Clinical Study On Treatment Of Cholelithiasis Syndrome With Gan Shu Capsule

Purpose of researchGallstones (Cholelithiasis) refer to the lithogenesis disease that takes place in the biliary system, including gall bladder, common bile duct, intrahepatic bile duct and other sites.In recent years, there is an increasing tendency of incidence of the Gallstones in our country and even around the world along with people’s lifestyle and eating habits change. In 2007, a epidemiological survey in the US showed that the incidence of Gallstones is 7.1%, in which cholecystectomy accounts for 5.3% among surgery. Now Western treatments of this disease are mainly by surgery, ERCP, Laparoscxcpic cholecystectorny,or extracorporeal shock wave lithotripsy (ESWL).While with surgical or minimally invasive treatment, there are side effects such as residual stones, high recurrence rate and surgeon fee, poor tolerance of patients, more indications and so on. This observation aims to research whether the Traditional Chinese medicine Danshu capsule can quickly ease the pain, reduce the incidence frequency, Shorten the duration of pain, and observe the changes of stone size and number, and evaluate the safety of Danshu capsule, providing proprietary Chinese medicines in the treatment of cholelithiasis with a new insight. Meanwhile, further exploring the peppermint oil’s function on Gallstones.Research of methodThe research is using methods as hierarchical block random, positive drug parallel controlling, double-blind single simulating, multi-centric clinical study,to observe the effect of traditional Chinese and western medicine on 144 patients. All the patients are coming from ward and outpatient of the Dongzhimen hospital of Beijing, Harbin hospital of traditional Chinese medicine,Daqing hospital of traditional Chinese medicine, Hegang mining industry group co., LTD., general hospital, Xinzhou people’s hospital, Changzhi people’s hospital in Shanxi Province,Tangshan hospital of traditional Chinese medicine,Qinzhou and Liuzhou hospital of traditional Chinese medicine that was diagnosed with Gallstones of liver stagnation, hot and humid stomach-delay syndrome.144 patients were randomly divided into experimental group 108 cases, control group 36 cases in the proportion of 3:1, with 9 cases falling and 7 cases violated in experimental group, while in the control group 4 cases are off, 4 cases were violated the scheme and 1 case was eliminated because of super window. That is to say there were 123 Per Protocol Set, among which,92 cases in experimental group and 31 in the control group. Two pills of Danshu capsule and two pills of simulant (i.e., Danshu capsule+capsule simulant totally 4pills, Tid.po.), All medicines were taken consecutively 4 weeks, and observation was made respectively in 1 day before the treatment, mid-treatment of 14 days, late-treatment of 28 days, to observe the main indicators such as the pain VAS score, the frequency and duration of the pain, efficacy in patients with TCM, as well as the secondary indicators such as the utilization and the average time of antibiotics using, the change of Ultrasound imaging, and the individual symptoms curative effect, with main change of Ultrasound imaging, and the individual symptoms curative effect, with main indicators as the primary efficacy evaluation.ResultCompared with the control group, the VAS score, frequency, and the TCM syndromes of Experimental group were obviously improved.In contrast, the VAS score (pain degree) of experimental group decreased obviously, with P<0.05,and the differences were statistically significant, indicating that Danshu capsule can significantly ease the pain of patients with GD. And statistical analyses, using the procedure of independent-simplest test, were conducted on the data from the pain frequency index,with P< 0.05, indicating that Danshu capsule can significantly reduce the frequency of attacks on patients with GD. While in terms of that of the duration of the pain, there seems no significant differences with P>0.05. When it comes to TCM syndromes, the differences between Experimental group and control were significant by using the CMH chi-square test, with P<0.05,and the main symptoms,that is to say,"right upper quadrant pain," "nausea and vomiting," "abdominal distention tightness" and "food anorexia" "heavy sensation in the limbs and body" syndromes were statistically striking, indicating that Danshu capsule can obviously improve the TCM syndromes during the acute-outbreak period of GD (liver stagnation, hot and humid stomach-delay syndrome). There were 5 cases using antibiotics in experimental group, and it seems no statistically difference between two groups with P> 0.05.Among the 92 cases in experimental group,7 cases cured,3 cases markedly effective,3 cases effective,79 cases invalid by imaging examination, so the overall efficiency is 14.13%. At the same time, in the control group, there were 4 cases cured,1 case markedly effective, and 3 cases effective,23 cases invalid respectively, so that the efficiency is 25.8%. Tested by CMH-x2,P> 0.05,there is no significant difference between experimental and control group,which indicates that Danshu capsule have non-inferiority than Danle capsule in resolving stones,and it was perhaps caused by short period of treatment,the nature of the stone and the study’s sample size.There were total 3 adverse events, among which, experimental group has 1,accounting for 0.93 percentage, and the control group has 2, accounting for 5.56 percentage. There was no significant difference between two groups by chi square test with P>0.05. In a word, The treatment of Dansh&u capsule is precise, effective and safe during the acute-outbreak period of GD(liver ease, hot and humid stomach lag), and it is worthy of further research and clinical applications as discretion.Conclusion① Danshu capsule can ease the pain during the acute outbreak period of GD(liver stagnation, hot and humid stomach-delay syndrome) with VAS score decreased, reduce the frequency of attacks, which is better than of Danle capsule.② Danshu capsule can obviously improve the TCM syndromes during the acute-outbreak period of GD (liver stagnation, hot and humid stomach-delay syndrome),particularly in the treatment of gallstone attack "right upper quadrant pain," "nausea and vomiting," "abdominal distention tightness" and "food anorexia" "heavy sensation in the limbs and body" syndromes, et al.③ ompared with Danle capsule, Danshu capsule have no significant difference during the acute-outbreak period of GD(liver stagnation, hot and humid stomach-delay syndrome) in the treatment of pain duration, antibiotic usage and imageological examination.④ The treatment of Danshu capsule is effective and safe during the acute-outbreak period of GD(liver ease, hot and humid stomach lag), and it is worthy of further research and clinical applications as discretion.