Escape Restraint by Health Concerns

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Abdominal pain. Although there has been interest in using oral atractylodes for abdominal pain, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Anorexia nervosa. Although there has been interest in using oral atractylodes for anorexia nervosa, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Cachexia. It is unclear if oral atractylodes is beneficial in patients with cachexia. Details: Preliminary clinical research in people with gastric cancer-related cachexia shows that taking an isolated constituent of atractylodes, atractylenolide I, 1.32 grams orally daily for 7 weeks moderately improves appetite scores and functional ability scores when compared with fish oil 0.45 grams (15706).
• Common cold. Although there has been interest in using oral atractylodes for the common cold, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Diarrhea. Although there has been interest in using oral atractylodes for diarrhea, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Gastroesophageal reflux disease (GERD). Although there has been interest in using oral atractylodes for GERD, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Influenza. Although there has been interest in using oral atractylodes for Influenza, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Intracranial hemorrhage. Atractylodes has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with chronic subdural hematoma (CSDH) who underwent burr hole surgery shows that taking atractylodes rhizome as part of traditional Japanese medicine products also containing Asian water plantain, mushrooms, and cinnamon for 3 months reduces postoperative recurrence of CSDH when compared with usual care. Subgroup analysis suggests the combination treatment containing atractylodes may be most effective for the acute on chronic CSDH subtype (112827). It is unclear whether these effects are due to atractylodes, other ingredients, or the combination.
• Lung cancer. Although there has been interest in using oral atractylodes for lung cancer, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Obesity. Although there has been interest in using oral atractylodes for obesity, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Peritoneal dialysis. Although there has been interest in using oral atractylodes for peritoneal dialysis, there is insufficient reliable information about the clinical effects of atractylodes for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral atractylodes for RA, there is insufficient reliable information about the clinical effects of atractylodes for this purpose. More evidence is needed to rate atractylodes for these uses.

(Read more about ATRACTYLODES)

LIKELY EFFECTIVE

• Coronary heart disease (CHD). Consuming barley 3-3.6 grams daily as a source of dietary fiber appears to reduce the risk of CHD. Details: Clinical research shows that a diet containing foods high in soluble fiber, such as whole grain barley or dry milled barley, reduces the risk of heart disease (2737,4962,4963,4964,4965,4966,4967,4968). In 1993, the US Food and Drug Administration (FDA) approved a health claim stating that consuming at least 3 grams of soluble fiber per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (5792,5797,102336). However, some clinical research shows that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5788,5795).
• Hypercholesterolemia. Consuming barley 3-12 grams daily seems to reduce total cholesterol and low-density lipoprotein (LDL) cholesterol levels in adults with hypercholesterolemia. Details: Clinical research shows that taking barley significantly reduces total cholesterol and low-density lipoprotein (LDL) cholesterol when used with a normal diet or added to the National Cholesterol Education Program's Step I diet (11134,11986,17129,33734,33748,33752). A meta-analysis of 11 clinical trials shows that consuming preparations containing barley 3-12 grams daily for at least 4-12 weeks reduces total cholesterol and LDL cholesterol levels by around 12 mg/dL and 10 mg/dL, respectively, with no change in triglyceride or high-density lipoprotein (HDL) cholesterol levels. These changes did not appear to be dose-dependent (17129). However, a small clinical study in males with hypercholesterolemia shows that the effect of barley on cholesterol is modestly dose-dependent. Taking 0.4 grams, 3 grams, or 6 grams of soluble fiber from barley daily for 5 weeks reduces total cholesterol by 14%, 17%, and 20%, respectively, and reduces LDL cholesterol by 17%, 17%, and 24%, respectively, when compared to baseline (11986). The form of barley used may alter its effect on cholesterol levels. Some research has shown that barley highly enriched (75% by weight) with beta-glucans does not seem to significantly affect cholesterol. This lack of effect seems to be the result of processing the barley into a highly enriched beta-glucans product (10166). Food processing seems to affect beta-glucans structure or solubility and therefore decreases the cholesterol lowering effects of barley.

POSSIBLY INEFFECTIVE

• Colorectal cancer. Increased consumption of barley as a source of fiber does not appear to be beneficial for primary or secondary prevention of colorectal cancer. Details: Clinical and observational research shows that consuming dietary cereal fiber, including barley fiber, does not reduce the risk of colorectal cancer or prevent colorectal cancer recurrence (160,4819,4820,4821,5104).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Coronavirus disease 2019 (COVID-19). It is unclear if oral barley is beneficial in patients with COVID-19. Details: A small clinical study in Iranian adults hospitalized with moderate COVID-19 shows that drinking 250 mL of Persian barley water daily for 2 weeks, along with conventional treatment, decreases length of hospital stay, body temperature, and markers of inflammation when compared with conventional treatment alone. However, Persian barley water does not appear to improve oxygen saturation or symptoms of COVID-19 (111148). The validity of these findings is limited by a lack of placebo control and concerns related to the statistical methods used.
• Diabetes. Although there has been interest in using oral barley for diabetes, there is insufficient reliable information about the clinical effects of barley for this purpose.
• Diarrhea. Although there has been interest in using oral barley for diarrhea, there is insufficient reliable information about the clinical effects of barley for this purpose.
• Gastric cancer. It is unclear if oral barley is effective for the prevention of gastric cancer. Details: Observational research suggests that increased consumption of dietary fiber, a component of barley, is associated with 70% lower odds of gastric cancer when compared with low consumption of dietary fiber (10435).
• Gastritis. Although there has been interest in using oral barley for gastritis, there is insufficient reliable information about the clinical effects of barley for this purpose.
• Hypertension. Although there has been interest in using oral barley for hypertension, there is insufficient reliable information about the clinical effects of barley for this purpose.
• Obesity. Although there has been interest in using oral barley for obesity, there is insufficient reliable information about the clinical effects of barley for this purpose.
• Ulcerative colitis. Small clinical studies suggest that oral barley might improve symptoms associated with ulcerative colitis. Details: Several small, open-label trials in patients with ulcerative colitis show that consuming food containing germinated barley 20-30 grams daily for 4-24 weeks reduces symptoms of ulcerative colitis when compared to baseline (33725,33729,33732,33777). However, the validity of these findings is limited by a lack of comparator groups. Barley has also been studied in combination with other ingredients. A small clinical study in adults with mild to moderate ulcerative colitis shows that taking a specific nutritional supplement (Profermin, Nordisk Rebalance) containing barley malt flour, oat flour, Lactobacillus plantarum, and lecithin twice daily for 8 weeks decreases symptom scores by at least 50% in an additional 26% of patients when compared with a control nutritional supplement. Disease remission occurred in 31% of patients taking this product compared with 15% of patients in the control group (92818). It is unclear if these findings are due to barley, other ingredients, or the combination. More evidence is needed to rate barley for these uses.

(Read more about BARLEY)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anxiety. Although there has been interest in using oral gardenia for anxiety, there is insufficient reliable information about the clinical effects of gardenia for this purpose.
• Dementia. Although there has been interest in using oral gardenia for dementia, there is insufficient reliable information about the clinical effects of gardenia for this purpose.
• Depression. Although there has been interest in using oral gardenia for depression, there is insufficient reliable information about the clinical effects of gardenia for this purpose.
• Diabetes. Although there has been interest in using oral gardenia for diabetes, there is insufficient reliable information about the clinical effects of gardenia for this purpose.
• Hypertension. Although there has been interest in using oral gardenia for hypertension, there is insufficient reliable information about the clinical effects of gardenia for this purpose.
• Influenza. Although there has been interest in using oral gardenia for influenza, there is insufficient reliable information about the clinical effects of gardenia for this purpose.
• Insomnia. Although there has been interest in using oral gardenia for insomnia, there is insufficient reliable information about the clinical effects of gardenia for this purpose.
• Stroke. Although there has been interest in using oral gardenia for stroke, there is insufficient reliable information about the clinical effects of gardenia for this purpose. More evidence is needed to rate gardenia for these uses.

(Read more about GARDENIA)

There is insufficient reliable information available about the safety of atractylodes.

PREGNANCY: POSSIBLY UNSAFE
when used orally. In animals, atractylodes has caused reproductive toxicity, including fetal death, as well as changes in gestation, growth, and skeletal formation (94304).

LACTATION:
There is insufficient reliable information available about the safety of atractylodes when used during breast-feeding.

(Read more about ATRACTYLODES)

LIKELY SAFE ...when used orally and appropriately in food amounts (4819,4820,4821,5104,10166,10435,11134,11463,11986,92818). There is insufficient reliable information available about the safety of barley when used orally in medicinal amounts or when applied topically.

PREGNANCY: LIKELY SAFE
when used orally in amounts commonly found in foods (19).

PREGNANCY: POSSIBLY UNSAFE
when barley sprouts are consumed in relatively high doses. Excessive amounts of barley sprouts should not be consumed during pregnancy (19).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about BARLEY)

There is insufficient reliable information available about the safety of gardenia.

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

(Read more about GARDENIA)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, atractylodes might increase the risk of bleeding when used concomitantly with anticoagulant and antiplatelet drugs.  Details Laboratory research suggests that atractylenolides II and III, constituents of atractylodes, reduce platelet activation (94299). So far, this has not been shown in humans.

AROMATASE INHIBITORS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, atractylodes may have an additive effect when used with other aromatase inhibitors.  Details Laboratory research suggests that atractylodes and its constituents exhibit aromatase inhibitor effects (94302).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Insignificant •  Occurrence = Possible •  Level of Evidence = D Theoretically, atractylodes might decrease the levels of CYP1A2 substrates.  Details In animals, atractylodes administered at high doses has been shown to induce CYP1A2 activity (112828). This effect has not been shown in humans.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Insignificant •  Occurrence = Possible •  Level of Evidence = D Theoretically, atractylodes might increase the levels of CYP3A4 substrates.  Details In animals, atractylodes administered at high doses has been shown to inhibit CYP3A1 activity, which is a homolog to the human CYP3A4 enzyme (112828). This effect has not been shown in humans.

HEXOBARBITAL Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking atractylodes may prolong the therapeutic and adverse effects of hexobarbital.  Details In animals, atractylodes has been shown to prolong the effects of hexobarbital (94303). These effects have not been shown in humans.

(Read more about ATRACTYLODES)

TRICLABENDAZOLE (Egaten) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, barley might decrease the clinical effects of triclabendazole.  Details Animal research suggests that a diet supplemented with barley can reduce the bioavailability of triclabendazole when taken concomitantly (23884). This effect has not been shown in humans.

(Read more about BARLEY)

STIMULANT LAXATIVES Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, gardenia might increase the effects and adverse effects of stimulant laxatives.  Details Animal research shows that geniposide, a glucoside found in gardenia fruit, may function as a laxative and cause diarrhea when taken orally (26534).

(Read more about GARDENIA)

General ...There is currently a limited amount of information on the adverse effects of atractylodes. A thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Allergic reaction, dry mouth, nausea.

Gastrointestinal ...Orally, atractylenolide I, an isolated constituent of atractylodes, can cause bad taste, nausea, and dry mouth (15706).

Immunologic ...Atractylodes can cause an allergic reaction in people sensitive to the Asteraceae/Compositae family (12450). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

(Read more about ATRACTYLODES)

General ...Orally, barley is well tolerated.
Most Common Adverse Effects:
Orally: Abdominal distension, bloating, flatulence, unpleasant taste. Allergic reactions in sensitive individuals.
Topically: Allergic reactions in sensitive individuals.

Dermatologic ...Topically, barley malt contained in beer has been reported to cause contact dermatitis (33762). After occupational exposure, barley has been reported to cause contact dermatitis of the eyelids and extremities, as well as contact urticaria (33735,33770,33774).

Gastrointestinal ...When consumed orally, barley provides fiber. Increasing fiber in the diet can cause flatulence, bloating, abdominal distention, and unpleasant taste. To minimize side effects, doses should be slowly titrated to the desired level. Adverse effects usually subside with continued use (12514).
Barley contains gluten. In patients with biopsy-proven celiac disease, consuming barley can cause gastrointestinal upset and impairment of xylose excretion (33763,33772).

Immunologic ...Orally, consumption of beer has been reported to cause allergic reactions in sensitive individuals (33722,33724). Symptoms included tingling in the face, lip, and tongue, angioedema, generalized urticaria, chest tightness, dyspnea, cough, fainting, and rhinoconjunctivitis. It can also cause anaphylaxis in sensitive individuals (317). Topically and with occupational exposure, barley has been reported to cause contact dermatitis and rash (33762,33735,33770,33774).
"Bakers' asthma" is an allergic response resulting from the inhalation of cereal flours by workers in the baking and milling industries, and has been reported to occur after barley flour exposure (1300,33756,33760). Cross-allergenicity has been shown to exist between different cereals (33758).

Pulmonary/Respiratory ..."Bakers' asthma" is an allergic response resulting from the inhalation of cereal flours by workers in the baking and milling industries, and has been reported to occur after barley flour exposure (1300,33756,33760). Cross-allergenicity has been shown to exist between different cereals (33758).
By inhalation, barley flours may be a source of allergens in asthma (33764,33773). Inhalation of wild barley grass pollen may result in bronchial irritation or pneumonitis (33726,33755).

(Read more about BARLEY)

General ...There is currently a limited amount of information on the adverse effects of gardenia.
Most Common Adverse Effects:
Topically: Allergic contact dermatitis in sensitive individuals.

Dermatologic ...Topically, exposure to gardenia fruit extract or the whole plant has been associated with allergic contact dermatitis (26518,49078).
Orally, there is a case report of blue-gray skin pigmentation associated with taking a product containing the extracts of gardenia fruit, phellodendron bark, and licorice for 7 years in a 77-year-old female. The pigmentation was thought to be due to melanin deposition enhanced by genipin, a constituent of gardenia. The patient gradually improved over 9 months after stopping this treatment (102698).

Gastrointestinal ...Orally, there are case reports of mesenteric phlebosclerosis, a thickening of the walls of the intestine and mesenteric veins, which can lead to obstruction and occlusion. Typical presenting symptoms are paroxysmal abdominal pain with nausea and vomiting, and imaging studies reveal thickening and stiffening of the walls of the ascending and transverse colon, with dark purple discoloration of the colonic and rectal mucosa, and linear calcification of the mesenteric veins. Treatment is supportive and conservative, leading to a slow resolution of signs and symptoms. In one case a 61-year-old female had been taking a Chinese herbal combination containing extracts of gardenia fruit, Baikal skullcap root, goldthread, phellodendron bark, honeysuckle, rhubarb, anemarrhenae, and trichosanthis root for 8 years (112954). In another case, a 77-year-old female took a product containing extracts of gardenia fruit, phellodendron bark, and licorice for 7 years. Mesenteric phlebosclerosis is thought to be caused by genipin, formed from geniposide after hydrolysis by intestinal bacteria. It is absorbed from the intestine, reacting with proteins in mesenteric veins, leading to progressive fibrosis, calcification, and venous occlusion (102698,112954).

Immunologic ...Topically, exposure to gardenia fruit extract or the whole plant has been associated with allergic contact dermatitis (26518,49078).

(Read more about GARDENIA)