The value of a study based on reports from the patients will be dependent on the cooperation of the patients. We found good cooperation in filling out the diaries; only seven patients discontinued the study for this reason. They should use the treatments every morning and evening, but most patients used the treatments more often. This indicates that they felt an immediate benefit from the maneuvers.

The physiologic effects of PEP cannot be explained by our study. It is possible that PEP worked by loosening secretions, improving ventilation, and/or dilating airways. To our knowledge, the present study is the first concerning long-term treatment of chronic bronchitis with PEP. The acute effect of PEP has been studied in the treatment of cystic fibrosis. These studies compared more vigorous regimens including postural drainage with percussion, and the effect parameters were the amount of expectoration and oxygen saturation during and after the treatment. Furthermore, the studied regimens were different, which make comparison difficult. Falk et al found PEP to be most effective concerning the amount mucus expectorated, whereas Hofmeyr et al found postural drainage with breathing exercises and forced expiration technique to be the most effective regimen. The PEP might enhance the effect of forced expiration by moving the equal pressure point of dynamic com­pression peripherally, thereby removing mucus from smaller bronchi.

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The significantly fewer symptoms, the significantly smaller number of acute exacerbations, and the rate of exacerbations in the PEP group showed that the use of PEP by PEP-mask relieved the symptoms and had a prophylactic effect on acute exacerbations in patients with chronic bronchitis. In this respect, PEP treatment was superior to conventional chest physio­therapy with diaphragmatic breathing and forced ex­piration technique. The reduced rate of acute exac­erbations in the PEP group was reflected in a reduced use of antibiotics and mucolytics compared to the control group.

The conclusions may be limited by the fact that the study was not double blind. It is not possible to design this kind of study in a double blind manner. It could be argued that the control group should use a mask without expiratory resistance, but an expiratory resis­tance will be felt by the patient using it. Furthermore, we found that breathing through the mask without expiratory resistance could give a positive airway pressure of less than 5 cm H_aO (unpublished). We were very anxious to attend the control group as carefully as the PEP group, giving repeated instruc­tions, etc. The control group, in fact, found the treatment useful by the final assessment, which was not supported by the other results of the study.

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Acute Exacerbations

The PEP group had fewer acute exacerbations compared to the control group (six vs 28). Also, the number of patients who experienced acute exacerba­tions were smaller in the PEP group compared to the control group (three vs 12). In the PEP group, 85 percent of the patients remained free from acute exacerbations, compared to 48 percent in the control group (p = 0.011, chi-square). No patient in the PEP group and three patients in the control group had more than three acute exacerbations (Fig 2).

The exacerbation rate defined as the number of acute exacerbations divided by the observation time was calculated for each patient, and this value was significantly lower in the PEP group compared to the control group (p<0.0005, chi-square test).

Sick Leaves

Only a few of the patients actually were still working. Five patients in the control group and four patients in the PEP group stayed home from work because of acute exacerbations. There was a large difference between the number of days on the sick list: 17 in the PEP group and 64 in the control group, but 36 of the sick list days were accorded to one patient, who left work during the study period.

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Clinical History and Lung Function

Fifty four patients were included in the study, and 43 completed the study. The reasons for exclusion were malignant lung tumor in three patients (all in the PEP group), long-term use of acetylcysteine in one patient (in the PEP group), discontinued treatment in seven patients (three in the PEP group and four patients in the control group). There was no significant difference between the control group and the PEP group with respect to age, smoking habits, duration of disease, number of acute exacerbations during the previous year, number of treatments with antibiotics during the previous year, and medication (corticoste­roid, be tag-agonist, parasympathicolytica and theo­phyllines) (Table 1). About one-third of the patients used theophylline or betas-agonist, only one patient in each group used oral corticosteroid, two patients in the РЁР group used low-dose inhaled corticosteroid.

The majority of the patients had retired from work because of age. One patient in the PEP group and three patients in the control group had stopped working because of lung disease.

The lung function was normal or moderately re­duced (Table 1), and there was no difference between the groups concerning the initial values of FEV1, FVC, and VC. The FEV₁ in relation to predicted normal was significantly lower in the PEP group compared to control group (p<0.025, Students f-test).

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Clinical Control

At the start of the study, a clinical history, physical examination, ECG, and chest x-ray film were done. Lung (unction tests were performed with measurement of FEV1, forced vital capacity, and vital capacity (dry spirometer) before and 20 minutes after 1.25 mg terbutaline inhaled through a 750 ml cone spacer.

The patients were seen at the clinic every month the first three months and then every second or third month during the summer period. In autumn and winter, they were again seen every month, giving a total of a minimum of seven visits. They were interviewed concerning symptoms and medical treatment. After one month and at the end of the study, the patients were asked to give an overall assessment of the treatment (definitely useful, useful, not useful, harmful, or definitely harmful).

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Criteria for Inclusion

Patients with a history of chronic bronchitis, ie, cough daily and expectoration for at least three consecutive months for the last two years were included in the study. They were recruited among the outpatients of the clinic. They should be cooperative and capable to follow the instructions for the treatment. Smokers and nonsmok- ers were included; exsmokers were included only if they had stopped smoking at least two years prior to the study. Patients with bronchial asthma, heart failure, or lung cancer were not included. Asthma was defined as a 20 percent or higher increase in forced expiratory volume in the first second (FEV,) after inhalation of 1.25 mg of terbutaline through a 750 ml volume cone spacer. Patients who already used a PEP mask, used prophylactic mucolytic drugs, or received more than 10 mg prednisolone (or equivalent doses of corticosteroids) daily could not take part in the study. A total of 44 patients were included in the study in the months of January or February and followed for 12 months, and 10 patients were included in October and followed for 4 to 5 months.

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Positive expiratory pressure is used in patients breathing spontaneously as continuous positive airway pressure mostly applied by mask. The С PAP is used in the treatment of respiratory failure and in conditions with impaired clearing of airway secretions, for example, after abdominal surgery.

The CPAP is not suitable for home treatments because of the high airflow needed. A simplified positive expiratory pressure system has been devel­oped as a PEP mask (Fig 1). This system is more convenient for self administration and home treat­ment. It consists of a facemask connected to a T-tube where inspiratory and expiratory airflow are separated by a valve. Variable expiratory resistances can be applied onto the expiratory tube as connections of different diameters, causing positive airway pressure only during expiration.

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