Elderberry Extract by Bluebonnet Herbals

POSSIBLY EFFECTIVE

• Influenza. Although some small clinical studies show that elderberry extracts can improve influenza symptoms in otherwise healthy adults, a small clinical study enrolling adults and children with or without high risk medical conditions shows it does not reduce the duration of symptoms. Details: Small clinical studies in otherwise healthy adults with influenza presenting within 48 hours of symptom onset show that taking elderberry extract syrup (Sambucol, Nature's Way) 15 mL four times daily for 5 days improves patient ratings of symptoms such as aches and pains, cough, and nasal congestion an average of 4 days earlier than in control groups. It also reduced the use of rescue medications (5260,12235). Another small clinical study in adults shows that taking an elderberry extract lozenge (ViraBLOC, HerbalScience) 175 mg four times daily for 2 days, starting within 24 hours of symptom onset, improves flu-like symptoms, typically within 48 hours, when compared with placebo (17022). However, in a small clinical study in children and adults 5 years and older with influenza, including those with high-risk conditions such as asthma, chronic lung disease, and heart disease, using Sambucol for 5 days starting within 48 hours of symptom onset did not reduce the time to complete resolution of symptoms for a 24-hour period when compared with placebo (103831). These negative findings may be due to the age and baseline health status of the enrolled patients, as well as the use of symptom resolution, as opposed to symptom improvement, as the primary outcome. Elderberry has also been evaluated in combination with echinacea for treating influenza symptoms (95650), but it is not clear whether the combination is better than either ingredient alone.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). Although there is interest in using oral elderberry for allergic rhinitis, there is insufficient reliable information about the clinical effects of elderberry for this purpose.
• Asthenopia (eye strain). Oral elderberry extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults without dry eye disease with occupations requiring the use of video display terminals shows that taking a specific combination product containing elderberry fruit extract 300 mg, zinc 10 mg, L-carnitine 50 mg, currant 100 mg, and Eleutherococcus root 50 mg (Meramirt CM) once daily for 1 month improves measures of eye strain and contrast sensitivity when compared to baseline. Improvements in these measures were lacking in the control group (111295). Statistical comparison between the two groups was not reported. It is unclear if these effects are due to elderberry, other ingredients, or the combination.
• Cardiovascular disease (CVD). It is unclear whether elderberry has any benefit in CVD. In one small study it did not alter disease markers. Details: Preliminary clinical research in postmenopausal women shows that taking elderberry extract 500 mg daily for 12 weeks does not significantly improve markers of CVD, including inflammatory biomarkers, vascular activity, or plasma lipid or glucose levels, when compared with placebo (21141).
• Chronic obstructive pulmonary disease (COPD). Elderberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in men aged 40-70 years with a history of smoking and Stage 2 COPD, shows that a combination of elderberry 165 mg, heart's ease herb 165 mg, and calendula flowers 165 mg (Inflaminat, INAT-Farma), 3 capsules daily for 6 months modestly improves the score on the 5-point breathlessness, cough, and sputum scale (BCSS) and modestly increases the mean forced expiratory volume in 1 second (FEV1), compared with no changes in the placebo group. However, the number of COPD exacerbations per month is not affected (103629). It is unclear if these effects are due to elderberry, the other ingredients, or the combination.
• Chronic fatigue syndrome (CFS). Although there has been interest in using oral elderberry for CFS, there is insufficient reliable information about the clinical effects of elderberry for this purpose.
• Common cold. Oral elderberry extract does not seem to PREVENT colds when taken prophylactically, but it may reduce the duration and severity of existing colds. Details: Clinical research in healthy adults shows that taking capsules containing elderberry extract (BerryPharma, Iprona AG) 600 mg daily for 8 days before overseas air travel, and then 900 mg daily starting 1 day before traveling and continuing for 4-5 days after arriving at the destination, does not reduce the number of colds or impact quality of life when compared with placebo. However, this product does reduce the duration of colds by about 2 days and the severity of colds by about 58% when compared with placebo (91374).
• Constipation. Oral elderberry extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial among airline flight crew shows that taking a specific product (ACTIVE) containing elderberry extract 70 mg and a specific probiotic formulation (SYNBIO) daily for 1 month improves constipation, stool volume and consistency, ease of defecation, intestinal regularity, flatulence, and diarrhea compared to baseline, but not when compared with placebo (112134). It is unclear if these effects are due to elderberry, the probiotics, or the combination.
• Gingivitis. Elderberry has been evaluated as a mouthwash or patch in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that using a mouth rinse (HM-302, Izun Pharmaceuticals) containing elderberry, echinacea, and gotu kola 15 mL three times daily for 14 days might prevent worsening of gingivitis when compared with a placebo rinse. However, it only minimally improves symptoms (20069). Other preliminary clinical research shows that applying a periodontal patch (PerioPatch, Izun Pharmaceuticals) containing elderberry, echinacea, and gotu kola either as a single dose, or three times daily for 1 day then once daily for 2 days, reduces some, but not all, measures of inflammation and gingivitis when compared with no treatment (20068,20070).
• HIV/AIDS. Although there has been interest in using oral elderberry for HIV/AIDS, there is insufficient reliable information about the clinical effects of elderberry for this purpose.
• Hyperlipidemia. It is unclear if elderberry is beneficial for the treatment of hyperlipidemia. Details: One preliminary clinical study in patients with hyperlipidemia shows that taking capsules containing spray-dried elderberry 400 mg, providing 10% anthocyanins, three times daily for 2 weeks does not reduce serum lipids when compared with placebo (21142).
• Lower respiratory tract infections. Oral elderberry extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that adding a specific combination product (Stimunex gocce) containing elderberry extract, beta-glucans, zinc, and vitamin D3 to standard therapy does not reduce the number or duration of lower respiratory tract infections when compared with standard therapy alone. In the four months after treatment completion, the number of infections was reduced by about 50%; however, the total number of infections in each group was small. The dose was 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212). The validity of this study is limited by lack of blinding.
• Obesity. Elderberry has been studied for weight loss in combination with other ingredients; its effect when used alone is unclear. Details: Observational research in overweight adults shows that replacing all meals for 8 days with a kit containing elderberry juice (from 120 grams of elderberries/day), dried elderberry (225 mg/day), dried elderflower (3.9 grams/day), elderflower extract (600 mg/day), and dried asparagus (40.5 grams/day), while also taking psyllium 2-3 teaspoons daily for 2 weeks, is associated with a mean decrease in body weight of 3.2 kg over 14 days when compared with baseline (94939). The validity of this study is limited by the lack of a comparator group. Also, it is unclear whether this effect is due to elderberry, other ingredients, the combination, or fasting from regular food.
• Psychological well-being. Oral elderberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial among airline flight crew shows that taking a specific product (ACTIVE) containing elderberry extract 70 mg and a specific probiotic formulation (SYNBIO) daily for 1 month improves scores on the Psychological General Well Being Index when compared with placebo. The index measures symptoms of anxiety and depression, general health status, and feelings of vitality and general self-control (112134). It is unclear if these effects are due to elderberry, the probiotics, or the combination.
• Respiratory tract infections. Oral elderberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that adding a specific combination product (Stimunex gocce) containing elderberry extract, beta-glucans, zinc, and vitamin D3 to standard therapy reduces the duration of respiratory tract infections by about 1.7 days and modestly improves parent-perceived symptom severity when compared with standard therapy alone. However, there was no effect on the number of total, upper, or lower respiratory tract infections, the use of antibiotics or antipyretics, or the number of days missed from school. The product was dosed as 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212). The validity of this study is limited by lack of blinding.
• Rhinosinusitis. Although there has been interest in using oral elderberry for rhinosinusitis, there is insufficient reliable information about the clinical effects of elderberry for this purpose.
• Upper respiratory tract infection (URTI). Oral elderberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that adding a specific combination product (Stimunex gocce) containing elderberry extract, beta-glucans, zinc, and vitamin D3 to standard therapy does not reduce the number or duration of upper respiratory tract infections when compared with standard therapy alone. At four months after treatment completion, the number of infections was reduced by about 44%; however, the total number of infections in both groups was small. The product was dosed as 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212). The validity of this study is limited by lack of blinding. More evidence is needed to rate elderberry for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Celiac disease. Although there has been interest in using oral lipase for celiac disease, there is insufficient reliable information about the clinical effects of lipase for this purpose.
• Dyspepsia. It is unclear if oral lipase is beneficial for improving symptoms of postprandial distress syndrome. Details: A small clinical trial shows that taking a specific acid-resistant lipase (Amano Enzyme USA) 280 mg immediately before a high-fat meal does not reduce postprandial bloating and nausea when compared with placebo in individuals with postprandial distress syndrome (101900).
• Inflammatory bowel disease (IBD). Although there has been interest in using oral lipase for IBD, there is insufficient reliable information about the clinical effects of lipase for this purpose.
• Prematurity. It is unclear if adding a specific form of lipase, recombinant human bile salt-stimulated lipase (rhBSSL), to infant formula improves outcomes in premature infants. Some research suggests a potential increased risk for adverse effects. Details: Human breast milk contains rhBSSL, but it is inactivated when breast milk is pasteurized for donation. Clinical research in infants born before 32 weeks' gestation shows that adding rhBSSL as 8700 units per 100 mL formula or pasteurized breast milk, for 4 weeks does not increase growth velocity, body length, or head circumference over the next 12 months when compared with formula or pasteurized breast milk devoid of lipase. However, the infants who were small for gestational age (SGA), which made up approximately 15% of the study population, grew by an additional 1.9 grams/kg daily on average when compared with placebo (101940). More evidence is needed to rate lipase for these uses.

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Proteolytic enzymes represent a wide group of enzymes that are used alone or in combination. See specific monographs for effectiveness information.

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LIKELY SAFE ...when used orally in the amounts typically found in foods. Elderberry has generally recognized as safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when elderberry fruit extract is used orally, short-term. One specific elderberry fruit extract (Sambucol, Nature's Way) has been used with apparent safety for up to 5 days (5260,12235,103831); another (BerryPharma, Iprona AG) has been used with apparent safety for up to 15 days (91374). A specific elderberry fruit extract lozenge (ViraBLOC, HerbalScience) has been used with apparent safety for 2 days (17022). Other elderberry fruit extracts have been used with apparent safety for up to 12 weeks (21141,21142).

POSSIBLY UNSAFE ...when elder tree leaves and stems, or unripe or uncooked elderberries, are consumed. The unripe green fruit, as well as the leaves and stems of the elder tree, contain a cyanide-producing chemical, which can cause serious toxicity (17020,17021,21143,21144,91374). Cooking eliminates the toxin.

CHILDREN: LIKELY SAFE
when consumed in the amounts typically found in foods.

CHILDREN: POSSIBLY SAFE
when used orally for up to 3 days. A specific fruit extract (Sambucol, Nature's Way) has been used in doses of 15 mL twice daily for 3 days in children 5 years and older (5260,103831).

CHILDREN: POSSIBLY UNSAFE
when unripe or uncooked elderberries are consumed. The unripe green fruit, as well as the leaves and stems of the elder tree, contain a cyanide-producing chemical , which can cause serious toxicity (17020,17021,21143,21144,91374). Cooking eliminates the toxin.

PREGNANCY AND LACTATION: LIKELY SAFE
when consumed in the amounts typically found in foods. There is insufficient reliable information available about the safety of elderberry when used for medicinal purposes; avoid using in amounts greater than those found in foods.

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

CHILDREN: POSSIBLY UNSAFE
when recombinant human bile salt-stimulated lipase (rhBSSL) is used orally by premature infants. Adding rhBSSL to infant formula or pasteurized breast milk increases the risk for serious gastrointestinal adverse effects in premature infants (101940).

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

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POSSIBLY SAFE ...when used orally and appropriately. Various proteolytic enzymes have been safely used orally in clinical research (716,964,965,968,969,6252,6253,10622,11457,18281,18284) (91104,91105,91106,91111,96449). Side effects are typically mild to moderate and most often include gastrointestinal effects. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes. ...when used topically and appropriately. Various proteolytic enzymes have been safely used topically in clinical research (67835,67843,67845,91113). Some proteolytic enzymes might cause allergic reactions when used topically. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes.

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

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IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, elderberry might interfere with immunosuppressant therapy due to its immunostimulant activity.  Details Elderberry has immunostimulant activity, increasing the production of cytokines, including interleukin and tumor necrosis factor (10796).

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General ...Orally, elderberry extracts prepared from ripe fruit seem to be well tolerated.
Most Common Adverse Effects:
Orally: When adverse effects occur, they are likely due to ingestion of raw and unripe elderberries, or seeds, leaves, and other plant parts. Due to cyanogenic glycosides, these may cause nausea, vomiting, severe diarrhea, weakness, dizziness, numbness, and stupor. Cooking eliminates the toxin.

Gastrointestinal ...Orally, nausea and vomiting have been reported after consuming a specific elderberry and echinacea product Vogel Bioforce AG) (95650). However, it is unclear if this was due to the elderberry or Echinacea contained in the product.
Raw and unripe elderberries, and the seeds, leaves, and other elder tree parts might cause nausea, vomiting, or severe diarrhea due to cyanogenic glycosides (17020,17021). Cooking eliminates the toxin.

Hepatic ...In one case report, a 60-year-old female with underlying autoimmune disease presented with autoimmune hepatitis after taking elderberry at an unknown dose for several years. The patient presented with nausea, jaundice, abdominal pain, and abdominal distention. Liver function tests returned to baseline 4 weeks after initiating treatment with prednisone 40 mg daily and discontinuing elderberry (110123).

Immunologic ...Elder tree pollen might cause an allergic reaction characterized by rhinitis and dyspnea in some patients who are allergic to grass pollen. These patients might also experience an allergic reaction to elderberry extracts (11095).

Neurologic/CNS ...Raw and unripe elderberries might cause weakness, dizziness, numbness, and stupor due to cyanogenic glycosides (17020,17021). Cooking eliminates the toxin.

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General ...No adverse effects have been reported in adults. However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal adverse effects, such as necrotizing enterocolitis, when recombinant human bile salt-stimulated lipase is used in premature infants.

Gastrointestinal ...Orally, when added to the formula or pasteurized breast milk consumed by premature infants, recombinant human bile salt-stimulated lipase (rhBSSL) can cause gastrointestinal adverse effects, including abdominal distension, flatulence, constipation, colic, abdominal pain, gastroenteritis, vomiting, regurgitation, and rectal bleeding (101940). Premature infants receiving rhBSSL also had a slightly higher rate of necrotizing enterocolitis (NEC) when compared with those receiving placebo. After review by a panel of experts, it was determined that the rate of confirmed or suspected NEC in infants consuming rhBSSL was 3.3%, compared with 0.5% in those receiving placebo. Although this rate of NEC is lower than the historical rate of occurrence in premature infants (11%), a possible increased risk for NEC cannot be ruled out (101940).

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General ...Orally, proteolytic enzymes are generally well tolerated. See specific monographs for detailed safety information related to individual proteolytic enzymes.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Serious Adverse Effects (Rare):
Topically: Allergic reactions.

Gastrointestinal ...Orally, some patients taking proteolytic enzymes may have gastrointestinal complaints (101517).

Immunologic ...Proteolytic enzymes are commonly found in laundry detergents and pre-spotter products. Rarely, protease specific IgE positive tests possibly related to these products have occurred. Exposure may be airborne or topical (102705). In addition, in case reports, occupational exposure to the airborne proteolytic enzyme pepsin has resulted in allergic rhinoconjunctivitis or asthma (102706,102707).

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