Puerarin Attenuates Iron Overload-Induced Ferroptosis in Retina through a Nrf2-Mediated Mechanism.

SCOPE: Age-related increases in retinal iron are involved in the development of retinal degeneration. The recently discovered iron-dependent mechanism of cell death known as ferroptosis has been linked to a wide range of pathologies. However, its role in iron overload-induced retinal degeneration is still uncertain. Puerarin has been associated with retinal protection. The purpose of this research is to determine how puerarin prevents retinal ferroptosis under iron overload conditions. METHODS AND RESULTS: Models of iron overload in Kunming mice, 661W cell, and ARPE-19 cell are established. Increased iron deposition significantly worsens retinal pathology, decreases cell viability, and induces ferroptotic changes. Puerarin mitigates iron overload-induced ferroptosis by decreasing excessive iron through the regulation of iron handling proteins and lowering lipid peroxidation through the inhibition of cyclooxygenase 2 expression and activation of the nuclear factor-E2-related factor 2 (Nrf2) signaling pathway and downstream ferroptosis-related proteins (solute carrier family 7 member 11, glutathione peroxidase 4 and heme oxygenase-1). The protective effect of puerarin on ferroptosis is diminished by the Nrf2-specific inhibitor ML385. CONCLUSION: These findings suggest targeting ferroptosis may be a novel strategy for the management of retinal degeneration. Puerarin may exert some of its ocular benefits by attenuating ferroptosis.

Efficacy and safety of Weifuchun tablet for chronic atrophic gastritis: A systematic review and meta-analysis.

BACKGROUND: Chronic atrophic gastritis is a significant premalignant lesion of gastric carcinoma. There is a great need to prevent the progression to gastric carcinoma through early intervention and treatment for chronic atrophic gastritis. Weifuchun, a famous Chinese patent drug, has been widely used for chronic atrophic gastritis in China. However, it remains unclear whether Weifuchun is effective for atrophic gastritis. OBJECTIVE: To determine the effectiveness and safety of Weifuchun for chronic atrophic gastritis. METHODS: We systematically retrieved seven databases (Cochrane Library, EMBASE, PubMed, China National Knowledge Infrastructure, Wanfang database, Chinese Scientific Journals Database, and Chinese Biological Medical Database) from their inception to October 5, 2022. Methodological quality was examined using the Cochrane Risk of bias tool. We also used RevMan 5.4 software for statistical analysis to examine the effectiveness and safety of Weifuchun. RESULTS: Fifteen studies with 1,488 patients were enrolled in this meta-analysis. The study indicated that Weifuchun was more effective (RR 1.52; 95% CI 1.41, 1.63; p<0.00001) than Western medicine and other Chinese patent medicine. In addition, Weifuchun was more effective in improving gastric mucosal under gastroscopy, improving histopathologic changes of gastric mucosal, and inhibiting Helicobacter pylori. However, no significant difference in safety was examined between Weifuchun and the control group (RR 2.83; 95% CI 0.85, 9.38; P = 0.09). CONCLUSIONS: The meta-analysis revealed a significant statistical difference with Weifuchun in effectiveness compared to the control group. However, there was no significant difference in safety. Thus, more high-quality clinical studies are needed in the future. TRIAL REGISTRATION: Registration number CRD42022365703.

Evaluation of individualized treatment of nonproliferative diabetic retinopathy: a multicenter, randomized, parallel-controlled study.

OBJECTIVE: To evaluate the differences in the efficacy of stationary treatment and individualized treatment for patients with nonproliferative diabetic retinopathy (NPDR). METHODS: This study was a randomized, controlled, multicenter clinical trial. Participants with NPDR were randomized into the stationary treatment group or the individualized treatment group. The stationary treatment group was given the basic treatment and Qiming granules, and the individualized treatment group was given the basic treatment, Qiming granules, and individualized Chinese herbal medicines over a 12-week period. The individualized therapeutic formula was also changed over time to adjust to the changes in the clinical presentation of the patient. We conducted observations of fundus retinal exudation and hemorrhage, visual acuity, Traditional Chinese Medicine symptom scores and other indicators. RESULTS: A total of 140 participants with NPDR were randomized into the stationary treatment group or the individualized treatment group, and 132 participants completed this study. Following the 12-week treatment, significant improvements in both primary and secondary outcomes were observed in the stationary and individualized treatment groups. No remarkable difference in the primary outcomes between the two groups was observed. However, there was a significant difference in the Traditional Chinese Medicine symptom scores (18 ± 7 vs 15 ± 6; P < 0.05). There were no severe adverse effects. CONCLUSION: Compared with stationary treatment, individualized treatment is more effective at relieving the Traditional Chinese Medicine symptoms and improving vision and fundus lesions at 12 weeks post treatment.

Ameliorative effects and mechanisms of salvianic acid A on retinal iron overload in vivo and in vitro.

Excessive iron can be accumulated in the retina and lead to retinal iron overload. Salvianic acid A (SAA) has a variety of pharmacologic effects, but there is only a limited understanding of its benefits for retinal iron overload. The aim of this study was to examine the protective effects and latent mechanisms of SAA on retinal iron overload. SAA reduced iron in the serum and retina, attenuated pathophysiological changes, and reduced retinal iron deposition in the retinas of iron-overloaded mice. It also reduced intracellular iron in ARPE-19 cells by regulating iron-handling proteins and chelating with iron. It also significantly inhibited cellular oxidative and inflammatory damage by increasing the nuclear translocation of nuclear erythroid 2-related factor 2 (Nrf2) while decreasing nuclear factor-kappa B (NF-κB), protecting the ARPE-19 cells from apoptosis by suppressing the Bax/Bcl-2 ratio, cytochrome c release, caspase activation, and poly ADP-ribose polymerase cleavage. The ability of SAA to inhibit apoptosis, increase nuclear Nrf2 expression, and decrease nuclear NF-κB expression was further confirmed in the retinas of iron-overloaded mice. This study demonstrates that SAA shows significant protective effects against retinal iron overload; its mechanisms might be associated with iron chelation; regulation of iron-handling proteins; and inhibition of oxidative stress, inflammation and apoptosis.

The efficacy and safety of Yuxingcao eye drops in the treatment of COVID-19 conjunctivitis: A protocol for a systematic review.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a global pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). There is no specific cure for this disease, and the clinical management mainly depends on supportive treatment. This disease may affect SARS-CoV-2 conjunctivitis. Yuxingcao eye drops is used in treating COVID-19 conjunctivitis in China. METHODS: A comprehensive literature search will be conducted. Two methodological trained researchers will read the title, abstract, and full texts and independently select the qualified literature according to inclusion and exclusion criteria. After assessment of the risk of bias and data extraction, we will conduct meta-analyses for outcomes related to COVID-19 conjunctivitis. The heterogeneity of data will be investigated by Cochrane X and I tests. Then publication bias assessment will be conducted by funnel plot analysis and Egger test. RESULTS: The results of our research will be published in a peer-reviewed journal. CONCLUSION: Our study aims to systematically present the clinical evidence of Yuxingcao eye drops in treating COVID-19 conjunctivitis, which will be of significant meaning for further research and clinical practice. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020209059.

miR-29a promotes osteoblast proliferation by downregulating DKK-1 expression and activating Wnt/ß-catenin signaling pathway.

BACKGROUND: MicroRNA (miRNA) is a kind of non-coding small RNA with a negative regulating function. Some miRNAs play a role in regulating the differentiation and function of osteoblasts, chondrocytes and osteoclasts. OBJECTIVES: In this study, we analyzed the role of miR-29a and dickkopf-1 (DKK-1) in osteoblast differentiation. MATERIAL AND METHODS: Specimens were collected from the surgical resection of pathological ankylosing spondylitis (AS) tissue and some normal tissues. The expression of miR-29a, DKK-1 and ß-catenin in normal and AS tissues were detected with real-time polymerase chain reaction (RT-PCR) and western blotting. Cell proliferation was detected with a Cell Counting Kit-8, cell migration and invasion were determined using a Transwell system and cell apoptosis was analyzed with flow cytometry. The luciferase reporter gene plasmid pGL3-DKK-1 and a point-mutation of the luciferase reporter gene plasmid mut-pGL3-DKK-1 were constructed. RESULTS: It was found that miR-29a could promote the proliferation of hFOB1.19 cells, while DKK-1 inhibited their proliferation. Also, miR-29a was able to inhibit the apoptosis of hFOB1.19 cells, while DKK-1 was able to promote the apoptosis of hFOB1.19 cells. When it comes to the invasion and migration of hFOB1.19 cells, miR-29a was found to promote it, while DKK-1 did not. CONCLUSIONS: These findings will lead to a better understanding of the proliferation and differentiation of osteoblasts and will provide new insights for the treatment of this disease.

Acupuncture as Adjunctive Therapy for Chronic Stable Angina: A Randomized Clinical Trial.

IMPORTANCE: The effects of acupuncture as adjunctive treatment to antianginal therapies for patients with chronic stable angina are uncertain. OBJECTIVE: To investigate the efficacy and safety of acupuncture as adjunctive therapy to antianginal therapies in reducing frequency of angina attacks in patients with chronic stable angina. DESIGN, SETTING, AND PARTICIPANTS: In this 20-week randomized clinical trial conducted in outpatient and inpatient settings at 5 clinical centers in China from October 10, 2012, to September 19, 2015, 404 participants were randomly assigned to receive acupuncture on the acupoints on the disease-affected meridian (DAM), receive acupuncture on the acupoints on the nonaffected meridian (NAM), receive sham acupuncture (SA), and receive no acupuncture (wait list [WL] group). Participants were 35 to 80 years of age with chronic stable angina based on the criteria of the American College of Cardiology and the American Heart Association, with angina occurring at least twice weekly. Statistical analysis was conducted from December 1, 2015, to July 30, 2016. INTERVENTIONS: All participants in the 4 groups received antianginal therapies as recommended by the guidelines. Participants in the DAM, NAM, and SA groups received acupuncture treatment 3 times weekly for 4 weeks for a total of 12 sessions. Participants in the WL group did not receive acupuncture during the 16-week study period. MAIN OUTCOMES AND MEASURES: Participants used diaries to record angina attacks. The primary outcome was the change in frequency of angina attacks every 4 weeks from baseline to week 16. RESULTS: A total of 398 participants (253 women and 145 men; mean [SD] age, 62.6 [9.7] years) were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 4 groups. Mean changes in frequency of angina attacks differed significantly among the 4 groups at 16 weeks: a greater reduction of angina attacks was observed in the DAM group vs the NAM group (difference, 4.07; 95% CI, 2.43-5.71; P < .001), in the DAM group vs the SA group (difference, 5.18; 95% CI, 3.54-6.81; P < .001), and in the DAM group vs the WL group (difference, 5.63 attacks; 95% CI, 3.99-7.27; P < .001). CONCLUSIONS AND RELEVANCE: Compared with acupuncture on the NAM, SA, or no acupuncture (WL), acupuncture on the DAM as adjunctive treatment to antianginal therapy showed superior benefits in alleviating angina. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01686230.

Efficacy and safety of umbilical therapy with the traditional Chinese medicine formulation Lishui Xiaogu cataplasm for cirrhotic ascites: protocol for a randomized controlled trial.

BACKGROUND: Ascites is one of the most common complications of cirrhosis. Umbilical therapy with traditional Chinese medicines has been increasingly prescribed to treat cirrhotic ascites. However, high-quality evidence from clinical trials supporting such application of traditional Chinese medicines remains limited. Therefore, we designed a clinical trial to evaluate the efficacy and safety of umbilical therapy with the Lishui Xiaogu cataplasm formulation applied to treat cirrhotic ascites. METHODS/DESIGN: This ongoing study is a double-blind, randomized, parallel, placebo-controlled trial. A total of 82 patients will be recruited and randomly assigned to either a treatment group or a placebo group, in a 1:1 ratio. The treatment group will receive umbilical therapy with the Lishui Xiaogu cataplasm plus red light irradiation along with conventional treatment; the placebo group will receive umbilical therapy with a placebo cataplasm plus red light irradiation along with conventional treatment. Interventions for both groups will be administered once daily for up to 10 days, with a 30-day follow-up after the last treatment. The primary efficacy measurement will be ascites depth. Secondary efficacy measurements will include abdominal perimeter, weight, urine volume, the symptomatic score of traditional Chinese medicine, and the Chronic Liver Disease Questionnaire. Adverse events will also be reported. DISCUSSION: This randomized trial will be the first rigorous study designed to evaluate the efficacy and safety of umbilical therapy with Lishui Xiaogu cataplasm applied for cirrhotic ascites. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-INR-16007686 . Registered on 1 January 2016.

CTHRC1 mediates IL­1ß­induced apoptosis in chondrocytes via JNK1/2 signaling.

Osteoarthritis (OA), also known as degenerative joint disease or degenerative arthritis, is characterized by chondrocyte apoptosis. The aim of the present study was to investigate the effects of collagen triple helix repeat containing 1 (CTHRC1) and the c­Jun N­terminal kinase (JNK) 1/2 inhibitor SP600125 on rat chondrocytes cultured in vitro with interleukin (IL)­1ß. Chondrocytes were treated with different doses of IL­1ß and cell viability and CTHRC1 expression were assessed using Cell Counting Kit­8 and western blot assays, respectively. In separate experiments, chondrocytes were treated with CTHRC1­expressing constructs (pLVX­Puro­CTHRC1) and/or SP600125, or IL­1ß with either CTHRC1 short hairpin (sh)RNA constructs (shNRA­CTHRC1) or SP600125. The expression of CTHRC1, B­cell lymphoma (Bcl)­2, Bcl­2­associated X protein (Bax), cleaved caspase­3, poly ADP ribose polymerase (PARP)­1 and matrix metalloproteinase (MMP)­13 was measured using reverse transcription­quantitative polymerase chain reaction and western blotting assays. A Cell Counting Kit­8 assay was performed to examine cell viability. Annexin V/propidium iodide staining and flow cytometry assays were used to detect chondrocyte apoptosis. The expression of JNK1/2 and phosphorylated JNK1/2 was measured using western blotting. CTHRC1 was highly expressed in patients with OA compared with normal controls. IL­1ß treatment (5, 10 and 20 ng/ml) increased the protein expression of CTHRC1 in a dose­dependent manner and decreased the viability of chondrocytes in a time­dependent manner. pLVX­Puro­CTHRC1 mimics the effect of IL­1ß on chondrocyte apoptosis and JNK1/2 activity, and this is reversed by SP600125 treatment. However, transfection with shRNA­CTHRC1 or treatment with SP600125 inhibited IL­1ß­induced cell apoptosis and JNK1/2 activation. These results indicate that CTHRC1 downregulation may protect chondrocytes from IL­1ß­induced apoptosis by inactivating the JNK1/2 pathway.

[Experimental research of articular cartilage defect repair using micro-fracture and insulin-like growth factor 1 in rabbits].

OBJECTIVE: To investigate the effects of micro-fracture and insulin-like growth factor 1 (IGF-1) in treatment of articular cartilage defect in rabbits. METHODS: Twenty-four New Zealand white rabbits (aged, 4-6 months; weighing, 2.5-3.5 kg) were randomly divided into 4 groups (n = 6): micro-fractures and recombinant human IGF-1 (rhIGF-1) treatment group (group A), micro-fracture control group (group B), rhIGF-1 treatment control group (group C), and blank control group (group D). Full thickness articular cartilage defects of 8 mm x 6 mm in size were created in the bilateral femoral condyles of all rabbits. The micro-fracture surgery was performed in groups A and B. The 0.1 mL rhIGF-1 (0.01 microg/microL) was injected into the knee cavity in groups A and C at 3 times a week for 4 weeks after operation, while 0.1 mL saline was injected in groups B and D at the same time points. At 4, 12, and 24 weeks, the gross, histological, and immunohistochemical observations were performed, and histological score also was processed according to Wakitani's score criteria. The collagen contents in the repair tissues and normal patellofemoral cartilage were detected by the improved hydroxyproline (HPR) method at 24 weeks. Electron microscope was used to observe repair tissues of groups A and B at 24 weeks. RESULTS: All animals were survival at the end of experiment. At 24 weeks after operation, defect was repaired with time, and the repair tissue was similar to normal cartilage in group A; the repair tissue was even without boundary with normal cartilage in group B; and the repair tissue was uneven with clear boundary with normal cartilage in groups C and D. Histological staining showed that the repair tissues had no difference with normal cartilage in group A; many oval chondrocytes-like cells and light-colored matrix were seen in the repair tissues of group B; only a few small spindle-shaped fibroblasts were seen in groups C and D. Moreover, histological scores of group A were significantly better than those of groups B, C, and D (P < 0.05) at 4, 12, and 24 weeks. Electron microscope observation showed that a large number of lacuna were seen on the surface of repair tissue in group A, and chondrocytes contained glycogen granules were located in lacunae, and were surrounded with the collagen fibers, which was better than that in group B. Collagen content of the repair tissue in group A was significantly higher than that in groups B, C, and D (P < 0.05), but it was significantly lower than that of normal cartilage (P < 0.05). CONCLUSION: Combination of micro-fracture and rhIGF-1 for the treatment of full thickness articular cartilage defects could promote the repair of defects by hyaline cartilage.

Effects of long-term acupuncture treatment on resting-state brain activity in migraine patients: a randomized controlled trial on active acupoints and inactive acupoints.

BACKGROUND: Acupuncture has been commonly used for preventing migraine attacks and relieving pain during a migraine, although there is limited knowledge on the physiological mechanism behind this method. The objectives of this study were to compare the differences in brain activities evoked by active acupoints and inactive acupoints and to investigate the possible correlation between clinical variables and brain responses. METHODS AND RESULTS: A randomized controlled trial and resting-state functional magnetic resonance imaging (fMRI) were conducted. A total of eighty migraineurs without aura were enrolled to receive either active acupoint acupuncture or inactive acupoint acupuncture treatment for 8 weeks, and twenty patients in each group were randomly selected for the fMRI scan at the end of baseline and at the end of treatment. The neuroimaging data indicated that long-term active acupoint therapy elicited a more extensive and remarkable cerebral response compared with acupuncture at inactive acupoints. Most of the regions were involved in the pain matrix, lateral pain system, medial pain system, default mode network, and cognitive components of pain processing. Correlation analysis showed that the decrease in the visual analogue scale (VAS) was significantly related to the increased average Regional homogeneity (ReHo) values in the anterior cingulate cortex in the two groups. Moreover, the decrease in the VAS was associated with increased average ReHo values in the insula which could be detected in the active acupoint group. CONCLUSIONS: Long-term active acupoint therapy and inactive acupoint therapy have different brain activities. We postulate that acupuncture at the active acupoint might have the potential effect of regulating some disease-affected key regions and the pain circuitry for migraine, and promote establishing psychophysical pain homeostasis. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-13003635.

Two sets of acupoint combination of similar functions engage shared neural representation: a functional magnetic resonance imaging study.

OBJECTIVE: To investigate whether the neural representations underlying alternating two acupoint combinations (ACs) are the same or not. METHODS: In this functional magnetic resonance imaging study, two sets of analgesia ACs were utilized, including Waiguan (TE5) and Qiuxu (GB40) for Group A, and Neiguan (PC6) and Taichong (LR3) for Group B, which are the most commonly adopted in clinical treatment. Each group had 20 healthy subjects. An experimental design was proposed, which consisted of a pre-needling resting phase, a needling phase and a post-needling resting phase. This paradigm optimally mimics the clinical protocol as well as focuses on both the stimulation and the resting periods. The results were subjected to general linear model analysis, conjunction analysis and the functional connectivity analysis. RESULTS: The rostral anterior cingulated cortex was engaged in the initiative period of the acupuncture effect in both groups, and it was chosen as the seed region for the functional connectivity analysis for the following resting period. The results showed that several shared brain regions were involved in both groups, in particular the insula, amygdala and hypothalamus. Moreover, significant differences were located at the posterior cingulated cortex as revealed by a two sample -test (P<0.05, corrected). Other regions showed no significant differences. This finding was further supported by the spatial correlation analysis that the two groups were significantly correlated (r =0.51, P<0.01). CONCLUSION: This preliminary research helps us understand the neurophysiological mechanisms of acupuncture when following clinical guidelines on ACs, as well as provides an important opportunity to develop better treatment strategies for reducing, or even preventing pain.

Systematic review and meta-analysis of 16 randomized clinical trials of radix astragali and its prescriptions for diabetic retinopathy.

Objective. To evaluate the efficacy and safety of radix astragali and its prescriptions for diabetic retinopathy. Methods. A computer-based online and manual search was conducted for randomized controlled trials addressing radix astragali and its prescriptions for diabetic retinopathy. Results. 16 RCTs involving 977 subjects and 1586 eyes were identified. Meta-analysis indicated that the effect of radix astragali and its prescriptions in improving visual acuity and fundus manifestations, lowering FBG, TG, plasma viscosity, and RAI, was superior to that of control group (WMD or OR 0.20, 0.27, -0.26, -0.36, -0.93, -1.27; 95% CI [0.09, 0.30], [0.17, 0.40], [-0.51, 0.00], [-0.60, -0.12], [-1.67, -0.20], [-2.35, -0.19]; P < 0.05, resp.). In contrary, the efficacy of radix astragali and its prescriptions was not superior to those of control group in descending HbA1C and TC with WMD 0.45, -0.96 and 95% CI [-1.00, 1.90], [-2.19, 0.27], P > 0.05, respectively. GRADE software suggested that the studies were of low methodological quality. Conclusion. Radix astragali and its prescriptions were superior to other treatments for diabetic retinopathy in terms of improving visual acuity and fundus manifestations, reducing FBG, TG, RAI, and plasma viscosity. The evaluated studies were of low methodological quality, indicating that the previous findings should be read with care.

[Mild cognitive impairment disease treated with electroacupuncture: a multi-center randomized controlled trial].

OBJECTIVE: To verify the clinical efficacy on mild cognitive impairment (MCI) treated with electroacupuncture (EA) intervention based on the principle as "promoting the circulation of the Governor Vessel and regulating the marrow" and plan to provide the A-grade evidence of the evidence-based medicine for the clinical treatment of this disease with acupuncture and moxibustion. METHODS: The multi-center randomized controlled trial (RCT) was adopted. One hundred and ninety-two cases of MCI were randomized into an EA group and a nimodipine group, 96 cases in each one. In the EA group, EA was applied to Shenting (GV 24), Baihui (GV 20), Sishen cong (EX-HN 1) and Fengchi (GB 20), once every other day. In the nimodipine group, Nimodipine was pre scribed for oral administration. Four weeks constituted one course, the treatment of 8 weeks was required. The minimum mental state examination (MMSE) and the graphic recognition test (GRT) were applied before and in the 1st and 2nd session of treatment separately. The follow-up visit of MMSE scale was provided in the 1st, 3rd and 6th months after treatment separately. RESULTS: The total effective rate was 50.0% (47/94) in the EA group, which was superior to 34.4% (32/93) in the nimodipine group (P < 0.05). At the end of the 1st session treatment, the differences in MMSE total score and the cognitive, memory and speech dimensional scores were not significant statistically between two groups (all P > 0.05). At the end of the 2nd session treatment, the MMSE total score and the cognitive, memory, visual-space skill dimensional scores were improved in comparison before treatment (all P < 0.05). The results in the EA group were superior to those in the nimodipine group (all P < 0.05). But the difference in the speech dimensional score was not significant statistically between the two groups (P > 0.05). In the EA group, the GRT score was improved significantly after 2 sessions of treatment as compared with that before treatment (P < 0.01) and was superior to that in the nimodipine group (P < 0.05). In the 1st, 3rd and 6th month after treatment, the MMSE scale total scores were different significantly in statistics between the two groups (all P < 0.01). The long-term efficacy in the EA group was superior to that in the nimodipine group. CONCLUSION: Both of the EA therapy based on the principle as "promoting the circulation of the Governor Vessel and regulating the marrow" and the nimodipine program improve significantly the cognitive function of MCI patients. Compared with the nimodipine program, the EA therapy improves the comprehensive cognitive and the short-term memory abilities much more significantly and is especially advantageous at improving cognitive, memory and visual-space skill dimensions for MCI patients. In the half a year follow-up visit after the end of treatment, the long-term efficacy of EA is better than that of Nimodipine.

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China.

BACKGROUND: In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs) to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. METHODS: This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. RESULTS: Among the 1968 patients, 74 patients (3.76%) suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. CONCLUSIONS: Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs) were related to the patients' gender and age and the local anatomical structure of the acupoints. AEs could be reduced and mitigated by improving the medical environment, ensuring a high technical level of the acupuncture practitioners and establishing a good relationship of mutual trust between doctor and patient. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00599586, NCT00599677, NCT00608660.

Effect on multifocal electroretinogram in persistently elevated intraocular pressure by erigeron breviscapus extract.

AIM: To observe the effect on multifocal electroretinogram (mfERG) in persistently elevated intraocular pressure (IOP) by erigeron breviscapus extract (also named Dengzhanhua in Chinese) in rat models. METHODS: The rat models with persistently elevated IOP were established by the method of Akira. Then, erigeron breviscapus extract was given for one month to observe the effect on mfERG in persistently elevated IOP in rats. RESULTS: As elevated IOP went on, the mfERG changes were mainly in weaken of reaction density with progressive development. After intervention of erigeron breviscapus extract, the total peak latency of P1 wave had recovered to some extent and the difference was significant when compared with control group (P<0.05); the total response density and P1 wave response density in second circle had risen noticeably, which had significant differences than those of control group (P<0.05). CONCLUSION: Erigeron breviscapus extract can improve the impaired visual function of persistently elevated IOP in rats, suggesting that this extract is the effective part of erigeron breviscapus for optic neuroprotection.

Improved quality monitoring of multi-center acupuncture clinical trials in China.

BACKGROUND: In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). METHODS: A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. RESULTS AND DISCUSSION: The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. CONCLUSIONS: Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

[Quality monitoring in multi-central large sample acupuncture clinical trials].

OBJECTIVE: To ensure and enhance the quality of multi-central large sample clinical trials of acupunc ture and moxibustion. METHODS: Take the multi-central clinical trials supported by National Key Technology R &- D Program of "the 11th Five-year Plan" as an example to introduce the duty of monitors and simply describe the formulation of the monitoring plan, the monitoring procedure and contents of the monitoring plan and treatment of the commonly-seen problems. CONCLUSION: Quality monitoring work in multi-central large sample clinical trials of acupuncture and moxibustion is equally serious and scientific with clinical medical trials and it is an important way to guarantee the credible results.

[Experimental study of corpus cavernosal nerve evoked potential in diabetic rats].

OBJECTIVES: To observe the cavernosal nerve dysfunction of diabetic Sprague Dawley rats. METHODS: Thirty-five Sprague-Dawley rats were divided randomly into diabetes model group(n = 25) and normal group(n = 10). Diabetes model was established by administration of streptozotocin (63 mg/kg) in single intraperitoneal dosing. Giving single wave stimulus, corpus cavernosal nerve was measured for its latent period of reaction and myopotential. RESULTS: Compared with other groups, diabetic rats had longer reflection latent period(P < 0.01) and higher corpus cavernosum smooth muscle myopotential (P < 0.01). CONCLUSIONS: The results indicate that corpus cavernosal nerve dysfunction may play an important role in the erectile dysfunction of diabetic rats.