Boldo by Herb Xtra

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Benign prostatic hyperplasia (BPH). Oral boldo has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with BPH, some of whom were already receiving conventional treatment such as alpha-1 blockers, shows that taking a specific product containing water-soluble extracts of boldo, goldenrod, chanca piedra, fireweed, and spiny restharrow (Fluxonorm, Omega Pharma) orally for 30 days improves lower urinary tract symptom scores by about 50% when compared with baseline. Maximum urinary flow rate and quality of life were also improved when compared with baseline (106432). The validity of these findings is limited by the lack of a comparator group.
• Gallbladder disease. Although there has been interest in using oral boldo for gallbladder disease, there is insufficient reliable information about the clinical effects of boldo for this purpose.
• Gonorrhea. Although there has been interest in using oral boldo for gonorrhea, there is insufficient reliable information about the clinical effects of boldo for this purpose.
• Kidney stones (nephrolithiasis). Oral boldo has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children 6-18 years of age with upper ureteral tract kidney stones shows that taking a specific combination product containing boldo 200 mg, uva ursi 300 mg and Herniaria hirsuta 40 mg (Renalit-combi, Bio-Stilogit Pharmaceuticals) orally for 12 days each month for 3 months after undergoing lithotripsy, in addition to standard care, reduces presence of residual stone fragments by 58% when compared with standard care alone (109936).
• Joint pain. Although there has been interest in using oral boldo for joint pain, there is insufficient reliable information about the clinical effects of boldo for this purpose. More evidence is needed to rate boldo for these uses.

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POSSIBLY INEFFECTIVE

• Diarrhea. Oral gelatin tannate does not seem to be beneficial for diarrhea treatment in infants and young children. Details: A pooled analysis of three clinical trials shows that taking gelatin tannate 250-500 mg four times daily for 5 days does not reduce the duration of diarrhea or stool frequency in infants and young children with acute diarrhea and gastroenteritis when compared with placebo (103296).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Although there has been interest in using oral gelatin for aging skin, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Beta-thalassemia. It is unclear if oral gelatin is beneficial for beta-thalassemia. Details: Preliminary clinical research in pregnant adults with minor or intermediate beta-thalassemia and mild iron-deficiency anemia shows that taking a specific form of gelatin made from donkey hide, colla corii asini, 15 grams daily for 4 weeks, increases hemoglobin by 11%, compared with a 5% reduction in those receiving no treatment (97634).
• Brittle nails. Although there has been interest in using oral gelatin for brittle nails, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Exercise-induced muscle soreness. Although there has been interest in using oral gelatin for exercise-induced muscle soreness and damage, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Joint pain. Although there has been interest in using oral gelatin for general joint pain, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Obesity. Although there has been interest in using oral gelatin for weight loss, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Osteoarthritis. Although there has been interest in using oral gelatin for osteoarthritis, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Osteoporosis. Although there has been interest in using oral gelatin for osteoporosis, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral gelatin for RA, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Ulcerative colitis. Rectal gelatin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults admitted to the hospital in China with mild to moderate ulcerative colitis lesions shows that administering a 1-gram suppository containing a specific form of gelatin made from donkey hide, colla corii asini, and multiple other ingredients rectally for 3 months improves diarrhea and bloody stool symptom scores when compared with an 0.8-gram suppository containing the same ingredients. Recurrence at 12 months occurred in approximately 10% of the patients who received the higher-dose combination product compared with 47% of patients who received the lower dose. Patients in each group received 2 suppositories twice daily for the first month, 1 suppository twice daily for the second month, and 1 suppository once daily for the third month (109673). The interpretation of these results is limited by the lack of comparison to placebo or active control with known effectiveness for ulcerative colitis.
• Uterine fibroids. Oral gelatin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Meta-analyses of a small number of preliminary clinical trials show that taking traditional Chinese medicines containing multiple ingredients including ejiao, a gelatin made from donkey hide, modestly reduces the volume of uterine fibroids and fibroid-related symptoms more effectively than mifepristone. When used in combination with mifepristone, benefits exceed those of mifepristone alone (106850). It is unclear whether any benefits are related to gelatin, one or more of the other ingredients, or their combination.
• Wrinkled skin. Although there has been interest in using oral gelatin for wrinkled skin, there is insufficient reliable information about the clinical effects of gelatin for this purpose. More evidence is needed to rate gelatin for these uses.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Boldo has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).

POSSIBLY UNSAFE ...when used orally in medicinal amounts. The volatile oil (2.5% in the leaf) contains the liver toxin ascaridole (4). Boldo has also been linked to a documented case of liver damage (13178). If boldo preparations are taken for medicinal purposes, only ascaridole-free preparations should be used. There is insufficient reliable information available about the safety of boldo when used topically.

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in medicinal amounts. In animals, boldo and the constituent boldine have abortive and teratogenic effects (100302). Also, the ascaridole constituent of boldo is a liver toxin (4).

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

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term . A specific type of gelatin from donkey hide, called colla corii asini, has been safely used in doses of 6-10 grams orally daily for 6-8 weeks. Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and oral ulcers (97634,107011). Since gelatin is often derived from bovine bones and skin, there is some concern about contamination with diseased animal parts (1825). So far, there are no reports of disease transmission to humans due to use of contaminated gelatin preparations.

CHILDREN: POSSIBLY SAFE
when gelatin tannate is used orally and appropriately in medicinal amounts, short-term. In children under 15 kg or under 3 years of age, gelatin tannate has been used with apparent safety at doses up to 250 mg four times daily for up to 5 days. In children over 15 kg or over 3 years of age, it has been used with apparent safety at doses up to 500 mg four times daily for up to 5 days (103296). There is insufficient reliable information available about the safety of other forms of gelatin in children.

PREGNANCY: LIKELY SAFE
when used orally in the amounts commonly found in foods.

PREGNANCY: POSSIBLY SAFE
when a specific type of gelatin from donkey hide, called colla corii asini, is used orally in doses of 10 grams daily for 6 weeks. Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and ulcers in the oral cavity (97634). There is insufficient reliable information available about the safety of other types of gelatin when used during pregnancy in medicinal amounts.

LACTATION: LIKELY SAFE
when used orally in the amounts commonly found in foods. There is insufficient reliable information available about the safety of using larger amounts of gelatin during lactation; avoid using.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking boldo with anticoagulant/antiplatelet drugs might increase the risk of bleeding.  Details Animal and in vitro research shows that boldine, a constituent of boldo, has antiplatelet activity (5191,36789). In one case report, an adult taking a combination of boldo and fenugreek with warfarin experienced an increase in international normalized ratio (INR); however, it is unclear if this effect was due to boldo, fenugreek, the combination, or another factor (5191).

HEPATOTOXIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking boldo with hepatotoxic drugs might increase the risk of hepatic injury and disease.  Details Boldo leaf contains ascaridole, a known liver toxin. Many cases of hepatotoxicity, including elevated liver transaminase levels and jaundice, have been reported in patients taking boldo (13178,100304,106431).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking boldo with lithium might increase the levels and clinical effects of lithium.  Details Boldo is believed to have diuretic effects (4). Theoretically, these diuretic effects might reduce the excretion of lithium. The dose of lithium might need to be decreased.

TACROLIMUS (Prograf) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Taking boldo with tacrolimus may decrease the levels and clinical effects of tacrolimus, potentially increasing the risk of transplant rejection.  Details In one case report, a patient with a long-term history of stable tacrolimus levels developed subtherapeutic levels after taking boldo 300 mg twice daily orally for several weeks. Tacrolimus levels returned to normal after discontinuing boldo. However, the mechanism of this interaction is unclear (92601).

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General ...Orally, boldo is generally well tolerated when used in amounts commonly found in foods. However, when used in medicinal amounts, boldo can cause significant adverse effects such as hepatotoxicity. There is currently a limited amount of information on the adverse effects of topical boldo; however, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Abdominal pain, nausea, vomiting.
Topically: Dermatitis.
Severe Adverse Effects (Rare):
Orally: Hepatotoxicity, jaundice.

Cardiovascular ...In one report, a 39-year-old obese female developed palpitations and syncope after taking a weight loss supplement containing a combination of boldo, dandelion, and bladderwrack for 3 weeks. The patient was found to have prolonged QT-interval on ECG and frequent episodes of sustained polymorphic ventricular tachycardia (14321). It is not clear whether boldo, another ingredient, or the combination of ingredients is responsible for this adverse effect. The product was not analyzed to determine the presence of any potential toxic contaminants.

Dermatologic ...Topically, boldo can be irritating when applied to the skin (4). In one case report, a healthy 64-year-old patient experienced allergic contact dermatitis in an airborne pattern on the face, arms, and dorsum of both hands following airborne exposure to boldo. After exposure to boldo was avoided, the dermatitis resolved (106433).

Gastrointestinal ...In one case report, a manufacturer of an herbal laxative reformulated their product to contain boldo. Within 5 months of switching to this reformulated product, an 82-year-old male developed abdominal discomfort with gastrointestinal upset including heartburn (13178). In another case, a 72-year-old female reported nausea, vomiting, and anorexia, which were thought to be associated with hepatotoxic effects of a boldo infusion (100304).

Hepatic ...Orally, boldo is thought to potentially cause hepatotoxicity. The volatile oil from the boldo leaf contains the liver toxin, ascaridole. In one case report, a manufacturer of an herbal laxative reformulated their product to contain boldo. Within 5 months of switching to this reformulated product, an 82-year-old male with mild hepatic steatosis and very small gallbladder stones developed elevated liver transaminase levels. Levels normalized following discontinuation of the herbal product (13178). Several other cases of hepatotoxicity have been reported in elderly patients who received infusions of boldo leaves. These patients presented with elevated liver transaminase and bilirubin levels, sometimes up to 200 times the upper limit of normal, as well as nausea, vomiting, anorexia, asthenia, and jaundice. Lab tests and symptoms normalized a few days after stopping boldo (100304,106431).

Immunologic ...Boldo intake has been linked to one case of IgE-mediated anaphylactic allergic reaction (13185).

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General ...Orally, gelatin seems to be well tolerated.
Most Common Adverse Effects:
Oral: Belching, bloating, and dyspepsia.
Serious Adverse Effects (Rare):
Injection: IgE-mediated allergic reactions, Kounis syndrome.

Gastrointestinal ...Orally, gelatin can cause unpleasant taste, sensation of heaviness in the stomach, bloating, dyspepsia, and belching (7704).

Immunologic ...Gelatin can cause allergic reactions. Gelatin in foods can cause initial sensitization (7703). Gelatin-containing medicines including oral medications, suppositories, vaccines, and injectable products can cause IgE-mediated allergic reactions, including urticaria, angioedema, wheezing, hypotension, and anaphylaxis (7708,7709,7710,97633,111345). In the US, gelatin is used as a stabilizer in some vaccines such as measles, mumps, and rubella (MMR), and diphtheria, pertussis, tetanus (DPT) (7711). In one case report, a 73-year-old male experienced anaphylactic symptoms within 10 minutes of receiving gelatin lysate as a plasma expander during a routine surgery. The patient proceeded to develop heart, respiratory, and kidney failure and died 76 days after receiving the gelatin infusion (97633). At least 12 case reports describe life-threatening anaphylaxis after administration of gelatin-containing hemostatic agents during surgery. In these cases, hypotension, tachycardia, and increased airway pressure occurred shortly after injection of the agent into the pedicle tract (111345).
There are at least two cases of Kounis syndrome, an acute coronary syndrome related to a massive mast cell activation, after the use of a gelatin infusion during general anesthesia. In one case, immediate symptoms included bradycardia and hypotension, followed by myocardial ischemia and coronary vasospasm (97631).

Other ...Since gelatin is sometimes produced from bovine bones and skin, there is some concern about the potential risk of contamination with diseased animals and transmission of bovine spongiform encephalopathy (BSE, mad cow disease) and other diseases (1825). So far, there are no reports of BSE or other disease transmission to humans from gelatin products.

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