A randomized study of quality of life during multiple risk factor intervention in treated hypertensive men at high...

To examine the effect on quality of life in hypertensive men of a multiple risk factor intervention programme compared with that of usual care.

A prospective, open, randomized, parallel-group study with allocation either to a comprehensive multiple risk factor modification programme or to usual care.

An outpatient clinic in a city hospital.

Five hundred and eight treated hypertensive men, aged 50-72 years, with at least one of the following: serum cholesterol > or = 6.5 mmol/l, smoking habit or diabetes mellitus.

Nutritional advice, behavioural treatment principles and drug therapy.

Minor symptoms evaluation profile (MSEP) was used to measure change in quality of life.

The intervention programme led to sustained effects on lifestyle-related variables such as hypercholesterolaemia, body mass index and smoking habits, whereas diastolic blood pressure and HbA1c remained unchanged. The change in the MSEP during follow-up did not differ between the intervention and the usual care groups. There was a close relationship between the measurements of the three MSEP dimensions at baseline and at follow-up (P < 0.0001). None of the potential risk factors measured at entry was significantly associated with change in the three MSEP dimensions during follow-up.

The multiple risk factor intervention programme directed towards smoking habits, hypercholesterolaemia and the metabolic control of diabetes mellitus in treated hypertensive men at high cardiovascular risk was not associated with an impaired quality of life compared with that in a control group. The method used, the MSEP, has previously been found to be a reliable method with good validity, and this study's results provide further evidence of its validity.