| ObjectiveThis study focused on patients with psychogenic erectile dysfunction(PED).A randomized,controlled clinical trial was conducted to investigate the clinical efficacy of acupuncture on the liver meridian in the treatment of PED.Based on blood oxygen level dependent-functional magnetic resonance imaging(BOLD-f MRI)technology,fractional amplitude of low-frequency fluctuation(f ALFF)and functional connection(FC)data analysis methods were used jointly to further explore the central response characteristics of acupuncture on the liver meridian for PED and provide research basis for further clarifying the clinical efficacy and mechanisms of acupuncture treatment of PED.Methods1.Clinical studyA randomized controlled trial was be applied.Eighty PED subjects who met the requirements were randomly divided into acupuncture and sham acupuncture groups.The acupuncture group was treated with electro-acupuncture,taking bilateral Taichong(LR3),Ligou(LR5),Ququan(LR8),and Jimai(LR12),while the sham acupuncture group was treated with sham electro-acupuncture,taking four non-meridian and non-acupoint points on the lateral heel,lateral calf and lateral thigh bilaterally.The study period was 21 weeks,with a baseline period of 1 week,a treatment period of 8 weeks,and a follow-up period of 12 weeks.Both groups were treated 3 times a week for 30 minutes,once every other day,with 2days off at the weekend,for a total of 24 treatments.The primary outcome indicator was the Five-Item International Index of Erectile Function(IIEF-5),and secondary outcome measures included the Erectile Function Domain of the International Questionnaire of Erectile Function(IIEF-EF),the Erection Quality Scale(EQS),the Self-Rating Anxiety Scale(SAS),the Self-Rating Depression Scale(SDS),Pittsburgh Sleep Quality Index(PSQI),self-evaluation of efficacy and safety evaluation.The therapeutic effects of acupuncture for PED were observed through inter-group and intra-group comparisons between the two groups at different time points.2.Mechanism study(1)Patients with PED in this part were from the Part 1 clinical trial and met this part inclusion criteria,and 26 healthy subjects matched for gender,age,years of education,and handedness of PED subjects were recruited.Clinical indicators and resting-state BOLD-f MRI brain imaging data were collected at baseline from PED patients and healthy subjects.Differential brain regions of spontaneous neural activity in PED patients and healthy subjects were obtained by applying the f ALFF analysis method.From these,seed points were then selected for subsequent whole-brain FC to obtain differences in the functional network connection strength between PED patients and healthy subjects.Finally,correlations of clinical indicators with spontaneous neural activity and functional network connection strength in PED subjects was analyzed.(2)The 40 patients with PED were divided into two groups,20 in the acupuncture group and 20 in the sham acupuncture group.Intervention method and treatment period were the same as part 1 clinical trial.Clinical indicators and brain imaging data were collected at enrollment and at 8th week of treatment.The intra-group and inter-group differences in f ALFF and FC between the two groups were analyzed and correlated with clinical indicators.Results1.Clinical study(1)A total of 80 PED patients were included in this study,of which 2 cases in the sham acupuncture group were excluded because the subjects were treated <3 times,and finally 78 patients with PED were included in the analysis,including 41 cases in the acupuncture group and 37 cases in the sham acupuncture group.(2)IIEF-5: Compared with the baseline period,the IIEF-5 score tended to increase in the acupuncture and sham acupuncture groups.During the treatment phase,the improvement of IIEF-5 scores was significantly better in the acupuncture group than in the sham acupuncture group,and the difference was statistically significant(P<0.05).During the follow-up phase,the improvement of IIEF-5 scores was better in the acupuncture group than in the sham acupuncture group,but the difference was not statistically significant(P>0.05).(3)IIEF-EF: At 8th week after enrollment,there were 31(75.61%)and 21(56.76%)subjects who showed clinically significant improvement in the acupuncture group and sham acupuncture group(P>0.05).At 20 th week,30(73.17%)and 21(56.76%)subjects who showed clinically significant improvement in the two groups(P>0.05).(4)EQS: Compared with the baseline period,the EQS scores of acupuncture group and sham acupuncture group showed an overall increasing trend(P<0.05).During the treatment phase,the trend of improvement in EQS scores was better in the acupuncture group than in the sham acupuncture group,especially at 8th week(P<0.05).During the follow-up phase,the improvement of EQS scores was better in the acupuncture group than in the sham acupuncture group,but the difference was not statistically significant(P>0.05).At 8th week,there were 28(68.29%)and 18(48.65%)subjects who showed clinically significant improvement in the acupuncture group and sham acupuncture group(P>0.05).At 20 th week,24(58.54%)and 20(54.05%)subjects who showed clinically significant improvement in the acupuncture group and sham acupuncture group(P>0.05).(5)SAS: Compared with the baseline period,SAS scores were significantly lower in the acupuncture and sham acupuncture groups(P<0.05).During the treatment phase,the improvement of SAS score in the acupuncture group was better than that in the sham acupuncture group,especially at 8th week(P<0.05).At the follow-up stage,the improvement of the two groups were comparable,and the difference was not statistically significant(P>0.05).(6)SDS: Compared with the baseline period,SDS scores were significantly lower in the acupuncture and sham acupuncture groups from week 8 onward(P<0.05).During the treatment phase,the improvement of SDS scores in the acupuncture group was better than that in the sham acupuncture group,especially at 8th week(P<0.05).At the follow-up stage,the improvement value of SDS scores was higher in the acupuncture group,but the difference was not statistically significant(P>0.05).(7)PQSI: There was no significant improvement in PQSI scores in the acupuncture and sham acupuncture groups compared with the baseline period(P>0.05).During the treatment phase and follow-up phase,the improvement between the two groups were comparable,and the differences were not statistically significant(P>0.05).2.Central mechanismForty patients with PED were included.3 patients were excluded due to excessive head movement and poor alignment quality.37 patients with PED(19 in the acupuncture group and 18 in the sham acupuncture group)and 26 healthy subjects were included in the analysis.(1)Characteristics of functional brain activity in PED subjectsThe baseline data for PED patients and healthy subjects were balanced and comparable(P>0.05).The differences in baseline IIEF-5,EQS,SAS,SDS and PQSI scores between the two groups were statistically significant(P<0.05).fALFF: Brain regions with increased f ALFF in PED patients compared to healthy subjects included: left cerebellar area 6(BA18),perirhinal cortex(BA17),middle occipital gyrus,right inferior occipital gyrus(BA18),superior frontal gyrus,precentral gyrus(BA6),middle temporal gyrus(BA37),and bilateral superior occipital gyrus(BA19＿L and BA19＿R).Brain region with reduced f ALFF in patients with PED included left inferior frontal gyrus of the orbit(BA47).Among them,increased f ALFF in the right superior frontal gyrus was negatively correlated with IIEF-5(r=-0.388,P=0.018),increased f ALFF in the left cerebellar area 6 was negatively correlated with IIEF-5(r=-0.333,P=0.044),increased f ALFF in the left perisylvian fissure cortex was positively correlated with SDS(r=0.357,P=0.030),and decreased f ALFF in the left inferior orbital frontal gyrus was positively correlated with the IIEF-5(r=0.396,P=0.015).FC: The left inferior orbital frontal gyrus(BA47)was selected as the seed point for whole-brain FC.Compared to healthy subjects,brain regions with reduced FC in PED patients included: left fusiform gyrus(BA18),lingual gyrus(BA18),right inferior temporal gyrus(BA20),bilateral middle temporal gyrus(BA37＿L and BA137＿R),and postcentral gyrus(BA43＿L and BA4＿R).There were no brain regions with enhanced FC in PED patients.Reduced FC in the left postcentral gyrus was positively correlated with EQS scores in patients with PED(r=0.381,P=0.020),and reduced FC in the right postcentral gyrus was positively correlated with EQS scores(r=0.418,P=0.010).(2)Study on the central response characteristics of acupuncture for PEDThe baseline data of the acupuncture group and sham acupuncture group were balanced and comparable(P>0.05).At 8th week,IIEF-5,EQS,SAS and SDS scores were significantly improved in the acupuncture group and sham acupuncture group compared to pre-treatment,and the difference was statistically significant(P<0.05).The improvement of IIEF-5 and SAS scores in the acupuncture group was better than that in the sham acupuncture group,with statistically significant differences(P<0.05).fALFF: Compared with the baseline period,the brain areas with increased f ALFF in the acupuncture group after treatment included: left middle temporal gyrus(BA38),inferior frontal gyrus of the orbit(BA47),middle occipital gyrus,and right cerebellar area 4-5(BA37).The brain areas with reduced f ALFF included: left triangular inferior frontal gyrus(BA45),anterior cingulate gyrus(BA24),middle cingulate gyrus,middle occipital gyrus(BA19),right supplementary motor area,superior frontal gyrus(BA10),middle frontal gyrus(BA46),postcentral gyrus,inferior parietal gyrus(BA7),bilateral posterior cingulate gyrus(BA26＿L and BA23＿R),orbital middle frontal gyrus.Increased f ALFF in the left inferior frontal gyrus of the orbit was positively correlated with improved IIEF-5 values(r=0.475,P=0.040),decreased f ALFF in the right superior frontal gyrus was positively correlated with improved SAS values(r=0.550,P=0.015),and decreased f ALFF in the left middle occipital gyrus was negatively correlated with improved IIEF-5 values(r=-0.521,P=0.022).Compared with the baseline period,brain areas with increased f ALFF in the sham acupuncture group after treatment included: left postcentral gyrus(BA48),right superior temporal gyrus(BA48),medial superior frontal gyrus(BA8),and bilateral middle temporal gyrus(BA21＿L and BA21＿R).The brain areas with reduced f ALFF included: left middle frontal gyrus,right cerebellar Crus 1,precuneus,precentral gyrus(BA6),superior frontal gyrus,and bilateral inferior parietal gyrus(BA48＿L and BA40＿R).The reduced f ALFF in the right superior frontal gyrus was negatively correlated with the improved EQS values(r=-0.470,P=0.049).Compared with the sham acupuncture group,f ALFF was increased in the left cerebellar area 6(BA18)and decreased in the left postcentral gyrus(BA48)and inferior parietal gyrus(BA5)in the acupuncture group,but no correlation with clinical indices was found.FC: Taking the left inferior frontal gyrus of the orbit(BA47)as seed point,the brain areas with enhanced FC after treatment in the acupuncture group included: left postcentral gyrus(BA48)and middle frontal gyrus(BA9),and right middle occipital gyrus(BA19).The brain region with weakened FC included left insula(BA48).Enhanced FC in the left postcentral gyrus in the acupuncture group was positively correlated with the improvement values of IIEF-5 and EQS(r=0.479,P=0.038;r=0.474,P=0.040)and negatively correlated with the improvement values of PQSI(r=-0.611,P=0.005).Brain area with increased FC after treatment in the sham acupuncture group included left precuneus.Brain regions with reduced FC included: left insula(BA48),superior frontal gyrus(BA10),and right superior temporal gyrus(BA48).Decreased FC in the right superior frontal gyrus after treatment in the sham acupuncture group was positively correlated with the improvement of SDS(r=0.474,P=0.047).Compared with the sham acupuncture group,the FC between left inferior orbital frontal gyrus and left middle temporal gyrus was increased after treatment in the acupuncture group,but no correlation with clinical indices was found.Conclusion1.The preliminary results of the study showed that the clinical effect of acupuncture of liver meridian points for PED is better than that of shallow acupuncture of non-meridian non-acupuncture points.2.Functional abnormalities in cognitive and emotion-related brain regions may be important central pathological features of PED.The left inferior frontal gyrus of the orbit may be a key brain region for central pathological changes in PED.3.Part of the central response to acupuncture on liver meridian points for PED may be characterized by regulating function of cognitive and emotional brain areas associated with PED.4.The left inferior frontal gyrus of the orbit may be the key brain area of acupuncture on the liver meridian points for PED. |
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