NoxyLane4 [Discontinued] by LaneLabs

POSSIBLY EFFECTIVE

• Dyslipidemia. Taking full-fat rice bran, reduced-fat rice bran, or rice bran oil daily appears to modestly reduce lipoprotein (LDL) cholesterol levels. The effects of rice bran on other types of cholesterol are unclear. Details: Clinical research in adults with hypercholesterolemia shows that taking full-fat rice bran 85 grams daily for 6 weeks lowers total cholesterol by 8% and LDL cholesterol by 14% when compared with placebo. Rice bran does not seem to affect triglycerides or high-density lipoprotein (HDL) cholesterol (865). Conversely, a meta-analysis of 8 small clinical studies in patients with hypercholesterolemia, type 2 diabetes, or who have survived colorectal cancer shows that taking rice bran 20 to 100 grams/day does not improve total cholesterol, LDL, HDL, or triglycerides when compared with control (112092). However, the interpretation of these findings is limited by the heterogeneity of patients, dosages, and study designs included in the analysis. The oil from rice bran has also been shown to affect the lipid profile (1354,97524,100481,106591). Multiple meta-analyses of small clinical studies show that taking rice bran oil for 2.5-13 weeks reduces LDL cholesterol levels by 7-8 mg/dL when compared with control. However, rice bran oil does not appear to affect HDL cholesterol levels. Rice bran oil may also modestly lower triglyceride levels; however, results are conflicting between meta-analyses (97524,106591). The validity of these findings is limited by inclusion of low-quality studies and the inclusion of patients without hypercholesterolemia at baseline. The effectiveness of rice bran oil may also depend on the content of gamma-oryzanol. A small clinical study in patients with hyperlipidemia shows that taking rice brain oil 30 mL containing 4000, 8000, and 11000 ppm gamma-oryzanol daily for 4 weeks decreases LDL-C levels when compared with control. The greatest effects occurred in the patients receiving higher gamma-oryzanol content (8000 and 11000 ppm) (100481).

POSSIBLY INEFFECTIVE

• Colorectal cancer. Clinical and population research suggest that consuming dietary cereal fiber, including rice bran, doesn't seem to reduce the risk of colorectal cancer. Details: Clinical research in adults with colorectal adenomas shows that increasing dietary fiber, including rice bran, for up to 4 years does not reduce the risk of recurrent adenomas (4820). Observational research in females has also found that increasing dietary fiber consumption, including rice bran, for up to 16 years is not associated with colorectal cancer risk (4821). However, the validity of these studies is limited by the use of multiple sources of dietary fiber.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alcohol use disorder. Although there has been interest in using oral rice bran for alcohol use disorder, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Alopecia areata. Although there has been interest in using topical rice bran for alopecia areata, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Androgenic alopecia. It is unclear if topical rice bran is beneficial in patients with androgenic alopecia. Details: One small clinical study shows that applying dermal rice bran 5% supercritical CO2 extract (RB-SCE) 4 mL to the scalp twice daily for 16 weeks improves hair density and visual ratings of hair growth in males, but not females, with androgenic alopecia when compared with placebo (97523).
• Athletic performance. Although there has been interest in using oral rice bran for athletic performance, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Atopic dermatitis (eczema). It is unclear if topical rice bran is beneficial in patients with atopic dermatitis. Details: Low-quality observational research has found that using a topical rice bran broth bath for 2-5 months reduces skin symptoms in approximately 69% to 94% of patients with atopic dermatitis when compared with baseline. However, the validity of this study is limited by the lack of a comparator group (872).
• Cardiovascular disease (CVD). There is limited evidence on the oral use of rice bran oil in coronary artery disease (CAD). Details: Preliminary clinical research in adult males who recently underwent angioplasty for CAD shows that taking oral rice bran oil 30 grams daily for 8 weeks improves left ventricular ejection fraction by 35% more when compared with taking sunflower oil 30 grams daily. Taking rice bran oil also improves triglyceride and low-density lipoprotein cholesterol levels, but not high-density lipoprotein cholesterol levels, when compared with placebo (106590).
• Diabetes. It is unclear if oral rice bran is beneficial in patients with type 2 diabetes. Details: A small clinical study in adults with type 2 diabetes shows that ingesting stabilized rice bran 20 grams once daily for 12 weeks does not reduce fasting blood glucose, postprandial glucose, or glycated hemoglobin (HbA1c) when compared with ingesting a placebo of 20 grams milled rice flour (97522). However, this study may not have been adequately powered to identify a difference between groups.
• Gastric cancer. Although there has been interest in using oral rice bran to prevent gastric cancer, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Halitosis. It is unclear if oral rice bran is beneficial in patients with halitosis. Details: Preliminary clinical research shows that swishing with 15 mL of rice bran oil for 10 minutes and spitting it out, also referred to as "oil pulling", once daily for 14 days, improves halitosis scores when compared with baseline in pregnant adults with halitosis. Rice bran oil was similarly effective to sesame oil or chlorhexidine for reducing halitosis (97526).
• HIV/AIDS. Although there has been interest in using oral rice bran for HIV/AIDS, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Hypercalciuria. It is unclear if oral rice bran is beneficial in patients with hypercalciuria. Details: Preliminary observational research in adults with idiopathic hypercalciuria shows that taking oral defatted rice bran 10 grams twice daily for up to 3 years reduces annual kidney stone recurrence by 83% when compared with baseline (876). The validity of this study is limited by the lack of a comparator group.
• Hypertension. Although there has been interest in using oral rice bran for hypertension, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Insomnia. It is unclear if oral rice bran is beneficial in patients with insomnia. Details: A small clinical study in patients with disturbed sleep shows that taking a specific rice bran extract (S&D Co.) 1000 mg daily for 2 weeks improves total sleep time by about 20 minutes when compared with placebo. Taking rice bran extract also modestly improves sleep efficiency and sleep quality scores when compared with placebo (103760).
• Obesity. Although there has been interest in using oral rice bran for obesity, there is insufficient reliable information about the clinical effects of rice bran for this purpose. More evidence is needed to rate rice bran for these uses.

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POSSIBLY INEFFECTIVE

• Dental Plaque. A solution containing an extract of shiitake mushroom is less effective than fluoride mouthwash for reducing dental plaque. Details: Clinical research shows that rinsing the mouth with a solution containing shiitake mushroom extract does not reduce dental plaque when compared with placebo and appears to be less effective than fluoride mouth rinse (Meridol) (94250).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging. Although there has been interest in using oral shiitake mushroom for aging, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Atherosclerosis. Although there has been interest in using oral shiitake mushroom for atherosclerosis, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Breast cancer. Although there has been interest in using oral shiitake mushroom for breast cancer, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Cancer. It is unclear if oral shiitake mushroom is beneficial in patients with cancer. Details: Although some small clinical studies in patients with gastric or colon cancer have found that patients taking the shiitake mushroom extract AHCC 3-6 grams daily have better survival rates and quality of life when compared with historical population data, other observational research has not found a benefit for patients with head, neck, lung, or breast cancer when compared with baseline (30421,30425,30454). The validity of these studies is limited by lack of a comparator group.
• Chemotherapy-induced anemia. It is unclear if oral shiitake mushroom is beneficial in patients with chemotherapy-induced anemia. Details: A small clinical study in adults receiving chemotherapy for pancreatic cancer shows that taking the shiitake mushroom extract AHCC 6 grams daily for 8-12 weeks does not reduce the rate of grade 2 to 3 anemia when compared with placebo (110131).
• Chemotherapy-induced leukopenia. It is unclear if oral shiitake mushroom is beneficial in patients with chemotherapy-induced leukopenia. Details: Preliminary clinical research in patients with breast cancer receiving chemotherapy shows that taking the shiitake mushroom extract AHCC significantly reduces chemotherapy-related neutrophil events and lipid abnormalities when compared with standard care (94829).Observational research in patients with resectable pancreatic ductal adenocarcinoma has found that taking this product orally 3 grams daily throughout 2 cycles of neoadjuvant gemcitabine improves the neutrophil-to-lymphocyte ratio and nutritional scores when compared with standard of care (106783). In contrast, other clinical research in patients with pancreatic or biliary tract cancer receiving gemcitabine chemotherapy shows that taking AHCC 6 grams daily for two months does not seem to affect neutropenia, thrombocytopenia, or hepatic dysfunction when compared with standard of care. However, taking AHCC did reduce C-reactive protein and increase hemoglobin and albumin when compared to standard of care (30424).
• Chemotherapy-induced nausea and vomiting (CINV). It is unclear if oral shiitake mushroom is beneficial in patients with CINV. Details: Preliminary clinical research in patients being treated for head and neck cancers shows that taking the shiitake mushroom extract AHCC 3 grams daily, beginning 3 days prior to chemotherapy and continuing until one week after chemotherapy, reduces gastric side effects and the need for antiemetic therapy when compared with baseline (30425). The validity of these findings is limited by the lack of a comparator group.
• Chemotherapy-induced taste changes. It is unclear if oral shiitake mushroom is beneficial for the prevention of taste changes due to chemotherapy. Details: A small clinical study in adults receiving chemotherapy for pancreatic cancer shows that taking the shiitake mushroom extract AHCC 6 grams daily for 8-12 weeks reduces the rate of patient-reported taste disorders by 27% when compared with placebo (110131). Although patients in the AHCC group had modest improvements in some nutritional parameters when compared with the placebo group, it is unclear if any changes would be considered clinically significant.
• Common cold. Although there has been interest in using oral shiitake mushroom for the common cold, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Coronavirus disease 2019 (COVID-19). Although there has been interest in using oral shiitake mushroom for COVID-19, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Diabetes. Although there has been interest in using oral shiitake mushroom for diabetes, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Genital herpes. Although there has been interest in using oral shiitake mushroom for genital herpes, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Hepatitis C. It is unclear if oral shiitake mushroom is beneficial in patients with hepatitis C. Details: Preliminary clinical research in adults with chronic hepatitis C shows that taking the shiitake mushroom extract AHCC 6 grams daily for 6 months does not significantly reduce alanine aminotransferase (ALT) or hepatitis C virus RNA levels when compared with placebo (30419).
• HIV/AIDS. Although there has been interest in using oral shiitake mushroom for HIV/AIDS, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Human papillomavirus (HPV). It is unclear if oral shiitake mushroom is beneficial in patients with HPV. Details: A small clinical study in adult females with persistent high-risk HPV shows that taking the shiitake mushroom extract AHCC 3 grams daily leads to clearance of HPV RNA and DNA in 64% of patients after 6 months of treatment, compared to 11% of patients taking placebo (110129). The validity of these findings is limited by lack of statistical comparison between groups.
• Hypercholesterolemia. It is unclear whether oral shiitake mushroom is beneficial for lowering blood lipid levels. Details: Clinical research in adults with borderline high levels of cholesterol or triglycerides shows that consuming bars providing shiitake mushroom for 66 days modestly reduces triglyceride levels, but does not affect levels of low-density lipoprotein (LDL) cholesterol or high-density lipoprotein (HDL) cholesterol, when compared with placebo bars. Each bar provided dried shiitake mushroom 3.5 grams daily and the number of bars consumed daily was based on body mass index (108300). The effect of shiitake mushroom in patients with hypercholesterolemia, specifically, is unclear due to the heterogenous patient population.
• Hypertension. Although there has been interest in using oral shiitake mushroom for hypertension, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Impaired glucose tolerance (prediabetes). Oral shiitake mushroom has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in adults with prediabetes shows that taking freeze-dried shiitake mushroom 0.96 grams in combination with chokeberry 1.36 grams, Panax ginseng 1.64 grams, and nattokinase 0.8 grams (Chakreis, YD Nutraceuticals Ltd.) twice daily for 12 weeks does not affect glycated hemoglobin, fasting blood glucose, or oral glucose tolerance test results when compared with placebo. However, there were some modest beneficial effects on insulin resistance and fasting insulin and liver transaminase levels (108301).
• Influenza. Although there has been interest in using oral shiitake mushroom for influenza, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Liver cancer. Small, low-quality clinical studies suggest that oral shiitake mushroom extract may improve overall survival in patients with liver cancer. Details: Preliminary clinical research in patients with advanced hepatic cancer shows that taking the shiitake mushroom extract AHCC orally 6 grams daily for a median of 3.5 months along with supportive care increases the median survival time by 2 months when compared with placebo. Taking AHCC also improved quality of life scores when compared with placebo (30359). Population research in patients with hepatocellular carcinoma has also found that taking AHCC 3 grams daily for up to 9 years after surgical resection reduces tumor recurrence and mortality by 48% and 56%, respectively, when compared with control (30353). In another small, open label clinical study of adults with advanced hepatocellular carcinoma, tumor recurrence occurred in 52% of patients who took AHCC 1 gram three times daily for 2 years after surgical resection (110130). The interpretation of these results is limited by the lack of a control group.
• Obesity. Although there has been interest in using oral shiitake mushroom for obesity, there is insufficient reliable information about the clinical effects of shiitake mushroom for this purpose.
• Prostate cancer. It is unclear whether shiitake mushroom has a role in preventing disease progression. Details: Preliminary clinical research shows that taking shiitake mushroom extract does not prevent disease progression, as determined by prostate-specific antigen (PSA) levels, when compared with baseline (10451). More evidence is needed to rate shiitake mushroom for these uses.

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LIKELY SAFE ...when used orally and appropriately. Rice bran and rice bran oil in doses of up to 30 grams daily have been used safely in studies lasting up to 5 years. Higher doses, up to 85 grams daily, have been used safely for 6 weeks in clinical trials (865,876,877,880,1354,106588,106590). There is insufficient reliable information available about the safety of topical rice bran.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in infants. Rice bran 1-5 grams daily for up to 6 months has been consumed with apparent safety by infants 6-12 months of age (103761).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods. There is insufficient reliable information available about the safety of rice bran when used for medicinal purposes during pregnancy and lactation; avoid using.

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LIKELY SAFE ...when consumed in typical food amounts (6).

POSSIBLY SAFE .... ..when the shiitake mushroom extract AHCC is used orally and appropriately. AHCC 4.5-6 grams daily has been used with apparent safety in clinical trials lasting up to 6 months (22926,30419). Population research identified no safety concerns with the use of AHCC 3 grams daily for up to 9 years (30353,94830).

POSSIBLY UNSAFE ...when shiitake mushroom powder is used orally in medicinal amounts. Ingestion of shiitake mushroom powder 4 grams daily for 10 weeks can cause eosinophilia (1149). ...when uncooked shiitake mushroom is ingested. The lentinan component, which is broken down by heat, can cause toxic reactions, including shiitake dermatitis (94354).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid consuming greater than food amounts.

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CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, shiitake mushroom might decrease levels of drugs metabolized by CYP2D6.  Details In vitro studies suggest that the shiitake mushroom extract AHCC might induce the CYP2D6 enzyme (30369,30420). This effect has not been reported in humans.

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking shiitake mushroom might decrease the effects of immunosuppressive therapy.  Details In vitro evidence suggests that shiitake mushroom extracts stimulate immune function (30351,30358,30360,30361,30366,30367,30368,30371,30376,30379,30381,30382,30416,30418) (74769,74783,74876,94245).

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General ...Orally, rice bran is generally well tolerated. However, increasing the amount of bran in the diet can cause transient abdominal discomfort, flatulence, and erratic bowel habits.
Most Common Adverse Effects:
Orally: Abdominal discomfort, erratic bowel habits, flatulence.
Topically: Erythema, itching.
Serious Adverse Effects (Rare):
All ROAs: Anaphylactic reactions, including urticaria and angioedema.

Dermatologic ...Topically, rice bran broth baths can cause itching and skin redness (872). In rare cases, rash and itching from rice bran has been associated with contact infestation with Pyemotes tritici, an arthropod commonly called straw itch mite (2284).

Gastrointestinal ...Orally, increasing the amount of bran in the diet can cause erratic bowel habits, flatulence, and abdominal discomfort during the first few weeks (272,106588).

Immunologic ...Orally and topically, rice bran can cause allergic reactions such as urticaria, angioedema, wheezing, itching, and cough (100733,106589). In a case report, a 5-year-old male presented with allergic eczema, urticaria, and cough due to rice bran ingestion (100733). In another case report, a 14-year-old male developed food-dependent, exercise-induced anaphylaxis after consuming 150 grams of rice bran. The 52-kDa and 63-kDa globulin constituents in rice bran have both been implicated as the source of allergic reactions (100732,106589). These constituents are not typically present in cooked, polished rice (106589).

Other ...Be aware that rice bran is a source of inorganic arsenic, which is known to negatively impact long-term health. The amount of inorganic arsenic in rice bran is unknown. However, a small analysis of powder and tablet rice bran products shows that, to exceed the provisional tolerable weekly intake of inorganic arsenic, a person weighing 65 kg would need to consume over 295 grams of rice bran tablets daily or 109 grams of rice bran powder daily. These amounts are higher than the recommended amount of rice bran tablet (3 grams daily) and rice bran powder (10-20 grams daily) listed on the labels of most available supplements (100500).

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General ...Orally, shiitake mushroom is generally well tolerated when cooked and consumed as a food.
Most Common Adverse Effects:
Orally: Abdominal discomfort, bloating, diarrhea, nausea, and vomiting.
Serious Adverse Effects (Rare):
Orally: Consumption of raw shiitake mushroom can cause shiitake dermatitis, a skin eruption resembling whiplash marks which can be accompanied by systemic symptoms. Large pieces that have been inadequately chewed can cause intestinal blockage, occasionally requiring surgery.

Dermatologic ...Orally, shiitake mushrooms can cause shiitake dermatitis, a skin eruption that resembles whiplash marks, usually found on the trunk and limbs. This dermatitis is thought to be a toxic response to lentinan or other compounds found normally in uncooked or inadequately cooked shiitake mushroom. The rash can be made worse by scratching. Symptom onset is usually within hours to days and can persist for 3-4 weeks before resolving on its own. There is some evidence that treatment with steroids alone or with antihistamines might reduce the duration of the rash by a small amount in some people (1148,1152,74782,74806,94236,94237,94238,94240,94241,94243) (94244,94246,94247,94248,94249,94252,94253,94254,94255,94256)(94257,94259,94261,94262,108302,111909,111912,111913). The dermatitis may include small purple spots from broken capillaries, skin plaques, burning, blanching, and pustules (94256,108302). Rarely the rash may look like measles rather than whiplash (94256). Histologically, there may be evidence of dermal and epidermal edema, lymphocyte infiltration, and skin thickening (94256,94257). Other symptoms associated with the dermatitis include fever, aching, malaise, eosinophilia, diarrhea, prickling in the hands, trouble swallowing, conjunctivitis, and pustules with small ulcers in the mouth (94240,94246,94247,94249,94256,94257,108302). It is likely that the dermatitis and other symptoms are due to a delayed type hypersensitivity reaction (94244,94255). Cooking shiitake mushroom generally prevents shiitake dermatitis, although some cases have occurred in people who have consumed cooked sources (94242,94244). It appears that to inactivate lentinan, cooking temperatures of at least 130°C are needed (94243).
Less common is a photosensitivity reaction associated with oral ingestion, which involves rash and pruritus after sun exposure (1148,94241).
Orally, the shiitake mushroom extract AHCC has been reported to cause mild itching (30375).

Gastrointestinal ...Orally, shiitake mushrooms can cause abdominal discomfort, including bloating, nausea, pain, vomiting, and diarrhea (1149,30365,30375,30419,94241). Gastrointestinal symptoms, such as diarrhea, problems swallowing, or mouth ulcers have been associated with shiitake dermatitis (94241,94256). Consumption of large pieces of shiitake mushroom with inadequate chewing can cause abdominal obstruction that has resulted in death in one case and surgical intervention in two others. In another case, parenteral nutrition was used exclusively until the shiitake mushroom pieces were passed (1147,94260,103160,108303,108304).
Topically, an oral rinse containing shiitake mushroom extract has been associated with teeth sensitivity, teeth staining, and burning in the mouth (94250).

Hematologic ...Ingestion of shiitake mushroom powder 4 grams daily for 10 weeks caused eosinophilia in 5 of 10 healthy humans (1149). Eosinophilia, and leukocytosis or leukopenia have been reported with shiitake dermatitis (94254,94256,94257).

Immunologic ...Allergic contact dermatitis can occur by contact with shiitake hyphae (filaments) (1153,74785,111913). It appears to be more common in growers or others that handle shiitake mushrooms extensively (94241,94259). Contact or inhalation also results in other symptoms of allergy, such as asthma, rhinitis, conjunctivitis, and pneumonia (94241,94249,94258,94259).

Musculoskeletal ...Orally, the shiitake mushroom extract AHCC has been reported to cause foot cramps and difficulty moving hand joints (30365,30416).

Neurologic/CNS ...In patients experiencing shiitake dermatitis, other symptoms may include prickling in the hands (94256). Malaise has also been reported following oral intake or contact (1151,94240).
Orally, the shiitake mushroom extract AHCC has been reported to cause mild and transient headache (30365).

Ocular/Otic ...Conjunctivitis has been reported rarely in mushroom growers and handlers, or following oral intake in patients with shiitake dermatitis (94241,94256,94259).

Pulmonary/Respiratory ...In mushroom workers, hypersensitivity pneumonitis due to shiitake spore inhalation has occurred. Symptoms include difficulty breathing, chest pain, a dry cough, asthma, and rhinitis (1150,1151,74776,74813,94239,94241,94258,94259).

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