FDgard Caraway Oil and I-Menthol by FDgard

POSSIBLY EFFECTIVE

• Dyspepsia. Oral caraway in combination with peppermint and possibly other ingredients, seems to reduce symptoms of dyspepsia. It is unclear if oral caraway alone is beneficial. Details: Several small, low-quality clinical studies and a meta-analysis of this research show that taking proprietary combinations of caraway oil 50 mg and peppermint oil 90 mg (Enteroplant or Menthacarin, Dr Willmar Schwabe GmbH & Co.), 1-3 times daily for 4 weeks, improves quality of life and reduces symptoms of dyspepsia, including feelings of fullness, pain, and mild gastrointestinal (GI) spasms, when compared with placebo (6740,6741,10075,96344,102600). A meta-analysis of three of these clinical studies shows that taking this combination product 2-3 times daily for 4 weeks modestly reduces abdominal pain when compared with placebo (110091). This combination appears to be comparable to cisapride for relieving dyspepsia (6740,6741,10075). It also improves postprandial distress syndrome and epigastric pain syndrome, two subtypes of dyspepsia, when compared with placebo (96344). Another small clinical study in patients with functional dyspepsia shows that taking a combination of caraway oil 50 mg and L-menthol 41.4 mg (equivalent to 100 mg peppermint oil), in a microsphere formulation that releases the oils in the duodenum (FDgard, IM HealthScience LLC), twice daily for 28 days reduces symptoms of postprandial distress syndrome within 24 hours and reduces severe symptoms of epigastric pain syndrome at 28 days when compared with placebo. However, when all patients with functional dyspepsia are considered, symptom scores are not significantly different than placebo at 28 days (103161). Another specific combination product containing caraway, peppermint leaf, clown's mustard plant, German chamomile, licorice root, milk thistle, angelica, celandine, and lemon balm (Iberogast, Steigerwald Arzneimittelwerk GmbH) has also been evaluated in patients with dyspepsia, with promising results (7049). A meta-analysis of three small clinical studies using this combination product shows that taking 1 mL three times daily for 4 weeks reduces severity of acid reflux, epigastric pain, cramping, nausea, and vomiting when compared with placebo (13089). Other clinical research in patients with dyspepsia shows that taking a similar combination product (STW 5-II, Steigerwald Arzneimittelwerk GmbH) that does not contain milk thistle, angelica, or celandine as 1 mL three times daily for up to 8 weeks eliminates gastrointestinal symptoms in 40% more patients when compared with placebo (12724). It is unclear if these findings are due to caraway, other ingredients, or the combination.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Amenorrhea. Although there has been interest in using oral caraway for amenorrhea, there is insufficient reliable information about the clinical effects of caraway for this purpose.
• Asthma. Oral caraway has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with allergic asthma shows that drinking one cup of tea containing caraway along with anise, black seed, saffron, cardamom, chamomile, fennel, and licorice twice daily for 6 months reduces sleep discomfort, cough frequency, and cough intensity when compared with placebo (19056). It is unclear if these findings are due to caraway, other ingredients, or the combination.
• Constipation. Although there has been interest in using oral caraway for constipation, there is insufficient reliable information about the clinical effects of caraway for this purpose.
• Dysmenorrhea. Although there has been interest in using oral caraway for dysmenorrhea, there is insufficient reliable information about the clinical effects of caraway for this purpose.
• Flatulence. Although there has been interest in using oral caraway for flatulence, there is insufficient reliable information about the clinical effects of caraway for this purpose.
• Irritable bowel syndrome (IBS). It is unclear if topical caraway oil is beneficial in patients with IBS. Details: A small, open-label study in patients with IBS shows that applying a heated poultice of caraway oil 2% to the abdomen for 20-30 minutes at least once daily for 3 weeks modestly improves the severity of IBS symptoms when compared with applying a nonheated, olive oil poultice. However, the improvement may not be clinically meaningful. Also, the heated caraway oil poultice is not more effective than a heated olive oil poultice. This suggests that any possible benefit might relate to the application of heat rather than caraway oil (94085).
• Obesity. It is unclear if oral caraway seed extract is beneficial in patients with obesity. Details: A small clinical study in physically active overweight and obese females shows that taking 30 mL of an aqueous extract providing about 3 grams of caraway seed once daily prior to lunch for 3 months decreases body weight by about 2 kg, body mass index by 0.84 kg/m², percent body fat by 0.7%, and waist circumference by 6 cm, and increases percent muscle mass by 0.19%, when compared to baseline (94088). These improvements are significant when compared with placebo; however, they might not be considered clinically meaningful. Taking caraway seed aqueous extract does not appear to improve blood pressure or lipid levels in these patients (94086). More evidence is needed to rate caraway for these uses.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Caraway has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when caraway oil is used orally in medicinal amounts. Caraway oil has been used with apparent safety at a dose of up to 150 mg daily for up to 4 weeks, in combination with peppermint oil (6740,6741,6742,10075,96344). ...when caraway seed is used orally, short-term. An aqueous caraway seed extract has been used with apparent safety at a dose of 3 grams daily for up to 3 months (94086,94087,94088). ...when used topically and appropriately. A heated poultice containing caraway oil 2% has been used with apparent safety for up to 3 weeks (94085).

PREGNANCY: POSSIBLY UNSAFE
when used in medicinal amounts (4912,6746). Caraway oil has been used to stimulate menstruation (6746); avoid using.

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, caraway might increase the risk of hypoglycemia when used with antidiabetes drugs.  Details Animal research suggests that caraway can reduce blood glucose levels (12736,39844). Monitor blood glucose levels closely. Medication dose adjustments may be necessary.

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, caraway might increase the effects and adverse effects of CNS depressants.  Details Animal research suggests that (S)-(+)-carvone, a major constituent of caraway seed extract, has sedative effects (39800).

CYTOCHROME P450 1A1 (CYP1A1) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, caraway might increase the levels and clinical effects of CYP1A1 substrates.  Details In vitro evidence suggests that caraway extract can inhibit the activity of CYP1A1 in a dose-dependent manner (39780). This interaction has not been reported in humans.

DIURETIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, caraway might increase the risk of hypokalemia when used with diuretics that deplete potassium.  Details Animal research suggests that a single dose of caraway fruit extract can promote diuresis and increase the urinary excretion of sodium and potassium. However, sub-chronic use of caraway fruit extract does not seem to significantly increase potassium excretion, although urine output continues to be increased for up to 6 days (39797).

ISONIAZID Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, caraway might increase the effects and adverse effects of isoniazid.  Details Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of isoniazid when administered concomitantly (25529). This interaction has not been reported in humans.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, caraway might reduce excretion and increase levels of lithium due to diuretic effects.  Details Animal research suggests that caraway fruit extract has diuretic properties (39797).

PYRAZINAMIDE Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, caraway might increase the effects and adverse effects of pyrazinamide.  Details Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of pyrazinamide when administered concomitantly (25529). This interaction has not been reported in humans.

RIFAMPIN (Rifadin) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, caraway might increase the effects and adverse effects of rifampin.  Details Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of rifampin when administered concomitantly (25529). This interaction has not been reported in humans.

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General ...Orally, caraway oil seems to be well tolerated.

Gastrointestinal ...Orally, caraway oil, when used in combination with peppermint oil, may cause a substernal burning sensation, belching, nausea, and vomiting (6741,6742,10075,96344). It is unclear if these adverse effects are due to caraway oil, peppermint oil, or the combination. Peppermint oil, when used alone, has been reported to cause similar adverse effects.

Immunologic ...Orally, an allergic reaction has been reported after use of caraway oil in combination with peppermint oil in a patient with a history of bronchial asthma (96344). It is unclear if this adverse effect is due to caraway oil, peppermint oil, or the combination.

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