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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. Although there has been interest in using oral alfalfa for diabetes, there is insufficient reliable information about the clinical effects of alfalfa for this purpose.
• Dyspepsia. Although there has been interest in using oral alfalfa for dyspepsia, there is insufficient reliable information about the clinical effects of alfalfa for this purpose.
• Hypercholesterolemia. It is unclear if oral alfalfa seeds are beneficial in patients with hypercholesterolemia. Details: A small, uncontrolled clinical study in patients with hypercholesterolemia shows that taking heat-prepared alfalfa seeds 40 grams three times daily for 8 weeks reduces total cholesterol and low-density lipoprotein (LDL) cholesterol levels when compared to baseline (5816). The validity of these findings is limited by the lack of a control group.
• Menopausal symptoms. Although there has been interest in using oral alfalfa for menopausal symptoms, there is insufficient reliable information about the clinical effects of alfalfa for this purpose. There is insufficient reliable information available about the effectiveness of alfalfa for its other uses.

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POSSIBLY EFFECTIVE

• Osteoarthritis. Topical arnica gel might reduce osteoarthritis pain. Details: One open-label clinical trial shows that applying arnica gel (A. Vogel Arnica Gel, Bioforce AG) twice daily for 3 weeks decreases total symptom scores, including pain, stiffness, and restriction-of-function, when compared to baseline (19112). A larger randomized clinical trial shows that applying the same gel is as effective as ibuprofen for reducing the intensity of pain and improving hand function (19108).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical arnica for acne, there is insufficient reliable information about the clinical effects of arnica for this purpose.
• Bleeding. It is unclear if oral arnica reduces bleeding after surgery. Details: A small clinical study in patients undergoing total mastectomy for breast cancer suggests that sublingual treatment with 5 drops of a homeopathic preparation of arnica extract (Arnica 1000 K) three times daily for 6 days might reduce the volume of blood and serum drainage by 95 mL over 5 days when compared with placebo (96769). However, because this product is a dilute homeopathic preparation, there is unlikely to be any arnica in the doses given. There is speculation that the slightly higher mean weight of the patients in the arnica group, rather than any effects of arnica itself, might have led to the statistically significant findings (96768).
• Breast cancer-related hot flashes. Oral homeopathic arnica has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A clinical study in females with non-metastatic breast cancer treated with tamoxifen or an aromatase inhibitor shows that taking a specific homeopathic medicine (Actheane, Laboratories Boiron) daily for 3 months does not reduce hot flashes when compared with placebo. This product contains 4CH each of arnica, black cohosh, bloodroot, and nitroglycerin and 5CH of snake Lachesis muta (103004).
• Bruises. Most small clinical trials show that neither topical nor oral arnica reduces postoperative bruising. Details: Most clinical research shows that topical products containing arnica 10%, as well as homeopathic oral products such as tablets, globules, and capsules, are not effective for reducing postoperative bruising (19107,19119,19120,19121,19122,19123,19124,90611,96769,96772). However, some conflicting research shows benefit. One clinical study shows that applying arnica 20% ointment 0.25 grams twice daily for 2 weeks reduces laser-induced bruising when compared to white petrolatum ointment (19125). Another clinical study shows that applying a specific arnica cream (Arnica Krem 75 g, MediTech) four times daily reduces periorbital bruising in the first week after rhinoplasty when compared with no local treatment (96773). One small study has also evaluated oral homeopathic arnica. In females undergoing a face-lift, taking a specific homeopathic oral arnica product (SinEcch, Alpine Pharmaceuticals) may reduce bruising on postoperative days 1 and 7 when compared with placebo (19124).
• Diabetic retinopathy. Small clinical studies suggest that oral homeopathic arnica may reduce symptoms of diabetic retinopathy. Details: Two preliminary clinical trials in patients with diabetic retinopathy associated with both type 1 and type 2 diabetes shows that taking three pearls of homeopathic arnica 5C orally for 6 months might modestly improve measures of vision when compared with placebo (19110,19111).
• Dry eye. It is unclear if eye drops containing arnica extract can improve dry eye in children. Details: A small observational study in children aged 9-14 years with dry eye disease and allergic conjunctivitis suggests that applying eye drops containing hyaluronic acid 0.2% and arnica extract 0.1% three times daily for four weeks is associated with improvements in subjective and objective measures of dry eye severity when compared to baseline. Improvements in these outcomes were smaller and mostly non-significant in patients using eye drops containing hyaluronic acid only (111421). The validity of these findings is limited by a lack of between-group analysis and randomization.
• Exercise-induced muscle soreness. Small studies suggest that oral homeopathic arnica does not reduce muscle soreness after exercise. It is unclear if topical arnica is beneficial. Details: Despite some conflicting evidence (19135), most clinical research shows that taking homeopathic arnica formulations orally does not prevent delayed-onset muscle soreness (19129,19130,19131,19132,19133). Research on the use of topical arnica formulations is conflicting. One small study in trained athletes shows that using a gel containing 25 mg of dry arnica herb on muscles immediately after a run and then every 4 hours while awake for 5 days improves muscle tenderness and pain by a small amount after 3 days, but not at other time points, when compared with placebo (90612). However, another small study suggests that applying arnica 7% cream (Boiron Group) increases muscle pain following calf raises when compared with placebo (17113).
• Postoperative swelling. It is unclear if topical arnica reduces swelling after surgery. Details: One clinical study shows that applying arnica 10% ointment following blepharoplasty does not reduce postoperative swelling when compared with using a placebo ointment (96772). However, lower quality studies have yielded more promising results. One small clinical study shows that applying a specific arnica cream (Arnica Krem 75 g, MediTech) four times daily reduces swelling by a small amount in the first week after rhinoplasty when compared with no local treatment (96773). The validity of this finding is limited by the lack of a placebo control. A small retrospective study suggests that using a topical homeopathic preparation containing arnica 50M and marsh tea 50M (OcuMend, Cearna Inc.) is associated with reduced postoperative swelling after oculofacial surgery (96770); however, this study is limited by poor design (96771).
• Postoperative pain. Findings related to the use of oral homeopathic arnica are mixed; most studies utilizing a placebo control have yielded negative results. Details: Many small clinical studies show that taking homeopathic arnica preparations orally modestly reduces postoperative pain following tonsillectomy, knee surgery, and carpal tunnel release when compared with baseline or control. Most studies have used homeopathic arnica in dilutions of 30C, 30X, D6, or D4, for up to two weeks postoperatively (19102,19114,19115,19116). In one study, oral homeopathic arnica has been used along with arnica 5% ointment from 72 hours after surgery for up to 2 weeks (19116). The validity of these findings is limited by the lack of a placebo comparator. Studies utilizing a placebo or active control have not yielded positive results. Clinical research in patients recovering from carpal tunnel surgery shows that taking a homeopathic Arnica montana solution by mouth is no more effective than taking placebo for reducing postoperative pain and bruising (19107). Other clinical research shows that taking homeopathic arnica 30C for 5 days after total abdominal hysterectomy does not reduce postoperative pain when compared with placebo and usual treatment (19117). Also, homeopathic arnica D4 is inferior to diclofenac following bunion surgery (109102). Some clinical research in patients recovering from a knee ligament reconstruction shows that a homeopathic solution containing Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH, and Ruta graveolens 3 DH is no more effective than placebo for reducing analgesic use (32413).
• Postoperative recovery. It is unclear if oral homeopathic arnica is beneficial for postoperative recovery. Details: One meta-analysis of small- to moderate-sized clinical trials shows that taking homeopathic arnica does not improve postoperative recovery when compared with controls. Recovery endpoints were combined and included pain, swelling, bruising, wound healing, and others (109061).
• Stroke. A small study suggests that oral homeopathic arnica does not improve outcomes after stroke. Details: Preliminary clinical research shows that taking one tablet of arnica 30C sublingually every 2 hours for six doses doesn't benefit stroke patients (19126). Endpoints included level of consciousness, mobility, incontinence, social performance, and mental state.
• Tooth extraction. It is unclear if oral homeopathic arnica improves symptoms after tooth extraction in adults or children. Details: A small clinical trial in children aged 8-12 years undergoing two sessions of tooth extraction in different parts of the mouth shows that taking homeopathic arnica 30 minutes prior to the procedure, and then 3 times daily for 72 hours, is as effective as taking ibuprofen for reducing patient-reported and operator-assessed pain levels 24 hours after extraction. However, 48 hours after extraction, ibuprofen was more effective. Each child was provided with both arnica and weight-based doses of ibuprofen in a crossover manner while undergoing two sessions of tooth extraction in different parts of the mouth ten days apart (109224). A small observational study in adults undergoing third molar extractions suggests that taking homeopathic arnica 30X (Hyland's Inc.) 4 tablets before the procedure and then 4 tablets four times daily for 4 days after the procedure is associated with less pain, bleeding, and swelling when compared with standard treatment alone (105062). However, the validity of this study is limited by the lack of a placebo control. More evidence is needed to rate arnica for these uses.

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POSSIBLY SAFE ...when the leaves are used orally and appropriately, short-term (4,6,12).

LIKELY UNSAFE ...when large amounts are used long-term. Chronic ingestion of alfalfa has been associated with drug-induced lupus effects (381,14828,30602).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in medicinal amounts. Alfalfa contains constituents with possible estrogenic activity (4,11,30592).

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POSSIBLY SAFE ...when used orally in amounts commonly found in foods. Arnica has Generally Recognized As Safe (GRAS) status for use as a food flavoring in the US (4912). However, Canadian regulations do not allow its use as a food ingredient (12). ...when used orally in homeopathic dilutions of 30C and up to 5C (19110,19111,19117,19124,19126,96769). ...when used topically on unbroken skin, short-term (12).

LIKELY UNSAFE ...when used orally or when applied topically to broken skin. Arnica is considered poisonous and has caused severe or fatal poisonings (5). Arnica can cause gastroenteritis, muscle paralysis, bleeding, arrhythmia, hypertension, shortness of breath, nausea and vomiting, multi-organ failure, and death (4,5,17,104,19101,19102,19103,19104,19105,19106,19107,19108).

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

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, alfalfa might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal research suggests that alfalfa decreases blood sugar in diabetic mice (30605). Also, in one case report, a diabetic patient experienced hypoglycemia after consuming alfalfa extract (30608). Monitor blood glucose levels closely. Dose adjustments might be necessary.

CONTRACEPTIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, alfalfa might interfere with the activity of contraceptive drugs.  Details Alfalfa contains coumestrol, a phytoestrogen, and isoflavonoids, which have estrogenic effects (4,30592).

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, alfalfa might interfere with hormone therapy.  Details Alfalfa contains coumestrol, a phytoestrogen, and isoflavonoids, which have estrogenic effects (4,30592).

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, alfalfa might decrease the efficacy of immunosuppressive therapy.  Details In vitro research and human case reports suggest that alfalfa may have immunostimulant effects (12174,14828,14829).

PHOTOSENSITIZING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of alfalfa with photosensitizing drugs might have additive effects.  Details Animal research suggests that excessive doses of alfalfa may increase photosensitivity, possibly due to its chlorophyll content (106043). It is unclear if this effect would be clinically relevant in humans.

WARFARIN (Coumadin) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = D Theoretically, alfalfa might reduce the anticoagulant activity of warfarin.  Details Alfalfa contains a large amount of vitamin K (4,6). This could theoretically interfere with the activity of warfarin.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, arnica might have additive effects with anticoagulant and antiplatelet drugs. Homeopathic arnica preparations are unlikely to have this interaction.  Details In vitro evidence shows that sesquiterpene lactones in arnica flowers can decrease platelet aggregation (104). However, this effect has not been reported in humans.

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General ...Orally, alfalfa leaf seems to be well tolerated. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Abdominal discomfort, diarrhea, and flatulence.
Serious Adverse Effects (Rare):
Orally: Lupus-like syndrome after chronic ingestion of alfalfa.

Dermatologic ...Dermatitis associated with alfalfa use has been reported. In a 1954 publication, dermatitis was noted in a 61-year-old female consuming 4-6 cups of tea made with two tablespoonfuls of alfalfa seeds for approximately two months prior to onset. Examination revealed diffuse, confluent edema and erythema on the face, eyelids, ears, hands, forearms, and distal humeral regions. The dermatitis improved with treatment; re-exposure to alfalfa resulted in a similar reaction (30609).

Endocrine ...Alfalfa contains constituents, including coumestrol, with reported estrogenic activity (30586,30592,4753). Effects in humans are not known.
One case report documents hypokalemia in a female who had been drinking a "cleansing tea" containing alfalfa, licorice, and stinging nettle. The potassium level returned to normal after discontinuing the tea and initiating potassium supplementation. The specific cause of the hypokalemia is not clear. Notably, both stinging nettle and licorice have been associated with hypokalemia and may have been responsible for this effect (30562).

Gastrointestinal ...Orally, flatulence and bulkier feces were reported during the first week of a case series of three subjects ingesting alfalfa (30598). In a case series of 15 patients ingesting alfalfa, increased fecal volume and increased stool frequency was reported. Additional adverse effects included abdominal discomfort in two patients, diarrhea in two patients, loose stools in six patients, and intestinal gas in 13 patients (5816).

Hematologic ...Pancytopenia and splenomegaly were reported in a 59-year-old male who had been taking 80-160 grams of ground alfalfa seeds for up to six weeks at a time, for a five month period. Hematologic values and spleen size returned to normal when alfalfa was discontinued (381).

Other ...Alfalfa products, including sprouts, seeds, and tablets, have been found to be contaminated with Escherichia coli, Salmonella, and Listeria monocytogenes, which have caused documented infections (5600,30566,30568,30572,30569,30564,30604,30610,30563,30607) (30566,30564,30604,30610,30563,30607,30576).
Orally, alfalfa has been associated with the development of a lupus-like syndrome in animals and humans (30594,14828,14830,30602), as well as with possible exacerbations of lupus in patients with known systemic lupus erythematosus (SLE). These reactions may be associated with the amino acid L-canavanine (30594), which appears to be present in alfalfa seeds and sprouts, but not leaves, and therefore should not be present in alfalfa tablets manufactured from the leaves (30601). However, case reports have included individuals ingesting tablets. A lupus-like syndrome was described in four patients taking 12-24 alfalfa tablets per day. Symptoms included arthralgias, myalgias, and rash; positive antinuclear antibodies (ANA) arose anywhere from three weeks to seven months after initiating alfalfa therapy. Upon discontinuation of alfalfa tablets, all four patients became asymptomatic. In two patients, ANA levels normalized (14828). Two additional reports have documented possible exacerbation or induction of SLE associated with alfalfa use. One case involved a female with a 26-year history of SLE, who had been taking 15 tablets of alfalfa daily for nine months prior to an exacerbation. Because of the delay in onset of the exacerbation from the initiation of alfalfa therapy, causation cannot be clearly established (30575). In a different report, SLE and arthritis were found in multiple family members who had been taking a combination of vitamin E and alfalfa tablets for seven years (30602). It is not known what other environmental or genetic factors may have affected these individuals, and the association with alfalfa is unclear.

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General ...Orally, arnica is unsafe and can cause toxicity. When used in homeopathic amounts, arnica seem to be generally well tolerated. Topically, arnica also seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Bleeding, gastroenteritis, hypertension, muscle paralysis, nausea and vomiting, shortness of breath.
Topically: Contact dermatitis and irritation.
Serious Adverse Effects (Rare):
Orally: Arrhythmia, coma, multi-organ failure, and death.

Cardiovascular ...Orally, arnica can cause tachycardia or a faster heart rate (11,17113,19101,19102). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).

Dermatologic ...Orally, arnica can cause irritation of mucous membranes (11,17113). Topically, arnica can cause contact itchiness, dry skin, and rash (17113). Oral lesions resulted in a woman who used a mouthwash incorrectly by not following dilution instructions. The mouthwash was 70% alcohol and contained arnica and oil of peppermint (19106).

Gastrointestinal ...Orally, arnica can cause stomach pain, nausea, vomiting, and diarrhea (11,17113,19101,19102). Homeopathic arnica has been reported to cause dry mouth (30C) and sore tongue (6C) (19107). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).

Musculoskeletal ...Adverse effects after ingesting arnica include muscle weakness (19101). Homeopathic arnica has been reported to result in the feeling of a "throbby" head or neck (19107).

Neurologic/CNS ...Orally, arnica may cause drowsiness, nervousness, and headache (11,17113,19101,19107).

Ocular/Otic ...In a case report, accidental intake of a large amount of a homeopathic Arnica-30 resulted in acute vision loss due to bilateral toxic optic neuropathy (19105).

Psychiatric ...Oral homeopathic arnica (6C) may cause depressed feelings, specifically a feeling of unhappiness (19107).

Pulmonary/Respiratory ...Orally, arnica can cause shortness of breath (11,17113).

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