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Results for “Randomised Controlled Trial”

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PubMed2006

Acupuncture for chronic neck pain: a pilot for a randomised controlled trial.

BACKGROUND: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. METHODS: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. RESULTS: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). CONCLUSION: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.

Acupuncture Therapy↗

PubMed1988

Balloon or bougie for dilatation of benign oesophageal stricture? An interim report of a randomised controlled trial.

Seventy one patients with benign oesophageal strictures were randomised to receive balloon or bougie dilatation. Sixty five patients were eligible for analysis. At the end of five months the balloon group had significantly more dysphagia and the calibre of the strictures in the balloon group had narrowed by a greater degree. The methods were equally safe and acceptable to patients. While the choice of the method of dilatation depends on the individual patient's needs and operator experience, bougie dilatation is more effective in reducing dysphagia and maintaining stricture patency.

Adult↗

PubMed2001

Effects of a flexible galantamine dose in Alzheimer's disease: a randomised, controlled trial.

OBJECTIVE: To assess the efficacy and safety of galantamine in Alzheimer's disease at 3 months using flexible dose escalation. METHODS: A randomised, double blind, placebo controlled trial in 43 centres in the United States, Canada, Great Britain, South Africa, Australia, and New Zealand. Patients with probable Alzheimer's disease (n=386; 171 women) with a score of 11-24 on the mini mental state examination, and a score> or =12 on the cognitive subscale of the Alzheimer's disease assessment scale (ADAS-cog) were randomised to placebo, or galantamine escalated over 4 weeks to a maintenance dose of 24 or 32 mg/day. The primary outcome measures were the change in ADAS-cog score and the clinician's interview based impression of change plus caregiver input (CIBIC-plus) score. Activities of daily living (ADL) and behavioural symptoms were secondary outcomes. To compare the effects of highest levels of dosing, an observed cases (OC) analysis was undertaken, with classic intention to treat (ITT) and ITT with last observation carried forward (LOCF) as confirmatory analyses. RESULTS: At 3 months, galantamine (24-32 mg/day) produced a significantly better outcome on cognitive function than placebo (treatment difference=1.9 points on ADAS-cog, p=0.002) and a significantly better global response than placebo, as measured by CIBIC-plus (deterioration in 21% of patients on galantamine v 37% on placebo; p<0.001). Galantamine produced significant benefits on basic and instrumental ADL. Behavioural symptoms did not change significantly from baseline levels in either group. Adverse events (primarily gastrointestinal) were of mild to moderate intensity. There were no important differences between the OC, ITT, and ITT/LOCF analyses. Most patients (82%) who were maintained on the higher dose of galantamine completed the study. CONCLUSIONS: Patients on galantamine, compared with those on placebo, experienced benefits in cognitive function and instrumental and basic activities of daily living. Flexible dose escalation of galantamine was well tolerated.

Activities of Daily Living↗

PubMed2000

Single-blind randomised controlled trial of chemonucleolysis and manipulation in the treatment of symptomatic lumbar disc herniation.

This single-blind randomised clinical trial compared osteopathic manipulative treatment with chemonucleolysis (used as a control of known efficacy) for symptomatic lumbar disc herniation. Forty patients with sciatica due to this diagnosis (confirmed by imaging) were treated either by chemonucleolysis or manipulation. Outcomes (leg pain, back pain and self-reported disability) were measured at 2 weeks, 6 weeks and 12 months. The mean values for all outcomes improved in both groups. By 12 months, there was no statistically significant difference in outcome between the treatments, but manipulation produced a statistically significant greater improvement for back pain and disability in the first few weeks. A similar number from both groups required additional orthopaedic intervention; there were no serious complications. Crude cost analysis suggested an overall financial advantage from manipulation. Because osteopathic manipulation produced a 12-month outcome that was equivalent to chemonucleolysis, it can be considered as an option for the treatment of symptomatic lumbar disc herniation, at least in the absence of clear indications for surgery. Further study into the value of manipulation at a more acute stage is warranted.

Adolescent↗

PubMed1998

A randomised controlled trial of general practitioner safety advice for families with children under 5 years.

OBJECTIVE: To assess effectiveness of general practitioner advice about child safety, and provision of low cost safety equipment to low income families, on use of safety equipment and safe practices at home. DESIGN: Randomised, unblinded, controlled trial with initial assessment and six week follow up by telephone survey. Twenty families from intervention and control groups were randomly selected for a home visit to assess validity of responses to second survey. SETTING: A general practice in Nottingham. SUBJECTS: 98% (165/169) of families with children aged under 5 years registered with the practice. INTERVENTIONS: General practitioner safety advice plus, for families receiving means tested state benefits, access to safety equipment at low cost. Control families received usual care. MAIN OUTCOME MEASURES: Possession and use of safety equipment and safe practices at home. RESULTS: Before intervention, the two groups differed only in possession of fireguards. After intervention, significantly more families in intervention group used fireguards (relative risk 1.89, 95% confidence interval 1.18 to 2.94), smoke alarms (1.14, 1.04 to 1.25), socket covers (1.27, 1.10 to 1.48), locks on cupboards for storing cleaning materials (1.38, 1.02 to 1.88), and door slam devices (3.60, 2.17 to 5.97). Also, significantly more families in intervention group showed very safe practice in storage of sharp objects (1.98, 1.38 to 2.83), storage of medicines (1.15, 1.03 to 1.28), window safety (1.30, 1.06 to 1.58), fireplace safety (1.84, 1.34 to 2.54), socket safety (1.77, 1.37 to 2.28), smoke alarm safety (1.11, 1.01 to 1.22), and door slam safety (7.00, 3.15 to 15.6). Stratifying results by receipt of state benefits showed that intervention was at least as effective in families receiving benefits as others. CONCLUSIONS: General practitioner advice, coupled with access to low cost equipment for low income families, increased use of safety equipment and other safe practices. These findings are encouraging for provision of injury prevention in primary care.

Accidents, Home↗

PubMed2004

Randomised controlled trial of effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux: Bristol helicobacter project.

OBJECTIVES: To investigate the effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux. DESIGN: Cross sectional study, followed by a randomised placebo controlled trial. SETTING: Seven general practices in Bristol, England. PARTICIPANTS: 10,537 people, aged 20-59 years, with and without H pylori infection (determined by the (13)C-urea breath test). MAIN OUTCOME MEASURES: Prevalence of heartburn and gastro-oesophageal acid reflux at baseline and two years after treatment to eradicate H pylori infection. RESULTS: At baseline, H pylori infection was associated with increased prevalence of heartburn (odds ratio 1.14, 95% confidence interval 1.05 to 1.23) but not reflux (1.05, 0.97 to 1.14). In participants with H pylori infection, active treatment had no effect on the overall prevalence of heartburn (0.99, 0.88 to 1.12) or reflux (1.04, 0.91 to 1.19) and did not improve pre-existing symptoms of heartburn or reflux. CONCLUSIONS: H pylori infection is associated with a slightly increased prevalence of heartburn but not reflux. Treatment to eradicate H pylori has no net benefit in patients with heartburn or gastro-oesophageal reflux.

Adult↗

PubMed1999

Neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: a randomised controlled trial. International collaboration of trialists.

BACKGROUND: Several non-randomised trials have shown that transitional-cell carcinoma of the bladder is a moderately chemosensitive tumour. We investigated whether the addition of neoadjuvant cisplatin-based chemotherapy to radical surgery or radiotherapy would improve survival. METHODS: Patients with T2 G3, T3, T4a, N0-NX, or M0 transitional-cell carcinoma of the bladder undergoing curative cystectomy or full-dose external-beam radiotherapy were randomly assigned three cycles of neoadjuvant chemotherapy (cisplatin, methotrexate, and vinblastine, with folinic acid rescue, n=491) or no chemotherapy (n=485). When possible, clinical tumour response was assessed cytoscopically after completion of chemotherapy but before cystectomy or radiotherapy; histopathologically assessed response was on cystectomy samples. We recorded every 6 months locoregional persistence or relapse of tumour, appearance of distant metastases, survival, and cause of death. FINDINGS: Median follow-up of patients still alive was 4.0 years. 485 patients died, and 78.6% of deaths were due to transitional-cell carcinoma. Chemotherapy mortality was 1% and operative (cystectomy) mortality was 3.7%. Kaplan-Meier curves compared by means of the log-rank test gave a calculated absolute difference between groups in 3-year survival of 5.5% (95% CI -0.5 to 11.0, p=0.075; 55.5% for chemotherapy, 50.0% for no chemotherapy). Median survival in the chemotherapy group was 44 months compared with 37.5 months for the no-chemotherapy group. 32.5% of cystectomy samples contained no tumour after neoadjuvant chemotherapy. INTERPRETATION: Three cycles of neoadjuvant chemotherapy before cystectomy or radiotherapy did not give the 10% improvement in 3-year survival that was judged to be necessary for introduction into routine use. The chemotherapy regimen was associated with a higher pathological complete-response rate in primary tumours, but there was no clear evidence that it would increase survival.

Aged↗

PubMed2003

Extracapsular cataract surgery compared with manual small incision cataract surgery in community eye care setting in western India: a randomised controlled trial.

AIM: To study "manual small incision cataract surgery (MSICS)" for the rehabilitation of cataract visually impaired and blind patients in community based, high volume, eye hospital setting; to compare the safety and effectiveness of MSICS with conventional extracapsular cataract surgery (ECCE). METHODS: In a single masked randomised controlled clinical trial, 741 patients, aged 40-90 years, with operable cataract were randomly assigned to receive either MSICS or ECCE and operated upon by one of eight participating surgeons. Intraoperative and postoperative complications were graded and scored according to the Oxford Cataract Treatment and Evaluation Team recommendations. The patients were followed up at 1 week, 6 weeks, and 1 year after surgery and their visual acuity recorded. RESULTS: This paper reports outcomes at 1 and 6 weeks. 706 of the 741(95.3%) patients completed the 6 week follow up. 135 of 362 (37.3%) of ECCE group and 165 of 344 (47.9%) of MSICS group had uncorrected visual acuity of 6/18 or better after 6 weeks of follow up. 314 of 362 (86.7%) of ECCE group and 309 of 344 (89.8%) of MSICS group had corrected postoperative vision of 6/18 or better. Four of 362 (1.1%) of ECCE group and six of 344 (1.7%) of MSICS group had corrected postoperative visual acuity less than 6/60. There were no significant differences between the two groups for intraoperative and severe postoperative complications. CONCLUSION: MSICS and ECCE are both safe and effective techniques for treatment of cataract patients in community eye care settings. MSICS needs similar equipment to ECCE, but gives better uncorrected vision.

Adult↗

PubMed1994

A randomised controlled trial of the effect of hormone replacement therapy on disease activity in postmenopausal rheumatoid arthritis.

OBJECTIVE: To assess the effects of hormone replacement therapy (HRT) on disease activity in postmenopausal rheumatoid arthritis (RA). METHODS: Two hundred postmenopausal outpatients (aged 45-65 years) were admitted into a single blind randomised placebo controlled trial of transdermal oestradiol (50 micrograms daily) over six months. Patients continued with routine antirheumatic medications. Compliance with HRT was monitored using serum oestradiol (E2) levels. Disease activity was monitored at entry, three and six months using erythrocyte sedimentation rate (ESR), articular index (AI), visual analogue pain scale (VPS) and early morning stiffness (EMS). RESULTS: Ninety one and 77 patients completed six months treatment with placebo and HRT respectively. There were no significant differences in baseline characteristics between the groups and no overall effects of treatment. However, 35 patients (41.6%), who completed HRT, failed to achieve serum E2 levels > 100 pmol/l at either three or six months and were considered 'poor-compliers'. In the remaining HRT 'compliers' (58.4%) there were significant improvements after six months in articular index (28.9%; p < 0.01) and pain score (21.7%; p < 0.05) compared with placebo, as well as reductions in ESR (8.9%; NS) and morning stiffness (25.2%; NS). Comparisons between HRT 'compliers' and 'poor-compliers' confirmed significant improvements in articular index (p < 0.001), pain score (p < 0.05) and morning stiffness (p < 0.001) in the 'compliers'. CONCLUSIONS: This study did not show an overall effect of HRT on disease activity when used as an adjunct therapy in postmenopausal patients. A subgroup of patients, who had greater increments in serum E2 whilst taking HRT, demonstrated improvements in some parameters of disease activity, suggesting a potential beneficial effect with good compliance and higher dose HRT. Most importantly, in the treatment of RA associated bone loss, HRT can be prescribed without fear of a disease flare up.

Aged↗

PubMed1999

Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomised controlled trial.

OBJECTIVES: To assess the effects of rivastigmine on the core domains of Alzheimer's disease. DESIGN: Prospective, randomised, multicentre, double blind, placebo controlled, parallel group trial. Patients received either placebo, 1-4 mg/day (lower dose) rivastigmine, or 6-12 mg/day (higher dose) rivastigmine. Doses were increased in one of two fixed dose ranges (1-4 mg/day or 6-12 mg/day) over the first 12 weeks with a subsequent assessment period of 14 weeks. SETTING: 45 centres in Europe and North America. PARTICIPANTS: 725 patients with mild to moderately severe probable Alzheimer's disease diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, and the criteria of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association. OUTCOME MEASURES: Cognitive subscale of the Alzheimer's disease assessment scale, rating on the clinician interview based impression of change incorporating caregiver information scale, and the progressive deterioration scale. RESULTS: At the end of the study cognitive function had deteriorated among those in the placebo group. Scores on the Alzheimer's disease assessment scale improved in patients in the higher dose group when compared with patients taking placebo (P<0.05). Significantly more patients in the higher dose group had improved by 4 points or more than had improved in the placebo group (24% (57/242) v 16% (39/238)). Global function as rated by the clinician interview scale had significantly improved among those in the higher dose group compared with those taking placebo (P<0.001), and significantly more patients in the higher dose group showed improvement than did in the placebo group (37% (80/219) v 20% (46/230)). Mean scores on the progressive deterioration scale improved from baseline in patients in the higher dose group but fell in the placebo group. Adverse events were predominantly gastrointestinal, of mild to moderate severity, transient, and occurred mainly during escalation of the dose. 23% (55/242) of those in the higher dose group, 7% (18/242) of those in the lower dose group, and 7% (16/239) of those in the placebo group discontinued treatment because of adverse events. CONCLUSIONS: Rivastigmine is well tolerated and effective. It improves cognition, participation in activities of daily living, and global evaluation ratings in patients with mild to moderately severe Alzheimer's disease. This is the first treatment to show compelling evidence of efficacy in a predominantly European population.

Activities of Daily Living↗

PubMed2002

Carotid sinus nerve blockade during carotid surgery: a randomised controlled trial.

OBJECTIVES: we investigated whether carotid sinus nerve infiltration with lignocaine reduced blood pressure lability during the first 24h following carotid endarterectomy (CEA). DESIGN: prospective randomised double-blind controlled trial. MATERIALS: eighty patients undergoing CEA for significant symptomatic stenosis of the internal carotid artery. METHODS: after initial dissection, 5 ml of 1% lignocaine or normal saline placebo according to randomisation was infiltrated around the carotid sinus nerve. Blood pressure was measured by intra-arterial cannula during surgery and for four hours afterwards every 15 min, then manually, hourly for 18 h. RESULTS: patients having excision of the carotid sinus nerve were grouped separately for analysis: 29 patients had lignocaine, 33 placebo and 17 excision (one early death with incomplete data was excluded). Mean systolic, diastolic and pulse pressures did not differ significantly between the three groups before carotid sinus nerve infiltration. After infiltration, those patients who had carotid sinus nerve excision, had significantly higher systolic [mean (SD)=155 (16)mmHg] and diastolic [75 (9)mmHg] pressures than those receiving LA [systolic=136 (15)mmHg, diastolic=65 (10)mmHg] or placebo [systolic=136 (19)mmHg, diastolic=65 (9)mmHg], (p<0.005 ANOVA). Nerve excision also resulted in wider variability of blood pressure as defined by the mean of individual standard deviations (systolic=25 mmHg, diastolic=13 mmHg) compared to LA (systolic=19 mmHg, diastolic=12 mmHg) or placebo (systolic=18 mmHg, diastolic=10 mmHg) (p<0.05 ANOVA). Normotensive patients had significantly lower mean diastolic pressures (p<0.001 ANOVA) and variability (p<0.05) if they received lignocaine although this did not influence pulse pressure. CONCLUSIONS: lignocaine injection of the carotid sinus nerve has no benefit in those patients with existing treated hypertension and only marginal effects in normotensives. It is more important to preserve the carotid sinus nerve if possible.

Aged↗

PubMed1992

Treatment of ulcerative colitis with fish oil supplementation: a prospective 12 month randomised controlled trial.

The effect of fish oil on the course of ulcerative colitis was investigated in a randomised blinded controlled study. Eighty seven patients received supplements of 20 ml HiEPA fish oil as triglyceride (4.5 g of eicosapentaenoic acid) or olive oil placebo daily for one year. The oils were given in addition to standard drug therapy and trial entry was stratified for disease activity. Fish oil significantly increased the eicosapentaenoic acid content of rectal mucosa to 3.2% of total fatty acids at six months, compared with 0.63% for patients on olive oil. This was associated with increased synthesis of leukotriene B5, and 53% suppression of leukotriene B4 synthesis by ionophore--stimulated neutrophils. Leukotriene B4 suppression persisted for at least two months after treatment was stopped. Treatment with fish oil resulted in measurable, but only limited clinical benefit. For patients entering the trial in relapse (n = 53), there was a significant reduction in corticosteroid requirement after one and two months treatment. There was a trend towards achieving remission (off corticosteroids) faster in the patients on fish oil, although differences were not significant. For patients in remission at trial entry or during the trial (n = 69), there was no significant difference in the rate of relapse by log rank analysis. We conclude that fish oil supplementation produces a modest corticosteroid sparing effect in active disease, but there is no benefit in maintenance therapy.

Adolescent↗

PubMed1987

Umbilical artery flow velocity waveforms in high-risk pregnancy. Randomised controlled trial.

300 patients at high fetal risk (mean gestational age 34 wk) were randomised to a group for antenatal doppler umbilical artery waveform studies and a control group. The timing of delivery was similar in the control and doppler-report-available groups overall. However, in the report group obstetricians allowed the pregnancies of those not selected for elective delivery to continue longer. There was no difference in the rates for elective delivery (induction of labour or caesarean section) in the two groups, whereas among those who went into labour (induced or spontaneous) emergency caesarean section was more frequent in the control group (23%) than in the report group (13%). Fetal distress in labour was also more common in the control group. Babies from the control group spent longer in neonatal intensive care (level 3) and needed more respiratory support than did those in the report group. The findings indicate that the availability of doppler studies leads to better obstetrical decision making.

Blood Flow Velocity↗

PubMed2004

Cost effectiveness of oral triptan therapy: a trans-national comparison based on a meta-analysis of randomised controlled trials.

OBJECTIVE: The objective of this study was to appraise the relative cost effectiveness of oral triptan therapy in the management of acute migraine, comparing the results obtained using drug cost data from six different countries, USA, UK, Canada, Germany, Italy and The Netherlands. METHOD: A meta-analysis of randomised placebo controlled trials of single dose oral triptans was carried out in order to calculate aggregate Numbers Needed to Treat (NNT) for each triptan and dose. Cost effectiveness ratios were then derived for each treatment by applying mean drug acquisition costs for each country to these NNTs. Using a graphical plot for each country, incremental cost effectiveness comparisons were then made versus sumatriptan 100 mg, the most commonly used oral triptan. RESULTS: When analysed in terms of 2-h pain one country to another. When compared to free outcomes, rizatriptan 10 mg and eletriptan 40 and 80 mg were the most effective oral triptans. Rizatriptan 10mg has the most advantageous absolute cost effectiveness ratio in all six countries studied, although levels of statistical significance compared to other agents varied from sumatriptan 100mg, rizatriptan 10 mg and eletriptan 40 mg are most consistently the cost effective treatment choices, both being cost dominant in five out of six countries studied. CONCLUSIONS: There are systematic differences in triptan efficacy that have an impact on treatment choice. Differences in pricing structure between countries mean that hierarchies of cost effectiveness will vary. Country-specific data should therefore be examined before defining treatment strategies.

Administration, Oral↗

PubMed2002

A randomised controlled trial investigating the effects of dopexamine on gastrointestinal function and organ dysfunction in the critically ill.

OBJECTIVE: To determine whether an infusion of dopexamine for up to 7 days has an effect on gastrointestinal (GIT) absorption and permeability, renal function or organ dysfunction in the critically ill. DESIGN AND SETTING: Prospective, randomised controlled clinical trial in two general adult intensive care units. PATIENTS: 102 critically ill adult patients predicted to require organ support for at least 4 days. INTERVENTIONS: After resuscitation patients were randomly assigned to receive an infusion of up to 2 mcg/kg/min [corrected] per minute of dopexamine or control. MEASUREMENTS AND RESULTS: GIT absorption and permeability were measured using the ratio of absorbed rhamnose to 3- O-methyl- D-glucose and the ratio of lactulose to rhamnose on days 1, 4 and 7. Creatinine clearance was measured concurrently. Daily Sequential Organ Failure Assessment scores were calculated. Fifty-two patients received dopexamine. No significant difference between the two groups emerged on any of the measured parameters during the study period. CONCLUSIONS: No benefit was seen from a prolonged infusion of dopexamine in this group of critically ill patients in terms of GIT absorption and permeability, creatinine clearance or organ dysfunction.

Creatinine↗

PubMed2006

A prospective double-blind randomised controlled trial of intraoperative pelvic instillation with bupivacaine for management of pain following laparoscopy and dye.

The aim of this randomised, double-blind, placebo-controlled trial was to evaluate the effectiveness of intraperitoneal instillation of bupivacaine following laparoscopy and dye test. Women received either 15 ml of 0.9% saline (n= 42) or 15 ml of 0.5% bupivacaine (n= 43), which was instilled intraperitoneally. Pain and nausea scores were recorded on a visual analogue scale (VAS). Pain perception was no different in the bupivacaine group compared with the control group with median values of VAS at 2 hours (18, 19; P= 0.8), 6 hours (21, 22; P= 0.5), 12 hours (19, 25; P= 0.8), 24 hours (27, 27; P= 0.9) and 48 hours (21, 13; P= 0.26). Women in the bupivacaine group were less nauseated than controls in the immediate postoperative period (with median VAS scores of 0, 8; P value = 0.03 at 2 hours and 0, 7; P= 0.01 at 6 hours).

Anesthetics, Local↗

PubMed2006

Oral misoprostol for induction of labour at term: randomised controlled trial.

OBJECTIVE: To compare oral misoprostol solution with vaginal prostaglandin gel (dinoprostone) for induction of labour at term to determine whether misoprostol is superior. DESIGN: Randomised double blind placebo controlled trial. SETTING: Maternity departments in three hospitals in Australia. Population Pregnant women with a singleton cephalic presentation at > or = 36+6 weeks' gestation, with an indication for prostaglandin induction of labour. INTERVENTIONS: 20 mug oral misoprostol solution at ourly intervals and placebo vaginal gel or vaginal dinoprostone gel at six hourly intervals and placebo oral solution. MAIN OUTCOME MEASURES: Vaginal birth within 24 hours; uterine hyperstimulation with associated changes in fetal heart rate; caesarean section (all); and caesarean section for fetal distress. RESULTS: 741 women were randomised, 365 to the misoprostol group and 376 to the vaginal dinoprostone group. There were no significant differences between the two treatment groups in the primary outcomes: vaginal birth not achieved in 24 hours (misoprostol 168/365 (46.0%) v dinoprostone 155/376 (41.2%); relative risk 1.12, 95% confidence interval 0.95 to 1.32; P = 0.134), caesarean section (83/365 (22.7%) v 100/376 (26.6%); 0.82, 0.64 to 1.06; P = 0.127), caesarean section for fetal distress (32/365 (8.8%) v 35/376 (9.3%); 0.91, 0.57 to 1.44; P = 0.679), or uterine hyperstimulation with changes in fetal heart rate (3/365 (0.8%) v 6/376 (1.6%); 0.55, 0.14 to 2.21; P = 0.401). Although there were differences in the process of labour induction, there were no significant differences in adverse maternal or neonatal outcomes. CONCLUSIONS: This trial shows no evidence that oral misoprostol is superior to vaginal dinoprostone for induction of labour. However, it does not lead to poorer health outcomes for women or their infants, and oral treatment is preferred by women. TRIAL REGISTRATION: National Health and Medical Research Council, Perinatal Trials, PT0361.

Administration, Intravaginal↗

PubMedDate not supplied

A randomised controlled trial of the caries-preventive efficacy of a chlorhexidine-containing varnish in high-caries-risk adolescents.

A professionally applied two-stage chlorhexidine varnish, Chlorzoin((R)), was developed to achieve sustained release and minimise the problems of staining and bad taste associated with chlorhexidine mouthrinses. The primary aim of this randomised controlled clinical trial was to assess the efficacy of Chlorzoin in reducing the caries increment in high-caries-risk adolescents. Secondary aims included investigating the effect of compliance upon caries increment, the effect of Chlorzoin upon salivary mutans streptococci levels and assessing the benefit of individual dental health advice by dental auxiliaries in a community setting. 1,240 children, initially aged 11-13 years, assessed to be at high caries risk were recruited into the trial. The trial design involved four arms: an observational group, a control group, an active (Chlorzoin) varnish group and a placebo varnish group. All subjects were examined annually by a calibrated examiner who was blind to the group allocation. Three-year caries increments were calculated using clinical, clinical and fibre-optic transillumination, and clinical and bitewing data sets. The results indicated that the use of Chlorzoin had an initial effect on mutans streptococci levels but that no long-term reduction in caries increment or mutans streptococci infection could be detected. One reason for this lack of efficacy may have been the regimen of reduced frequency of varnish applications after the initial period. Children who followed the protocol and, therefore, were seen regularly by dental auxiliaries had a lower caries increment than those who did not. This finding was independent of varnish allocation. In summary, under this regimen, Chlorzoin has been found to be effective in decreasing salivary mutans streptococci but ineffective as a caries-preventive agent in high-risk Scottish children when applied pragmatically in a community setting.

Adolescent↗