A Clinlcal Study On Therapeutic Effects Of Dr. Li Ke Po Ge Jiu Xin Decoction Treating Patients With Congestive Heart Failure

BackgroundShanxi Chinese medicine (CM) practitioner, Dr. Li Ke created the decoction Po Ge Jiu Xin Decoction. The formula has rescued more than1,000patients from heart failure. While preliminary clinical observation of the decoction in the treatment of critically ill patients with heart failure shows promising results, there is a lack of objective, evidence based research to support the claims, confirm prognosis, assure its safety and support the modifications of the prescription when used as an intervention in the field of critical care.Objectives1. Observation and evaluation of short-term and long-term clinical efficacy in patients with chronic cardiac insufficiency (heart function grade â…¢-â…£) patients using biomedicine diagnosis and treatment according to clinical guidelines for heart failure treatment with the additional treatment, of taking Po Ge Jiu Xin Decoction.2. Po Ge Jiu Xin Decoction, contains a large dose of toxic drugs, therefore it is necessary to evaluate the safety of the drug.3. Observe the use and results of Po Ge Jiu Xin Decoction and its modifications in order to provide an objective basis for its CM pattern differentiation application.Methods1.This is a pioneering study. Over the same time period, using an open, non-randomized controlled trial design,54subjects who met the inclusion criteria (all patients in-hospital) were selected who were experiencing an acute exacerbation of their chronic heart failure condition. They were divided into the treatment group or the control group. The control group was given standard conventional therapy; the treatment group was given Po Ge Jiu Xin Decoction in addition to standard conventional therapy; continuous interviews were conducted for6months prior to and following treatment recording cardiac-function grading, Lee's cardiac risk index, BNP scoring, the main symptoms and signs in CM, CM pattern differentiation scoring, occurrence and recurrence of adverse events and mortality rates for statistical analysis were taken.2. Acute toxicity test was done to obtain the experimental safety data; collection of daily toxic drugs doses, safety information data and assess the drug safety for patients with heart failure given Po Ge Jiu Xin Decoction was conducted.3. Data mining methods were used to analyze the effect of Po Ge Jiu Xin Decoction and its modifications based on the observation of clinical signs before and after its application.Results1. Our clinical research shows that there is a significant difference in the CM pattern differentiation score on the day following treatment (p<0.01), the six-month follow-up relapse rate (P<0.049), relapses (p<0.01), patients treated with Po Ge Jiu Xin Decoction is superior to the conventional therapy group.2. The mice were given a daily dosage of Po Ge Jiu Xin Decoction equivalent to about75times that of a50kg human weight dosage in an acute toxicity test. Experimental results:while two mice died due to incorrect gavaging causing esophageal perforation, none of the mice in the test group died or showed nor did they show any significant adverse reactions.3. Blood test results showed that in the34cases taking Po Ge Jiu Xin Decoction liver and kidney function were normal, no abnormal ECG fluctuations and no significant adverse events occurred.4. Observation of modifications made to Po Ge Jiu Xin Decoction showed that combining it with San Sheng Yin, Zhen Wu Tang further improve shortness of breath symptoms; combination with3qian (9g) of Sheng Si Wei, ebony, Yin Huo Tang or Rehmannia significantly improved fatigue, anorexia and insomnia.Conclusion1. In serious heart failure, Po Ge Jiu Xin Decoction is efficactive and provides good long-term prognosis;2. Po Ge Jiu Xin Decoction is safe if decocted using the standardized decoction process.3. Po Ge Jiu Xin Decoction and its modifications follow the principle of "supporting the healthy qi and dispelling the pathogenic qi "4. In this study, a unique and important exploration into the use of CM treatment for acute exacerbation of congestive heart failure was made. It has laid a good foundation for the use of CM in the field of intensive care medicine.