Anise Pyrite 3X by Weleda

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Oral anise has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with allergic asthma shows that drinking one cup of tea prepared with multiple ingredients, including anise, 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 anise, other ingredients, or the combination.
• Constipation. Oral anise has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A very small crossover trial in patients with constipation shows that taking an herbal tea containing a combination of anise, fennel, elderberry, and senna daily for 5 days can decrease colon transit time, increase the number of daily evacuations, and improve the perception of bowel function when compared with placebo (49494). It is unclear if these findings are due to anise, other ingredients, or the combination.
• Depression. It is unclear if oral anise oil is beneficial in patients with depression. Details: A small clinical study in adults with mild to moderate depression and irritable bowel syndrome (IBS) shows that taking enteric-coated anise oil 200 mg three times daily for 4 weeks improves symptoms of depression by an additional 28% when compared with placebo and an additional 32% when compared with peppermint (94947).
• Diabetes. It is unclear if oral anise seed powder is beneficial in patients with diabetes. Details: A small clinical study in adults with type 2 diabetes shows that taking anise seed powder 5 grams daily for 60 days decreases fasting blood glucose levels by 36%, total cholesterol levels by 7.5%, and triglyceride levels by 15% when compared to baseline. Fasting blood glucose significantly increased in the control group, and total cholesterol and triglyceride levels were relatively unchanged (94953).
• Dysmenorrhea. Although there has been interest in using oral anise for dysmenorrhea, there is insufficient reliable information about the clinical effects of anise for this purpose.
• Dyspepsia. It is unclear if oral anise powder is beneficial in patients with dyspepsia. Details: A small clinical study in adults with postprandial distress syndrome shows that taking anise powder 3 grams three times daily for 4 weeks improves quality of life and symptoms of functional dyspepsia when compared with placebo. Of the evaluated symptoms, improvement was seen in all categories when compared to placebo except for nausea and vomiting, which were present in less than 5% of patients at baseline (94944,94945).
• Irritable bowel syndrome (IBS). It is unclear if oral anise oil is beneficial inpatients with IBS. Details: A small clinical study in adults with IBS shows that taking enteric-coated anise oil 200 mg three times daily for 4 weeks eliminates IBS symptoms in 75% of patients, compared with 53% of patients taking peppermint oil and 35% taking placebo. The greatest symptom improvement occurred with abdominal pain, bloating, and reflux, and was maintained for an additional 2 weeks after treatment completion (94946).
• Lactation. It is unclear if oral anise tea is beneficial for increasing human milk production. Details: A moderate-sized clinical study in post-partum adults shows that drinking a tea containing anise 2 grams and black tea 1 gram 3 times daily with meals for 7 days increases the volume of pumped human milk on day 7 by an average of 98 mL and 113 mL, respectively, when compared with a placebo of black tea 3 grams daily and when compared with a control group not assigned to any tea or galactagogues (112863).
• Lice. Topical anise has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in children 6-14 years of age shows that application of a topical spray containing anise oil, coconut oil, and ylang ylang oil three times at 5-day intervals is 92% effective for the treatment of head lice and seems to be comparable in effectiveness to a spray containing permethrin, malathion, piperonyl butoxide, and isododecane (13483).
• Menopausal symptoms. It is unclear if oral anise seed extract is beneficial in patients with menopausal symptoms. Details: A small clinical study in postmenopausal adults shows that taking anise seed extract 330 mg three times daily for 4 weeks reduces the frequency and severity of hot flashes by approximately 75% when compared with placebo (94948).
• Migraine headache. It is unclear if topical anise essential oil is beneficial in patients with migraine headache. Details: A small clinical study in adults with migraine headache shows that applying 2 mL of a cream containing anise essential oil 7% to the temporal and forehead zones at the onset of a migraine reduces the impact of the headache by approximately 10% when compared with a control cream. However, there was no effect of the anise cream on analgesic use or average headache severity when compared with placebo cream. Additionally, due to the strong smell of the anise cream, patient blinding may have been compromised (100166).
• Premenstrual syndrome (PMS). It is unclear if oral anise extract is beneficial in patients with PMS. Details: A small clinical study in female college students with PMS shows that taking anise extract 110 mg three times daily, starting 7 days before menstruation and ending 3 days after, improves concentration, mood, irritability, sleep, food cravings, and other symptoms of PMS, as measured using the Premenstrual Symptoms Screening Tool, when compared with placebo (103875). More evidence is needed to rate anise for these uses.

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LIKELY SAFE ...when used orally in amounts commonly found in food. Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when anise powder is used orally and appropriately in medicinal amounts. Anise powder has been used with apparent safety in clinical research at doses of up to 9 grams daily for up to 4 weeks (94944,94945). ...when anise oil is used orally and appropriately in medicinal amounts. Anise oil has been used with apparent safety in clinical research at doses of up to 600 mg daily for up to 4 weeks (94946,94947).

CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in food. Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of anise when used by children in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in food. Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of anise when taken orally in medicinal amounts during pregnancy or breast-feeding.

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ACETAMINOPHEN (Tylenol, others) Interaction Rating = Minor Be watchful with this combination. Severity = Insignificant •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise oil might decrease the levels and clinical effects of acetaminophen.  Details Animal research shows that taking anise oil with acetaminophen decreases peak plasma levels of acetaminophen but does not reduce overall bioavailability (94951). Whether this interaction will occur in humans is unclear.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, anise seed might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details A small clinical study shows that anise seed powder decreases fasting blood glucose levels by 36% when compared to baseline (94953).

CAFFEINE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise oil might decrease the efficacy of caffeine.  Details Animal research shows that taking anise oil with caffeine decreases the bioavailability of caffeine (94951). Whether this interaction will occur in humans is unclear.

CODEINE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise oil might increase the effects and adverse effects of codeine.  Details Animal research shows that anise oil increases the analgesic effects of codeine, possibly by inducing its phase I metabolism and increasing conversion to morphine (94950). Whether this interaction occurs in humans is unclear.

CONTRACEPTIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise might interfere with contraceptive drug therapy.  Details Some in vitro research suggests that anise has estrogenic effects (13506), while other in vitro research suggests that anise has antiestrogenic effects (12728).

DIAZEPAM (Valium) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise oil might increase the effects and adverse effects of diazepam.  Details Animal research shows that taking anise oil with diazepam increases the motor impairment associated with diazepam, possibly by inhibiting its breakdown by cytochrome P450 3A4 (94950). Whether this interaction occurs in humans is unclear.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise might interfere with estrogen-based hormone replacement therapy.  Details Some in vitro research suggests that anise has estrogenic effects (13506), while other in vitro research suggests that anise has antiestrogenic effects (12728).

FLUOXETINE (Prozac) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise oil might decrease the efficacy of fluoxetine.  Details Animal research shows that taking anise oil with fluoxetine reduces the antidepressant effects of fluoxetine, possibly by promoting its breakdown by cytochrome P450 2D6 (94950). Whether this interaction occurs in humans is unclear.

IMIPRAMINE (Tofranil) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise oil might decrease the efficacy of imipramine.  Details Animal research shows that taking anise oil with imipramine reduces the antidepressant effects of imipramine, possibly by promoting its breakdown by cytochrome P450 2D6 (94950). Whether this interaction occurs in humans is unclear.

MIDAZOLAM (Versed) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise oil might increase the effects and adverse effects of midazolam.  Details Animal research shows that taking anise oil with midazolam increases the motor impairment associated with midazolam, possibly by inhibiting its breakdown by cytochrome P450 3A4 (94950). Whether this interaction occurs in humans is unclear.

TAMOXIFEN (Nolvadex) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, anise might interfere with tamoxifen therapy.  Details Some in vitro research suggests that anise has estrogenic effects (13506), while other in vitro research suggests that anise has antiestrogenic effects (12728).

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General ...Orally, anise seems to be well tolerated.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Dermatologic ...Topically, anise, in combination with other herbs, has been reported to cause localized pruritus (13483).

Immunologic ...Anise can cause allergic reactions in sensitive individuals. Orally or by inhalation, anise can cause rhinoconjunctivitis, occupational asthma, and anaphylaxis (13484). Topically, anise can cause contact dermatitis, rhinitis, and asthma (31319,31341). Contact dermatitis and cheilitis have also been reported following the use of toothpaste containing anethole, a constituent of anise (31403,31528).

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