Clinical Efficacy and Safety of a Modified Moxibustion Therapy for Low Back Pain in Lumbar Disc Herniation: A Two-Center, Randomized, Controlled, Non-Inferiority Trial.

Objective: Our pilot study shows that a modified moxibustion therapy called Ma's bamboo-based medicinal moxibustion can alleviate the symptoms of low back pain in lumbar disc herniation (LDH), and has the potential to treat LDH. The aim of this study is to evaluate the efficacy and safety of Ma's bamboo-based medicinal moxibustion for low back pain in LDH. Methods: A total of 312 LDH patients with low back pain were randomized to receive Ma's bamboo-based medicinal moxibustion (MBMM) or acupuncture (AT). The primary efficacy measure was the change of Visual Analogue Scale (VAS) on the 14th day compared with that at baseline. The secondary efficacy measures included VAS score, Oswestry disability index (ODI), modified Japanese Orthopaedic Association (M-JOA) score, and the content of ß-endorphin (ß-EP) and substance-P (SP). The safety measures included the occurrence of adverse events and the changes in laboratory indicators. Results: In total, 304 patients were incorporated for the analysis of efficacy, including 96 males and 208 females, aged 21-65 years. There was no statistically significant difference in the change of VAS score between the two groups on the 14th day [mean difference (95% CI) = -2.31 (-2.48, -2.13) and -2.28 (-2.45, -2.11), respectively; p = 0.819]. The VAS, ODI, and M-JOA scores changed after the intervention in both groups (p <0.001), with increased ß-EP content (p = 0.014, p = 0.032) and decreased SP content (p <0.001, p = 0.048). The ODI score (p = 0.039) and M-JOA score (p = 0.032) of the MBMM group on the 28th day were lower than those of the AT group. Conclusion: The efficacy of Ma's bamboo-based medicinal moxibustion therapy in relieving low back pain of LDH patients is comparable to that of acupuncture, and it has post-effect advantages in improving lumbar dysfunction and daily living ability, which can be used as a safe and effective alternative method for LDH treatment.

Acupuncture for erectile dysfunction: a randomized controlled trial. / é’ˆåˆºæ²»ç–—å‹ƒèµ·åŠŸèƒ½éšœç¢ï¼šéšæœºå¯¹ç §è¯•éªŒ.

OBJECTIVES: To observe the clinical efficacy of acupuncture in treating erectile dysfunction (ED). METHODS: A total of 64 ED patients were randomly divided into an acupuncture group (32 cases, 2 case dropped out) and a western medication group (32 cases, 2 cases dropped out). In the acupuncture group, acupuncture treatment was applied at Baihui (GV 20), Qihai (CV 6), Guanyuan (CV 4), Zhongji (CV 3), Dahe (KI 12), Qugu (CV 2), Zusanli (ST 36), and etc., two groups of acupoints were used alternately, 30 min each time, once every other day. In the western medication group, 50 mg of sildenafil tablet was took orally 1 h before sexual activity. Both groups were treated for 30 d. The international index of erectile function citrate (IIEF-5) score, self rating anxiety scale (SAS) score, self rating depression scale (SDS) score, TCM syndrome score were observed before and after treatment, and in follow-up of 2 weeks after treatment completion, the serum testosterone (T) level was detected before and after treatment, and the clinical efficacy was evaluated in the two groups. RESULTS: After treatment and in follow-up, the IIEF-5 scores were increased compared with those before treatment in the two groups (P<0.01). In follow-up, the IIEF-5 score in the acupuncture group was ascended compared with that in the western medication group (P<0.05). Except for the SDS and TCM syndrome scores in the western medication group of follow-up, the SAS scores, SDS scores, and the TCM syndrome scores were decreased after treatment and in follow-up compared with those before treatment in the two groups (P<0.01, P<0.05); in the acupuncture group, the SAS scores, SDS scores and the TCM syndrome scores after treatment and in follow-up were lower than those in the western medication group (P<0.01). After treatment, the serum T levels were increased compared with those before treatment in the two groups (P<0.01). The total effective rate of the acupuncture group was 83.3% (25/30), and it was 86.7% (26/30) in the western medication group, there was no significant difference in total effective rate between the two groups (P>0.05). CONCLUSIONS: Acupuncture can effectively improve erectile function, anxiety and depression state, and TCM syndrome in ED patients, and has a advantage of posterior effect compared with western medication treatment.

Differential expression of circular RNAs in interleukin 6-promoted osteogenic differentiation of human stem cells from apical papilla.

INTRODUCTION: Studies have shown that interleukin 6 (IL-6) can regulate stem cell osteogenic differentiation; however, the exact mechanism is not clear. Circular RNAs (circRNAs) are closed circular non-coding RNAs that are involved in the process of stem cell osteogenic differentiation. Therefore, the purpose of this present study was to investigate the effect of IL-6 treatment on osteogenic differentiation of human apical tooth papillae stem cells (hSCAPs), and to detect the difference in circRNA expression using gene microarray technology. METHODS: After extraction and identification of hSCAPs, alkaline phosphatase (ALP) activity, alizarin red staining, and calcium ion quantitative assay were used to determine the changes of ALP enzyme, mineralized nodules, and matrix calcium levels before and after IL-6 treatment of hSCAPs gene microarray technology was used to analyze the changes in circRNA expression levels before and after IL-6 induction of mineralization. The four selected circRNAs were validated by qRT-PCR. Moreover, gene ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) were used to predict the potential functions and biological signaling pathways of circRNAs. Finally, these data are integrated and analyzed to construct circRNA-microRNA-mRNA networks. RESULTS: Alp and Alizarin red staining confirmed that IL-6 promoted the osteogenic differentiation of hSCAPs. The gene microarray results identified 132 differentially expressed circRNAs, of which 117 were upregulated and 15 were downregulated. Bioinformatic analysis predicted that the circRNA-406620/miR-103a-3p/FAT atypical cadherin 4 (FAT4) pathway might be involved in regulating IL-6 to promote osteogenic differentiation of hSCAPs. CONCLUSION: Differentially expressed circRNAs might be closely involved in regulating IL-6 to promote osteogenic differentiation of hSCAPs.

The bioceramic sealer iRoot SP promotes osteogenic differentiation of human stem cells from apical papilla via miR-141-3p/SPAG9/MAPK signalling pathway.

AIM: The premixed bioceramic sealer iRoot SP that is widely used clinically has been reported to kill bacterial biofilms and promote osteogenic differentiation of human stem cells from the apical papilla (hSCAPs). Although miR-141-3p has been substantiated to be involved in the osteogenic process, the underlying mechanisms remain unclear. The aim of this study was to investigate the role of miR-141-3p in osteogenic differentiation and underlying mechanisms of iRoot SP-treated hSCAPs. METHODOLOGY: hSCAPs were extracted from tissue blocks with enzyme digestion and identified by using immunofluorescence, flow cytometry and alizarin red staining. The mRNA expression level of miR-141-3p in hSCPAs after culture with iRoot SP was examined by quantitative real-time PCR (qRT-PCR) assay. SPAG9 was identified as a downstream target gene of miR-141-3p by dual-luciferase report assay. Alkaline phosphatase (ALP) staining and activity detection, alizarin red staining, calcium concentration assay, qRT-PCR and western blot were used to estimate osteogenic differentiation ability and involved protein expression levels of the osteogenic makers and signalling pathway-related factors in iRoot SP-treated hSCAPs. Data were analysed by one-way anova and post hoc Tukey's test to determine any statistical differences between the experimental groups and the control group. p < .05 was considered statistically significant. RESULTS: Expression of miR-141-3p was reduced in iRoot SP-treated hSCAPs with the increased exposure time up to 7 days, and the western blot and qRT-PCR results revealed that the osteogenic markers osteocalcin (OCN), osterix (OSX), runt-related transcription factor 2 (RUNX2) and dentin sialophosphoprotein (DSPP) were inversely correlated with miR-141-3p. The negative regulatory relationship between miR-141-3p and SPAG9/ mitogen-activated protein kinases (MAPK) signalling axis was validated in this in vitro experiments. CONCLUSIONS: The bioceramic sealer iRoot SP promoted osteogenic differentiation of hSCAPs by inhibiting miR-141-3p following down-regulated SPAG9 expression, and activated MAPK pathway. These findings proposed a novel therapeutic impact of bioceramic sealer iRoot SP inducing bone regeneration in refractory periapical periodontitis.

[Bamboo-based medicinal moxibustion for chronic fatigue syndrome: a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy of bamboo-based medicinal moxibustion for chronic fatigue syndrome (CFS), and to preliminarily explore its action mechanism. METHODS: Sixty-four patients with CFS were randomly divided into a moxibustion group (32 cases, 1 case dropped off, 1 case excluded) and an acupuncture group (32 cases, 2 cases dropped off). The patients in the moxibustion group were treated with bamboo-based medicinal moxibustion, while the patients in the acupuncture group were treated with routine acupuncture. Both groups were treated once a day, 6 days as a course of treatment with 1 day interval, for a total of 2 courses of treatment. Before treatment, 1 and 2 courses into treatment and in the follow-up of 14 days after treatment, the fatigue scale-14 (FS-14) and somatic and psychological health report (SPHERE) scores were observed in the two groups. Before and after treatment, the contents of CD+3, CD+4, CD+8 of peripheral blood T lymphocyte subsets were measured and CD+4/CD+8 ratio was calculated; the clinical efficacy of the two groups was compared. RESULTS: Compared before treatment, the FS-14 and SPHERE scores in the two groups were decreased 1 and 2 courses into treatment and in the follow-up (P<0.01), and the FS-14 and SPHERE scores in the moxibustion group were lower than those in the acupuncture group (P<0.01, P<0.05). Compared before treatment, the contents of CD+3, CD+4 and CD+4/CD+8 ratio in the moxibustion group were increased after treatment (P<0.01). There was no significant difference of CD+3, CD+4, CD+8 and CD+4/CD+8 ratio between before and after treatment in the acupuncture group (P>0.05). After treatment, the contents of CD+3 and CD+4 in the moxibustion group were higher than those in the acupuncture group (P<0.05). The total effective rate was 93.3% (28/30) in the moxibustion group, which was higher than 73.3% (22/30) in the acupuncture group (P<0.05). CONCLUSION: Bamboo-based medicinal moxibustion could improve the physical and mental fatigue symptoms and psychological status in patients with CFS. Its effect may be related to regulating the contents of CD+3, CD+4 of peripheral blood T lymphocyte subsets and CD+4/CD+8 ratio.

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 clinics. 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. The aim of this trial is to evaluate the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy in the treatment of LDH low back pain. 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 analog scale(VAS) at baseline, after 6 times of treatment, 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 ß-endorphin (ß-EP), and serum substance P (SP). ß-EP and SP, as well as safety evaluation indexes (routine blood, liver, and kidney function and electrocardiogram), will be measure at baseline and after the end of treatment. The number, nature, and severity of adverse events will be recorded. DISCUSSION: The results of the trial will compare the efficacy of low back pain in LDH between Ma's bamboo-based medicinal moxibustion group and the acupuncture group and will be expected to make a systematic and objective evaluation of the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy. TRIAL REGISTRATION: ChiCTR2000038725 . Registered on 29 September 2020.

[Treatment of chronic fatigue syndrome from yangming meridian].

Based on the theory of "brain-gut communication" and "heart-stomach disease simultaneously", the thinking and method of treating chronic fatigue syndrome (CFS) from yangming meridian were discussed. CFS is related to brain and heart. Based on the analysis of meridian circulation, zang-fu function and the indication characteristics of yangming meridian, the indications of yangming meridian are closely related to brain and heart, so it is proposed to start from yangming meridian and use Chinese herbs combined with acupuncture to treat CFS, including the four methods of clearing away heat and moisturizing dryness, cooling blood and removing blood stasis, promoting qi to clear the organs, and strengthening and replenishing deficiency. It has certain guiding and reference significance for clinical treatment of CFS.

Effects of iRoot SP on osteogenic differentiation of human stem cells from apical papilla.

BACKGROUND: Research shows that nano-bioceramics can modulate the differentiation of dental stem cells. The novel ready-to-use calcium-silicate-based root-canal sealer iRoot SP is widely used in root filling. Accordingly, the aim of this study was to evaluate the effects of iRoot SP on proliferation and osteogenic differentiation in human stem cells from the apical papilla (hSCAPs). METHODS: hSCAPs were isolated and characterized in vitro, then cultured with various concentrations of iRoot SP extract. Cell proliferation was assessed by CCK-8 assay, and scratch-wound-healing assays were performed to evaluate cell-migration capacity. hSCAPs were then cultured in osteogenic medium supplemented with iRoot SP extracts. Alkaline phosphatase (ALP) activity assay was used to evaluate ALP enzyme levels. Alizarin red staining and cetylpyridinium chloride (CPC) assays were performed to assess calcified-nodule formation and matrix-calcium accumulation of hSCAPs. The mRNA and protein expression levels of the osteogenic markers OCN, OSX, Runx2, and DSPP were determined by qRT-PCR and Western blotting. The data were analyzed using one-way ANOVA and LSD-t tests. RESULTS: iRoot SP at low concentrations (2, 0.2, and 0.02 mg/mL) is nontoxic to hSCAPs. iRoot SP at concentrations of 0.02 and 0.2 mg/mL significantly increases cell-migration capacity. In terms of osteogenic differentiation, 0.2 mg/mL iRoot SP promotes intracellular ALP activity and the formation of mineralized nodules. Moreover, the expression of osteogenic markers at the mRNA and protein levels are upregulated by iRoot SP. CONCLUSION: iRoot SP is an effective filling material for periapical bone regeneration.

The efficacy and safety of fire needle for cervical spondylotic radiculopathy: A protocol for systematic review and meta-analysis.

BACKGROUND: Cervical spondylotic radiculopathy (CSR) is one of the most common types of cervical spondylosis, and its treatments are mainly for relieving radicular pain and improving dysfunction. The existing randomized controlled trials (RCTs) suggest that fire needle may be a potential therapy in the treatment of CSR, but there is no evidence-based medical evidence to date. Therefore, this study will systematically evaluate the efficacy and safety of fire needle in the treatment of CSR. METHODS: We will search for 7 electronic databases (PubMed, EMBASE, Cochrane library, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Sinomed, and Wanfang Database) and 2 trial registration platforms (ClinicalTrials.gov and Chinese Clinic Trials.gov) to collect eligible studies. The RCTs related to fire needle for CSR and published up to June 30, 2021 will be included, regardless of language. We will consider the visual analogue scale as the primary outcome and the secondary outcome will include cervical range of motion, assessment of muscle strength, neck disability index, the MOS item short from health survey, activities of daily living, total efficiency, and adverse reactions. We will use the standard proposed in Cochrane Handbook 5.1.0 to assess the quality and bias risk of every RCT, and all analyses will be conducted through RevMan software V5.3 (Copenhagen: Nordic Cochrane Center, Cochrane, Collaborative Organization, 2014). RESULTS: This systematic review and meta-analysis will provide a convincing synthesis of existing evidences on the efficacy and safety of fire needle for CSR, and the results will be submitted to a peer-reviewed journal for publication. CONCLUSION: The results of this study will provide high-quality evidence of fire needle in the treatment of CSR for clinical decision-making. INPLASY REGISTRATION NUMBER: INPLASY202170041.

The efficacy and safety of moxibustion for chronic fatigue syndrome: A protocol for systematic review and meta-analysis.

BACKGROUND: The pathogenesis of chronic fatigue syndrome (CFS) is not clear. The main purpose of treatment is to improve autoimmune function and relieve fatigue symptoms. Moxibustion is often used to treat diseases caused by low autoimmunity, especially in relieving fatigue symptoms. It is a superior therapy for CFS in traditional Chinese medicine. At present, there is a lack of the high level clinical evidence to support the moxibustion in the treatment of CFS, so this study will systematically review and analyze the currently available randomized controlled trials to evaluate the efficacy and safety of moxibustion in the treatment of CFS. METHODS: We will systematically search PubMed, EMBASE, Cochrane library, Sinomed, CNKI, VIP, and Wanfang Database, ClinicalTrials.gov and Chinese Clinical Trial Registry will also be searched. The time range for the search will be from database activation to March 31, 2021. The randomized controlled trials (RCTs) associated with moxibustion for CFS will be included, regardless of language.We will use the standard proposed in Cochrane Handbook 5.1.0 to assess the bias risk of a single RCT. The main outcome index of the study is Fatigue Assessment Instrument (FAI), secondary outcome indexes will include Fatigue Scale -14 (FS-14), Fatigue Severity Scale (FSS), Pittsburgh sleep quality index (PSQI), natural killer (NK) cells, interleukin- 2 (IL-2), T lymphocyte subsets (CD4+, CD8+), cure rate, total efficiency and adverse reactions. The random effect model meta was used to analyze the effect data of a single RCT. Heterogeneity will be measured by Cochran Q test and I-squared statistics. We will use 2 subgroup analyses to explore the source of heterogeneity. RCTs with high bias risk was excluded and adjustment effect model was used for sensitivity analysis to test the robustness of the meta-analysis results. The publication bias included in RCTs will be assessed by funnel plot and Egger test. RESULTS: This study will objectively and comprehensively evaluate the efficacy and safety of randomized controlled trials of moxibustion in the treatment of chronic fatigue syndrome, and the results will be submitted to peer-reviewed journals for publication. CONCLUSION: This systematic review will provide clinicians with the latest high-quality evidence for the use of moxibustion in the treatment of chronic fatigue syndrome. INPLASY REGISTRATION NUMBER: INPLASY202140063.