Cerebral mechanism of puncturing at He-Mu point combination for functional dyspepsia: study protocol for a randomized controlled parallel trial

Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlying mechanisms remain unclear. Therefore, a randomized controlled parallel clinical trial is currently underway at Chengdu University of Traditional Chinese Medicine, China. This trial is designed to explore the efficacy of and central responses to the He-Mu point combination in patients with functional dyspepsia using functional magnetic resonance imaging. A total of 105 patients with functional dyspepsia will be allocated into 3 groups： the low-He point group（puncturing at Zusanli（ST36））, Mu point group（puncturing at Zhongwan（CV12））, and He-Mu point combination group（puncturing at ST36 and CV12）. Every participant will receive 20 sessions of manual acupuncture for 4 weeks. The needles will be inserted perpendicularly to a depth of 1 to 2 cun. The angle of rotation and twisting will range from 90 to 180 degrees, while lifting and thrusting will range from 0.3 to 0.5 cm. The various manipulations will be performed 60 to 90 times per minute. The needles will remain in place for 30 minutes, during which manipulation will be applied every 10 minutes. Magnetic resonance imaging will be performed before and after 20 sessions of acupuncture. The primary outcome is symptom improvement according to the Chinese version of the Nepean Dyspepsia Index. Secondary outcomes include the Leeds dyspepsia questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Beck Anxiety Inventory, Beck Depression Inventory, and visual analogue scale scores before and after 10 and 20 sessions of acupuncture. Needle sensation and adverse events will be used to assess the therapeutic effects. This study will promote more widespread awareness of the benefits of acupoint combination in the clinical setting and provide a further explanation of the neuromechanism by which acupuncture at the He-Mu point combination for functional dyspepsia. Registration： Chinese Clinical Trial Registry, Chi CTR-IOR-15006402.

Changed ACC-DMN functional connectivity after acupuncture with deqi for functional dyspepsia treatment

Objective:To clarify altered whole brain functional connectivity of the anterior cingulate cortex(ACC)in functional dyspepsia(FD)patients,and then to explore cerebral influence of acupuncture with deqi treating for FD.Methods:Thirty-two FD patients and 35 healthy subjects(HS)were firstly scanned by the resting-state blood oxygenation level-dependent functional magnetic resonance imaging(BOLD-fMRI)to compare differences of ACC-based functional connectivity(FC).Then 32 FD patients were randomized to receive 20 sessions’acupuncture treatment with(n=16)and without deqi(n=16),as well as underwent functional magnetic resonance imaging(fMRI)scans after treatment.After group re-division according to deqi response,changes of ACC subregions-based resting-state FC(rsFC)were compared between the actual with and without deqi group.Two seeds with bilateral of each were selected as regions of interest(ROIs)of the ACC,including two from the dorsal ACC:S2(BA24)(x=±5,y=2,z=46,r=3.5 mm)and two from the pregenual ACC:17(BA24)(x=±5,y=38,z=6,r=3.5 mm).The clinical changes of the Nepean Dyspepsia Index(NDI)that measuring symptoms and quality of life(QOL)were also used to further assess the correlation with ACC subregions rsFC in FD patients.Results:Compared to HS,FD patients showed significantly increased ACC subregions rsFC with left fusiform gyrus,temporal cortex,hippocampus(HIPP)/amygdala,temporal pole,and right INS,superior occipital gyrus,and bilateral precuneus,superior parietal lobule(SPL),and decreased rsFC with left postcentral/precentral gyrus(PoG/PrG),supplementary motor area(SMA)and right cerebellum.32 FD patients which were then re-divided into the actual deqi group(n=16)and actual without deqi group(n=16).The decrease of the NDI symptom score(pre-pos)in the actual deqi group was significantly greater than that in the actual without deqi group(P<0.05).Among the two groups,the actual deqi group showed increased ACC subregions rsFC with right SMA and bilateral PrG/PoG,and decreased rsFC with right precuneus,middle occipital gyrus,bilateral posterior cingulate cortex(PCC),HIPP/paraHIPP,angular gyrus and SPL after treatment.In addition,the changed NDI QOL scores(pre-post)of the actual deqi group was significantly positively correlated with their Fisher’s transformed Z value of the altered ACC subregion(left I7)rsFC with right SPL(r=-0.597,P=0.04<0.05,FDR corrected P>0.05).Conclusion:The results tested the hypothesis that the advantage of deqi on efficacy is related to affecting the ACC subregions rsFC.It suggested that deqi might participate in the adaptive modulation of disrupted relationship between the ACC subregions and the default mode network(DMN).