Sleep+ Tincture by Fushi Wellbeing Ltd.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). Although there has been interest in using oral German chamomile for allergic rhinitis, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Anxiety. It is unclear if inhaled German chamomile essential oil, as aromatherapy, is beneficial in patients with anxiety. Details: A large clinical study in adults in Iran hospitalized with acute coronary syndrome shows that placing 7 drops of German chamomile essential oil 10% on a cotton ball and inhaling for 12 hours nightly for 2 nights modestly lowers anxiety scores when compared with a control group (114528). The validity of this finding is limited by the potential for inadequate blinding and the short study duration. However, a small clinical study in adults with gastrointestinal, neuroendocrine, and skin cancers receiving intravenous infusion therapy shows that inhaling German chamomile essential oil 3 times daily for 7 days does not reduce self-reported anxiety when compared with a control group (111379). German chamomile has also been studied in combination with other ingredients. A small, open-label study in critically ill children in the pediatric intensive care unit shows that aromatherapy massage with an essential oil 1% blend of lavender, German chamomile, and neroli in grapeseed oil reduces distress, anxiety, and heart rate when compared to baseline (111378). However, the validity of these findings is limited by a lack of blinding and control group. It is unclear if these effects are due to German chamomile, other ingredients, or the combination.
• Atopic dermatitis (eczema). It is unclear if topical German chamomile is beneficial in patients with atopic dermatitis. Details: Clinical research in patients with atopic dermatitis shows that applying a specific cream containing a 2% ethanolic extract of German chamomile flowers (Kamillosan, Asta Medica AG) up to three times daily for up to 4 weeks improves pruritus, erythema, and desquamation when compared with placebo or hydrocortisone 0.5% cream (19707).
• Attention deficit-hyperactivity disorder (ADHD). Although there has been interest in using oral German chamomile for ADHD, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Burning mouth syndrome. German chamomile has only been evaluated as a mouthwash in combination with flaxseed; its effect when used alone is unclear. Details: Preliminary clinical research in female patients with burning mouth syndrome shows that using a mouthwash containing German chamomile and flaxseed 3-4 times daily for 3 months decreases subjective burning and dry mouth symptoms, increases salivary flow rate, and decreases saliva viscosity when compared with baseline (104807). However, the validity of these results is limited by the lack of a control group and product standardization, as the mouthwash was prepared by each patient from ingredients they purchased.
• Cancer-related anorexia. It is unclear if inhaled German chamomile essential oil, as aromatherapy, is beneficial in patients with cancer-related anorexia. Details: A small clinical study in adults with gastrointestinal, neuroendocrine, and skin cancers receiving intravenous infusion therapy shows that inhaling German chamomile essential oil 3 times daily for 7 days does not increase self-reported appetite when compared with a control group (111379).
• Chemotherapy-induced fatigue. It is unclear if inhaled German chamomile essential oil, as aromatherapy, is beneficial in patients with chemotherapy-induced fatigue. Details: A small clinical study in adults with gastrointestinal, neuroendocrine, and skin cancers receiving intravenous infusion therapy shows that inhaling German chamomile essential oil 3 times daily for 7 days does not reduce self-reported fatigue when compared with a control group (111379).
• Chemotherapy-induced nausea and vomiting (CINV). It is unclear if inhaled German chamomile essential oil, as aromatherapy, is beneficial in patients with CINV. Details: A small clinical study in adults treated for gastrointestinal, neuroendocrine, and skin cancers with intravenous infusion therapy shows that inhaling German chamomile essential oil 3 times daily for 7 days does not improve self-reported nausea when compared with a control group. (111379).
• Colic. Oral German chamomile has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical studies in infants with colic show that two multi-ingredient products given orally twice daily for 1-4 weeks reduce crying times when compared with placebo or simethicone 60 mg twice daily. The products studied contained German chamomile 178 mg with fennel and lemon balm (ColiMil, Milte Italia SPA) and German chamomile 9 mg with lemon balm and Lactobacillus acidophilus (ColiMil Plus, Milte Italia SPA) (16735,96278). Other clinical research in infants shows that taking 150 mL of a specific herbal tea preparation (Calma-Bebi, Bonomelli) containing extracts of German chamomile, vervain, licorice, fennel, and lemon balm up to three times daily after each episode of colic for 7 days increases the percentage of infants with relief by 31% when compared with placebo, although there was no effect on the number of night awakenings (19715).
• Common cold. It is unclear if inhaling the steam from a solution of German chamomile in hot water is beneficial in patients with a common cold. Details: Preliminary clinical research shows that inhaling the steam from a solution containing 13-39 mL of German chamomile alcoholic extract (Kneipp Kamillen-Konzentrat, Kneipp Werke) dissolved in 1000 mL of hot water for 10 minutes reduces symptoms when compared to baseline in patients suffering from an uncomplicated common cold (19360).
• Diarrhea. Oral German chamomile has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children aged 6 months to 6 years with acute diarrhea, using a specific combination product (Diarrhoesan, Dr. Loges + Co. GmbH) containing apple pectin and German chamomile extract for 1-3 days reduces stool frequency and improves symptom relief when compared with placebo (19705).
• Dysmenorrhea. Although there has been interest in using oral German chamomile for dysmenorrhea, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Dyspepsia. Oral German chamomile has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Two specific combination products containing German chamomile (Iberogast, Steigerwald Arzneimittelwerk GmbH; STW-5-S, Steigerwald Arzneimittelwerk GmbH), 1 mL three times daily for 4 weeks, seem to improve symptoms of dyspepsia. The combinations include German chamomile plus milk thistle, peppermint leaf, licorice, caraway, celandine, angelica, and lemon balm, with (Iberogast) or without (STW-5-S) clown's mustard plant (19532). A meta-analysis of studies using Iberogast product suggests that taking 1 mL orally three times daily for 4 weeks reduces severity of acid reflux, epigastric pain, cramping, nausea, and vomiting when compared with placebo (13089). Also, using a preparation containing clown's mustard plant, German chamomile, peppermint, caraway, licorice, and lemon balm (STW 5-II, Steigerwald Arzneimittelwerk GmbH), 1 mL three times daily for up to 12 weeks, improves symptoms in 40% more patients than placebo (12724).
• Fibromyalgia. Although there has been interest in using oral German chamomile for fibromyalgia, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Flatulence. It is unclear if oral German chamomile is beneficial in adults with flatulence post-laparoscopic cholecystectomy. Details: A moderate-sized clinical study in adults undergoing laparoscopic cholecystectomy conducted in Iran shows that German chamomile extract 20 drops given once orally 1 hour before surgery mitigates the severity and incidence of flatulence 2 hours postoperatively when compared with placebo (112364). The interpretation of these findings is limited by the use of self-reported outcomes. In addition, providers had influence on who received German chamomile, raising concerns about selection bias.
• Generalized anxiety disorder (GAD). It is unclear if oral German chamomile is beneficial in adults with GAD. Details: Small clinical studies in adults with GAD show that taking German chamomile extract 220-1500 mg daily for 8-26 weeks improves anxiety rating scores but does not reduce the risk of relapse when compared with placebo (19377,111380). Clinical practice guidelines from the World Federation of Societies of Biological Psychiatry and the Canadian Network for Mood and Anxiety Treatments do not currently recommend German chamomile as monotherapy or adjunctive therapy in patients with GAD (110318).
• Gingivitis. Topical German chamomile has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in people with gingivitis shows that using a toothpaste containing German chamomile, sage, myrrh, eucalyptus, calcium carbonate, and sodium monofluorophosphate twice daily for 30 days reduces gingivitis scores when compared with baseline, but not when compared with standard toothpaste (19702).
• Hemorrhoids. Topical German chamomile might improve symptoms after anal surgery for hemorrhoids. Details: Preliminary clinical research in patients with hemorrhoids shows that German chamomile ointment (Kamillosan, Asta Medica AG) applied twice daily for 6 weeks, in combination with band ligation plus anal dilation surgery, improves anal bleeding, itching, burning, and oozing when compared with surgery alone (19714).
• Hyperprolactinemia. Oral German chamomile might lower prolactin levels, but is not likely to work as well as conventional medications. Details: Preliminary clinical research in female patients with idiopathic hyperprolactinemia shows that taking a syrup containing 10% of a German chamomile dried flower extract 5 mL twice daily for 4 weeks produces a significant decline in serum prolactin levels when compared with baseline. However, the decrease is less than that associated with taking cabergoline 0.25 mg twice weekly for 4 weeks. Serum prolactin levels normalized in 96% of patients taking cabergoline, and 72% of patients taking German chamomile (104806).
• Inflammatory bowel disease (IBD). Although there has been interest in using oral German chamomile for IBD, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Insomnia. Oral German chamomile does not seem to be beneficial in patients with primary insomnia. Details: Preliminary clinical research in patients with primary insomnia shows that taking German chamomile 270 mg twice daily for 28 days does not improve total sleep time, sleep efficiency, sleep latency, sleep quality, waking after sleep onset, or number of awakenings when compared with placebo (19716).
• Leukemia. It is unclear if oral German chamomile is beneficial in children with leukemia. Details: One small clinical study in children aged 2-18 years with acute lymphoblastic leukemia suggests that taking German chamomile flower extract 125 mg in 2.5 mL syrup daily for 30 days during induction chemotherapy is associated with a more rapid recovery in absolute neutrophil counts, but not white blood cell counts, when compared with placebo (103180). However, statistical methods used are unclear, and it is not known if German chamomile altered the effectiveness of chemotherapy.
• Mastalgia. Preliminary research suggests that German chamomile might be effective for reducing the pain of premenstrual mastalgia. Details: Preliminary clinical research in patients with cyclic (premenstrual) mastalgia shows that taking 5 drops of German chamomile extract orally three times daily for 2 months reduces the severity of mastalgia when compared with placebo (104811).
• Nocturnal enuresis. Topical German chamomile has only been evaluated in combination with almond oil; its effect when used alone is unclear. Details: Preliminary clinical research in children with enuresis shows that applying 6 drops of almond oil infused with German chamomile flower to the perineal and suprapubic areas nightly for 6 weeks reduces the frequency of enuresis by about 3 episodes per week when compared with placebo (98621).
• Oral mucositis. Small clinical studies suggest that oral rinses containing German chamomile might help to prevent or treat oral mucositis associated with radiation therapy, chemotherapy, or hematopoietic stem cell transplantation (HSCT). Details: Clinical research shows that using an oral rinse containing German chamomile extract (Kamillosan Liquidum, Asta Media AG) three times daily might help prevent or treat mucositis associated with radiation therapy and several chemotherapy drugs, but not 5-fluorouracil (6655,6656). Other clinical research in patients undergoing HSCT shows that using German chamomile 1% oral rinse twice daily along with standard care reduces the risk of oral mucositis by 67% when compared with standard care alone. However, 0.5% and 2% rinses did not decrease the risk, suggesting that the study may have been underpowered to detect differences (99853). German chamomile has also been studied in combination with other herbal ingredients. One clinical study shows that using an oral rinse containing 1% peppermint oil and 1% German chamomile extract, diluted in water, three times daily starting 1 week before HSCT might help to reduce the severity and duration of oral mucositis induced by high-dose pre-HSCT chemotherapy when compared with placebo. However, the oral rinse does not prevent oral mucositis or reduce the duration of hospitalization when compared with placebo (95622). Another small clinical study in adults with head and neck cancer receiving radiotherapy shows that rinsing with 5 mL of a mouthwash containing German chamomile, peppermint oil, aloe vera, and honey 3 times daily for 60 seconds for 6 weeks starting on the first day of radiotherapy reduces oral mucositis incidence, severity, and pain compared with chlorhexidine and placebo (111291). It is unclear if these findings are due to German chamomile, other ingredients, or the combination.
• Peptic ulcers. Although there has been interest in using oral German chamomile for peptic ulcers, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Periodontitis. German chamomile 1% mouthwash may be similarly effective to chlorhexidine 0.12% mouthwash. Details: Preliminary clinical research shows that using 15 mL of a 1% German chamomile flower mouthwash twice daily for 30 days reduces symptoms and severity of periodontitis by a similar amount when compared with chlorhexidine 0.12% mouthwash (104808).
• Pressure ulcers. Although there has been interest in using oral German chamomile for pressure ulcers, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Radiation dermatitis. It is unclear if topical German chamomile is beneficial for preventing dermatitis caused by radiotherapy. Details: A small clinical study in adults with head and neck cancer undergoing radiotherapy who developed dry desquamation shows that applying a German chamomile 2.5% compress, 20 minutes 3 times daily, results in complete or partial regression of the dry desquamation in 65% and 35% of patients, respectively, and delays the development of moist desquamation by 5-10 days (111376). The validity of these findings is limited by a lack of a comparator group. Another small clinical study in females with breast cancer shows that using a lotion containing a microencapsulated German chamomile extract 0.2%, applied daily after radiation therapy, starting on the first day and continued until the end of treatment, does not improve the incidence or time to onset of any grade of radiation dermatitis on day 35, although it may delay the time to onset of grades 2 or greater, when compared with an identical lotion vehicle control. German chamomile may modestly improve the rate of skin recovery in those with more severe dermatitis over the 15 days following therapy completion (108993). However, due to the small size of the study and short follow-up duration, the validity of these findings is unclear.
• Rhinosinusitis. Using German chamomile nose drops might improve symptoms of rhinosinusitis. Details: Preliminary clinical research in patients with rhinosinusitis shows that using 3 drops of an ethanolic German chamomile extract in each nostril three times daily for 3 weeks reduces symptom scores and improves quality of life when compared with a sesame seed oil placebo (104810).
• Sexual dysfunction. A 5% German chamomile vaginal gel may have similar efficacy to conjugated estrogen vaginal cream in postmenopausal patients. Details: Preliminary clinical research in postmenopausal patients with sexual dysfunction shows that using a 5% German chamomile vaginal gel, 1 gram nightly for 2 weeks then twice weekly for 10 weeks, decreases dyspareunia and increases sexual satisfaction to a similar extent as conjugated estrogen vaginal cream used in the same dosage (104809).
• Vaginitis. Although there has been interest in using oral German chamomile for vaginitis, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Venous leg ulcers. Although there has been interest in using oral German chamomile for venous leg ulcers, there is insufficient reliable information about the clinical effects of German chamomile for this purpose.
• Wound healing. It is unclear if topical German chamomile is beneficial for wound healing. Details: Preliminary clinical research in adults undergoing abrasive tattoo removal shows that applying a topical German chamomile product (Kamille Spitzner, W. Spitzner Arzneimittelfabrik GmbH) three times daily for 14 days reduces wound size by day 4 of treatment when compared with placebo (19718). However, no significant differences in wound healing were observed after 18 days. More information is needed to rate German chamomile for these uses.

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LIKELY EFFECTIVE

• Coronary heart disease (CHD). A diet high in soluble fiber, such as that found in oats, reduces the risk of CHD. Details: Clinical research shows that a diet containing foods high in fiber, such as oats, oat bran, or whole oat flour, reduces the risk of CHD (2737,4960,4962,4963,4964,4965,4966,4967,4968). 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 (102336). However, clinical studies show that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5786,5787,5788,5794,5795,5796).
• Dyslipidemia. A diet rich in soluble fiber, such as that found in oats, can reduce cholesterol by a moderate amount. Details: Oats, oat bran, and other soluble fibers can modestly reduce total and low-density lipoprotein (LDL) cholesterol, especially when consumed as part of a diet low in saturated fat. Consuming 56-150 grams of whole oat products such as oatmeal and oat bran, containing 3.6-10 grams of soluble fiber daily, can significantly lower total and LDL cholesterol levels. For each gram of soluble fiber consumed, total cholesterol decreases by about 1.4 mg/dL and LDL by about 1.2 mg/dL. Eating 3-10 grams of soluble fiber daily can reduce total cholesterol by about 4-14 mg/dL (4976,4977,5786,5788,5792,5794,5795,8521,107749,113488,113495). For example, eating 3 bowls of oatmeal (28 gram servings) daily, providing a total of 3 grams of soluble fiber daily, can decrease total cholesterol by about 5 mg/dL (5788). However, consuming more than 10 grams of soluble fiber daily doesn't seem to increase effectiveness (5788). A meta-analysis comparing the effects of oats and isolated beta-glucans shows that both products similarly impact lipid profiles, suggesting that the bioactive component of oats are beta-glucans (113488). Oat bran products, such as oat bran muffins and oat bran flakes, may vary in their ability to lower cholesterol, depending on the total soluble fiber content and other dietary variables (6188). Whole oat products might be more effective for lowering LDL and total cholesterol than foods containing oat bran plus soluble fiber (10145). Although oats are shown to lower total and LDL cholesterol, a meta-analysis and a small clinical study in adults with and without dyslipidemia shows that consuming oatmeal or oat products does not reduce triglycerides or increase high-density lipoprotein (HDL) cholesterol when compared with controls (113488,113495).

POSSIBLY EFFECTIVE

• Diabetes. A diet rich in whole grains, such as oats, may help prevent diabetes or improve blood glucose control in patients with type 1, type 2, or gestational diabetes. Details: Population research shows that for every 16 gram daily serving of whole grains, including oats, there is a 7% to 11% lower risk of developing type 2 diabetes (100622). There is also evidence that consuming oats can decrease blood glucose and insulin levels, as well as lipid levels, in patients with diabetes. The glycemic effects of oats depend on the level of processing of the oat products. Consuming intact oat kernels or thick-cut oats (>0.6 mm) reduces postprandial blood glucose and insulin, but consuming thin-cut, or "quick", oats has no effect (105536). Clinical research shows that consuming oats and oat bran for 4-8 weeks decreases pre-prandial blood glucose, 24-hour plasma glucose, glycated hemoglobin (HbA1c), insulin levels, and low-density lipoprotein (LDL) cholesterol in people with type 2 diabetes (4980,4982,6266,103345). Various doses have been used, including 3 grams of soluble fiber daily, or bread providing 34 grams of total fiber daily (9 grams of soluble fiber) (4961,4980). Additional clinical research in obese adults with type 2 diabetes shows that eating whole grain oats 50-100 grams daily in place of other carbohydrates reduces postprandial blood glucose by 19-27 mg/dL when compared with other carbohydrates in a healthy diet. After 1 year, the groups consuming 50 grams and 100 grams of oats had an additional 0.48% and 0.64% reduction in HbA1c, respectively, when compared with the regular healthy diet group (97520). There is also some evidence that consuming oats 50 grams daily, containing 25 grams of soluble fiber, might be more effective for improving glycemic control and decreasing hyperinsulinemia than the standard moderate fiber diet recommended by the American Diabetes Association (ADA) (6266). Oats have also been evaluated in adolescents with type 1 diabetes. One very small clinical study shows that taking 50 grams of a specific oat product (Betaglucare), providing beta-glucans 6 grams, in three divided doses daily for one week is beneficial for glycemic control and variability when compared with a standard diet without beta-glucans or with taking only 25 grams of the product daily. Maximal, mean, and pre- and post-meal blood glucose levels were modestly lower, and minimal blood glucose levels were modestly higher. Most measures of glycemic variability were statistically different, although there were no differences in the duration of hypoglycemia or hyperglycemia between groups (105261). Oats have also been evaluated in patients with gestational diabetes. A randomized, controlled trial shows that taking 30 grams of a specific oat bran product (OAB; Golden Light Cup Company) orally twice daily at lunch and dinner for 4 weeks improves mean fasting blood glucose and two-hour postprandial glucose when compared with a control group. After 4 weeks, the mean fasting blood glucose and 2-hour postprandial glucose in the treatment group were 85 mg/dL and 104 mg/dL, respectively, compared with 93 mg/dL and 117 mg/dL, respectively, in the control group (107751). The validity of this study is limited by the short treatment duration and lack of follow-up.
• Gastric cancer. A diet rich in soluble fiber, such as that found in oats, might reduce the risk of gastric cancer. Details: Observational research has found that consuming a diet that includes cereal fiber, such as oats and oat bran, might reduce the incidence of gastric cancer (10435).

POSSIBLY INEFFECTIVE

• Colorectal cancer. Regular consumption of oats does not seem to reduce the risk of colorectal cancer. Details: Observational research has found that consuming oat bran or oats orally doesn't seem to reduce the risk of colon cancer. Additionally, consuming fiber, including oat-bran fiber, is not associated with a reduction in the risk for recurrence of colorectal adenomas (4820,5104).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical oats for acne, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Anxiety. Although there is interest in using oral oats for anxiety, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Atopic dermatitis (eczema). Topical colloidal oatmeal cream may be beneficial in patients with atopic dermatitis. Details: Preliminary clinical research shows that applying a cream containing colloidal oatmeal 1% daily for 2 weeks moderately reduces the severity of atopic dermatitis when compared with baseline (103344). The validity of this finding is limited by the lack of a comparator group. Other research suggests that colloidal oatmeal may be beneficial when used in combination with topical steroids. Clinical research shows that the benefits obtained from applying an ointment containing fluocinolone 0.025% to the hands for 2 weeks were better maintained in the patients who also used a cream containing colloidal oatmeal 1% during this time period and for an additional 4 weeks when compared with patients using fluocinolone and the cream base without colloidal oatmeal. Quality of life was also improved in the patients using colloidal oatmeal (103340).
• Breast cancer. Observational research suggests that regular oatmeal intake may be associated with reduced mortality from breast cancer. Details: Population research in postmenopausal patients has found that those who have eaten 50 grams of oatmeal daily prior to a breast cancer diagnosis have a 20% reduced risk of all-cause mortality in the 7 years following the diagnosis when compared with patients who have not eaten oatmeal. However, no benefit was seen when post-diagnostic oatmeal intakes were examined (103343).
• Burns. Although there is interest in using topical oats for burns, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral oats for CFS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Cognitive function. It is unclear if oral oats are beneficial in healthy adults with mild memory impairment. Details: Preliminary clinical research in healthy middle-aged adults with self-reported memory decline shows that consuming a specific wild green-oats extract (Neuravena, Frutarom) 800 mg as a single dose improves overall speed, but not overall accuracy, of cognitive performance when compared with placebo. However, a higher dose of 1600 mg was ineffective (97519).
• Dry skin. It is unclear if applying lotion containing colloidal oat extract improves dry skin to a greater extent than other lotion products. Details: Preliminary clinical research shows that applying a lotion containing colloidal oat extract (Aveeno Active Naturals Skin Relief 24Hr Moisturizing Lotion, Johnson & Johnson) twice daily for 2 weeks improves itchiness, cracking, scaling, dryness, and roughness when compared to baseline in females with dry skin (91458). Additional preliminary clinical research shows that applying a colloidal oatmeal lotion to the legs twice daily for three weeks reduces skin dryness and improves skin integrity when compared to baseline in adults with dry skin (97518). The validity of these findings is limited by the lack of a comparator group.
• Exercise-induced muscle soreness. It is unclear if oral oats are beneficial for exercise-induced muscle soreness. Details: A small clinical trial shows that eating two cookies containing oat flour 60 grams daily for 8 weeks reduces muscle soreness 48 or 72 hours after downhill running when compared with baseline (103341).
• Fat redistribution syndrome. It is unclear if oral oats are beneficial for fat redistribution syndrome. Details: Consumption of a high fiber diet, including oats, with adequate energy and protein might prevent fat deposition in patients with HIV. A one-gram increase in total dietary fiber may decrease the risk of fat deposition by 7% (12517).
• Gallbladder disease. Although there is interest in using oral oats for gallbladder disease, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Hypertension. It is unclear if oral oats are beneficial for hypertension. Details: A meta-analysis of 21 clinical studies in healthy adults and those with a variety of metabolic conditions including hypertension shows that consumption of oat products reduces systolic blood pressure (SBP) by 3 mmHg but has no effect on diastolic blood pressure (DBP) when compared with control. Subgroup analysis suggests that consuming oat products reduces SBP by 10 mmHg in patients with hypertension at baseline. An additional subgroup analysis suggests that consuming at least 5 grams of beta-glucan-enriched oats daily or consuming oats for a duration at least 8 weeks reduces SBP and DBP (113494). Observational research has found that consumption of oats as oatmeal or oat cereal does not seem to reduce DBPor SBP in males with minor elevations in blood pressure or patients with dyslipidemia (2956,113495). A randomized, controlled trial in patients with stage 1 hypertension receiving dietary guidance shows that taking 30 grams of oat bran, providing 8.9 grams of dietary fiber, once daily with breakfast or in between meals for 3 months improves various blood pressure measures when compared with dietary guidance alone. After 3 months of treatment, 24-hour maximum SBP and DBP decreased by 14 mmHg and 11 mmHg, respectively, and office SBP and DBP decreased by 15 mmHg and 10 mmHg, respectively. Oat consumption may also have impacted antihypertensive medication use. Two patients in the control group increased doses of antihypertensive medications, whereas 6 patients in the treatment group decreased doses and 1 patient discontinued use (107750). The effect of oral oat bran on patients with stage 2 hypertension or pre-hypertension is unknown.
• Irritable bowel syndrome (IBS). Although there is interest in using oral oats for IBS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Metabolic syndrome. Limited research suggests that oats may not be beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome shows that adding oat bran 40 grams daily for 6 weeks to a low-calorie diet does not reduce the incidence of metabolic syndrome. Oat bran also does not improve body weight, blood pressure, low-density lipoprotein (LDL) cholesterol, triglycerides, or blood glucose levels when compared with a low-calorie diet alone in patients with metabolic syndrome (103342).
• Osteoarthritis. Although there is interest in using oral oats for osteoarthritis, there is insufficient reliable information about the clinical effects of oats for this condition.
• Pruritus. Applying oat lotion topically may improve some types of pruritus. Details: Preliminary clinical research shows that applying an oat lotion (Espanol) twice daily for up to 2 weeks can decrease itching intensity by about 20% when compared to baseline in patients with pruritus associated with chronic kidney disease (uremic pruritus). This decrease is similar to the effects of applying vinegar 5% solution or taking hydroxyzine 10 mg orally. However, applying the oat lotion does not appear to decrease the frequency of itching (91457).
• Psoriasis. Although there is interest in using topical oats for psoriasis, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Rheumatoid arthritis (RA). Although there is interest in using oral oats for RA, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Stroke. It is unclear if oral oats are beneficial for reducing the risk of stroke. Details: Population research suggests that consuming oatmeal for breakfast once weekly might reduce the incidence of stroke by a small amount when compared with consuming white bread or eggs for breakfast (103337).
• Ulcerative colitis. Oral oats have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a specific oat-based product (Profermin, Nordisk Rebalance) containing fermented oat flour, Lactobacillus plantarum, barley malt flour, and lecithin, 250 mL orally twice daily for 8 weeks, reduces disease activity and increases remission in about two-fold more patients with relapsing ulcerative colitis, when compared with treatment with a specific nutritional beverage (Fresubin Original, Fresenius Kabi) (90271).
• Wound healing. Although there is interest in using topical oats for wound healing, there is insufficient reliable information about the clinical effects of oats for this purpose. More evidence is needed to rate oats for these uses.

(Read more about OATS)

LIKELY SAFE ...when used orally in amounts commonly found in foods. German chamomile has Generally Recognized as Safe (GRAS) status in the US (4912,110318).

POSSIBLY SAFE ...when used orally, for medicinal purposes, short-term. German chamomile has been used with apparent safety at doses of up to 1500 mg daily for up to 26 weeks (6655,12724,12729,13089,19377,19716,104806,111380). ...when applied topically. A lotion containing 0.2% microencapsulated German chamomile extract has been applied to the skin with apparent safety for up to 35 days (108993). ...when used topically as an oral rinse (99853).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Preliminary clinical research suggests that several multi-ingredient products containing German chamomile are safe in infants when used for up to 4 weeks (16735,19705,19715,96278). ...when used topically and appropriately, short-term. Six drops of oil infused with German chamomile flower has been applied nightly with apparent safety for up to 6 weeks in children 6-18 years old (98621).

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

(Read more about GERMAN CHAMOMILE)

LIKELY SAFE ...when used orally and appropriately in food amounts (4960,4969,5792,5797). Oat bran has Generally Recognized as Safe (GRAS) status in the US (4912). Whole grain oats 50-100 grams daily have been used for up to 1 year without serious adverse effects (97520).

POSSIBLY SAFE ...when used topically and appropriately (12). Lotion containing colloidal oat 1% has been used topically without adverse effects for up to 6 weeks (97518,103340). There is insufficient reliable information available about the safety of oats when used orally in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts (5792,5797).

(Read more about OATS)

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, German chamomile might have additive effects when used with CNS depressants.  Details German chamomile has mild sedative effects. Theoretically, concomitant use with drugs with sedative properties can cause additive effects and side effects (9765,12725,19719).

CONTRACEPTIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, large amounts of German chamomile might reduce the effectiveness of oral contraceptives.  Details In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, concomitant use of large amounts of German chamomile might interfere with contraceptive drugs through competition for estrogen receptors.

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, German chamomile might inhibit CYP1A2 and increase levels of drugs metabolized by these enzymes.  Details In vitro and animal research shows that German chamomile might inhibit CYP1A2 (12734,19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP1A2 in patients taking German chamomile.

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, German chamomile might inhibit CYP2C9 and increase levels of drugs metabolized by these enzymes.  Details In vitro evidence shows that German chamomile might inhibit CYP2C9 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2C9 in patients taking German chamomile.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, German chamomile might inhibit CYP2D6 and increase levels of drugs metabolized by these enzymes.  Details In vitro evidence shows that German chamomile might inhibit CYP2D6 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2D6 in patients taking German chamomile.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, German chamomile might inhibit CYP3A4 and increase levels of drugs metabolized by these enzymes.  Details In vitro evidence shows that German chamomile might inhibit CYP3A4 (6450,19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP3A4 in patients taking German chamomile.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, large amounts of German chamomile might reduce the effectiveness of estrogens.  Details In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, large amounts of German chamomile might interfere with hormone replacement therapy through competition for estrogen receptors.

TAMOXIFEN (Nolvadex) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, large amounts of German chamomile might interfere with the activity of tamoxifen.  Details In vitro, German chamomile has demonstrated antiestrogenic activity (12728).

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D German chamomile might increase the effects of warfarin and increase the risk of bleeding.  Details In one case, a 70-year-old female taking warfarin developed retroperitoneal hematoma and bilateral recti muscle bleeding along with an INR of 7.9 following ingestion of German chamomile tea 4-5 cups daily and use of a topical chamomile-based lotion applied 4-5 times daily (14309).

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, oats may have additive effects with antidiabetic agents and might increase the risk of hypoglycemia.  Details Consuming oats can decrease blood glucose in patients with diabetes (4980,4982,6266,103345). In those who require insulin, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Concomitant use of oats and insulin might increase the risk of hypoglycemia.  Details In patients with insulin-dependent type 2 diabetes, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

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General ...Orally and topically, German chamomile is well tolerated.
Most Common Adverse Effects:
Orally and topically: Allergic reactions and irritation.

Dermatologic ...Topically, German chamomile may cause allergic dermatitis and eczema (9766,9768,10377,110318).

Gastrointestinal ...When used topically as an oral rinse, German chamomile has been reported to cause nausea and burning in the mouth in some patients (99853).

Immunologic ...Orally, German chamomile tea can cause allergic reactions including severe hypersensitivity reactions and anaphylaxis in some patients (567). In one case report, a 47-year-old female who tolerated drinking chamomile tea, reported sneezing, nasal and ocular itching, red and watery eyes, and severe rhinorrhea after 10 years of occupational exposure to German chamomile dust (90542).

Ocular/Otic ...If used near the eyes, German chamomile can cause irritation (10377).

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General ...Orally, oats are well tolerated.
Most Common Adverse Effects:
Orally: Abdominal distension, bloating, flatulence, and unpleasant taste.
Topically: Burning, contact dermatitis, itching, and redness.

Dermatologic ...Topically, oat-containing preparations can cause contact dermatitis (12515). Redness, burning, and itchiness have also been reported (103340).

Gastrointestinal ...When consumed orally, oats provide 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. These adverse effects usually subside with continued use (12514).
In patients who have difficulty chewing food, or those with conditions that decrease small bowel motility, oat bran may cause bezoars (concretions) and intestinal obstruction. Oats and oat bran are unlikely to cause obstruction without other causative factors (4979,4985).

Immunologic ...In a case report, a 45-year-old male developed acute generalized urticaria, facial angioedema, and dyspnea immediately after consuming oat flour. The reaction resolved after emergency care for anaphylaxis. Further investigation revealed an IgE-mediated hypersensitivity reaction to oat proteins (113490).

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