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Double-blind, randomized, crossover, controlled clinical trial of NaCl + Chitosan 3% versus NaCl on mild or moderate high blood pressure during the diet and lifestyle improvement period before possible prescription of an antihypertensive treatment.

AIM
The aim of the study was to examine the effect on blood pressure of replacing NaCl sea salt by NaCl + chitosan 3% (Symbiosal) during the diet and lifestyle improvement period prescribed to patients before any antihypertensive treatment.


METHODS
This was a double-blind, randomized, crossover, controlled clinical trial of Symbiosal (NaCl + chitosan 3%) versus NaCl over two eight-week periods on 40 patients with mild hypertension for which they had never previously been treated.


RESULTS
The effect of Symbiosal appeared as early as the first period of the crossover trial showing a reduction in systolic blood pressure (SBP) from 149.2 ± 4.9 mmHg to 136.1 ± 9.5 mmHg in patients on Symbiosal (reduction of 13.1 ± 10.8 mmHg) versus a reduction from 149.7 ± 4.6 mmHg to 142.9 ± 7.7 mmHg in patients on traditional NaCl (reduction of 6.8 ± 7.5 mmHg) (P=0.0404). Similar results were observed for diastolic blood pressure (DBP) with a reduction of 11.2 ± 7.4 mmHg versus 7 ± 8 mmHg (P=0.0560). HBP was brought under control (SBP ≤ 140 and DBP ≤ 90) in 76.2% (16/21) versus 36.8% (7/19)% of patients, respectively (P=0.0119). The crossover analysis confirmed the results showing Symbosial effects for both SBP (P=0.0156) and DBP (P=0.0285).


CONCLUSION
Replacing traditional NaCl by Symbiosal in conjunction with recommended alterations to lifestyle and diet significantly contributes to better control of hypertension and may postpone the prescription of antihypertensive drugs.