Caprylic Acid Combination [Discontinued] by Nature's Sunshine

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Coronary heart disease (CHD). It is unclear if consuming black walnut as part of the diet can reduce the risk for CHD. Details: Epidemiological research has found that people who increase dietary consumption of nuts in general might have a lower risk of CHD and death due to coronary events. However, there is no available evidence showing that eating black walnut, specifically, reduces the risk of CHD (8478,13299). Still, in 2004, the US Food and Drug Administration (FDA) determined that it would allow a qualified health claim stating that consuming 1.5 ounces of walnuts per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD. The FDA has concluded that this claim is based on supporting, rather than conclusive, evidence (102335).
• Wound healing. Although there is interest in using topical black walnut hull and bark for wound healing, there is insufficient reliable information about the clinical effects of black walnut for this purpose. More evidence is needed to rate the effectiveness of black walnut for these uses.

(Read more about BLACK WALNUT)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Epilepsy. Although there has been interest in using oral caprylic acid for epilepsy, there is insufficient reliable information about the clinical effects of caprylic acid for this purpose.
• Essential tremor. Small clinical studies suggest that oral caprylic acid may slightly improve symptoms of central and peripheral essential tremor, as well as essential voice tremor. Details: Two very small crossover studies in patients with essential tremor show that taking caprylic acid 4 mg/kg as a single dose may slightly reduce the power of both central and peripheral essential tremor. However, the impact of caprylic acid on tremor power was not consistently demonstrated across all time points after administration (97663,100175). One study only found a significant improvement over placebo at 300 minutes after administration, with no statistically significant benefit of caprylic acid at any other time point prior to 300 minutes (97663). These studies may have been underpowered to detect differences between caprylic acid and placebo. One very small clinical trial in patients with essential tremor of the voice shows that taking caprylic acid 16 mg/kg daily for 20 days improves tremor amplitude and frequency by 31% and 23%, respectively, compared with 4% in those taking placebo. However, there were no benefits on audio-perceptual ratings or voice handicap (100176). A secondary analysis of results from this study suggests that patients with more severe acoustic tremors respond better to caprylic acid treatment than those with weaker acoustic tremors (106519). More evidence is needed to rate caprylic acid for these uses.

(Read more about CAPRYLIC ACID)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Topical elecampane has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in young adults with facial acne shows that application of a cream containing elecampane flower and leaf 0.8%, red soapwort root 0.32%, and black nightshade leaf 0.8%, 2 to 3 times daily for 6 weeks, reduces acne severity index scores by 55%, 85%, and 91% from baseline at 2, 5, and 6 weeks, respectively, compared with no change in the placebo group (105733). The poor study methodology and lack of statistical comparison to the placebo group limit the validity of these findings.
• Cough. Oral elecampane has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in children 3-6 years of age with acute cough shows that taking a specific syrup (KalobaTUSS, Schwabe Pharma Italia Srl) based on acacia honey with extracts of elecampane, mallow, great plantain, and sandy everlasting, as 5 mL four times daily for 8 days, produces rapid and sustained reductions in both nighttime and daytime cough scores when compared with placebo (105734). More evidence is needed to rate elecampane for these uses.

(Read more about ELECAMPANE)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Topical red raspberry leaf has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in females aged 30-65 years shows that applying a specific liquid (Antioxidant and Collagen Booster Serum, Max Biocare Pty Ltd.) containing red raspberry leaf cell culture extract 0.0005%, vitamin C 20%, and vitamin E 1% to the face nightly for 8 weeks, in addition to regular facial skin products, improves skin color, elasticity, radiance, smoothness, and appearance of wrinkles when compared with regular facial skin products alone (102355).
• Cardiovascular disease (CVD). Although there has been interest in using oral red raspberry leaf for CVD, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Congestive heart failure (CHF). Although there has been interest in using oral red raspberry leaf for CHF, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Diabetes. Although there has been interest in using oral red raspberry leaf for diabetes, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Dysmenorrhea. Although there has been interest in using oral red raspberry leaf for dysmenorrhea, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Hypertension. Although there has been interest in using oral red raspberry leaf for hypertension, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Influenza. Although there has been interest in using oral red raspberry leaf for influenza, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Labor pain. Some research suggests that oral red raspberry leaf does not reduce analgesic use during labor. Details: Clinical research shows that taking red raspberry leaf 2.4 grams daily, beginning at 32 weeks' gestation and continuing until delivery, does not decrease the need for analgesics in the perinatal time period when compared with placebo (9796). A systematic review of retrospective studies also supports these findings, showing no improvement in perineal outcomes in patients consuming red raspberry leaf prior to labor (108005).
• Menorrhagia. Although there has been interest in using oral red raspberry leaf for menorrhagia, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Obesity. It is unclear if oral red raspberry fruit is beneficial in patients with obesity. Details: Preliminary clinical research in overweight and obese adults shows that consuming frozen red raspberry fruit 280 grams daily for 8 weeks does not reduce body mass index or waist circumference when compared with control (105873).
• Osteoarthritis. It is unclear if oral red raspberry leaf extract is beneficial for knee osteoarthritis. Details: A moderate-sized clinical study in patients with knee osteoarthritis shows that taking red raspberry leaf extract 200 or 400 mg once daily for 12 weeks reduces pain at the higher dose when measured by the visual analog scale, but does not improve physical performance, physical activity, walking distance, or Western Ontario McMaster osteoarthritis index (WOMAC) global score or pain, stiffness, and function subscores when compared with placebo (112127).
• Parturition. Some research suggests that oral red raspberry leaf does not shorten the duration of labor. Details: Clinical research shows that taking red raspberry leaf 2.4 grams daily, beginning at 32 weeks' gestation and continuing until delivery, does not reduce the length of labor when compared with placebo (108005). Traditionally, doses of up to 4 grams daily have been recommended for this purpose; however, doses greater than 2.4 grams daily have not been evaluated for safety or efficacy. Further high-quality research is needed to determine the optimal dose, duration, and formulation, if any, of red raspberry leaf for this purpose.
• Pharyngitis. Although there has been interest in using topical red raspberry leaf for pharyngitis, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Pregnancy-induced nausea and vomiting. Although there has been interest in using oral red raspberry leaf for pregnancy-induced nausea and vomiting, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Respiratory tract infections. Although there has been interest in using oral red raspberry leaf for respiratory tract infections, there is insufficient reliable information about the clinical effects of red raspberry for this purpose. More evidence is needed to rate red raspberry leaf for this use.

(Read more about RED RASPBERRY)

LIKELY SAFE ...when the fruit (nut) is consumed in amounts normally found in food.

POSSIBLY UNSAFE ...when the bark is used orally or topically, due to its juglone content (2). When applied topically, juglone-containing bark can cause skin irritation. When used orally on a daily basis, the juglone-containing bark of a related species (English walnut) is associated with increased risk of tongue cancer and lip leukoplakia (2,12). There is insufficient reliable information available about the safety of the leaf or hull when used orally as a medicine or when applied topically.

PREGNANCY AND LACTATION: LIKELY SAFE
when the fruit (nut) is consumed in amounts normally found in foods.

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when the bark is used orally or topically (12); avoid using. There is insufficient reliable information available about the safety of black walnut leaf or hull when used orally in medicinal amounts during pregnancy or lactation; avoid using.

(Read more about BLACK WALNUT)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Caprylic acid has Generally Recognized as Safe (GRAS) status in the US (19507).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Caprylic acid has been safely used in clinical research at a daily dose of 16 mg/kg for 20 days (97662,100176).

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

(Read more about CAPRYLIC ACID)

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (12).

POSSIBLY UNSAFE ...when used orally in large amounts. Elecampane can cause gastrointestinal upset and symptoms of paralysis (12).

PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (12); avoid using.

(Read more about ELECAMPANE)

LIKELY SAFE ...when the fruit is used orally in amounts commonly found in foods (13622).

POSSIBLY SAFE ...when the fruit is used orally and appropriately in medicinal amounts (6481,9796). There is insufficient reliable information available about the safety of red raspberry leaf when used orally or topically.

PREGNANCY: LIKELY SAFE
when the fruit is used orally in amounts commonly found in foods (13622).

PREGNANCY: POSSIBLY SAFE
when red raspberry leaf is used orally and appropriately in medicinal amounts during late pregnancy under the supervision of a healthcare provider. Red raspberry leaf is used by nurse midwives to facilitate delivery. There is some evidence that red raspberry leaf in doses of up to 2.4 grams daily, beginning at 32 weeks' gestation and continued until delivery, can be safely used for this purpose (6481,9796). Make sure patients do not use red raspberry leaf without the guidance of a healthcare professional.

PREGNANCY: LIKELY UNSAFE
when red raspberry leaf is used orally in medicinal amounts throughout pregnancy or for self-treatment. Red raspberry leaf might have estrogenic effects (6180). These effects can adversely affect pregnancy. Tell pregnant patients not to use red raspberry leaf at any time during pregnancy without the close supervision of a healthcare provider.

LACTATION: LIKELY SAFE
when the fruit is used orally in amounts commonly found in foods (13622). There is insufficient reliable information available about the safety of red raspberry leaf; avoid using.

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(Read more about BLACK WALNUT)

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, caprylic acid might increase the risk of hypotension when used with antihypertensive drugs.  Details Animal research suggests that caprylic acid might have positive inotropic effects, resulting in reduced arterial pressure and vascular resistance and increased cardiac output (25805).

NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, caprylic acid might increase plasma concentrations of NSAIDs.  Details In vitro research suggests that caprylic acid might displace NSAIDs from binding sites on albumin (25804,25806). This effect has not been reported in humans.

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, caprylic acid might increase plasma concentrations of warfarin.  Details In vitro research suggests that high doses of caprylic acid might displace warfarin from albumin binding sites (25807). This effect has not been reported in humans.

(Read more about CAPRYLIC ACID)

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, elecampane may cause additive sedative effects when taken with CNS depressants.  Details Elecampane might have sedative effects (4).

(Read more about ELECAMPANE)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking red raspberry leaf with anticoagulant/antiplatelet drugs might increase the risk of bleeding.  Details In vitro research suggests that red raspberry leaf extract has antiplatelet activity and enhances the in vitro effects of the antiplatelet medication cangrelor (96300). This interaction has not been reported in humans.

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Red raspberry leaf might reduce glucose levels in patients being treated with insulin.  Details In one case report, a 38-year-old patient with gestational diabetes, whose blood glucose was being controlled with medical nutrition therapy and insulin, developed hypoglycemia after consuming two servings of raspberry leaf tea daily for 3 days beginning at 32 weeks' gestation. The patient required an insulin dose reduction. The hypoglycemia was considered to be probably related to use of red raspberry leaf tea (96299).

(Read more about RED RASPBERRY)

General ...Orally, black walnut fruit (nut) is well tolerated. However, the leaf, bark, and hull of black walnut contain high quantities of tannins, which may cause adverse effects when used orally or topically.
Most Common Adverse Effects:
Orally: The leaf, bark, and hull can cause gastrointestinal upset.
Topically: Hull preparations may cause a temporary yellow or brown discoloration at the site of application. The leaf, bark, and hull can cause skin irritation.
Serious Adverse Effects (Rare):
Orally: The bark may increase the risk for tongue cancer or lip leukoplakia when used long-term.
All routes of administration: Allergic reactions, including anaphylaxis.

Dermatologic ...Topically, black walnut leaf, bark, or hull may have an irritating effect on the skin due to tannin content. Black walnut hull preparations might cause a temporary yellow or brown discoloration of the skin at the site of application (12).

Gastrointestinal ...Orally, black walnut leaf, bark, or hull may cause gastrointestinal upset due to tannin content (12). Also, daily use of the juglone-containing bark of a related species (English walnut) is associated with increased risk of tongue cancer and lip leukoplakia (2,12).

Hepatic ...Orally, black walnut leaf, bark, or hull may cause liver damage if taken for extended periods of time due to tannin content (12).

Immunologic ...Tree nuts, which include black walnuts, 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).

Renal ...Orally, black walnut leaf, bark, or hull may cause kidney damage if taken for extended periods of time due to tannin content (12).

(Read more about BLACK WALNUT)

General ...Orally, caprylic acid seems to be well tolerated, short-term.
Most Common Adverse Effects:
Orally: Mild abdominal discomfort and change in taste perception.
Topically: Skin irritation.

Dermatologic ...Topically, caprylic acid is irritating to the skin of some people (20277,25076). Orally, a single dose of caprylic acid was associated with the development of a rash under the dressing of an inserted catheter in one patient in a clinical study (97662).

Gastrointestinal ...Orally, caprylic acid may cause mild abdominal discomfort and a change in taste perception (97662).

Neurologic/CNS ...Orally, caprylic acid has rarely been reported to cause mild dizziness, headache, and fatigue (97662).

(Read more about CAPRYLIC ACID)

General ...There is a limited amount of information available about the adverse effects of elecampane.
Most Common Adverse Effects:
Topically: Allergic contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Diarrhea, vomiting, spasms, and symptoms of paralysis at high doses.

Gastrointestinal ...Orally, large doses of elecampane may cause vomiting and diarrhea (12).

Immunologic ...Topically, elecampane can cause allergic contact dermatitis (6958,48729,48731), especially in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

Musculoskeletal ...Orally, large doses of elecampane may cause spasms and symptoms of paralysis (12).

(Read more about ELECAMPANE)

General ...Orally, red raspberry fruit is well tolerated. There is currently a limited amount of information on the adverse effects of red raspberry leaf.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal upset, and epigastric pain. However, these adverse effects do not commonly occur with typical doses.

Dermatologic ...A liquid containing red raspberry leaf cell culture extract 0. 0005%, vitamin C 20%, and vitamin E 1% (Antioxidant and Collagen Booster Serum, Max Biocare Pty Ltd.) has been reported to cause mild tingling and skin tightness (102355). It is unclear if these effects are due to red raspberry leaf, the other ingredients, or the combination.

Gastrointestinal ...Orally, red raspberry may cause gastrointestinal upset, diarrhea, and epigastric pain (112127).

Pulmonary/Respiratory ...A case of occupational asthma due to the inhalation of red raspberry powder has been reported for a 35-year-old female. Symptoms included wheezing and shortness of breath (70370).

(Read more about RED RASPBERRY)