Patricia Yudkin

Effects of fruit and vegetable consumption on plasma antioxidant concentrations and blood pressure: a randomised controlled trial

BACKGROUND High dietary intakes of fruit and vegetables are associated with reduced risks of cancer and cardiovascular disease. Short-term intensive dietary interventions in selected populations increase fruit and vegetable intake, raise plasma antioxidant concentrations, and lower blood pressure, but long-term effects of interventions in the general population are not certain. We assessed the effect of an intervention to increase fruit and vegetable consumption on plasma concentrations of antioxidant vitamins, daily fruit and vegetable intake, and blood pressure. METHODS We undertook a 6-month, randomised, controlled trial of a brief negotiation method to encourage an increase in consumption of fruit and vegetables to at least five daily portions. We included 690 healthy participants aged 25-64 years recruited from a primary-care health centre. FINDINGS Plasma concentrations of alpha-carotene, beta-carotene, lutein, beta-cryptoxanthin, and ascorbic acid increased by more in the intervention group than in controls (significance of between-group differences ranged from p=0.032 to 0.0002). Groups did not differ for changes in lycopene, retinol, alpha-tocopherol, gamma-tocopherol, or total cholesterol concentrations. Self-reported fruit and vegetable intake increased by a mean 1.4 (SD 1.7) portions in the intervention group and by 0.1 (1.3) portion in the control group (between-group difference=1.4, 95% CI 1.2-1.6; p<0.0001). Systolic blood pressure fell more in the intervention group than in controls (difference=4.0 mm Hg, 2.0-6.0; p<0.0001), as did diastolic blood pressure (1.5 mm Hg, 0.2-2.7; p=0.02). INTERPRETATION The effects of the intervention on fruit and vegetable consumption, plasma antioxidants, and blood pressure would be expected to reduce cardiovascular disease in the general population.

Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial.

Objective To determine whether self monitoring, alone or with instruction in incorporating the results into self care, is more effective than usual care in improving glycaemic control in non-insulin treated patients with type 2 diabetes. Design Three arm, open, parallel group randomised trial. Setting 48 general practices in Oxfordshire and South Yorkshire. Participants 453 patients with non-insulin treated type 2 diabetes (mean age 65.7 years) for a median duration of three years and a mean haemoglobin A1c level of 7.5%. Interventions Standardised usual care with measurements of HbA1c every three months as the control group (n=152), blood glucose self monitoring with advice for patients to contact their doctor for interpretation of results, in addition to usual care (n=150), and blood glucose self monitoring with additional training of patients in interpretation and application of the results to enhance motivation and maintain adherence to a healthy lifestyle (n=151). Main outcome measure HbA1c level measured at 12 months. Results At 12 months the differences in HbA1c level between the three groups (adjusted for baseline HbA1c level) were not statistically significant (P=0.12). The difference in unadjusted mean change in HbA1c level from baseline to 12 months between the control and less intensive self monitoring groups was −0.14% (95% confidence interval −0.35% to 0.07%) and between the control and more intensive self monitoring groups was −0.17% (−0.37% to 0.03%). Conclusions Evidence is not convincing of an effect of self monitoring blood glucose, with or without instruction in incorporating findings into self care, in improving glycaemic control compared with usual care in reasonably well controlled non-insulin treated patients with type 2 diabetes. Trial registration Current Controlled Trials ISRCTN47464659.

Routine follow up of breast cancer in primary care: randomised trial.

Abstract Objective: To assess the effect on time to diagnosis of recurrence and on quality of life of transferring primary responsibility for follow up of women with breast cancer in remission from hospital to general practice. Design: Randomised controlled trial with 18 month follow up in which women received routine follow up either in hospital or in general practice. Subjects and setting: 296 women with breast cancer in remission receiving regular follow up care at district general hospitals in England. Main outcome measures: Time between first presentation of symptoms to confirmation of recurrence; quality of life measured by specific dimensions of the SF-36 schedule, the EORTC symptom scale, and hospital anxiety and depression scale. Results: Most recurrences (18/26, 69%) presented as interval events, and almost half (7/16, 44%) of the recurrences in the hospital group presented first to general practice. The median time to hospital confirmation of recurrence was 21 days in the hospital group (range 1-376 days) and 22 days in the general practice group (range 4-64). The differences between groups in the change in SF-36 mean scores from baseline were small: -1.8 (95% confidence interval -7.2 to 3.5) for social functioning, 0.5 (-4.1 to 5.1) for mental health, and 0.6 (-3.6 to 4.8) for general health perception. The change from baseline in the mean depression score was higher in the general practice group at the mid-trial assessment (difference 0.6, 0.1 to 1.2) but there was no significant difference between groups in the anxiety score or the EORTC scales. Conclusion: General practice follow up of women with breast cancer in remission is not associated with increase in time to diagnosis, increase in anxiety, or deterioration in health related quality of life. Most recurrences are detected by women as interval events and present to the general practitioner, irrespective of continuing hospital follow up. Key messages Broadly, the goals of follow up are to detect recurrence, detect new contralateral primaries, and provide psychosocial support For women who are free of disease, general prac- tice follow up was not associated with increased time to diagnosis of recurrence or deterioration in health related quality of life

Influence of maternal nutrition on outcome of pregnancy: prospective cohort study

Abstract Objective: To investigate the relations of maternal diet and smoking during pregnancy to placental and birth weights at term. Design: Prospective cohort study. Setting: District general hospital in the south of England. Participants: 693 pregnant nulliparous white women with singleton pregnancies who were selected from antenatal booking clinics with stratified random sampling. Main outcome measures: Birth and placental weights at term. Results: Placental and birth weights were unrelated to the intake of any macronutrient. Early in pregnancy, vitamin C was the only micronutrient independently associated with birth weight after adjustment for maternal height and smoking. Each ln mg increase in vitamin C was associated with a 50.8 g (95% confidence interval 4.6 g to 97.0 g) increase in birth weight. Vitamin C, vitamin E, and folate were each associated with placental weight after adjustment for maternal characteristics. In simultaneous regression, however, vitamin C was the only nutrient predictive of placental weight: each ln mg increase in vitamin C was associated with a 3.2% (0.4 to 6.1) rise in placental weight. No nutrient late in pregnancy was associated with either placental or birth weight. Conclusions: Concern over the impact of maternal nutrition on the health of the infant has been premature Maternal nutrition, at least in industrialised populations, seems to have only a small effect on placental and birth weights. Other possible determinants of fetal and placental growth should be investigated. Key messages Placental and infant birth weights were not associated with the intake of any macronutrient early or later in pregnancy After adjustment for the effects of maternal height and smoking, only vitamin C independently predicted birth weight. The expected mean difference in birth weight for infants with mothers in the upper and lower thirds of intake was about 70 g Vitamin C was the only nutrient that independently predicted placental weight, but again this relation was of doubtful clinical significance Among relatively well nourished women in industrialised countries, maternal nutrition seems to have only a marginal impact on infant and placental size. Other causes of variation in the size of clinically normal infants should now be investigated

Prevalence and incidence of chronic pelvic pain in primary care: evidence from a national general practice database

Objectives To estimate the prevalence and incidence in primary care of chronic pelvic pain in women in the UK.

Effectiveness of health checks conducted by nurses in primary care: Results of the OXCHECK study after one year

Abstract Objective : To assess the effectiveness of health checks by nurses in reducing risk factors for cardiovascular disease in patients from general practice. Design : Randomised controlled trial. Setting : Five urban general practices in Bedfordshire. Subjects : 2136 patients receiving an initial health check in 1989-91 and scheduled to be re-examined one year later in 1990-2 (intervention group); 3988 patients receiving an initial health check in 1990-2 (control group). All patients were aged 35-64 years at recruitment in 1989. Main outcome measures : Serum total cholesterol concentration, blood pressure, body mass index, confirmed smoking cessation. Results : Mean serum total cholesterol was 2.3% lower in the intervention group than in the controls (difference 0.14 mmol/l (95% confidence interval 0.08 to 0.20)); the difference was greater in women (3.2%, P<0.0001) than men (1.0%, P=0.18). There was no significant difference in smoking prevalence, quit rates, or body mass index. Systolic and diastolic blood pressure were 2.5% and 2.4% lower respectively in the intervention group. The proportion of patients with diastolic blood pressure >=100 mm Hg was 2.6% (55/2131) in the intervention group and 3.4% (137/3987) in the controls (difference 0.9% (0.0 to 1.7); the proportion with total cholesterol concentration >=8 mmol/l 4.8% (100/2068) and 7.6% (295/3905) (difference 2.7% (1.5 to 4.0)); and that with body mass index >=30 12.4% (264/2125) and 14.0% (559/3984) (difference 1.6% (-0.2 to 3.4)). Conclusion : General health checks by nurses are ineffective in helping smokers to stop smoking, but they help patients to modify their diet and total cholesterol concentration. The public health importance of this dietary change depends on whether it is sustained.

Graphical method for depicting randomised trials of complex interventions.

Making the what, when, and who of non-drug treatments easier to understand would benefit researchers and readers

Genetic variation in dopaminergic pathways and short-term effectiveness of the nicotine patch.

Polymorphisms in the dopamine D2 receptor (DRD2 C/T and DRD2 A/G) and in dopamine beta hydroxylase (DBH A/G) have been implicated in modulation of smoking and other reward-seeking behaviours. We hypothesized that these alleles would predict the outcome of nicotine patch therapy for smoking cessation. In 1991-93, we performed a randomized controlled trial of the nicotine patch on 1686 heavy smokers (> or = 15 cigarettes/day). In 1999-2000, we contacted 1532 of the 1612 subjects still available; 767 (50%) completed a questionnaire and gave a blood sample. In the 755 cases in which DNA was successfully genotyped, we examined associations between the polymorphisms in DRD2 and DBH, and smoking cessation. At 1 week, the patch was more effective for smokers with DRD2 CT/TT genotype [patch/placebo odds ratio (OR) 2.8, 95% confidence interval (CI) 1.7-4.6] than with CC (OR 1.4, 0.9-2.1; P for difference in ORs 0.04). Smokers with both DRD2 CT/TT and DBH GA/AA genotypes had an OR of 3.6 (2.0-6.5) compared to 1.4 (1.0-2.1) for others (P = 0.01). At 12 weeks, the ORs for these genotypic groups were 3.6 (1.7-7.8) and 1.4 (0.9-2.3), respectively (P = 0.04). There was no association between patch effectiveness and DRD2 exon 8. Short-term effectiveness of the nicotine patch may be related to dopamine beta-hydroxylase and dopamine D2 receptor genotype. Our results support the need for further investigation into personalized therapies for smoking cessation based on individual genotype.

Follow-up of breast cancer in primary care vs specialist care: results of an economic evaluation.

SummaryA randomized controlled trial (RCT) comparing primary-care-centred follow-up of breast cancer patients with the current standard practice of specialist-centred follow-up showed no increase in delay in diagnosing recurrence, and no increase in anxiety or deterioration in health-related quality of life. An economic evaluation of the two schemes of follow-up was conducted concurrent with the RCT. Because the RCT found no difference in the primary clinical outcomes, a cost minimization analysis was conducted. Process measures of the quality of care such as frequency and length of visits were superior in primary care. Costs to patients and to the health service were lower in primary care. There was no difference in total costs of diagnostic tests, with particular tests being performed more frequently in primary care than in specialist care. Data are provided on the average frequency and length of visits, and frequency of diagnostic testing for breast cancer patients during the follow-up period.

Acid-base status at birth and neurodevelopmental outcome at four and one-half years

Two hundred thirty term infants with measured acid-base status in umbilical arterial blood at birth were selected from 1210 consecutive deliveries for detailed neurodevelopmental follow-up at age 4 1/2 years; 203 were examined. Cutoff points approximately 1 SD from the mean (pH less than or equal to 7.10; base deficit greater than 12 mmol/L) were used to define acidosis. No statistically significant associations between acidosis and developmental outcome were found. The highest proportion of unimpaired children was found among those who were most severely acidotic at birth (pH less than or equal to 7.04; 2 SD below mean), but this finding was not statistically significant. These findings suggest that the ability of the fetus to produce an acidosis in response to the stress of labor may be beneficial to long-term outcome. The 10 nonacidotic babies with 1-minute Apgar scores of less than or equal to 3 showed statistically significant deficits in some areas. Coincident acidosis was not associated with a worse outcome for infants with low Apgar scores.