A pilot study on efficacy and safety of a new salt substitute with very low sodium among hypertension patients on regular treatment

Abstract

Objectives:To understand the possible effect of a novel salt substitute with very low sodium in reducing blood pressure, salt intake and use of anti-hypertensive medications among patients on regular medications, to inform the future randomized trials.Design:Single-arm pilot trial.Setting:A community health service center in Chongqing, China.Participants:A total of 43 patients with hypertension taking anti-hypertensive medications regularly.Intervention:Patients received the salt substitute with 18% sodium chloride for 8 weeks.Main outcome measures:Patients were followed up weekly for the use of antihypertensive medications and measurements of blood pressure. We collected 24-h urine before and after the trial to measure sodium and potassium intake.Results:Among 39 patients who completed the 8 weeks' intervention, 30.8% patients stopped or reduced anti-hypertensive medications during the trial. For patients that stopped or reduced medication, the mean SBP and DBP before intervention were 122.1±9.6 and 68.9±9.4mmHg and both did not increase after intervention (SBP change: 2.8mmHg (-5.1, 10.8), P=.48; DBP change: 1.8mmHg (-2.2, 5.7), P=.38). For the rest patients, the mean SBP and DBP before intervention were 141.6±16.9 and 74.6±6.6mmHg but reduced significantly after the intervention (SBP change: -16.0mmHg (-21.3, -10.6), P