Efficacy of thunder-fire moxibustion in treating ankylosing spondylitis of kidney deficiency and governor meridian cold and its influence on TNF-α and RANKL: study protocol for a prospective, nonblinded, single-center, randomized controlled trial.

BACKGROUND: Ankylosing spondylitis (AS) is a common chronic inflammatory spondyloarthropathy. It is considered in traditional Chinese medicine (TCM) that the pathogenesis of AS is mainly due to Yang deficiency of kidney governor meridian and internal prosperity of cold evil. Thunder-fire moxibustion is a kind of moxibustion that is characterized in abundance in drug composition, high heat radiation, and strong penetration. Thunder-fire moxibustion on the spinal segment of the governor meridian in treating AS seems compatible with the main pathogenesis of kidney deficiency and governor meridian cold. The trial aims to explore the efficacy of thunder-fire moxibustion in patients with AS of kidney deficiency and governor meridian cold and its influence on bone metabolism, through a prospective randomized trial. METHODS: Sixty patients with AS of kidney deficiency and governor meridian cold will be recruited and randomly assigned to the treatment group (thunder-fire moxibustion three times a week plus basic treatment) and the control group (basic treatment) at the Center of TCM of Beijing Luhe Hospital Affiliated to Capital Medical University (Beijing, China). Each patient will be treated for 4 weeks. The primary outcome is the efficacy of TCM syndrome, and the secondary outcome indexes will include the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Short-Form-36 Questionnaire (SF-36), tumor necrosis factor-α (TNF-α), and receptor activator of nuclear factor-κB ligand (RANKL). TNF-α and RANKL with observation will be determined once respectively before and after treatment, while the other indexes will be observed once prior to the treatment, 2 weeks post-treatment, and at the end of the treatment. Side effects will be recorded and analyzed as well. Inter-group comparison and analysis will be performed based on the intention-to-treat set and per-protocol set. DISCUSSION: This prospective randomized trial will help verify the efficacy of thunder-fire moxibustion in treating AS of kidney deficiency and governor meridian cold, discuss preliminarily its mechanism in treating this disease, and provide high-quality evidences for scientific researches on clinical treatment with thunder-fire moxibustion against AS. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100044227 . Registered on 12 March 2021.

Evaluation of Modified Youguiwan and Governor Meridian Moxibustion in Treatment of Erectile Dysfunction of Renal Yang Deficiency Type and Its Influence on Sex Hormone Level and Penile Hemodynamics / 中国实验方剂学杂志

ObjectiveTo observe the clinical effect of governor meridian moxibustion combined with modified Youguiwan in treating erectile dysfunction of kidney Yang deficiency type and its influence on the level of sex hormones and penile hemodynamics. MethodA total of 120 patients were randomized into the control group （60 cases in total， 3 dropouts/lost to follow-ups， 57 finally included） and treatment group （60 cases in total， 2 dropouts/lost to follow-ups， 58 finally included） with the random number table method. Both groups received governor meridian moxibustion （1 time/w， a total of 4 times）. In addition， the control group took oral compound Xuanju capsule （3 capsules/time， 3 times/d）， and the treatment group was given Jiawei Youguiwan （Chinese medicine decoction， 1 dose/d）. The administration lasted 4 weeks for both groups. The scores of 5th edition international index of erectile function （IIEF-5）， erection quality scale （EQS）， and erectile hardness score （EHS）， traditional Chinese medicine （TCM） syndrome score， levels of sex hormones ［testosterone （T）， follicle-stimulating hormone （FSH）， luteinizing hormone （LH）， prolactin （PRL）］， and parameters of penile hemodynamics ［peak systolic velocity （PSV）， end-diastolic volume （EDV）， and resistance index （RI）］ were recorded. ResultAfter treatment， the total effective rate was 87.93% （51/58） in the treatment group， higher than the 71.93% （41/57） in the control group （χ2=4.600 3， P<0.05）. After treatment， compared with before treatment，the treatment group registered increase in the scores of IIEF-5， EQS， and EHS （P<0.01）， decrease in TCM syndrome score （P<0.01）， rise of serum T level （P<0.05）， reduction in the levels of FSH， LH， and PRL （P<0.05）， increase in the levels of PSV and RI （P<0.05）， and down-regulation of EDV level （P<0.05）. ConclusionGovernor meridian moxibustion combined with modified Youguiwan can effectively improve the penile erectile function， erectile hardness， and erection quality， and relieve the clinical symptoms of erectile dysfunction patients of kidney Yang deficiency type.

Effect of Xiao Xumingtang Combined with Ultra-acupuncture Along Governor Meridian on Autophagy-related Protein NF-κB p65 in Cerebral Ischemia Reperfusion Model / 中国实验方剂学杂志

Objective:To investigate the effect of Xiao Xumingtang combined with super-acupuncture along governor meridian on autophagy-related protein nuclear factor-kappa B p65 (NF-κB p65) in cerebral ischemia-reperfusion model rats, so as to study the relationship between autophagy-related protein NF-κB p65 and brain protection mechanism, and look for the best intervention time point of acupuncture. Method:A total of 152 adult SD male rats were randomly divided into sham operation group, model group, high-dose Xiao Xumingtang group (high-dose drug group), low-dose Xiao Xumingtang group (low-dose drug group) and acupuncture group. There were seven groups including high-dose Xiao Xumingtang + acupuncture group (high acupuncture group) and low-dose Xiao Xumingtang + acupuncture (low acupuncture group). Model group, high-dose drug group, low-dose drug group, and acupuncture group were divided into 4 subgroups according to 30 minutes, 2, 4， 6 h of ischemia-reperfusion, with 6 animals in each group. After successful modeling, according to Zea Longa's neural function score, eligible rats were included into the corresponding groups. The sham operation group only received carotid artery dissection, the model group was only modeled without any treatment, high and low-dose Xiao Xumingtang groups were calculated based on the body surface area of the animal and given 60 g·kg-1·d-1 and 15 g·kg-1·d-1 drug by gavage for treatment, acupuncture was performed to smooth governor meridian and regulate the mind. After 14 days of consecutive treatment, neurological function was scored. Western blot was used to detect the expression of autophagy-related protein NF-κB p65 in rat brain tissue. Result:Compared with the sham operation group, the neurological impairment scores of the model group, the high-dose drug group, the low-dose drug group, the acupuncture group, the high acupuncture group, and the low acupuncture group were significantly increased at each time point (P<0.01). The neurological impairment scores were significantly lower at each time point than those of the high-dose drug group, low-dose drug group, acupuncture group, high acupuncture group, and low acupuncture group (P<0.01), compared with the sham operation group, NF-κB p65 in model group, high-dose drug group, low-dose group, acupuncture group, high acupuncture group and low acupuncture group was significantly increased in the brain tissue at each time point (P<0.01), compared with the model group, the expression of NF-κB p65 protein in the brain tissue of model group, high-dose drug group, low-dose group, acupuncture group, high acupuncture group and low acupuncture group was decreased at each time point (P<0.05), particular in the high acupuncture group (P<0.01). Conclusion:Xiao Xumingtang combined with ultra-early acupuncture along governor meridian can significantly alleviate neurological impairment in rats with cerebral ischemia-reperfusion model. Xiao Xumingtang combined with ultra-early acupuncture along governor meridian can inhibit cerebral ischemia-reperfusion model rats. The activity of autophagy-related protein NF-κB P65 protects the brain function. There is no significant difference in the brain protective effect of Xiao Xumingtang combined with ultra-early acupuncture along governor meridian within 6 hours.

Clinical Efficacy of 30 Cases about Filiform-fire Needle Combined with Abdominal Acupuncture Therapy in Ankylosing Spondylitis / 浙江中医药大学学报

[Objective] To observe the clinical effects of filiform-fire needle combined with abdominal acupuncture in treating ankylosing spondylitis(cold-dampness syndrome). [Methods] Sixty patients who met the criteria of AS were included in the study. They were randomly divided into treatment group and control group for 30 patients in each group. The patients of control group were treated with Diclofenac sodium sustained -release tablet and Salazosul-fpyridine intestinal solution, while treatment group were treated with filiform-fire needle combined with abdominal acupuncture on the basis of western medicine mentioned above.All patients were treated and observed for three months, and they were evaluated by score of TCM symptoms, thoracic activity, spinal activity, finger-floor distance, pillow-wall distance and blood parameters, such as C-reactive Protein(CRP), Erythrocyte Sedimentation Rate (ESR)and Immune Globulin A(IgA). [Results] The total effective rate in treatment group was higher than that in control group(P＜0.05).After treatment, the two groups all got lower scores of TCM symptoms than before, and the scores of the treatment group were significantly lower than the control group(P＜0.05).The thoracic activity, spinal activity, finger-floor distance and pillow-wall distance of all patients improved in varying degrees, and the blood parameters of CRP, ESR and IgA decreased compared with that before treatment, and significantly the treatment group was superior to control group(P＜0.05).[Conclusion] The filiform-fire needle combined with abdominal acupuncture can effectively relieve pain, improve functional activity of the spine and peripheral joints, reduce inflammation, slow disease progression and raise the quality of life of the patients.