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Background. In the past, moxibustion has been widely used to treat endocrine system disorders, but evidence of its effectiveness is scarce at this point. The aim of this multicenter, randomized, controlled trial is to evaluate the efficacy and safety of treating menopausal obesity with moxibustion. Methods/Design. There are six centers taking part in this randomized, controlled, parallel trial. A total of 216 patients with menopausal obesity will be randomly divided into two equal groups: the "moxibustion for harmonization of Yin and Yang" group and the gentle moxibustion group. A 12-week study period with moxibustion will be preceded by a 1-week baseline, followed by a 12-week follow-up. We will conduct an interim analysis to determine whether or not the treatment is efficacious and safe after 216 participants have completed a 12-week treatment period. Evaluations will be conducted at weeks 0, 4, 8, 12, 18, and 24. The main outcome is waist circumference (WC), and the rate of WC reduction will be compared to the baseline. An intention-to-treat analysis will be performed with a two-sided P value of <0.05 considered significant. Participants who withdraw from the trial will be analyzed according to the intention-to-treat formula (ITT). Discussion. These results will be used to support selecting the right moxibustion prescription and guiding the improvement of clinical efficacy. This trial will provide convincing evidence of moxibustion's effectiveness and safety in the treatment of obesity by "moxibustion for harmonization of Yin and Yang," which will be conducive to the promotion and clinical application of the theory of "moxibustion for harmonization of Yin and Yang." Trial Registration. This trial is registered with Clinical Trials.gov: NCT04943705 (registered on June 27, 2021).
RESUMO
OBJECTIVE: To observe the effect of electroacupuncture (EA) on expression of eukaryotic initiation factor 2α (EIF2α), activating transcription factor 4 (ATF4), glucose regulator protein-78 / immunoglobulin heavy-chain-binding protein (GRP78/Bip) in the substantia nigra (SN) in rats with Parkinson's disease (PD), so as to explore its mechanism underlying improvement of PD. METHODS: Forty-eight male SD rats were randomly divided into control, sham-operation, model and EA groups (n=12 in each group). The PD model was established by 28-day consecutive subcutaneous injection of rotenone (1 mg/kg dissolved in dimethyl sulfoxide and normal saline) at the back shoulder. EA (2 Hz, 1 mA) was applied to "Fengfu" (GV16) and "Taichong" (LR3) for 30 min, once daily for 2 weeks. The behavio-ral changes of rats in each group were measured and scored at 28th day and 44th day, respectively. The expressions of tyrosine hydroxylase (TH) and α-synuclein (α-syn) in the SN were observed by immunohistochemistry, and the expressions of EIF2α, ATF4 and GRP78/Bip were detected by Western blot. RESULTS: Following modeling and compared with the control and sham-operation groups, the behavioral scores of rats in the model group were elevated (P<0.01), which were significantly decreased by EA intervention (P<0.01). The expression of TH decreased whereas the α-syn, EIF2α, ATF4 and GRP78/Bip increased in the rats of model group, and EA intervention reversed these changes (all P<0.01). CONCLUSION: EA at GV16 and LR3 can improve PD rats' behavioral changes, which is probably related with its effects in up-regulating the expression of TH in the SN and down-regulating the expression of α-syn and EIF2α-ATF4-GRP78/Bip signaling.
Assuntos
Eletroacupuntura , Doença de Parkinson , Fator 4 Ativador da Transcrição , Animais , Masculino , Doença de Parkinson/terapia , Ratos , Ratos Sprague-Dawley , Substância NegraRESUMO
OBJECTIVE: To observe the effect of electroacupuncture (EA) on behavioral changes, and expression of tyrosine hydroxylase (TH), α-synuclein(α-syn), transcription activating factor 6 (ATF6) and transcription factor X box binding protein 1 (XBP-1) in the substantia nigra of Parkinson's disease (PD) rats, so as to explore its mechanisms underlying improvement of motor function. METHODS: Thirty-six male SD rats were randomly divided into control, model and EA groups (n=12 rats in each group). The PD model was established by subcutaneous injection of rotenone (2 mg/kg) at the neck and back, once a day for 28 days. EA (2 Hz, 1 mA) was applied to "Fengfu" (GV16) and bilateral "Taichong" (LR3) for 20 min, once a day for 14 successive days. The voluntary motor behavioral changes (total distance, average speed, total movement time, total rest time in 8 min) were detected by open field tests. The immuno-activity of TH and α-syn in the substantia nigra was detected by immunohistochemistry, and the expression of ATF6 mRNA and XBP-1 mRNA detected by fluorescence real-time quantitative PCR. RESULTS: Following modeling and compared with the control group, the total distance, average speed and total movement time of voluntary movement were significantly decreased (P<0.01), and the total rest time was significantly increased (P<0.01). Moreover, the expression of TH was significantly decreased (P<0.01), and that of α-syn protein, ATF6 mRNA and XBP-1 mRNA significantly increased in the model group in comparison with the control group (P<0.01). After the intervention, the total distance, average speed, and total movement time of voluntary movement in the EA group were considerably higher than those in the model group (P<0.01), and the total rest time was obviously decreased in the EA group (P<0.01). The expression level of TH was significantly increased (P<0.01), and those of α-syn, ATF6 mRNA and XBP-1 mRNA were notably decreased in the EA group compared with the model group (P<0.01). CONCLUSION: EA intervention can improve the locomotor function in PD model rats, which is associated with its functions in up-regulating the expression of TH protein and down-regulating the expression of α-syn protein, and ATF6 mRNA and XBP-1 mRNA in the substantia nigra of mesencephalon.