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At least 19 recordsLinked to original sources
PubMed2000

A randomized controlled trial comparing topical piroxicam gel with a homeopathic gel in osteoarthritis of the knee.

OBJECTIVE: : To evaluate the efficacy and safety of a homeopathic gel vs an NSAID (piroxicam) gel in the treatment of osteoarthritis of the knee. METHOD: : One hundred and eighty-four out-patients with radiographically confirmed symptomatic osteoarthritis of the knee were entered into a pragmatic, randomized, double-blind controlled trial and treated with 1 g of gel three times daily for 4 weeks. Main outcome measures were pain on walking as a Visual Analogue Score (VAS) and a single-joint Ritchie index. RESULTS: : One hundred and seventy-two of the 184 enrolled patients had endpoints for the main outcome parameters. The pain reduction was 16.5 mm VAS in the homeopathy group (n = 86) and 8.1 mm in the piroxicam group (n = 86); the difference between treatment groups was 8.4 mm (95% confidence interval 0.8-15.9), and after adjustment for pain at baseline it was 6.8 mm (95% confidence interval -0.3 to 13.8). There was no significant difference between treatment groups in the single-joint Ritchie index (P = 0.78). Adverse events occurred in 28 patients (12 homeopathy group, 5 withdrawn; 16 piroxicam group, 9 withdrawn); 18 of the events involved a local reaction (7 homeopathy group, 2 withdrawn; 11 piroxicam group, 5 withdrawn). CONCLUSION: : The homeopathic gel was at least as effective and as well tolerated as the NSAID gel. The presence of a clinically relevant difference between treatment groups cannot be excluded. The homeopathic gel supplemented by simple analgesics if required may provide a useful treatment option for patients with osteoarthritis.

Administration, Topical↗
PubMed1988

Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers.

The effect of 2 wk of topical hyperbaric oxygen (THO) treatment on the healing of diabetic foot ulcers without associated gangrene was evaluated in a prospective, controlled, and randomized manner in 28 patients. There were 12 patients in the THO group (group 1) and 16 in the control group (group 2). Clinical management of the two patient groups was similar except for THO treatment in the group 1 patients. Clinical parameters, including age, sex, baseline fasting serum glucose levels, duration of diabetes mellitus, duration of foot ulcers, presence of peripheral neuropathy or arterial insufficiency, and evidence of osteomyelitis as determined by radiographs and/or radionuclide scans, were comparable in both groups of patients. No statistical differences (Student's t test) were seen in the number of microorganisms isolated from curettage cultures of the base of the ulcer at days 0, 7, and 14 of the study between groups 1 and 2. In contrast to previous studies, there was a paucity of anaerobic microorganisms isolated from these foot ulcers without associated gangrenous changes. Ulcer areas were estimated by multiplying the maximum width by the maximum length in millimeters at days 0, 7, and 14. Analysis of variance and Student's t test revealed progressive significant reductions in the ulcer areas in both groups when days 0, 7, and 14 were compared and in ulcer depths in both groups when days 0 and 14 were compared. However, such ulcer size changes did not differ statistically between the control and THO groups. A trend toward slower healing was observed in the THO group. Healing of diabetic foot ulcers was not accelerated by THO in this study.

Bacteria↗
PubMed2002

A randomized controlled trial of topical exit site mupirocin application in patients with tunnelled, cuffed haemodialysis catheters.

BACKGROUND: Central venous catheters are frequently needed for the provision of haemodialysis, but their clinical usefulness is severely limited by infectious complications. The risk of such infections can be reduced by topical application of mupirocin to the exit sites of non-cuffed catheters or by the use of tunnelled, cuffed catheters. Whether mupirocin offers any additional protection against infection in patients with tunnelled, cuffed haemodialysis catheters has not been studied. METHODS: An open-label, randomized controlled trial was performed comparing the effect of thrice-weekly exit site application of mupirocin (mupirocin group) vs no ointment (control group) on infection rates and catheter survival in patients receiving haemodialysis via a newly inserted, tunnelled, cuffed central venous catheter. All patients were followed until catheter removal and were monitored for the development of exit site infections and catheter-associated bacteraemias. RESULTS: Fifty patients were enrolled in the study. Both the mupirocin (n=27) and control (n=23) groups were similar at baseline with respect to demographic characteristics, comorbid illnesses and causes of renal failure. Compared with controls, mupirocin-treated patients experienced significantly fewer catheter-related bacteraemias (7 vs 35%, P<0.01) and a longer time to first bacteraemia (log rank score 8.68, P<0.01). The beneficial effect of mupirocin was entirely attributable to a reduction in staphylococcal infection (log rank 10.69, P=0.001) and was still observed when only patients without prior nasal Staphylococcus aureus carriage were included in the analysis (log rank score 6.33, P=0.01). Median catheter survival was also significantly longer in the mupirocin group (108 vs 31 days, log rank score 5.9, P<0.05). Mupirocin use was not associated with any adverse patient effects or the induction of antimicrobial resistance. CONCLUSIONS: Thrice-weekly application of mupirocin to tunnelled, cuffed haemodialysis catheter exit sites is associated with a marked reduction in line-related sepsis and a prolongation of catheter survival.

Administration, Topical↗
PubMed2000

Randomized, controlled trial of topical phenylephrine for fecal incontinence in patients after ileoanal pouch construction.

INTRODUCTION: Fecal incontinence is experienced by some patients with an ileoanal reservoir pouch. The alpha1-adrenergic agonist phenylephrine raises resting anal sphincter pressure in healthy volunteers and may be of value in these patients. METHODS: Twelve patients (7 female), median age 44 (range, 29-67) years were studied. All had fecal incontinence despite a noninflamed pouch of normal size and ultrasonographically structurally normal anal sphincter muscles. Patients were treated with topical 10 percent phenylephrine and placebo gels, allocated in random order in a double-blind, crossover study for two four-week periods. Before and during treatment, maximum resting anal sphincter pressure and anodermal blood flow were measured, a symptom questionnaire was completed, and incontinence score was determined using a validated scale. RESULTS: Six of 12 (50 percent) patients improved subjectively after phenylephrine compared with one on placebo (P = 0.07). Four patients had complete cessation of incontinence with active treatment. Phenylephrine significantly reduced the incontinence score (P = 0.015). It also resulted in a significant rise in mean maximum resting anal sphincter pressure when compared with placebo (P = 0.012). For all 12 patients, mean percent subjective improvement was higher after phenylephrine compared with placebo (P = 0.04). There were no side effects. CONCLUSIONS: Topical phenylephrine significantly improves fecal continence in patients with an ileoanal pouch. In some patients it totally eliminates nocturnal episodes. The mechanism of benefit is likely to be one of altered neural sphincter control. This is the first study of the use of a topical pharmacologic agent to treat fecal incontinence and may have a wider application.

Administration, Topical↗
PubMed2005

A double-blind, randomized, controlled trial of topical glyceryl trinitrate for transrectal ultrasound guided prostate biopsy.

PURPOSE: We evaluated the efficacy and tolerance of topical 0.2% glyceryl trinitrate (GTN) paste vs placebo to decrease pain associated with transrectal ultrasound guided prostate biopsy. MATERIALS AND METHODS: Between October 2003 and April 2004, 134 consecutive patients referred for a first prostate biopsy were randomized to receive topical 0.2% GTN paste or placebo 30 minutes prior to biopsy. Participants completed a 10 point visual analog pain score following the procedure. RESULTS: Mean patient age was 68.5 years in the GTN group and 68.8 in the placebo group. There was a significant decrease in mean pain score in the GTN group compared with placebo (3.7 vs 4.8, p <0.05). Six patients (10%) in the GTN group complained of headache. CONCLUSIONS: Topical GTN paste is an effective and well tolerated method of decreasing pain associated with transrectal ultrasound guided prostate biopsy. It is safe and easy to use, and it should be offered to patients undergoing this procedure.

Administration, Topical↗
PubMed2005

Randomized, controlled trial of topical exit-site application of honey (Medihoney) versus mupirocin for the prevention of catheter-associated infections in hemodialysis patients.

The clinical usefulness of hemodialysis catheters is limited by increased infectious morbidity and mortality. Topical antiseptic agents, such as mupirocin, are effective at reducing this risk but have been reported to select for antibiotic-resistant strains. The aim of the present study was to determine the efficacy and the safety of exit-site application of a standardized antibacterial honey versus mupirocin in preventing catheter-associated infections. A randomized, controlled trial was performed comparing the effect of thrice-weekly exit-site application of Medihoney versus mupirocin on infection rates in patients who were receiving hemodialysis via tunneled, cuffed central venous catheters. A total of 101 patients were enrolled. The incidences of catheter-associated bacteremias in honey-treated (n = 51) and mupirocin-treated (n = 50) patients were comparable (0.97 versus 0.85 episodes per 1000 catheter-days, respectively; NS). On Cox proportional hazards model analysis, the use of honey was not significantly associated with bacteremia-free survival (unadjusted hazard ratio, 0.94; 95% confidence interval, 0.27 to 3.24; P = 0.92). No exit-site infections occurred. During the study period, 2% of staphylococcal isolates within the hospital were mupirocin resistant. Thrice-weekly application of standardized antibacterial honey to hemodialysis catheter exit sites was safe, cheap, and effective and resulted in a comparable rate of catheter-associated infection to that obtained with mupirocin (although the study was not adequately powered to assess therapeutic equivalence). The effectiveness of honey against antibiotic-resistant microorganisms and its low likelihood of selecting for further resistant strains suggest that this agent may represent a satisfactory alternative means of chemoprophylaxis in patients with central venous catheters.

Adult↗
PubMed2003

Randomized controlled trial of topical aspirin in the treatment of bee and wasp stings.

BACKGROUND: The New South Wales Poisons Information Centre (NSW PIC) has been recommending the use of topical aspirin paste for bee and wasp stings since the early 1980s. Anecdotal evidence from calls suggested it was effective in reducing the swelling and duration of pain, but a literature search found no evidence to support this. OBJECTIVE: The objective of this study was to assess the effectiveness of advice given by a PIC to apply topical aspirin for the treatment of bee and wasp stings. METHODS: Patients were recruited from callers to the NSW PIC who reported a bee or wasp sting. They were randomly assigned, using a 2:1 ratio, to two different treatment advices: to apply an ice pack (control group), or to apply an ice pack and topical aspirin paste (treatment group). Initial follow-up was within 24-48 hours. Primary outcome was the presence of swelling at 12 hr. Secondary outcomes included the presence of pain at 12 hr, the presence of itchiness, and duration of redness. RESULTS: There were 37 patients who received treatment advice and 19 in the control group. Of the 37 patients advised to apply aspirin, 21 (57%) had no swelling at 12 hr compared with 14 of the 19 (74%) patients with ice alone (difference -17%; 95% CI: -47-12%; p = 0.26). Eighty-one percent (30/37) of patients advised to apply aspirin had no pain at 12 hr compared with (18/19) 95% of the others (-14%; 95% CI: -39-14%; p = 0.34). The median duration of redness was 6 hr [interquartile range (IQR): 2-48 hr] in those advised to apply aspirin paste compared with 2 hr (IQR: 0-10 hr) in those that only applied ice (p = 0.04). CONCLUSIONS: Topical aspirin paste was not effective in reducing the duration of swelling or pain in bee and wasp stings, and significantly increased the duration of redness. Symptoms rapidly subsided with ice alone as treatment.

Administration, Topical↗
PubMed2000

Randomized controlled trial of topical phenylephrine in the treatment of faecal incontinence.

BACKGROUND: Anal incontinence due to internal sphincter dysfunction is not amenable to simple surgical repair. The alpha-adrenergic agonist phenylephrine produces contraction of the internal sphincter and raises resting pressure when applied topically in healthy volunteers. The effect of topical phenylephrine in the treatment of faecal incontinence due to internal sphincter dysfunction was investigated. METHODS: Thirty-six patients (22 women) aged 28-81 (mean 58) years with faecal incontinence and ultrasonographically structurally normal anal sphincter muscles were treated with topical 10 per cent phenylephrine and placebo gels, allocated in random order in a double-blind crossover study. Maximum resting anal sphincter pressure and anodermal blood flow were measured. A symptom questionnaire was completed and incontinence score determined using a validated scale. RESULTS: There were no significant differences in incontinence score, resting anal pressure and anodermal blood flow between the active and placebo treatments. Six patients on active treatment and two on placebo experienced more than 75 per cent subjective improvement. Three patients developed allergic dermatitis to phenylephrine. CONCLUSION: This is the first study of the use of a topical pharmacological agent to treat faecal incontinence. This concentration of topical phenylephrine did not produce a significant improvement in symptoms or function. A subgroup of patients may respond. Further studies are required with increased concentrations.

Administration, Topical↗
PubMed2004

Can clinical trials requiring frequent participant contact be conducted over the Internet? Results from an online randomized controlled trial evaluating a topical ointment for herpes labialis.

BACKGROUND: The Internet has tremendous appeal for conducting randomized clinical trials and may be especially applicable to trials requiring frequent participant contact. Trials of cold sore remedies, for example, often require daily clinic visits during outbreaks, imposing substantial burden on participants. An Internet-based randomized clinical trial design may reduce this burden, permitting frequent symptom reports with considerably less effort. OBJECTIVE: To evaluate the feasibility of a Web-based randomized clinical trial requiring frequent participant interaction, using a 6-month, double-blind, randomized, placebo-controlled pilot trial of a topical ointment containing dioctyl sodium sulfosuccinate (DSS) (Zilex; Meditech Pharmaceuticals, Inc, Scottsdale, Arizona, USA) intended for treatment of recurrent herpes labialis. A secondary objective was to obtain preliminary data on effectiveness outcomes, to assist in planning a fully-powered trial of DSS. METHODS: Adults with physician-confirmed herpes labialis were recruited to apply to the trial. Eligible applicants were randomized to DSS or placebo, mailed to them upon enrolment with instructions to apply topically every 2 hours for the duration of every cold sore outbreak. Participants were instructed to complete online questionnaires at 2-week intervals and, at the initiation of a cold sore, daily "outbreak questionnaires" until outbreak termination. Feasibility outcome measures included trial participant characteristics, frequency of cold sores, participant retention and adherence (to study medication), and data completeness. Treatment effectiveness outcome measures included outbreak duration, days to crust formation, and pain. RESULTS: Of the 292 individuals applying, 182 screened eligible; 32 participants with confirmed herpes labialis enrolled in the trial. 16 were randomized into the verum group and 16 into the placebo group. 29 (91%) participants completed the trial. During the trial, 34 outbreaks were reported among 23 (72%) participants, resulting in a cold sore incidence rate of 19.8 per 100 person-months of observation. Online data were available for 32 outbreaks; the absence of a resolution date made it impossible to accurately calculate the duration of 12 (38%) outbreaks. Although the DSS treatment group had a shorter mean outbreak duration (6.6 vs 7.7 days, P =.2) and fewer mean days to crust formation (3.5 vs 4.9, P =.1), these differences did not reach statistical significance. The DSS group has statistically significant lower mean pain scores (3.1 vs 7.6, P =.04), but participants in this group also consumed more acetaminophen tablets than the placebo group (1.1 versus 0.5, P=.55). Adherence to medication was similar in both groups: 7 (50%) of the verum group reported using the cream as directed compared to 6 (46.2%) in the placebo group; (P =.8). CONCLUSIONS: We efficiently recruited participants and achieved high overall retention rates. However, participant adherence to the daily outbreak visit schedules was low and only 7 (50%) participants used the cream as directed. These limitations could be addressed in future Internet-based studies by using Personal Digital Assistants (PDAs), using reminder devices, and providing incentives. By enhancing participant adherence, clinical trials requiring frequent participant contact may be feasible over the Internet.

Administration, Topical↗
PubMed2002

Patient education for adults with rheumatoid arthritis.

BACKGROUND: Because of the unpredictability people with arthritis face on a daily basis, patient education programmes have become an effective complement to traditional medical treatment giving people with arthritis the strategies and the tools necessary to make daily decisions to cope with the disease. OBJECTIVES: To assess the effectiveness of patient education interventions on health status in patients with rheumatoid arthritis. SEARCH STRATEGY: We searched MEDLINE, EMBASE and PsycINFO and the Cochrane Controlled Trials Register. A selection of review articles (see references) were examined to identify further relevant publications. There was no language restriction. SELECTION CRITERIA: Randomised controlled trials (RCT's) evaluating patient education interventions that included an instructional component and a non-intervention control group; pre- and post-test results available separately for RA, either in the publication or from the studies' authors; and study results presented in full, end-of-study report. MAIN RESULTS: Twenty-four studies with relevant data were included. We found significant effects of patient education at first follow-up for scores on disability, joint counts, patient global assessment and psychological status. Physician global assessment was not assessed in any of the included studies. The two separate dimensions of psychological status: anxiety and depression showed no significant effects, nor did the dimensions of pain and disease activity. At final follow up no significant effects of patient education were found. REVIEWER'S CONCLUSIONS: Patient education as provided in the studies reviewed here had moderate short-term effects on patient global assessment, and small short-term effects on disability, joint counts and psychological status. There were no long-term benefits.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2004

Topical lidocaine patch 5% may target a novel underlying pain mechanism in osteoarthritis.

Recent literature and animal research has provided insight to potentially new analgesic targets for managing osteoarthritis (OA) pain. Primary afferent neurons located in affected joints express excessive amounts of abnormally functioning sodium (Na) channels on their surface in response to the inflammatory process. These Na channels may play an integral role in production of pain and hyperalgesia. Hence, the authors set out to conduct a 2-week, open-label, multicenter proof-of-concept study to evaluate the effectiveness and safety of lidocaine patch 5% monotherapy in adults with OA pain of the knee (n = 20). Patients with OA of one or both knees who were experiencing inadequate pain relief (defined as an average daily pain intensity of > 4 on a 0 to 10 pain scale) with their current analgesic regimen (i.e. APAP, NSAIDs, COX-2 inhibitors, tramadol) were enrolled and had all analgesic medications discontinued. Treatment with the lidocaine patch 5% resulted in significant improvements in the Western Ontario and McMaster Universities OA Index (WOMAC) pain, stiffness, physical function subscales and composite index (48.4, 41.1, 47.0, and 46.8% improvements respectively, p < 0.01). In addition, significant improvement was noted for pain intensity, pain relief, and pain interference with quality of life as measured by the Brief Pain Inventory (p < 0.05). The lidocaine patch 5% was generally well tolerated and no patients discontinued due to treatment-related adverse events. Given the open-label design, lack of a control group, and small sample size, the findings from our pilot study need to be confirmed by larger randomized controlled trials. Topical lidocaine patch 5% may provide clinicians with a novel, non-systemic therapy for OA pain with a unique mechanism of action.

Administration, Cutaneous↗
PubMed1990

Does patient education cause side effects? A controlled trial.

Ninety-eight adults treated with erythromycin for a variety of illnesses were randomized to two groups: the informed group received patient education about drug side effects, and the uninformed group were given no such information. Overall, 10% of the uniformed and 8% of the informed group felt the erythromycin bothered them in some way. There were no significant differences in the occurrence of various individual side effects. Compliance with therapy and the results of treatment were the same for both groups. In this study, informing patients about side effects of therapy did not have any detectable adverse effects.

Adult↗
PubMed2001

Media-based behavioural treatments for behavioural disorders in children.

BACKGROUND: Prevalence studies show that behaviour problems in children are quite common (10-15% in preschoolers). These problems may manifest as, for example anxiety, sadness, over-activity and tantrums. Some studies have shown that these problems can be persistent, and that they lead to a range of problems in adolescence and adulthood. Many approaches are used to address behavioural problems such as medication, or more usually, psychological treatments either directly with the child and/or his/her family. Behavioural interventions have been shown to be highly effective but access to these treatments is limited due to factors such as time and expense. Presenting the information parents need in order to manage these behaviour problems in booklet or other media-based format would reduce the cost and thus increase access to these interventions. In the adult population it seems that media-based interventions such as these can be moderately effective. Given that the cost of media-based treatment is so low it is useful to know how effective they are when given to parents. It was hypothesised that media-based treatments would be less effective than conventional psychological treatments and that efficacy would improve with increasing amounts of therapist intervention. OBJECTIVES: To review the effects of media-based behavioural therapies (definitions below), for any young person with a behavioural disorder (however diagnosed) compared to standard care and no treatment controls. SEARCH STRATEGY: A range of electronic databases were systematically searched using a specified search strategy. Individual journals of interest were hand-searched where necessary, references in all selected trials were checked for other trials and, where it was thought to be of possible use, individual authors were contacted for additional information. SELECTION CRITERIA: Randomised controlled trials of behavioural media-based treatments for behaviour problems in children. DATA COLLECTION AND ANALYSIS: Abstracts and titles of studies identified from searches of electronic databases were read to determine whether they met the inclusion criteria. Full copies of those possibly meeting these criteria from electronic or other searches were assessed by the reviewer and queries were resolved by discussion with an independent rater. Data were analysed using Revman. MAIN RESULTS: In general, media-based therapies for behavioural disorders in children had a moderate effect when compared with both no-treatment controls and with standard care. Significant improvements were often made with the addition of up to 2 hours of therapist time. REVIEWER'S CONCLUSIONS: These formats of delivering behavioural interventions for carers of children are possibly worth considering in clinical practice. For straightforward cases media-based interventions may be enough to make clinically significant changes in a child's behaviour, and reduce the amount of time primary care workers have to devote to each case. Consequently this would increase the number of families who could possibly benefit from this type of intervention. Media-based therapies would therefore appear to have both clinical and economic implications as regards the treatment of children with behavioural problems.

Caregivers↗
PubMed1999

Descriptive characteristics of the dietary patterns used in the Dietary Approaches to Stop Hypertension Trial. DASH Collaborative Research Group.

The Dietary Approaches to Stop Hypertension trial was a randomized, multicenter, controlled feeding study to compare the effect on blood pressure of 3 dietary patterns: control, fruits and vegetables, and combination diets. The patterns differed in selected nutrients hypothesized to alter blood pressure. This article examines the food-group structure and nutrient composition of the study diets and reports participant nutrient consumption during intervention. Participants consumed the control dietary pattern during a 3-week run-in period. They were then randomized either to continue on the control diet or to change to the fruits and vegetables or the combination diet for 8 weeks. Sodium intake and body weight were constant during the entire feeding period. Analysis of variance models compared the nutrient content of the 3 diets. Targeting a few nutrients thought to influence blood pressure resulted in diets that were profoundly different in their food-group and nutrient composition. The control and fruits and vegetables diets contained more oils, table fats, salad dressings, and red meats and were higher in saturated fat, total fat, and cholesterol than was the combination diet. The fruits and vegetables and combination diets contained relatively more servings of fruits, juices, vegetables, and nuts/seeds, and were higher in magnesium, potassium, and fiber than was the control diet. Both the fruits and vegetables and combination diets were low in sweets and sugar-containing drinks. The combination diet contained a greater variety of fruits, and its high calcium content was obtained by increasing low-fat dairy products. In addition, the distinct food grouping pattern across the 3 diets resulted in substantial differences in the levels of vitamins A, C, E, folate, B-6, and zinc.

Adult↗
PubMed1999

Dietary Approaches to Stop Hypertension: a summary of study results. DASH Collaborative Research Group.

The Dietary Approaches to Stop Hypertension multicenter trial examined the impact of dietary patterns on blood pressure in 459 adults with blood pressure < 160 mm Hg systolic and 80 to 95 mm Hg diastolic. After a 3-week run-in period on a control diet low in fruits, vegetables, and dairy products, and with a fat content typical for Americans, participants were randomized for 8 weeks to either the control diet, a diet rich in fruits and vegetables, or a combination diet that emphasized fruits, vegetables, and low-fat dairy products. Body weight and sodium intake were held constant, and physical activity did not change during the intervention. Baseline mean +/- standard deviation systolic and diastolic blood pressures were 131.3 +/- 10.8 mm Hg and 84.7 +/- 4.7 mm Hg, respectively. Relative to the control diet, the combination diet reduced blood pressure by 5.5 mm Hg and diastolic blood pressure by 3.0 mm Hg (P < .001). For those on the fruits and vegetables diet, blood pressure reductions relative to control were 2.8 mm Hg systolic (P < .001) and 1.1 mm Hg diastolic (P < .07). In 133 participants with hypertension, the combination diet produced a net blood pressure reduction of 11.4 and 5.5 mm Hg systolic and diastolic, respectively (P < .001). In participants without hypertension (n = 326), the corresponding blood pressure reductions were 3.5 mm Hg systolic (P < .001) and 2.1 mm Hg diastolic (P < .003). In other subgroup analyses, minorities showed relatively larger reductions in blood pressure than nonminorities (P < .001). We conclude that the dietary pattern reflected in the combination diet can substantially reduce blood pressure, and, accordingly, provides an additional lifestyle approach to preventing and treating hypertension.

Adult↗
PubMed1992

Clinical experience with a once-daily, extended-release formulation of diltiazem in the treatment of hypertension.

Although calcium channel blockers were only recently approved for antihypertensive therapy, 10 years of data have demonstrated their beneficial effects. Among the available calcium channel blockers, diltiazem hydrochloride appears to have a highly favorable side-effect profile. A new, extended-release formulation of diltiazem has been developed for the treatment of essential hypertension. The safety and efficacy of various once-daily doses of this new formulation were assessed in two multicenter studies. The first study was a dose-ranging trial of 275 patients with mild-to-moderate hypertension. Patients were randomly assigned to once-daily diltiazem (120, 240, 360, or 480 mg) or placebo for a 4-week, double-blind treatment period. A patient subgroup underwent ambulatory blood pressure monitoring (ABPM) twice. Once-daily diltiazem (dose range, 240-480 mg) significantly lowered trough systolic and diastolic blood pressure in a clearly dose-related fashion. ABPM results demonstrated consistent decreases in systolic and diastolic blood pressure throughout the 24-hour dosing interval. Dosages greater than or equal to 240 mg/day provided trough drug blood levels within the therapeutic range (i.e., greater than or equal to 40 ng/mL). The second study was a forced-escalation trail of 115 patients with mild-to-moderate hypertension. Patients were randomized to treatment with either placebo or escalating dosages of diltiazem (180 mg/day for 2 weeks, 360 mg/day for 2 weeks, and then 540 mg/day for 2 weeks). Statistically significant (p less than 0.01) reductions in supine systolic and diastolic blood pressure were observed with the 360 mg/day and 540 mg/day dosages. Dose escalations resulted in incremental blood pressure reductions and an increase in the percentage of responders. There was a significant correlation between diltiazem peak and trough plasma concentrations and antihypertensive effects in both studies, supporting the 24-hour efficacy of this extended-release formulation. Diltiazem administered once daily was found to be safe and well tolerated by the patients in these studies; adverse events were generally mild, with an incidence similar to placebo. Results indicate that this new extended-release formulation of diltiazem, administered once daily in doses greater than 120 mg, effectively lowers systolic and diastolic blood pressure in patients with mild-to-moderate essential hypertension.

Adolescent↗
PubMed1990

Controlled study of the impact of educational home visits by pharmacists to high-risk older patients.

Lack of information about medications coupled with high rates of utilization complicates compliance with medication regimens and increases the risk of adverse effects among older adults. We undertook a study of the efficacy of community-based interventions by pharmacists in a randomly-allocated one-half of a sample of 284 older adults considered to be at high risk for medication-related problems. Information and attitudes towards prescription and over-the-counter medications did not differ significantly between the intervention and comparison groups, either before or after the pharmacist interventions. However, visits to physicians were significantly less in the intervention group, suggesting an important if unexpected impact on health-related behavior.

Aged↗