PMC:4875991 / 15996-22712 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/4875991","sourcedb":"PMC","sourceid":"4875991","source_url":"https://www.ncbi.nlm.nih.gov/pmc/4875991","text":"4.2. The Selection of Participants\nThe rigorous inclusion and exclusion criteria, as important guaranty for the homogeneity of the participants, are of great significance in the quality control of clinical trial.\n\n4.2.1. Classification of Participants\nThis study indicated that the majority of neuroimaging studies (72.78%) were performed on healthy subjects. It might be a reason for the inconsistent results. Because the traditional Chinese acupuncture theory holds that acupuncture treatment focuses on strengthening the body resistance to removing pathogenic factors and restoring the balance of Yin and Yang, the efficacy of acupuncture treatment is specific to the pathological conditions (imbalance of Yin and Yang), not the physiological state (Yin and Yang in equilibrium). So during the pathological conditions, the actions of acupoints are disease-oriented, while in the physiological state, the acupoint keeps in silence and the actions of acupoints lack orientation. In this case, patient is the better choice for acupuncture-neuroimaging studies.\nIn this study, we found that there was a preponderance of nervous system disorders such as stroke among the diseases involved in acupuncture-neuroimaging studies. The result indicated that acupuncture stimulation promoted the action of neural rehabilitation and its mechanism is a focus of acupuncture study. Furthermore, we noticed that some studies were performed on functional disorders such as functional dyspepsia and irritable bowel syndrome [65, 101]. As we know, regulating functional disorder is the advantage of acupuncture, so functional disorder might be a new approach in future studies.\nMoreover, the subtypes of a disease should be taken into consideration when you choose patients as the participants in neuroimaging study for the patients with different subtypes might have functional or/and structural differences in brain. For example, schizophrenic subjects with predominantly negative symptoms have greater metabolic abnormalities than subjects with predominantly positive symptoms [181]. So, in acupuncture-neuroimaging study, it is better to choose the same subtype of a disease to ensure the homogeneity of participants.\n\n4.2.2. Demographic Characteristics of Participants\nSome demographic characteristics of participants including age, gender, race, and handedness should be defined in the inclusion criteria.\nThe changes of cerebral function and structure come with age. Some studies indicated that the cerebral glucose metabolism decreased unevenly and brain tissues began aging after 40 years old [182, 183]. Older age directly correlated with reduced gray matter volume in bilateral rostral and right dorsal ACC [184]. So the age range of participants should not be ignored in neuroimaging studies. However we found that most of these studies (101 studies) described the age range of participants, that the average age range of healthy subjects was 18.3 years old, and that the average age range of patients was 29 years old. Even in some studies, the age range was more than 50 years old. It is better to keep the age range within 20 years to reduce the effect of outlier.\nThe functional and structural differences in human brain induced by handedness have long been investigated [185–188], although the mechanism remains unclear. So the majority of the current studies (137 studies) choose right-hand participants.\nFurthermore, gender differences of the human brain are an important issue in neuroimaging studies. It has been identified that gender has significant influence on the regional neuronal activity [189, 190] and brain structure [191]. Race differences may lead to differences of brain function and structure. For example, it is reported that brain size varies by race [192]. In this study, we found that 14 studies (8.33%) described and restricted the race of the participants. Taking gender and race as covariates is needed when designing acupuncture-neuroimaging experiments.\n\n4.2.3. Emotional State\nThe psychological factors have significant influence on the function and structure of human brain. For example, Drevets et al. have found an area of abnormally decreased activity in the prefrontal cortex ventral to the genu of the corpus callosum in both unipolar depressives and bipolar depressives [193]. Our study shows that only 4 articles described the psychological assessment performed on the participants; more attention should be paid to the emotional state of subjects during the inclusion and data analysis in future studies, except for the study which focuses on the mechanism of acupuncture treating for psychological disorders.\nFurthermore, our study demonstrated that participants with claustrophobia have been excluded in 9 studies. Claustrophobia is a phobic disorder which will cause panic, fear, or anxiety in the confined space. Scanning cannot be accomplished when it is performed on a participant with claustrophobia. So the participants with claustrophobia should be excluded in acupuncture-neuroimaging studies.\n\n4.2.4. Menstrual Period\nIn this study, we found that female participants were involved in 145 studies. Recently, some studies performed on healthy subjects indicated the cerebral functional and structural changes in menstrual period. For example, Veldhuijzen et al. [194] found that the pain-related cerebral activation varied significantly across the menstrual cycle. Hagemann et al. [195] found a significant gray matter volume peak and cerebral spinal fluid loss at the time of ovulation in females. So, for female participants, scanning should be performed during the same physiological period to avoid the possible changes in brain size and activity in menstrual cycles.\n\n4.2.5. Accompanying Symptoms/Disorders\nThe accompanying symptoms/disorders such as head trauma, pain (including headache and dysmenorrhea), and insomnia should be excluded as possible as we could considering their influence on the neuroimaging data. Tu et al. [196, 197] found that abnormal gray matter volume changes are presented in primary dysmenorrhea patients even in the absence of pain. Furthermore, some investigators held that blood coagulation disorders should be excluded in acupuncture studies [6].\n\n4.2.6. Acupuncture Experience\nSome studies have reported the significant differences in cerebral response between the participant with acupuncture experience and the participant without acupuncture experience [198]. In our study, we found that participants in 44.04% of the studies were acupuncture naive. To ensure the consistency of the baseline of the participants and the comparability of consequence, the acupuncture experience of participants should be taken into 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