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Results for “Randomised Controlled Trial”

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PubMed2002

Improving maximum walking distance in early peripheral arterial disease: randomised controlled trial.

The purpose of this study was to determine the impact of increased physical activity and cessation of smoking on the natural history of early peripheral arterial disease. We conducted a randomised controlled trial in Perth, Western Australia, involving 882 men with early peripheral arterial disease identified via population-based screening using the Edinburgh Claudication Questionnaire and the ankle:brachial index. Members of the control group (n = 441) received "usual care" from their general practitioner while members of the intervention group (n = 441) were allocated to a "stop smoking and keep walking" regime - a combined community-based intervention of cessation of smoking (where applicable) and increased physical activity. Postal follow-up occurred at two and 12 months post-entry into the trial. The main outcome of interest was maximum walking distance. There were no statistically significant differences in the characteristics of the "intervention" and "usual care" groups at recruitment. Follow-up information at two and 12 months was available for 85% and 84% of participants, respectively. At 12 months, more men allocated to the intervention group had improved their maximum walking distance (23% vs 15%; chi2 = 9.74, df = 2, p = 0.008). In addition, more men in the intervention group reported walking more than three times per week for recreation (34% vs 25%, p = 0.01). Although not statistically significant, more men in the intervention group who were smokers when enrolled in the trial had stopped smoking (12% vs 8%, p = 0.43). It is concluded that referral of older patients with intermittent claudication to established physiotherapy programs in the community can increase levels of physical activity and reduce disability related to peripheral arterial disease. A combination of simple and safe interventions that are readily available in the community through physiotherapists and general practitioners has the potential to improve early peripheral arterial disease.

Activities of Daily Living↗

PubMedDate not supplied

Once versus three-times daily regimens of tobramycin treatment for pulmonary exacerbations of cystic fibrosis--the TOPIC study: a randomised controlled trial.

BACKGROUND: Intravenous tobramycin (three-times daily) is widely used for pulmonary exacerbations in patients with cystic fibrosis who have chronic Pseudomonas aeruginosa infection. We undertook a double-blind, randomised controlled trial to assess the safety and efficacy of once versus three-times daily tobramycin in these patients. METHODS: 244 patients from 21 cystic-fibrosis centres in the UK were randomly assigned to once or three-times daily tobramycin (with ceftazidime) for 14 days. Treatment was given as 30-min infusions of tobramycin in 0.9% saline. Primary outcome measure was change in forced expiratory volume in 1s (FEV1), over the 14 days of treatment, expressed as a percentage of the predicted normal value for age, sex, and height. We also measured the change in FEV1 expressed as a percentage of baseline. Secondary outcomes included change in serum creatinine. The study was powered for equivalence, and primary analysis was per protocol. FINDINGS: 219 patients (107 once daily, 112 three-times daily) completed the study per protocol. None was lost to follow-up, although 20 discontinued intervention. Of 122 patients assigned to once daily treatment, three did not receive the study regimen. The mean change in FEV1 (% predicted) over 14 days was similar on the two regimens (10.4% [once daily] vs 10.0% [three-times daily]; adjusted mean difference 0.4% [95% CI -3.3 to 4.1]). Mean% change in FEV1 from baseline was also similar in both treatments (21.9% vs 22.1%; -0.1% [-8.0 to 7.9]). There was no significant difference in% change in creatinine from baseline (-1.5% [once daily] vs 1.7% [three-times daily]). However, in children, once daily treatment was significantly less nephrotoxic than was thrice daily (mean% change in creatine -4.5% [once daily] vs 3.7% [thrice daily]; adjusted mean difference -8.0%, 95% CI -15.7 to -0.4). No patients developed hearing loss during the study, although two reported acute dizziness and were withdrawn from the study. INTERPRETATION: Intravenous tobramycin has equal efficacy if given once or three-times daily (with ceftazidime) for pulmonary exacerbations of cystic fibrosis. The once daily regimen might be less nephrotoxic in children.

Acetylglucosaminidase↗

PubMed2003

Randomised controlled trial of the effectiveness of feedback in improving test ordering in general practice.

OBJECTIVE: To assess the effectiveness of feedback on the number of pathology tests ordered by general practices. DESIGN: Randomised controlled trial. SETTING: General practices in two primary care groups in Leicestershire, UK. SUBJECTS: 58 general practitioners in 17 practices received guidelines then feedback at 3-month intervals for 1 year about the numbers of thyroid function, rheumatoid factor tests and urine cultures they ordered, and 38 general practitioners in 16 practices received guidelines then feedback about lipid and plasma viscosity tests. MAIN OUTCOME MEASURES: Numbers of tests requested per thousand patients registered with each practice. RESULTS; There were no changes in the numbers of tests per thousand requested in either of the study groups for any of the tests. CONCLUSIONS: Feedback did not have an influence on test ordering by general practitioners in this study. More intensive strategies may be required to change the use of laboratory tests.

Diagnostic Tests, Routine↗

PubMed2002

Short compared with standard duration of antibiotic treatment for urinary tract infection: a systematic review of randomised controlled trials.

AIMS: To compare the effectiveness of short course (2-4 days) with standard duration oral antibiotic treatment (7-14 days) for urinary tract infection (UTI). METHODS: Meta-analysis of randomised controlled trials using a random effects model. Ten trials were eligible, involving 652 children with lower tract UTI recruited from outpatient or emergency departments. Main outcome measures were UTI at the end of treatment, UTI during follow up (recurrent UTI), and urinary pathogens resistant to the treating antibiotic. RESULTS: There was no significant difference in the frequency of positive urine cultures between the short (2-4 days) and standard duration therapy (7-14 days) for UTI in children at 0-7 days after treatment (eight studies: RR 1.06; 95% CI 0.64 to 1.76) and at 10 days to 15 months after treatment (10 studies: RR 1.01; 95% CI 0.77 to 1.33). There was no significant difference between short and standard duration therapy in the development of resistant organisms in UTI at the end of treatment (one study: RR 0.57, 95% CI 0.32 to 1.01) or in recurrent UTI (three studies: RR 0.39, 95% CI 0.12 to 1.29). CONCLUSION: A 2-4 day course of oral antibiotics is as effective as 7-14 days in eradicating lower tract UTI in children.

Adolescent↗

PubMed1996

Specialist nurse support for patients with stroke in the community: a randomised controlled trial.

OBJECTIVE: To evaluate whether specialist nurse visits enhance the social integration and perceived health of patients with stroke or alleviate stress in carers in longer term stroke care. DESIGN: Stratified randomised controlled trial; both groups assessed at time of recruitment and at 3, 6, and 12 months. SETTING: Patients with disability related to new stroke who lived in their own homes in the Bradford Metropolitan District. SUBJECTS: 240 patients aged 60 years or over, randomly allocated to control group (n = 120) or intervention group (n = 120). Intervention--Visits by specialist outreach nurses over 12 months to provide information, advice, and support; minimum of six visits during the first six months. The control group received no visits. MAIN OUTCOME MEASURES: The Barthel index (functional ability), the Frenchay activities index (social activity), the Nottingham health profile (perceived health status). Stress among carers was indicated by the general health questionnaire-28 (28 items). The nurses recorded their interventions in trial diaries. RESULTS: There were no significant differences in perceived health, social activities, or stress among carers between the treatment and control groups at any of the assessments points. A subgroup of mildly disabled patients with stroke (Barthel index 15-19) had an improved social outcome at six months (Frenchay activities index, Median difference 3 (95% confidence interval 0 to 6; P = 0.03) and for the full 12 months of follow up (analysis of covariance P = 0.01) compared with the control group. CONCLUSIONS: The specialist nurse intervention resulted in a small improvement in social activities only for the mildly disabled patients. No proved strategy yet exists that can be recommended to address the psychosocial difficulties of patients with stroke and their families.

Aged↗

PubMed2000

Determination of who may derive most benefit from aspirin in primary prevention: subgroup results from a randomised controlled trial.

OBJECTIVE: To determine which groups of patients may derive particular benefit or experience harm from the use of low dose aspirin for the primary prevention of coronary heart disease. DESIGN: Randomised controlled trial. SETTING: 108 group practices in the Medical Research Council's general practice research framework who were taking part in the thrombosis prevention trial. PARTICIPANTS: 5499 men aged between 45 and 69 years at entry who were at increased risk of coronary heart disease. MAIN OUTCOME MEASURES: Myocardial infarction, coronary death, and stroke. RESULTS: Aspirin reduced coronary events by 20%. This benefit, mainly for non-fatal events, was significantly greater the lower the systolic blood pressure at entry (interaction P=0.0015), the relative risk at pressures 130 mm Hg being 0.55 compared with 0.94 at pressures >145 mm Hg. Aspirin also reduced strokes at low but not high pressures, the relative risks being 0.41 and 1.42 (P=0.006) respectively. The relative risk of all major cardiovascular events-that is, the sum of coronary heart disease and stroke-was 0.59 at pressures <130 mm Hg compared with 1.08 at pressures >145 mm Hg (P=0.0001). CONCLUSION: Even with the limitations of subgroup analyses the evidence suggests that the benefit of low dose aspirin in primary prevention may occur mainly in those with lower systolic blood pressures, although it is not clear even in these men that the benefit outweighs the potential hazards. Men with higher pressures may be exposed to the risks of bleeding while deriving no benefit through reductions in coronary heart disease and stroke.

Aged↗

PubMed2001

Compliance, satisfaction, and quality of life of patients with colorectal cancer receiving home chemotherapy or outpatient treatment: a randomised controlled trial.

OBJECTIVE: To compare chemotherapy given at home with outpatient treatment in terms of colorectal cancer patients' safety, compliance, use of health services, quality of life, and satisfaction with treatment. DESIGN: Randomised controlled trial. SETTING: Large teaching hospital. PARTICIPANTS: 87 patients receiving adjuvant or palliative chemotherapy for colorectal cancer. INTERVENTIONS: Treatment with fluorouracil (with or without folinic acid or levamisole) at outpatient clinic or at home. MAIN OUTCOME MEASURES: Treatment toxicity; patients' compliance with treatment, quality of life, satisfaction with care, and use of health resources. RESULTS: 42 patients were treated at outpatient clinic and 45 at home. The two groups were balanced in terms of age, sex, site of cancer, and disease stage. Treatment related toxicity was similar in the two groups (difference 7% (95% confidence interval -12% to 26%)), but there were more voluntary withdrawals from treatment in the outpatient group than in the home group (14% v 2%, difference 12% (1% to 24%)). There were no differences between groups in terms of quality of life scores during and after treatment. Levels of patient satisfaction were higher in the home treatment group, specifically with regard to information received and nursing care. There were no significant differences in use of health services. CONCLUSIONS: Home chemotherapy seemed an acceptable and safe alternative to hospital treatment for patients with colorectal cancer that may improve compliance and satisfaction with treatment.

Ambulatory Care↗

PubMed2003

Analgesic effect of breast feeding in term neonates: randomised controlled trial.

OBJECTIVES: To investigate whether breast feeding is effective for pain relief during venepuncture in term neonates and compare any effect with that of oral glucose combined with a pacifier. DESIGN: Randomised controlled trial. PARTICIPANTS: 180 term newborn infants undergoing venepuncture; 45 in each group. INTERVENTIONS: During venepuncture infants were either breast fed (group 1), held in their mother's arms without breast feeding (group 2), given 1 ml of sterile water as placebo (group 3), or given 1 ml of 30% glucose followed by pacifier (group 4). Video recordings of the procedure were assessed by two observers blinded to the purpose of the study. MAIN OUTCOME MEASURES: Pain related behaviours evaluated with two acute pain rating scales: the Douleur Aiguë Nouveau-né scale (range 0 to 10) and the premature infant pain profile scale (range 0 to 18). RESULTS: Median pain scores (interquartile range) for breast feeding, held in mother's arms, placebo, and 30% glucose plus pacifier groups were 1 (0-3), 10 (8.5-10), 10 (7.5-10), and 3 (0-5) with the Douleur Aiguë Nouveau-né scale and 4.5 (2.25-8), 13 (10.5-15), 12 (9-13), and 4 (1-6) with the premature infant pain profile scale. Analysis of variance showed significantly different median pain scores (P<0.0001) among the groups. There were significant reductions in both scores for the breast feeding and glucose plus pacifier groups compared with the other two groups (P<0.0001, two tailed Mann-Whitney U tests between groups). The difference in Douleur Aiguë Nouveau-né scores between breast feeding and glucose plus pacifier groups was not significant (P=0.16). CONCLUSIONS: Breast feeding effectively reduces response to pain during minor invasive procedure in term neonates.

Analgesia↗

PubMed2004

Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding.

OBJECTIVE: To investigate whether offering volunteer support from counsellors in breast feeding would result in more women breast feeding. DESIGN: Randomised controlled trial. SETTING: 32 general practices in London and south Essex. PARTICIPANTS: 720 women considering breast feeding. MAIN OUTCOME MEASURES: Primary outcome was prevalence of any breast feeding at six weeks. Secondary outcomes were the proportion of women giving any breast feeds, or bottle feeds at four months, duration of any breast feeding, time to introduction of bottle feeds, and satisfaction with breast feeding. RESULTS: Offering support in breast feeding did not significantly increase the prevalence of any breast feeding to six weeks (65% (218/336) in the intervention group and 63% (213/336) in the control group; relative risk 1.02, 95% confidence interval 0.84 to 1.24). Survival analysis up to four months confirmed that neither duration of breast feeding nor time to introduction of formula feeds differed significantly between control and intervention groups. Not all women in the intervention group contacted counsellors postnatally, but 73% (123/179) of those who did rated them as very helpful. More women in the intervention group than in the control group said that their most helpful advice came from counsellors rather than from other sources. CONCLUSIONS: Women valued the support of a counsellor in breast feeding, but the intervention did not significantly increase breastfeeding rates, perhaps because some women did not ask for help.

Adolescent↗

PubMed2005

Partner notification of chlamydia infection in primary care: randomised controlled trial and analysis of resource use.

OBJECTIVE: To evaluate the effectiveness of a practice nurse led strategy to improve the notification and treatment of partners of people with chlamydia infection. DESIGN: Randomised controlled trial. SETTING: 27 general practices in the Bristol and Birmingham areas. PARTICIPANTS: 140 men and women with chlamydia (index cases) diagnosed by screening of a home collected urine sample or vulval swab specimen. INTERVENTIONS: Partner notification at the general practice immediately after diagnosis by trained practice nurses, with telephone follow up by a health adviser; or referral to a specialist health adviser at a genitourinary medicine clinic. MAIN OUTCOME MEASURES: Primary outcome was the proportion of index cases with at least one treated sexual partner. Specified secondary outcomes included the number of sexual contacts elicited during a sexual history, positive test result for chlamydia six weeks after treatment, and the cost of each strategy in 2003 sterling prices. RESULTS: 65.3% (47/72) of participants receiving practice nurse led partner notification had at least one partner treated compared with 52.9% (39/68) of those referred to a genitourinary medicine clinic (risk difference 12.4%, 95% confidence interval -1.8% to 26.5%). Of 68 participants referred to the clinic, 21 (31%) did not attend. The costs per index case were 32.55 pounds sterling for the practice nurse led strategy and 32.62 pounds sterling for the specialist referral strategy. CONCLUSION: Practice based partner notification by trained nurses with telephone follow up by health advisers is at least as effective as referral to a specialist health adviser at a genitourinary medicine clinic, and costs the same. Trial registration Clinical trials: NCT00112255.

Chlamydia Infections↗

PubMed2005

Flucloxacillin alone or combined with benzylpenicillin to treat lower limb cellulitis: a randomised controlled trial.

OBJECTIVE: To determine whether using intravenous benzylpenicillin in addition to intravenous flucloxacillin would result in a more rapid clinical response in patients with lower limb cellulitis. METHODS: This was a randomised controlled trial set in an inner city teaching hospital, comprising 81 patients with lower limb cellulitis requiring intravenous antibiotics. The main outcome measure was the mean number of doses of antibiotic required until clinical response. RESULTS: The mean number of doses required was 8.47 (95% confidence interval (CI) 7.09 to 9.86) in the benzylpenicillin and flucloxacillin combined group. In the flucloxacillin only group it was 8.71 doses (95% CI 6.90 to 10.5), a mean difference of -0.24 doses (95% CI -2.48 to 2.01, p = 0.83). Other markers of treatment efficacy showed no difference between groups at review the following day; temperature decrease (mean difference -0.07 degrees C, 95% CI -0.76 to 0.62, p = 0.84), or diameter decrease of affected area (mean difference -34 mm, 95% CI -99 to 31, p = 0.30). Patient subjective assessments were also similar between the different drug regimen; improvement on a visual analogue scale of pain/discomfort from admission to first review (mean difference 10 mm, 95% CI -12.6 to 14.2, p = 0.91) and on second review (mean difference 15 mm, 95% CI -18.6 to 21.6, p = 0.88). Patient overall subjective feelings of improvement on first review (p = 0.32) and on second review (p = 0.64) were also similar. CONCLUSIONS: This study provides no evidence to support the addition of intravenous benzylpenicillin to intravenous flucloxacillin in the treatment of lower limb cellulitis.

Adult↗

PubMed1996

Breast screening: a randomised controlled trial in UK general practice of three interventions designed to increase uptake.

STUDY OBJECTIVES: To determine the relative effectiveness of three interventions designed to increase the uptake of breast screening. DESIGN: Randomised controlled trial of a nurse visit with health education (group A), nurse visit without health education (group B), and GP letter (group C). SETTING: The area of south east London served by the Butterfly Walk Breast Screening Unit in Camberwell. PARTICIPANTS: Women aged between 50 and 64 years who were registered with 27 GPs in the Lambeth, Southwark and Lewisham family health services authority and who had not attended for first round screening. MAIN RESULTS: Altogether 799 women were randomly allocated to the three groups. In general, delivering the nurse based interventions proved difficult. In group A, 11.4% (95% CI 7.9, 14.9%) of women subsequently attended for screening compared with 7.8% (95% CI 5.1, 11.4%) in group B and 13.1% (95% CI 7.9, 18.4%) in group C. The differences between the groups (95% CIs) were not statistically significant: A versus C, -1.7% (-8.0, +4.6%); B versus C, -5.3% (-11.3, +0.7%); A versus B, +3.6% (-1.0, +8.2%). CONCLUSIONS: A personal letter from the GP seems to be at least as effective at increasing the uptake of breast screening in non-attenders as a nurse making a home visit to discuss the issue of breast screening, and is not noticeably less effective than a visit at which a health education intervention is delivered. It is possible that the GP letter is considerably more effective than either of the two interview-based interventions. With regard to implementing strategies which will increase breast screening uptake and are cost effective, further trials of similar minimal interventions in primary care are required.

Breast Neoplasms↗

PubMed2003

"Start to stop": results of a randomised controlled trial of a smoking cessation programme for teens.

OBJECTIVE: To examine the feasibility, acceptability, and effectiveness of a school based smoking cessation programme among students caught smoking at school. DESIGN: A randomised controlled trial comparing cessation rates among students in a behavioural cessation programme and those receiving self help materials only. SETTING: Eighteen schools in the Memphis, Tennessee area. SUBJECTS: Two hundred and sixty one adolescent cigarette smokers (166 male, 95 female) averaging 15.8 years of age. INTERVENTION: Students assigned to the intervention received a four session behavioural treatment programme administered individually by a health educator. In addition, these students received stage matched intervention in brief phone calls monthly until the one year follow up. MAIN OUTCOME MEASURE: Self reported and biochemically verified smoking cessation at post-test and 12 month follow up. RESULTS: Recruiting students who were caught smoking at school proved to be highly successful. Participants rated the programme favourably, and retention rates were high. Although treated participants improved more in tobacco related knowledge relative to controls (p = 0.002), there were no group differences in changes in attitudes toward smoking. In addition, treated and control participants demonstrated no significant differences in cessation rates both at post-test and follow up. Comparisons between self reported cessation rates and those obtained under bogus pipeline conditions or with biochemical verification suggested significant falsification of cessation among participants. CONCLUSIONS: Our results failed to demonstrate any significant effect of the cessation programme on smoking rates for treated adolescents compared with controls. Our findings also highlight the importance of utilising strong methodology in research on adolescent smoking cessation, including control groups and biochemical verification of smoking status.

Adolescent↗

PubMed2004

Ethics of randomised controlled trials--not yet time to give up on equipoise.

In this commentary on Fries and Krishnan's argument that 'design bias' undermines the status of equipoise as the ethical justification for randomised controlled trials, it is argued that their argument is analogous to Bayesian arguments for the use of informative priors in trial design, but that this does not undermine the importance of equipoise. In particular, mismatches between the outcomes of interest to industrial sponsors of research and outcomes of interest to patients and clinicians ensure that in many cases industry-sponsored trials can fail to reflect the reasonable equipoise of working clinicians.

Bayes Theorem↗

PubMed1999

Randomised controlled trial of general practice based asthma clinics.

OBJECTIVE: To compare the effects on asthma morbidity of asthma clinics based in general practice with standard general practice care. DESIGN AND SETTING: A randomised controlled trial in eight general practices. Patients, general practitioners and outcomes assessors were not blinded to treatment allocation. PARTICIPANTS: 195 patients with asthma aged 5-64 years; 191 completed the trial. INTERVENTION: Three asthma clinic sessions over six months involving nurse counselling, education about asthma management, spirometry and consultation with the general practitioner. MAIN OUTCOME MEASURES: Patients reporting days lost from work or school, number of days lost, the presence of morning or nocturnal asthma symptoms, use of an action plan, medication use, current smoking, hospitalisation, and emergency visits. RESULTS: Asthma clinics were associated with a greater reduction in nocturnal symptoms, an increase in the ownership of peak flow meters and an increase in the number of patients commencing or resuming smoking. Both control and intervention groups showed similar improvement in days lost from work or school, the presence of symptoms, use of an action plan and taking reliever medication. CONCLUSION: Our study does not show that asthma clinics are more effective than standard general practice care in reducing asthma morbidity. It is uncertain how much of the improvement in outcomes was due to the asthma clinic, the influence of the study itself upon patients and practitioners, or other factors, such as the tendency for a patient's asthma management to improve over time.

Absenteeism↗

PubMed2002

The demise of a planned randomised controlled trial in an urban Aboriginal medical service.

To fill a gap in knowledge about the effectiveness of brief intervention for hazardous alcohol use among Indigenous Australians, we attempted to implement a randomised controlled trial in an urban Aboriginal Medical Service (AMS) as a joint AMS-university partnership. Because of low numbers of potential participants being screened, the RCT was abandoned in favour of a two-part "demonstration project". Only 16 clients were recruited for follow-up in six-months, and the trial was terminated. Clinic, patient, Aboriginal health worker, and GP factors, interacting with study design factors, all contributed to our inability to implement the trial as designed. The key points to emerge from the study are that alcohol misuse is a difficult issue to manage in an Indigenous primary health care setting; RCTs involving inevitably complex study protocols may not be acceptable or sufficiently adaptable to make them viable in busy, Indigenous primary health care settings; and "gold-standard" RCT-derived evidence for the effectiveness of many public health interventions in Indigenous primary health care settings may never be available, and decisions about appropriate interventions will often have to be based on qualitative assessment of appropriateness and evidence from other populations and other settings.

Adolescent↗

PubMed2005

Effect of a consultation teaching behaviour modification on sleep performance in infants: a randomised controlled trial.

OBJECTIVE: To evaluate the effect of a behaviour modification program, taught to parents in a single visit to a trained nurse, in improving sleep performance in newborn infants, Australia. DESIGN: Randomised controlled trial. SETTING AND PARTICIPANTS: 268 families with normal newborn infants in the community, recruited between October 1996 and March 1997 from birth notices published in a South Australian daily newspaper. INTERVENTION: A 45-minute consultation with a nurse 2-3 weeks after the birth, including a tutorial discussion on normal sleep patterns in newborn infants, supported by retained written material and, for infants with weight gain < 30 g daily, referral to their usual postnatal care provider. MAIN OUTCOME MEASURES: Hours of daytime sleep (0600-1800), night sleep (1800-0600) and total sleep per 24 h; and number of daily records with total sleep >/= 15 h per 24 h, assessed by 7-day sleep diary at ages 6 and 12 weeks. RESULTS: 268 families returned at least one sleep diary (137/171 intervention, 131/175 control), recording 3273 days. Two intervention infants were referred for low weight gain. Total sleep time was 15 h or more per 24 h on 62% of recorded days in the intervention group, compared with 36% in the control group (P < 0.001). At 6 weeks of age, intervention infants slept a mean 1.3 h per day more than control infants (95% CI, 0.95-1.65), comprising a mean 0.5 h more night sleep (95% CI, 0.32-0.69) and 0.8 h more daytime sleep (95% CI, 0.56-1.07). At 12 weeks, intervention infants slept a mean 1.2 h per day more (95% CI, 0.94-2.14), comprising 0.64 h more night sleep (95% CI, 0.19-0.89) and 0.58 h more daytime sleep (95% CI, 0.39-1.03). There was no significant difference in crying time between the groups. CONCLUSIONS: A single consultation supported by written material in the first 3 weeks of a child's life improves sleep performance at 6 weeks of age. This improvement is maintained at 3 months.

Behavior Therapy↗

PubMed1999

The effects of different dosages of oestrogen on the bone mineral density of postmenopausal Hong Kong Chinese women: randomised controlled trial.

OBJECTIVE: To determine the effects of different dosages of conjugated equine oestrogen on the bone mineral density of postmenopausal Hong Kong Chinese women. DESIGN: A 1-year three-arm randomised controlled trial. SETTING: Out-patient setting at a governmental hospital in Hong Kong. PARTICIPANTS: One hundred and five women aged 45 years or older, in whom menopause had occurred not more than 2 years previously. INTERVENTION: Women were assigned randomly to treatment with conjugated equine oestrogen 0.625 mg/d or 0.3 mg/d, or no oestrogen. MAIN OUTCOME MEASURE: Bone mineral density. RESULTS: Women who were assigned to the control group showed a significant reduction in bone mineral density in both the femoral neck and the lumbar spine (3.6%; P=0.001 and 4.0%; P<0.001, respectively). Those who received oestrogen 0.3 mg/d showed a significant reduction (3.9%; P=0.010) and a non-significant reduction (2.2%; P=0.141) in their lumbar spine and femoral neck bone mineral densities, respectively. In contrast, there was little change in the spinal and femoral neck bone mineral densities in women who received estrogen 0.625 mg/d. CONCLUSION: The minimum effective dosage of conjugated equine oestrogen to prevent osteoporosis in postmenopausal Hong Kong Chinese women is 0.625 mg/d. The bone mineral density, however, was maintained but not increased.

Journal Article↗