Spleen Activating And Dampness Resolving Granules Treatment Of Hypertension Of Stagnation Of Phlegm And Dampness

Objective:This was a randomized,controlled trial to explore the clinical efficacy and safety of Spleen Activating and Dampness Resolving Granules for the treatment of hypertension with phlegm-dampness syndrome,in search of a novel,safe and effective therapeutic option for hypertensive patients with phlegm-dampness syndrome.Methods:Sixty hypertensive patients who visited the outpatient clinic or arrhythmia department of Guangdong Provincial Hospital of Traditional Chinese Medicine from October 2020 to December 2020 and met the inclusion criteria were selected and randomly divided into the test group and control group each including 30 patients.The test group was treated with amlodipine besylate combined with Spleen Activating and Dampness Resolving Granules;the control group was treated with amlodipine besylate alone(for both groups,in case of SBP≥160mmHg and/or DBP≥100mmHg after 2 weeks of treatment,Valsartan Capsules 80mg qd was to be added as a hypotensive treatment).After 4 weeks of continuous treatment,relevant data were collected for both groups for statistical analysis;blood pressure,ambulatory blood pressure,TCM symptoms score,hepatic and renal function,and ECG were compared between the two groups for efficacy and safety evaluation.Results:(1)Blood pressure:In both groups,SBP and DBP at 4 weeks of treatment had decreased significantly from those pre-treatment,with statistically significant differences(P<0.05).There was a greater decrease in SBP from pre-treatment to post-treatment in the test group than in the control group,with a statistically significant difference(P<0.05),and no statistically significant difference between the two groups in post-treatment DBP(P>0.05).There were statistically significant differences between the two groups in changes from pre-treatment to post-treatment in both SBP and DBP(P<0.05).(2)Ambulatory blood pressure:In both groups,ambulatory SBP and ambulatory DBP at 4 weeks of treatment had decreased significantly from those pre-treatment,with statistically significant differences(P<0.05).There was a greater decrease in ambulatory SBP from pre-treatment to post-treatment in the test group than in the control group,with a statistically significant difference(P<0.05),and no statistically significant difference between the two groups in post-treatment ambulatory DBP(P>0.05).There were statistically significant differences between the two groups in changes from pre-treatment to post-treatment in both ambulatory SBP and ambulatory DBP(P<0.05).(3)TCM symptoms score:In both groups,TCM symptoms score at 4 weeks of treatment had decreased significantly from that pre-treatment,with statistically significant differences(P<0.05).There was a greater decrease in TCM symptoms score from pre-treatment to post-treatment in the test group than in the control group,with a statistically significant difference(P<0.05).(4)Efficiency:In terms of lowering blood pressure,the total effective rate was 90%in the test group,with the treatment being markedly effective for 10 patients,effective for 17 patients,and ineffective for 3 patients,and 60%in the test group,with the treatment being markedly effective for 4 patients,effective for 16 patients,and ineffective for 10 patients;there was a statistically significant difference between the two groups in the total effective rate(P<0.05).In terms of improving the TCM syndromes,the total effective rate was 90%in the test group,with the treatment being markedly effective for 14 patients,effective for 13 patients,and ineffective for 3 patients,and 60%in the test group,with the treatment being markedly effective for 2 patients,effective for 16 patients,and ineffective for 12 patients;there was a statistically significant difference between the two groups in the total effective rate(P<0.05).(5)In terms of single symptom of traditional Chinese medicine,the scores of vertigo,headache,head bandage and chest tightness decreased after treatment in the two groups compared with before treatment,with statistical significance(P<0.05).The scores of vomiting and salivation in the experimental group were lower after treatment than before treatment,and the difference was statistically significant(P<0.05).There was no significant difference in salivary scores of vomiting sputum before and after treatment in the control group(P>0.05).Comparison between the two groups showed that the experimental group was better than the control group in improving vertigo,headache,head like bandage,vomiting sputum and salivation,with statistical significance(P<0.05).The experimental group and the control group had no obvious advantage in improving the symptoms of chest tightness(P>0.05).Conclusion:Spleen Activating and Dampness Resolving Granules combined with amlodipine besylate is superior over oral amlodipine besylate alone in lowering blood pressure and improving the TCM symptoms.Spleen Activating and Dampness Resolving Granules could produce a substantial hypotensive effect,and improve the TCM clinical symptoms,which supports its further clinical application.