20 The primary outcome variable was change in diastolic blood pressure from the baseline screening visits to the average of the midpoint and closing visits. Patients who withdrew from the study after the midpoint were included in the primary analysis. Blood pressure for each subject at baseline, midpoint, and closing was the average of nine measurements (three measurements on each of 3 days). The trial was designed to have at least 80% power to detect a change in blood pressure of 3 mm Hg diastolic with two-sided P< .05. The actual sensitivity of the trial for the effect of each cation combination was determined from the 95% confidence intervals of the differences in the blood pressure changes between supplement and placebo groups (for an example, see “Performance”). Multiple regression analyses determined the effect of each treatment compared with placebo using treatment group as an independent variable. Additional analyses were conducted on systolic blood pressure and on the changes at midpoint and closing, separately. Covariates were added to the multiple regression model to assess the effects of treatment in various subgroups of the patients, eg, baseline urinary electrolyte excretion. The model included treatment group, baseline urinary excretion, and the interaction term, treatment?urinary excretion. The effects of the treatments were also examined in subgroups with urinary electrolyte excretion levels above and below the median.
Results
The 125 clients exactly who means an important data group finished on minimum new midpoint blood pressure levels measurements. 7 clients was taken on demo due to an excellent diastolic hypertension >102 mm Hg (eight ahead of and you can step one following midpoint specifications); 2 of them was indeed getting placebo, step 3 was in fact acquiring calcium supplements and you may potassium, 2 was searching potassium and magnesium, and you may step 1 was acquiring calcium and magnesium. Eight people kept brand new trial private causes before the midpoint, and you will 5 most people kept just before getting closing specifications.Continue reading