Recently, VitaMedica has received a number of emails with questions about Arnica Montana and Bromelain. Since these two botanicals are very popular, and frequently taken together during the peri-operative period, I thought it would be helpful to provide an update to our FAQs for Arnica and Bromelain.
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Article Highlights: - Homeopathic Arnica montana has been used for centuries to safety treat bruising and swelling. - Bromelain is a proteolytic enzyme with activity that reduces edema, pain and healing time following surgical procedures. - The FDA regulates Homeopathic Arnica montana as a drug requiring Drug Facts; the agency regulates bromelain as a dietary supplement requiring Supplement Facts. - Safety issues, particularly bleeding, relate to herbal doses of Arnica montana. The highly diluted Homeopathic form of the plant does not present any safety issues. - Only Homeopathic Arnica montana can use treatment claims for the reduction of bruising and swelling. - Products that combine herbal Arnica montana with bromelain are regulated as dietary supplements and cannot make treatment claims like “reduces bruising.” - Combining herbal Arnica montana with bromelain into a single dietary supplement is not recommended due to safety and regulatory issues. |
I’ve seen a few nutritional supplements that combine Arnica montana with bromelain. I like the idea of taking both supplements in a single pill. Why do you offer your Arnica Montana and Bromelain with Quercetin as two separate products?
Lately, we’ve seen an uptick in patient inquiries regarding supplements that combine these two botanical compounds. Although it may seem like a good idea to combine Arnica montana with Bromelain in a single pill, unfortunately this practice is not recommended, both from a safety and a regulatory standpoint.
To better understand why this is the case, it’s important to know the difference between herbal and Homeopathic Arnica montana. Herbal Arnica montana and Homeopathic Arnica montana are formulated, manufactured and regulated in very different ways. Homeopathic Arnica is a drug that has been widely used and accepted for bruising, swelling and surgical procedures for decades. Herbal Arnica is contraindicated during the peri-operative period. The actual herb is toxic to the liver and can be fatal in some cases, thus the FDA has classified Arnica as an unsafe herb. Physicians generally advise against using Arnica in any form other than in a highly diluted Homeopathic form, and we do not use herbal Arnica in any of our formulations.
What is Arnica Montana?
Arnica montana is a plant native to Europe, Asia and North America that is sometimes referred to as the “mountain daisy” or “leopard’s bane”. This perennial plant from the sunflower family (Asteraceae), grows 1-2 feet with flowers that resemble daisies.
Arnica is actually a toxic herb, but in its Homeopathic form, it can heal. Homeopathic Arnica uses micro-doses of the Arnica plant, which are both safe and beneficial. In its Homeopathic form, Arnica can restore health with negligible side-effects and is safe for children, adults and seniors. Like other homeopathic medicines, Arnica has been regulated as a drug by the FDA since 1938 and manufactured according to the guidelines in the Homeopathic Pharmacopoeia of the United States (HPUS). Homeopathic Arnica has no reported drug interactions and is safe for individuals who require other medications.
Herbal preparations of Arnica are very different from the Homeopathic medicines made from the plant. In herbal form, the amount of plant extract is substantially higher. This can cause adverse effects when taken internally. Home brewed teas and tinctures can cause dizziness, diarrhea, irregular heartbeat and even death. Topical herbal applications can cause reactions as well. For this reason, professional practitioners recommend Arnica only when used in Homeopathic form
In particular, Homeopathic Arnica, is often recommended during the peri-operative period for the treatment of bruising, swelling and inflammation.
How Does Arnica Montana Help Bruising?
The Arnica montana plant contains compounds that are especially important in the reduction of bruising and swelling from soft tissue injury. The major active constituent found in the Arnica montana plant is helenalin, a phytochemical with documented anti-inflammatory effects. Helenalin, can be poisonous if large amounts of the Arnica plant are eaten or small amounts of concentrated Arnica are consumed.
The exact mechanism of action for arnica in the treatment of bruises is unknown. However, it is believed that arnica inhibits platelet function in vitro. Arnica increases the flow of blood around bruised tissue causing escaped fluids to be reabsorbed by the body. The absorption of the fluids speeds up the disappearance of “black and blue” marks and reduces pain and swelling by relieving the pressure on nerve endings.
What is Homeopathy?
Homeopathy is a school of alternative medicine developed over 200 years ago by Samuel Hahnemann, M.D. in Germany. Homeopathy is based on the doctrine similia similibus curentur, literally meaning “like cures like”. According to Homeopathy, a substance that causes symptoms of disease in healthy people can cure that disease in people who are ill.
Plants are the primary source for Homeopathic drugs, but animal products and minerals are also used. As natural medications, Homeopathic drugs work safely without side-effects to gently stimulate healing.
How Do Homeopathic Drugs Differ from Conventional Drugs?
The human body has natural, innate defense mechanisms to aid in healing. These defense mechanisms (such as inflammation), when activated are often reflected as symptoms. While conventional (allopathic) drugs tend to suppress symptoms, Homeopathic drugs try to elicit them. This approach helps to promote healing and is also intended to stimulate a patient’s overall resistance to infection.
Another principle of homeopathy is that the healing power of a medicine can be increased or potentiated while reducing its toxicity. In other words, the healing power of a substance may be increased at the same time its concentration is decreased. This is in marked contrast to allopathic medicines that use a greater potency by increasing the amount of a drug given to a patient. All Homeopathic medicines are diluted progressively and proportionately. This is accomplished either through shaking (succession) or crushing and grinding (trituration).
How are Homeopathic Drug Products Regulated?
Homeopathic drugs in the United States are subject to well-defined regulatory processes that closely resemble those that apply to conventional medications (required pre-market clinical trials and approval) than to dietary supplements (subject to post market regulations).
Since its inclusion in the 1938 Federal Food, Drug, and Cosmetic Act, Homeopathic medicines have been acknowledged and treated as drugs, not herbs or dietary supplements, in the United States. The manufacture and distribution of Homeopathic products are regulated by the Food and Drug Administration (FDA).
Premarket approval for Homeopathic drugs is provided by Monographs which are approved by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homœopathic Pharmacopœia of the United States (HPUS) which has been in publication since 1897.
Monographs define the collection, preparation, processing, OTC standards, and quality control specifications for a single remedy. The criteria for inclusion in the HPUS require that a Homeopathic drug product be safe and effective and prepared according to the specifications set forth in the general pharmacy section of HPUS. These guidelines specify the manufacturing and quality control standards to ensure the purity and potency of each Homeopathic drug.
What Does “HPUS” Mean on a Homeopathic Drug?
“HPUS” means the product has been prepared according to the manufacturing standards of the Homœopathic Pharmacopœia of the United States and is an assurance of product quality. The initials “HPUS” should be listed after the drug name on all Homeopathic medicines.
Although a Homeopathic remedy can be formulated with one (single remedy) or multiple ingredients (e.g., Traumeel®), all of the active ingredients must be listed in HPUS to be considered a Homeopathic drug.
What Homeopathic Dosing is Appropriate?
Most over-the-counter oral Homeopathic Arnica montana products are available in “X” or “C” potencies. Lower potencies (3X, 12X, 6C, 12C) are reserved for minor injuries. Medium potencies (30X, 30C) are used following injury, surgery or trauma. Higher potencies (1M, 10M) are most often prescribed by practitioners.
Can Homeopathic Drugs Make Disease Claims?
Yes. Unlike dietary supplements, over-the-counter (OTC) and Homeopathic drugs are approved by the FDA to make disease claims such as the bruise treatment claims in Homeopathic Arnica montana.
Homeopathic remedies are drugs, not herbs or nutritive supplements, and thus the FDA holds the industry accountable for maintaining the same standards of cleanliness, purity and accuracy as are mandated for other drug companies, only in accordance with the HPUS not the United States Pharmacopeia (USP).
What is the Safety Record of Arnica Montana?
In recent years, many research studies have been carried out to explore the effectiveness of Homeopathic Arnica.
The safety issues associated with oral intake of Arnica relate to an herbal and not a Homeopathic dose of the plant. As the authors explained in a March 2012 Aesthetic Surgery Journal (ASJ) article, most adverse effects are associated with herbal arnica.
Reported side-effects of consuming herbal Arnica include gastroenteritis, internal gastrointestinal bleeding, elevated liver enzymes, and accelerated heart rate. Contact with the plant can also cause skin irritation.
Why is Herbal Arnica Problematic?
In the Commentary section of the same 2012 ASJ issue, Michael I. Kulick, M.D. reminds readers that understanding the differences between herbal and Homeopathic medicines is crucial. He writes that the pharmacokinetics are not the same and that bleeding problems were noted primarily with the herbal form of Arnica montana. He suggests that the higher concentration in an herbal form (as opposed to the minuscule presence of A. montana in a Homeopathic form) could contribute to bleeding.
A number of companies offer a dietary supplement that is formulated with herbal Arnica montana (plus other dietary supplement ingredients), commonly providing 1,000 mg of herbal Arnica per daily serving.
As an anesthesiologist, I would be concerned that ingesting this amount of herbal Arnica may be significant enough to pose a bleeding risk to patients especially if taken pre-operatively. However, in a highly diluted, Homeopathic dose, I have found Arnica montana to be very safe based on over two decades of clinical use and the experience of over one million patients.
How to Determine Herbal from Homeopathic Arnica?
The easiest way to determine if an Arnica product has been manufactured and marketed as a Homeopathic drug versus an herbal supplement is by examining the packaging.
The FDA requires that Homeopathic drug products include Drug Facts whereas dietary supplements must include a Supplement Facts panel. A company must be transparent in displaying any pertinent Drug Facts or Supplement Facts on product packaging, their website and any marketing materials. Patients and physicians have good reason to be concerned and a red flag should be raised if this information is not readily available.
What is Bromelain?
Bromelain is an enzyme that is naturally found and derived from the pineapple plant. Although it can be found in all parts of the fruit, it is typically extracted from the stem of the pineapple.
Bromelain has been shown to exhibit beneficial therapeutic effects while maintaining low toxicity and producing few harmful or undesired side-effects.
A 2006 Safety & Efficacy Report on Bromelain published in PRS Journal, Robert Orsini, M.D. described the benefit of using bromelain in a plastic surgery practice because of its ability to reduce pain, edema, inflammation and platelet aggregation as well as potentiate antibiotics.
Why Not Combine Arnica with Bromelain?
Given that Homeopathic drugs and dietary supplements are regulated differently by the FDA and the FTC, a product cannot contain both a Homeopathic drug and a dietary supplement ingredient. If so, the product is considered an unapproved drug and is in violation of FDA/FTC rules.
Therefore, any products that combine Arnica montana and a dietary supplement ingredient such as Bromelain in a single product are in violation of federal regulations.
What About Drug Claims?
The distinction between using Arnica Montana as a dietary supplement ingredient vs. Homeopathic drug ingredient is important, because drug claims are only allowed for Homeopathic drugs. If a company uses a drug claim on a dietary supplement, the FDA and FTC consider the product an unapproved drug.
Claims that are permissible for Homeopathic A. montana include “reduces bruising and swelling” or “anti-inflammatory”. No dietary supplement can legally make this – or any other – treatment claim.
Additionally, dietary supplements must reference the standard FDA disclaimer on all packaging and advertising claims: “These statements have not been approved by the Food and Drug Administration. This product is not intended to diagnose, treat or cure any disease.”
REFERENCES
Lyss G1, Schmidt TJ, Merfort I, Pahl HL. Helenalin, an anti-inflammatory sesquiterpene lactone from Arnica, selectively inhibits transcription factor NF-kappaB. Biol Chem. 1997; Sep; 378: 951-61.
Schröder H1, Lösche W, Strobach H, et al. Helenalin and 11 alpha,13-dihydrohelenalin, two constituents from Arnica montana L., inhibit human platelet function via thiol-dependent pathways. Thromb Res. 1990: 57:839-45.