Citrus Bergamot [Discontinued] by Jarrow Formulas

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.

(Read more about BERGAMOT)

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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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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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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