| Objective :The aim of this study is to test the effectiveness and safety of awn needle acupuncture as well as to explore the relationship between the amount of stimulation and efficacy,hoping to provide more evidence for awn needle treatment.Methods :This study was a parallel randomized controlled trial of two groups.The sample size was estimated by PASS15.0 software according to the effective rate provided by clinical expert,and the minimum sample size of 36 cases in each group.Random number table was made by SPSS25.0 software and the numbers were divided into two groups equally.The grouping results were put into envelopes for distribution hiding.Envelopes were assigned to 72 patients with postprandial discomfort syndrome after ischemic stroke according to the order of signing informed consent,and were divided into strong stimulation group and weak stimulation group,with 36 cases in each group.For ischemic stroke and its complication,“Xingnao Kaiqiao ”acupuncture treatment and other conventional symptomatic treatment were given to both groups.Acupuncture operator slowly advanced the awn needle with small angle and high frequency at Zhongwan(CV4)and bilateral Tianshu(CV4)in both groups and retreat the needle to subcutaneous 30 mm–50 mm after Deqi.The strong stimulation group were given lifting,inserting,twisting,reinforcing manipulation for 1 min after withdrawal of the needle,while the weak stimulation group was no longer given acupuncture.Every patient received an acupuncture treatment for each day,12 times in total.The self-made dyspepsia symptom score scale,which was used as the main outcome measure,was evaluated not only at the beginning and the end of treatment but also at the middle of the study.The Simple Nepean Dyspepsia Index(SF-NDI),Self-rating Depression Scale(SDS)and Self-rating Anxiety Scale(SAS),as outcome measures to evaluate quality of life and mental health,were applied before and after treatment.The above scales were scored by researchers who did not know the grouping situation.The adverse reactions and treatment results during the treatment were recorded,and the safety was evaluated.The overall curative effect was evaluated according to the integral change value of the main observation indexes.Excel 2019 was used to establish the research database,and SPSS25.0 statistical software was used to analyze the experimental data.Results:1.The baselines of two groups,which includes age,gender,course of disease,occurrence of underlying diseases and the values of each observation index before treatment(SDS score,SAS score,SF-NDI total score and scores in various fields,total score of dyspepsia symptom score scale and integral of each item)have no difference(P>0.05).2.Dyspepsia Symptom Score Scale : After 6 times of treatment,both single and total score of the strong stimulation group were lower than those before treatment,and the abdominal distension,early satiety,acid regurgitation,nausea,hiccup score and total score of the weak stimulation group were lower than those before treatment(P<0.025).The abdominal distension,early satiety score and total score of the strong stimulation group were lower than those of the weak stimulation group,and the difference was statistically significant(P<0.05).After 12 times of treatment,the single and total scores of both groups were increased(P<0.025).The abdominal distension,early satiety,antiacidity,hiccup scores and total scores of the strong stimulation group were lower than those of the weak stimulation group(P<0.05).3.Short Form-Nepean Dyspepsia Index : After treatment,the total SF-NDI score and scores in various fields of the two groups were lower(P<0.05),and the stress,diet,cognition,work and study and overall score of the strong stimulation group were lower than those of the weak stimulation group(P<0.05).4.Self-rating Depression Scale and Self-rating Anxiety Scale : the anxiety and depression scores of the two groups after treatment were lower than those at the beginning of treatment(P<0.05).5.The total effective rates of the strong stimulation group(88.24 %)was higher than the weak stimulation group(77.14 %)(P<0.05).The curative effect of the strong stimulation group was better than that of the weak stimulation group.6.Observation of adverse reactions and safety evaluation : the incidence of adverse reactions in the strong stimulation group was 5.88 %,2 cases of safety grade 2,32 cases of grade 1.The incidence of adverse reactions in the weak stimulation group was 2.86 %,1 case of safety grade 2,34 cases of grade 1.The difference was not statistically significant(P>0.05).Conclusion :1.Both strong stimulation and weak stimulation can effectively relieve the clinical symptoms of postprandial discomfort syndrome in middle-aged patients with ischemic stroke,but the effect of strong stimulation is better.2.The relief of abdominal distension,early satiety,acid regurgitation and hiccup symptoms after meal was more obvious by strong stimulation of awn needle,while the anesis of gastric burning and nausea symptoms was similar to that by weak stimulation,but the effect of strong stimulation on alleviating gastric burning was faster.3.Both strong stimulation and weak stimulation can improve the quality of life of patients with ischemic stroke,and the improvement effect of strong stimulation is better.4.Both strong stimulation and weak stimulation can effectively reduce the anxiety and depression,but the improvements are equivalent.5.The strong stimulation of awn needle is effective and safe,which provides more evidence for the future application of awn needle in the treatment of postprandial discomfort syndrome after ischemic stroke. |
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