Hops 500 mg Tablet by ProMed Pharmaceutical Inc.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral hops-derived bitter acids are beneficial for memory and attention in patients with age-related cognitive decline. Details: A small exploratory clinical study in older adults aged 45-64 years, with self-awareness of cognitive decline, shows that taking matured hops bitter acids (Kirin Holdings Co. Ltd) 35 mg daily for 12 weeks does not improve memory, attention, or performance on most cognitive tests when compared with placebo (102899). A follow-up clinical study in patients aged 45-69 years with subjective cognitive decline shows that taking the same dose of the same product for 12 weeks also does not improve memory, learning, or selective attention, but might improve divided attention as measured on the Symbol Digit Modalities Test (SDMT), when compared with placebo (105953). Both studies were funded by the supplement manufacturer and conducted in Japan; it is unclear if these findings are generalizable to other geographic locations.
• Anxiety. Although there is interest in using oral hops for anxiety, there is insufficient reliable information about the clinical effects of hops for this condition.
• Attention deficit-hyperactivity disorder (ADHD). Although there is interest in using oral hops for ADHD, there is insufficient reliable information about the clinical effects of hops for this condition.
• Body odor. Although there is interest in using topical hops to reduce body odor, there is insufficient reliable information about the clinical effects of hops for this purpose.
• Insomnia. Taking oral hops extract in combination with valerian root extract seems to be modestly beneficial in patients with insomnia. However, the effect of hops extract when used alone is unclear. Details: In patients with diagnosed sleep disorders, taking hops extract in combination with valerian root for at least 28 days seems to be beneficial. One clinical study in adults with mild insomnia shows that taking two tablets of a combination product containing a total of 83.8 mg hops extract and 374 mg valerian root extract nightly seems to modestly improve subjective sleep measures, including sleep latency, when compared with placebo, after 28 days. However, there was no difference in efficacy between treatment groups after only 14 days (15018). Additionally, a small clinical study in patients with non-organic sleep disorders shows that taking a specific fixed combination product (Ze91019) containing hops extract 120 mg and valerian root extract 500 mg daily for 28 days improves sleep latency when compared with placebo (19413). It is unclear if taking hops and valerian root as a single dose is beneficial in healthy patients. One small clinical study in healthy volunteers with poor sleep shows that taking a specific preparation (Dormeasan, Bioforce AG) containing hops extract 460 mg and valerian root extract 460 mg dissolved in 50 mL of honey water once at night increases total sleep time and time spent in deep sleep when compared with placebo (19418). However, another preliminary clinical study in healthy adults shows that taking a single dose of a specific product (Hova, Zyma S.A.) containing hops extract 200 mg and valerian root extract 400 mg does not improve sleep latency when compared with placebo (6248). Research also shows that taking certain combination products containing hops and at least two other ingredients can improve sleep quality. These combination products have combined hops with lemon balm and valerian (Valerina Natt) (19417); or passionflower and valerian (NSF-3, M/s Tablets India) (88193,89406). However, other combination products have not been beneficial. These have combined hops with soya oil, soya lecithin, and cannabis (Cyclamax, Persee Medica) (55382); or with vitamin B6, zizyphus extract, hydrolyzed milk protein (Lactium), and magnesium oxide (LZ Complex3, Sanofi) (95971).
• Dyspepsia. Although there is interest in using oral hops-derived bitter acids for dyspepsia, there is insufficient reliable information about the clinical effects of hops for this condition.
• Lactation. Although there is interest in using oral hops for increasing lactation, there is insufficient reliable information about the clinical effects of hops for this purpose.
• Menopausal symptoms. It is unclear if oral hops extract is beneficial in patients with menopausal symptoms. Details: Small clinical studies in menopausal patients show that taking a specific hops extract (MenoHop, Biodynamics) 75.1-300 mg standardized to contain 100-200 mcg of 8-prenylnaringenin daily does not improve menopausal symptoms, including hot flashes, after 8-12 weeks of treatment when compared with placebo (55338,55370).
• Overactive bladder. Oral hops extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An observational study in females with overactive bladder has found that taking a specific combination product (Granu Fink femina, Omega Pharma) containing hops extract 18 mg, sweet sumac bark extract 56 mg, and pumpkin seed oil 227 mg three times daily for 12 weeks decreases the frequency of urination from an average of 0.9 to 0.4 episodes daily and the frequency of leakage when compared with baseline. The study also shows this specific combination product (Granu Fink femina, Omega Pharma) improves quality of life when compared with baseline (103253). The validity of these findings is limited by the lack of a control group. Also, it is unclear if these findings are due to hops extract, other ingredients, or the combination.
• Psychological well-being. It is unclear if drinking non-alcoholic beer containing matured hops bitter acids is beneficial in healthy adults. Details: A clinical study in healthy adults shows that consuming 350 mL of non-alcoholic beer containing matured hops bitter acids 35 mg (Kirin Holdings Co. Ltd) daily for 3 weeks improves mood scores on the Profile of Mood States 2 (POMS2) and Two-dimensional Mood Scale (TDMS) when compared with baseline (107813). The validity of these findings is limited by the lack of a control group.
• Shift work disorder. It is unclear if drinking non-alcoholic beer containing hops is beneficial in patients with shift work disorder. Details: A small open-label clinical study in healthy female nurses working rotating or night shifts shows that drinking 333 mL of non-alcoholic beer containing hops (San Miguel 0% alcohol) at dinner for 2 weeks diminishes sleep latency by about 8 minutes, decreases total activity during the night, and decreases anxiety when compared with baseline. However, it does not appear to increase duration of sleep (55403). The validity of these findings is limited by the lack of a control group and unconfirmed hops content in the beer.
• Vaginal atrophy. Topical hops extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An open-label, multicenter clinical study in postmenopausal patients with vaginal atrophy shows that inserting 2.5 grams of a vaginal gel containing hops extract 1%, hyaluronic acid, liposomes, and vitamin E (Gynomunal Vaginal gel or Esvegyne, Polichem SA) into the vagina daily for one week followed by twice weekly for 11 weeks reduces vaginal dryness, burning, itching, and rash when compared with baseline (55339). The validity of these findings is limited by the lack of a control group. Also, it is unclear if these effects are due to hops, other ingredients, or the combination.
• Venous leg ulcers. Although there is interest in using topical hops for venous leg ulcers, there is insufficient reliable information about the clinical effects of hops for this condition. More evidence is needed to rate hops for these uses.

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LIKELY SAFE ...when consumed in amounts commonly found in foods. Hops extract and hops oil have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when hops extract and hops-derived bitter acids are used orally and appropriately for medicinal purposes, short-term. Hops extract has been used with apparent safety in doses of up to 300 mg daily for 2-3 months. Hops-derived bitter acids have been used with apparent safety at a dose of 35 mg daily for 3 months (12,55338,55370,102899,105953,107813).

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

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CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of hops with sedative drugs might cause additive sedation.  Details Some animal research shows that hops has sedative effects (55415,55340,105930).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Hops extract does not seem to affect the metabolism of CYP1A2 substrates.  Details In vitro research suggests that flavonoid constituents of hops inhibit CYP1A2 enzyme activity (10686). However, a pharmacokinetic study in healthy postmenopausal patients shows that taking a standardized extract of spent hops containing prenylated phenols, as 59.5 mg twice daily for 2 weeks, does not affect levels of caffeine, a CYP1A2 probe substrate (105954).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, hops extract might alter metabolism of CYP3A4 substrates; however, this effect may not be clinically significant.  Details Animal research suggests that specific constituents of hops, called lupulones, can induce hepatic CYP3A4 enzyme activity (55325). However, a pharmacokinetic study in healthy postmenopausal patients with normal metabolism shows that taking a standardized extract of spent hops containing prenylated phenols, as 59.5 mg twice daily for 2 weeks, decreases the concentration of alprazolam, a CYP3A4 probe substrate, by 7.6%. This reduction is unlikely to be clinically relevant (105954).

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of large amounts of hops might interfere with hormone replacement therapy due to competition for estrogen receptors.  Details In vitro research suggests that certain hops constituents can competitively bind to estrogen receptors (3701,10684,10685). However, most hops extracts contain very small amounts of these constituents (105930).

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General ...Orally, hops extract and oil are generally well tolerated when used in food amounts. Hops extract also seems to be well tolerated when used in supplemental amounts.
Most Common Adverse Effects:
Orally: Drowsiness, sedation.

Dermatologic ...Topically, allergic reactions have been reported after contact with the fresh hops plant and plant dust. Contact dermatitis is attributed to the pollen (4,12,105930).

Genitourinary ...Orally, supplements containing hops and soy have been associated with 4 cases of postmenopausal bleeding (55404). It is unclear if this effect is due to hops, soy, or the combination. Also, menstrual disturbances have been reported in female workers harvesting hops (10684,55405).

Neurologic/CNS ...Orally, hops might cause drowsiness and sedation. Historically, hops are thought to have sedative effects, since workers harvesting hops were observed to tire easily after oral contact with hop resin. The European Medicines Agency states that hops may have sedative effects; however, there is a lack of clinical research confirming that hops extract causes drowsiness and sedation (105930).

Pulmonary/Respiratory ...Occupational exposure to dust from hops, usually in combination with dust from other products, is associated with chronic respiratory symptoms such as dry cough, dyspnea, chronic bronchitis, and other occupational respiratory diseases (55333,55414).

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