BergaCor Plus [Discontinued] by XYMOGEN

POSSIBLY EFFECTIVE

• Hyperlipidemia. Oral bergamot seems to reduce levels of low-density lipoprotein (LDL) cholesterol in patients with hyperlipidemia. It is unclear if bergamot is beneficial for improving high-density lipoprotein (HDL) cholesterol or triglyceride levels. Details: Preliminary clinical research in patients with hyperlipidemia shows taking a bergamot polyphenol fraction 1000 mg orally daily for 30 days increases HDL cholesterol and decreases total cholesterol, LDL cholesterol, and triglycerides similarly to rosuvastatin 10 mg daily, but to a lesser extent than rosuvastatin 20 mg daily. Taking the bergamot polyphenol fraction 1000 mg daily in combination with rosuvastatin 10 mg daily appears to result in similar improvements as those seen with rosuvastatin 20 mg daily (96357). A meta-analysis of 5 clinical trials shows that taking bergamot 500-1300 mg daily reduces total cholesterol, LDL cholesterol, and triglyceride levels, and increases HDL cholesterol levels. However, the included studies had high heterogeneity (109982). Clinical research in overweight or obese patients with mild hypercholesterolemia shows that taking bergamot phytosome (Vazguard, Indena SpA) 500 mg twice daily for 12 weeks modestly decreases total and LDL cholesterol, but does not affect HDL cholesterol or triglyceride levels, when compared with placebo (105317). Also, preliminary clinical research in statin-intolerant patients with moderate hypercholesterolemia shows that taking a specific bergamot extract (Bergavit, Bionap) providing 150 mg flavonoids daily for 6 months reduces LDL cholesterol and triglycerides by 20% and 17%, respectively, and increases HDL cholesterol by 8%, when compared with baseline (102599). Bergamot has also been evaluated in combination with other ingredients, usually in lower doses than the studies with single-ingredient products, and with inconsistent results (109982). One product (Colber, Esserre Pharma srl), containing bergamot extract, phytosterols, vitamin C, and dry artichoke extract, was taken as 2 pills daily for 8 weeks (102596); another product (CitriCholess, GardaVita Inc.), containing bergamot extract 500 mg along with unspecified additional ingredients, was taken daily for 12 weeks (96366). Another specific product (Vazguard; Indena SpA), containing bergamot phytosome 600 mg and artichoke leaf extract (Indena SpA) 100 mg, has also shown benefit in patients with mild hypercholesterolemia when taken twice daily for 2 months (108712). However, it is unclear if any effects from these products are due to bergamot, other ingredients, or the combination.

POSSIBLY INEFFECTIVE

• Anxiety. Inhaled bergamot essential oil does not seem to be beneficial for anxiety associated with radiotherapy treatment. Details: Clinical research in patients receiving concurrent radiotherapy shows that using bergamot essential oil as aromatherapy does not reduce anxiety when compared with placebo (11452).
• Mental alertness. Inhaled bergamot essential oil does not seem to improve mental alertness. Details: Some clinical research shows that using bergamot essential oil as aromatherapy does not improve mental alertness and might actually impair mental alertness in healthy people due to its relaxing effects (34438,34440).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Antipsychotic-induced metabolic side effects. It is unclear if oral bergamot is beneficial for reducing antipsychotic-induced metabolic side effects. Details: Preliminary clinical research shows that taking bergamot extract (Bergamot Polyphenolic Fraction BPF, H&AD SRL) 500 mg orally daily for 60 days along with dietary advice does not affect body weight, body mass index, glucose, or lipid parameters when compared to baseline in patients taking second generation antipsychotics (96355). The lack of a comparator group limits the validity of these results.
• Aromatase inhibitor-induced arthralgia. Oral bergamot has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in postmenopausal adults with aromatase inhibitor-induced arthralgia shows that taking two tablets of a product containing bergamot juice flavonoids, phytosterols, artichoke leaf extract, and vitamin C (ColBer, Esserre Pharma SRL) orally daily for 6 months along with dieting and exercise modestly reduces joint pain when compared to baseline (96367). The lack of a comparator group limits the validity of these results.
• Autism spectrum disorder. It is unclear if inhaled bergamot essential oil is beneficial for reducing anxiety in children with autism spectrum disorder. Details: Preliminary clinical research in children aged 6-11 years with autism spectrum disorder shows that inhaling 5 drops of bergamot essential oil on a scent strip for 15 minutes while waiting in a medical office does not reduce anxiety when compared with no aromatherapy (102597).
• Depression. Inhaled bergamot essential oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in community-dwelling older adults shows that a combination of lavender, sweet orange, and bergamot essential oils in a 2:1:1 ratio, for a final combined concentration of 1% in sweet almond oil, administered via inhalation or aromatherapy massage to the upper body with 5 mL of the combination oil, twice weekly for 8 weeks improves symptoms of depression in 55% to 65% of patients when compared with control (98474). It is unclear if this benefit is associated with bergamot, other aromatherapy oils, or the combination.
• Impaired glucose tolerance (prediabetes). Oral bergamot has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with prediabetes shows that taking a product containing fenugreek seed extract 200 mg, olive leaf extract 100 mg, and bergamot extract 500 mg for 6 months does not improve levels of glycated hemoglobin (HbA1c), fasting glucose or insulin, insulin resistance, or lipids, when compared with placebo (102251).
• Insomnia. Inhaled bergamot essential oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients hospitalized for cardiac rehabilitation shows that bedside aromatherapy with lavender, ylang ylang, and bergamot in a 1:1:1 ratio on a cotton ball for 5 nights moderately improves subjective sleep quality, but not sleep duration or sleep time, when compared with placebo (102594).
• Lice. Although there is interest in using topical bergamot oil for lice, there is insufficient reliable information about the clinical effects of bergamot for this purpose.
• Menopausal symptoms. Inhaled bergamot oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in postmenopausal adults with mild to moderate anxiety shows that inhaling bergamot oil 0.04% with lavender oil 5% as aromatherapy three times daily for 8 weeks reduces anxiety and depression symptom scores when compared with placebo (109981).
• Metabolic syndrome. Oral bergamot has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with both nonalcoholic fatty liver disease and metabolic syndrome, preliminary clinical research shows that taking a combination of a bergamot polyphenolic fraction 650 mg, oleuropein 20% 100 mg, and ascorbic acid 50 mg twice daily for 120 days modestly reduces levels of fasting blood glucose, low-density lipoprotein (LDL) cholesterol, and triglycerides and increases high-density lipoprotein (HDL) cholesterol levels when compared with baseline (105318). The validity of these findings is limited by the lack of a comparator group.
• Mycosis fungoides. Although there is interest in using topical bergamot oil for mycosis fungoides, there is insufficient reliable information about the clinical effects of bergamot for this condition.
• Nausea and vomiting. It is unclear if inhaled bergamot essential oil is beneficial for nausea and vomiting in children undergoing stem cell transplantation. Details: Preliminary clinical research shows that using bergamot essential oil (Elizabeth Van Buren) as aromatherapy does not reduce nausea when compared with an unscented control in children and adolescents undergoing stem cell transplantation (90508).
• Nonalcoholic fatty liver disease (NAFLD). Oral bergamot has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with both NAFLD and metabolic syndrome, preliminary clinical research shows that taking a combination of a bergamot polyphenolic fraction 650 mg, oleuropein 20% 100 mg, and ascorbic acid 50 mg twice daily for 120 days modestly reduces levels of fasting blood glucose, low-density lipoprotein (LDL) cholesterol, and triglycerides and increases high-density lipoprotein (HDL) cholesterol levels when compared to baseline. It also improves ultrasonographic markers of NAFLD (105318). The validity of these findings is limited by the lack of a comparator group. Bergamot polyphenolic fraction has also shown some benefit in combination with artichoke extract. In patients with NAFLD and type 2 diabetes, preliminary clinical research shows that taking a specific product (Bergacyn, Seris srl) containing 150 mg each of these ingredients, daily for 16 weeks, modestly improves levels of liver markers when compared with placebo; although bergamot polyphenolic fraction alone may have modest benefits, comparisons to the placebo group were lacking (105315). In patients with NAFLD without diabetes, clinical research shows that taking a similar combination for 12 weeks reduces liver fat by approximately 80% more than placebo. After controlling for a modest weight reduction in patients using this product, this benefit was limited to individuals over 50 years of age (105316).
• Obesity. It is unclear if oral bergamot is beneficial for weight loss or improving metabolic parameters in adults with obesity. Details: Clinical research in overweight or obese patients with mild hypercholesterolemia shows that taking bergamot phytosome (Vazguard, Indena SpA) 500 mg twice daily for 12 weeks modestly decreases visceral adipose tissue and levels of total and low-density lipoprotein cholesterol when compared with placebo. However, there was no effect on body weight, fat mass, high-density lipoprotein cholesterol, triglycerides, or glycemic indices (105317). A clinical study in adults with obesity following a reduced-calorie diet and performing 30-60 minutes of daily, light-intensity exercise, shows that a specific oral product (CitruSlim; NHR Science) containing bergamot extract 83% and Eurycoma longifolia root extract 17%, taken as 200 mg or 400 mg daily as three divided doses before meals for 112 days, decreases body mass index by 3.3% and 3.2%, respectively, but does not impact lipid parameters or waist-to-hip ratio, when compared with diet and exercise alone (108452). It is unclear if this effect is due to bergamot, Eurycoma longifolia, or the combination.
• Postpartum depression. It is unclear if inhaled bergamot essential oil is beneficial for reducing depressive symptoms in postpartum adults. Details: A small clinical trial in healthy adults voluntarily residing in a postpartum care center in Taiwan for 1 month shows that diffusing bergamot essential oil as aromatherapy daily for 15 minutes, beginning after childbirth and continuing for approximately 3 weeks, modestly reduces scores on the Edinburgh Postnatal Depression Scale, but not on the Postpartum Sleep Quality Scale, when compared with diffusing water. However, these patients did not have a diagnosis of postpartum depression at baseline, and depression scores improved in both groups (108992). The validity of these findings is limited by concerns with the study methodology.
• Psoriasis. It is unclear if topical bergamot is beneficial for chronic plaque psoriasis. Details: Preliminary clinical research shows that applying bergamot essential oil topically 30 minutes prior to ultraviolet B (UVB) therapy three times weekly is no more effective than UVB therapy alone for reducing plaque severity in patients with chronic plaque psoriasis. The duration of treatment varied according to plaque outcome, with discontinuation occurring either after plaque resolution, or after five consecutive procedures produced no observable effects (34381).
• Pre-procedural anxiety. It is unclear if inhaled bergamot essential oil is beneficial for reducing preoperative anxiety in adults or children. Details: In patients undergoing laparoscopic cholecystectomy, preliminary clinical research shows that bergamot essential oil as aromatherapy has a small beneficial effect on anxiety when compared with inhalation of grape seed oil (105319). However, bergamot essential oil (Elizabeth Van Buren) as aromatherapy does not appear to help reduce anxiety in children and adolescents undergoing stem cell transplantation (90508).
• Schizophrenia. It is unclear if oral bergamot is beneficial for improving executive functioning in patients with schizophrenia. Details: Preliminary clinical research in patients with schizophrenia taking second generation antipsychotics shows that taking a bergamot extract product (Bergamot Polyphenolic Fraction BPF, H&AD SRL) 500 mg orally twice daily for 8 weeks improves some, but not all, measures of executive functioning when compared to baseline (96356). The validity of these findings is limited by the lack of a comparator group.
• Vitiligo. Although there is interest in using topical bergamot oil for vitiligo, there is insufficient reliable information about the clinical effects of bergamot for this condition. More evidence is needed to rate bergamot for these uses.

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POSSIBLY EFFECTIVE

• Dyslipidemia. Oral Indian gooseberry seems to be beneficial for dyslipidemia. Details: Meta-analyses of 12 small clinical studies in healthy adults or patients with dyslipidemia, diabetes, hypertension, or metabolic syndrome show that taking Indian gooseberry fruit extract or powder 0.5-3 grams daily or Indian gooseberry fruit 12 grams daily for 2-12 weeks reduces total cholesterol by around 39 mg/dL, low-density lipoprotein (LDL) cholesterol by around 15-34 mg/dL, and triglycerides by around 22-52 mg/dL when compared with control groups. Results are conflicting whether Indian gooseberry increases high-density lipoprotein (HDL) cholesterol (111567,111568). Subgroup analysis suggests that Indian gooseberry is more effective at doses greater than 1 gram daily and in adults with triglycerides above 150 mg/dL (111568). Clinical research in patients with dyslipidemia shows that taking Indian gooseberry whole fruit extract (Tri-low, Arjuna Natural Ltd.) 500 mg twice daily for 12 weeks reduces triglyceride and low-density lipoprotein (LDL) cholesterol levels by 34% and 20%, respectively, compared with 15% and 5%, respectively, in patients taking placebo (99238).
• Gastroesophageal reflux disease (GERD). Oral Indian gooseberry seems to be beneficial for reducing symptoms of GERD. Details: Clinical research in adults who have had non-erosive symptoms of GERD for at least 3 months shows that taking Indian gooseberry fruit extract 1000 mg twice daily for 4 weeks reduces the frequency and severity of heartburn and regurgitation by about 63% and 50%, respectively, compared with reductions of 24% and 5%, respectively, in patients taking placebo (99240).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Oral Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in healthy, middle-aged females shows that drinking 50 mL of a juice containing Indian gooseberry extract 30-60 mg and lingonberry extract 25-50 mg daily for 12 weeks improves skin elasticity, thickness, wrinkles, and hydration when compared with placebo (102856). It is unclear if these effects are due to Indian gooseberry, lingonberry, or the combination. Another small clinical study in healthy, middle-aged females shows that applying a topical emulsion containing extracts of Indian gooseberry 3% and gotu kola 3% twice daily for 60 days improves skin hydration, some measures of skin wrinkles, and elasticity of the cheek but not the eye when compared with placebo (111571). It is unclear if these effects are due to Indian gooseberry, gotu kola, or the combination.
• Androgenic alopecia. Topical Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In individuals with self-perceived hair loss, preliminary clinical research shows that applying a hair product containing Indian gooseberry modestly improves hair growth rate and density, as well as hair thinning, when compared with baseline. Patients used a leave-in product containing Indian gooseberry (Saberry), coconut water solids (Cococin), gamma-L-glutamyl-selenomethionine (Peptiselect), and other ingredients as 3.5 mL in females and 2 mL in males, once daily for 3 months (105353).
• Cancer. Although there is interest in using oral Indian gooseberry for cancer, there is insufficient reliable information about the clinical effects of Indian gooseberry for this purpose.
• Cardiovascular disease (CVD). It is unclear if oral Indian gooseberry is beneficial for the prevention of CVD. Details: A meta-analysis of 9 small clinical studies in adults who are healthy or have CVD risk factors shows that taking Indian gooseberry fruit extract or powder 500-1500 mg daily for 2-12 weeks reduces low-density lipoprotein (LDL) cholesterol by around 15 mg/dL, very low-density lipoprotein (VLDL) cholesterol by around 5 mg/dL, triglycerides by around 22 mg/dL, and high-sensitivity C-reactive protein when compared with control groups. However, the meta-analysis suggests that Indian gooseberry does not improve high-density lipoprotein (HDL) cholesterol, systolic blood pressure, or diastolic blood pressure (111567). The validity of these findings is limited by small sample sizes and considerable heterogeneity among the included studies.
• Coronavirus disease 2019 (COVID-19). It is unclear if oral Indian gooseberry is beneficial for the treatment of COVID-19 in hospitalized adults. Details: A small clinical trial in adults hospitalized with COVID-19 shows that receiving Indian gooseberry powder 2 grams twice daily for 10 days does not impact RT-PCR positivity rate at day 10 when compared with placebo. Additionally, there were no clear trends in clinical improvement in patients receiving Indian gooseberry when compared with placebo. All patients in this study also received oral hydroxychloroquine and lopinavir/ritonavir (110012).
• Diabetes. Several small or limited-quality clinical studies suggest that oral Indian gooseberry may modestly improve glycemic control and blood lipid levels in patients with type 2 diabetes. Details: A moderate-sized, open-label study in adults with newly-diagnosed type 2 diabetes and dyslipidemia shows that taking Indian gooseberry extract, standardized to 10% beta-glucogallin, 2 grams daily for 90 days reduces glycated hemoglobin (HbA1c), fasting blood glucose, and postprandial blood glucose when compared to baseline, with superior effects on fasting blood glucose and postprandial blood glucose when compared with metformin 500 mg (111569). A smaller clinical study in patients with type 2 diabetes on stable doses of metformin shows that taking Indian gooseberry fruit extract (Capros, Natreon Inc) 500 mg twice daily for 12 weeks reduces HbA1c by around 0.5% and improves low-density lipoprotein (LDL) cholesterol, triglyceride, and high-density lipoprotein (HDL) levels when compared with placebo. Taking a lower dose, 250 mg twice daily, does not seem to improve HbA1c but has a modest effect on lipid levels (105356). Another small clinical study in patients with type 2 diabetes using various antidiabetes drugs shows that taking powdered Indian gooseberry fruit 1 gram, 2 grams, or 3 grams daily for 3 weeks modestly reduces fasting and 2-hour postprandial blood glucose levels and improves lipid levels when compared to baseline (105355). The validity of these findings is limited by the lack of a comparator group.
• Hangover. It is unclear if oral Indian gooseberry is beneficial for hangover prevention. Details: A small clinical trial shows that taking Indian gooseberry leaf extract (Phyllpro) 750 mg daily for 10 days prior to alcohol intoxication modestly reduces some hangover symptoms 10 hours later, including nausea, headache, lack of appetite, and dizziness, when compared with placebo. Blood alcohol levels after 12 hours were also reduced. However, the overall hangover score was not significantly different between groups (99846).
• Hepatitis B. Although there is interest in using oral Indian gooseberry for hepatitis B, there is insufficient reliable information about the clinical effects of Indian gooseberry for this condition.
• Hypercholesterolemia. Small studies suggest that oral Indian gooseberry might help to reduce low-density lipoprotein (LDL) cholesterol levels. Details: Preliminary clinical research shows that taking Indian gooseberry might reduce levels of LDL cholesterol in patients with hypercholesterolemia. One preliminary clinical study shows that taking Indian gooseberry 50 grams for 4 weeks decreases LDL cholesterol by 15% when compared to baseline (2077). Other preliminary clinical research shows that taking Indian gooseberry fruit extract (Amlamax, Arjuna Natural Ltd.) 500 mg or 1000 mg daily for 6 months reduces levels of LDL cholesterol by about 13% when compared with baseline (99241). Also, one small study shows that taking an Indian gooseberry fruit juice powder 500 mg daily for 6 weeks modestly decreases LDL cholesterol and triglyceride levels when compared with baseline (99242). Some preliminary clinical research also shows that Indian gooseberry reduces LDL cholesterol in obese individuals. One small study shows that taking Indian gooseberry fruit extract (Capros, Natreon Inc.) 500 mg twice daily for 12 weeks reduces LDL cholesterol by 16 mg/dL in this population when compared to baseline (92515). However, the validity of these studies is limited by the lack of comparator groups.
• Hypertension. It is unclear if oral Indian gooseberry is beneficial for hypertension. Details: In patients with uncontrolled hypertension using standard therapies, clinical research shows that taking Indian gooseberry dried fruit powder 500 mg three times daily for 8 weeks reduces systolic blood pressure (SBP) and diastolic blood pressure (DBP) by 16% and 12%, respectively, from baseline, which is significantly greater than reductions seen with placebo. The frequency of response to treatment, based on a reduction in SBP or DBP of at least 10 mmHg or 5 mmHg, respectively, was also increased from up to 50% to at least 83% of patients (105352). However, other clinical research in adults with cardiovascular risk factors shows that taking Indian gooseberry 500-1500 mg twice daily for 2-12 weeks does not reduce SBP or DBP more than placebo (105354,111567).
• Irritable bowel syndrome (IBS). Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, open-label study of adults with IBS shows that taking 7 grams of an Unani medicinal product called Jawarish Shahi, containing Indian gooseberry, terminalia, coriander, cardamom, and willow bark, twice daily for 45 days reduces the severity of IBS, as measured by improvements in abdominal pain and distension, bowel habits, and quality of life, when compared to baseline (111570). The validity of these findings is limited by insufficient blinding and the lack of a comparator group. It is unclear if these effects are due to Indian gooseberry, other ingredients, or the combination.
• Metabolic syndrome. It is unclear if oral Indian gooseberry is beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome shows that taking a specific Indian gooseberry extract (Capros, Natreon Inc.) 250 mg twice daily for 12 weeks reduces total cholesterol by nearly 10%, low-density lipoprotein (LDL) cholesterol by 15%, and triglycerides by 10%, and increases high-density lipoprotein (HDL) cholesterol by about 7% when compared with placebo. Additionally, taking this product as 500 mg twice daily reduces total cholesterol by 14%, LDL cholesterol by 26%, and triglycerides by 19%, and increases HDL cholesterol by 22% when compared with placebo. Both doses also seem to improve markers of endothelial function, oxidative stress, and systemic inflammation (102857).
• Obesity. It is unclear if oral Indian gooseberry is beneficial for improving weight loss or metabolic parameters in adults with obesity. Details: Preliminary clinical research in overweight or obese individuals shows that taking Indian gooseberry fruit extract (Capros, Natreon Inc.) 500 mg twice daily for 12 weeks reduces low-density lipoprotein (LDL) cholesterol by 16 mg/dL when compared to baseline. However, there was no effect on other lipids or on blood pressure, body weight, or body mass index (92515). The validity of these findings is limited by the lack of a comparator group.
• Oral mucositis. It is unclear if oral Indian gooseberry is beneficial in patients with radiation-induced mucositis. Details: A retrospective observational study in patients with head and neck cancer receiving radiotherapy suggests that rinsing the mouth with Indian gooseberry 1% and povidone-iodine twice daily is associated with delayed development of mucositis and intolerable mucositis and a decreased incidence of intolerable mucositis when compared with povidone-iodine alone (111566). The validity of these findings is limited by the retrospective study design.
• Osteoarthritis. Oral Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with knee osteoarthritis suggests that specific Ayurvedic formulas containing Indian gooseberry may be equivalent to glucosamine sulfate 2 grams daily or celecoxib 200 mg daily for reducing pain. Two capsules containing Indian gooseberry 166.66 mg/capsule, ginger 33.33 mg/capsule, and Tinospora cordifolia 73.33 mg/capsule, with or without Boswellia serrata 100 mg/capsule, taken three times daily for 24 weeks, were used. All four treatments reduced active pain by about 28% to 38%, functional pain by 19% to 29%, and functional difficulty by 18% to 25%, with no significant between-group differences in the observed improvements (89557). It is not clear if these effects are due to Indian gooseberry, the other ingredients, or the combination.
• Periodontitis. It is unclear if subgingival Indian gooseberry is beneficial for periodontitis. Details: Clinical research in patients with chronic periodontitis shows that the subgingival application of a sustained-release Indian gooseberry fruit 10% gel following scaling and root planing does not affect plaque or gingivitis development over 2-3 months when compared with placebo. However, there was a modest benefit on periodontal destruction based on probing pocket depth (105358).
• Vitiligo. Oral Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with vitiligo shows that taking 1 tablet containing Indian gooseberry 100 mg, vitamin E 10 mg, and carotenoids 4.7 mg orally 3 times daily for 6 months, in combination with conventional topical therapy and/or phototherapy, increases re-pigmentation in the head, neck, and trunk and decreases signs of inflammation when compared with conventional treatment alone (92513). More evidence is needed to rate Indian gooseberry for these uses.

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LIKELY SAFE ...when bergamot essential oil is used orally in amounts commonly found in foods. Bergamot oil has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).

POSSIBLY SAFE ...when bergamot extract is used orally, short-term. A bergamot extract (Bergamot Polyphenolic Fraction BPF, H&AD SRL) has been used with apparent safety at a dose of 650 mg daily for up to 120 days (96355,105318). Another bergamot extract providing 150 mg of flavonoids (Bergavit, Bionap) daily has been used with apparent safety for up to 6 months (102599). Bergamot phytosome (Vazguard, Indena SpA) has been used with apparent safety at a dose of 500 mg twice daily for 12 weeks (105317). ...when inhaled as aromatherapy, short-term. Bergamot oil 3% has been used with apparent safety as 2 drops poured on a cotton ball, attached to the collar, and breathed in for 20 minutes (105319).

POSSIBLY UNSAFE ...when used topically. Bergamot essential oil that is not free of furocoumarins or psoralens can act as a photosensitizer and can induce malignant changes (6,96370).

CHILDREN: LIKELY SAFE
when bergamot essential oil is used orally in amounts commonly found in foods. Bergamot oil has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).

CHILDREN: POSSIBLY UNSAFE
when large amounts of the oil are ingested. Bergamot essential oil can cause intestinal colic, convulsions, and death (12). There is insufficient reliable information available about the safety of bergamot extract when used orally.

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when the oil is used topically (6). There is insufficient reliable information available about the safety of bergamot when taken by mouth in medicinal amounts; avoid use.

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LIKELY SAFE ...when consumed in amounts commonly found in foods (6,2076).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Indian gooseberry fruit extract has been used safely in doses of up to 1000 mg daily for up to 6 months, 1500 mg daily for up to 8 weeks, or 2000 mg daily for up to 4 weeks (92515,99238,99240,99241,102855,102857,105352,105354,105356). Indian gooseberry leaf extract has been used with apparent safety at a dose of 750 mg daily for 10 days (99846). ...when used topically and appropriately. An emulsion containing Indian gooseberry extract 3% and other ingredients has been applied safely to the skin twice daily for up to 60 days (111571).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking bergamot with antidiabetes drugs might increase the risk of hypoglycemia.  Details Animal research suggests that bergamot juice has hypoglycemic effects (34407).

PHOTOSENSITIZING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, topical bergamot essential oil might increase the risk of side effects when used along with photosensitizing drugs.  Details Bergamot contains bergapten, which has photosensitizing effects (11019,34343,34350,34363,34377,34408,34410,34417,34421,34422,34426,34428).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian gooseberry may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs; however, research is conflicting.  Details Clinical research shows that taking Indian gooseberry 500 mg as a single dose or twice daily for 10 days reduces platelet aggregation by about 24% to 36%, increases bleeding time by about 3.8-5.9 seconds, and increases clotting time by about 9.8-12.7 seconds when compared to baseline. However, taking Indian gooseberry 500 mg along with clopidogrel 75 mg or ecosprin 75 mg, as a single dose or for 10 days, does not significantly reduce platelet aggregation or increase bleeding time or clotting time when compared with clopidogrel 75 mg or ecosprin 75 mg alone (92514). Until more is known, use caution when taking Indian gooseberry in combination with anticoagulant/antiplatelet drugs.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Taking Indian gooseberry with antidiabetes drugs might increase the risk of hypoglycemia.  Details Clinical research shows that taking Indian gooseberry fruit or fruit extract alone or in conjunction with antidiabetes medications can lower blood glucose levels (31025,105355,105356,111569). Dose adjustments to diabetes medications might be necessary.

ASPIRIN Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian gooseberry may increase the risk of bleeding if used with aspirin; however, research is conflicting.  Details Clinical research shows that taking Indian gooseberry 500 mg as a single dose or twice daily for 10 days reduces platelet aggregation by about 24% to 36%, increases bleeding time by about 3.8-5.9 seconds, and increases clotting time by about 9.8-12.7 seconds when compared to baseline. However, taking a single dose of Indian gooseberry 500 mg along with ecosprin 75 mg, or taking a combination of Indian gooseberry 500 mg twice daily plus ecosprin 75 mg once daily for 10 days, does not significantly reduce platelet aggregation or increase bleeding time or clotting time when compared with ecosprin 75 mg alone (92514).

CLOPIDOGREL (Plavix) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian gooseberry may increase the risk of bleeding if used with clopidogrel; however, research is conflicting.  Details Clinical research shows that taking Indian gooseberry 500 mg as a single dose or twice daily for 10 days reduces platelet aggregation by about 24% to 36%, increases bleeding time by about 3.8-5.9 seconds, and increases clotting time by about 9.8-12.7 seconds when compared to baseline. However, taking a single dose of Indian gooseberry 500 mg along with clopidogrel 75 mg, or taking a combination of Indian gooseberry 500 mg twice daily plus clopidogrel 75 mg once daily for 10 days, does not significantly reduce platelet aggregation or increase bleeding time or clotting time when compared with clopidogrel 75 mg alone (92514).

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General ...Orally or as aromatherapy, bergamot seems to be well tolerated when used short-term. Topically, bergamot is possibly unsafe.
Most Common Adverse Effects:
Topically: Blisters, erythema, photosensitivity, pigment spots, pustules, and skin lesions.

Dermatologic ...Frequent contact with the peel or oil of bergamot can cause erythema, blisters, pustules, dermatoses leading to scab formation, and pigment spots (18).
Topically, photosensitivity can also occur, especially in fair-skinned people (11019).

Gastrointestinal ...Orally, bergamot extract has been associated with one case of heartburn in clinical research (96356).

Musculoskeletal ...Orally, muscle cramps have been reported for a patient starting one week after switching from drinking 4 liters of black tea to drinking 4 liters of Earl Grey tea daily. The muscle cramps were attributed bergapten, a constituent of bergamot essential oil in Earl Grey tea. The patient's symptoms subsided after discontinuing Earl Grey tea intake and remained absent upon re-initiation of Earl Grey tea intake 1 liter daily (34344).

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General ...Orally, Indian gooseberry seems to be well tolerated.

Dermatologic ...Orally, itching has been reported by one individual in a clinical trial (105354).

Gastrointestinal ...Orally, epigastric discomfort or dyspepsia have been reported by up to four individuals in clinical trials (105354,105356).

Hepatic ...In clinical research, increased serum glutamic pyruvic transaminase (SGPT) levels, with otherwise normal liver function, occurred in patients taking Ayurvedic formulations containing ginger, Tinospora cordifolia, and Indian gooseberry, with or without Boswellia serrata. The SGPT levels normalized after discontinuing the treatments (89557). It is unclear if these hepatic effects were due to Indian gooseberry or other ingredients contained in the formulations.

Musculoskeletal ...Orally, musculoskeletal pain has been reported by three individuals in a clinical trial (105354).

Neurologic/CNS ...Orally, fatigue has been reported by one individual in a clinical trial (105354).

Pulmonary/Respiratory ...Orally, breathlessness has been reported by one individual in a clinical trial (105354).

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