| [Research purposes]Through this clinical study,we would like to verify the clinical efficiency of acupuncture combined with acupoint application in treatment of patients with refractory gastroparesis after gastrointestinal surgery and to evaluate its safety.The acupuncture combined with acupoint application was guied by the Traditional Chinese Medicine(TCM)theory of dispelling coldness from stomach and regulating the function of liver.Besides,we hope to lay a foundation for the establishment and optimization of TCM treatment plan for refractory gastroparesis after gastrointestinal cancer surgery,which is easy to be put into practice and to be promoted,to find a safer,more effective,more comprehensive external TCM treatment for patients with refractory gastroparesis,making it operationally compliant,repeatable and good for popularization.[Research methods]A single-center,prospective clinical research methodwas applied in this study.After a number of program discussion meetings,the final study program was finalized,and the preparative work for recruitment of patients was complete after having gone through ethical review of this research center.The researchers were trained by purchasing of drugs and acupuncture appliances before the trial.The patients were recruited based on the inclusion criteria and have completed screening stage before enrollment,including standing abdominal X-ray,gastrointestinal imaging,abdominal CT,gastroscopy,hematuria routine,liver and kidney function,electrolyte,and electrocardiogram,etc,meanwhile,symptoms were scored.Patients who met the inclusion criteria were treated strictly in accordance with the trial program.On the basis of western medicine routine treatment(nutrition support and gastric motility drugs),the TCM external treatment methods of dispelling coldness from the stomach and regulating the function of liverwere applied.The recovery time of gastric motility,the symptom score of gastroparesis,gastric drainage/vomiting volume,oral feeding and bowel sounds recovery time and adverse reactionswere observed and recorded on the 1st,4th,7th,and 14th day of treatment.Patients who completed the trial program were also examined with the same indicators for out-grouping.The main indicator of outcome in this study was the clinical efficiency;secondary outcome indicators included gastric motility recovery time,gastroparesis symptom score,gastric drainage/vomiting volume,oral feeding recovery time,bowel sound recovery time and adverse reactions.The study was carried out under strict quality control from all aspects of the preliminary preparation,start-up and implementation process,and was in line with the quality control standards expected in the study.[Research result]In this study,34 patients with postsurgical refractory gastroparesiswere included.One of the patients withdrew from the clinical study because of using the method not permitted by trial for treatment of gastroparesis.Thirty-three cases completed during the 14-day research period.(1)The main outcome indicator of this study is clinical efficacy.According to the criteria,among these 33 patients in the group,29 patients recovered gastric motility,with a total effective rate of 87.88%.Among 24 patients with indwelled gastric tube,21 patients of them started feeding by mouth after the treatment,with an effective rate of 87.5%;8 of 9 patients without indwelling gastric tube recovered to oral feeding and stopped using totalparenteral nutrition support,with an effective rate of 88.89%.There is no significant difference between two groups(P>0.05).(2)The secondary outcome indicators of this study:①29 of 33 patients in this study recovered gastric motility within 14 days of observation.The median recovery period is 7.63 days,57.57%of the 29 patients recovered gastric motility within 1 week.The time required for gastric motility recovery for the group with indwelling gastric tube was 7.5 days and for the group without ndwelling gastric tube is 7.75 days respectively,and there is no significant difference between the two groups(P>0.05).②The total symptom score of patients with gastroparesis gradually decrease with treatment,showing a significant difference from the beginning of treatment to the 4th day(P<0.05).Except the score of retching(P>0.05),the score of the other 8 symptoms all dramatically drop(P<0.05),like nausea,vomiting,stomach fullness,inability to eat normally,extreme sensation of fullness after meals,no appetite,abdominal distension and marked increase in stomach or abdomen.There is no significant difference(P>0.05)in the total symptom score between the indwelling gastric tube group and the contrast group in the period of pre-treatment and the 1st,4th,7th,and 14th day.The total symptom score of both groups show a decreasing trend both before and after the treatment,while this marked difference show up earlier in the indwelling gastric tube group than another group.③The gastric fluid drainage/vomiting volume of the 33 patients decrease significantly from the 4th day of treatment(P<0.05),and gradually decrease with the prolongation of treatment time.④The median time of oral feeding recovery for 33 patients is 5.88 days.There is no significant difference(P>0.05)between the indwelling gastric tube group(6.33 days)and the other group without indwelling gastric tube group(3.83days).⑤The normal time for recovery of bowel sounds is 8.25 days.There is no significant difference(P>0.05)between the indwelling gastric tube group(6.87 days)and the other group without indwelling gastric tube group(10.17days).(3)Safety evaluation:There is 1 case with adverse skin reactions(erythema)in degree 1 in 33 patients,and none of the other patients had skin-related adverse reactions.No adverse reactions related to acupuncture appeared,such as fainting,delayed needles,curved needles,broken needlesand hematoma occurred in all patients.In the routine blood test,there is a significant difference between the count of white blood cell and the platelet both before and after treatment,P<0.05;In indicators of the liver and kidney,a significant difference show between two groups both before and after treatment,P<0.05.However,they are all within the normal range and have no clinical significance.There is a significant difference in potassium ion and chloride ion both before and after treatment,P<0.05.Potassium ion is within the normal range both before and after treatment,so there is no clinical significance.However,the chloride ion changes from lower than normal value to normal range,showing clinical improvement.There is no significant difference in routine urine,stool sampling and electrocardiogram both before and after treatment,P>0.05.[Conclusions]The treatment of refractory postsurgical gastroparesis with acupuncture combined with acupoint application,guided by TCM theory of dispelling cold from stomach and regulating the liver function,has changed the traditional way of oral meditation.This treatment can get good curative effect and take rapid action through external therapy of TCM,most patients can restore gastric motility,recover oral feeding and bowel sound within a short period of time,which gain time for further treatment for patients of postsurgical gastroparesis.After acupuncture combined With acupoint application,main clinical symptoms of gastroparesis can be significantly relieved in a short period of time.The method can also effectively reduce gastric liquid drainage/vomiting volume for patients with postsurgical gastroparesis and improve the patient’s quality of life.It is simple and easy to apply the therapy,with no obvious adverse reactions been found.It also helps to avoid re-surgery,which will aggravate the patient’s mental and economic burden,better and easy for the patient to accept.Therefore,this method is a preferable treatment for gastroparesis after resection of refractory gastrointestinal cancer,worthy for clinical promotion and further large-scale,multi-center,random controlled clinical studies. |
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