Clinical Research Of Combined Pinelliae And Atractylodis Macrocephalae And Gastrodiae Decoction (PAD) And Decoction For Clearing Away Gallbladder Heat (DCH) For Treating High Blood Pressure (HBP)

ObjectiveThe research deployed clinical marched ran-control study, which was observed the clinical curative effect and safety of combined Pinelliae and Atractylodis Macrocephalae and Gastrodiae Decoction (PAD) and Decoction for Clearing Away Gallbladder Heat (DCH) for treating high blood pressure (HBP) with phlegmatic hygrosis flourishing syndrome patients in order to approach the clinical basement of formula and syndrome corresponding research for phlegmatic hygrosis flourishing syndrome.MethodsTo select the 60 candidates that treated in the TCM clinic service department of Chongguang in Taiwan from Nov.2008 to Dec.2009, which coincidence with the bolting standard of HBP. The diagnosis and classification of standard in western medicine was refered to the Treatment Guidance of WHO/ISH HBP 1999. The diagnosis and classification of standard in Chinese medicine was refered to Clinical Research Guidance Principle of Chinese New Drug (2000, sample version). The 60 candidates were all consistent with the standard as above, who belong to phlegmatic hygrosis flourishing syndrome andⅠ～Ⅱdegree. The patient who had secondary hypertension combined liver,brain,heart,kidney and hematopoietic system serious primarily disease was not included. Divided the candidates at the ratio of 1:1 into the treatment group and the control group randomly. The treatment group was treated with combined PAD and DCH for HBP patients with phlegmatic hygrosis flourishing syndrome. The control group was treated with Decoction of Four Mild Drugs. These two kinds of medicine that packed 9g in NO.0 Chinese medicine caps with GMP standard were all reqused at similar shape,color,package and regimen in ord to guarantee the practice of double-blind. Each group was taken 5pills at morning and evening time respectively, lmonth as a course of treatment. Before and after a course of treatment, respectively recorded the clinical symptom (dizzy,headache,heaviness of head,chest distress,spit phlegm) and blood pressure and evaluated the curative effect of symptom and high blood pressure. Observed and recorded the possible adverse effect in the treatment procedure.Statistical methods:Database was set up with the software of Epi Data3. 1.The statistical analysis was used with the software of SPSS17.0. Two group mean comparison was observed using t-test. Matched t-test was applied for self-AP:PA comparison. The classification data was observed using 2 Test. The ranked data was observed using Ridit analysis. The software of Graph Pad Prism 4.03 was used for statistical figure.ResultsThere were 60 candidates and each group was 30 cases. The ages of two groups were 57.9 years old and 60.5 years old respectively.34 cases were male and 26 cases were female. Comparability of baseline characteristics of patients in two groups of age,gender,disease course,high blood pressure staging,clinical symptom in TCM distribution and the level of blood pressure, there was no statistical significance between two groups which showed that the baseline data were comparable (P>0.05)After a course of treatment, results of research as follows:(1) The clinical curative effect in two groups It was showed that the excellence rate of the treatment group was 23.3%, and the effective rate was 63.3%, the total effective rate was 86.7%. While in the control group, the excellence rate of the treatment group was 10%, and the effective rate was 66.7%, the total effective rate was 76.7%. It was showed that the excellence rate of the treatment group was 23.3%, and the effective rate was 63.3%, the total effective rate was 86.7%. While in the control group, the excellence rate of the treatment group was 10%, and the effective rate was 66.7%, the total effective rate was 76.7%. There was not significant difference between two groups of symptom effect in TCM (P>0.05).It was presented that these two groups had good effect on improving the total effect score in TCM symptom. Athough there was not statistically significant, it was showed that there was effective of treating phlegmatic hygrosis flourishing syndrome with TCM.(2)The hypertension curative effect in two groupsThe hypertension curative effect after I stage:It was showed that the excellence rate of the treatment group was 20.0%, and the effective rate was 50.0%, the total effective rate was70.0%. While in the control group, the excellence rate of the treatment group was 0%, and the effective rate was28.6%, the total effective rate was 28.6%. The total effective rate was 40% highter than the control group, although there was not statistically significant, it showed that there was more effective of treating in Pinelliae and Atractylodis Macrocephalae and Gastrodiae Decoction than Decoction of Four Mild Drugs in degrading blood pressurein II stage.The hypertension curative effect after II stage:It was showed that the excellence rate of the treatment group was 5.0%, and the effective rate was 80.0%, the ineffective rate was70.0%. While in the control group, the excellence rate of the treatment group was 0%, and the effective rate was43.5%, the total effective rate was 43.5%. Compare with the two groups, there was statistically significant (P<0.05), it showed that there was more effective of treating in the II stage in treatment group than the control group. It shows that the Pinelliae and Atractylodis Macrocephalae and Gastrodiae Decoction plus Decoction for Clearing Away Gallbladder Heat have excellence effective in degrading blood pressure in II stage.(3) The improvement extent and the disappearance situation of the clinical symptomIn the treatment group, the patients who had improved more than 1 degree extent in dizzy,headache,heaviness of head,chest distress,spit phlegm and insomnia were account for 90.0%,96.3%,88.5%,90.0%,80.0%,50.0%,95.5% respectively after treatment, while in the control group for 48.0%,57.1%,78.3%,83.3%,50.0%,23.1%,47.6% respectively. There was statistical significance between two groups in dizzy,headache,heaviness of head,chest distress,and insomnia(P<0.01). The treatment group was better then the control group. There was not statistical significance between two groups in spit phlegm and cardiopalmus (P>0.05).It was presented that the treatment group had more significant effect than the control group on improving the clinical symptom for HBP patients with phlegmatic hygrosis flourishing syndrome, especially on heaviness of head and heaviness of head.The disappearance rate of dizzy,headache,heaviness of head,chest distress and insomnia in treatment group was higher then that of the control group (P<0.05). while there was not statistical significance between two groups in spit phlegm and cardiopalmus (P>0.05).It was showed that the effect of combined PAD and DCH for treating HBP patients with phlegmatic hygrosis flourishing syndrome was better than Decoction of Four Mild Drugs.(4) the changeable situation of systolic blood pressure and diastolic blood pressure at the AP:PA treatment timeAfter treatment, the diastolic blood pressure of the treatment group averagely decreased 2.86±1.14 kpa and there was significant difference compared with at the before and after treatment time (P<0.05). There was statistical significance in diastolic blood pressure between two groups (P<0.05). It was considered that these two groups could decrease the systolic blood pressure and diastolic blood pressure. The treatment group was better then the control group, especially at the treatment before.(5) The situation of blood pressure back to normalIt was showed that there was 83.3% patients of blood pressure had back to normal with the evalution stardurd of blood pressure was≥21.3Kpa and/or diastolic blood pressure was≥12.7, while of which in the control group was 30.0%. There was statistical significance wihin the rate of blood pressure back to normal between two groups. The treatment group was better then the control group.The results of safety evaluation:there was not any adverse effect at the periold of before and after treatment.Conclusion1. Combined PAD and DCH had the same effect on the HBP patients with phlegmatic hygrosis flourishing syndrome in different stage, alos had the effect on the improvement of the systolic blood pressure and diastolic blood pressure.2. Combined PAD and DCH could effectively improve the symptom of the HBP patients with phlegmatic hygrosis flourishing syndrome, especially for dizzy,headache,heaviness of head,chest distress,spit phlegm and insomnia.3. Combined PAD and DCH could effectively curing dizzy and headache of two cardinal symptoms.4. It was safe that combined PAD and DCH for treating the HBP patients with phlegmatic hygrosis flourishing syndrome, which had more obviously advantage than Decoction of Four Mild Drugs.