Organic Sweet Almond Oil by Zongle Therapeutics

LIKELY EFFECTIVE

• Cystic fibrosis. Long-term nebulized hypertonic sodium chloride improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. Details: Meta-analyses of clinical research in adults with cystic fibrosis show that, when taken along with a bronchodilator and other standard therapies, nebulized hypertonic sodium chloride in concentrations of 3% to 7%, up to 10 mL twice daily for 4 weeks, increases forced expiratory volume at one second (FEV1) when compared with isotonic saline (sodium chloride 0.9%) (26230,26230). This benefit was not seen at 48 weeks. Other clinical research in adults with cystic fibrosis shows that inhaling sodium chloride 7%, 4 mL twice daily for 48 weeks, does not improve FEV1 when compared with isotonic saline. However, chronic treatment with hypertonic saline does reduce the number of pulmonary exacerbations and increase the number of patients without pulmonary exacerbations when compared with isotonic saline (29402). It is not clear if this benefit occurs in children with cystic fibrosis. The Pulmonary Clinical Practice Guidelines Committee of the Cystic Fibrosis Foundation recommends that individuals with cystic fibrosis aged 6 years or older use nebulized hypertonic saline long-term to improve lung function, reduce the number of exacerbations, and improve quality of life (29403).

POSSIBLY EFFECTIVE

• Amphotericin B nephrotoxicity. Oral sodium chloride seems to prevent nephrotoxicity associated with use of amphotericin B. Details: Clinical research shows that administering oral or intravenous sodium chloride 150 mEq daily during treatment with amphotericin B can attenuate the rise in serum creatinine levels and preserve renal function when compared to treatment with amphotericin B alone (26226).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bipolar disorder. It is unclear if oral sodium is beneficial in preventing lithium level fluctuations in patients with bipolar disorder. Details: A moderate-sized open-label clinical study in adults with type I bipolar disorder receiving lithium carbonate shows that taking sodium chloride 1 gram daily for 12 weeks along with dietary salt restriction of 1 gram daily reduces the percentage of patients with lithium level fluctuations above 0.8 mEq/L, but does not significantly affect serum sodium, potassium, aldosterone, or creatinine levels when compared with controls who were not salt restricted, but were advised not to consume additional salt at the table (112909). However, the interpretation of these findings is limited by missing data in both groups.
• Canker sores. Although there is interest in using topical sodium chloride for canker sores, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Congestive heart failure. It is unclear if oral sodium is beneficial in patients with acute decompensated heart failure requiring decongestive therapy with diuretics. Details: A moderate-sized clinical study in adults hospitalized with acute decompensated heart failure requiring high-dose intravenous furosemide shows that taking sodium chloride 2 grams three times daily for up to 96 hours does not affect patient weight or serum creatinine levels when compared with placebo (112911). However, the clinical relevance of this study is unclear and it may have been inadequately powered to detect a difference between groups.
• Conjunctivitis. Although there is interest in using ophthalmic sodium chloride for conjunctivitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Hyponatremia. Although there is interest in using oral sodium chloride for hyponatremia, there is insufficient reliable information about the clinical effects of oral sodium chloride for this condition.
• Pharyngitis. Although there is interest in using topical sodium chloride for pharyngitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Prematurity. It is unclear if oral sodium is beneficial for premature infants. Details: Preliminary clinical research in infants born at less than 32 weeks' gestation shows that adding sodium 4 mEq/kg daily to enteral feedings, starting from the 7th day after birth and continuing through the 35th day, reduces the risk of developing hyponatremia and improves weight gain when compared with adding water (98180). A small, open-label clinical study in newborns less than 35 weeks gestation shows that high sodium intake, defined as an average of 0.25% sodium in maintenance fluids, for 48 hours on day 2 and 3 after birth results in less weight loss within the first 72 hours of life when compared with control, but does not improve mortality, length of hospital stay, or complications from prematurity (112908). However, interpretation of these findings is limited by varied concentrations of sodium as an intervention. More evidence is needed to rate sodium for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. It is unclear if oral sweet almond is beneficial in patients with aging skin. Details: Preliminary clinical research in postmenopausal females shows that consuming sweet almonds as 20% of daily energy intake for 16 weeks reduces wrinkle severity scores by approximately 8% when compared with consuming a calorie-matched snack (101756).
• Atopic dermatitis (eczema). Topical sweet almond oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with xerotic eczema shows that applying an emollient containing lactic acid 5% and refined sweet almond oil 10%, with or without polidocanol 5%, twice daily (Antidry Lotion or Antidry Calm) for 2 weeks reduces itching by up to 69% when compared with baseline. Benefits occurred within 30 minutes of the first use and seemed to be related to improved moisture and lipid content of the skin (101788).
• Attention deficit-hyperactivity disorder (ADHD). It is unclear if oral sweet almond extract is beneficial in patients with ADHD. Details: Preliminary clinical research in children aged 6-14 years old with ADHD shows that taking sweet almond extract syrup, 5 mL three times daily, for 8 weeks does not affect parent- or teacher-rated hyperactivity or inattention scores when compared with methylphenidate 1 mg/kg orally daily. This study may have been inadequately powered to detect a difference between groups (101783).
• Cancer. Although there has been interest in using oral sweet almond for cancer, there is insufficient reliable information about the clinical effects of sweet almond for this purpose.
• Cardiovascular disease (CVD). Although there has been interest in using oral sweet almond for CVD, there is insufficient reliable information about the clinical effects of sweet almond for this purpose.
• Coronary heart disease (CHD). It is unclear if oral sweet almond is beneficial for the prevention or treatment of CHD. Details: A small clinical trial in patients with hypercholesterolemia has found that intake of sweet almonds for 4 weeks is associated with decreased CHD risk based on the Framingham 10-year risk score. Each 30-gram intake of sweet almonds was associated with an estimated 3.5% decrease in risk scores (99940). In 2003, the US Food and Drug Administration (FDA) determined that it would allow a qualified health claim stating that consuming 1.5 ounces of almonds per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD. However, the FDA has concluded that this claim is based on supporting, rather than conclusive, evidence (102331). It is unclear if sweet almonds improve outcomes in patients with CHD. Preliminary clinical research in adults with CHD shows that incorporating sweet almonds 85 grams daily into a National Cholesterol Education Program (NCEP) Step I diet for 6 weeks does not improve total or low-density lipoprotein (LDL) cholesterol, blood pressure, vascular function, or inflammatory markers when compared to the NCEP Step 1 diet without sweet almonds (99938). However, the short duration of this study limits the validity of the findings.
• Constipation. It is unclear if oral or topical sweet almond is beneficial in patients with constipation. Details: A small single-blinded clinical study in older adults with constipation shows that taking sweet almond oil 9 mL twice daily or abdominal massage with 18 mL of sweet almond oil every other day for 2 weeks both independently improve symptoms of constipation, stool consistency, and quality of life when compared with no treatment. Improvement in constipation and quality of life were also superior with oral sweet almond oil over sweet almond oil massage (111392). The validity of these findings is limited by a lack of placebo control.
• Diabetes. It is unclear if oral sweet almond is beneficial in patients with diabetes. Details: Research on whether sweet almond improves glycemic control in patients with diabetes is conflicting. A small study in patients with type 2 diabetes and mild hyperlipidemia shows that consuming sweet almonds as 20% of energy intake (approximately 60 grams daily) as part of a National Cholesterol Education Program (NCEP) Step II diet for 4 weeks, along with hypoglycemic medications, improves measures of glycemic control, as well as lipids and adiposity. Fasting insulin and glucose levels decreased by 4% and 1%, respectively, when compared with the diet without sweet almonds. Also, low-density lipoprotein (LDL) cholesterol levels were reduced by about 12% (99941). Preliminary clinical research also shows that regularly consuming sweet almonds as part of a low-carbohydrate diet for 12 weeks is more effective than consuming cheese, but no more effective than peanuts, for reducing glycated hemoglobin (HbA1c) levels (99943,101787). However, the change in HbA1c demonstrated in these small trials may not be considered clinically relevant. In contrast, meta-analyses of many clinical trials in patients with a variety of metabolic disorders, including diabetes, shows that eating almonds 5-85 grams daily, or as 10% to 20% of energy, for 4-24 weeks does not improve fasting blood glucose levels, HbA1c, insulin levels, or measures of insulin resistance when compared with control (109019,111395).
• Hyperlipidemia. Small clinical studies suggest that oral sweet almond might reduce total cholesterol and low-density lipoprotein (LDL) cholesterol in patients with hyperlipidemia, but it does not appear to improve other lipid levels in these patients. Details: Several small clinical studies in adults with hyperlipidemia show that consuming raw sweet almonds 42.5-100 grams or taking sweet almond oil 10 mL daily for 4-9 weeks reduces low-density lipoprotein (LDL) cholesterol levels by 3% to 15% when compared with control diets or baseline levels. Most of these studies failed to show improvements in high-density lipoprotein (HDL) cholesterol levels or triglyceride levels when compared with control (76725,76737,99939,101786), although one study showed a 4% improvement in HDL levels (99940). A meta-analysis of 8 clinical trials in patients with hyperlipidemia or in which at least half of the patients were classified as having hyperlipidemia shows that consuming sweet almonds or taking sweet almond oil daily for 4-12 weeks modestly reduces total cholesterol and LDL cholesterol but does not improve very low-density lipoprotein (VLDL) cholesterol, triglycerides, or HDL cholesterol when compared with placebo or no treatment (111395).
• Hypertension. It is unclear if oral sweet almond is beneficial in patients with hypertension. Details: A meta-analysis of 10 small clinical studies in which at least half of the patients in each study were classified as having hypertension at baseline shows that taking sweet almond does not improve systolic or diastolic blood pressure when compared with placebo or no treatment (111395). The validity of these findings is limited by a high degree of heterogeneity across the studies.
• Insomnia. It is unclear if oral sweet almond is beneficial in patients with insomnia. Details: Preliminary clinical research in students shows that consuming ten sweet almonds daily for 2 weeks reduces the percentage of students reporting insomnia on sleep surveys from 78% to 69% (101784). The validity of this study is limited by the lack of a control group.
• Impaired glucose tolerance (prediabetes). It is unclear if oral sweet almond is beneficial in patients with prediabetes. Details: A small clinical study in adults with prediabetes shows that consuming 20 grams of sweet almonds 30 minutes before breakfast, lunch, and dinner daily for 3 months reduces fasting blood glucose and glycated hemoglobin (HbA1c) by 6 mg/dL and 0.4%, respectively, and improves measures of insulin resistance when compared with a control group. For every 4 patients consuming sweet almonds, one additional patient experienced normalization of HbA1c. Body weight, body mass index (BMI), total cholesterol, and low-density lipoprotein (LDL) cholesterol were also improved with sweet almond over control (111389).
• Irritable bowel syndrome (IBS). It is unclear if oral sweet almond flour is beneficial in patients with IBS. Details: Preliminary clinical research in patients with diarrhea-predominant IBS shows that taking sweet almond flour 40 grams orally daily for 20 days does not improve IBS symptom scores when compared with a wheat flour placebo. In fact, those taking sweet almond flour experienced an increase in severity of pain and the number of bowel movements (101785).
• Obesity. It is unclear if oral sweet almond is beneficial in patients with obesity. Details: A moderate-sized clinical study in adults with overweight and obesity shows that consuming 30-50 grams of sweet almonds does not reduce self-reported appetite ratings or subsequent short-term energy intake despite favorable changes in appetite-regulating hormones when compared with a carbohydrate-rich snack as a control (111388). Other preliminary clinical research in adults with overweight or obesity shows that following a calorie-restricted diet with almonds as 15% of total daily energy for 12 weeks increases fat loss by 2.4-fold, but does not affect total weight loss, when compared with a nut-free, calorie-restricted diet (99937). Another preliminary clinical study in mainly overweight individuals shows that consuming sweet almonds 56 grams daily for 4 weeks in addition to the regular diet reduces levels of total and low-density lipoprotein (LDL) cholesterol by approximately 5% when compared with eating isocaloric cookies. However, there was no effect on body weight, body composition, glycemic control, or blood pressure (101790).
• Psoriasis. Although there has been interest in using topical sweet almond oil for psoriasis, there is insufficient reliable information about the clinical effects of sweet almond for this purpose.
• Radiation dermatitis. It is unclear if topical sweet almond ointment is beneficial in patients with radiation dermatitis. Details: Preliminary clinical research in females receiving radiation therapy for breast cancer shows that topical use of a sweet almond ointment once before each treatment and once a few hours after each treatment does not prevent radiation dermatitis when compared with chamomile extract cream (76740).
• Stretch marks (striae distensae). It is unclear if topical sweet almond oil is beneficial in patients with stretch marks. Details: Preliminary clinical research in nulliparous patients shows that topical application of sweet almond oil twice daily, starting at gestational week 16 and continued until delivery, does not reduce the size or number of stretch marks when compared with control. However, using the sweet almond oil modestly reduced itching scores (97322). More evidence is needed to rate sweet almond for these uses.

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LIKELY SAFE ...when used orally and appropriately. Sodium is safe in amounts that do not exceed the Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams daily (100310). Higher doses can be safely used therapeutically with appropriate medical monitoring (26226,26227).

POSSIBLY UNSAFE ...when used orally in high doses. Tell patients to avoid exceeding the CDRR intake level of 2.3 grams daily (100310). Higher intake can cause hypertension and increase the risk of cardiovascular disease (26229,98176,98177,98178,98181,98183,98184,100310,109395,109396,109398,109399). There is insufficient reliable information available about the safety of sodium when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately (26229,100310). Sodium is safe in amounts that do not exceed the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310).

CHILDREN: POSSIBLY UNSAFE
when used orally in high doses. Tell patients to avoid prolonged use of doses exceeding the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310). Higher intake can cause hypertension (26229).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Sodium is safe in amounts that do not exceed the CDRR intake level of 2.3 grams daily (100310).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in higher doses. Higher intake can cause hypertension (100310). Also, both the highest and the lowest pre-pregnancy sodium quintile intakes are associated with an increased risk of hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia, and the delivery of small for gestational age (SGA) infants when compared to the middle intake quintile (106264).

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LIKELY SAFE ...when used in amounts commonly found in foods. Sweet almond is commonly eaten as a food (99937,99938,99939,99941). There is insufficient reliable information available about the safety of sweet almond when used orally or topically in medicinal amounts.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts greater than those commonly found in foods.

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ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Theoretically, a high intake of dietary sodium might reduce the effectiveness of antihypertensive drugs.  Details High intake of dietary sodium can increase systolic and diastolic blood pressure (26222). Also, high intake of sodium may necessitate increased use of antihypertensive medications to achieve blood pressure control in some patients, such as those with chronic kidney disease (26223).

CORTICOSTEROIDS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of mineralocorticoids and some glucocorticoids with sodium supplements might increase the risk of hypernatremia.  Details Mineralocorticoids and some glucocorticoids (corticosteroids) cause sodium retention. This effect is dose-related and depends on mineralocorticoid potency. It is most common with hydrocortisone, cortisone, and fludrocortisone, followed by prednisone and prednisolone (4425).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Altering dietary intake of sodium might alter the levels and clinical effects of lithium.  Details High sodium intake can reduce plasma concentrations of lithium by increasing lithium excretion (26225). Reducing sodium intake can significantly increase plasma concentrations of lithium and cause lithium toxicity in patients being treated with lithium carbonate (26224,26225). Stabilizing sodium intake is shown to reduce the percentage of patients with lithium level fluctuations above 0.8 mEq/L (112909). Patients taking lithium should avoid significant alterations in their dietary intake of sodium.

SODIUM-CONTAINING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of sodium-containing drugs with additional sodium from dietary or supplemental sources may increase the risk of hypernatremia and long-term sodium-related complications.  Details The Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams of sodium daily indicates the intake at which it is believed that chronic disease risk increases for the apparently healthy population (100310). Some medications contain high quantities of sodium. When used in conjunction with sodium supplements or high-sodium diets, the CDRR may be exceeded. Additionally, concomitant use may increase the risk for hypernatremia; this risk is highest in the elderly and people with other risk factors for electrolyte disturbances.

TOLVAPTAN (Samsca) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = C Theoretically, concomitant use of tolvaptan with sodium might increase the risk of hypernatremia.  Details Tolvaptan is a vasopressin receptor 2 antagonist that is used to increase sodium levels in patients with hyponatremia (29406). Patients taking tolvaptan should use caution with the use of sodium salts such as sodium chloride.

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General ...Orally, sodium is well tolerated when used in moderation at intakes up to the Chronic Disease Risk Reduction (CDRR) intake level. Topically, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Worsened cardiovascular disease, hypertension, kidney disease.

Cardiovascular ...Orally, intake of sodium above the CDRR intake level can exacerbate hypertension and hypertension-related cardiovascular disease (CVD) (26229,98176,100310,106263). A meta-analysis of observational research has found a linear association between increased sodium intake and increased hypertension risk (109398). Observational research has also found an association between increased sodium salt intake and increased risk of CVD, mortality, and cardiovascular mortality (98177,98178,98181,98183,98184,109395,109396,109399). However, the existing research is unable to confirm a causal relationship between sodium intake and increased cardiovascular morbidity and mortality; high-quality, prospective research is needed to clarify this relationship (100312). As there is no known benefit with increased salt intake that would outweigh the potential increased risk of CVD, advise patients to limit salt intake to no more than the CDRR intake level (100310).
A reduction in sodium intake can lower systolic blood pressure by a small amount in most individuals, and diastolic blood pressure in patients with hypertension (100310,100311,106261). However, post hoc analysis of a small crossover clinical study in White patients suggests that 24-hour blood pressure variability is not affected by high-salt intake compared with low-salt intake (112910). Additionally, the available research is insufficient to confirm that a further reduction in sodium intake below the CDRR intake level will lower the risk for chronic disease (100310,100311). A meta-analysis of clinical research shows that reducing sodium intake increases levels of total cholesterol and triglycerides, but not low-density lipoprotein (LDL) cholesterol, by a small amount (106261).
It is unclear whether there are safety concerns when sodium is consumed in amounts lower than the adequate intake (AI) levels. Some observational research has found that the lowest levels of sodium intake might be associated with increased risk of death and cardiovascular events (98181,98183). However, this finding has been criticized because some of the studies used inaccurate measures of sodium intake, such as the Kawasaki formula (98177,98178,101259). Some observational research has found that sodium intake based on a single 24-hour urinary measurement is inversely correlated with all-cause mortality (106260). The National Academies Consensus Study Report states that there is insufficient evidence from observational studies to conclude that there are harmful effects from low sodium intake (100310).

Endocrine ...Orally, a meta-analysis of observational research has found that higher sodium intake is associated with an average increase in body mass index (BMI) of 1. 24 kg/m2 and an approximate 5 cm increase in waist circumference (98182). It has been hypothesized that the increase in BMI is related to an increased thirst, resulting in an increased intake of sugary beverages and/or consumption of foods that are high in salt and also high in fat and energy (98182). One large observational study has found that the highest sodium intake is not associated with overweight or obesity when compared to the lowest intake in adolescents aged 12-19 years when intake of energy and sugar-sweetened beverages are considered (106265). However, in children aged 6-11 years, usual sodium intake is positively associated with increased weight and central obesity independently of the intake of energy and/or sugar-sweetened beverages (106265).

Gastrointestinal ...In one case report, severe gastritis and a deep antral ulcer occurred in a patient who consumed 16 grams of sodium chloride in one sitting (25759). Chronic use of high to moderately high amounts of sodium chloride has been associated with an increased risk of gastric cancer (29405).

Musculoskeletal ...Observational research has found that low sodium levels can increase the risk for osteoporosis. One study has found that low plasma sodium levels are associated with an increased risk for osteoporosis. Low levels, which are typically caused by certain disease states or chronic medications, are associated with a more than 2-fold increased odds for osteoporosis and bone fractures (101260).
Conversely, in healthy males on forced bed rest, a high intake of sodium chloride (7.7 mEq/kg daily) seems to exacerbate disuse-induced bone and muscle loss (25760,25761).

Oncologic ...Population research has found that high or moderately high intake of sodium chloride is associated with an increased risk of gastric cancer when compared with low sodium chloride intake (29405). Other population research in patients with gastric cancer has found that a high intake of sodium is associated with an approximate 65% increased risk of gastric cancer mortality when compared with a low intake. When zinc intake is taken into consideration, the increased risk of mortality only occurred in those with low zinc intake, but the risk was increased to approximately 2-fold in this sub-population (109400).

Pulmonary/Respiratory ...In patients with hypertension, population research has found that sodium excretion is modestly and positively associated with having moderate or severe obstructive sleep apnea. This association was not found in normotensive patients (106262).

Renal ...Increased sodium intake has been associated with impaired kidney function in healthy adults. This effect seems to be independent of blood pressure. Observational research has found that a high salt intake over approximately 5 years is associated with a 29% increased risk of developing impaired kidney function when compared with a lower salt intake. In this study, high salt intake was about 2-fold higher than low salt intake (101261).

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General ...Orally, when consumed as food, sweet almond is well tolerated. Orally and topically, when used as medicine, adverse effects from sweet almond seem to be rare; however, a thorough safety evaluation has not been conducted.
Most Common Adverse Effects:
Orally: Allergic reactions.
Topically: Dermatitis, itching.

Dermatologic ...Topically, itching, dermatitis, and worsening eczema have been reported in a clinical trial (101788).

Immunologic ...Tree nuts, which include almonds, can cause allergic reactions in sensitive individuals. Due to the prevalence of this allergy in the general population, tree nuts are classified as a major food allergen in the United States (105410).

Neurologic/CNS ...Orally, adverse effects to sweet almond extract in syrup have included increased sleep (101783).

Other ...Orally, adverse effects to sweet almond extract in syrup have included increased appetite (101783).

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