3.Systematic review and Meta-analysis on efficacy and safety of berberine for dyslipidemia.
Ying ZHAO ; Yuan-Yuan YANG ; Ya-Wei DU ; Hui-Min YANG ; Sheng-Xian WU
China Journal of Chinese Materia Medica 2020;45(3):664-673
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.
Berberine/therapeutic use*
;
Dyslipidemias/drug therapy*
;
Humans
;
Hypolipidemic Agents/therapeutic use*
;
Lipids
;
Randomized Controlled Trials as Topic
4.Therapeutic Effects of Berberine Capsule on Patients with Mild Hyperlipidemia.
Li WANG ; Long-yun PENG ; Guo-hong WEI ; Hui GE
Chinese Journal of Integrated Traditional and Western Medicine 2016;36(6):681-684
OBJECTIVETo observe the therapeutic effects of Berberine Capsule (BC) on patients with mild hyperlipidemia.
METHODSTotally 102 mild hyperlipemia patients were recruited. All patients were suggested to have proper diet and physical activity as basic therapy for 1 month of run-in period. Totally 97 patients completed it. Then they were randomly assigned to the berberine group (the treatment group, 49 cases) and the placebo group (the control group, 48 cases). Patients in the treatment group took BC 300 mg, while those in the control group took placebo 300 mg, thrice per day for 3 successive months. Then placebos and BC were interrupted for 2 months (as washout period). All subjects received only diet control and physical activity during washout period. After washout period, placebos and BC were re-administered to all patients in the same way for 3 months. Body mass index (BMI), fasting plasma glucose (FPG), TG, TC, LDL-C, and HDL-C were assessed after run-in period, washout period, at month 1, 2, 3 after the first therapy, at month 1, 2, 3 after second treatment, respectively.
RESULTSCompared with the end of run-in period, TG, TC, and LDL-C decreased, and HDL-C increased in the treatment group (P < 0.05) after first 3 months of treatment. Compared with 3 months after the first therapy, TG, TC, and LDL-C increased and HDL-C decreased in the treatment group after washout period (P < 0.05). Compared with the end of wash- out period, TC and LDL-C decreased in the treatment group at month 2 after second treatment (P < 0.05); TG, TC, and LDL-C decreased (P < 0.01, P < 0.05), and HDL-C increased (P < 0.05) at month 3 after second treatment. Compared with the control group at month 3 after second treatment, TG, TC, and LDL-C all decreased, and HDL-C increased in the treatment group (all P < 0.05).
CONCLUSIONBC was effective in improving blood lipid level in mild hyperlipidemia patients.
Berberine ; therapeutic use ; Blood Glucose ; analysis ; Body Mass Index ; Capsules ; Humans ; Hyperlipidemias ; drug therapy ; Lipids ; blood
5.Berberine might block colorectal carcinogenesis by inhibiting the regulation of B-cell function by Veillonella parvula.
Yun QIAN ; Ziran KANG ; Licong ZHAO ; Huimin CHEN ; Chengbei ZHOU ; Qinyan GAO ; Zheng WANG ; Qiang LIU ; Yun CUI ; Xiaobo LI ; Yingxuan CHEN ; Tianhui ZOU ; Jingyuan FANG
Chinese Medical Journal 2023;136(22):2722-2731
BACKGROUND:
Colorectal carcinogenesis and progression are related to the gut microbiota and the tumor immune microenvironment. Our previous clinical trial demonstrated that berberine (BBR) hydrochloride might reduce the recurrence and canceration of colorectal adenoma (CRA). The present study aimed to further explore the mechanism of BBR in preventing colorectal cancer (CRC).
METHODS:
We performed metagenomics sequencing on fecal specimens obtained from the BBR intervention trial, and the differential bacteria before and after medication were validated using quantitative polymerase chain reaction. We further performed ApcMin/+ animal intervention tests, RNA sequencing, flow cytometry, immunohistochemistry, and enzyme-linked immunosorbent assays.
RESULTS:
The abundance of fecal Veillonella parvula ( V . parvula ) decreased significantly after BBR administration ( P = 0.0016) and increased through the development from CRA to CRC. Patients with CRC with a higher V. parvula abundance had worse tumor staging and a higher lymph node metastasis rate. The intestinal immune pathway of Immunoglobulin A production was activated, and the expression of TNFSF13B (Tumor necrosis factor superfamily 13b, encoding B lymphocyte stimulator [BLyS]), the representative gene of this pathway, and the genes encoding its receptors (interleukin-10 and transforming growth factor beta) were significantly upregulated. Animal experiments revealed that V. parvula promoted colorectal carcinogenesis and increased BLyS levels, while BBR reversed this effect.
CONCLUSION:
BBR might inhibit V. parvula and further weaken the immunomodulatory effect of B cells induced by V. parvula , thereby blocking the development of colorectal tumors.
TRIAL REGISTRAION
ClinicalTrials.gov, No. NCT02226185.
Animals
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Humans
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Berberine/therapeutic use*
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Carcinogenesis
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Veillonella
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Colorectal Neoplasms/genetics*
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Tumor Microenvironment
6.Study of total alkaloids from Rhizoma Coptis Chinensis on experimental gastric ulcers.
Bei LI ; Jing-chuan SHANG ; Qi-xin ZHOU
Chinese journal of integrative medicine 2005;11(3):217-221
OBJECTIVETo study the effects of total alkaloids (TA) extracted from Rhizoma Coptis Chinensis on experimental gastric ulcer models.
METHODSFour kinds of experimental ulcer models were established respectively by water-immersion stress, intragastric ethanol, acetic acid erosion, and pylorus ligation. The anti-ulcer effects of TA were evaluated, and compared with that of berberine (Ber) and cimetidine (Cim).
RESULTSTA showed significant inhibitory effects on ulcerative formation induced by water-immersion stress, intragastric ethanol, and pylorus ligation in dose-dependent manner, and showed therapeutic effect on acetic acid erosion-inducing ulcer, in comparison with the control group. The anti-ulcer activity of Ber was less than TA containing equal content of Ber. TA significantly reduced the free acidity, total acidity and total acid output, but didn't affect the gastric juice volume, gastric pepsin activity, adherent mucus quantity of stomach wall and free mucus dissolving in gastric juice. The suppressive activities of TA on gastric acid secretion didn't occur when it was administered into dodecadactylon at a dose of 360 mg/kg wt. Moreover, when compared with Cim, the inhibitory effect of TA on gastric acid secretion isn't proportional to the inhibitory effects on the formation of the 4 kinds of experimental ulcers.
CONCLUSIONTA is a potent candidate in therapeutic drugs for treating gastric ulcer. Its anti-ulcer effective components and mechanism is not only related to Ber and inhibition of gastric acid, but also to other ingredients of TA and mechanism so far unknown.
Alkaloids ; therapeutic use ; Animals ; Anti-Ulcer Agents ; therapeutic use ; Berberine ; therapeutic use ; Cimetidine ; therapeutic use ; Coptis ; Disease Models, Animal ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Male ; Mice ; Phytotherapy ; Plant Extracts ; therapeutic use ; Rats ; Stomach Ulcer ; drug therapy ; prevention & control
7.Simultaneous determination of six alkaloids in Coptis chinensis of different regions by RP-HPLC.
Zhipeng GENG ; Haijie ZHENG ; Yi ZHANG ; Weizao LUO ; Xianyou QU
China Journal of Chinese Materia Medica 2010;35(19):2576-2580
A reversed-phase HPLC method for simultaneous determination of gatrorrhizine, columbamine, epiberberine, coptisine, palmatine and berberine in Coptis chinensis was developed. Analysis was carried out on an Xtimate C18 column (4.6 mm x 250 mm, 5 microm) eluted with acetonitrile-30 mmol x L(-1) ammonium bicarbonate solution (including 0.7% ammonia and 0.1% triethylamine) by gradient elution. The detective wavelength was 270 nm, the column temperature was 30 degrees C, and the flow rate was 1.0 mL x min(-1). By the above method, the linear ranges of gatrorrhizine, columbamine, epiberberine, coptisine, palmatine and berberine were 0.85-16.96 (r = 0.9997), 1.25-24.96 (r = 0.999 5), 2.05-40.96 (r = 0.999 9), 3.65-72.96 (r = 0.999 9), 2.88-57.60 (r = 0. 999 8),13.25-264.96 mg x L(-1) (r = 0.999 6), respectively. The average recoveries (n = 6) of the six alkaloids were 101.6% (RSD 1.3%),102.5% (RSD 1.5%), 100.8% (RSD 1.9%),102. 6% (RSD 1.2%), 97.80% (RSD 1.3%), 99.01% (RSD 1.5%), respectively. The determined results demonstrate that there is a significant difference in the contents of six alkaloids and total alkaloids among the tested samples. The method is accurate, reliable and repeatable for simultaneous determination of gatrorrhizine, columbamine, epiberberine, coptisine, palmatine and berberine in C. chinensis.
Alkaloids
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isolation & purification
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Berberine
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analogs & derivatives
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isolation & purification
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pharmacology
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therapeutic use
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Berberine Alkaloids
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isolation & purification
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Chromatography, High Pressure Liquid
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methods
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Coptis
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chemistry
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Drugs, Chinese Herbal
8.Efficacy and safety of triple therapy containing berberine, amoxicillin, and vonoprazan for Helicobacter pylori initial treatment: A randomized controlled trial.
Shasha CHEN ; Weina SHEN ; Yuhuan LIU ; Qiang DONG ; Yongquan SHI
Chinese Medical Journal 2023;136(14):1690-1698
BACKGROUND:
With the development of traditional Chinese medicine research, berberine has shown good efficacy and safety in the eradication of Helicobacter pylori (H. pylori). The present study aimed to evaluate the efficacy and safety of triple therapy containing berberine, amoxicillin, and vonoprazan for the initial treatment of H. pylori.
METHODS:
This study was a single-center, open-label, parallel, randomized controlled clinical trial. Patients with H. pylori infection were randomly (1:1:1) assigned to receive berberine triple therapy (berberine 500 mg, amoxicillin 1000 mg, vonoprazan 20 mg, A group), vonoprazan quadruple therapy (vonoprazan 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, B group), or rabeprazole quadruple therapy (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, C group). The drugs were taken twice daily for 14 days. The main outcome was the H. pylori eradication rate. The secondary outcomes were symptom improvement rate, patient compliance, and incidence of adverse events. Furthermore, factors affecting the eradication rate of H. pylori were further analyzed.
RESULTS:
A total of 300 H. pylori-infected patients were included in this study, and 263 patients completed the study. An intention-to-treat (ITT) analysis showed that the eradication rates of H. pylori in berberine triple therapy, vonoprazan quadruple therapy, and rabeprazole quadruple therapy were 70.0% (70/100), 77.0% (77/100), and 69.0% (69/100), respectively. The per-protocol (PP) analysis showed that the eradication rates of H. pylori in these three groups were 81.4% (70/86), 86.5% (77/89), and 78.4% (69/88), respectively. Both ITT analysis and PP analysis showed that the H. pylori eradication rate did not significantly differ among the three groups (P >0.05). In addition, the symptom improvement rate, overall adverse reaction rate, and patient compliance were similar among the three groups (P >0.05).
CONCLUSIONS
The efficacy of berberine triple therapy for H. pylori initial treatment was comparable to that of vonoprazan quadruple therapy and rabeprazole quadruple therapy, and it was well tolerated. It could be used as one choice of H. pylori initial treatment.
Humans
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Amoxicillin/therapeutic use*
;
Helicobacter pylori
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Anti-Bacterial Agents
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Clarithromycin/therapeutic use*
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Rabeprazole/therapeutic use*
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Berberine/therapeutic use*
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Bismuth
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Helicobacter Infections/drug therapy*
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Drug Therapy, Combination
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Treatment Outcome
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Proton Pump Inhibitors/therapeutic use*
10.Berberine alleviates programmed necrosis of metabolic-associated fatty liver disease via activating Nrf2 pathway in mice.
Ming Yue HAO ; Lin Lin SUN ; Ming Wei SHENG ; Jing Shu LYU ; Yuan Bang LIN ; Yu Hua YANG ; Jia Hao ZHI ; Wen Li YU ; Hong Yin DU
Chinese Journal of Hepatology 2022;30(2):224-229
Objective: To investigate the effect of berberine on programmed necrosis of hepatocytes induced by metabolic-associated fatty liver disease (MAFLD) in mice and its related molecular mechanism. Methods: Twenty male C57BL/6N mice were randomly divided into four groups (n=5 in each group): control group (S), fatty liver group (H), berberine group(B), nuclear factor erythroid 2-related factor 2 inhibitor group (Nrf2), and all-trans-retinoic acid (ATRA) group (A). Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), triglycerides (TG), total cholesterol (TC), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) concentrations were detected at the end of week 12 to calculate fatty liver index (liver mass/body mass ratio). Liver tissue was stained with HE, Masson and Oil Red O, and SAF score was used to evaluate the degree of liver injury. The expression levels of hepatic programmed necrosis-related proteins, namely receptor-interacting protein kinase 3 (RIPK3), phosphorylated mixed series protease-like domain (p-MLKL) and Nrf2 were detected by Western blot method. One-way ANOVA was used for intragroup comparisons and LSD-t tests were used for intergroup comparisons. Results: Compared with S group, H group serum ALT, AST, LDH, TG, TC, TNF-α, IL-1β levels and fatty liver index were significantly increased. The liver tissue was filled with vacuolar-like changes and inflammatory cell infiltration. Numerous red lipid droplets were observed with oil red O staining. Collagen fiber hyperplasia was evident with Masson staining. SAF scores (6.60 ± 0.55 and 0.80 ± 0.45) were significantly increased. The expressions of RIPK3 and p-MLKL were up-regulated. Nrf2 level was relatively increased, and the differences were statistically significant (P < 0.05). Compared with H group, berberine intervention group liver biochemical indexes, lipid levels, pro-inflammatory mediator expression, fatty liver index, and SAF score were significantly reduced, and the expression of RIPK3 and p-MLKL were down-regulated, while Nrf2 levels were further increased, and the differences were statistically significant (P<0.05). Compared with B group, treatment with Nrf2 inhibitor had antagonized the protective effect of berberine on fatty liver. Serum ALT, AST, LDH, TG, TC and TNF-α, IL-1β levels, fatty liver index, and SAF scores were significantly increased and the expressions of RIPK3 and p-MLKL were relatively increased, and the differences were statistically significant (P < 0.05). Conclusion: Berberine can significantly improve the metabolic-associated fatty liver disease injury in mice, and its mechanism is related to activation of Nrf2 and inhibition of programmed necrosis of hepatocytes.
Animals
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Berberine/therapeutic use*
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Fatty Liver
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Male
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Mice
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Mice, Inbred C57BL
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NF-E2-Related Factor 2/metabolism*
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Necrosis