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Berberine

Research reviewed: up until 12/23

Berberine is a dietary supplement with 14 published peer-reviewed studies involving 1,519 participants, researched for Diabetes, Cardiovascular Health, GI Health and 3 more areas.

14
Studies
1,519
Participants
2003–2023
Research Span

Evidence at a Glance

Strength is scored by study design, sample size, study type, and outcomes

Overall: Strong Evidence

Diabetes

Moderate
3 studies 1 of 3 positive 201 participants

Cardiovascular Health

Strong
5 studies 3 of 5 positive 749 participants

GI Health

Moderate
2 studies 1 of 2 positive 260 participants

Schizophrenia

Moderate
1 study 0 of 1 positive 106 participants

Anti-inflammatory

Moderate
1 study 1 of 1 positive 130 participants

Metabolic function

Moderate
2 studies 0 of 2 positive 73 participants

Research Visualised

Visual breakdown of the clinical data.

Study Quality Breakdown

What types of studies were conducted

12/14
Randomised
10/14
Double-Blind
11/14
Placebo-Controlled

Participants Per Study

Larger samples = more reliable results

Study 1 (2008)
116
Study 2 (2008)
36
Study 3 (2023)
49
Study 1 (2003)
156
Study 2 (2013)
144
Study 3 (2004)
91
Study 4 (2019)
158
Study 4 (2022)
200

Research Timeline

When the studies were published

1
2003
1
2004
2
2008
1
2012
2
2013
1
2015
2
2019
2
2022
2
2023

All Studies

Detailed breakdown of each trial. Click to expand.

Diabetes

1

To evaluate the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia, a medical condition characterised by abnormal levels of lipids (fats) in the blood.

2008 116 participants 3-month treatment period 1 g of berberine (2 x 0.5 g tablets) or placebo
Human Study RCT Double-Blind Placebo Mixed

Study Type

Randomised, double-blind, placebo-controlled trial

Purpose

To evaluate the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia, a medical condition characterised by abnormal levels of lipids (fats) in the blood.

Dose

1 g of berberine (2 x 0.5 g tablets) or placebo

Participants

116 male and female patients with type 2 diabetes and dyslipidemia with an average age of 51 years (106 competed the study)

Duration

3-month treatment period

Results

Fasting plasma glucose decreased from 7.0 to 5.6 mM/litre with berberine and decreased from 6.8 to 6.4 mM/litre with placebo, with corresponding falls in postload plasma glucose from 12.0 to 8.9 vs. 12.2 to 11.0 and in Haemoglobin A1c (HbA1c), a measure of average blood sugar levels from 7.5 to 6.6% vs. from 7.6 to 7.3, with all parameters differing significantly. Triglyceride decreased from 2.51 to 1.61 mM/L with berberine treatment and increased from 1.97 to 2.05 mM/L with placebo, total cholesterol decreased from 5.31 to 4.35 mM/L vs. 5.38 to 5.28 mM/L, and LDL cholesterol (bad cholesterol) decreased from 3.23 to 2.55 mM/L vs. 3.37 to 0.74 mM/L. If there is an excess of LDL cholesterol or if it is not effectively removed from the bloodstream, it can contribute to the formation of atherosclerosis, a condition where plaque builds up in the arteries. This can narrow and block blood vessels, leading to reduced blood flow to the heart or brain, which can result in heart attacks or strokes. A decrease in LDL cholesterol is generally considered a positive outcome for cardiovascular health. Berberine treatment also led to a greater reduction in body weight and BMI compared to the placebo group. Mild to moderate constipation occurred in five participants receiving berberine and one participant in the placebo group. However, the frequency of constipation was not significantly different between the berberine and placebo groups.

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2

To assess the efficacy of berberine To compare the effects of berberine with metformin (a medication often prescribed as a first-line treatment for type 2 diabetes) in human subjects with type 2 diabetes and to evaluate the additive effects of berberine on the classical anti-diabetic treatments.

2008 36 participants 13-week treatment Study A: 1500 mg/day berberine (3 x 500 mg capsules at the b...
Human Study Mixed

Study Type

Pilot study

Purpose

To assess the efficacy of berberine To compare the effects of berberine with metformin (a medication often prescribed as a first-line treatment for type 2 diabetes) in human subjects with type 2 diabetes and to evaluate the additive effects of berberine on the classical anti-diabetic treatments.

Dose

Study A: 1500 mg/day berberine (3 x 500 mg capsules at the beginning of each meal) or 1500 mg/day metformin (3 x 500 mg capsules after major meal) Study B (uncontrolled): 1500 mg/day berberine (in addition to the participants’ existing treatment e.g. sulfonylureas, metformin, acarbose or insulin therapy alone or with a combination) If heavy gastrointestinal adverse effects occurred, the dose of berberine was reduced to 300 mg 3 times daily.

Participants

Study A: 36 male and female newly diagnosed patients for type 2 diabetes (31 completed the study) Study B: 48 male and female type 2 diabetes patients with existing anti-diabetic treatment (43 completed the study)

Duration

13-week treatment

Results

Results from study A revealed similar effects between berberine and metformin, demonstrating significant reductions by the study's conclusion in Haemoglobin A1c (HbA1c), a metric reflecting average blood sugar levels over time (decreasing from 9.5% to 7.5% in the berberine group and from 9.15% to 7.7% in the metformin group), fasting blood sugar (reducing from 10.6 mmol/L to 6.9 mmol/L in the berberine group and from 9.96 mmol/L to 7.16 mmol/L in the metformin group), and postprandial blood sugar, a measure of blood sugar levels post-meal (falling from 19.8 mmol/L to 11.1 mmol/L in the berberine group and from 20.5 mmol/L to 12.9 mmol/L in the metformin group). These reductions signify enhanced blood sugar control. Additionally, the berberine group demonstrated significant decreases in plasma triglycerides (from 1.13 mmol/L to 0.89 mmol/L) and total cholesterol (from 4.40 mmol/L to 3.83 mmol/L) compared to the start of the study, while no significant changes were observed in the metformin group. High levels of plasma triglycerides are often associated with an increased risk of heart disease and other health problems. Reductions in HDL-cholesterol (good cholesterol) and LDL-cholesterol (bad cholesterol) were also observed however these results were not significant. In study B where berberine was used in combination with an existing anti-diabetic treatment, the researchers observed consistent improvements in diabetic patients with significant decreases in HbA1c (from 8.1% to 7.3%), fasting blood sugar(9.6 to 7.6 mmol/L), and postprandial blood sugar (from 14.8 to 9.7 mmol/L). Fasting plasma insulin and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) were significantly reduced by 28.1% and 44.7%, respectively. Both fasting plasma insulin and HOMA-IR are valuable measurements in understanding insulin resistance, a condition where the body's cells do not respond effectively to insulin, a hormone produced by the pancreas that regulates blood sugar levels. Reductions in these parameters may suggest improved insulin sensitivity, meaning that the body is more effectively using insulin to regulate blood glucose levels. Interestingly, when berberine was used together with insulin, patients exhibited significant increases in fasting and postprandial C-peptides, which suggests that long-term berberine treatment may improve insulin secretion of the patients. C-peptides are short chains of amino acids that are released into the bloodstream during the synthesis of insulin. The researchers also observed significant decreases in total cholesterol (from 4.97 to 4.38 mmol/L) and LDL cholesterol (3.00 mmol/L to 2.59 mmol/L) at week 13 compared to the start of the study. A decrease in total and LDL cholesterol (bad cholesterol) levels typically signifies an improvement in cardiovascular health, reducing the risk of atherosclerosis and related complications. Moreover, the safety assessment found that berberine did not cause any liver or kidney damage, although 34.5% patients experienced temporary gastrointestinal adverse effects.These events included diarrhoea (10.3%), constipation (6.9%), flatulence (19.0%) and abdominal pain (3.4%). The side effects were observed only in the first four weeks in most patients. In combination-therapy, the adverse events disappeared in one week after reduction in berberine dosage (900 mg/day). The researchers concluded that berberine at dosage of 300 mg thrice daily is well tolerated in combination-therapy.

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3

To evaluate the potential benefit of oral intake of berberine on glycemic (blood sugar levels) and lipid (fat and cholesterol levels) values in individuals with impaired fasting blood sugar, a condition sometimes referred to as prediabetes in which the body is having difficulty regulating blood sugar levels, but the levels are not yet high enough to be classified as diabetes.

2023 49 participants 2 months 376 mg/day of berberine (2 x 188 mg of berberine tablets, ta...
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomised, double-blind, placebo-controlled trial

Purpose

To evaluate the potential benefit of oral intake of berberine on glycemic (blood sugar levels) and lipid (fat and cholesterol levels) values in individuals with impaired fasting blood sugar, a condition sometimes referred to as prediabetes in which the body is having difficulty regulating blood sugar levels, but the levels are not yet high enough to be classified as diabetes.

Dose

376 mg/day of berberine (2 x 188 mg of berberine tablets, taken before lunch and dinner) or placebo

Participants

49 male and female overweight subjects with an average age of 60 years

Duration

2 months

Results

The researchers observed that after two months of berberine treatment, there was a statistically significant difference between the supplemented and placebo groups in terms of glycemia (a measure of the amount of sugar present in the bloodstream), with a greater significant decrease observed in the berberine-treated group (from 6.15 mmol/L to 5.42 mmol/L vs 6.22 mmol/L to 5.97 mmol/L in the placebo group). In addition to glycemia, the study also found an association between administration of berberine and a significant decrease in insulin levels in the supplemented group from 18.03 mcIU/mL at the start of the study to 12.75 mcIU/mL. These changes were significantly greater than that of the placebo group (from 13.67 mcIU/ML to 11.92 mcIU/mL). The berberine supplemented group also showed improvements in lipid profile, with statistically significant reductions observed in total cholesterol levels, triglycerides, and the total/HDL cholesterol ratio. The total cholesterol to HDL (high-density lipoprotein) cholesterol ratio is a measure used in assessing cardiovascular risk. HDL cholesterol is often referred to as "good" cholesterol because it helps remove other forms of cholesterol from your bloodstream. A lower total/HDL cholesterol ratio is generally considered better because it suggests a higher proportion of HDL cholesterol compared to total cholesterol. Furthermore, the researchers also observed a decrease in the ApoB/ApoA ratio following berberine treatment. The ApoB/ApoA ratio refers to the ratio of apolipoprotein B (ApoB) to apolipoprotein A (ApoA) in the blood. Apolipoproteins are proteins that bind to lipids (fats) to form lipoproteins. A lower ApoB/ApoA ratio is often associated with a lower risk of cardiovascular events. No side effects were reported with the administration of berberine, suggesting its potential use as a natural alternative to pharmacological therapies for impaired fasting blood sugar.

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Cardiovascular Health

1

To assess the efficacy and safety of berberine for chronic congestive heart failure, a medical condition where the heart is unable to pump blood effectively, leading to inadequate circulation of blood throughout the body To examine Berberine's effects in patients with chronic heart failure, a medical condition where the heart is unable to pump blood effectively, leading to inadequate circulation of blood throughout the body.

2003 156 participants 8 weeks 8 weeks 1.2-2.0 g/day of berberine (4 x 0.3-0.5 g tablets) or placeb...
Human Study RCT Placebo Positive

Study Type

Randomised, single-blind, placebo-controlled trial Randomised, single-blind, placebo-controlled trial

Purpose

To assess the efficacy and safety of berberine for chronic congestive heart failure, a medical condition where the heart is unable to pump blood effectively, leading to inadequate circulation of blood throughout the body To examine Berberine's effects in patients with chronic heart failure, a medical condition where the heart is unable to pump blood effectively, leading to inadequate circulation of blood throughout the body.

Dose

1.2-2.0 g/day of berberine (4 x 0.3-0.5 g tablets) or placebo 1.2-2.0 g/day of berberine (4 x 0.3-0.5 g tablets) or placebo

Participants

156 male and female patients with chronic congestive heart failure, with an average age of 64 years. 156 male and female patients with chronic congestive heart failure, with an average age of 64 years

Duration

8 weeks 8 weeks

Results

The researchers observed greater significant improvements in cardiac function based on the NYHA classification among patients treated with berberine compared to the placebo group. In the treatment group, the NYHA classification improved from an initial average of 2.9 (indicating moderate to severe symptoms) to 2.0 (reflecting mild to moderate symptoms), while in the placebo group, the NYHA classification showed a modest improvement from an initial average of 2.9 to 2.4. Patients who received berberine also demonstrated significantly greater improvements in exercise capacity and the heart's ability to pump blood (Left Ventricular Ejection Fraction) compared to the control group. Additionally, they reported experiencing less shortness of breath, reduced fatigue, and fewer abnormal heartbeats. These findings indicate that berberine may be effective in enhancing the health outcomes of patients with congestive heart failure. During long-term follow-up, the berberine-treated patients exhibited a lower total mortality rate (8.8%, 7 patients) compared to the placebo group (16.4%, 13 patients). This decrease was attributed to a notable reduction in both sudden cardiac death and death due to congestive heart failure. Additionally, the berberine-treated patients experienced fewer hospital admissions (20.2%, 16 patients) in contrast to the placebo group (36.3%, 28 patients). There was a nonsignificant trend toward an increase in gastrointestinal side effects, consisting of diarrhoea, constipation, vomiting, and abdominal pain that did not result in discontinuation of medications or evidence of worsening congestive heart failure. Participants with heart-failure who took berberine experienced significantly greater improvements in heart function and exercise capacity compared to the control group. They also reported less shortness of breath, less fatigue, and fewer abnormal heartbeats, and long-term follow-up revealed fewer deaths due to sudden cardiac death and congestive heart failure.

How They Measured It

Cardiac function was assessed using the New York Heart Association (NYHA) classification system, which categorises patients based on their symptoms and functional limitations. The classification system consists of four classes, ranging from Class I (mild symptoms and no limitation of physical activity) to Class IV (severe symptoms and inability to carry out any physical activity without discomfort). Exercise capacity was assessed using the 6-minute walking distance which measures patients' exercise tolerance.

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2

To evaluate the effects of berberine in patients with low cardiovascular risk.

2013 144 participants 6 months treatment period 1000 mg/day of berberine (2 x 500 mg capsules, taken at lunc...
Human Study RCT Double-Blind Placebo Positive

Study Type

Multicenter, double-blind, randomised, placebo-controlled, clinical trial

Purpose

To evaluate the effects of berberine in patients with low cardiovascular risk.

Dose

1000 mg/day of berberine (2 x 500 mg capsules, taken at lunch and dinner) or placebo

Participants

144 male and female patients with an average age of 53 years (137 completed the study)

Duration

6 months treatment period

Results

The researchers observed reduced total cholesterol (-11.6%), triglycerides (-21.2%), and LDL cholesterol (-16.4%), as well as increased HDL cholesterol (+9.1%) after 3 months of berberine treatment. LDL cholesterol, commonly termed as "bad cholesterol," is linked to an elevated risk of cardiovascular diseases due to its association with atherosclerosis (characterised by the gradual buildup of plaque such as cholesterol, fatty deposits, etc inside the arteries). Conversely, HDL cholesterol, known as "good cholesterol," exerts a protective effect on the cardiovascular system. An improvement in heart health is indicated when LDL cholesterol decreases and HDL cholesterol increases, resulting in a more favourable lipid profile. No significant changes were observed in the placebo group in any of the parameters measured. After the 2 months washout period (time during which participants refrain from taking any intervention related to the study), lipid (fat) profile worsened in the berberine group with significant increases in total cholesterol (+18.4%), LDL cholesterol (+23.6%) and triglycerides (+30.3%) were observed. There was also a significant decrease in HDL-cholesterol after the washout period (-8.9%) in the berberine group, while no significant changes were obtained in the placebo group. Afterwards, when berberine was reintroduced, the lipid profile improved again, both compared with the washout period and with the placebo. A significant decrease in total cholesterol and LDL-cholesterol was observed after 2 months (-12.9% and -17.9%, respectively) and after 3 months compared with the washout period (-18.0% for total cholesterol and -23.0% for triglycerides) in the berberine group. Additionally, there was a significant increase in HDL cholesterol (+10.9%) and a decrease in triglycerides (-25%) compared to the washout period, three months after berberine reintroduction. These trends were not observed with the placebo. Moreover, all lipid profile values recorded three months after the reintroduction of berberine showed improvement compared with the placebo group. No patients had serious adverse events in both groups; one patient reported transient headache and two patients reported transient flatulence. The researchers concluded that berberine may be both effective and safe for mildly improving the lipid profile in individuals with a low risk of cardiovascular disease.

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3

To investigate the cholesterol-lowering effects of berberine in patients with elevated cholesterol levels (hypercholesterolemic) To investigate the cholesterol-lowering effects of berberine

2004 91 participants 3 months 3 months 1 g/day of berberine (2 x 0.5 g) or placebo 1 g/day of berbe...
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomised, double-blind, placebo-controlled trial Randomised, double-blind, placebo-controlled trial

Purpose

To investigate the cholesterol-lowering effects of berberine in patients with elevated cholesterol levels (hypercholesterolemic) To investigate the cholesterol-lowering effects of berberine

Dose

1 g/day of berberine (2 x 0.5 g) or placebo 1 g/day of berberine or placebo

Participants

91 hypercholesterolemic male and females 91 men and women with elevated cholesterol levels

Duration

3 months 3 months

Results

The researchers observed a significant decrease by 18% in serum cholesterol, by 28% in triglycerides, and by 20% in LDL cholesterol (often referred to as "bad" cholesterol because elevated levels can contribute to the buildup of plaque in the arteries) among participants after 3 months of berberine treatment compared to the levels at the start of the study. No significant effects were observed in any of these parameters in the placebo group. The researchers wanted to further ensure that the results were not influenced by other medications, so they re-evaluated the data by analysing only the participants who were not taking any other drugs or herbs and were not on special diets before or during the berberine therapy (n=32). The results showed that patients taking berberine have significantly lowered the levels of cholesterol by 29%, triglycerides by 35%, and LDL cholesterol by 25%. The level of HDL cholesterol remained unchanged. All subjects tolerated berberine well and no side effects were observed, with the exception of one subject having mild constipation during treatment, which was relieved after reducing the dose to 0.25 g twice per day. After 3 months of berberine treatment, significant health improvements were observed: there was an 18% decrease in cholesterol, a 28% reduction in triglyceride levels, and a 20% reduction in bad cholesterol (LDL), with no similar observations in the placebo group. Further analysis focusing on individuals not taking other medications or special diets revealed even more pronounced effects of berberine, including a 29% drop in cholesterol, a 35% decrease in triglycerides, and a 25% reduction in bad cholesterol, while good cholesterol (HDL) remained unchanged. Berberine was well-tolerated, with the exception of one individual experiencing mild constipation, which was resolved by adjusting the dosage.

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4

To evaluate the effects of a nutraceutical combination of berberine, red yeast rice extract and policosanol (a nutraceutical compound) in reducing left ventricular mass (the amount of muscle tissue in the left ventricle of the heart) in patients with metabolic syndrome and left ventricular hypertrophy, a condition where the muscle wall of the left ventricle becomes thickened, usually as a result of high blood pressure or other factors.

2019 158 participants 24 weeks 500 mg of berberine with 200 mg red yeast rice and 10 mg pol...
Human Study RCT Double-Blind Placebo Positive

Study Type

Multicenter, randomised, double-blind, placebo-controlled trial

Purpose

To evaluate the effects of a nutraceutical combination of berberine, red yeast rice extract and policosanol (a nutraceutical compound) in reducing left ventricular mass (the amount of muscle tissue in the left ventricle of the heart) in patients with metabolic syndrome and left ventricular hypertrophy, a condition where the muscle wall of the left ventricle becomes thickened, usually as a result of high blood pressure or other factors.

Dose

500 mg of berberine with 200 mg red yeast rice and 10 mg policosanol per tablet per day or placebo

Participants

158 male and female patients with an average age of 56 years (145 completed the study)

Duration

24 weeks

Results

The researchers observed a significant reduction by -2.7% in left ventricular mass in the group treated with a nutraceutical combination of berberine, red yeast rice extract and policosanol compared to the values at the start of the study (52.6 g/m2.7 vs 54.1 g/m2.7 at the start of the study). On the other hand, a mild increase in left ventricular mass was observed in the placebo group from 52.3 g/m2.7 at the start of the study to 53.0 g/m2.7). An increase in left ventricular mass leads to left ventricular hypertrophy, a condition where the muscular wall of the left ventricle, the main pumping chamber of the heart, becomes thickened. This thickening is often a response to conditions such as high blood pressure or other factors that make the heart work harder, and it can lead to changes in the heart's structure and function, potentially increasing the risk of cardiovascular events. Furthermore, the proportion of subjects showing reduction of left ventricular mass from the start of the study was significantly higher in the intervention group with 42 subjects (57%) than in the placebo group with 20 subjects (28%). The study also found an association between treatment with the nutraceutical combination and improvements in lipid (fat) profile, including significant reductions in total cholesterol, low density lipoprotein-cholesterol (bad cholesterol), and triglycerides, as well as an improvement in high density lipoprotein-cholesterol (good cholesterol). These improvements were not observed in the placebo group. Overall. the results suggest that a 24-week treatment with a nutraceutical combination of berberine, red yeast rice extract and policosanol has the potential to effectively reduce left ventricular mass in subjects with metabolic syndrome and left ventricular hypertrophy, as well as improve lipid profile, potentially reducing the associated cardiovascular risk.

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4

To investigate the effects of berberine on postoperative atrial fibrillation, the most common complication of cardiac surgery often characterised by an irregular and often rapid heart rate. To research how berberine affects irregular and often fast heartbeats after heart surgery.

2022 200 participants 14-day treatment (7 days before surgery and 7 days post operation) 14-day treatment (7 days before surgery and 7 days post operation) 1.2 g/day of berberine (3 x 0.4 g) or placebo 1.2 g/day of b...
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomised, double-blind, placebo-controlled trial Randomised, double-blind, placebo-controlled trial

Purpose

To investigate the effects of berberine on postoperative atrial fibrillation, the most common complication of cardiac surgery often characterised by an irregular and often rapid heart rate. To research how berberine affects irregular and often fast heartbeats after heart surgery.

Dose

1.2 g/day of berberine (3 x 0.4 g) or placebo 1.2 g/day of berberine or placebo

Participants

200 male and female patients, aged up to 80 years who underwent isolated coronary artery bypass grafting (a surgical procedure that is commonly performed to treat coronary artery disease). 200 male and female patients, up to 80 years old, who had surgery to treat coronary artery disease.

Duration

14-day treatment (7 days before surgery and 7 days post operation) 14-day treatment (7 days before surgery and 7 days post operation)

Results

Postoperative atrial fibrillation is the most common complication of cardiac surgery. In this study, the berberine group exhibited a lower incidence of postoperative atrial fibrillation, with 20 out of 100 patients (20%), compared to the placebo group, where 35 out of 100 patients (35%) experienced this condition. The study also found an association between berberine treatment and a significant decrease in lipopolysaccharide (a potent stimulator of the immune system and can trigger inflammation) and inflammation biomarkers such as CRP (C-reactive protein), and IL (interleukin)-6 levels. Elevated lipopolysaccharide after surgery has been found to be associated with postoperative atrial fibrillation. No serious adverse event was reported in the study. Two patients reported mild rash and 4 patients reported mild constipation after taking berberine. Overall, the findings suggest that the administration of berberine may be effective for reducing the occurrence of postoperative atrial fibrillation after coronary artery bypass grafting. Postoperative atrial fibrillation is the most common complication of cardiac surgery. In this study, the berberine group exhibited a lower incidence of postoperative atrial fibrillation, with 20 out of 100 patients (20%), compared to the placebo group, where 35 out of 100 patients (35%) experienced this condition. The study also found an association between berberine treatment and significant reductions in lipopolysaccharide (a potent immune system stimulator that triggers inflammation) and inflammation biomarkers. Higher levels of lipopolysaccharide after surgery have been associated with postoperative atrial fibrillation. No serious adverse events were reported in the study, with only two patients experiencing mild rash and four reporting mild constipation after taking berberine. Overall, the findings suggest that administering berberine may be effective in reducing the occurrence of postoperative atrial fibrillation following coronary artery bypass grafting.

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GI Health

1

To investigate the effects of berberine hydrochloride is effective in alleviating diarrhoea-predominant irritable bowel syndrome. To investigate whether berberine hydrochloride effectively relieves diarrhoea-predominant irritable bowel syndrome.

2015 196 participants 14 weeks (8-week treatment period) 14 weeks (8-week treatment period) 400 mg/day of berberine hydrochloride (2 x 200 mg tablet) or...
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomised, double-blind, placebo-controlled trial Randomised, double-blind, placebo-controlled trial

Purpose

To investigate the effects of berberine hydrochloride is effective in alleviating diarrhoea-predominant irritable bowel syndrome. To investigate whether berberine hydrochloride effectively relieves diarrhoea-predominant irritable bowel syndrome.

Dose

400 mg/day of berberine hydrochloride (2 x 200 mg tablet) or placebo (vitamin C) 400mg of a berberine hydrochloride supplement or placebo (vitamin C)

Participants

196 male and female patients with aged 18-65 years with diarrhoea-predominant irritable bowel syndrome (132 completed the study) 196 male and female patients aged 18-65 with irritable bowel syndrome

Duration

14 weeks (8-week treatment period) 14 weeks (8-week treatment period)

Results

After 8 weeks of berberine hydrochloride treatment, the researchers observed a significant reduction in diarrhoea frequency in the berberine group compared to the value at the start of the study (from 4.67 to 1.39). However, after the 8-week treatment period, the berberine group discontinued taking berberine hydrochloride for the next 4 weeks (follow-up period), and during this time, the diarrhoea frequency increased compared to week 8 (from 1.39 to 3.58). In contrast, there was no significant difference in diarrhoea frequency among different weeks in the placebo group. These findings indicate that berberine hydrochloride has a positive impact on reducing diarrhoea frequency in patients with IBS-D, but the effects may not be sustained after discontinuing the treatment. In addition, the researchers observed an average 64.6% reduction in abdominal pain frequency on week 8 in the berberine group compared to the initial abdominal pain frequency at the start of the study. On the other hand, there was a small reduction in the placebo group (29.4%). A significant reduction in the urgent need for defecation in patients with diarrhoea-predominant irritable bowel syndrome was also observed. Furthermore, patients taking berberine hydrochloride also exhibited a trend of improvement in irritable bowel syndrome symptom score, depression score, anxiety score, and irritable bowel syndrome quality of life compared to placebo. Overall, the results suggest that berberine hydrochloride has the potential to reduce symptoms and improve the quality of life in patients with diarrhoea-predominant irritable bowel syndrome. Participant questionnaires revealed that patients treated with berberine experienced significant improvements in symptoms of irritable bowel syndrome, including greater reductions in diarrhoea frequency, abdominal pain, and urgency to defecate over an 8-week period, compared to the control group.

How They Measured It

The frequency of diarrhoea, abdominal pain, urgent need for defecation, and the patients’ quality of life, were assessed using self-reported questionnaires which measure the frequency and severity of irritable bowel syndrome-related symptoms, as well as the domains of anxiety and depression.

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2

To investigate the effect of berberine hydrochloride on inflammatory factors and the diversity of intestinal flora (the collection of microorganisms that reside in the gastrointestinal tract) in patients with Parkinson's disease. Previous studies have shown an association between the imbalance of the intestinal flora and Parkinson's disease which provides a new avenue for the treatment of targeting and restoring the balance of the intestinal flora could potentially be a therapeutic strategy for managing Parkinson's disease.

2022 64 participants 3 months Control group: Conventional treatment for neurological disor...
Human Study RCT Positive

Study Type

Randomised clinical trial

Purpose

To investigate the effect of berberine hydrochloride on inflammatory factors and the diversity of intestinal flora (the collection of microorganisms that reside in the gastrointestinal tract) in patients with Parkinson's disease. Previous studies have shown an association between the imbalance of the intestinal flora and Parkinson's disease which provides a new avenue for the treatment of targeting and restoring the balance of the intestinal flora could potentially be a therapeutic strategy for managing Parkinson's disease.

Dose

Control group: Conventional treatment for neurological disorders (anticholinergic drugs, amantadine, and dopamine receptor agonists) were administered according to the patient’s condition Treatment group: 0.6 g/day of berberine (3 x 2 x 0.1 g tablets) in addition to conventional treatment

Participants

64 male and female patients with an average age of 53 years (observation group) and 54 years (control)

Duration

3 months

Results

After 3 months of treatment with berberine hydrochloride, the levels of interleukin-8, interleukin-6, and tumour necrosis factor-α, which are inflammatory factors that play important roles in the immune response and inflammation processes in the body, were significantly lower in the observation group compared to the control group. Lower levels of IL-8, IL-6, and TNF-α indicate reduced inflammation. The Chao index, Ace index, and Shannon index, which indicate the diversity of intestinal flora, were higher in the berberine group than in the control group after treatment. The Simpson index, which measures the evenness of species distribution, was lower in the observation group compared to the control group after treatment. Additional analysis showed a significant difference in the overall structure of the intestinal flora between the observation and control groups after treatment. Overall, the results suggest that berberine hydrochloride can improve the diversity and structure of intestinal flora in Parkinson's disease patients and reduce the expression of inflammatory factors.

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Schizophrenia

1

To investigate the effects of berberine in treating negative symptoms and cognitive deficits in adult patients with chronic schizophrenia. Negative symptoms in schizophrenia refer to a reduction or absence of thoughts and behaviours that the person used to have before becoming ill, including reduced emotions, speech, motivation, social engagement, and pleasure.

2023 106 participants 3 months 900 mg/day of berberine (3 x 300 mg tablets) or placebo
Human Study RCT Double-Blind Placebo Mixed

Study Type

Randomised, double-blind, placebo-controlled trial

Purpose

To investigate the effects of berberine in treating negative symptoms and cognitive deficits in adult patients with chronic schizophrenia. Negative symptoms in schizophrenia refer to a reduction or absence of thoughts and behaviours that the person used to have before becoming ill, including reduced emotions, speech, motivation, social engagement, and pleasure.

Dose

900 mg/day of berberine (3 x 300 mg tablets) or placebo

Participants

106 male and female patients with an average age of 43 (experimental group) and 45 years (placebo group)

Duration

3 months

Results

The patients who took berberine for three months experienced an improvement in their negative symptoms and cognitive function. They also showed a reduction in inflammatory markers such as interleukin-1β, interleukin-6, and tumour necrosis factor-α compared to the placebo group. In addition, there were positive correlations between the change in inflammatory markers and the changes in the scores of the clinical scales and cognitive tests after berberine treatment. This means that as the levels of these inflammatory markers decreased, there was an improvement in the negative symptoms and cognitive function of the patients. Previous research has suggested that medications with anti-inflammatory effects, such as antibiotics and non-steroidal anti-inflammatory drugs, can improve negative symptoms and cognitive impairments in schizophrenia. These correlations suggest that berberine, an anti-inflammatory agent, may have contributed to the improvement in negative symptoms and cognitive function.

How They Measured It

Negative symptoms were assessed using an assessment tool which involves a structured interview where a trained clinician observes and rates the severity of patient's behaviour, affect, and other indicators related to negative symptoms. Cognitive function was assessed using different learning tests which measured immediate memory, executive function (e.g. problem-solving and decision-making), attention and processing speed.

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Anti-inflammatory

1

To evaluate the effects of berberine on circulating inflammatory markers in patients with acute coronary syndrome following percutaneous coronary intervention. Acute coronary syndrome refers to a group of conditions that occur due to reduced blood flow to the heart muscle. Percutaneous coronary intervention has become a common therapeutic method for the treatment of coronary artery disease and acute coronary syndrome. However, after the said intervention, there can be an inflammatory response in the body as a result of the procedure. This inflammation can have adverse effects on the patient's clinical outcomes.

2012 130 participants 1-month berberine treatment 900 mg/day of berberine (3 x 300 mg) with standard therapy o...
Human Study Positive

Study Type

Quasi-experimental study

Purpose

To evaluate the effects of berberine on circulating inflammatory markers in patients with acute coronary syndrome following percutaneous coronary intervention. Acute coronary syndrome refers to a group of conditions that occur due to reduced blood flow to the heart muscle. Percutaneous coronary intervention has become a common therapeutic method for the treatment of coronary artery disease and acute coronary syndrome. However, after the said intervention, there can be an inflammatory response in the body as a result of the procedure. This inflammation can have adverse effects on the patient's clinical outcomes.

Dose

900 mg/day of berberine (3 x 300 mg) with standard therapy or control (standard therapy alone)

Participants

130 male and female patients

Duration

1-month berberine treatment

Results

The study found an association between berberine treatment in combination with standard therapy following percutaneous coronary intervention and significant reductions in total cholesterol by 20% and significant reductions in LDL cholesterol (bad cholesterol) by 24% relative to the values at the start of the study. Low levels of LDL cholesterol are generally beneficial for cardiovascular health, reducing the risk of atherosclerosis (the gradual buildup of plaque in arteries, causing them to harden and narrow, potentially leading to reduced blood flow and increased risk of complications). The control group also showed significant, albeit lower, reductions in LDL cholesterol levels, amounting to a 17% decrease. The researchers also observed significant reductions in various inflammatory markers compared to their initial levels at the start of the study in the berberine treated group. These inflammatory markers include: Matrix metalloproteinase (MMP)-9: an enzyme involved in tissue remodelling and inflammation. Intercellular adhesion molecule (ICAM)-1: a protein involved in the adhesion of immune cells to blood vessel walls during inflammation. Vascular cell adhesion molecule (VCAM)-1: another protein involved in the adhesion of immune cells to blood vessel walls during inflammation. C-reactive protein: a marker of inflammation in the body. Interleukin-6: a type of signalling molecule involved in inflammation. Monocyte chemoattractant protein-1: a type of signalling molecule that attracts immune cells to sites of inflammation. Furthermore, the changes in MMP-9, ICAM-1 and VCAM-1 from baseline to after 1 month of treatment differed significantly between the berberine and control groups. No severe adverse effects of berberine were observed, indicating its safety for use in patients with acute coronary syndrome following percutaneous coronary intervention.

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Metabolic function

1

To evaluate the effect of berberine administration on metabolic syndrome (a cluster of conditions that increase the risk of heart disease, stroke, and type 2 diabetes), insulin sensitivity, and insulin secretion. To evaluate the effect of berberine supplementation on metabolic syndrome, which encompasses a range of health problems such as high blood pressure, high blood sugar, excess waist fat, and abnormal cholesterol or triglyceride levels. These issues collectively increase the risk of heart disease, stroke, and type 2 diabetes.

2013 24 participants 3 months 3 months 1500 mg/day of berberine (3 x 500 mg) or placebo 1500 mg/day...
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomised, double-blind, placebo-controlled clinical trial Randomised, double-blind, placebo-controlled clinical trial

Purpose

To evaluate the effect of berberine administration on metabolic syndrome (a cluster of conditions that increase the risk of heart disease, stroke, and type 2 diabetes), insulin sensitivity, and insulin secretion. To evaluate the effect of berberine supplementation on metabolic syndrome, which encompasses a range of health problems such as high blood pressure, high blood sugar, excess waist fat, and abnormal cholesterol or triglyceride levels. These issues collectively increase the risk of heart disease, stroke, and type 2 diabetes.

Dose

1500 mg/day of berberine (3 x 500 mg) or placebo 1500 mg/day of berberine or placebo

Participants

24 male and female patients with a diagnosis of metabolic syndrome, aged 30-40 years 24 male and female patients with metabolic syndrome, aged 30-40

Duration

3 months 3 months

Results

After berberine administration, patients experienced a remission of 36% in the presence of metabolic syndrome. In addition, participants taking berberine demonstrated a significant decrease in blood pressure, triglycerides, area under the curve (AUC) of glucose (the total amount of sugar in the blood over a period of time), compared to the levels at the start of the study. These results can be indicative of improved blood glucose control. In addition, a decrease in area under the curve (AUC) of insulin (a hormone that helps regulate blood sugar levels) and the insulinogenic index were observed. The insulinogenic index is a measure of the ability of the pancreas to secrete insulin in response to a rise in blood sugar levels. A significant decrease in the insulinogenic index means that the patients had a reduction in their insulin secretion after taking berberine. The researchers also observed an increase in the Matsuda index, which is a measure of insulin sensitivity or the body's ability to respond to and use insulin effectively. An increase in the Matsuda index means that the patients had an improvement in their insulin sensitivity after taking berberine. There were no significant adverse events reported with the administration of berberine. Participants who took berberine experienced a 36% improvement in the symptoms of metabolic syndrome. This included significant improvements in waist circumference (a measure of abdominal obesity), systolic blood pressure, triglycerides (fat in the blood), blood sugar levels, total insulin secretion, and an increase in insulin sensitivity (how well the body uses insulin to control blood sugar).

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2

To investigate the effects of berberine on metabolic disturbances in patients with schizophrenia, a mental disorder characterised by abnormal social behaviour, disorganised thinking, hallucinations or delusions. Several studies have reported that individuals with schizophrenia often experience metabolic disturbances, with the prevalence of metabolic syndrome in schizophrenia being approximately 30%, roughly twice that of the general population.

2019 49 participants 8 weeks 900 mg/day of berberine hydrochloride (3 x 300 mg capsules) ...
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomised, double-blind, placebo-controlled trial

Purpose

To investigate the effects of berberine on metabolic disturbances in patients with schizophrenia, a mental disorder characterised by abnormal social behaviour, disorganised thinking, hallucinations or delusions. Several studies have reported that individuals with schizophrenia often experience metabolic disturbances, with the prevalence of metabolic syndrome in schizophrenia being approximately 30%, roughly twice that of the general population.

Dose

900 mg/day of berberine hydrochloride (3 x 300 mg capsules) or placebo

Participants

49 male and female patients with an average age of 45 years (berberine group) and 41 years (placebo group)

Duration

8 weeks

Results

The study found that berberine adjunctive treatment led to significant declines in total cholesterol, low-density lipoprotein cholesterol (LDL-cholesterol), fasting serum insulin, and insulin resistance in patients with schizophrenia compared to placebo. On average, the berberine group had a total cholesterol level that was 0.532 mmol/L lower than the placebo group and had an LDL-cholesterol level that was 0.474 mmol/L lower than the placebo group. LDL-cholesterol is often referred to as "bad cholesterol" because elevated levels are associated with an increased risk of cardiovascular diseases. Additionally, the berberine treatment group exhibited a 3.373 uU/mL lower fasting serum insulin and a 0.781 lower insulin resistance (HOMA-IR value) compared to the placebo group. When fasting serum insulin levels are lower, it often suggests that the body is efficiently managing blood sugar without requiring excessive insulin production. Additionally, a decrease in insulin resistance signifies improved sensitivity of cells to insulin, allowing for better regulation of glucose and, subsequently, improved metabolic function. Baseline body mass index and serum prolactin concentration were identified as predictive factors for the effect of berberine on insulin resistance. One patient withdrew due to abdominal distention, possibly related to berberine, but no serious adverse events occurred during the study.

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Frequently Asked Questions

Common questions about Berberine research

What does the research say about Berberine?

There are currently 14 peer-reviewed studies on Berberine, involving 1,519 total participants. Research covers Diabetes, Cardiovascular Health, GI Health and 3 more areas. The overall evidence strength is rated as Strong.

How strong is the evidence for Berberine?

The evidence is currently rated as "Strong Evidence". This rating is based on study design quality (randomisation, blinding, placebo controls), sample sizes, study types (14 human studies), and reported outcomes.

What health goals has Berberine been studied for?

Berberine has been researched for: Diabetes, Cardiovascular Health, GI Health, Schizophrenia, Anti-inflammatory, Metabolic function. Each area has its own body of evidence which you can explore in the study breakdowns above.

Are the studies on Berberine based on human trials?

Yes, 14 out of 14 studies are human trials. Human trials carry more weight in our evidence scoring system.