The over-the-counter (OTC) aisle is typically full of several options, and in some cases, misleading products are present. A significant amount of time could be spent discussing all of the different items, but for the current discussion, the focus will be on one group of products that has been on the shelves of pharmacies for years: homeopathic products.
Image 1: OTC Aisle
Homeopathic, which comes from the Greek: ὅμοιος hómoios, “-like” and πάθος páthos, “suffering”, is a pseudoscientific form of medicine developed in the late 1700s. Products are typically labeled “homeopathic” and have ingredients listed with dilutions such as “1X”, “2C”, and more. Dilutions will be discussed more in detail below. Two of the most prominent ideas or theories related to the practice are bolded below.
A substance that causes symptoms in a healthy person can be used in diluted form to treat illness.
This idea is known as “like cures like”, or the Law of Similars. In other words, this is a belief that substances have an “essence” that can be transferred. To date, there is no reliable scientific data to support a conviction that a small dose of a substance will trigger the effects it treats at higher doses.
Individuals who advocate for homeopathic products often compare the Law of Similars to vaccines. However, this comparison has a lack of supporting evidence. Vaccines use small doses of inactivated or live-attenuated viruses to prevent future viral infections. However, there are known, well-studied mechanisms to prove effectiveness in vaccines. Vaccines trigger an immune response that can be replicated in high-quality clinical trials. There is no mechanism for homeopathy that bears the same scientific rigor.
The more diluted the substance, the more potent it is.
This is known as the Law of Infinitesimals. The Roman numeral “X” is used to represent dilutions of 1 to 10 (1X = 1/10, 2X = 1/100, 3X = 1/1,000, 6X = 1/1,000,000). Similarly, the Roman numeral “C” is used to denote dilutions of 1 to 100 (1C = 1/100, 2C = 1/10,000, 3C = 1/1,000,000, and so on). Ranges of 6X to 30C are commonplace for homeopathic products today, but some products record up to 200C or higher.
Image 2: Outlining Homeopathic Dilutions
For example, 10C means that one part of the “cure” was diluted in 100 parts of water, so one part of the resulting solution was diluted in 100 parts of water again, and so on until it has been done 10 times. Avogadro’s Limit is typically around 12C and is the limit at which no substance remains if one mole of the original substance was used when everything was initially diluted. As stated previously, some products go up to 200C. Harriet Hall put it well when she said for a specific product purporting to contain an active ingredient of duck liver, “the liver may be gone, but the quack remains.”
This begs the question – how do these products work if there are little to no active ingredients left in the solution?
According to homeopaths, it is because of “water memory”. With no strong evidence to support this claim, it is claimed that the essence imbued upon the water by the ingredient will stick around to have effects on the user. This is not true. By comparison, this would mean that for every sip of water someone drinks, they also would be ingesting the memory of all that it has come into contact with in the past—feces, toxins, soil, animals, etc. This is also not true. Additionally, water’s chemical structure is constantly changing through the creation and breaking of hydrogen bonds. These changes happen quickly and often and they cannot endure dilutions, stomach acid, or absorption, distribution, metabolism, and excretion (ADME) processes.
Now that a preliminary understanding of homeopathy has been introduced, let’s discuss why these products can be dangerous and why pharmacists typically steer individuals clear of them.
Given that many homeopathic remedies typically contain inert ingredients, there is most likely no harm in taking them in most cases. However, due to poor regulation and oversight among OTC products in general, there are still potential risks — toxic risks.
In 2017, the Food and Drug Administration (FDA) issued a recall to the creators of Hyland’s Baby Teething Tablets after discovering amounts of belladonna alkaloids in the product. Belladonna, also know as “deadly nightshade” is a poisonous plant that can induce rapid heartbeat, dilated pupils, delirium, vomiting, hallucinations, and death due to respiratory failure. In their statement, the FDA said “there is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it.”
Furthermore, some products are marketed to treat serious diseases or conditions, yet there are no homeopathic products that are FDA-approved for the treatment of any condition.
A large list of FDA actions and alerts against homeopathic products can be found at: https://www.fda.gov/drugs/information-drug-class/homeopathic-products.
As a bottom line, homeopathic products do not have evidence for use.
The National Center for Complementary and Integrative Health (NCCIH), which is a part of the National Institutes of Health (NIH), stated “there is little evidence to support homeopathy as an effective treatment for any specific condition.” A meta-analysis performed in 2015 by Australia’s National Health and Medical Research Council (NHMRC), “found no good quality, well-designed studies with enough participants to support the idea that homeopathy works better than a placebo or causes health improvements equal to those of another treatment.” Out of 1,800 papers published on homeopathy, only 225 met the inclusion criteria to be fit enough to withstand scrutiny. The remainder were considered to be inadequate.
How do pharmacists fit in to all of this? Pharmacists are the gatekeepers of the pharmacy and, in some cases, are the healthcare professional that patients interact with the most. They have a responsibility to effectively collect information and make an evidence-based recommendation when patients present with a question. When pharmacists make a recommendation, it needs to be safe, effective, and appropriate for the specific patient at-hand. Unfortunately, homeopathy does not check any of those boxes. Consider referencing the Center for Inquiry’s letter to the Joint Commission of Pharmacy Practitioners regarding homeopathy, which inspired this article.
Image 3: Pharmacist-Patient Consultation
Utilizing homeopathic products, even if they are properly manufactured and contain no harmful ingredients, can delay access of proper treatment for patients. When a person opts to purchase homeopathic products for a child suffering from the flu rather than seeing a doctor, for example, it can result in unnecessary suffering and in some cases, serious adverse events or death. One website, www.whatstheharm.net, is one possible tool to utilize for real-life examples of when bad decisions have led to unnecessary harm.
In short, homeopathic products have little evidence for use and should be avoided in most cases. However, if a decision is made to use a homeopathic product, it is important to ask a pharmacist or other healthcare professional about the specific product prior to use to help ensure its safety. Homeopathic products typically have the word “homeopathic” (or similar) printed on the package’s container.
Key takeaways:
- Homeopathy is a centuries-old form of pseudoscientific medicine that has been shown to be ineffective.
- In many documented cases, homeopathic products have been shown to contain harmful amounts of ingredients, leading to multiple crackdowns from the FDA as well as the Federal Trade Commission (FTC).
- Pharmacists are an essential part of the patient-care process and must work to steer patients away from homeopathic products due to their ineffective nature and the risk of patients foregoing otherwise effective and validated courses of treatment.
References:
- Center for Drug Evaluation and Research. Homeopathic Products. U.S. Food and Drug Administration. Published 2020. Accessed April 20, 2021. https://www.fda.gov/drugs/information-drug-class/homeopathic-products
- NHMRC Statement: Statement on Homeopathy. 2015. Accessed April 22, 2021. https://www.nhmrc.gov.au/sites/default/files/images/nhmrc-statement-on-homeopathy.pdf
- Office of the Commissioner. FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs. U.S. Food and Drug Administration. Published 2020. Accessed March 15, 2021. https://www.fda.gov/news-events/press-announcements/fda-proposes-new-risk-based-enforcement-priorities-protect-consumers-potentially-harmful-unproven
- Kreidler M. Homeopathy’s “Law of Infinitesimals” | Quackwatch. Quackwatch.org. Published March 20, 2002. Accessed April 20, 2021. https://quackwatch.org/homeopathy/basic/infinitesimals/
- Office of Regulatory Affairs. Standard Homeopathic Company Issues Nationwide Recall of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets Due to Mislabeling. U.S. Food and Drug Administration. Published 2020. Accessed April 20, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/standard-homeopathic-company-issues-nationwide-recall-hylands-baby-teething-tablets-and-hylands-baby
- Solanaceae: Belladonna. Fs.fed.us. Published 2021. Accessed April 20, 2021. https://www.fs.fed.us/wildflowers/ethnobotany/Mind_and_Spirit/belladonna.shtml
- Harriet Hall. An Intro to Homeopathy. Skeptical Inquirer. Published April 30, 2014. Accessed April 18, 2021. https://skepticalinquirer.org/exclusive/an-intro-to-homeopathy/
- Homeopathy. Science-Based Medicine. Published June 13, 2013. Accessed April 1, 2021. https://sciencebasedmedicine.org/reference/homeopathy/
- Homeopathy: What You Need To Know. NCCIH. Published 2012. Accessed April 22, 2021. https://www.nccih.nih.gov/health/homeopathy#hed8
- Rafi Letzter. What Is “Water Memory”? Why This Homeopathy Claim Doesn’t Hold Water. livescience.com. Published December 26, 2017. Accessed April 18, 2021. https://www.livescience.com/61273-homeopathy-chemistry-water-memory.html
- What’s The Harm? Whatstheharm.net. Published 2021. Accessed April 25, 2021. http://whatstheharm.net/
- Nicholas Little and Aaron Green. Pharmacists’ Role in Protecting Patients from the Harms of Homeopathy. Centerforinquiry.org. Published 2021. Accessed April 25, 2021. https://cdn.centerforinquiry.org/wp-content/uploads/2021/02/22145856/CFI-Letter-to-JCPP-re-Homeopathy.pdf
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