| The hypertension patients coupled with metabolic syndrome (MetS) are of the high risk population of cardiovascular and cerebrovascular diseases. To reduce the prevalence of cardiovascular and cerebrovascular diseases, it is imminent to control the blood pressure together with other cardiovascular risk factors. The current study was designed to investigate the therapeutic effects on blood pressure, blood pressure variability and other cardiovascular risk factors by giving the Yi-Qi-Hua-Ju formula in addition to the routine treatment to those hypertension patients coupled with MetS, and clarify the mechanism of Chinese medicine theory in term of controlling in blood pressure.Subjects and Method1.Subjects59hypertension patients coupled with MetS (MetS group)were recruited in this study. The enrolled patients were randomly divided into Chinese herbal formula group (CHF) and the control group. CHF group received30cases while the control group received29cases according to random number table method. At the same time30cases of hypertension without metabolic syndrome (no-MetS group) were also recruited. All subjects underwent relevant questionnaire about disease history and disease family history, treatment and personal information and clinical exam.2.InterventionsPatients in both groups were required to have same diet control and physical exercises. Keep the same treatment providing any anti-hypertension drugs and/or anti-hyperglycemic drugs were already used prior to the study. CHF group:The Yi-Qi-Hua-Ju formula was added on routine western medicine treatment. Yi-Qi-Hua-Ju formula was produced in the form of granule for12weeks.Control group:The placebo of Yi-Qi-Hua-Ju formula was added on routine western medicine treatment. The placebo was produced in the form of granule for12weeks.3.MeasurementsParameters examined include anthropometric index such as body height(BH), body weight(BW), waist circumference(WC), hip circumference(HC). Fasting glycosylated hemoglobin Alc (HbAlc), fasting blood glucose (FBG),2hour postprandial blood glucose (2hPBG), fasting insulin (FINS), serum lipidproile (TC, TG, HDL-C, LDL-C), MA, UACR, leptin, adiponectin, hs-CRP, IL-6, TNF-α, PAI-1, t-PA, NE were tested by laboratory. Body mass index (BMI), waist to hip ratio (WHR) and HOMA-IR were calculated by formula.24h ambulatory blood pressure monitoring (24habpm) such as the24h mean SBP, DBP, MBP in different duration;24h SBPv, DBPv, MBPv in different duration;24h SBPp, DBPp in different duration;24h pulse pressure in different duration and the blood pressure smoothness index was calculated.ResultPart1Control study on hypertension coupled with MetS and hypertension without MetSIn59cases of MetS group, there were male37cases and female22cases. The average age of MetS group was49.49±10.67years old. There were male18cases and female12cases in no-MetS group. The average age of MetS group was50.40±10.42years old.1. Comparison of anthropometric index, prevalence of complication and family disease history between MetS group and no-MetS groupThere was apparently metabolic disorder and seriously central obesity in MetS group. In MetS group, the body weight was84.13±12.80kg, the BMI was29.82±3.84, the WC was102.77±8.47cm and WHR was0.95±0.06, which were much higher than those in no-MetS group.The prevalence of diabetes, dyslipidemia, NAFLD and CVD in MetS group was28.8%(17/59),62.7%(37/59),93.2%(55/59),20.3%(12/59), respectively, which was higher than that of no-MetS group (p<0.05). In the family history of first-degree relatives, the prevalence of central obesity, diabetes in MetS group was higher than that in no-MetS group (p<0.05). There was no difference in family history of hypertension between two groups.2.Comparison of clinical manifestations between MetS group and no-MetS groupThe clinical manifestations of two groups included heaviness in body, shortness of breath and lassitude, spontaneous perspiration, mass and fullness in epigastrium, dizziness, stuffiness, numbness in the body, phlegm palpitations, dry or loose stool, insomnia and dreaminess and so on. The frequency which appeared more frequently in MetS group in turn was shortness of breath and lassitude, spontaneous perspiration, thirst, heaviness in body, irritable. The frequency which appeared more frequently in no-MetS group in turn was irritable, spontaneous perspiration, shortness of breath and lassitude, dizziness, thirst. It indicated that the deficiency of qi was the basic clinical manifestation in MetS group and the deficiency of gan qi and shen qi leading to gan; yang kang was the basic clinical manifestation in no-MetS group. Moreover, the frequency of insomnia and dreaminess, tidal fever and night sweating, loose stool, yellow or red urine, etc. in MetS group was higher than that in no-MetS group (p<0.05). The frequency of oral onyx dark purple, blood stasis block, phlegm palpitations, etc. in no-MetS group was higher than that in MetS group(p<0.05).The frequency of tongue body like pale and enlarged with tooth dent in the margins in MetS group was27.12%, which was higher than that in no-MetS group (p<0.05). The frequency of tongue body like dark purple in no-MetS group was53.33%, which was higher than that in MetS group(p<0.05). The frequency of tongue coating like white or yellow greasy coating in MetS group was27.12%and25.42%, respectively, which was higher than that in no-MetS group(p<0.05). The frequency of tongue coating like little coating in no-MetS group was50.00%, which was higher than that in MetS group (p<0.05).The frequency of pulse like rapid in MetS group was22.03%, which was higher than that in no-MetS group (p<0.05). The frequency of tongue coating like wiry in no-MetS group was40.00%, which was higher than that in MetS group (p<0.05)3. Comparison of FBG,2hPBG, FINS, HbAlc, HOMA-IR, TC, TG, LDL-C, MA, UACR, leptin, hs-CRP, IL-6, TNF-α, PAI-1, t-PA, NE between MetS group and no-MetS groupIn addition, the levels of FBG,2hPBG, FINS, HbA1c, HOMA-IR, TC, TG, LDL-C, MA, UACR, leptin, hs-CRP, PAI-1in MetS group were much higher than those in no-MetS group (p<0.01-0.05). The levels of adiponectin and t-PA in MetS group were much lower than those in no-MetS group (p<0.05). There was no statistically significant difference in the levels of IL-6、TNF-α and NE between between MetS group and no-MetS group.4. Comparison of the characteristics of24habpm between MetS group and no-MetS groupThe levels of24h, daytime, nighttime blood pressure range, nDBPv,24hDBPp, dDBPp in MetS group were higher than those in no-MetS group (p<0.01-0.05). It was highly correlated (p<0.01)between the occurrence of HOMA-IR in MetS group and the levels of24hSBP、24hDBP、24hMBP、24hSBPp、24hDBPp、dSBP、dDBP、 dMBP、dSBPp、dDBPp、nSBP、nDBP、nMBP、nSBPp、nDBPp、The relation of night time diastolic pressure variability and mean arterial pressure variability with IR was much closer. However, it was no related between HOMA-IR with parameters of24abpm in no-MetS group.Part2Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on the patients of hypertension with MetS1. Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on anthropometric index and HOMA-IRPrior to treatment, no difference in anthropometric index and HOMA-IR were observed between CHF group and control group. After treatment, the levels of BW, BMI, WC, WHR, HOMA-IR in CHF group were significantly decreased (p<0.01), while those in control group remained no difference. There was a significant difference (p<0.01-0.05) in the levels of BW, BMI, WC, WHR HOMA-IR between the CHF group and control group after treatment.2. Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on FBG,2hPBG, HbAlc, FINS, TC, TG, HDL-C, LDL-C, MA, UACRThere was no difference in the levels of FBG,2hPBG, HbAlc, FINS, TC, TG, HDL-C, LDL-C between two groups before treatment. After the treatment, the levels of FBG,2hPBG, HbA1c and FINS in CHF group were significantly decreased (p<0.01-0.05), but the same measures in control group did not exhibit significant change. The levels of2hPBG, HbAlc and FINS in CHF group were lower than those in control group (p<0.05). The serum lipid profile, MA and UACR in both groups displayed no obvious change after treatment. There was no statistically significant difference between the two groups.3. Changes of mean blood pressure in different duration before and after treatmentThe average blood pressure amplitude including24h, day time and night time in both groups showed no significant difference before and after treatment. However, the levels of24hSBP、24hDBP、24hMBP、dSBP、dDBP、dMBP、nSBP、nDBP、nMBP in CHF group were decreased after the treatment (p<0.01～0.05). The levels of24hSBP、24hDBP、24hMBP、dSBP、dDBP、dMBP、nSBP、nDBP、nMBP in CHF group were lower than those in control group (p<0.01-0.05). The average blood pressure in each period in the control group after treatment compared with before treatment was no significant difference.4. Changes of BPV in different duration before and after treatmentThe BPV of two groups in different duration displayed no difference before and after treatment. The levels of24hSBPv、24hDBPv、24hMBPv、dSBPv、dDBPv、 dMBPv、nDBPv in CHF group were decreased after the treatment (p<0.01-0.05). Especially, the BPV at day time was improved more significantly than that at night time. The levels of24hSBPv、24hDBPv、24hMBPv、dSBPv、dDBPv、dMBPv、 nSBPv、nDBPv、nMBPv in CHF group were lower than those in control group (p<0.01-0.05). The levels of dSBPv、dDBPv、dMBPv in control group after treatment were higher than before treatment (p<0.01). There was no difference in other parameters of BPV in control group between before and after treatment.5. Changes of pressure load in different duration before and after treatmentThere was no difference in pressure load in different duration in both groups before and after treatment. The levels of24hSBPp、24hDBPp、dSBPp、dDBPp、nSBPp、 nDBPp in CHF group were decreased after the treatment (p<0.01). The levels of24hSBPp、24hDBPp、dSBPp、dDBPp、nSBPp、nDBPp in CHF group were lower than those in control group (p<0.01-0.05). There was no difference in blood pressure load in control group between before and after treatment.6. Changes of pulse pressure in different duration before and after treatmentThere was no difference in pulse pressure in different duration in both groups before and after treatment. The levels of24hPP、dPP%nPP in CHF group were decreased after the treatment (p<0.01). The levels of24hPP、dPP、nPP in CHF group were lower than those in control group (p<0.01-0.05). There was no difference in pulse pressure in control group between before and after treatment.7. Changes of blood pressure smoothness index in different duration before and after treatmentThere was no difference in blood pressure smoothness index in both groups before and after treatment. The level of systolic blood pressure smoothness index in CHF group was increased from1.10±0.19to1.26±0.19after the treatment (p<0.05), which was higher than that in control group (1,10±0.17) after treatment (p<0.01) The level of diastolic blood pressure smoothness index in CHF group was increased from1.08±0.22to1.29±0.16after the treatment (p<0.05), which was higher than that in control group (1.13±0.25) after treatment (p<0.05).The levels of systolic blood pressure smoothness index and diastolic blood pressure smoothness index in control group were no differences between before and after treatment.Part3Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on cytokines of the patients of hypertension with MetS1. Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on adipocytokines, inflammatory cytokine and fibrinolytic system factors1.1AdipocytokinesThere was no difference in the levels of leptin and adiponectin between two groups before treatment. After treatment, the level of leptin in CHF group was significantly decreased and was lower than that in the control group (p<0.01-0.05), but the same measure in control group did not exhibit significant change. The level of adiponectin in CHF group was significantly increased and was higher than that in the control group (p<0.01-0.05). Conversely, the level of adiponectin in control group was decreased after treatment (p<0.05)1.2Inflammatory cytokineThere was no difference in the levels of hs-CRP, IL-6, TNF-α between two groups before treatment. After treatment, the levels of hs-CRP, IL-6, TNF-α in CHF group were significantly decreased and the levels of hs-CRP、TNF-α in CHF group were lower than those in control group (p<0.05). The level of IL-6in control group was significantly decreased after treatment (p<0.05), but there was no statistically significant difference between the two groups. The levels of hs-CRP、TNF-α in control group after treatment were no difference prior to treatment.1.3Fibrinolytic system factorsThere was no difference in the levels of PAI-1and t-PA before treatment. After treatment, the level of PAI-1in CHF group was significantly decreased (p<0.01), but the same measures in control group did not exhibit significant change. There was no statistically significant difference of PAI-1after treatment between the two groups. The level of PAI-1in control group was decreased, but it was no difference prior to treatment. After treatment, the level of t-PA in CHF group was significantly increased and was higher than that in the control group (p<0.01-0.05). The level of t-PA in control group was higher than before treatment, but there was no significant difference.2. Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on NEThere was no difference in the levels of NE between two groups before treatment. After treatment, the level of NE in CHF group was significantly decreased and was lower than that of control group (p<0.01-0.05). The level of NE in control group was higher than before treatment, but there was no significant difference.Part4Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on components of MetS and clinical manifestations1. Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on changes in the occurrence of component disease of MetSThe occurrence of central obesity, hypertension, hyperglycemia, high TG and low HDL-C was decreased in CHF group compared to that from the control group after treatment. Among all these component diseases of MetS, the occurrence of central obesity, uncontrolled hypertension and hyperglycemia in CHF group showed a significant decreasing after treatment (p<0.05). The efficiency on occurrence of component disease of MetS in CHF group was better than that in control group (p<0.05)2. Impact of Chinese Herbal Formula of Yi-Qi-Hua-Ju on clinical manifestations.After treatment, the total efficiency of clinical syndrome in CHF group was90.00%, and in control group was58.60%. There was significantly difference between two groups. The improvement rate of occurrence of shortness of breath and lassitude in CHF group was48.28%, and the improvement rate of the total score of shortness of breath and lassitude in CHF group was70.31%. There was statistically significant difference between the two groups (p<0.05). The improvement rate of occurrence of spontaneous perspiration in CHF group was51.85%, and the improvement rate of the total score of spontaneous perspiration in CHF group was65.00%. There was statistically significant difference between the two groups (p<0.05). The improvement rate of occurrence of thirst in CHF group was32.00%, and the improvement rate of the total score of thirst in CHF group was17.86%. There was statistically significant difference between the two groups (p<0.05). The improvement rate of occurrence of heaviness in body in CHF group was47.83%, and the improvement rate of the total score of heaviness in body in CHF group was66.67%. There was statistically significant difference between the two groups (p<0.05). The improvement rate of occurrence of irritable in CHF group was68.18%, and the improvement rate of the total score of irritable in CHF group was62.50%. There was statistically significant difference between the two groups (p<0.05). Other clinical manifestations in CHF group incuding dizziness, numbness in the body, dry or loose stool, stuffiness, tidal fever and night sweating, phlegm palpitations, poor appetite, yellow or red urine and so on were alleviated accompanied with improvement of tongue and tongue coating and pulse. The clinical manifestations in control group such as stuffiness, insomnia and dreaminess were alleviated. The improvement of other clinical manifestations in control group was not obvious, some even increased before treatment.Conclusion1. It presented that more serious cardiovascular risks in hypertension coupled with MetS than hypertension without MetS. The family genetic susceptibility and bad living habits were important cause factors on hypertension coupled with MetS. It was the basement that establishing a healthy lifestyle on the treatment of hypertension coupled with MetS.2. There were differences of the blood pressure range and blood pressure variability in a certain period of time between hypertension patients with MetS and without MetS patients, which was closely associated with degree of insulin resistance. Insulin resistance may be involved in the abnormal changes of blood pressure, amplify the blood pressure of the damage.3. The integrative treatment with conventional drug therapy and Chinese herbal formula of Yi-Qi-Hua-Ju to MetS patients with hypertension has been studied. It indicated that:1) Compared with anti-hypertension drugs alone, the integrative treatment exhibited better results in reducing blood pressure amplitude, blood pressure variability due to reducing the sympathetic activity, blood pressure load and pulse pressure, improving blood pressure smoothness index, which redcued the damage of the target organs due to hypertension.2) The integrative treatment effectively decreased the risks of vascular diseases such as central obesity and insulin resistance, improved abnormal fat distribution, relieved metabolic and fibrinolytic system disorder, decreased the level of plasma glucose, adipocytokines and inflammatory cytokines leading to relieving insulin resistance.3) The integrative treatment can control and reduce the occurrence of component diseases of MetS, reducing the metabolic syndrome cardiovascular risk. |
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