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Results for “Randomised Controlled Trial”

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PubMed1998

Diabetes care in general practice: meta-analysis of randomised control trials.

OBJECTIVE: To assess the effectiveness of care in general practice for people with diabetes. DESIGN: Meta-analysis of randomised trials comparing general practice and shared care with follow up in hospital outpatient clinic. IDENTIFICATION: Trials were identified from searches of eight bibliographic and research databases. RESULTS: Five trials identified included 1058 people with diabetes, overall mean age 58.4 years, receiving hospital outpatient follow up for their diabetes. Results were heterogeneous between trials. In shared care schemes featuring more intensive support through a computerised prompting system for general practitioners and patients, there was no difference in mortality between care in hospital and care in general practice (odds ratio 1.06, 95% confidence interval 0. 53 to 2.11); glycated haemoglobin tended to be lower in primary care (weighted difference in means of -0.28%, -0.59% to 0.03%); and losses to follow up were significantly lower in primary care (odds ratio 0.37, 0.22 to 0.61). However, schemes with less well developed support for family doctors were associated with adverse outcomes for patients. CONCLUSIONS: Unstructured care in the community is associated with poorer follow up, worse glycaemic control, and greater mortality than in hospital care. Computerised central recall, with prompting for patients and their family doctors, can achieve standards of care as good as or better than hospital outpatient care, at least in the short term. The evidence supports provision of regular prompted recall and review of selected people with diabetes by willing general practitioners. This can be achieved if suitable organisation is in place.

Blood Pressure↗

PubMed2006

Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials.

BACKGROUND: No drugs are approved for treatment of premature ejaculation. Our aim was to determine the efficacy and tolerability of on-demand dapoxetine in patients with severe premature ejaculation. METHODS: We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature ejaculation in stable, heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as needed, 1-3 h before anticipated sexual activity). The primary endpoint was intravaginal ejaculatory latency time (IELT) measured by stopwatch. Safety and tolerability were assessed. All analyses were done on an intention-to-treat basis. The trials are registered at ClinicalTrials.gov, numbers NCT00211107 and NCT00211094. FINDINGS: 672, 676, and 610 patients completed in the placebo, 30 mg dapoxetine, and 60 mg dapoxetine groups, respectively. Dapoxetine significantly prolonged IELT (p<0.0001, all doses vs placebo). Mean IELT at baseline was 0.90 (SD 0.47) minute, 0.92 (0.50) minute, and 0.91 (0.48) minute, and at study endpoint (week 12 or final visit) was 1.75 (2.21) minutes for placebo, 2.78 (3.48) minutes for 30 mg dapoxetine, and 3.32 (3.68) minutes for 60 mg dapoxetine. Both dapoxetine doses were effective on the first dose. Common adverse events (30 mg and 60 mg dapoxetine, respectively) were nausea (8.7%, 20.1%), diarrhoea (3.9%, 6.8%), headache (5.9%, 6.8%), and dizziness (3.0%, 6.2%). INTERPRETATION: On-demand dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation.

Adult↗

PubMed1998

5-Fluorouracil and cisplatin as palliative treatment of advanced oesophageal squamous cell carcinoma. A multicentre randomised controlled trial. The French Associations for Surgical Research.

OBJECTIVE: To compare chemotherapy with no chemotherapy as palliative treatment for oesophageal squamous cell carcinoma. DESIGN: Randomised study. SETTING: Multicentre trial in France. SUBJECTS: Of 161 patients with histologically confirmed oesophageal squamous cell carcinoma located more than 5 cm from the mouth of the oesophagus, five were withdrawn because of protocol violation. The remaining 156 patients, 149 men and 7 women, mean (SD) age 58 (9) years range 36 to 77, were randomly allocated to either a control group without chemotherapy (n = 84) or a group treated by chemotherapy (n = 72). Patients were divided into four strata: I = complete resection of the tumour but with lymph node involvement (n = 62); II = incomplete resection of tumour leaving gross tumour behind (n = 58); III = no resection because of local or regional invasion (n = 22) ; and IV = no resection because of distant metastasis (n = 14). Exclusion criteria were histologically confirmed tracheobronchial involvement, oesophagotracheal fistula, Karnosky score < 50, cerebral metastases, or hepatic metastases occupying more than 30% of the liver, peritoneal carcinomatosis, associated or previously treated ear-nose-throat carcinoma, or complete resection of tumour without lymph node involvement. INTERVENTIONS: 5 fluorouracil (5FU) and cisplatin (CDDP) were given in 5-day courses, once every 28 days, for a maximum of eight cycles. 5 FU, 1 g/m2, was infused for 24 hours after a water overload, during five days. Cisplatin was given either in one dose of 100 mg/m2 at the beginning of the cycle or 20 mg/m2/day over three hours for five days. Duration of treatment ranged from 6-8 months. OUTCOME MEASURES: Median and actuarial survival. The subsidiary endpoint was quality of survival judged by complications of treatment, swallowing disorders, and the duration of ability to feed normally. RESULTS: There was no difference in survival, either overall (median = 12 months) or in any of the strata. There were however significantly more patients with neurological (p < 0.003), haematological (p < 0.0001), and renal (p < 0.0002) complications in the treated group compared with the control group. Four patients (6%) died of complications of chemotherapy. The course of swallowing disorders did not differ between the two groups. The duration of autonomous oral feeding was exactly the same in both groups (median = 10.5 months). CONCLUSION: The results suggest that 5FU and CDDP do not help in patients with squamous cell carcinoma of the oesophagus whether or not the tumour has been resected.

Adult↗

PubMed1998

Randomised controlled trial of combined diphtheria, tetanus, whole-cell pertussis vaccine administered in the same syringe and separately with Haemophilus influenzae type b vaccine at two, three and four months of age.

An open randomised controlled multicentre study compared the immunogenicity and reactogenicity of three vaccines given by injection at two, three and four months of age. Children (89) received Haemophilus influenzae type b (Hib) vaccine (SmithKline Beecham Biologicals [SB]) administered in the same syringe with combined diphtheria-tetanus-whole-cell pertussis (DTPw) vaccine (Evans); 75 received Hib vaccine (SB) administered as a separate injection with DTPw vaccine; 66 received Hib vaccine (Pasteur Merieux [PM]) administered as a separate injection with DTPw vaccine. All subjects in both groups receiving Hib (SB) vaccine had levels of antibodies to the Hib polysaccharide polyribosylribitol phosphate (PRP) greater than 0.15 microgram ml-1 as did 97% of those receiving Hib (PM) vaccine 1 month after administration of the final vaccine dose. Subjects in all three groups demonstrated an immunological response to pertussis, diphtheria and tetanus antigens. The geometric mean titres of the group given Hib (SB) and DTPw vaccine mixed in the same syringe were lower than the other groups. There were no apparent differences between the treatment groups in the incidence of local or systemic reactions, or serious adverse events. This study has confirmed that it is possible to halve the number of injections necessary to offer protection, with advantages to parents, children, doctors and nurses, using a combined DTPwHib vaccine and in accordance with the UK's accelerated primary immunisation schedule at two, three and four months of age.

Antibodies↗

PubMed2000

Randomised controlled trial of thiopental for intubation in neonates.

AIMS: To determine the effects of premedication with thiopental on heart rate, blood pressure, and oxygen saturation during semi-elective nasotracheal intubation in neonates. METHODS: A randomised, placebo controlled, non-blinded study design was used to study 30 neonates (mean birthweight 3.27 kg) requiring semi-elective nasotracheal intubation. The babies were randomly allocated to receive either 6 mg/kg of thiopental (study group) or an equivalent volume of physiological saline (control group) one minute before the start of the procedure. Six infants were intubated primarily and 24 were changed from orotracheal to a nasotracheal tube. The electrocardiogram, arterial pressure wave, and transcutaneous oxygen saturation were recorded continuously 10 minutes before, during, and 20 minutes after intubation. Minute by minute measurements of heart rate, heart rate variability, mean blood pressure (MBP) and transcutaneous oxygen saturation (SpO(2)) were computed. The differences for all of these between the baseline measurements and those made during and after intubation were determined. Differences in the measurements made in the study and the control groups were compared using Student's t test. RESULTS: During intubation, heart rate increased to a greater degree (12.0 vs -0.5 beats per minute, p < 0.03) and MBP increased to a lesser degree (-2.9 vs 4.4 mm Hg; p < 0.002) in the infants who were premedicated with thiopental. After intubation only the changes in MBP differed significantly between the two groups (-3.8 vs 4.6 mm Hg; p < 0.001). There were no significant changes in the oxygen saturation between the two groups during or after intubation. The time taken for intubation was significantly shorter in the study group (p < 0.04). CONCLUSIONS: The heart rate and blood pressure of infants who are premedicated with thiopental are maintained nearer to baseline values than those of similar infants who receive no premedication. Whether this lessening of the acute drop in the heart rate and increase in blood pressure typically seen during intubation of unmedicated infants is associated with long term advantages to the infants remains to be determined.

Birth Weight↗

PubMed1998

Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants.

AIM: To assess the safety and efficacy of EMLA cream (eutectic mixture of local anaesthetics) used to induce surface anaesthesia for venepuncture in healthy preterm infants. METHODS: Nineteen infants, median gestational age 31 weeks (range 26-33 weeks) were assessed in a randomised, double blind, placebo controlled, cross-over trial. Changes in physiological variables (heart rate, blood pressure, oxygen saturation) and behavioural responses (neonatal facial coding system score, crying time) before and after venepuncture with EMLA cream were compared with those obtained with a placebo cream to assess efficacy. Toxicity was assessed by comparing methaemoglobin concentrations at 1 hour and 8 hours after application. RESULTS: There was no significant difference in efficacy between EMLA and placebo creams in physiological and behavioural responses. There was no significant difference in methaemoglobin concentrations one hour after the cream had been applied. At eight hours, however, concentrations were significantly higher after EMLA than placebo (p = 0.016). There was no evidence of clinical toxicity. CONCLUSION: This study does not support the routine use of EMLA for venepuncture in healthy preterm infants.

Anesthesia, Local↗

PubMed2001

Randomised controlled trial of the effect of cisapride on the pyloric muscle in preterm infants.

UNLABELLED: In this study we determined the effects of cisapride on the pyloric muscle in preterm infants. To perform a randomised, double blind, placebo controlled study, two groups each of 16 preterm newborns were given either cisapride (0.2 mg/kg every 8 h) or a placebo for at least 7 days. Infants were studied first on the day when treatment with cisapride or placebo was to be initiated (time 0), and then after 3 (time 1) and 7 days (time 2). In each group, the following parameters were studied by ultrasonography: cross-sectional diameter of the entire pylorus, muscle thickness, and length of the pyloric canal. Also, the mean daily total gastric aspirate volume was studied for the entire week of the study. At time 0, we observed no significant differences between the two groups with respect to diameter, muscle thickness and length of the pyloric muscle. At time 1 and time 2, both diameter and muscle thickness were significantly greater in the cisapride group than in the placebo group. Furthermore, the length of the pyloric canal was significantly greater in the cisapride group than in placebo group at time 2, though not so at time 1. For the entire week of the study, we found a significantly larger mean daily total gastric aspirate volume in the group of infants treated with cisapride compared to the placebo treated group. CONCLUSION: Cisapride significantly affects all of the main measurements of the pyloric muscle and causes a significantly larger amount of daily total gastric aspirate volume. Its use to promote feeding intolerance in preterm newborns cannot be recommended.

Analysis of Variance↗

PubMed2001

A randomised controlled trial of epidural compared with non-epidural analgesia in labour.

OBJECTIVES: To investigate possible short and long term side effects of epidural analgesia, compared with non-epidural analgesia for pain relief in labour. DESIGN: Randomised controlled study, with long term follow up by questionnaire. Analysis by intention-to-treat. SETTING: Busy maternity unit within a district general hospital in England. PARTICIPANTS: Three hundred and sixty nine primigravid women in labour were included (randomised allocation: epidural n = 184, non-epidural n = 185). MAIN OUTCOME MEASURES: Backache at three and twelve months after delivery, instrumental delivery rates and maternal opinion of pain relief in labour. RESULTS: No significant differences were found in the reported incidence of backache between the groups at three months: middle backache [22% vs 20%, chi2 = 0.057, P = 0.81; odds ratio (95% CI) 1.4(0.9-2.3)]; low backache [35% vs 34%, chi2 = 0.009, P = 0.92; odds ratio (95% CI) 1.0(0.6-1.6)]. Nor were there significant differences at 12 months: [middle backache 16% vs 16%, chi2 = 0.013, P = 0.91; odds ratio (95% CI) 1.0(0.5-1.8)]; or low backache [35% vs 27%, chi2 = 1.91, P = 0.17; odds ratio (95% CI) 1.4(0.9-2.3)]. The incidence of instrumental delivery was somewhat higher in the epidural group [30% vs 19%, odds ratio (95% CI) 1.77(1.09-2.86)]. Maternal satisfaction was not significantly different between the groups. CONCLUSIONS: This study provided no evidence to support the suggestion of a direct association between the use of epidural anaesthesia in labour and the incidence of long term backache. Despite a significant proportion of women in each group not receiving their allocated analgesia, a significant difference in terms of instrumental delivery rates remained. Satisfaction in both groups of women was high.

Adult↗

PubMed2006

A double-blind, randomised, controlled trial to study the effects of an enteral feed supplemented with glutamine, arginine, and omega-3 fatty acid in predicted acute severe pancreatitis.

CONTEXT: Current best evidence is in favour of early institution of enteral feeding in acute severe pancreatitis with promising results from trials in immunonutrition on other patient groups. OBJECTIVE: To identify which groups of patients and products are associated with benefit, we investigated immunonutrition in patients with predicted acute severe pancreatitis. DESIGN: A randomised trial of a study feed containing glutamine, arginine, tributyrin and antioxidants versus an isocaloric isonitrogenous control feed was undertaken. PATIENTS: Thirty-one patients with a diagnosis of acute pancreatitis predicted to develop severe disease: 15 study feeds and 16 control feeds. INTERVENTIONS: Enteral feeding via nasojejunal tube for 3 days. If patients required further feeding the study was continued up to 15 days. MAIN OUTCOME MEASURES: Reduction in C-reactive protein (CRP) by 40 mg/L after 3 days of enteral feeding was the primary endpoint. Carboxypeptidase B activation peptide (CAPAP) levels were taken at regular intervals. RESULTS: After 3 days of feeding, in the study group 2/15 (13%) of patients had reduced their CRP by 40 mg/L or more. In the control group 6/16 (38%) of patients had reduced their CRP by this amount. This difference was found to be near the statistical significant limit (P=0.220). CONCLUSIONS: The cause of the unexpectedly higher CRP values in the study group is unclear. The rise in CRP was without a commensurate rise in CAPAP or outcome measures so there was no evidence that this represented pancreatic necrosis. The contrast between the CRP and CAPAP results is of interest and we believe that specific pancreatic indices such as CAPAP should be considered in larger future studies.

Acute Disease↗

PubMed1986

Maintenance chemotherapy for anaplastic small cell carcinoma of the bronchus: a randomised, controlled trial.

Since March 1980, 309 patients with anaplastic small cell carcinoma of the bronchus (ASCB) have received remission induction therapy prior to randomisation to maintenance (M) or no maintenance (NM) chemotherapy. Induction therapy consisted of six courses of vincristine, doxorubicin and cyclophosphamide (VAC) given IV every 3 weeks. Those with limited disease also received mediastinal irradiation. Consenting patients with no unequivocal residual disease were randomised to have no further treatment until relapse or a further eight courses of VAC, at a lower dosage, every 4 weeks. Patients failing to achieve randomisation status received palliative treatment only. The median survival for all patients with limited disease (LD) is 363 days and that for patients with extensive disease (ED) is 272 days (P less than 0.00001). Sixty-one patients with ED were randomised. Those having maintenance chemotherapy lived significantly longer (median 372 days) than those who did not continue therapy (median 259 days) (P = 0.006). An imbalance in the proportion of 'complete remitters' randomised to maintenance therapy does not account for this difference. There is no significant difference between the M and NM groups in the 32 randomised LD patients. Continuing treatment during remission with agents used to induce the remission can prolong survival in patients with extensive stage ASCB.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2002

Economic comparison of leflunomide and methotrexate in patients with rheumatoid arthritis: an evaluation based on a 1-year randomised controlled trial.

OBJECTIVE: To compare disease-related medical care and productivity costs, and utilities, in 482 patients with rheumatoid arthritis randomised to receive leflunomide, methotrexate or placebo during a 12-month period. DESIGN AND SETTING: Prospective pharmacoeconomic analysis of a 1-year randomised double-blind trial set in North America. PERSPECTIVE: Societal and the Ontario Ministry of Health. METHODS: Information on healthcare resources, out-of-pocket expenses, loss of working time and time spent on chores, related to the disease or the medication, were collected at 4-week intervals and at study discontinuation. Rating scale and standard gamble (SG) utilities (0 = worse; 100 = best) were collected at baseline and at 6 and 12 months or study exit. Medical care costs in Canadian dollars (Can dollars) were calculated using Ontario reimbursement schedules. US patients' expenses were converted to Can dollars using 1995 purchasing power parity. Lost wages were calculated by age and gender according to 1995 Canadian wage data. All costs were adjusted to 1999 Can dollars and arithmetic mean costs were compared using the nonparametric bootstrap. Analysis of covariance was performed to compare utilities between groups. RESULTS: Mean (standard deviation) rating scale values and SG utilities, respectively, for leflunomide, methotrexate and placebo were 67.7 (18.0), 64.8 (18.1) and 57.5 (9.2), and 80.2 (22.1), 83.2 (18.0) and 77.0 (20.5). Both leflunomide and methotrexate had higher rating scale values (p < 0.05) compared with placebo; SG utilities were significantly different between methotrexate and placebo (p < 0.05). Annualised total rheumatoid arthritisb- or drug-related costs for leflunomide, methotrexate and placebo, respectively, were Can dollars 1761, Can dollars 1280 and Can dollars 1324, and medical care costs were Can dollars 753, Can dollars 620 and Can dollars 167 (all costs exclude drug acquisition and monitoring costs). Annual drug acquisition/ routine monitoring costs were estimated, respectively, at Can dollars 3853/Can dollars 483 for leflunomide and Can dollars 258/Can dollars 599 for methotrexate. Differences between overall costs (excluding drug acquisition and monitoring costs) and medical care costs were not statistically significant. The costs of treating patients with leflunomide were significantly higher than for methotrexate when drug acquisition and monitoring costs were included (p < 0.0001). CONCLUSIONS: No statistically significant differences in utilities could be found between leflunomide or methotrexate. When drug monitoring and acquisition costs are excluded, leflunomide has an otherwise similar economic profile compared with methotrexate, the current gold standard. The acquisition cost of leflunomide is a driving factor in increasing the costs of therapy. These higher costs need to be assessed relative to the therapeutic value of leflunomide.

Adolescent↗

PubMed2002

Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial.

BACKGROUND: Nonoxynol-9 (rINN, nonoxinol-9) is an over-the-counter spermicide that has in-vitro anti-HIV-1 activity. Results of studies of its effectiveness in prevention of HIV-1 infection in women have been inconclusive. We aimed to assess effectiveness of this vaginal gel. METHODS: We did a randomised, placebo-controlled, triple-blinded, phase 2/3 trial with COL-1492, a nonoxynol-9 vaginal gel, in 892 female sex workers in four countries: Benin, Côte d'Ivoire, South Africa, and Thailand. 449 women were randomly allocated nonoxynol-9 and 443 placebo. Primary endpoint was incident HIV-1 infection. Secondary endpoints included Neisseria gonorrhoeae and Chlamydia trachomatis infections. Analysis was by intention to treat. FINDINGS: 765 women were included in the primary analysis. HIV-1 frequency in nonoxynol-9 users was 59 (16%) of 376 compared with 45 (12%) [corrected] of 389 in placebo users (402.5 vs 435.0 woman-years; hazard ratio adjusted for centre 1.5; 95% CI 1.0-2.2; p=0.047). 239 (32%) women reported use of a mean of more than 3.5 applicators per working day, and in these women, risk of HIV-1 infection in nonoxynol-9 users was almost twice that in placebo users (hazard ratio 1.8; 95% CI 1.0-3.2). 516 (68%) women used the gel less frequently than 3.5 times a day, and in these, risk did not differ between the two treatments. No significant effect of nonoxynol-9 on N gonorrhoeae (1.2; 0.9-1.6) or C trachomatis (1.2; 0.8-1.6) infections was reported. INTERPRETATION: This study did not show a protective effect of COL-1492 on HIV-1 transmission in high-risk women. Multiple use of nonoxynol-9 could cause toxic effects enhancing HIV-1 infection. This drug can no longer be deemed a potential HIV-1-prevention method. Assessment of other microbicides should continue.

Adult↗

PubMed2006

Treatment of alcoholic polyneuropathy with vitamin B complex: a randomised controlled trial.

AIMS: To evaluate the therapeutic efficacy and safety of BEFACT Forte 'new formulation' and BEFACT Forte 'old formulation' in the treatment of sensory symptoms of alcoholic polyneuropathy. METHODS: A multi-centre, randomised, double-blind, placebo-controlled study was conducted on 325 patients with sensory symptoms and signs of alcoholic polyneuropathy. Patients were randomised to the 'old formulation' (i.e. vitamins B1, B2, B6, and B12), 'new formulation' [i.e. identical to the 'old formulation' with additional folic acid (vitamin B9)], or placebo in a 1:1:1 ratio. One tablet of the study medication ('new formulation' or 'old formulation') or placebo was taken orally, three times a day, over a 12-week treatment period. RESULTS: Therapeutic efficacy was assessed in 253 patients by measuring vibration perception threshold (biothesiometry), intensity of pain, sensory function, co-ordination, and reflex responses. Patients treated with the 'new formulation' or 'old formulation' showed significant improvement in the primary efficacy endpoint (vibration perception threshold at the big toe) and secondary efficacy endpoints in comparison to placebo. The active treatment groups were comparable to placebo in terms of safety. CONCLUSIONS: A specific vitamin B complex (with and without folic acid) significantly improved symptoms of alcoholic polyneuropathy over a 12-week treatment period.

Alcoholic Neuropathy↗

PubMed2006

Can atrial fibrillation with a coarse electrocardiographic appearance be treated with catheter ablation of the tricuspid valve-inferior vena cava isthmus? Results of a multicentre randomised controlled trial.

OBJECTIVE: To see if strategy of ablating the tricuspid annulus-inferior vena cava isthmus (TV-IVC) is superior to electrical cardioversion to prevent recurrences in patients with coarse atrial fibrillation. DESIGN: Prospective randomised controlled multicentre study. SETTING: Four tertiary referral hospitals in the UK. PATIENTS: 57 patients with persistent coarse atrial fibrillation (irregular P waves > or =0.15 mV in > or =1 ECG lead). INTERVENTIONS: Patients were randomised to receive external cardioversion (group A, n = 30) or TV-IVC ablation +/- DC cardioversion (group B, n = 27). MAIN OUTCOME MEASURES: Cardiac rhythm, scores on quality of life and symptom questionnaires were assessed at 4, 16 and 52 weeks after the procedure. RESULTS: 20 (67%) patients in group A and 19 (70%) patients in group B were in sinus rhythm immediately after their index procedure. At 4, 16 and 52 weeks, the number of patients in sinus rhythm were 5, 3 and 2 in group A and 3, 3 and 1 in group B (p = NS). The quality of life and symptom questionnaire scores were similar in the two groups at each period of follow-up, although they were significantly better for sinus rhythm than for atrial fibrillation at each follow-up visit. CONCLUSIONS: As a first-line strategy, TV-IVC ablation offers no advantages over direct current cardioversion for the management of coarse atrial fibrillation.

Atrial Fibrillation↗

PubMed2005

A randomised controlled trial of the effects of albendazole in pregnancy on maternal responses to mycobacterial antigens and infant responses to Bacille Calmette-Guérin (BCG) immunisation [ISRCTN32849447].

BACKGROUND: Maternal schistosomiasis and filariasis have been shown to influence infant responses to neonatal bacille Calmette-Guérin (BCG) immunisation but the effects of maternal hookworm, and of de-worming in pregnancy, are unknown. METHODS: In Entebbe, Uganda, we conducted a randomised, double-blind, placebo-controlled trial of a single dose of 400 mg of albendazole in the second trimester of pregnancy. Neonates received BCG. Interferon-gamma (IFN-gamma) and interleukin (IL)-5 responses to a mycobacterial antigen (crude culture filtrate proteins (CFP) of Mycobacterium tuberculosis) were measured in a whole blood assay. We analysed results for binary variables using chi2 tests and logistic regression. We analysed continuous variables using Wilcoxon's tests. RESULTS: Maternal hookworm was associated with reduced maternal IFN-gamma responses to CFP (adjusted odds ratio for IFN-gamma > median response: 0.14 (95% confidence interval 0.02-0.83, p = 0.021). Conversely, maternal hookworm was associated with subsequent increased IFN-gamma responses in their one-year-old infants (adjusted OR 17.65 (1.20-258.66; p = 0.013)). Maternal albendazole tended to reduce these effects. CONCLUSION: Untreated hookworm infection in pregnancy was associated with reduced maternal IFN-gamma responses to mycobacterial antigens, but increased responses in their infants one year after BCG immunisation. The mechanisms of these effects, and their implications for protective immunity remain, to be determined.

Adult↗

PubMed2004

Worksite health promotion using individual counselling and the effectiveness on sick leave; results of a randomised controlled trial.

AIMS: To investigate the effectiveness of a worksite health promotion programme by individual counselling on sick leave. METHODS: Three municipal services of Enschede, the Netherlands, participated in this trial. A total of 299 civil servants were measured at baseline and were randomised by cluster into the intervention (n = 131) or the control group (n = 168). During nine months, subjects in the intervention group received a total of seven consultations, particularly aimed at increasing their physical activity level and improving their dietary habits. Both the intervention and the control subjects received written information as to several lifestyle factors. Sick leave data regarding the nine month intervention period (from May until January) were collected from each municipal service's personnel department. In addition, sick leave data concerning the nine month period pre- and post-intervention were collected. Sick leave data were analysed using multilevel analysis. RESULTS: For both groups, the mean sick leave rate during the intervention increased compared to before the intervention. After the intervention period, the control group increased even more (from 22.9 to 27.6 days), whereas the intervention group slightly decreased (from 21.5 to 20.5 days). Median values of sick leave rate decreased for both groups. No statistically significant intervention effect was found. In both groups, the mean sick leave frequency slightly decreased over time (intervention effects were not significant). CONCLUSIONS: Results showed no significant effect of individual counselling on sick leave. Continued research investigating the effectiveness of this individual counselling programme on several health related outcomes is useful to clarify the trend observed in sick leave.

Adult↗

PubMed2000

Subjective imagery in obsessive-compulsive disorder before and after exposure therapy. Pilot randomised controlled trial.

BACKGROUND: Distressing mental imagery is hard to study experimentally in obsessive--compulsive disorder (OCD). AIMS: To develop a way to assess mental imagery in OCD during functional magnetic resonance imaging (fMRI). METHOD: A small randomised study, controlled for type and order of mental imagery and for treatment condition (exposure therapy guided by a computer or by a therapist, or relaxation guided by audio-tape). Before and after treatment, during fMRI scanning, patients imagined previously-rehearsed scenarios that evoked an urge to ritualise or non-OCD anxiety or a neutral state, and rated their discomfort during imagery. RESULTS: The method evoked greater discomfort during OCD imagery and anxiety (non-OCD) imagery than during neutral imagery. Discomfort was reduced by cancelling imagery. Discomfort during OCD imagery (but not during anxiety non-OCD imagery) fell after exposure therapy but not after relaxation. CONCLUSIONS: Results showed differences between OCD and non-OCD images and their change after successful treatment, and confirmed clinical suggestions that cancelling images reduced OCD discomfort. The method's success paves the way for further studies of mental imagery in OCD: for instance, during fMRI.

Adult↗

PubMed2004

Rectal analgesia for the relief of perineal pain after childbirth: a randomised controlled trial of diclofenac suppositories.

OBJECTIVE: To evaluate rectal diclofenac in the relief of perineal pain after trauma during childbirth. DESIGN: A randomised, double-blind trial. SETTING: Delivery Suite, Women's and Children's Hospital, South Australia. POPULATION: Women with a second-degree (or greater) perineal tear or episiotomy. METHODS: Women were randomly allocated to either diclofenac or placebo suppositories (Anusol), using a computer-generated randomisation schedule with stratification for parity and mode of birth. Treatment packs contained two x 100 mg diclofenac or two placebo suppositories, the first being inserted when suturing was complete, and the second 12-24 hours after birth. Women were asked to complete questionnaires at 24 and 48 hours after birth relating to their degree of perineal pain using the validated Short Form McGill Pain Questionnaire. MAIN OUTCOME MEASURES: Pain scores at 24 and 48 hours after birth. RESULTS: A total of 133 women were recruited, with 67 randomised to diclofenac suppositories and 66 to placebo. Women in the diclofenac group were significantly less likely to experience pain at 24 hours while walking (RR 0.8; 95% CI 0.6 to 1.0), sitting (RR 0.8; 95% CI 0.6 to 1.0), passing urine (RR 0.6; 95% CI 0.4 to 1.0) and on opening their bowels (RR 0.6; 95% CI 0.2 to 0.9) compared with those women who received placebo. These differences were not sustained 48 hours after birth. CONCLUSIONS: The use of rectal non-steroidal anti-inflammatory drug suppositories is a simple, effective and safe method of reducing the pain experienced by women following perineal trauma within the first 24 hours after childbirth.

Administration, Rectal↗