Ma's Bamboo-Based Medicinal Moxibustion Therapy of Low Back Pain in Lumbar Disc Herniation: Study Protocol for a Randomized Controlled Trial

Background Lumbar disc herniation (LDH) is a common and frequently-occurring disease in clinic. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma's bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. Methods/design: The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma's bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156).Patients in each group will receive treatment every day,6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analogue scale(VAS)at baseline, after 6 times of treatment,the end of treatment, and follow-up. the secondary outcomes will include Oswestry disability indexes (ODI) ,modified Japanese Orthopaedic Association low back pain (M-JOA) score,serum β-endorphin (β-EP) and serum substance P (SP). β-EP and SP as well as safety evaluation indexes (routine blood test, liver and kidney function, and ECG) will be measure at baseline and after the end of treatment. Discussion The results of the trial will compare the efficacy on low back pain in LDH between Ma's bamboo-based medicinal moxibustion group and acupuncture group and will be expected to make a systematic and objective evaluation on the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy. Trial registration: ChiCTR, ChiCTR2000038725. Registered on 29 September 2020.

The Effects of Moxibustion on PD-1/PD-L1-Related Molecular Expression and Inflammatory Cytokine Levels in RA Rats

Objective. Rheumatoid arthritis (RA) is an autoimmune disease that starts with inflammation of the synovium. The pain and joint dysfunction caused by RA urgently need an effective treatment to alleviate the inflammatory reaction and delay the progression of the disease. The pathological damage of RA is proposed to associate with the dysfunction of the programmed cell death 1/programmed cell death ligand 1 (PD-1/PD-L1) pathway. Moxibustion, as a main complementary therapy of traditional Chinese medicine (TCM), has been proved effective to reduce chronic inflammatory reaction on RA, but whether the anti-inflammatory effects are mediated by PD-1/PD-L1 pathway is still unclear. Therefore, moxibustion was conducted in the rats with RA to investigate its effect on PD-1/PD-L1. Methods. The rats' right hind paws were injected with Freundʼs complete adjuvant (FCA) to establish the model of RA. Seven days after the injection of FCA, moxibustion therapy was performed on the acupoints of Shenshu (BL23) and Zusanli (ST36) once a day for three weeks. Then, ELISA and immunohistochemical methods were used to analyze the influence of moxibustion on the expression of PD-1/PD-L1. If the moxibustion had an effect on the expression of PD-1/PD-L1-related molecules, we would knock down PD-1 with adenovirus vector. After moxibustion therapy, ELISA and histological analysis were performed to observe the anti-inflammatory effect of moxibustion. Results. The results demonstrated that moxibustion had an effect on the expression of PD-1-related molecules. The results of ELISA manifested that moxibustion decreased the level of IFN-γ and increased the level of IL-4 and IL-10. HE staining revealed that moxibustion alleviated the proliferation of synovial tissue. However, the anti-inflammatory effect and pathological improvement were weakened when PD-1 was blocked. Conclusions. The results indicate that moxibustion affected the expression of PD-1/PD-L1-related molecules and can effectively treat RA damage. The anti-inflammatory effect of moxibustion was weakened when PD-1 was knocked down.

Clinical Observation on the Improvement of Serum Sex Hormone and Ovarian Function in Premature Ovarian Failure Patients with Deficiency-Cold Syndrome by Combining Wenjing Decoction with Tiaobu Chongren Acupuncture and Moxibustion

Objective. To explore the effect of Wenjing Decoction and Tiaobu Chongren acupuncture and moxibustion therapy on serum sex hormones and ovarian function recovery in premature ovarian failure (POF) patients with deficiency-cold syndrome. Methods. From February 2018 to October 2019, 119 POI patients with deficiency-cold syndrome who met the selection criteria were randomly divided into the control group (n = 59) and the observation group (n = 60). The control group was treated with hormone replacement therapy, and the observation group was treated with Wenjing Decoction and Tiaobu Chongren acupuncture and moxibustion therapy on the basis of the control group. Both groups were treated continuously for 3 months. After treatment, the clinical efficacy of the two groups was compared, the Chinese medicine syndrome score, serum estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), anti-mullerian hormone (AMH) and bilateral antral follicle count (AFC), mean ovarian volume, and endometrial thickness of the two groups before and after treatment were compared. Result. The effective rate of the observation group (93.10%) was higher than that of the control group (77.59%) ( P < 0.05 ). After treatment, the index scores of traditional Chinese medicine syndromes in two groups were lower than before ( P < 0.05 ), and the observation group was lower than the control group ( P < 0.05 ). The serum E2 and AMH levels in the two groups increased, while FSH and LH levels decreased compared with before treatment, and the observation group improved significantly compared with the control group ( P < 0.05 ). The bilateral AFC, mean ovarian volume, and endometrial thickness of the two groups increased compared with before treatment, and the observation group was higher than the control group ( P < 0.05 ). Conclusion. On the basis of hormone replacement therapy, the combination of Wenjing Decoction and Tiaobu Chongren acupuncture and moxibustion therapy is effective in treating POF patients with deficiency-cold syndrome, which can effectively regulate their serum sex hormone levels and promote the recovery of ovarian function.