Secondary prevention after PCI: the cost-effectiveness of statin therapy in the Netherlands.

BACKGROUND: Little is known about the cost-effectiveness of secondary prevention after percutaneous coronary intervention (PCI). The aim of this study was to estimate the cost-effectiveness of statin therapy. METHODS: A cost-effectiveness analysis was performed using data from the Lescol Intervention Prevention Study (LIPS). In the LIPS trial, patients with normal-to-moderate hypercholesterolaemia who had undergone a first PCI were randomised to receive either fluvastatin 40 mg twice-daily plus dietary counselling or dietary counselling alone. A Markov model was used to estimate the incremental costs per quality-adjusted life year (QALY) and life year gained (LYG). Costs were based on prices and reimbursed charges, utility data were drawn from literature. Monte Carlo simulations and multivariate analysis were used to assess uncertainty. RESULTS: Routine statin treatment costs an additional €734 (SD €686) per patient over ten years compared with controls. It resulted in an additional 0.078 (0.047) QALYs or 0.082 (0.041) LYG. The incremental costs per QALY and LYG were €9312 (€14,648) and €8954 (€16,617) respectively. Anticipating a willingness to pay of €20,000 per QALY, there is a 75.1% chance that fluvastatin treatment is cost-effective. CONCLUSION: Statin therapy with fluvastatin is economically efficient with regard to reducing heart disease in the Netherlands when given routinely to all patients following PCI.

Gender and adult undernutrition in developing countries.

BACKGROUND: Information on the prevalence of undernutrition in adults in developing countries is mainly restricted to data on women. Literature reporting on the occurrence of female deprivation in developing countries, in particular in South Asia, suggests that differences between undernutrition prevalence in adult men and adult women might occur, but systematic information on the subject is lacking. AIM: The study compares undernutrition prevalence rates, based on prevalence of low body mass index (BMI < 18.5), in adult men and adult women in developing countries. Regional comparison is made between the main developing regions: Sub-Saharan Africa, South/Southeast Asia and Latin America. SUBJECTS AND METHODS: The study uses data as reported in 75 samples from 31 countries(divided over the three developing regions), in which anthropometric information has been collected in adult men and women within one and the same community. RESULTS: Results indicate that, in general, prevalence rates of undernutrition are rather similar in adult men and women. However, there are regional differences. In communities in Sub-Saharan Africa, prevalence of low BMI is, on average, a few percent higher in men than in women; in South/Southeast Asia the reverse is the case. In some communities differences in undernutrition prevalence between men and women are exceptionally large. CONCLUSIONS: It can be concluded that, in general, information on undernutrition prevalence in women can be considered a proxy for undernutrition prevalence in all adults, men and women together. However, the finding that in South/Southeast Asia women's nutritional status relative to men's nutritional status compares unfavourably with results from other developing regions, in particular Sub-Saharan Africa, provides some support for the concept of female deprivation in South/Southeast Asia. Where large differences between prevalence of low BMI in men and women occur, gender-specific policies aimed at reducing under-nutrition should be considered.

Food-consumption patterns in central West Africa, 1961 to 2000, and challenges to combating malnutrition.

We discuss food-consumption patterns in Central West Africa from 1961 to 2000 and some implications for combating malnutrition. The availability of food in the region improved in the 1960s, declined sharply in the 1970s and the early 1980s, and has shown a modest positive trend since the mid-1980s. Notwithstanding obvious progress over the past decades and in the region as a whole, food availability today remains below the required levels for large parts of the population and appears unstable over time, particularly in the Sahelian zone. On average, diets in this zone contain fewer than 2,200 kcal, compared with almost 2,500 kcal in the coastal zone. Conversely, protein deficiency is more common in the coastal zone, where a typical diet contains only 45 g of protein, compared with 60 g in the Sahelian zone. Furthermore, consumption is showing a dietary shift toward cereals, while yield growth lags far behind population growth. The associated import dependency and pressure on land seem to gain significance regardless of the region's agro-ecological capacity to increase and to substitute cereal imports for locally produced food. Moreover, food consumption appears responsive to income changes (calorie-income elasticity ranges from 0.25 to 0.62), while, in turn, it has a significant impact on nutritional outcomes (stunting-calorie elasticity of -1.42). We conclude that combating malnutrition requires first broad-spectrum income growth, and next specific policies that promote the yield and the contribution to diets of nutritious food produced within the region.

[Drug treatment of chronic myeloid leukemia: a cost effectiveness analysis of first- and second-line treatment ]. / Medicamenteuze behandeling van chronische myeloïde leukemie: een kosteneffectiviteitsanalyse van 1e- en 2e-lijnsbehandeling.

OBJECTIVE: To determine the average cost-effectiveness ratio of treatment of patients with chronic myeloid leukaemia (CML): with first-line interferon alpha-2a (IFN) or with second-line imatinib following IFN failure. DESIGN: Cost-effectiveness analysis. METHOD: A general cost-effectiveness analysis was performed using a model. This model consists of two phases: an induction phase of eight months, in which newly-diagnosed patients are treated with either IFN or imatinib, and a chronic treatment phase wherein patients are treated according the result of the induction phase. The model calculated the costs and effects of the treatment. Input for this model was derived from literature and expert opinion. Costs were based on real cost prices and tariffs. RESULTS: Treatment with imatinib resulted in 6.67 quality-adjusted life years (QALYs) and treatment with IFN resulted in 4.98 QALYs. Average costs of treatment with 5 million IU/day of IFN were [symbol: see text] 76,969 and [symbol: see text] 53,257 with 3 million IU/day. For imatinib at 400 mg/day the costs were [symbol: see text] 140,765 per patient. Costs per QALY were [symbol: see text] 15,445, [symbol: see text] 10,687 and [symbol: see text] 21,082, respectively. CONCLUSION: The addition of imatinib to the treatment options in CML resulted in increased quality-adjusted survival, but also higher costs of treatment.

Epidemiological aspects and early detection of chronic obstructive airway diseases in the elderly.

The burdens of chronic obstructive airway diseases among the elderly in Europe, and worldwide, are increasing. Although asthma is common in all ages, the main airway disease affecting the elderly is chronic obstructive pulmonary disease (COPD). The aim of this paper is to review the prevalence and incidence of COPD on the basis of population studies. As the prevalence estimates of asthma are probably well known, only the incidence and remission of asthma will be discussed. The underdiagnosis of obstructive airway diseases is huge. A Dutch programme for early detection of obstructive airway disease among the elderly has, thus, been included in the presentation. A prerequisite for fighting COPD is to acquire data on illnesses and death. COPD has only recently been defined by cut-off points of spirometric outcomes, which is why measures of the prevalence of COPD have been distorted by use of a large number of different diagnostic terms and lung function criteria. The prevalence of clinically-relevant COPD has been estimated in several community studies to 4-6% in adult population samples, with a considerable increase by age, particularly among smokers. The incidence of COPD not only increases heavily with age and smoking, but also occupational exposure to dust, gas and damp. Precise estimates of the incidence of COPD or spirometric airflow limitation are not available. Demographic changes will result in a further substantial increase of chronic obstructive airway disorders, mainly chronic obstructive pulmonary disease, among the elderly. The increasing burden of chronic obstructive pulmonary disease has to come to the awareness of the public, governments, health authorities, and industry.

Self-management of asthma in general practice, asthma control and quality of life: a randomised controlled trial.

BACKGROUND: A study was undertaken to determine the effectiveness of asthma self-management in general practice. METHODS: Nineteen general practices were randomly allocated to usual care (UC) or self-management (SM). Asthma patients were included after confirmation of the GP diagnosis. Follow up was 2 years. Patients kept diary cards and visited the lung function laboratory every 6 months. Outcomes were number of successfully treated weeks, limited activity days, asthma specific quality of life, forced expiratory volume in 1 second (FEV(1)), FEV(1) reversibility, concentration of histamine provoking a fall in FEV(1) of 20% or more (PC(20) histamine), and amount of inhaled steroids. RESULTS: A total of 214 patients were included in the study (104 UC/110 SM; one third of the total asthma population in general practice); 62% were female. The mean percentage of successfully treated weeks per patient in the UC group was 72% (74/103 weeks) compared with 78% (81/105 weeks) in the SM group (p=0.003). The mean number of limited activity days was 1.2 (95% CI 0.5 to 1.9) in the SM group and 3.9 (95% CI 2.5 to 5.4) in the UC group. The estimated increase in asthma quality of life score was 0.10 points per visit in the UC group and 0.21 points per visit in the SM group (p=0.055). FEV(1), FEV(1) reversibility, and PC(20) histamine did not change. There was a saving of 217 puffs of inhaled steroid per patient in favour of the SM group (p<0.05). CONCLUSION: Self-management lowers the burden of illness as perceived by patients with asthma and is at least as effective as the treatment usually provided in Dutch primary care. Self-management is a safe basis for intermittent treatment with inhaled corticosteroids.

The cost effectiveness of early treatment with fluticasone propionate 250 microg twice a day in subjects with obstructive airway disease. Results of the DIMCA program.

In a two-stage detection program, subjects with signs of obstructive airway disease were selected from a random sample of the general population. Subjects (n = 82) were randomly assigned to either fluticasone propionate 250 microg twice a day or placebo twice a day via pMDI in a 1-yr, double-blind trial if they met criteria for persistent airway obstruction, increased bronchial hyperresponsiveness, or a rapid decline in FEV(1). Main outcome measures were postbronchodilator FEV(1), quality-adjusted life years (QALYs), and direct medical cost. Secondary measures were prebronchodilator FEV(1), PC(20), health-related quality of life (CRQ), symptom-free weeks, episode-free weeks, exacerbations, and indirect cost. Subgroup analysis was based on reversibility of obstruction. Analysis revealed a significant gain in postbronchodilator FEV(1) (98 ml/yr; p = 0.01) in favor of fluticasone. Only subjects with reversible obstruction showed an improvement in PC(20) (1.4 doubling dose; p = 0.03). Early treatment resulted in 2.7 QALYs gained per 100 treated subjects (p = 0.17) and in a clinically relevant improvement in dyspnea (CRQ; p < 0.03). The incremental cost effectiveness ratios were US$13,016/QALY for early treatment and US$33,921/QALY for the combination of detection and treatment. The incremental cost for one additional subject with a clinically relevant difference in dyspnea was US$1,674. In conclusion, early intervention with fluticasone resulted in significant health gains at relatively low financial cost.

Underdiagnosis of asthma: is the doctor or the patient to blame? The DIMCA project.

BACKGROUND: It is important to diagnose asthma at an early stage as early treatment may improve the prognosis in the long term. However, many patients do not present at an early stage of the condition so the physician may have difficulty with the diagnosis. A study was therefore undertaken to compare the proportion of patients who underpresented their respiratory symptoms with the proportion of underdiagnosed cases of asthma by the general practitioner (GP). A secondary aim was to investigate whether bad perception of dyspnoea by the patient was a determining factor in the underpresentation of asthma symptoms to the GP. METHODS: A random sample of 1155 adult subjects from the general population in the eastern part of the Netherlands was screened for respiratory symptoms and lung function and the results were compared with the numbers of asthma related consultations registered in the medical files of the GP. In subjects with reduced lung function the ability to perceive dyspnoea was investigated during a histamine provocation test in subjects who did and did not report their symptoms to their GP. RESULTS: Of the random sample of 1155 subjects 86 (7%) had objective airflow obstruction (forced expiratory volume in one second (FEV(1)) below the reference value corrected for age, length, and sex minus 1.64SD on two occasions) and had symptoms suggestive of asthma. Of these 86 subjects only 29 (34%) consulted the GP, which indicates underpresentation by 66% of patients. Of all subjects with objective airflow obstruction who presented to their GP with respiratory symptoms, 23 (79%) were recorded in the medical files as having asthma, indicating underdiagnosis by the GP in 21% of cases. Of the subjects with objective airflow obstruction who visited the GP with respiratory symptoms 6% had bad perception of dyspnoea compared with 26% of those who did not present to the GP in spite of airflow obstruction (chi(2) = 3.02, p = 0.08). CONCLUSIONS: Underpresentation to GPs of respiratory symptoms by asthmatic patients contributes significantly to the problem of underdiagnosis of asthma. Underdiagnosis by the GP seems to play a smaller role. Furthermore, there are indications that underpresentation of symptoms by the patient is at least partly explained by a worse perception of dyspnoea.

The economic effects of screening for obstructive airway disease: an economic analysis of the DIMCA program.

BACKGROUND: A large, population-based intervention (the DIMCA study) has shown substantial underdiagnosis of chronic obstructive pulmonary disease and asthma. Detection of undiagnosed patients by means of screening and subsequent monitoring was relatively inexpensive per detected patient, compared with other mass screening programs. The objectives of this study were to assess whether early detection according to the DIMCA protocol leads to increased utilization of health care resources and cost, other than the cost of the scheduled visits. METHODS: In a prospective randomized consent trial, the utilization of health care resources and cost were ascertained in two groups: a screened group (n = 416) and a control group (n = 462). In a subsample of 100 screened subjects, consultation frequency before screening was compared with the frequency after screening. Subjects were a random sample from the general population of between 25 and 70 years of age. RESULTS: During an average follow-up of 3.6 years, there were no significant differences in health care resource utilization and cost between the screened subjects and the controls. Resource utilization before screening was not significantly different from resource utilization after screening. Statistically significant differences were found within the screened group: subjects with a positive screening result (i.e., with signs or symptoms of obstructive airway disease) consulted their general practitioners 3.7 times more frequently (P = 0.001) for respiratory reasons than subjects with a negative screening result. The total health care cost due to respiratory disease in screen-positive subjects was 6.4 times higher (P = 0.008). CONCLUSION: There were no indications that screening for obstructive airway disease led to increased cost, above that of average care.

[Role of spirometry in primary practice]. / De plaats van spirometrie in de eerste lijn.

Spirometry is increasingly used in general practice and improves the possibilities regarding mainly the early detection and treatment of obstructive pulmonary diseases. However, spirometry performed in general practice is less reliable than that performed in lung function laboratories and primary care laboratories, so that spirometry performed by the GP personally appears to be less suitable for monitoring purposes. Spirometry is a useful and feasible tool for GP's, providing that test results are adequately integrated within the GP's management of patients with obstructive lung disease. If sufficient attention on quality assurance of spirometry cannot be guaranteed in general practice, lung function laboratories and primary care laboratories may play an important supportive role.

Volume calibration alone may be misleading.

The use of spirometry is becoming more and more widespread in non-laboratory situations such as general practice or occupational medicine. In these non-laboratory situations, volume calibration with a 3000 ml syringe is often the only feasible method to ensure that the spirometer produces valid and reproducible data. Sophisticated equipment to calibrate forced manoeuvres with standard waveforms are not present. In this study, we assessed whether volumetric calibration is a guarantee for valid and comparable spirometric results. Two portable spirometers were tested. On 8 consecutive test days, both spirometers were calibrated with a 3000 ml syringe in accordance with the American Thoracic Society (ATS) guidelines. The comparability of the spirometric results (forced expiratory volume in 1 S, FEV1) was tested in two ways. Firstly, the spirometers were compared to each other using the results from 43 volunteers on the same 8 test days. The spirometers were presented in a randomized order and volunteers were asked to perform a series of reproducible manoeuvres in both spirometers. Paired observations were analysed, using Bland and Altman plots. Secondly, the spirometers were compared to a 'gold standard', a computer-driven syringe (CDS). Calibration with the 3000 ml syringe showed that both spirometers complied with the ATS criteria for volume calibration for diagnostic spirometry. However, paired FEV1 data obtained in subjects showed a systematic, volume-dependent difference between the two spirometers (mean difference: 289 ml, P < 0.001, systematic difference: 8.6%, P < 0.0001). This systematic difference was confirmed by the comparisons with the CDS. Volume calibration may be misleading. The results from volume calibration may meet the ATS criteria, but this is no guarantee that data from forced manoeuvres are accurate. If CDS equipment to simulate standard wave forms is not available, it is recommended that biological calibration is performed regularly and, if possible, that paired data from two (or more) different spirometers are compared.

Present and future management of asthma and COPD: proceedings from WONCA 1998.

On 15 June 1998, a workshop on asthma and chronic obstructive pulmonary disease (COPD) was held at the WONCA conference in Dublin. Based on the current guidelines for diagnosis and treatment of asthma and COPD, new developments and present and future research projects were discussed. Based on these guidelines and the research findings, new developments were positioned. The final conclusion of this workshop was that there is a need to continue exchanging ideas at an international level. So an initiative to start a Scientific Group of Primary Care Research within the European Respiratory Society has been taken.

Active detection of chronic obstructive pulmonary disease and asthma in the general population. Results and economic consequences of the DIMCA program.

The aim of this prospective study was to detect subjects in the general population with objective signs of chronic obstructive pulmonary disease (COPD) or asthma at an early stage. This was done by means of a two-stage protocol involving screening and a subsequent 2-yr monitoring of all subjects with positive results of screening. The study was done in 10 general practices located in the eastern part of the Netherlands. A random sample was taken from the general population aged 25 to 70 yr. All known COPD and asthma patients were excluded. A total of 1,749 subjects met the inclusion criteria: 1,155 subjects (66%) agreed to participate in the screening stage of the study. A total of 604 subjects (52.3%) showed symptoms or objective signs of COPD or asthma during the screening and were considered "positive." Of those with positive screening results, 384 subjects (64%) agreed to participate in the second, 2-yr monitoring stage of the study. The costs involved in detection were calculated for three different scenarios, as follows: (1) The detection of subjects with persistently decreased lung function or an increased level of bronchial hyperresponsiveness (BHR) during 6 mo of monitoring; (2) Scenario 1 plus the detection of subjects with a rapid decline in lung function with signs of BHR during 12 mo of monitoring; (3) Scenario 2 plus the detection of subjects with a moderate increase in the decline in lung function or signs of BHR during 24 mo of monitoring. The costs of lung function assessments, organization, transportation, and patient time were included. The costs were converted to United States dollars on the basis of purchasing power (1 United States dollar = 2.08 Netherlands guilders). During the second stage, 252 subjects were detected with objective signs of COPD or asthma at an early stage. Smoking status as a screening criterion was neither sensitive nor specific. Because there was no evidence of biased recruitment or selection during the program, the proportions of subjects found to have objective signs of COPD or asthma at an early stage could be extrapolated to the general population. Of the general population, 7.7% showed persistently reduced lung function or increased BHR. Another 12.5 % of the general population showed a rapid decline in lung function (> 80 ml/yr) in combination with signs of BHR, and a further 19.4% of the general population showed mild objective signs of COPD or asthma. The average costs per detected case varied from US$953 (Scenario 1) to US$469 (Scenario 3). In conclusion, detection of COPD or asthma at an early stage by means of a two-stage protocol was feasible at relatively little expense in comparison with other mass screening programs. Persistently decreased lung function or a rapid decline in lung function (Scenario 2) was observed in approximately 20% of the general adult population.

Association between health-related quality of life and consultation for respiratory symptoms: results from the DIMCA programme.

In general practice, diagnosis of chronic obstructive pulmonary disease (COPD) is hampered by underpresentation. A substantial proportion of subjects experiencing respiratory complaints do not consult their general practitioner (GP). In this study, the relationship between disease-specific quality of life and presentation of respiratory symptoms to a GP is investigated. A random sample from the general population (undiagnosed subjects) was screened for symptoms and objective signs of COPD (n=1,155). The lung function of subjects with symptoms of COPD was monitored for 6 months. During this period, 48 new COPD patients with a persistently reduced lung function (forced expiratory volume in one second (FEV1) less than or equal to the predicted value minus 2 SD) were detected. A disease-specific quality-of-life questionnaire (chronic respiratory questionnaire (CRQ)) was administered and clinical and GP consultation data were collected. Multivariate analysis showed that quality-of-life impairments due to dyspnoea and fatigue and variability in lung function (bronchial hyperresponsiveness, reversibility and peak expiratory flow rate variability) were related to medical consultation. Only 31% of the newly detected patients reported that they had ever visited their GP for respiratory complaints. A similarly low percentage was found in the rest of the sample (26%). It is concluded that the mere presence of respiratory symptoms or a (gradually) reduced lung function is insufficient reason for patients to seek medical help. Subjects are more likely to consult their general practitioner once their quality of everyday life is affected or they experience variability in lung function.

Body mass index as indicator of standard of living in developing countries.

OBJECTIVE: To assess the suitability of the body mass index (BMI) as an indicator of standard of living in developing countries. DESIGN, SETTING AND SUBJECTS: The analysis is based on data collected in the first two rounds of the Ghana Living Standards Survey, held in 1987/88 (GLSS-I) and 1988/89 (GLSS-II). The dataset provides information on a wide range of socio-economic variables, at the individual, the household and the community level, including the height and weight data of approximately 9000 adults in the 20-65 y age bracket. METHOD: Bivariate analysis was used to assess, at the individual level and at the level of population groups, the relationships between adult Body Mass Index and selected household characteristics such as income and expenditure, years of schooling of head of household, access to services, quality of housing, and nutritional status of children. Through multiple regression, indicative estimates have been derived of the effects of these variables on adult BMI. For comparison, the same relationships were investigated for weight and height. RESULTS AND CONCLUSION: At the individual level, BMI shows a significantly positive relation with the various socio-economic indicators of living standard, though the correlation coefficients indicate a poor fit. However, at the level of population groups, The relationship between BMI and other characteristics of socio-economic development is strong with a correlation coefficient of 0.86 between mean BMI and mean per capita expenditures of 12 population groups in Ghana, presumed to be at different levels of standard of living. The relationships between weight and the various socioeconomic characteristics were comparable to those for BMI, while height was poorly correlated with the selected household variables. Result suggest that in low-income countries, information on adult BMI (mean and distribution) can be used for assessing differences in standards of living between population groups or for monitoring changes over time.

Prevalence of asthma and COPD in general practice in 1992: has it changed since 1977?

BACKGROUND: Asthma and COPD are common diseases of the airways which are mainly diagnosed and treated in general practice. AIM: Various studies have reported an increase in the morbidity of asthma and COPD. There are two possible reasons for such an increase. The first is an apparent increase caused by using different criteria in defining asthma/COPD, and by increased awareness of the disease by doctors and patients. The second is a real increase caused by an increase in the prevalence of airway pathology. The aim of this study was to determine the cause of the observed increase in morbidity. METHOD: In 1977, a sample of 2328 adults from the general population were screened for asthma and COPD. Those screened were then divided into five sub-groups (grades 1-5), according to severity of: (1) respiratory symptoms; and (2) loss in FEV1. The number of patients who were not known to the general practitioner prior to the screening as having asthma or COPD grades 1-5 were also assessed. In 1992, we studied a different sample of 1184 adults of the general population in the same area. We used the same criteria as in 1977 to analyse our results. The number of patients not known to the general practitioner prior to the screening was also studied. RESULTS: The overall prevalence (grades 1-5) of asthma and COPD has increased from +/- 19% in 1977 to +/- 31% in 1992 (range 21-42). The main reason for this is an increase in prevalence of very mild to moderate asthma and COPD (grades 1-3) from 17% in 1977 to 27% in 1992. The prevalence of severe cases (grades 4-5) increased from 2% in 1977 to 4% in 1992. In 1992, around 65% of the patients were not known to the general practitioner as having any grade of asthma or COPD. This was only slightly lower than the 72% in 1977. All patients with a severe disease (grade 5) were known to the general practitioner. CONCLUSIONS: There is a real increase in the prevalence of asthma and COPD, caused predominantly by an increase in the number of mild cases. The percentage of patients not known to the GP were predominantly mild cases.

Cost effectiveness of medical versus surgical treatment in patients with severe or refractory gastroesophageal reflux disease in the Netherlands.

BACKGROUND: For a significant number of patients with severe or refractory gastroesophageal reflux disease, maintenance treatment with omeprazole and reflux surgery (Nissen fundoplication) are alternative treatment options. In this study maintenance treatment with omeprazole is compared with open and laparoscopic Nissen fundoplication from a health-economic perspective. METHODS: Meta-analysis of published articles to assess effectiveness and simple decision-analytic techniques to combine costs and effects are used. Findings and assumptions are submitted to sensitivity analysis. RESULTS: It is estimated that it costs approximately 1880 Dutch guilders to initially heal a patient with severe or refractory esophagitis with 40 mg omeprazole daily. When medical maintenance therapy was compared with surgery, it appeared that medical maintenance therapy with omeprazole (20-40 mg daily) for a prolonged period of time (more than 4 years) is less cost effective than a Nissen procedure. It is estimated that a laparoscopic Nissen will shift this so-called break-even point towards 1.4 years, mainly due to a shorter hospital stay. CONCLUSIONS: Although caution is required in drawing conclusions, it appears that replacing treatment with (laparoscopic) Nissen fundoplications in these patients might lead to substantial savings.

The influence of an inhaled steroid on quality of life in patients with asthma or COPD.

Relatively little is known about the influence of inhaled corticosteroids on general well-being (quality of life) in patients with asthma or COPD. In a 4-year prospective controlled study, we examined the influence of beclomethasone dipropionate (BDP), 400 micrograms, two times daily, on quality of life in 56 patients with asthma or COPD in comparison with the effects of BDP on symptoms and lung function. During the first 2 years, patients received only bronchodilator therapy with salbutamol or ipratropium bromide. During the third and fourth years, additional treatment with BDP was given. Fifty-six patients (28 with asthma, 28 with COPD) with an annual decline in the forced expiratory volume in 1 s (FEV1) of at least 80 mL/yr in combination with at least two exacerbations per year during bronchodilator therapy alone participated. Quality of life was assessed at the start and after 2 and 4 years by means of the Inventory of Subjective Health (ISH) and the Nottingham Health Profile (NHP). Although BDP significantly improved the course of lung function (FEV1)(p < 0.0001), it did not improve the ISH score or the six dimensions of the NHP neither in asthma nor in COPD. Beclomethasone dipropionate temporarily decreased respiratory symptoms during months 4 to 6 of BDP treatment in patients with asthma (p < 0.01) and during months 7 to 12 in patients with COPD (p < 0.05). A weak correlation was found both cross-sectionally and longitudinally between (change in) symptoms and quality of life on the one hand, and the (change in) FEV1 on the other. It was concluded that BDP did not improve the general well-being of patients with asthma or COPD as measured by these generic health instruments. However, BDP significantly improved the course of lung function and temporarily decreased the severity of symptoms. It seems probable that changes in quality of life would have been better detected by use of a disease-specific health instrument. Such an instrument was not available at the start of the study. Another possible explanation for these observations is that patients soon get used to different levels of lung function and learn to live with their disease. It is advised that disease-specific health instruments are used in future intervention studies and that quality of life is measured frequently during the early phase of the intervention, eg, once every month.