Evidence-based Evaluation Of Heat-sensitive Moxibustion Self-administration In Patients In The Community With Essential Hypertension

Objective: To explore the understanding of traditional Chinese medicine on the pathogenesis of hypertension,and systematically evaluate the efficacy and safety of moxibustion in the treatment of essential hypertension.Heat-sensitive moxibustion self-administration in patients in the community with primary hypertension: a multicenter,pragmatic,non-randomized trial to verify its effectiveness and safety.Methods: A combination of literature research and clinical empirical research was adopted.Literature research searched by CNKI,Wangfang,VIP,CBM,PubMed,EMBASE,and Cochrane Library,the 5th edition of the Chinese Medical Dictionary,electronic library,and clinical trial registration platform,etc.Manually supplements searched paper documents,and Yimaitong website to obtain ancient and modern literature on hypertension,and the retrieval time until December 31,2020,regardless of language.Two researchers independently and repeatedly screened the literature and data extraction according to the predefined inclusion/exclusion criteria,and discrepancies were discussed and resolved by a third researcher.RevMan 5.3.5 software was used for Meta analysis,and Cochrane Handbook 5.1.0 evaluation tool was used to evaluate the risk of bias of a single RCT.Effect data from individual RCTs were analyzed by random-effects model.Heterogeneity was measured using Cochran’s Q test and I-squared statistics.Four subgroup analyses were performed to explore sources of heterogeneity based on clinical experience.Studies considered to be at high risk of bias in the RCT were excluded,and conduct a sensitivity analysis after adjusting the effect model to test the robustness of the meta-analysis results.The publication bias was assessed by funnel plot and Egger’s test.Meanwhile,a multi-center,pragmatic,non-randomized trial of the heat-sensitive moxibustion self-administration in patients in the community with primary hypertension was conducted.According to the inclusion/exclusion criteria,subjects with essential hypertension were recruited in each community.The primary outcome is blood pressure(the difference between blood pressure and baseline).The secondary outcomes include quality of life,and adverse events.Data analysis adopts t-test,Pearson c2,propensity score and other multi-level analysis heat-sensitive moxibustion for essential hypertension.Results: The symptoms of hypertension in ancient literature often manifested as dizziness,headache and palpitations.The etiology was mostly wind,phlegm,deficiency,emotional disorders,dietary disorders and internal deficiency.The pathogenesis was deficiency of kidney yin and hyperactivity of liver yang.A total of 27 RCTs with 1882 patients were included in the systematic review.The results of Meta analysis showed that:(1)The experimental group could reduce systolic blood pressure(MD=-5.55 mm Hg,95% CI-6.53～-4.58)and diastolic blood pressure(MD=-3.27 mm Hg,95% CI-3.97～-2.56)to maintain stable blood pressure level.(2)The curative effect of improving blood pressure(OR= 2.78,95% CI2.03～3.82)and TCM symptom(OR=3.42,95% CI 2.12～5.51).(3)Reduce the TCM syndrome score(MD=-2.78,95% CI-3.59～-1.97).(4)The symptoms of headache(MD=-0.59,95% CI-0.76～-0.42)and dizziness(MD=-0.79,95% CI-0.98～-0.61)improved.(5)The effect on insomnia(MD=0.05,95%CI-0.21～0.31)and irritability(MD=-0.04,95% CI-0.19～0.12)were not significant.(6)The effect on lipid indices was minimal.A total of 767 patients(255 cases in the heat-sensitive moxibustion group and 512 cases in the control group)were included in the clinical study,and 26 weeks of followup were completed.(1)The results of propensity matched pre-data analysis showed that the reduced of systolic blood pressure(MD=-6.16 mm Hg,95% CI-7.45～-4.86)and diastolic blood pressure(MD=-5.12 mm Hg,95% CI-6.23～-3.98)was greater in the heat-sensitive moxibustion,Compared with the control group.The total scores of the two groups quality of life(MD-6.61,95% CI-7.97～-5.26)and the differences in the scores of each dimension(MD=-4.08 for physical dimension,MD=-0.74 for psychological dimension,and MD=-1.61 for family-social dimension)were significant in the heat-sensitive moxibustion group.(2)After matching,368 patients(184 in each group)were included.Compared with the control group,the heat-sensitive moxibustion group significantly reduced systolic blood pressure(MD=-5.11,95% CI-7.04～-3.19)and diastolic blood pressure(MD=-5.14,95% CI-6.66～-3.62);the patients’ quality of life(MD=-5.74,95% CI-7.53～-3.95),and changes in each dimension are different,which can improve symptoms.(3)During the follow-up,2 patients in the heat-sensitive moxibustion group developed blisters,the blisters disappeared after treatment,and no serious adverse effects occurred.Conclusion: A large number of literature studies have confirmed the efficacy of heat-sensitive moxibustion in the treatment of essential hypertension.The results of the systematic review show that moxibustion can lower blood pressure,improve curative effect,and relieve some of the symptoms of hypertension(headache,dizziness),with a lack of evidence for lipid effects.Given the quality of the literature,there is a need for higher quality clinical evidence that can be used to support clinical decision making.The aim of clinical research is to promote the wider popularization of heatsensitive moxibustion in the treatment of essential hypertension in the community.The results of data analysis suggest that: before propensity matching,the heat-sensitive moxibustion group can reduce systolic and diastolic blood pressure;the patients’ total quality of life score does not change significantly,and the improvement of quality of life is not obvious;after matching,the results significantly improved patients’ quality of life,and the safety of heat-sensitive moxibustion is better.