Clinical Study On Er Di Tian Ma Ban Xia Decoction For Treatment Of Diabetes Mellitus-Hypertension Due To Yin Deficiency Yang Hyperactivity With Phlegm

Objective:To do a clinical study on the effectiveness of using Er Di Tian Ma Ban Xia Decoction in treating Diabetes Mellitus-Hypertension due to Yin Defieciency Yang Hyperactivity with Phlegm by observing the Traditional Chinese Medicine(TCM)sympttoms and evaluate theparameters of bloodsugar,bloodpressure,blood lipid and also to confirm the safety of the treatment.Methods:Selected 60 patients conformed to diagnoseof T2DM with Hypertension according to the WHO-ISH and ADA standards.The selected patients are also conformed to the Chinese medicine diagnose asYin deficiency Yang hyperactivity with phlegm(CMDCYDYHP)according to Evidence-based Guidelines of Clinical Practice in Chinese Medicine version year 2002,which consists of the 4 major symptomsand 5 minor symptoms.Besides,combine with the tongue and pulse diagnose.Besides complying the both Western and Chinese Medicine diagnose standards that mentioned earlier,the selected patients are from the age range between 30 to 70 years old,still active,entirely and clearly informed subsequently agreed with the research details.The exclusions of the research participants are ①patient not complying to the diagnose standards,②patient with Type 1 DM and others,③ patient with Secondary Hypertension,④patients with age range younger than 30 years old and elder than 70 years old,⑤patient suffers DM ketoacidosis and acute metabolic disorder complicated with infection within a month,⑥Patient suffers heart,liver and kidney disease,⑦patient suffers cancers,hepatitis,tuberculosis(TB)and others communicable diseases,pregnant and lactation,⑧ not cooperative in following diet and medication prescribed,⑨ allergic constitution and to medication,⑩ Other complicated conditions which is disqualified to participate in this study according to the researcher’s justifications.The qualified 60 patients were selected from the clinic patients of Prof.Dr.Wang Xuin Nanjing University of Chinese Medicine Hospital,Nanjing China.The software SPSS 19.0 was applied throughout the study and assigned the participants to the treatment group(n=30)and control group(n=30).Both groups were receiving basic medications,health consultation,diet and exercise programmed.The control group was given Glimepiride(Amoli)2mg;take orally,each time a day.Melbine(DMBG)500mg,taken orally,3 times a day.Irbesartan(Aprovel)150mg,intake orally,each time a day.The treatment group were given additional Er Di Tian Ma Ban Xia Decoction.Boiled decoction,intake orally,each decoction divided to 2 times a day.Both groups were taken 4 weeks as a course and together 3 courses were observed.Treatment effectiveness were observed and compare before and after the treatment as followings,①Relevant clinical major and minor symptoms according to the Chinese Medicine diagnose as Yin deficiency Yang hyperactivity with phlegm(CMDCYDYHP)shall be observed and recorded every 4 weeks.②Blood Sugar Level-FBG,PBG,HbAlc.③ Blood Pressure-SBP,DBP ④ Blood test on-TG,TC,HDL-C,LDL-C ⑤ Hemorheological parameter ⑥ FINS,HOMA2-IR,HOMA2=%B.Safety observation depends on the blood test result on the testing of blood,urine and motion to detect the side effects(if any)related to liver function and kidney function.Results:The total 60 patients participated in the study had completed the entire treatment.The results of this study are concluded as followings:Total effective rate for the treatment group is93.33%.On the other hand,the efficiency ratio of the control group is only 76.6%.As a result,the comprehensive clinical treatment group has provided an effective treatment and better compares the control group(P<0.5).① For CMDCYDYHP results-it is effective for both group compared to before and the treatment group shows significant improvement in compare to the controlled group(P<0.05)②Blood Sugar level-all tested results shows the readings of FBG.PBG,HbAlc iseffective in compare to before the treatment and better than the control group.③Blood Pressure-SBP and DBP also effective in compare to before and better improvement than the control group(P<0.05).④Tested parameters for TC,TG,LDL-C was improved in compare to before for the treatment group and better than thecontrol group(P<0.05or P<0.01).Reading of HDL-C is also recorded improved in compare to before and better compare to the control group.⑤ Hemorheologi cal parameters ⑥ Parameters of FINS,HOMA2-IR,HOMA2-%B for treatment group showed significant improvement compare to before(P<0.05),and better than the control group(P<0.05).Conclusion:1.Prescription of Er Di Tian Ma Ban Xia Decoction has improved the condition of blood sugar and blood pressure among the Type 2 Diebetes Mellitus-Hypertension.The treatment as such is also nourishing better’qi’ and blood circulation can improve the all major and minor TCM symptoms。Total effectiveness after the treatment for the treatment group is 93.33%and for the control group is 76.67%.2.The treatment group having Er Di Tian Ma Ban Xia Decoction did not affect the liver and kidney functions and in fact improving both functions compared to the control group.This means Er Di Tian Ma Ban Xia Decoction is generally safe for treating the Type 2 Diebetes Mellitus-Hypertension in similar conditions.