction of labour by either oxytocin, prostaglandins or amniotomy; 2. women's discomfort and side effects attributable to sweeping of the membranes. RESULTS: Women allocated to sweeping of the membranes required formal induction of labour less frequently than women in the control group, but this difference was not statistically significant (49% vs 60%, RR 0.83, 95% CI 0.64-1.07). Pain during vaginal examination and other side effects were more frequently reported by women allocated to the sweeping group. CONCLUSIONS: The observed reduction in the need for formal induction of labour is smaller than in previous studies. Side effects and discomfort associated with sweeping of the membranes must be taken into account when counselling women who require induction of labour.

Adult↗
PubMed1997

Long-term effect of calcium supplementation during pregnancy on the blood pressure of offspring: follow up of a randomised controlled trial.

OBJECTIVE: To explore the long-term effect of calcium supplementation during pregnancy on the offspring's blood pressure during childhood. DESIGN: Follow up of a population enrolled in a double blind, randomised, placebo controlled trial. SETTING: Perinatal research unit, World Health Organisation's collaborative research centre. SUBJECTS: 591 children at a mean age of 7 years whose mothers were randomly assigned during pregnancy to receive 2 g/day of elemental calcium (n = 298) or placebo (n = 293). MAIN OUTCOME MEASURES: Mean blood pressure and rate of high blood pressure of children. RESULTS: Overall, systolic blood pressure was lower in the calcium group (mean difference -1.4 mm Hg; 95% confidence interval -3.2 to 0.5) than in the placebo group. The effect was found predominantly among children whose body mass index at assessment was above the median for this population (mean difference in systolic blood pressure -5.8 mm Hg (-9.8 mm Hg to -1.7 mm Hg) for children with an index > 17.5 and -3.2 mm Hg (-6.3 mm Hg to -0.1 mm Hg) for those with an index of > 15.7 to 17.5). The risk of high systolic blood pressure was also lower in the calcium group than in the placebo group (relative risk 0.59; 0.39 to 0.90) and particularly among children in the highest fourth of body mass index (0.43; 0.26 to 0.71). CONCLUSION: Calcium supplementation during pregnancy is associated with lower systolic blood pressure in the offspring, particularly among overweight children.

Blood Pressure↗
PubMed1998

Randomised controlled trial of aminosidine (paromomycin) v sodium stibogluconate for treating visceral leishmaniasis in North Bihar, India.

OBJECTIVES: To assess the efficacy and tolerability of aminosidine compared with sodium stibogluconate for treating visceral leishmaniasis. DESIGN: Randomised, unblinded, controlled trial with 180 day follow up. SETTING: Kala-Azar Research Centre, Brahmpura, Muzaffarpur, Bihar, India. SUBJECTS: People of either sex aged 6-50 years with symptoms and signs suggestive of visceral leishmaniasis (fever, loss of appetite, enlarged spleen) with leishmania amastigotes detected in Giemsa stained aspirates of spleen or bone marrow. INTERVENTIONS: Aminosidine at three daily doses (12, 16, and 20 mg/kg) for 21 days and sodium stibogluconate 20 mg/kg/day for 30 days. MAIN OUTCOME MEASURES: Laboratory measures of efficacy: parasite count, haemoglobin concentration, white cell count, platelet count, serum albumin concentration. Clinical measures of efficacy: spleen size, fever, body weight, and liver size. Measures of safety: liver and renal function tests, reports of adverse events. RESULTS: Of the 120 patients enrolled (30 per treatment arm), 119 completed treatment and follow up. Cure at end of follow up was achieved in 23 (77%), 28 (93%), and 29 (97%) patients treated with 12, 16, and 20 mg aminosidine/kg/day respectively, and in 19 (63%) patients given sodium stibogluconate. At 16 and 20 mg/kg/day, aminosidine was significantly more active than sodium stibogluconate in both clinical and laboratory measures of efficacy. No significant clinical or laboratory toxicity occurred in any treatment group. CONCLUSIONS: A 21 day course of aminosidine 16 or 20 mg/kg/day should be considered as first line treatment for visceral leishmaniasis in Bihar.

Adolescent↗
PubMed1987

Effects of a fish oil supplement on serum lipids, blood pressure, bleeding time, haemostatic and rheological variables. A double blind randomised controlled trial in healthy volunteers.

Sixty male volunteers were randomised to take 10-16 ml of a fish oil supplement (MaxEPA) or 10-16 ml of olive oil for a period of 3-6 weeks. A fall in serum triglyceride of 54% (P less than 0.01) and a fall in diastolic blood pressure of 7% (P less than 0.05) was attributable to taking fish oil supplements. The bleeding time was prolonged by 12%, but this did not reach conventional levels of statistical significance. A global test of heparin-neutralising activity, the heparin thrombin clotting time, increased by 14% (P = 0.05) but there was no demonstrable effect on thrombin time, fibrinogen or (intraplatelet) platelet factor 4. A fall in red cell pore transit time of 23% was attributable to fish oil, but was not statistically significant. There was no convincing evidence of an effect of fish oil supplementation on total serum cholesterol, HDL-cholesterol, blood counts or platelet aggregation. A beneficial effect of fish oil on the cardiovascular risk profile was confirmed in this study. However, with this regime changes in total cholesterol, HDL-cholesterol and platelet aggregation are of unlikely clinical importance.

Adult↗
PubMed1995

Prospective, randomised, controlled trial comparing suture needle drainage and argon laser drainage of subretinal fluid.

AIMS: This study was designed to compare suture needle drainage (SND) with argon laser drainage (ALD) of subretinal fluid. METHODS: A prospective, randomised, controlled, clinical trial was carried out on 93 patients undergoing external drainage of subretinal fluid during scleral buckling surgery for rhegmatogenous retinal detachment. The incidence of successful drainage, incidence of subretinal haemorrhage, incidence of retinal incarceration, and incidence of retinal perforation were determined. RESULTS: The success rate was 97.9% in the ALD group and 84.8% in the SND group (difference-13.1%, 95% CI-26.4% to 2.0%). The incidence of clinically significant subretinal haemorrhage was 4.3% in the ALD group compared with 28.3% in the SND group (difference 24.0%, 95% CI 7.6% to 40.4%). The incidence of incarceration was comparable in each group. There were no cases of retinal perforation. CONCLUSIONS: The use of ALD was associated with a higher rate of successful SRF drainage, and a lower incidence of clinically significant subretinal haemorrhage than SND. ALD is preferred when an endolaser is available.

Adolescent↗
PubMed2005

Effects of prenatal multimicronutrient supplements on birth weight and perinatal mortality: a randomised, controlled trial in Guinea-Bissau.

OBJECTIVES: To assess the effects of daily prenatal multimicronutrient supplementation on birth weight (BW) and perinatal mortality. DESIGN: Randomised, controlled, double masked trial. SETTING: Urban Guinea-Bissau, West Africa. SUBJECTS: A total of 2100 pregnant women (22+/-7 weeks pregnant at entry) were recruited through antenatal clinics, of which 1670 (79.5%) completed the trial. BW was available for 1100 live born babies. INTERVENTIONS: Identical-looking supplements containing one (MN-1) or two (MN-2) Recommended Dietary Allowances (RDA) of 15 micronutrients, or iron and folic acid (control). RESULTS: Mean BW among 1100 live born infants was 3050+/-498 g with 11.9% being low birth weight (LBW, BW < 2500 g). Perinatal mortality was 82 per 1000 deliveries (N = 1670), and neonatal mortality 45 per 1000 live births (N = 1599). Mean BW in MN-1 (n = 360) and MN-2 (n = 374) groups were 53 [-19; 125] and 95 [24; 166] g higher than controls (n = 366). Proportion of LBW was 13.6% in control, and 12.0 and 10.1% in the MN-1 and MN-2 groups, respectively (P = 0.33). Among anaemic women (30%), MN-2 increased BW with 218 [81; 354] g compared to controls, with a decreased risk of LBW of 69 [27; 87]%. There were apparently no differences in perinatal mortality between groups. CONCLUSIONS: Prenatal micronutrient supplementation increased BW but did not reduce perinatal mortality in this study. Multimicronutrient supplementation with two RDA should be considered in future programmes to reduce the proportion of LBW.

Adult↗
PubMed2003

The Doppler assessment in multiple pregnancy randomised controlled trial of ultrasound biometry versus umbilical artery Doppler ultrasound and biometry in twin pregnancy.

OBJECTIVE: To assess the addition value of umbilical artery Doppler ultrasound added to standard ultrasound biometry measurements in the management of twin pregnancies. DESIGN: A prospective randomised controlled multicentre trial of women with twin pregnancies. SETTING: Tertiary level referral hospitals in Australia, New Zealand and Southeast Asia. POPULATION: Pregnant women with twin pregnancies. METHODS: Women were randomised at 25 weeks of gestation to receive either standard ultrasound biometric assessment or standard assessment plus Doppler ultrasound umbilical artery flow velocity waveform analysis. The studies were repeated at 30 and 35 weeks unless otherwise indicated. Physicians were advised to institute close fetal surveillance in the presence of an abnormal umbilical artery Doppler study or with biometry indicators of fetal compromise. MAIN OUTCOME MEASURES: Standard obstetric (mode of delivery, perinatal mortality, hypertension, antenatal admissions and gestation at delivery) and neonatal (5 minute Apgar scores <5, admissions to neonatal nursery and requirements for ventilation) outcomes and statistical analysis was on intention-to-treat. There were no significant differences between the two groups with respect to demography, antenatal, peripartum and neonatal outcomes. There was no difference in the perinatal mortality rate in the no Doppler group (n = 264), which was 11/1000 live births, and the Doppler group (n = 262), which was 9/1000 live births. There were three unexplained intrauterine deaths in the no Doppler group and none in the Doppler group (OR 0.14, 95% CI 0.01-1.31). Two intrauterine deaths in the Doppler group were due to cord prolapse in labour and a fetomaternal haemorrhage, both very unlikely to be influenced by Doppler surveillance. CONCLUSIONS: In this study, close surveillance in twin pregnancy resulted in a lower than expected fetal mortality from 25 weeks of gestation in both the no Doppler and Doppler groups. The lower rate of unexplained fetal death in the no Doppler group was not significantly different from the Doppler group.

Adult↗