Systematic review and Meta-analysis on efficacy and safety of berberine for dyslipidemia / 中国中药杂志

To evaluate the clinical efficacy and safety of berberine in the treatment of dyslipidemia. In this review, CNKI, WanFang, VIP, CBM, PubMed, Cochrane Library, EMbase, and Medline(OVID) were retrieved from database establishment to January, 2019 in any language. Randomized controlled trials(RCTs) of berberine with or without lipid-lowering drugs vs placebo, without drugs or lipid-lowering drugs only in treatment of dyslipidemia were collected. Data extraction and paper quality assessment were conducted according to the Cochrane Handbook. Then RevMan 5.3 software was used for Meta-analysis. A total of 25 trials were included, covering 3 042 cases, including 1 552 cases in the experimental group and 1 490 cases in the control group. The clinical heterogeneity of the included trials was relatively high, and the methodological quality of most trials was generally low, with bias in terms of random sequence generation, allocation hiding, blind method and result data. Interventions were divided into different subgroups for analysis. Meta-analysis suggested that use berberine alone or along with lipid lowing drugs could reduce TC, TG, LDL-C levels and increased HDL-C levels with statistically significant difference as compared with control group. As compared with control group, there was no statistically significant difference in the incidence of adverse events. No severe adverse effects were reported in all trials. Berberine has good efficacy and safety in the treatment of dyslipidemia. Due to the quality limitations of the included trials, the above conclusions need to be further verified by high-quality, large sample size and multi-center clinical trials.

Technical specification for re-evaluation of post-marketing clinical effectiveness of traditional Chinese medicine (first draft) / 中国中药杂志

The post-marketing re-evaluation of traditional Chinese medicine (TCM) is a crucial stage for drug evaluation. Due to the particularity of TCM, it is necessary to re-evaluate the effectiveness of certain Chinese medicines by studying and collecting the studies on safety of long-term/extensive populations under actual clinical application, in order to verify the effectiveness of post-marketing TCM. However, there is an absence in technical specifications for relevant clinical trials on re-evaluation of effectiveness at present. As a consequence, the preliminary technical specifications were drafted in this article, focusing on several perspectives related to the re-evaluation of post-marketing clinical effectiveness of TCM, including ethical protection, research plan formulation, real-world research methods, randomized controlled trial methods, research methods of clinical pharmacological mechanism, sublimation method of TCM theory and so on. The objective of writing this article is to provide general methodological guidance for the re-evaluation of TCM post-marketing effectiveness, so that the process and results of post-marketing re-evaluation of TCM can be more scientific and reasonable.

Effect of triangle drugs as ginseng, Trichosanthes kirilowii maxim and rhubarb on the level of blood lipids and related pro-inflammatory cytokines during the process of treating atherosclerosis / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study the effect of triangle drugs as ginseng, Trichosanthes kirilowii Maxim, and rhubarb on the levels of blood lipids as [total cholesterol (TC), triglyeride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)] and pro-inflammatory cytokines as intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and high sensitive C reactive protein (hs-CRP) during the process of treating atherosclerosis.</p><p><b>METHODS</b>Twenty New Zealand rabbits were randomly divided into three groups after one-week adaptive feeding, i.e., the normal control group (n=6), the model group (n=6), and the triangle drugs group (n=8). High fat diet was fed to rabbits in the triangle drugs group and the model group at the daily dose of 100 g for six weeks. Iliac artery was injured in the model group and the triangle drugs group at the seventh week using balloon injury. High fat diet was successively fed to those after surgery for six weeks. At the same time of modeling, preventive medication (at the daily dose of dry ginseng 0.64 g/kg, Trichosanthes kirilowii Maxim 2.14 g/kg, and prepared Radix et Rhizoma Rhei with wine 0.43 g/kg, with the volume of 2 mL/kg) was administered by gastrogavage to rabbits in the triangle drugs group. Changes of blood lipids levels and related pro-inflammatory cytokines were dynamically observed.</p><p><b>RESULTS</b>On the 7th week (before surgery), the levels of TC, TG, HDL-C, and LDL-C in the model group, TC, HDL-C, and LDL-C in the triangle drugs group significantly increased, showing significant difference when compared with those of the normal control group (P < 0.05). The levels of pro-inflammatory cytokines in the model group and the triangle drugs group were significantly higher than those in the normal control group (P < 0.05). Levels of TC, TG, and LDL-C were lower in the triangle drugs group than in the model group, showing statistical difference (P < 0.05). After the 8th week the levels of blood lipids and ICAM-1 in the model group, and levels of TC, LDL-C, HDL-C, and ICAM-1 in the triangle drugs group were significantly higher than those of the normal control group, showing statistical difference (P < 0.05). After the 12th week levels of blood lipids in the model group, LDL-C and HDL-C in the triangle drugs group were significantly higher than those of the normal control group, showing statistical difference (P < 0.05). The LDL-C level was lower in the triangle drugs group than in the model group, showing statistical difference (P < 0.05). The levels of VCAM-1, ICAM-1, and hs-CRP in the model group were obviously higher than those in the triangle drugs group and the normal control group, showing statistical significance (P < 0.05). The hs-CRP level was higher in the triangle drugs group than in the normal control group, showing statistical difference (P < 0.05).</p><p><b>CONCLUSIONS</b>The triangle drugs may postpone the process of atherosclerosis by lowering blood lipids levels, especially by lowering the elevating levels of TC and LDL-C. Its roles in decreasing the level of pro-inflammatory cytokines might be associated with lipids lowering and anti-inflammation. Its roles may also be associated with improvement of the endothelial function and inhibition of the smooth muscle proliferation.</p>

Clinical observation on effect of compound Shiwei Tablet in treating urinary tract infection / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To evaluate the safety and efficacy of Compound Shiwei Tablet (CST) in treating upper and lower urinary tract infection (UTI, pyretic stranguria of dampness-heat of the Lower-jiao type in 'TCM).</p><p><b>METHODS</b>A multi-center, randomized, and opened clinical trial was conducted in the UTI patients with Sanjin Tablet (ST) as the parallel positive control medicine. The comprehensive efficacy, effect on TCM syndrome score, and change of urinary leukocyte count were observed, and the adverse reaction was recorded.</p><p><b>RESULTS</b>In the 147 upper UTI cases and the 312 lower UTI cases after treatment, the comprehensive effect was higher and urinary leukocyte was less in the CST treated patients than in the ST treated patients (P < 0.05); but significant difference in the improvement of TCM symptoms was found between them only in the lower UTI cases ( P < 0.05); and no adverse reaction was observed during the treatment course.</p><p><b>CONCLUSION</b>CST has definite therapeutic efficacy on UTI and is safe in clinical application.</p>

Clinical assessment on treatment of hyperlipidemia with pushen capsule / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To explore the therapeutic effect of Pushen capsule (PSC) in treating primary hyperlipidemia.</p><p><b>METHODS</b>Two hundred and forty patients with primary hyperlipidemia were randomly divided into two groups, the 120 patients in the treated group treated with PSC (4 capsules, tid) and the 120 patients in the control group treated with Zhibituo tablet (3 tablets, tid), and they were administered at the same time with Zhibituo placebo. The therapeutic course for both groups was 4 weeks. The therapeutic effect and the effects on blood lipids and viscosity were observed.</p><p><b>RESULTS</b>The effective rate in the treated group was 76.3%, which was significantly higher than that in the control group (48.7%, P < 0.01). PSC showed a significant lowering effect on TC, TG and LDL-C and raising effect on HDL-C, and the effect in lowering TG was significantly better than that of Zhibituo (P < 0.01). PSC also showed a certain effect in decreasing whole blood viscosity of both high-sheared and low-sheared viscosity.</p><p><b>CONCLUSION</b>Pushen capsule has promising blood lipid regulating effect in patients with hyperlipidemia, and some effects in lowering the blood viscosity.</p>