Efficacy of Bi Qi Capsules in combination with methotrexate in the treatment of rheumatoid arthritis: A protocol of double-blind randomized controlled trial.

BACKGROUND: It is known that Bi Qi Capsules (BQC) have synergistic effects when combined with Methotrexate, but there is a lack of clinical studies on the long-term efficacy and safety of the combination of the 2 in the treatment of rheumatoid arthritis (RA). Therefore, the purpose of this randomized controlled trial was to evaluate the long-term efficacy and safety of this treatment. METHODS: This was a prospective, double-blind, single-simulation, randomized controlled trial investigating the efficacy and safety of BQC in combination with Methotrexate in the treatment of RA, and was approved by the Clinical Research Ethics Committee of the hospital. Patients were randomized in a 1:1 ratio to either the observation or control group and were respectively followed up for 6 months after receiving 12 weeks of treatment. The observation indexes included: total effective rate, DAS-28 score, inflammatory indexes, and adverse reactions. Finally, the collected data was statistically analyzed by SPSS version 18.0. DISCUSSION: This study evaluated the long-term efficacy of BQC in combination with Methotrexate in the treatment of RA. The trial results of this study will provide new ideas for choosing a combination of Chinese and Western medicine protocols for the treatment of RA. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/U85GX.

Efficacy of warming needle moxibustion in the treatment of ankylosing spondylitis: A protocol of a randomized controlled trial.

BACKGROUND: Ankylosing spondylitis is a recurrent autoimmune disease, which has a high disability rate and seriously affects patients' daily life. Conventional treatment cannot effectively solve the clinical problems of patients, and long-term medication is accompanied by adverse reactions. The evidence shows that warming needle moxibustion has advantages in the treatment of ankylosing spondylitis, but there is still a lack of clinical studies on warm acupuncture alone and long-term follow-up. METHODS: This is a prospective randomized controlled trial to study the efficacy and safety of needle warming through moxibustion in the treatment of ankylosing spondylitis. It was approved by the Ethics Committee of Clinical Research of our hospital. Patients were randomly assigned to an observation group or a control group. The patients were followed up for 6 months after 30 days of treatment. Observation indicators include; activity index, functional ability, Bath Ankylosing Spondylitis Metrology Index, inflammatory indicators, adverse reactions, and so on. Finally, SPASS 22.0 software is used for statistical analysis of the data. DISCUSSION: This study will evaluate the clinical efficacy of warming needle moxibustion in the treatment of ankylosing spondylitis. The results of this study will provide a reference basis for the clinical use of warm needle moxibustion in the treatment of ankylosing spondylitis. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/GWPX3.

Antioxidant micronutrient supplementation increases erythrocyte membrane fluidity in adults from a rural Chinese community.

The objective of the present study was to investigate age-related differences in erythrocyte membrane fluidity (EMF) and changes in antioxidant capacity following supplementation. A total of seventy-four children were randomly divided into two groups: group A1 was the placebo-controlled group and group A2 was supplemented daily with 600 µg retinol, 1·0 mg ß-carotene, 100 mg tocopherol, 300 mg ascorbic acid and 200 µg Se. A total of ninety young people were randomly divided into B1 and B2 groups, and ninety-one elderly subjects were divided into C1 and C2 groups. Groups B1 and C1 were placebo-controlled groups, and groups B2 and C2 were daily supplemented with 900 µg retinol, 1·5 mg ß-carotene, 200 mg tocopherol, 500 mg ascorbic acid and 400 µg Se. Results showed that plasma malondialdehyde (MDA) was 5·35 µmol/l in children, which was lower than in young and elderly people. The MDA levels of the young and elderly individuals in the treated groups were significantly lower compared with the control groups, but the supplementation did not alter MDA levels in children. At baseline, there was a lower value of polarisation (ρ) and microviscosity (η) in children, indicating a higher EMF, than in both the young and elderly subjects. After the 2-month trial, the ρ and η values of young and elderly subjects in the treated groups decreased significantly in comparison with the placebo groups, indicating an increase in EMF. In conclusion, there was a background of higher MDA levels and lower EMF in young and elderly people than in children, which could be improved by antioxidant supplementation.

[Effect of multiple micronutrients supplementation on anti-oxidative activity and oxidized DNA damage of lymphocytes in children].

OBJECTIVE: To examine the effect of multiple micronutrients supplementation on anti-oxidative activity and decreasing oxidized DNA damage of lymphocytes in Chinese children. METHODS: 82 healthy children in a rural areas, aged 9-11 years, were selected and randomized allocated into group receiving supplements and control group with each of them 41. 24-hour dietary recall was used to collect data on daily nutrient intakes of the research subjects. The subjects in the supplement group were given vitamin A (VA) 600 microg, beta-carotene (beta-C) 1.0 mg, vitamin E (VE) 100 mg, vitamin C (VC) 300 mg and Na2SeO3(Se) 200 microg in a tablet on daily base while those in the control group took a same-sized color placebo tablet. The trial lasted 8 weeks. 5 ml blood samples from each subject were taken during 7 to 9 o'clock in the morning. DNA damage of lymphocytes and levels of plasma VA, VE, VC, beta-C, Se, malondialdehyde (MDA), activities of superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) were then analyzed twice before and after the 8-week of trial. RESULTS: The low intakes of VA, VC and Se only accounted for 50.6%, 65.6% and 67.3% of their recommended nutrient intake (RNI) respectively. After the trial, levels of plasma beta-C, VA, VE, VC and Se in the supplemented group increased by 13.4%, 32.8%, 11.5%, 46.9% and 24.6% respectively, compared with the control group, indicating that nutritional status regarding antioxidant nutrients had largely been improved. GSH-Px activity had a significant increase in the supplement group than before the supplement and in the control group (P < 0.01). GSH-Px before the trial (the 100.4 U/ml) also showed significant increase after the trial (161.7 U/ml) (P < 0.01). However, the values of SOD and MDA significantly decreased after the trial. Analysis of DNA damage indicated that there was no significant difference in the intrinsic damage of DNA (P > 0.05). Significant decreases of oxidized DNA damage induced by 5 micromol/L, 10 micromol/L and 25 micromol/L H2O2 were found more in peripheral lymphocytes of the supplemented group, than in pre-supplement and the control group after the trial (P < 0.01). CONCLUSION: Supplementation of multiple micronutrients could effectively increase the levels of beta-C, VA, VE, VC and Se in plasma, and GSH-Px activity. In the meantime, MDA and oxidized DNA damage induced by a low level H2O2 decreased significantly after the trial. The reason accounted for the decrease of SOD activity after the trial needs to be further studied.