Stone Breaker [Discontinued] by Herb Pharm

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical burdock for acne, there is insufficient reliable information about the clinical effects of burdock for this purpose.
• Aging skin. It is unclear if topical burdock is beneficial for reducing wrinkles. Details: A very small study in females aged 39-65 years shows that applying an emulsion containing burdock fruit extract 1.2% to the face twice daily for 4 weeks slightly reduces skin wrinkles around the eyes when compared with placebo (37420).
• Atopic dermatitis (eczema). Although there is interest in using topical burdock for eczema, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Breast cancer. Oral burdock root has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Population research in breast cancer patients has found that using a specific product containing burdock root, sheep sorrel, slippery elm bark, and Indian rhubarb (Essiac, Resperin Canada Limited) is not associated with improved quality of life when compared with no intervention (37419).
• Common cold. Although there is interest in using oral burdock for symptoms of the common cold, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Diabetes. Although there is interest in using oral burdock for diabetes, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Diverticulitis. It is unclear if oral burdock is beneficial in patients with diverticulitis. Details: A small open-label clinical study in patients with colonic diverticulitis shows that taking burdock tea (Ajikan, Co., Ltd.) providing 1.5 grams three times daily for a median of 26 months is associated with an acute diverticulitis recurrence rate of 11%, compared with 32% of those not taking burdock tea. Furthermore, the recurrence-free duration was increased by about 14 months. However, taking burdock tea for a median of 16 months does not prevent colonic diverticular bleeding recurrence (102696).
• Dry skin. Although there is interest in using topical burdock for dry skin, there is insufficient reliable information about the clinical effects of burdock for this purpose.
• Gout. Although there is interest in using oral burdock for gout, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Hepatitis. Although there is interest in using oral burdock for hepatitis, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Metabolic syndrome. It is unclear if oral burdock is beneficial in patients with metabolic syndrome. Details: A very small clinical study in patients with metabolic syndrome shows that drinking burdock extract 100 mL three times daily after meals for 16 weeks does not reduce body weight, abdominal fat, blood pressure, lipid levels, or glucose when compared with baseline or control (105667).
• Obesity. Although there is interest in using oral burdock for obesity, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Urinary tract infections (UTIs). Although there is interest in using oral burdock for UTI, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Vaginitis. Topical burdock has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Observational research in adults and children with vaginitis has found that applying a specific solution containing burdock, chamomile, and aloe (Zelesse, ITF Research Pharma S.L.U., Alcobendas) to the vaginal area once or twice daily for 5-20 days is associated with moderate improvements in symptoms such as pruritus, erythema, and discharge when compared with baseline (102695,102697). The validity of this finding is limited by its observational nature and the lack of a control group. More evidence is needed to rate burdock for these uses.

(Read more about BURDOCK)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anxiety. It is unclear if oral celery seed extract is beneficial in patients with anxiety. Details: A small clinical study in Iranian adults with hypertension on standard antihypertensive therapy shows that taking celery seed extract 1.34 grams daily for 4 weeks reduces symptoms of anxiety and depression when compared with placebo (112409). However, it is unclear if these benefits can be extrapolated to patients in geographic locations other than Iran.
• Depression. It is unclear if oral celery seed extract is beneficial in patients with depression. Details: A small clinical study in Iranian adults with hypertension on standard antihypertensive therapy shows that taking celery seed extract 1.34 grams daily for 4 weeks reduces symptoms of anxiety and depression when compared with placebo (112409). However, it is unclear if these benefits can be extrapolated to patients in geographic locations other than Iran.
• Diabetes. It is unclear if oral celery seed extract is beneficial in patients with diabetes. Details: A small clinical study in adults with type 2 diabetes shows that taking celery seed powder 250 mg three times daily for 12 weeks does not improve fasting blood glucose, fasting insulin, insulin resistance, total cholesterol, low-density lipoprotein or high-density lipoprotein cholesterol, triglycerides, or blood pressure when compared with placebo (112411). However, the study may have been inadequately powered to detect a difference between groups.
• Dysmenorrhea. Oral celery seed has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical trial in female college students shows that taking a specific combination product containing celery seed, saffron, and anise extracts (SCA, Gol Daro Herbal Medicine Laboratory) 500 mg three times daily for 3 days, starting at the beginning of bleeding or pain, reduces severity and duration of pain symptoms associated with menstruation when compared with placebo (17214). It is not clear if these effects are due to celery, other ingredients, or the combination.
• Dyspepsia. Oral celery seed has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A moderate-sized clinical trial in adults with functional dyspepsia conducted in Iran shows that taking celery seed powder 500 mg daily with bishop's weed 500 mg daily spread over three doses after meals for 4 weeks reduces patient-reported dyspepsia symptom severity when compared with domperidone. Taking celery and bishop's weed also reduces patient-reported symptom frequency when compared to baseline (112410). However, it is unclear if these effects are due to celery, bishop's weed, or the combination, or if results can be extrapolated to patients in geographic locations other than Iran. The interpretation of these results is also limited by the lack of a placebo group.
• Gout. Oral celery has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, open-label clinical study in patients with gout shows that taking a specific combination product (GoutFigher, Max Biocare) containing celery seed extract 600 mg, devil's claw root extract 300 mg, sour cherry extract 200 mg, and other ingredients twice daily for 45 days reduces pain, joint inflammation, and uric acid levels when compared to baseline (106488). The validity of these findings is limited by the lack of a control group. Additionally, it is unclear if these findings are due to celery, other ingredients, or the combination.
• Headache. Although there has been interest in using oral celery for headache, there is insufficient reliable information about the clinical effects of celery for this purpose.
• Hypertension. It is unclear if oral celery seed extract is beneficial in patients with hypertension. Details: A small clinical study in Iranian adults with hypertension on standard antihypertensive therapy shows that taking celery seed extract 1.34 grams daily for 4 weeks reduces daytime systolic blood pressure by about 12 mmHg compared to less than 1 mmHg with placebo. Celery seed extract also reduces night-time blood pressure, diastolic blood pressure, and mean arterial pressure, but does not impact the heart rate (110755). However, it is unclear if these benefits can be extrapolated to patients in geographic locations other than Iran.
• Impaired glucose tolerance (prediabetes). It is unclear if oral celery leaf extract is beneficial in patients with prediabetes. Details: A small clinical study in elderly patients with prediabetes shows that taking celery leaf extract 250 mg three times daily for 12 days reduces postprandial plasma glucose levels, but not insulin levels, when compared to baseline (99572). Although a control group was included in the study, statistical comparisons between treatment and control groups were not reported.
• Mosquito repellent. It is unclear if topical celery seed extract is beneficial for use as a mosquito repellant. Details: One small clinical study shows that applying gel formulations containing celery seed extract 5% to 25% can repel mosquitos in a dose-dependent manner for up to 4.5 hours. These formulations show similar repellant action when compared with DEET-containing formulations and appear to be superior to commercial repellants without DEET (40988). Celery extract has also been evaluated in combination with other ingredients. Two clinical studies show that application of a specific formulation (G10, E.A.R. Samunpri) containing celery seed extract 5%, along with vanillin, eucalyptus oil, orange oil, and citronella oil, seems to repel mosquitos for up to 4.5 hours comparably to other commercial products, including DEET 25% and Insect Block 28 (41049,41052). It is unclear if these findings are due to celery, other ingredients, or the combination.
• Osteoarthritis. Oral celery seed has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small, open-label clinical study in patients with mild knee osteoarthritis shows that taking a specific combination product (Tregocel, Max Biocare) providing celery seed 1000 mg, Boswellia serrata resin extract 1000 mg, devil's claw 1000 mg, ginger rhizome 330 mg, and curcumin 180 mg daily for 36 weeks reduces pain, improves functional capacity, and increases walking distance when compared to baseline (106078). The validity of these findings is limited by the lack of a control group. Additionally, it is unclear if these findings are due to celery, other ingredients, or the combination.
• Rheumatoid arthritis (RA). Although there has been interest in using oral celery juice for RA, there is insufficient reliable information about the clinical effects of celery for this purpose.
• Sexual dysfunction. It is unclear if oral celery seed powder is beneficial in females with sexual dysfunction. Details: One small clinical study in females with sexual dysfunction shows that taking celery seed powder 500 mg three times daily for 6 weeks improves sexual dysfunction symptom scores, primarily due to patient-rated improvements in sexual desire, arousal, lubrication, and pain, when compared with placebo (106486).
• Urinary tract infections (UTIs). Although there has been interest in using oral celery juice for UTIs, there is insufficient reliable information about the clinical effects of celery for this purpose. More evidence is needed to rate celery for these uses.

(Read more about CELERY)

There is insufficient reliable information available about the effectiveness of hydrangea.

(Read more about HYDRANGEA)

LIKELY SAFE ...when used in amounts commonly found in foods (12659,12660). Burdock root is commonly eaten as a vegetable (37422,92153,92154)

POSSIBLY SAFE ...when used topically, short-term. An emulsion containing burdock fruit extract 1.2% has been safely applied to the face twice daily for 4 weeks (37420). There is insufficient reliable information available about the safety of burdock when used orally in supplemental doses.

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

(Read more about BURDOCK)

LIKELY SAFE ...when celery stems are consumed as food. ...when celery oil or seeds are consumed in amounts commonly found in foods. Celery seed has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when celery seed is used orally and appropriately in medicinal amounts, short-term (12). Celery seed powder has been safely used at doses up to 1500 mg daily for up to 6 weeks and 750 mg daily for up to 12 weeks. Celery seed extract has been safely used at doses up to 1340 mg daily for up to 4 weeks (106486,110755,112409,112411). ...when celery seed extract is used topically and appropriately, short-term (40988,41049,41052).

PREGNANCY: LIKELY UNSAFE
when celery oil or seeds are used orally in larger amounts; celery might have uterine stimulant or abortifacient effects (4,19,19104).

LACTATION:
There is insufficient reliable information available about the safety of medicinal amounts of celery during lactation; avoid using.

(Read more about CELERY)

POSSIBLY UNSAFE ...when used orally in excessive amounts. Doses of dried hydrangea rhizome/root greater than 2 grams have been associated with reports of dizziness and a feeling of tightness in the chest (4,12). There is insufficient reliable information available about the safety of hydrangea when used in lower amounts.

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

(Read more about HYDRANGEA)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking burdock with anticoagulant or antiplatelet drugs might increase the risk of bleeding.  Details In vitro research shows that lignans from burdock reduce rabbit platelet aggregation by inhibiting platelet activating factor (12619). This interaction has not been reported in humans.

(Read more about BURDOCK)

ACETAMINOPHEN (Tylenol, others) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, celery juice might increase the effects and side effects of acetaminophen.  Details Animal research suggests that concomitant use of celery juice plus acetaminophen prolongs the effects of acetaminophen. This effect has been attributed to a decrease in hepatic cytochrome P450 activity (25362). However, other animal research shows that pretreatment with celery root extract protects against acetaminophen-induced acute liver failure (106487). These effects have not been reported in humans.

AMINOPYRINE Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, celery juice might increase the effects and side effects of aminopyrine.  Details Animal research suggests that concomitant use of celery juice plus aminopyrine prolongs the effects of aminopyrine. This effect has been attributed to a decrease in hepatic cytochrome P450 activity (25362). This effect has not been reported in humans.

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, celery root might increase the risk of bleeding when taken with anticoagulant/antiplatelet drugs.  Details Celery root contains the constituents falcarinol and falcarindiol. Laboratory research suggests that these constituents can inhibit platelet aggregation (6048,40991). This effect has not been reported in humans.

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Theoretically, celery seed extract might have additive effects with antihypertensive drugs.  Details Clinical research suggests that taking celery seed extract may reduce daytime systolic blood pressure by about 12 mmHg compared to less than 1 mmHg with placebo (110755).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, celery might increase levels of drugs metabolized by CYP1A2.  Details In vitro and animal research suggests that constituents of celery can inhibit CYP1A2 (68176). This effect has not been reported in humans.

LEVOTHYROXINE (Synthroid, others) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, celery seed might decrease the effects of levothyroxine.  Details Several cases of hypothyroidism with low T4 levels have been reported in people who were previously stabilized on levothyroxine and then started taking celery seed tablets. They presented with symptoms such as lethargy, bloating, and dry skin, and recovered when celery seed was stopped (10646). However, celery stem and leaf has been associated with case reports of hyperthyroidism in patients with no pre-existing thyroid disorders (102912,102914).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, celery might reduce excretion and increase levels of lithium due to potential diuretic effects.  Details Celery is thought to have diuretic properties (4,6). However, this effect has not been confirmed in humans.

PHOTOSENSITIZING DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, celery might increase the risk of photosensitivity reactions when taken with photosensitizing drugs.  Details Laboratory research shows that celery contains photosensitizing agents such as phenols and psoralens (6178,40894,40917,41073,41121).

VENLAFAXINE (Effexor) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, celery root extract might increase blood levels of venlafaxine.  Details There is one case report of a patient who experienced medication-induced bipolar disorder after beginning to take celery root extract 1000 mg daily along with venlafaxine 75 mg and St. John's wort 600 mg daily. Symptoms included confusion, speech abnormalities, manic affect, and visual hallucinations. The plasma level of venlafaxine was 476.8 ng/mL (normal range 195-400 ng/mL). It is theorized that celery root increased venlafaxine levels by inhibiting cytochrome P450 2D6 (92854).

(Read more about CELERY)

(Read more about HYDRANGEA)

General ...Orally, burdock is well tolerated when consumed as a food. Although a thorough evaluation of safety outcomes is lacking, there has been long-standing historical use of burdock with few noted adverse effects.
Serious Adverse Effects (Rare):
All ROAs: Allergic reactions, including contact dermatitis and anaphylaxis.

Dermatologic ...Contact dermatitis has been reported secondary to burdock, especially after prolonged use of the root oil (37422). There are cases of allergic dermatitis secondary to using burdock plasters. Two males and a 14 year-old female developed erythematous and vesicular, pruritic, and exudative reactions in areas corresponding to the application of burdock root plasters (12667). Reactions occurred up to 7 days after initial use. Patch testing was positive for burdock sensitivity in all three patients and was nonreactive in matched controls.

Hematologic ...In one case report, a 38-year-old female developed immune-mediated thrombocytopenia after consuming a "cleansing" tea containing unknown amounts of burdock and yellow dock. The patient presented with bruising, mild weakness, and fatigue, which started 2-3 days after consuming the tea, and was found to have a platelet count of 5,000 per mcL. Symptoms resolved after platelet transfusion and treatment with oral dexamethasone (108971). It is unclear if these effects were caused by burdock, yellow dock, the combination, or other contributing factors.

Hepatic ...A case of idiosyncratic drug-induced liver disease (DILI) is reported in a 36-year-old female who presented with abdominal pain after 1 month of taking an herbal liver detox tea containing burdock and other ingredients. Remarkable laboratory values included elevated liver enzymes, alkaline phosphatase, and total bilirubin. The patient received a loading dose of N-acetylcysteine and was hospitalized for 12 days (112178). However, it is unclear if the adverse effect was due to burdock, other ingredients, or the combination.

Immunologic ...There is one case of anaphylactic shock secondary to eating boiled burdock. One hour after eating boiled burdock the patient presented with redness over the entire body and dyspnea. He was found to have low blood pressure and was treated with subcutaneous epinephrine 1 mg and intravenous lactated ringer's solution containing hydrocortisone 100 mg and dexamethasone 8 mg. The cause of anaphylactic shock was attributed to allergenicity to burdock based on positive skin prick test results. Previously, the patient had experienced urticaria after eating boiled burdock (12660).

Neurologic/CNS ...Anticholinergic reactions including dry mouth, dizziness, blurred vision, weakness, dilated pupils, inability to urinate, and bradycardia have been reported following the consumption of burdock products (12662,37421,37431,37434,37435). However, these anticholinergic reactions are believed result from contamination of burdock with belladonna alkaloids. Burdock itself does not contain atropine or other constituents that would be responsible for these reactions.

(Read more about BURDOCK)

General ...Orally, celery seems to be well tolerated.
Most Common Adverse Effects:
Orally: Photosensitivity. Oral allergy syndrome in sensitive individuals.
Topically: Photosensitivity. Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Dermatologic ...Due to its psoralen content, contact with or ingestion of celery and exposure to ultraviolet radiation may cause photodermatitis (4,34347,40968,40969,40986,41085,41087,41143,41146,41151). Acute symptoms include skin eruption with edema and erythema; the main chronic symptom is hyperpigmentation at the eruption site (41093).
Celery can also cause contact or atopic dermatitis (19,41118,41124) and urticaria pigmentosa (40908).

Endocrine ...Celery has been associated with hyperthyroidism in otherwise healthy adults. In one case report a 36-year-old female presented with weight loss, blurred vision, nausea, palpitations, sweating, exophthalmos, elevated serum T4 levels, and low thyroid stimulating hormone (TSH) levels after taking 8 grams of a powdered celery extract for 78 days (102912). In another case report, a 48-year-old male presented with weight loss, exophthalmos, sweating, elevated serum T4 levels, and low TSH levels after taking 4 grams of dried celery leaves for 45 days (102914). In both of these cases, symptoms resolved and thyroid function tests normalized after discontinuing celery and completing a course of methimazole.
In contrast, several cases of hypothyroidism with low T4 levels have been reported in people who were previously stabilized on levothyroxine and then started taking celery seed tablets. They presented with symptoms such as lethargy, bloating, and dry skin, and recovered when celery seed was stopped (10646).

Gastrointestinal ...Symptoms of celery allergy have included oral allergy syndrome, characterized by itching and burning in the mouth and throat (41159,40977), and laryngeal edema (40953).

Immunologic ...Raw celery, cooked celery, and celery juice can all cause allergic reactions (40908,40926,41118,41131,92852,92855). Symptoms of celery allergy include laryngeal edema, skin reactions, an urticaria-edema-anaphylactic shock syndrome, celery-dependent exercise-induced anaphylaxis, and anaphylactic shock (40953,41100,41102,41107,41115,41124,41129,41135,41137,92852)(92855). Additionally, in clinical research, itchy throat has been reported in individuals taking celery seed powder (112410).
There is a case report of anaphylactic shock involving hypotension, tachycardia, and tachypnea in a patient who had ingested raw celery 15 minutes prior to symptom onset. The patient was treated with epinephrine, dexamethasone, and antazoline (92855). Another case report describes a patient with positive skin prick tests to celery, pollens including birch, chrysanthemum, mugwort, and ragweed, and to dust mites. When celery was consumed 30 minutes prior to exercise, the patient had an anaphylactic reaction that required treatment with intravenous pheniramine and corticosteroid, as well as nebulized albuterol (92852). Another patient with a history of anaphylactic reactions to undeclared celery in restaurant meals was able to undergo desensitization with gradually increasing oral doses of celery juice over several months, and then chronic daily ingestion of the juice to maintain hyposensitization (40908).

(Read more about CELERY)

General ...Orally, hydrangea may cause gastroenteritis, dizziness, and a feeling of tightness in the chest (4).

Cardiovascular ...Orally, hydrangea may cause a feeling of tightness in the chest (4).

Gastrointestinal ...Orally, hydrangea may cause gastroenteritis (4).

Neurologic/CNS ...Orally, hydrangea may cause dizziness (4).

(Read more about HYDRANGEA)