| Objective:This study was conducted on patients with Essential Hypertension(EH).Based on a real world study(RWS)perspective,the clinical efficacy of thermosensitive navel moxibustion for the treatment of EH in a real community setting was observed,providing clinical data for the treatment of EH in the community with thermosensitive navel moxibustion.Methods:Using the use of thermosensitive refining umbilical moxibustion as an exposure factor,163 patients with essential hypertension with inclusion criteria were formed into an exposed group(65 patients)and a non-exposed group(98 patients).Both groups maintained the frequency and type of antihypertensive medication taken prior to enrollment and were given lifestyle instructions.In the exposed group,heat-sensitive navel moxibustion was administered once a day for 60 minutes,and the frequency of moxibustion was guaranteed to be at least 4 times a week.The two groups were treated for a total of 3 courses of treatment.Blood pressure was measured before treatment,at the end of the first course of treatment,at the end of the second course of treatment and at the end of treatment.All data were pooled into SPSS25.0 software for statistical analysis,and baseline data were corrected by propensity score matching(PSM),and comparable patient data were compared and analysed.Results1.Study completion: From December 2021 to November 2022,a total of174 patients were screened for this trial.11 patients were excluded at baseline entry due to not meeting the inclusion criteria,leaving a total of 163 patients in the study cohort.After 3 months of treatment,a total of 6 patients(2 in the exposed group and 4 in the non-exposed group)were excluded and dislodged,resulting in an overall dislodgement rate of 3.7%and 157 eligible patients(63 in the exposed group and 94 in the non-exposed group)included in the final statistical analysis.2.Comparison of baseline data: The baseline data of 157 patients were compared and analysed.There were no statistical differences between the two groups in terms of gender,age,lifestyle habits,history of co-morbidities,medication history,diastolic blood pressure,hypertension quality of life score and Chinese medicine symptom score(P>0.05),but there were statistical differences in body mass index(BMI),disease duration and systolic blood pressure values between the two groups(P<0.05).However,there was a statistical difference in body mass index(BMI),duration of illness and systolic blood pressure between the two groups(P<0.05),and there was an imbalance between the two groups at baseline.A total of 66 pairs of patients(33 in the exposed group and33 in the non-exposed group)with balanced baseline data were successfully matched after correcting the baseline data by propensity score matching.3.Comparison of systolic blood pressure between the two groups by treatment after matching: pre-treatment systolic blood pressure 146.20±5.21 mm Hg in the non-exposed group and 145.76±4.39 mm Hg in the exposed group,P=0.710>0.05 for inter-group comparison of pre-treatment systolic blood pressure between the two groups.(1)Comparison of systolic blood pressure at the end of the 1st course:143.91±6.81 mm Hg in the exposed group and 146.16±4.43 mm Hg in the non-exposed group.P=0.182>0.05 for the exposed group compared with the pre-treatment.P=0.973>0.05 for the non-exposed group compared with the pre-treatment.P=0.117>0.05 for the inter-group comparison of systolic blood pressure at the end of the 1st course in both groups;(2)Comparison of systolic blood pressure at the end of the 2nd course:143.91±6.81 mm Hg in the exposed group and 146.03±6.23 mm Hg in the non-exposed group,P=0.017<0.05 in the exposed group compared with the pre-treatment,P=0.889>0.05 in the non-exposed group compared with the pre-treatment,P=0.019<0.05 in the inter-group comparison of systolic blood pressure at the end of the 2nd course in both groups;(3)Comparison of systolic blood pressure at the end of the 3rd course:the mean systolic blood pressure in the exposed group was 141.82±7.76 mm Hg and 145.39±5.68 mm Hg in the non-exposed group,P=0.017<0.05 in the exposed group compared with that before treatment,P=0.889>0.05 in the non-exposed group compared with that before treatment,P=0.025 <0.05.4.Comparison of diastolic blood pressure between the two groups by treatment after matching: 93.61±5.79 mm Hg pre-treatment diastolic blood pressure in the non-exposed group and 92.74±6.01 mm Hg pre-treatment diastolic blood pressure in the exposed group,P=0.554>0.05 for comparison between the two groups.(1)Comparison of diastolic blood pressure at the end of the 1st course:diastolic blood pressure in the exposed group 91.04±4.96 mm Hg,diastolic blood pressure in the non-exposed group 93.27±5.58 mm Hg,P=0.125>0.05 in the exposed group compared with the pre-treatment P=0.810>0.05 in the non-exposed group compared with the pre-treatment,P=0.090< 0.05;(2)Comparison of diastolic blood pressure at the end of the 2nd course:91.04±4.96 mm Hg in the exposed group and 93.42±3.67 mm Hg in the non-exposed group,P=0.157>0.05 in the exposed group compared with the pre-treatment,P=0.874>0.05 in the non-exposed group compared with the pre-treatment,P=0.028< 0.05;(3)Comparison of diastolic blood pressure at the end of the 3rd course:90.27±4.95 mm Hg in the exposed group and 94.18±3.06 mm Hg in the non-exposed group,P=0.083>0.05 in the exposed group compared with before treatment,P=0.587>0.05 in the non-exposed group compared with before treatment,P=0.000< 0.01.5.Comparison of hypertensive quality of life scores between the two groups after matching: 158.11±9.11 pre-treatment quality of life points in the exposed group,157.31±6.44 pre-treatment quality of life points in the non-exposed group,P=0.682>0.05 for the pre-treatment quality of life comparison between the two groups.after the end of treatment,192.87±18.53 quality of life points in the exposed group,169.54±16.86 quality of life points in the non-exposed group 169.54±16.86 points,P=0.000<0.01 for intra-group comparison before and after treatment in the exposed group,P=0.000<0.01 for intra-group comparison before and after treatment in the non-exposed group,and P=0.000<0.05 for inter-group comparison after treatment in both groups.6.Comparison of TCM symptom scores between the two groups after matching: 17.18±3.72 points before treatment for TCM symptoms in the exposed group,16.30±4.52 points before treatment for TCM symptoms in the non-exposed group,P=0.392>0.05 for inter-group comparison between the two groups before treatment for TCM symptoms.10.39±5.45 points after treatment for TCM symptoms in the exposed group,14.24±4.19 points for TCM symptoms in the non-exposed group,P=0.001<0.01 for intra-group comparison between the two groups after treatment for TCM symptoms.P=0.000<0.01 for intra-group comparison before and after treatment in the exposed group,P=0.001<0.01 for intra-group comparison before and after treatment in the non-exposed group,and P=0.002<0.05 for inter-group comparison after treatment in both groups.7.Comparison of the antihypertensive efficacy between the two groups:15.2% in the exposed group and 3.0% in the non-exposed group,the apparent efficiency of the two groups was compared by rank sum test,Z=-1.07,P=0.089>0.05,there was no significant statistical difference between the apparent efficiency of the two groups;the total effective rate of the exposed group was 60.6% and the total effective rate of the non-exposed group was 15.2%.The total effective rate of the two groups was compared by rank sum test,Z=-4.063,P=0.000<0.01,and there was a statistically significant difference between the total effective rate of the two groups.8.Adverse events: A total of 3 cases of adverse events occurred in both groups,with an overall adverse event rate of 1.9%.In the exposed group,there was one case of self-induced itching around the umbilicus during the application of moxibustion,which disappeared after stopping the application.In the non-exposed group,there were two cases of mild dizziness due to untimely administration of antihypertensive medication,which resolved after medication and rest.No serious adverse events occurred in either group during the treatment period.ConclusionsThermal reflexology moxibustion method can effectively reduce the blood pressure value of patients with essential hypertension,among which the most significant effect is on systolic blood pressure,and can effectively improve the clinical symptoms of patients with essential hypertension. |
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