Huai Hua Mi Non-Alcohol [Discontinued] by Hawaii Pharm

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Hemorrhoids. Oral pagoda tree flower has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in adults with active hemorrhoids shows that taking a sophora flower formula, containing pagoda tree, oriental arborvitae, schizonepeta, and bitter orange, 2 grams daily for 2 weeks, does not improve symptoms of hemorrhoids when compared with placebo (99963).
• Menopausal symptoms. It is unclear if oral pagoda tree fruit is beneficial for patients with menopausal symptoms. Details: Preliminary clinical research in adults with mild to moderate menopausal symptoms shows that taking a specific pagoda tree fruit extract (Rexflavone, Rexgene Biotech Co. Ltd.) 175 mg twice daily for 12 weeks reduces overall menopausal symptom scores by an additional 30% when compared with placebo. However, there was no effect on hot flashes, insomnia, nervousness, headache, or vaginal dryness (99966). More evidence is needed to rate pagoda tree for these uses.

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POSSIBLY SAFE ...when the fruit is used orally and appropriately. A specific brand of pagoda tree fruit extract (Rexflavone, Rexgene Biotech Co. Ltd.) has been used safely in doses of up to 350 mg daily for up to 12 weeks (99966).

POSSIBLY UNSAFE ...when the seeds are used orally (18). Regular use of seed meal can cause facial edema or even death (18).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when the seed is used orally (18); avoid using. There is insufficient reliable information available about the safety of the fruit when used orally during pregnancy or lactation.

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CAFFEINE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, pagoda tree might reduce the clearance of caffeine.  Details Pagoda tree contains genistein. Taking genistein 1 gram daily for 14 days seems to inhibit caffeine clearance and metabolism in healthy females (23582). This effect has been attributed to inhibition of the cytochrome P450 1A2 (CYP1A2) enzyme, which is involved in caffeine metabolism. It is unclear if this effect occurs with the lower amounts of genistein found in pagoda tree.

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General ...Orally, pagoda tree flower and fruit seem to be well tolerated. No adverse effects have been reported; however, a thorough evaluation of safety outcomes has not been conducted. The pagoda tree seed is possibly unsafe when consumed long-term.
Serious Adverse Effects (Rare):
Orally: With use of the seed, death and edema.

Other ...Orally, using pagoda tree seed long-term may cause edema and death (18).

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