Efficiency Of Moxibustion On Hyperlipidemia And Influence Of Moxibustion In Different Time Courses On Liquid-Regulating Effect

Part IObjectiveTo verify the efficiency and advantage of moxibustion on hyperlipidemia and to investigate its action characters and effect trends through the comparison between lipid-lowering effects of syndrome differentiation moxibustion and drug.MethodsRandomization and control:In this randomized block trial, all the enrolled cases were divided into the treatment group (moxibustion group, n=32) and the control group (western medicine group, n=33) randomly with block size of6according to their visiting sequence. There were no statistical differences in gender, age, disease and other aspects between two groups (all P>0.05), and they were comparable.Treatment methods:In moxibustion group, all the cases can be divided into qi-deficiency-with-phlegm type, yin-deficiency-with-yang-hyperactivity type and yang-deficiency-of-spleen-and-kidney type referring to Guidelines for Clinical Research of Traditional Chinese Medicine. The basic point formula was composed by Zusanli (ST36), Shenque (RN8) and Sanyinjiao (SP6). Fenglong (ST40) was used in qi-deficiency-with-phlegm type, Taixi (KI3) was used in yin-deficiency-with-yang-hyperactivity type, and Guanyuan (RN4) was used in yang-deficiency-of-spleen-and-kidney type. The treatment in pure moxa stick was used for10min on each point every time. The frequency was3times a week in once two days.12times were a course, and the treatment last for2courses. Fenofibrate tablet was taken in the dosage of100mg3times a day after dinner in western medicine group.Observation and evaluation time points:All the indexes were recorded before treatment and evaluated2months after treatment.Observation indexes:The observation indexes include serum lipids indexes, clinical symptoms and signs, and safety indexes. The serum lipids indexes include TC, TG, HDL-C and LDL-C. The purpose of evaluation on clinical symptoms and signs is to investigate the influence of moxibustion on QOL during lipid regulation. The safety indexes include GOT, GPT, UN and CR.Data statistics processing:Analyse the basal levels, therapeutic effects and safety of two groups according to the characters of clinical datum and related statistics principle using SPSS13.0. During the statistics, enumeration data is analysed by x2test or Fisher exact chi-square test, while ranked data is analysed by rank sum test. Test of normality is given first to enumeration data, variance analysis is used if it is normal. Normal transformation is given first if the data is non normal. Parametric test is used for data in accordance with normal distribution after transformation, while rank num test is used for that in non normal distribution after transformation. Measurement data is represented by Mean±SD. All the hypothesis tests use two-side test.ResultsSerum lipids indexes:For serum lipids indexes, the total therapeutic effect in moxibustion group was71.88%(23/32), while that in western medicine group was90.91%(30/33). The statistical difference between the total therapeutic effects of two groups on regulating lipid was insignificant (P>0.05).All the serum lipid indexes in two groups decreased after treatment. The effect of moxibustion on decreasing TC and LDL-C was better, while the effect of western medicine on decreasing TG was better, but the differences were both insignificant (P>0.05).Total clinical symptom integrals:The statistical difference between total clinical symptom integrals in two groups was very significant (P<0.001). The differences on relieving fatigue, poor appetite, abdominal distension, lassitude in loin and legs, dysphoria and aversion to coldness in two groups after treatment were statistically significant (P<0.05). The effect on relieving clinical symptoms of moxibustion was obviously better than that of western medicine, so moxibustion can relieve clinical symptoms and improve the QOL of hyperlipidemia patients obviously.Serum lipids related indexes:Pain in two groups relieved in different degree after treatment, and the relieving degree in moxibustion group was higher than that in western medicine group with significant difference (P<0.05). Blood glucose in two groups both decreased after treatment, but the difference between two groups was statistically insignificant (P>0.05).Safety indexes:GOT and GPT in moxibustion group both decreased after treatment, while those in western medicine group both increased after treatment. It shows that western medicine can injure hepatic function. But the difference in changes of two groups was statistically insignificant (P>0.05). UN in moxibustion group decreased, while that in western medicine group increased after treatment. CR in two groups both increased after treatment, and the increase in western medicine group was more obvious. The differences of these two indexes in two groups were both statistically insignificant (P>0.05). There was no statistical difference on systolic pressure and diastolic pressure in two groups after treatment (P>0.05). Heart rate in two groups decreased in different degree after treatment, but the difference was statistically insignificant (P>0.05). There was no harmful effect on blood routine, urine routine, electrocardiogram and so on in two groups after treatment, and the difference was statistically insignificant (P>0.05).Conclusion 1The effect of moxibustion on regulating serum lipid is similar to that of western medicine. Moxibustion can produce benign regulation in all of the serum lipid indexes especially in TC and LDL-C.2Moxibustion can relieve clinical symptoms related to the hyperlipidemia and improve the QOL of patients effectively. The effect is better than that of western medicine group obviously.3Moxibustion is safe in regulating serum lipid without harmful effect on safety indexes.Part IIObjectiveTo screen the best time course scheme for hyperlipidemia treated by moxibustion through setting different time course groups and comparing the effects on lipid regulation of moxibustion in different groups. To lay foundation for further studies on time-effect and dose-effect relationships of moxibustion.MethodsRandomization and control:Seventy six cases visiting Acupuncture and Moxibustion Hospital was fit into this study from Nov2009to Dec2011. All these cases couldn’t control their serum lipid to normality through diet control. In this randomized block trial, all these cases were divided into10min group (n=25),20min group (n=25) and30min group (n=26). There were no statistical differences in gender, age, disease and other aspects among three groups (all P>0.05), and they were comparable.Treatment method:Acupoints were selected according to patients’constitutions and pathological basis of yang-deficiency-of-spleen-and-kidney type and phlegm-and-blood-stasis type combined with related clinical reports. The basic point formula was composed by Fenglong (ST40), Zusanli (ST36), Shenque (RN8) and Sanyinjiao (SP6). Moxibustion with pure moxa stick was applied for10minutes in10min group,20minutes in20min group and30minutes in30min group. The frequency was3times a week in once two days.12times were a course, and the treatment last for2courses.The observation and evaluation time points, observation indexes and data analysis methods are all the same to Part IResultsSerum lipids indexes:For serum lipids indexes, the total therapeutic effect in10min group was52.00%(13/25), in20min group was84.00%(21/25), and in30min group was88.46%(23/26). There were obviously statistical differences between the total therapeutic effects of3groups on regulating lipid effect (all P<0.01).The differences between the levels of TC, TG and LDL-C before and after treatment in3groups were all obviously significant in statistics (all P<0.001), while that of HDL-C was statistically insignificant (P>0.05). The result shows that moxibustion can regulate all related indexes to be normal.The difference between the effects on decreasing TC and LDL-C in30min group and10min group was statistically significant (P<0.05), while that between30min group and20min group was statistically insignificant (P>0.05). At the same time, the time of moxibustion and the decreasing mean number of effective indexes was positively related. Comparing the mean numbers of differences of TC and LDL-C before and after treatment, the30min group was the best, and the lOmin group was the worst. The differences between effects on regulating TG and HDL-C in3groups were statistically insignificant (P>0.05). The result shows that the regulating effect of moxibustion on TC and LDL-C is better than on the other serum lipid indexes.Total clinical symptom integrals:The differences between total clinical symptom integrals before and after treatment in3groups were all obviously statistically significant (all P<0.001). It shows moxibustion can relive patients’clinical symptoms and improve their QOL obviously. Comparing the integrals of clinical symptoms among different groups, the difference between10min group and30min group was statistically significant (P<0.05). The integrals in30min groups were the lowest, and in10min group were the highest. It shows that the treatment time and the effect on relieving clinical symptoms of moxibustion are positive related.Serum lipids related indexes:Patients’fasting blood glucose decreased after moxibustion, and the differences before and after treatment in all3groups were statistically significant (P<0.001). It shows that moxibustion can also regulate patients’fasting blood glucose effectively. The differences on this aspect among3groups were statistically insignificant (P>0.05). The differences of pain before and after treatment in all3groups were statistically significant (P<0.001). It shows that moxibustion can relieve patients’pain effectively through warming and dredging meridians, promoting blood circulation, dispelling coldness and killing pain. The differences of relieving pain effect among3groups were statistically insignificant (P>0.05). The pain relieving degree in30min group was the best, and in20min group was the worst.Safety indexes:The differences between GOT and GPT before and after treatment in3groups were statistically insignificant (P>0.05). It shows that there isn’t harmful influence on hepatic function in the course of regulating lipid in moxibustion. The difference between UN before and after treatment in3groups was statistically significant (P<0.05), the UN decreased after moxibustion. It shows that moxibustion can promote the clearance of protein’s end products and is good for metabolism. The differences between CR and BP before and after treatment in3groups were all statistically insignificant (P>0.05). The difference between heart rate before and after treatment in all3groups was statistically significant (P<0.05), but the differences between different groups after moxibustion were all insignificant (all P>0.05). It shows that moxibustion can decrease patients’heart rate effectively. There was no statistical difference between blood routine, urine routine and electrocardiogram before and after treatment in3groups (P>0.05). It shows that there is no harmful effect on these three aspects during moxibustion.Conclusion1The effect on regulating serum lipid of moxibustion in30min group is better than that in other two groups obviously. The effect on regulating single lipid index of moxibustion in30min group is better than that in10min group, but similar to20min group.2The effect on relieving clinical symptoms of moxibustion in30min group is better than that in10min group obviously. The time of moxibustion and the relieving degree of clinical symptoms is positively related.3These three time courses of moxibustion are all safe without harmful effect on safety indexes.Distinctive and Innovative Points1Clarify the pathogenesis of hyperlipidemia and propose the theory of warm moxibustion in treating hyperlipidemia.Clarify the relationship between hyperlipidemia and phlegm, and propose the theory of warm moxibustion in treating hyperlipidemia aiming at its pathogenesis. Provide evidence for discussion of the pathogenesis, clinical treatment and establishment of treatment principle.2Propose the view that points should be selected according to syndrome differentiation and reveal the advantage of moxibustion.Make the theory and principles of moxibustion detailed, and increase the clinical practicality of moxibustion in treating hyperlipidemia.Screened out points descriptions according to syndrome differentiation, and make moxibustion on regulating lipid more accord with TCM features through using these descriptions.3Screen the best time course and discuss the time-effect relationship of moxibustion on regulating lipid.In the setting of different time courses, this study verifies the differences between effects of different time courses through prolonging treatment time in each group and enlarging the time difference between different groups according to the accumulate effect of moxibustion and clinical maneuverability.