Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial.

BACKGROUND: Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions. METHODS: A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. DISCUSSION: This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS. TRIAL REGISTRATION: Chinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 .  Registered on October 21, 2019.

The effect of acupuncture on depression and its correlation with metabolic alterations: A randomized controlled trial.

BACKGROUND: Electroacupuncture (EA) treatment has antidepressant effect and when patients were treated with EA and antidepressants, the effect could be maintained for a longer time. However, the effect of EA combined with antidepressants based on metabolism is still in the initial observation stage, which requires further research. METHODS: A total of 60 patients with moderate depression were assigned into 2 groups at a ratio of 1:1, the EA group (receiving EA and antidepressants) and the control group (taking antidepressants only) in this randomized controlled pilot trial. The EA treatment was performed 3 times a week for 8 consecutive weeks and then follow up for 4 weeks. The patients' depressive mood was measured by the Hamilton Depression scale (HAMD) at baseline, week 4, week 8 and week 12. Before and after 8-week treatment, morning urine samples from all patients were analyzed by the gas chromatography-mass spectrometry (GC-MS) to find possible metabolic markers of depression and of EA treatment related changes. RESULTS: Compared with the control group, the EA group showed more significant improvements in depressive symptoms measured by HAMD at week 4 (16.89 ±â€Š5.74 vs 25.58 ±â€Š7.03, P < .001), week 8 (9.59 ±â€Š5.13 vs 25.04 ±â€Š7.49, P < .001) and week 12 (11.07 ±â€Š6.85 vs 27.25 ±â€Š7.14, P < .001). The significant differences in urinary specific metabolites before and after EA treatment were malonic acid (fatty acid biosynthesis), cysteine (glutamate metabolism), glutathione (glutamate metabolism), tryptophan (tryptophan metabolism), proline (glutamate metabolism), and N-acetyl-5-hydroxytryptamine. These metabolites are involved in tryptophan metabolism, glutamate metabolism, and fatty acid biosynthesis. CONCLUSION: EA treatment combined with antidepressants is more effective in improving depressive symptoms than antidepressants alone. EA may treat depression by acting on tryptophan metabolism, glutamate metabolism, and fatty acid biosynthesis. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-2000030786.