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Randomized Controlled Trial And FMRI Brain Functional Imaging Study On Acupuncture Treatment Of Chronic Spontaneous Urticaria

Posted on:2024-05-19Degree:DoctorType:Dissertation
Country:ChinaCandidate:S Y QuFull Text:PDF
GTID:1524306926950079Subject:Chinese traditional surgery
Abstract/Summary:PDF Full Text Request
Urticaria is a localized edema reaction caused by the dilation and increase of permeability of small blood vessels in the skin and mucosa.The clinical manifestation is a wind mass that spontaneously subsides within 24 hours,often accompanied by varying degrees of itching.Treatment with antihistamines can lead to problems such as withdrawal or recurrence.Acupuncture therapy can effectively alleviate the symptoms of itching and wind mass in patients with chronic urticaria.Pruritus is a conscious symptom caused by various skin and systemic diseases.It is an uncomfortable sensation that causes the body to have a desire to scratch and a scratch reflex.The brain is the integration center of itching and the key hub for the effects between acupuncture and various target organs.ObjectiveA randomized,blind,and sham acupuncture controlled study design was conducted to objectively evaluate the effectiveness and safety of acupuncture treatment for chronic spontaneous urticaria(CSU)patients.At the same time,with the help of functional magnetic resonance imaging(fMRI)technology,the brain function differences of CSU patients and healthy people,as well as the brain function differences of CSU patients before and after the treatment course,were compared and observed to explore the brain function mechanism of CSU and acupuncture treatment of itching.Methods1.Clinical research74 CSU patients who met the requirements were randomly divided into acupuncture group and sham acupuncture group,with 37 patients in each group.The selected acupoints are bilateral Shenmen,Neiguan,Hegu,Quchi,Zusanli,and Sanyinjiao.The acupoint selection for the sham acupuncture group is the same as that of the acupuncture group,using blunt head comfort needles that do not penetrate the meridians and do not receive acupuncture.The course of treatment is 3 times a week for 4 consecutive weeks,and a follow-up of 4 weeks is conducted after the end of the course.The primary efficacy endpoint was the Urticaria activity score over 7 days(UAS7),while the secondary efficacy endpoint was the Chronic Urticaria Quality of Life Questionnaire(Cu Q2ol),Urticaria control test(UCT),Self Rating Anxiety Scale(SAS),Self Rating Depression Scale(SDS)The Insomnia Severity Index(ISI)score was evaluated at weeks 0,2,and 4 after enrollment,and the subjects were followed up at weeks 2 and 4 after treatment.2.fMRI brain functional imaging research60 CSU patients were all from subjects without contraindications to magnetic resonance imaging in Study 1.In addition,30 healthy subjects were recruited through hospital advertisements,matching the age and gender distribution of CSU patients.CSU subjects received 4 weeks of acupuncture treatment and underwent 2 fMRI examinations before and after treatment.Healthy subjects underwent two fMRI examinations every 4 weeks,with no intervention during the two examinations.The scanning sequence consists of T1 three-dimensional magnetization preparation rapid gradient echo(MPRAGE)and blood oxygen level dependent gradient echo echo echo plane imaging(BOLD-EPI).Calculate the low-frequency amplitude analysis(ALFF),fractional low frequency amplitude(fALFF),regional consistency analysis(ReHo),and functional connection density(FCD)of CSU patients and healthy subjects.The image data was extracted using GRF multiple comparison correction,with individual voxels having a statistical significance threshold of P<0.001,The statistical significance threshold for clumps is P<0.05.Use xjview and MRIcron software for image presentation.Results1.Clinical researchA total of 74 randomized patients were enrolled,and 32 patients in the acupuncture group and 28 patients in the sham acupuncture group were ultimately included in this study.There was no significant difference in demography characteristics and disease characteristics between the two groups(P>0.05),which was comparable.UAS7 score:Intragroup comparison:After 4 weeks of treatment,the UAS7 score of patients in the acupuncture group decreased compared to before treatment(P<0.05),and the UAS7 score of patients in the sham acupuncture group also decreased compared to before treatment(P<0.05).27 patients in the acupuncture group achieved MCID,while 17 patients in the sham acupuncture group achieved MCID.Inter group comparison:From the second week of treatment until the end of follow-up,the UAS7 score of the acupuncture group was lower than that of the sham acupuncture group,and the difference was statistically significant(P<0.05).After 4 weeks of treatment,4 patients in the acupuncture group had no urticaria attacks,6 patients had no urticaria attacks at the end of follow-up,and 1 patient in the sham acupuncture group had no urticaria attacks at the 4th week of follow-up.Wind mass score over the 7 days:After 4 weeks of treatment,the wind mass score of patients in the acupuncture group decreased compared to before treatment(P<0.05),while the wind mass score of patients in the sham acupuncture group decreased compared to before treatment(P<0.05).Inter group comparison:From the second week of treatment until the end of follow-up,the wind mass score of the acupuncture group was lower than that of the sham acupuncture group(P<0.05),and the difference in wind mass score between the acupuncture group and the pre treatment group was greater than that of the sham acupuncture group,with statistical significance(P<0.05).After 4 weeks of treatment,there were 8 patients in the acupuncture group who did not have a wheeze attack,and 1 patient in the sham acupuncture group who did not have a wheeze attack.After the follow-up,10 patients in the acupuncture group did not have any wheal attacks,while 3 patients in the sham acupuncture group did not.Itch score over the past 7 days:After 4 weeks of treatment,the itching score of patients in the acupuncture group decreased compared to before treatment(P<0.05),while the false acupuncture group decreased compared to before treatment(P<0.05).19 patients in the acupuncture group achieved MCID,while 14 patients in the sham acupuncture group achieved MCID.Comparison between groups:After 4 weeks of treatment,the itching score in the acupuncture group was lower than that in the sham acupuncture group(P<0.05).Four patients in the acupuncture group had no itching,while all patients in the sham acupuncture group still had itching.At the end of followup,nine patients in the acupuncture group had no itching,and two patients in the sham acupuncture group had no itching.Cu-Q2ol score:Intragroup comparison:During the treatment and follow-up period,the Cu Q2ol score of the acupuncture group patients at each observation point decreased compared to before treatment(P<0.05),while the Cu-Q2o1 score of the sham acupuncture group patients decreased compared to before treatment(P<0.05)from the fourth week of treatment.Inter group comparison:From the second week of treatment until the end of follow-up,the itching score of the acupuncture group was lower than that of the sham acupuncture group,but the difference was not statistically significant(P>0.05).UCT score:Intragroup comparison:During the treatment and follow-up period,the UCT score of the acupuncture group patients at each observation point increased compared to before treatment(P<0.05),while the UCT score of the sham acupuncture group patients increased compared to before treatment after treatment(P<0.05).Inter group comparison:At the 4th week of treatment and follow-up,the UCT score of the acupuncture group was higher than that of the sham acupuncture group(P<0.05).SAS score:After treatment,the SAS scores of the acupuncture group were compared with those before treatment,and there was no statistically significant difference(P>0.05).After follow-up,the SAS score decreased compared to before treatment(P<0.05).There was no statistically significant difference(P>0.05)in the scores after sham acupuncture treatment and after follow-up compared to before treatment.After treatment,there was no statistically significant difference between the acupuncture group and the sham acupuncture group(P>0.05).SDS score:The SDS score of the acupuncture group showed a downward trend during the treatment and follow-up periods,while the SDS score of the sham acupuncture group decreased during the treatment period and increased during the follow-up period.However,there was no statistically significant difference between the two groups in the scores after treatment and follow-up compared to before treatment(P>0.05).Compared between the two groups,at the 4th week of follow-up,the score of the acupuncture group was lower than that of the sham acupuncture group(P<0.05).ISI score:The ISI scores of the two groups of patients during treatment and followup showed a downward trend,but there was no statistically significant difference compared to the ISI scores before treatment(P>0.05).There was no statistically significant difference between the two groups(P>0.05).Emergency drug consumption:during the treatment period,the antihistamine consumption of patients in both groups showed a downward trend.During the followup period,the antihistamine consumption of patients in the acupuncture group continued to decrease,less than that before treatment(P<0.05).The dosage of patients in the sham acupuncture group increased during the follow-up period.Safety evaluation:2 patients in the acupuncture group developed subcutaneous hemorrhage after acupuncture,1 patient felt acupuncture pain,and the symptoms were relieved after symptomatic treatment,1 patient complained of elbow joint pain during acupuncture treatment,and inquired in detail about the cause of local cold and relief after hot compress.One patient in the sham acupuncture group had acupuncture pain,and no patient in the two groups withdrew from the study due to adverse events.Blind evaluation:At the end of the treatment,the correct rate of the two groups of patients for their own grouping judgment is equal.2.fMRI brain functional imaging researchFCD:Comparison between CSU patients and healthy subjects:Before treatment,the FCD value in the left middle temporal gyrus of CSU patients was lower than that of healthy subjects.After 4 weeks of treatment,there was no statistically significant difference in the FCD value between CSU patients in the acupuncture group,CSU patients in the sham acupuncture group,and healthy subjects.Comparison between the acupuncture group and the sham acupuncture group:Before treatment,there was no statistically significant difference in FCD values between the acupuncture group and the sham acupuncture group;After 4 weeks of treatment,the FCD value of the right orbital superior frontal gyrus in the acupuncture group was higher than that in the sham acupuncture group.ALFF:Comparison between CSU patients and healthy subjects:Before treatment,the ALFF value in the left supplementary motor area of CSU patients was lower than that of healthy subjects;After 4 weeks of treatment,there was no statistically significant difference in ALFF values among CSU patients in the acupuncture group,CSU patients in the sham acupuncture group,and healthy subjects.Comparison between the acupuncture group and the sham acupuncture group:Before treatment,there was no statistically significant difference in ALFF values between the acupuncture group and the sham acupuncture group;After 4 weeks of treatment,there was no statistically significant difference in ALFF values between the acupuncture group and the sham acupuncture group.fALFF:Comparison between CSU patients and healthy subjects:Before treatment,fALFF values in the left medial and lateral cingulate gyrus of CSU patients were higher than those in healthy subjects;After 4 weeks of treatment,there was no statistically significant difference in fALFF values among CSU patients in the acupuncture group,CSU patients in the sham acupuncture group,and healthy subjects.Comparison between the acupuncture group and the sham acupuncture group:Before treatment,there was no statistically significant difference in fALFF values between the acupuncture group and the sham acupuncture group;After 4 weeks of treatment,there was no statistically significant difference in fALFF values between the acupuncture group and the sham acupuncture group.ReHo:Comparison between CSU patients and healthy subjects:Before treatment,the ReHo values in the right middle frontal gyrus of CSU patients decreased compared to healthy subjects,while the ReHo values in the medial and paracingulate gyrus increased compared to healthy subjects;After 4 weeks of treatment,there was no statistically significant difference in ReHo values among CSU patients in the acupuncture group,CSU patients in the sham acupuncture group,and healthy subjects.Comparison between the acupuncture group and the sham acupuncture group:Before treatment,there was no statistically significant difference in ReHo values between the acupuncture group and the sham acupuncture group;After 4 weeks of treatment,there was no statistically significant difference in ReHo values between the acupuncture group and the sham acupuncture group.Conclusions1."Acupuncture treatment with the methods of calming the heart,calming the nerves,and dispersing wind and nourishing blood can alleviate the symptoms of CSU wind and itching,with the characteristics of rapid onset and lasting action time.It can reduce the dosage of antihistamines and reduce recurrence.".2.CSU patients may have abnormal brain function in the supplementary motor area,medial and paracingulate gyrus,and middle temporal gyrus.Acupuncture may improve brain function by activating the supraorbital frontal gyrus.
Keywords/Search Tags:chronic spontaneous urticaria, acupuncture, sham acupuncture, fMRI, Brain functional imaging
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