[Show abstract][Hide abstract] ABSTRACT: Background: Arnica montana has been used as a remedy for centuries, and is common today for the treatment of pain, swelling and bruises. However its efficacy remains controversial. The authors systematically review the literature on the efficacy of A. montana applied topically. Literature searches of the main electronic databases on topical Arnica were performed. Also relevant experts and the herbal industry were consulted. Data was analyzed and the methodological quality assessed.Findings: Eleven controlled trials were found, five in volunteers and six in patients. Heterogeneity in the health conditions, Arnica dosage, co-interventions, and effects measurements was high, and many studies had important methodological flaws. Often, the number of participants was small and there were potential risks for bias. We identified a trend to better quality as the studies were more recent. Even the better studies showed at most a modest effect.Conclusion: The efficacy of Arnica in doses of 10% and below is not supported by the available evidence. More research is needed to determine if higher doses would be effective and remain safe.
[Show abstract][Hide abstract] ABSTRACT: Back schools offer an education and skills programme in a group setting and are primarily directed towards pain management. Randomised clinical trials including one carried out by our research group do not show back schools to be very effective. These research findings are summarised in a short overview. In order to determine the impact of this overview on health care practice, we conducted a randomised survey of general practitioners and physiotherapists (n = 170). The main aim was to see to what extent they would change their belief in the efficacy of back schools when confronted with the empirical evidence. After stratification for prior belief and profession, the participants were randomly divided into two groups: one was shown the short overview of the empirical evidence (n = 82) and the other was not (n = 88). Subsequently, they had to state their belief in the efficacy of the back school again. In the experimental group, 52% reported reduced confidence in back schools, compared to 22% in the control group. It can be concluded that the short overview led to a reduction in confidence in the expected direction, although somewhat smaller than was anticipated. Future studies should further elucidate the determinants of the impact of empirical evidence on health care practice.
[Show abstract][Hide abstract] ABSTRACT: Het doel van deze literatuurstudie is om de effectiviteit na te gaan van intensieve huisbezoekenprogramma's aan ouderen met gezondheidsproblemen of functionele beperkingen. Het doorzoeken van de literatuur was gebaseerd op de ingesloten experimenten van vier literatuurstudies over de effectiviteit van huisbezoeken, gepubliceerd vanaf 2000, en de databestanden van Cinahl, Cochrane, Embase, Medline en PsycINFO vanaf 2001. De zoekstrategie identificeerde 844 studies, waarvan acht voldeden aan de inclusiecriteria. Zeven experimenten waren van voldoende methodologische kwaliteit; geen van deze experimenten hadden, op basis van de belangrijkste analyses, een significant gunstig effect voor de interventiegroep in vergelijking met de controlegroep op mortaliteit, gezondheid, zorggebruik of kosten. De inclusie van minder intensieve programma's voor kwetsbare ouderen zou weinig invloed uitgeoefend hebben op de conclusies van onze literatuurstudie. We concluderen dat huisbezoekenprogramma's niet zinvol lijken voor oudere personen met (ervaren) gezondheidsproblemen binnen het gezondheidszorgsysteem van westerse landen.
Tijdschrift voor Verpleeghuisgeneeskunde 04/2009; 33(5):148-154. DOI:10.1007/BF03078542
[Show abstract][Hide abstract] ABSTRACT: To evaluate the effectiveness of a home visiting program on health-related measures in a population of older people with poor health status.
Randomized, clinical trial.
Community-dwelling citizens in The Netherlands.
Three hundred thirty people aged 70 to 84 randomly assigned to an intervention group (n=160) or a control group (n=170).
Eight home visits, lasting 1 hour or more, with telephone follow-up, over an 18-month period, conducted by experienced home nurses under supervision of a public health nurse; key elements of the (systematic) visits were assessment of health problems and risks, advice, and referral to professional and community services.
Self-rated health, functional status, quality of life, and changes in self-reported problems.
No differences were found between the intervention and control group in these and other outcome measures at the end of the intervention period (18 months).
The home visiting program did not appear to have any effect on the health status of older people with poor health and are probably not beneficial for such persons.
Journal of the American Geriatrics Society 04/2008; 56(3):397-404. DOI:10.1111/j.1532-5415.2007.01565.x · 4.57 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Home visiting programs have been developed to improve the functional abilities of older people and subsequently to reduce the use of institutional care services. The results of trials have been inconsistent and their cost-effectiveness uncertain. Home visits for a high-risk population rather than the general population seems a promising approach. We therefore studied the effects of a home visiting program for older people with poor health. This article describes the effects on health care use and associated cost.
We conducted a randomized clinical trial among 330 community-dwelling citizens, aged 70-84 years, in the Netherlands. Participants in the intervention group (n = 160) received eight home visits by a trained home nurse over an 18-month period; a multidimensional geriatric assessment of problems was included. The main outcomes are: admissions to hospital, nursing home, and home for older persons; contacts with medical specialists, general practitioners, and paramedics; and hours of home care help. The data on health care use were mostly obtained from computerized databases of various medical administration offices; the follow-up period was 24 months.
Inpatient and outpatient health care use was similar for both groups, with the exception of a higher distribution of aids and in-home modifications in favor of the intervention group. No differences were found between the intervention and control group in health care cost.
The home visiting program did not appear to have any effect on the health care use of older people with poor health and had a low chance of being cost-effective. We conclude that these visits are probably not beneficial for such persons within the health care setting in the Netherlands or comparable settings in other Western countries.
The Journals of Gerontology Series A Biological Sciences and Medical Sciences 04/2008; 63(3):291-7. DOI:10.1093/gerona/63.3.291 · 5.42 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Home visiting programs have been developed aimed at improving the health and independent functioning of older people. Also, they intend to reduce hospital and nursing home admission and associated cost. A substantial number of studies have examined the effects of preventive home visiting programs on older people living in the community; the findings have been inconsistent. The objective of this review was to assess the effectiveness of intensive home visiting programs targeting older people with poor health or otherwise with functional impairments.
A search for literature was based on included trials from four reviews on the effectiveness of home visits published after 2000 and on a database search of Cinahl, the Cochrane Central Register of Controlled Trials, Embase, Medline and PsycINFO from 2001 onwards. We also manually searched reference lists from potentially relevant papers. Randomized controlled trials were included assessing the effectiveness of intervention programs consisting of at least four home visits per year, an intervention duration of 12 months or more, and targeting older people (aged 65 years and over) with poor health. Two reviewers independently abstracted data from full papers on program characteristics and outcome measures; they also evaluated the methodological quality.
The search identified 844 abstracts; eight papers met the inclusion criteria. Seven trials were of sufficient methodological quality; none of the trials showed a significant favorable effect for the main analysis comparing the intervention group with the control group on mortality, health status, service use or cost. The inclusion of less-intensive intervention programs for frail older persons would not have exerted a great influence on the findings of our review.
We conclude that home visiting programs appear not to be beneficial for older people with poor health within the health care setting of Western countries.
BMC Health Services Research 02/2008; 8(1):74. DOI:10.1186/1472-6963-8-74 · 1.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To find out if administration of melatonin facilitates discontinuation of benzodiazepine (BD) therapy in patients with insomnia.
A placebo controlled trial in nine general practices in the Netherlands. Long-term users of benzodiazepines were asked by their GP to participate in a discontinuation program in combination with melatonin or placebo. The intervention and follow-up period lasted one year. During this period participants received four questionnaires about their use of sleeping medication and several health instruments. The urine of all participants was tested for the presence of benzodiazepines, as proof of the discontinuation.
The discontinuation of benzodiazepine use measured by questionnaires and urine samples at three assessment points.
A total of 503 long-term users were selected by the GPs, of whom 38 patients (16M/22F) participated. After one year 40% had stopped their benzodiazepine use, both in the intervention group on melatonin and in the placebo control group. Comparing stoppers and non-stoppers did not reveal significant differences in benzodiazepine use, or awareness of problematic use.
Our findings do not conclusively indicate that melatonin is helpful for the discontinuation of the use of benzodiazepines, but the average dose of benzodiazepines in the group was low. Further investigation is necessary, with special attention to the possible influence of the daily dose on the facilitation effect of melatonin.
International Journal of Clinical Pharmacy 01/2008; 29(6):641-6. DOI:10.1007/s11096-007-9118-y · 1.27 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Title. Home visiting programme for older people with health problems: process evaluation
Aim. This paper is a report of a process evaluation of the content, patient compliance and participant experiences of a home visiting programme for older people with self-reported health problems.
Background. Systematic home visits by nurses to older people are a public health strategy to improve their functional abilities and prevent institutionalization. Evidence of the usefulness of these visits is conflicting, partly due to a lack of information on the intervention process in these programmes.
Method. One hundred and sixty people (aged 70–84 years) participated in the programme and were visited eight times during an 18-month period (February 2003–October 2004) by experienced home nurses. The nurses recorded key elements of each visit on standard forms: topics discussed, interventions regarding health problems and risks, and compliance with these interventions. Participants’ and nurses’ opinions on the visits were obtained through interviews at the end of the programme.
Findings. Nearly 80% of the group received the complete programme. Problems were detected in nearly all visits, mainly regarding social and psychological functioning, circulatory and musculoskeletal problems, and vision or hearing impairment. On average, ten problems and 11 interventions were recorded per participant. Nearly 40% of interventions related to referrals, 45% to advice and 17% consisted of information-giving. The compliance rate was 65% for referrals and 58% for advice. Both nurses and participants were positive about the programme.
Conclusion. A health visiting programme, performed by home nurses, is feasible and appreciated by frail elders. The latter seem to be a relevant target population in view of the many and varied problems detected.
[Show abstract][Hide abstract] ABSTRACT: Several animal studies have shown that bladder performance improves as a result of diuresis. Whether increased urine output also has beneficial effects on elderly male bladder function and lower urinary tract symptoms is unknown.
We performed a randomized placebo-controlled trial of 141 men, 55 to 75 years of age, with moderate lower urinary tract symptoms. The experimental group drank 1.5 L of extra water daily. The control group consumed one tablespoon of placebo syrup daily. After 6 months, we evaluated bladder contractility, voided volumes, and the severity of lower urinary tract symptoms. The actual increase in water consumption was measured using the deuterium urine dilution method.
Water consumption in the intervention group increased by 359 mL (95% confidence interval [CI] 171 to 548) per 24 hours compared with the control group. At 6 months, no statistically significant effect was found in the maximal flow rate (0.9 mL/s, 95% CI -0.4 to 2.2) compared with placebo. A statistically significant effect was found for bladder pressure (20 cm H2O, 95% CI 6 to 34) and bladder wall stress (1.9 N/cm2, 95% CI 0.3 to 3.5). In addition, it showed that the experimental group had greater maximal (44 mL, 95% CI -1 to 90) and average (26 mL, 95% CI 1 to 51) voided volumes per urination. The subjective effect parameters improved in both groups, but no statistically significant differences were found between the two groups.
It seems possible to improve some aspects of male bladder function by drinking more water. However, the effects are too small to be clinically relevant.
[Show abstract][Hide abstract] ABSTRACT: To examine whether telling symptomatic patients that they will soon be better shortens the duration of their illness.
We repeated an earlier trial in general practice on this subject. All our patients were reassured that they probably had no serious underlying disease. We randomized 128 patients into two groups. Half of them got a clear diagnosis and were told that they would soon be better. The others heard from their general practitioners (GPs) that they probably had no serious underlying disease but that the GP did not know exactly what was wrong; these patients were advised to come back later if necessary. For 78 patients, study protocol was followed exactly.
Our trial could not show an effect. The Kaplan-Meier curves of patients with a positive and negative consultation ran nearly parallel. The hazard ratio in the total group was 0.97 (95% precision interval PI=0.69-1.41) and in the optimal subgroup 0.91 (95% PI=0.57-1.46). We still cannot rule out a modest placebo effect.
Our finding contrasts with that of the earlier trial. We think that symptomatic patients mainly want to know that they do not have a serious problem. Often, they will miss the extra information that they get--and then they certainly cannot benefit from it.
[Show abstract][Hide abstract] ABSTRACT: Background
Preventive home visits to elderly people by public health nurses aim to maintain or improve the functional status of elderly and reduce the use of institutional care services. A number of trials that investigated the effects of home visits show positive results, but others do not. The outcomes can depend on differences in characteristics of the intervention programme, but also on the selection of the target population. A risk group approach seems promising, but further evidence is needed. We decided to carry out a study to investigate the effects in a population of elderly with (perceived) poor health rather than the general population. Also, we test whether nurses who are qualified at a lower professional level (home nurses instead of public health nurses) are able to obtain convincing effects. The results of this study will contribute to the discussion on effective public health strategies for the aged.
The study is carried out as a parallel group randomised trial. To screen eligible participants, we sent a postal questionnaire to 4901 elderly people (70–84 years) living at home in a town in the south of the Netherlands. After applying inclusion criteria (e.g., self-reported poor health status) and exclusion criteria (e.g., those who already receive home nursing care), we selected 330 participants. They entered the randomisation procedure; 160 were allocated to the intervention group and 170 to the control group. The intervention consists of (at least) 8 systematic home visits over an 18 months period. Experienced home nurses from the local home care organisation carry out the visits. The control group receives usual care. Effects on health status are measured by means of postal questionnaires after 12 months, 18 months (the end of the intervention period) and after 24 months (the end of 6-months follow-up), and face-to-face interviews after 18 months. Data on mortality and service use are continuously registered during 24 months. A cost-benefit analysis is included.
The design and setting of the study, the selection of eligible participants and the study interventions are described in this article. Other included items are: the primary and secondary outcome measures, the statistical analysis and the economic evaluation.
BMC Health Services Research 12/2004; 4(1):35. DOI:10.1186/1472-6963-4-35 · 1.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Preparations based on special extracts of the Ginkgo biloba tree are popular in various European countries. Previous studies have suggested the clinical efficacy of Ginkgo in patients with dementia, cerebral insufficiency, or related cognitive decline. However, most of these studies did not fulfill the current methodologic requirements. We assessed the efficacy of the G. biloba special extract EGb 761 in patients with dementia and age-associated memory impairment in relation to dose and duration of treatment. Our study was a 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Study participants were elderly patients with dementia (Alzheimer disease or vascular dementia) or age-associated memory impairment (AAMI). A total of 214 participants, recruited from 39 homes for the elderly in the Netherlands, were randomly allocated to Ginkgo (either 240 mg/d or 160 mg/d) or placebo (0 mg/d). After 12 weeks, the subjects in the two Ginkgo groups were randomized to continued Ginkgo treatment or placebo treatment. Primary outcome measures in this study were the Syndrome Kurz Test (SKT; psychometric functioning), the Clinical Global Impression of change (CGI-2; psychopathology, assessed by nursing staff), and the Nuremberg Gerontopsychological Rating Scale for Activities of Daily Living (NAI-NAA; behavioral functioning). One hundred twenty-three patients received Ginkgo (n=79, 240 and 160 mg/d combined) or placebo (n=44) during the 24-week intervention period. We found no statistically significant differences in mean change of scores between Ginkgo and placebo. The differences were SKT: +0.4 (90% confidence interval [CI] -0.9-1.7); CGI-2: +0.1 (90% CI -0.3-0.4), and NAI-NAA: -0.4 (90% CI -1.9-1.2). A positive difference is in favor of Ginkgo. Neither the dementia subgroup (n=36) nor the AAMI subgroup (n=87) experienced a significant effect of Ginkgo treatment. There was no dose-effect relationship and no effect of prolonged Ginkgo treatment. The trial results do not support the view that Ginkgo is beneficial for patients with dementia or age-associated memory impairment.
[Show abstract][Hide abstract] ABSTRACT: Few interventions have proved to be effective in the prevention and treatment of common colds. Anecdotal reports suggest the possible beneficial effect of hydrotherapy (stimulation of the body surface with warm and cold water). This study's objective was to evaluate the clinical effect of hydrotherapy on common colds in children. Children aged 3-7 years with six or more common cold episodes during the preceding 12 months were randomised to receive either daily inhalation of normal saline in the control group or daily inhalation plus daily hydrotherapy in the experimental group for 12 months. The main outcome measurements were incidence, duration and severity of common cold episodes as reported by the children's parents in a daily symptom diary. Groups did not differ at baseline with regard to age, gender, or number of cold episodes in the year before the study. Diaries were available from 81 patients in the control group and 65 patients in the experimental group. In the study period, there were no significant differences in the incidence of colds (control vs. experimental group, mean +/- SD, 4.8+/-3.5 vs. 4.1+/-3.3 episodes) or the average duration of episodes (7.7+/-3.5 vs. 7.6+/-3.8 days). CONCLUSION: This study does not demonstrate any beneficial effect of hydrotherapy on preschool children with frequent common colds.
European Journal of Pediatrics 04/2003; 162(3):168-76. DOI:10.1007/s00431-002-1138-y · 1.89 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: I do not know how many randomized clinical trials are positive, and how many of these trials are false positive. Still, I get the feeling that among the published ones that are positive, the majority is false positive. This article tells you how you can end a trial with a positive result even if your trial data do not or hardly support your favorite treatment. It deals with many deliberate and less deliberate biases, in the introduction, in the patients and methods section, in the results, and in the data interpretation and report.