Reduction in blood pressure with statins: results from the UCSD Statin Study, a randomized trial.

BACKGROUND: Some studies have suggested reductions in blood pressure (BP)with statin treatment, particularly in persons with hypertension. Randomized trial evidence is limited. METHODS: We performed a randomized, double-blind, placebo-controlled trial with equal allocation to simvastatin, 20 mg; pravastatin sodium,40 mg; or placebo for 6 months. Nine hundred seventy-three men and women without known cardiovascular disease or diabetes mellitus, with low-density lipoprotein cholesterol screening levels of 115 to 190 mg/dL, had assessment of systolic and diastolic BP (SBP and DBP, respectively). Blood pressure values were compared for placebo vs statins by intention-to-treat (ITT) analysis. Additional analyses were performed that (1) were confined to subjects with neither high baseline BP (SBP>140 mm Hg or DBP>90 mm Hg) nor receiving BP medications, to exclude groups in whom BP medications or medication changes may have influenced results, and (2) separately evaluated simvastatin and pravastatin (vs placebo). The time course of BP changes after statin initiation and the effect of stopping statins on BP were examined. RESULTS: Statins modestly but significantly reduced BP relative to placebo,by 2.2 mm Hg for SBP (P=.02) and 2.4 mm Hg for DBP (P<.001) in ITT analysis. Blood pressure reductions ranged from 2.4 to 2.8 mm Hg for both SBP and DBP with both simvastatin and pravastatin, in those subjects with full follow-up, and without potential for influence by BP medications (ie, neither receiving nor meriting BP medications). CONCLUSIONS: Reductions in SBP and DBP occurred with hydrophilic and lipophilic statins and extended to normotensive subjects. These modest effects may contribute to the reduced risk of stroke and cardiovascular events reported on statins. Trial Registration clinicaltrials.gov Identifier: NCT00330980.     

The impact of increased contact on psychosocial outcomes in patients with osteoarthritis: a randomized, controlled trial

After baseline in home interviews, 439 patients with osteoarthritis (OA) were randomly assigned to the control or one of 3 intervention groups which differed only in method of delivery (i.e., phone, clinic, both). Trained nonclinical interviewers reviewed medications, problems with joint pain, gastrointestinal symptoms, early warning signs for common chronic diseases, scheduled outpatient visits, an evening/weekend clinic telephone number, barriers to care, and suggestions to encourage participation during clinic visits. We hypothesized that the intervention would enhance social support, satisfaction with care, morale, and medication compliance. We found that none of the interventions had any effect upon these outcomes.     

Topical treatment of tungiasis: a randomized, controlled trial

Tungiasis is caused by the penetration of the female sand flea Tunga penetrans into the epidermis of its host. Human infestation with this ectoparasite is hyper-endemic in many resource-poor communities in sub-Saharan Africa, the Caribbean and South America and is associated with considerable morbidity. Currently, there is no effective drug available to treat tungiasis (or at least none for which a parasiticidal effect has been clearly demonstrated). In an attempt to fill this gap, the effects of treatment with topical ivermectin (lotion), thiabendazole (ointment and lotion), metrifonate (lotion) or placebo lotion were compared in a randomized trial. A total of 108 subjects with 169 tungiasis-infested feet participated in the study. The results show that topical ivermectin, metrifonate or thiabendazole can each significantly reduce the number of lesions caused by embedded sand fleas. Further studies are needed to optimise the doses and administration of these compounds.     

The impact of dedicated medication nurses on the medication administration error rate: a randomized controlled trial

BACKGROUND: Concerns about hospital medication safety mount as the pace of new drug releases accelerates. METHODS: We performed a randomized study at 2 hospitals (A and B) to examine whether the medication administration error rate could be decreased by having "dedicated" nurses focus exclusively on administering drugs. "Medication nurses," after receiving a brief review course on safe medication use, were responsible solely for drug delivery for up to 18 patients each. "General nurses," who did not attend the course, provided comprehensive care, including drug delivery, for 6 patients each. A direct observation technique was used to record drug errors, process-variation errors, and total errors. RESULTS: At both hospitals combined, the total error rate was 15.7% for medication nurses and 14.9% for general nurses (P<.84). Comparing hospitals, the total error rate for medication nurses at hospital B was significantly higher than it was at hospital A (19.7% vs 11.2%; P<.04). At hospital A, there was a significantly lower error rate for medication nurses than for general nurses in the surgical units (P<.01) but no significant differences in total errors comparing nurse types in the medical units (P<.77). CONCLUSIONS: This trial suggests that use of dedicated medication nurses does not reduce medication error rates. However, subgroup analysis indicates that medication nurses might be useful in some settings. The differences in findings at the 2 hospitals and their differences in medication-use processes reinforce the concept that medication errors are usually related to systems design issues.     

Cognitive behavior therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison

BACKGROUND: Chronic sleep-onset insomnia is a prevalent health complaint in adults. Although behavioral and pharmacological therapies have been shown to be effective for insomnia, no placebo-controlled trials have evaluated their separate and combined effects for sleep-onset insomnia. The objective of this study was to evaluate the clinical efficacy of behavioral and pharmacological therapy, singly and in combination, for chronic sleep-onset insomnia. METHODS: This was a randomized, placebo-controlled clinical trial that involved 63 young and middle-aged adults with chronic sleep-onset insomnia. Interventions included cognitive behavior therapy (CBT), pharmacotherapy, or combination therapy compared with placebo. The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning. RESULTS: In most measures, CBT was the most sleep effective intervention; it produced the greatest changes in sleep-onset latency and sleep efficiency, yielded the largest number of normal sleepers after treatment, and maintained therapeutic gains at long-term follow-up. The combined treatment provided no advantage over CBT alone, whereas pharmacotherapy produced only moderate improvements during drug administration and returned measures toward baseline after drug use discontinuation. CONCLUSIONS: These findings suggest that young and middle-age patients with sleep-onset insomnia can derive significantly greater benefit from CBT than pharmacotherapy and that CBT should be considered a first-line intervention for chronic insomnia. Increased recognition of the efficacy of CBT and more widespread recommendations for its use could improve the quality of life of a large numbers of patients with insomnia.     

Ceruminolytic effects of docusate sodium: a randomized, controlled trial

STUDY OBJECTIVE: Assessment of the tympanic membrane is often impeded by the presence of cerumen. We compared the ceruminolytic effects of triethanolamine polypeptide and docusate sodium in patients with cerumen. METHODS: We conducted a prospective, randomized, controlled, double-blind trial on a convenience sample of cooperative adult and pediatric patients presenting to a university-based emergency department who required removal of cerumen to visualize the tympanic membrane. Structured data collection was performed, and the physician determined whether visualization of the tympanic membrane was partially or totally obscured by cerumen (interobserver agreement, rho=0.79). Patients received intra-aural instillation of 1mL of either docusate sodium or triethanolamine polypeptide in a liquid form. If not completely cleared within 15 minutes, the external ear canal was irrigated with 50 or 100 mL of normal saline solution and additional attempts to visualize the tympanic membrane were made. The main outcome was the proportion of ears in which the tympanic membrane could be totally visualized after ceruminolytic instillation with or without irrigation. This study had 80% power to detect a 40% difference between groups in the proportion of totally visualized tympanic membranes (chi(2) test, alpha=.05). RESULTS: Of 50 enrolled patients, 23 received triethanolamine polypeptide and 27 received docusate sodium. Mean patient age was 40 years (range 1 to 81 years); 35% were female. Groups were similar in age, sex, and proportion of completely obscured tympanic membranes at presentation (78%). The ability to completely visualize the tympanic membrane was significantly greater after treatment with docusate sodium versus triethanolamine polypeptide (81% versus 35%; difference in proportions 47%; 95% confidence interval [CI], 22 to 71) particularly in children aged 5 or less (90% versus 0%; difference in proportions 89%; 95% CI 50 to 100). CONCLUSION: Docusate sodium solution is a more effective ceruminolytic than triethanolamine polypeptide, allowing complete or partial visualization of the tympanic membrane in most patients after a single application when followed with irrigation. Use of docusate sodium as a ceruminolytic should be encouraged, particularly in children.     

The impact of insecticide-treated bednets on malaria and anaemia in pregnancy in Kassena-Nankana district, Ghana: a randomized controlled trial

The impact of insecticide-treated bednet use on malaria and anaemia in pregnancy was assessed, as a supplementary study, in a major WHO/TDR-supported bednet trial in northern Ghana between July 1994 and April 1995. The study area was divided into 96 clusters of compounds, with 48 clusters being randomly allocated to intervention. All pregnant women were included in the study but the focus was on primigravidae and secundigravidae. 1961 pregnant women were recruited into the study--1033 (52.7%) in the treated bednet group and 928 (47.3%) in the no net group. 1806 (92.1%) had blood taken for malaria microscopy and haemoglobin determination in the third trimester. Pregnancy outcomes were reported for 847 women. The characteristics of women in intervention and control groups were comparable. The odds ratios, with 95% confidence interval (CI), for different study endpoints were, for Plasmodium falciparum parasitaemia--0.89 (0.73, 1.08), for anaemia--0.88 (0.70, 1.09), for low birthweight (LBW)--0.87 (0.63, 1.19), indicating no benefit for treated bednet use. Effective net use by parity varied from 42% in primigravidae to 63% in multigravidae, in spite of free nets and insecticide impregnation. The main reasons for not using a net were warm weather and perceived absence of mosquito biting. Chloroquine use in pregnancy was low and comparable in both groups. Implications of findings for malaria control in pregnancy and further research are discussed.     

Guiding individual decisions: a randomized, controlled trial of decision analysis

In early 1983, all 1,280 faculty and resident physicians at one hospital who were eligible to be vaccinated against hepatitis B were divided randomly into three groups: Group 1 physicians received general information about the risks and benefits of alternative vaccine decisions; Group 2 physicians were additionally invited to provide personal information for an individualized decision analysis (12.6 percent responded); and Group 3 physicians, who served as controls, were not contacted. In one year's follow-up, 20 percent of physicians were screened for hepatitis B antibody or vaccinated. More Group 2 physicians whose decision analyses recommended screening or vaccination took these actions (39 percent) than any other group. Group assignment remained significantly associated with vaccine decisions after analyzing results by the "intention to treat" principle, and after adjusting for training status, exposure to blood and blood products, and pre-study intentions about the vaccine. Despite the low overall vaccine acceptance rate, it is concluded that individualized decision analysis can influence the clinical decisions taken by knowledgeable and interested patients.     

The impact of monitoring on adherence and persistence with antiresorptive treatment for postmenopausal osteoporosis: a randomized controlled trial

Long-term adherence and persistence with any therapy are very poor ( approximately 50%). Adherence to therapy is defined as the percentage of prescribed medication taken, and persistence is defined as continuing to take prescribed medication. We examined whether monitoring by nursing staff could enhance adherence and persistence with antiresorptive therapy and whether presenting information on response to therapy provided additional benefit. In addition we evaluated the impact of monitoring on treatment efficacy. Seventy-five postmenopausal women with osteopenia were randomized to 1) no monitoring, 2) nurse-monitoring, or 3) marker-monitoring. All subjects were prescribed raloxifene. At 12, 24, and 36 wk, the nursing staff reviewed subjects in the monitored (nurse-monitoring or marker-monitoring) groups using a predefined protocol. The marker-monitored group were also presented a graph of response to therapy using percentage change in urinary N-telopeptide of type I collagen (uNTX), a bone resorption marker, at each visit. Biological response to therapy at 1 yr was determined using the percent change in bone mineral density (BMD) and uNTX. Treatment adherence and persistence were assessed using electronic monitoring devices. Survival analysis showed that the monitored group increased cumulative adherence to therapy by 57% compared with no monitoring (P = 0.04). There was a trend for the monitored group to persist with therapy for 25% longer compared with no monitoring (P = 0.07). Marker measurements did not improve adherence or persistence to therapy compared with nurse-monitoring alone. Adherence at 1 yr was correlated with percent change in hip (BMD) (r = 0.28; P = 0.01) and percent change in uNTX (r = -0.36; P = 0.002). In conclusion, monitoring of patients increased adherence to therapy by 57% at 1 yr. Increased adherence to therapy increased the effectiveness of raloxifene therapy determined using surrogate end points.     

The New Zealand Diabetes Passport Study: a randomized controlled trial of the impact of a diabetes passport on risk factors for diabetes-related complications.

AIMS: To assess the efficacy (change in HbA1c) of a patient-held communication, self-empowerment and educational device for people with diabetes (the New Zealand Diabetes Passport) in patients with poor glycaemic control. RESEARCH DESIGN AND METHODS: A 12-month, multicentre, general practice-based randomized controlled trial in urban, provincial and rural New Zealand involving 398 people with poorly controlled Type 1 or Type 2 diabetes. The intervention included a specifically designed and piloted New Zealand Diabetes Passport including information relating to diabetes knowledge, self-assessments, and guidance concerning how to engage with diabetes health professionals. The primary end point was change in HbA1c. Assessments were made at 0, 6 and 12 months. RESULTS: Two hundred and twenty-two patients received the Passport, 176 the control booklet, coming from 69 and 66 general practitioners, respectively. Use of the Passport was associated with a relative reduction in HbA1c of 0.4% (P = 0.017) and a relative increase in weight of 1.0 kg/m2 (P = 0.028), but no changes in diabetes knowledge, attitudes to diabetes or risk factors for diabetic tissue damage. CONCLUSIONS: The dissemination of the New Zealand Diabetes Passport, in isolation, was not associated with improvements in either diabetes knowledge or self-empowerment. While a small improvement in glycaemic control occurred, this was probably due to changes in insulin therapy in the intervention group. It is possible that linking the use of the Passport with other behavioural and educational interventions may make the Passport more useful. Further study is required to confirm the effect of such multifaceted interventions.