Berberine is a bitter-tasting and yellow-colored chemical. The mean difference (blue squares), 95% CI (horizontal lines through blue squares), and pooled-effect sizes (green diamonds) were presented using random-effect Hedges models. The mechanisms and effects, specifically Cardiovascular disease (CVD) is a major contributor to the global burden of disease. Berberine is a dietary supplement that comes from the roots, stems, and bark of various plants and has been used for centuries in traditional Chinese medicine. The MBP-NC pills were identical in taste and appearance to the placebo pills, which contained an inactive compound. P value indicates within-group difference (ie, from baseline). Effect of Traditional Chinese Medicine Berberine on Type 2 Diabetes Based on Comprehensive Metabonomics. Our inclusion criteria were as follows: 1) study design must be a RCT of placebo controlled or parallel controlled; 2) the patients must have a metabolic disorder; 3) lifestyle intervention must be the same in the control group and trial group; 4) data of monitoring patients before and after HDL\TC\TG\LDL\FPG\HOMA-IR treatment; 5) the drug in the trial group must be berberine without any combination; 6) the drug dose in the trial group must be greater than the minimum effective dose. Gu Y., Zhang Y., Shi X., Li X., Hong J., Chen J., et al. The placebo group experienced slightly more adverse effects than the intervention group, including kidney stones, pruritus, dyspepsia, and constipation.23, A limitation of this study was that it did not use a validated menopause scale to assess severity of menopause symptoms. Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus, Nutraceutical pill containing berberine versus ezetimibe on plasma lipid pattern in hypercholesterolemic subjects and its additive effect in patients with familial hypercholesterolemia on stable cholesterol-lowering treatment. The screening and extraction of trial data were independently and simultaneously performed by Yu Ye and Xiufen Liu. Moreover, authors did not specify how many patients were retained in the study for analysis after 4 and 8 weeks. < 25% for low heterogeneity goes fixed-effect models) to calculate the SMD and 95%CI. Barenbrock M., Spieker C., Kerber S., Vielhauer C., Hoeks A. P., Zidek W., et al. Inclusion in an NLM database does not imply endorsement of, or agreement with, 7) The current study is not registered, and it may have a small deviation, but we still strictly follow the steps of a systematic review. Including this information would have allowed for more meaningful interpretation of the intervention impact. Forest plot illustrates the differences in changes in homeostasis model assessment of insulin resistance in adults with metabolic disease who did or did not receive berberine in 5 trials (n = 471). No serious adverse events were reported. Moreover, FPG and HOMA-IR were selected as indicators to measure the therapeutic effect of berberine in lowering blood sugar and insulin resistance. Scientific Research Plan of Hubei Provincial Department of Education (D20202803), Hubei University of Science and Technology School-level Fund (No.2020XZ13, BK202009). The study failed to include specific objectives and hypotheses, and did not clearly differentiate between primary and secondary outcomes. Berberine has been studied for its potential effects, including controlling an irregular heartbeat and lowering lipid levels, blood pressure, and blood sugar levels. Average TC and LDL values at the point of randomization following the 6-month run-in period were 216 13 and 159 10 mg/dL, respectively. It may have been beneficial to evaluate patients who required add-on therapy versus those who did not and observe whether there were any differences in baseline characteristics (such as LDL values) that were associated with the need for additional therapy. In TC subgroup analysis, overall differences were found in the therapeutic effects of different treatment periods (p = 0.01), whereas no difference was found in the therapeutic effects of different treatment doses (p = 0.60) and study designs (p = 0.06). The findings of the present meta-analysis demonstrated that berberine alone can reduce TG, TC, LDL, HDL, FPG, and HOMA-IR levels in patients with metabolic disorders, and this effect was observed in healthy participants. Li M., Shu X., Xu H., Zhang C., Yang L., Zhang L., et al. In one study, 32 patients who were not receiving other lipid-lowering therapies were given berberine 500 mg twice daily for three months.12 In these patients, significant reductions in LDL, triglycerides, and total cholesterol were seen from baseline (25% reduction in LDL, 35% reduction in triglycerides, and 29% reduction in total cholesterol, P < .0001 for change from baseline).12 In a 2-month study of 63 patients, berberine 500 mg twice daily lowered LDL by an average of 23.8%, and a combination of simvastatin 20 mg daily and berberine lowered LDL by an average of 31.8%.13 These results need to be confirmed in larger, well-designed studies, and berberine needs to be evaluated both on its own and as an adjunct to other lipid-lowering agents. The I P value indicates between-group differences of study end results. These CBD candies offer a simple and flexible . Derosa G, DAngelo A, Bonaventura A, et al. The TG levels in the berberine and placebo groups at baseline were 91 10 and 89 9 mg/dL, respectively. Additionally, it did not adequately define the exclusion criteria of acute forms of severe diseases. Concomitant disease states were not reported in the baseline characteristics, so it is unknown whether or not some of the women in the study had comorbid conditions that would have warranted treatment with a statin (ie, diabetes or conditions resulting in an ASCVD risk >7.5%). Safety data were also collected in this study by means of physical examination, vital sign assessment, weight, electrocardiogram, adverse events, and treatment tolerability.17, Of the 141 patients who completed the run-in phase, 71 were randomized to berberine and 70 to placebo. 4) Life interventions, including diet intervention and exercise intervention of each study design, are not exactly the same. It is reported with 261 volunteers in the control group and 278 in the trial group using a randomized model. Patients were eligible for inclusion if they were older than 18 years, diagnosed with moderate metabolic syndrome, and had LDL levels within the range of 130 to 170 mg/dL. Berberine, a quinoline alkaloid, can be used in combination with statins to enhance hypolipidemic effects and reduce the dose and side effects of statins. 75%). While the authors discussed the content of the placebo and the similarities in appearance to the active treatment, they did not provide a rationale for the choice of calcium and vitamin D over an inactive placebo. Furthermore, the percent reductions were only shown graphically, without fully disclosing specific percentages. All of the 18 included trials have proclaimed a randomized trial; however, only 8 trials proclaimed the method of randomization. These strengths improve both the applicability and reproducibility of the results. Modern science focused mostly on berberine as an isolated plant compound. (2018). The methods section indicated that 270 patients were randomized: however, baseline characteristics were only provided for 135 of the patients. One bottle of Thorne's Berberine Capsules costs $38 if you purchase it once. Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterolUnited States, 1999-2002 and 2005-2008, The effects of berberine on blood lipids: a systemic review and meta-analysis of randomized controlled trials. The I Another limitation of the study was that 8 patients were excluded from the EZE group for poor compliance and adverse effects, but the severity of these side effects was not reported. Baseline characteristics were similar between NC and EZE groups, with baseline LDL levels of 149 16 and 150 8 mg/dL in each group, respectively. Increases in HDL were also statistically significant in both the BERB and COMB groups compared with baseline (+2.15 5.06 and +1.95 3.36 mg/dL for the BERB and COMB groups, respectively, P < .05 for both). Included studies were reviewed and approved by the fourth author (RDB). When the lipid profile values in the berberine group were compared with the placebo group, all differences were found to be statistically significant (P < .05). Figure 3 illustrates the efficacy of berberine treatment on TG. The primary endpoint was percentage change in LDL cholesterol at 12 weeks, although the authors also collected and reported data for changes in TC, HDL cholesterol, TG, menopause symptom severity, blood pressure, waist circumference, weight, transaminases, and creatinine phosphokinase.23, Baseline characteristics were similar between groups. HDL decreased in both groups from baseline at all points of follow-up, although this difference was only significant for the placebo group at 4, 12, and 24 weeks (P < .01, P < .05, P < .01, respectively). (2003). Background Berberine (BBR), as a new medicine for hyperlipidemia, can reduce the blood lipids in patients. The current match involves a Texas lawsuit . Objective, systematic methods were also used to determine which trials were included in the review in a way that selected for the strongest studies in terms of design. Drug users have different physiological conditions such as gender, age, individual differences, and dietary structure, and the effects of taking the same drug are different. Zhang Y., Li X., Zou D., Liu W., Yang J., Zhu N., et al. The Role of Nutraceuticals in Statin Intolerant Patients. (2016). Baseline characteristics were similar between groups. Recently, berberine (BBR) has received increasing attention as a safer and more cost-effective option to . Screening was performed by passing 1,660 papers through title and abstract review; precluding duplicate papers, non-clinical trial papers, and irrelevant papers; selecting 56 papers for full-text review; and ultimately excluding articles with non-data, drug combination treatment, different life intervention strategy, non-blank, or placebo controlled. No assistance was provided that did not merit authorship. Forest plot illustrates the differences in changes in low-density lipoprotein in adults with metabolic disease who did or did not receive berberine in 14 trials (n = 1,233). Armolipid Plus reduced LDL from 151 23 mg/dL at baseline to 119 25 mg/dL at 8 weeks (P < .001). In the abovementioned clinical treatment process, only a few patients have occasional abdominal pain, and drug safety is significantly higher than the original treatment measures. Our subgroup analysis explored the possible reasons based on three aspects: treatment period, treatment dose, and study design (Table 1). > 75% for high heterogeneity goes random-effect models, I Forest plot illustrates the differences in changes in high-density lipoprotein in adults with metabolic disease who did or did not receive berberine in 13 trials (n = 1,133). (2019). Patients were eligible for inclusion in the study if they were between 18 and 60 years of age and had a BMI of 18.5 to 29.9 kg/m2, a serum LDL >150 mg/dL, and an estimated ASCVD risk of <20%. At the end of the washout period, patients were restarted on the same medication, placebo, or berberine, for an additional 3 months. 2 High Cholesterol Nutrition Can Berberine Lower Your Lipid Levels? It has a cholesterol-lowering effect, which may help prevent heart disease. The data demonstrate that berberine can reducethe TC level of the patients (Figure 4). Berberine can be used to treat many diseases, such as cancer and digestive, metabolic, cardiovascular, and neurological diseases. Asbaghi O., Ghanbari N., Shekari M., Reiner ., Amirani E., Hallajzadeh J., et al. Common study limitations included lack of reporting of precision in their endpoints, description of blinding, transparency in flow of patients, and reporting of baseline concomitant medications. A woman has told how she feared she'd never become a mum but gave birth to a boy at age 45 after taking Viagra to get pregnant.. Carin Rockind, 48, welcomed a "miracle" baby after trying to have a . As if these berberine benefits weren't enough, the compound also "minimizes the absorption of carbs and fat from the food we eat," according to berberine fan Stephanie Redmond, PharmD., co . Excluding duplicates, a total of 21 articles were identified for possible inclusion. It is thought to upregulate the expression of LDL receptors (LDLR) on hepatocytes by stabilizing LDLR mRNA, and suppress the expression of proprotein convertase substilisin/kexin type 9 (PCSK9) by accelerating degradation of hepatocyte nuclear factor 1 (HNF1) and decreasing PCSK9 mRNA transcription.68 Its effects on PCSK9 are of particular interest, considering the recent Food and Drug Administration approval of PCSK9 inhibitors as a new class of highly effective lipid-lowering drugs. At the end of 3 months, the LDL levels were 140 23 and 157 20 mg/dL, respectively, in the berberine and placebo groups (P < .05). Additionally, the study only included patients with moderate cardiovascular risk and primary hypercholesteremia, so the results can only be applied to this subgroup of patients. sharing sensitive information, make sure youre on a federal In the process of foam cell formation, autophagy reportedly contributes to the facilitation of cholesterol discharge and the enhancement of intracellular . Other cholesterol parameters measured at baseline included TC (239.4 2.8 and 234.3 2.9 mg/dL for the NC group and the calcium + vitamin D group, respectively), HDL cholesterol (53.9 1.38 and 51.7 1.26 mg/dL, respectively), and TG (180.9 9.95 and 175.2 7.51 mg/dL, respectively). The treatment difference between these groups was 10.46 mg/dL (95% CI 19.81 to 1.12 mg/dL, P = .029). The site is secure. The study only assessed the use of the medication in elderly patients, so the results should only be applied to this patient population.20, A prospective, multicenter, double-blind, randomized trial assessed the effects of an NC pill versus placebo in participants who had mild to moderate hypercholesterolemia.21 The study included 102 patients who were >18 years of age, had LDL cholesterol between 130 and 189 mg/dL, and were not eligible for pharmacotherapy intervention but were eligible for lifestyle modifications. The identified patients were randomized in a 1:1 ratio to receive placebo or Armolipid Plus, a European NC product containing berberine 500 mg, policosanol 10 mg, red yeast rice 200 mg, folic acid 0.2 mg, coenzyme Q10 2 mg, and astaxanthin 0.5 mg, for a total of 12 weeks. Figure 4 illustrates the efficacy of berberine treatment on TC. Effects of berberine on lipid profile in subjects with low cardiovascular risk, Eulipidemic effects of berberine administered alone or in combination with other natural cholesterol-lowering agents. (3) Blinding of participants and personnel (performance bias): the literature states that a double-blind study design is considered low risk. Srivastava R. A. K., Pinkosky S. L., Filippov S., Hanselman J. C., Cramer C. T., Newton R. S. (2012). Authors did not specify that safety data would be collected; however, CPK and liver enzyme values were assessed.24, The number of patients placed in each group is unclear. 5 min read. Simvastatin-induced Cognitive Dysfunction: Two Case Reports. It might help strengthen the heartbeat, which could benefit people with certain heart conditions. No significant difference in the change in HDL levels was seen between the berberine group and the placebo group (51 18 to 53 31 mg/dL in the berberine group vs 50 10 to 50 9 mg/dL in the placebo group, P = .415).16, A limitation of this trial was the lack of statistical analysis: there was no discussion of effect size or confidence intervals. Forest plot illustrates the differences in changes in fasting plasma glucose in adults with metabolic disease who did or did not receive berberine in 13 trials (n = 1,052). At this stage, the common clinical treatment strategy is mostly the combined use of hypolipidemic and hypoglycemic drugs. Kong W., Wei J., Abidi P., Lin M., Inaba S., Li C., et al. Zilaee M., Kermany T., Tavalaee S., Salehi M., Ghayour-Mobarhan M., Ferns G. A. Yang J., Leng J., Li J.-J., Tang J.-f., Li Y., Liu B.-L., et al. The difference between 3-month TC values in the 2 groups was statistically significant (P < .001). Secondary outcomes of the study included changes in TC, LDL, HDL, TG, and treatment tolerability.26, Fifty patients were randomized to each treatment group (NC pill or EZE). Berberine has a theorized mechanism that is similar to PCSK9 inhibitors, and it has been postulated that combination therapy of berberine with red yeast rice is pharmacologically analogous to combination therapy of PCSK9 inhibitors with statins. The TG level in the berberine group decreased from 97 79 mg/dL at baseline to 62 43 mg/dL after 3 months (P < .000 for change from baseline); in the placebo group, TG increased from 76 36 to 79 49 mg/dL (P = .543 for change from baseline). Previous studies have demonstrated that metabolic disorders are prone to diabetic encephalopathy and atherosclerosis (Barenbrock et al., 1995), which will generate Alzheimers disease and coronary heart disease (Razay et al., 2007). The majority of evaluated articles consistently suggest that berberine has a beneficial effect on low-density lipoprotein (reductions ranging from approximately 20 to 50 mg/dL) and triglycerides (reductions ranging from approximately 25 to 55 mg/dL). Based on the effects of dose and time on different monitoring indicators, subgroup analysis can also be used as a clinical treatment guide. (2016). (2008). Ethical Approval: It was determined that this project was exempt from institutional review board review. Razay G., Vreugdenhil A., Wilcock G. (2007). The difference in administration frequency and lack of blinding increases the risk of bias. The primary outcome was the reduction in TC at the end of 6 weeks; secondary endpoints included LDL, TG, and HDL. Our findings are consistent with previous studies showing a beneficial effect of berberine on total cholesterol and possibly LDL-c [5,6,24]. These results were also compared to those achieved with pravastatin. A Systematic Review and Meta-Analysis of Randomized Controlled Trials on the Effects of Turmeric and Curcuminoids on Blood Lipids in Adults with Metabolic Diseases. Meta-analysis and migration analysis of the effect of berberine on fasting plasma glucose. Eight trials specified a double-blind study design. Statins are recommended in individuals with clinical ASCVD, LDL >190 mg/dL, diabetes mellitus aged 40 to 75 years with LDL 70 to 189 mg/dL and without clinical ASCVD, or LDL 70 to 189 mg/dL and ASCVD risk at least 7.5%. (2006). No patient discontinued study treatment or reported adverse effects.26, One caveat to this study is although baseline characteristics were similar between the NC and EZE groups at baseline, the average baseline LDL in both groups was below the prespecified inclusion criteria value of >160 mg/dL (mean LDL values were 149 16 and 150 8 mg/dL in the NC and EZE groups, respectively). The percent change in TC was 13.5% 0.7% versus 0.2% 0.5% with placebo (P < .001), the percent change in HDL cholesterol was +4.7% 1.5% versus 1.2% 1.0% with placebo (P < .001), and the percent change in TG was 18.9% 2.5% versus 1.3% 1.2% with placebo (P < .001). (2015). HHS Vulnerability Disclosure, Help We used RevMan5.2 software, random-effect models, or fixed-effect models (selection criteria is heterogeneity test I It should be noted that most trials provided berberine in formulations that included other herbal products (see Table 2). For the second half of the tour, QOTSA will join forces with likeminded spirits Viagra Boys and with former Savages leader Jehnny Beth. Twenty-eight patients in the MBP-NC group and 29 patients in the placebo group completed the study. The original contributions presented in the study are included in the article/Supplementary Material, further inquiries can be directed to the corresponding authors. Figure 1 illustrates the primary reasons for exclusion of articles. (2018). Authors neither discussed how sample size was determined, nor did they specify a particular lipid value as the primary efficacy endpoint. AW and AR led the summary and evaluation of identified studies, and LMK led the editing and proofreading process. Among the factors, TG, TC, LDL, HDL, HOMA-IR, and FPG were random-effect models (I The objective of this review is to identify, summarize, and evaluate clinical trials to determine the efficacy of berberine, both alone and in combination with other herbal products, for the treatment of hyperlipidemia and other dyslipidemias. The Consolidated Standards of Reporting Trials (CONSORT) Extension for Reporting Herbal Medicinal Interventions14 was used as the primary basis for evaluation of study quality; however, other author-identified limitations were also considered. Marazzi G, Cacciotti L, Pelliccia F, et al. The BERB group had 8 males (mean age: 55.4 14.2 years) and 12 females (mean age: 63.8 12.1 years); the COMB group also had 8 males (mean age: 57.8 14.2 years) and 12 females (mean age: 63.1 16.2 years). Figure 5 illustrates the efficacy of berberine treatment on LDL. Figure 7 illustrates the efficacy of berberine treatment on HOMA-IR. The mean difference (blue squares), 95% CI (horizontal lines through blue squares), and pooled-effect sizes (green diamonds) were presented using random-effect Hedges models. The details were related to the six domains that contained (1) random sequence generation (selection bias): the literature proclaims that the random sequence method is considered low risk. 6) Differences may be found in the efficacy and metabolism of drugs for different races, and more data are needed to verify the results. However, aside from inhibiting the intestinal absorption of cholesterol, the effects of BBR on other metabolic pathways of cholesterol . The frequency of return visits and specific procedures during the experiment are not mentioned. The majority of patients had a low 10-year cardiovascular risk (78.4% and 82.4% of patients in the intervention and placebo groups, respectively). Berberine is clinically safe and well-tolerated by the human body. All patients were instructed to follow a hypolipidic diet (low cholesterol/low saturated fat). Average LDL cholesterol levels at baseline were 148.2 3.03 mg/dL for the NC group and 151.2 3.02 mg/dL for the calcium + vitamin D group. After 12 weeks of treatment, patients continued their assigned therapy only if they had achieved the primary endpoint goal of LDL <100 mg/dL. As a library, NLM provides access to scientific literature. Clinical Study of Berberine Intervention in Patients with Impaired Fasting Blood Glucose (Chinese), Clinical Study of Berberine Intervention in Delaying the Development of Diabetes in Pre-diabetic Population (Chinese). Guo Y, Chen Y, Tan ZR, Klaassen CD, Zhou HH. In March 2016, a literature search using a combination of the terms berberine, hyperlipidemia, cholesterol, and dyslipidemia was performed using PubMed, both with and without medical subject headings (MeSH) terminology. Attrition rate was low with 137 patients completing the study. 8600 Rockville Pike The investigators reported that no deaths were observed during the 12-month follow-up period. Interpretation of Random Effects Meta-Analyses. FOIA 2 (2011). (2009). An official website of the United States government. The Metabolic Syndrome and Alzheimer Disease. Effect of Statins on Fasting Plasma Glucose in Diabetic and Nondiabetic Patients. They also did not delineate specific primary and secondary outcomes. The Search strategy is (Berberine OR Berberine Alkaloids OR Berberine hydrochloride OR Berberidaceae OR Berberis vulgaris L. OR Coptidis Rhizoma OR Berberis) AND (diabetes OR metabolic syndrome OR hyperinsulinemia OR hyperglycemia OR diabetes mellitus OR insulin resistance OR glycemic OR glycaemic OR hyperlipidemia OR hypertension OR hypercholesterolemia OR hypertriglyceridemia OR lipid metabolism OR dyslipidemia OR overweight OR obese OR obesity OR hepatic adipose infiltration OR low-density lipoprotein cholesterol OR low-density lipoprotein cholesterol OR high-density lipoprotein cholesterol OR LDL-c OR HDL-c OR total cholesterol OR TC OR triglycerides OR TC OR adipokine OR adiponectin OR adiponectins OR leptin OR leptins) AND (human [MeSH Terms] OR Clinical Trial OR Controlled Clinical Trial). Efficacy of Berberine in Patients with Non-Alcoholic Fatty Liver Disease. Hyperlipidemia is a major risk factor for cardiovascular disease that affects approximately 33.5% of the US population.1 When high lipid levels are present in the blood, lipids begin to deposit in the walls of the arteries, forming plaques. 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