risk/benefit
A new market report predicts that the worldwide market for so-called alternative medicine (SCAM) will grow from $100 billion in 2022 to $438 billion by 2032.
According to the report, the SCAM market is expected to see innovation and expansion through mergers, acquisitions, and partnerships among large companies. Companies that are capitalizing on these trends include health supplement companies, companies that specialize in Ayurvedic health, those that offer TCM solutions, and those that offer more general holistic solutions to health. Major supplement brands include Herb Pharm LLC, Gaia Herbs, NOW Foods, Life Extension, Pure Encapsulations, Douglas Laboratories, Nordic Naturals, Nordic Nutraceuticals, Quality of Life Labs, Nature’s Bounty Co., Valensa International, Herbo Nutra, and Emerson Ecologics.
Other major players mentioned in the report are:
- AYUSH Ayurvedic Pte Ltd, Dabur India Ltd., Himalaya Global Holdings Ltd., Banyan Botanicals, and Arya Vaidya Pharmacy offer Ayurvedic health and wellness products while aiming to advance the science behind Ayurveda.
- Sheng Chang Pharmaceutical Company produces traditional Chinese medicines and herbal products that is one of the largest TCM pharma companies.
- All and One Medical provides healthcare solutions that combine conventional medicine with complementary and alternative therapies to promote overall wellness and preventive care.
- The John Schumacher Unity Woods Yoga Center is another that focuses on enhancing physical and mental well-being through the practice of Iyengar Yoga and offers classes and workshops.
- New Life Chiropractic aims to improve overall health and well-being by providing comprehensive chiropractic care that focuses on spinal health and preventive wellness.
- The Chicago Body Works offers a range of therapies and treatments designed to enhance physical and mental well-being, including massage and bodywork services.
- Weleda AG aims to connect people with nature by producing natural organic products that support health, beauty, and overall wellness while practicing sustainability and social responsibility.
- Quantum-Touch Inc. teaches energy healing techniques that promote physical, emotional, and spiritual health.
- Spectrum Chemical Manufacturing Corporation focuses on delivering high-quality chemicals and laboratory supplies to support scientific research and innovation across various industries, including health and wellness.
I must admit, I do like these market reports. They never fail to amuse me – for two main reasons:
- They are as reliable as reading tea leafs.
- The only reliable info they do provide is that the SCAM proponents’ often-voiced argument, “we are very different from BIG PHARMA” is pure nonsense.
To accuse anyone of an abuse of science is a hefty charge, I know. In the case of proponents of so-called alternative medicine (SCAM) doing science, it is, however, often justified. Let me explain this by using the example of chiropractors (I could have chosen homeopathy, faith heaalers, acupuncturists or almost any other type of SCAM professional, but in recent times it was the chiros who provided the clearest examples of abuse).
Science can be seen as a set of tools that is used to estabish the truth. In therapeutics, science is employed foremost to answer three questions:
- Is the therapy plausible?
- Is the therapy effective?
- Is the therapy safe?
The way to answer them is to falsify the underlying hypotheses, i.e. to demonstrate that:
- The therapy is not plausible.
- The therapy is not effective.
- The therapy is not safe.
Only if rigorous attempts at falsifying these hypotheses have falied can we conclude that:
- The therapy is plausible.
- The therapy is effective.
- The therapy is safe.
I know, this is rather elementary stuff. It is taught during the first lessons of any decent science course. Yet, proponents of SCAM are either not being properly taught or they are immune to even the most basic facts about science. On this blog, we regularly have the opportunity to observe exactly that when we read and are bewildered by the comments made by SCAM proponents. This is often clearest in the case of chiropractors.
- They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is plausible.
- They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is effective.
- They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is safe.
If they conduct research, they set up their investigations in such a way that they confirm their beliefs:
- Spinal manipulations are plausible.
- Spinal manipulations are effective.
- Spinal manipulations are safe.
In other words, they do not try to falsify hypotheses, but they do their very best to confirm them. And this, I am afraid, is nothing other than an abuse of science.
QED
And how can the average consumer (who may not always be in a position to realize whether a study is reliable or not) tell when such abuse of science is occurring? How can he or she decide who to trust and who not?
A simplest but sadly not fool-proof advice might consist in 2 main points:
- Never rely on a single study.
- Check whether there is a discrepancy in the results and views of SCAM proponents and independent experts; e.g.:
- Chiropractors claim one thing, while independent scientists disagree or are unconvinced.
- Homeopath claim one thing, while independent scientists disagree or are unconvinced.
- Acupuncturists claim one thing, while independent scientists disagree or are unconvinced.
- Energy healers claim one thing, while independent scientists disagree or are unconvinced.
- Naturopaths claim one thing, while independent scientists disagree or are unconvinced.
- Etc., etc.
In all of those cases, your alarm bells should ring and it might be wise to be cautious and avoid the treatment in question.
People living with HIV (PLWH) are common users of so-called alternative medicine (SCAM). The main objective of this study was to study the frequency and patterns of SCAM natural products use in a large cohort of PLWH and to identify potential drug–drug interactions (DDIs) and the impact on their antiretroviral treatment (ART) adherence and efficacy.
This was a cross-sectional multicenter survey including 420 PLWH from different Spanish hospitals. Participants completed a face-to-face questionnaire on SCAM consumption and different sociodemographic and clinical data were collected. DDIs between SCAM and ART were identified and classified according to the Liverpool University Database and patient factors related to SCAM consumption were assessed.
In total, 420 participants were included (82.6% male, mean age 47 years); 209 patients (49.8%) were taking at least one SCAM. The most consumed SCAM were:
- green, black and red tea (n=146, 25.4%),
- ginger (n=26, 4.5%),
- fish oil (n=25, 4.4%),
- cannabis (n=24, 4.2%).
An ART based on integrase inhibitors was the only factor independently associated with SCAM consumption (OR 1.54, 95% CI 1.04 to 2.26). 50 potential SCAM–ART interactions in 43 (20.6%) patients taking SCAM were identified, being clinically significant in 80% of the cases. SCAM products most frequently involved with a potential significant DDI were supplements containing divalent cations (n=11) and garlic (n=7). No differences in ART efficacy and adherence were observed between patients with and without SCAM consumption.
The authors concluded that almost 50% of patients were taking at least one SCAM product and its use was associated with an integrase inhibitor based ART. One out of every six patients was at risk of presenting with an interaction between a SCAM and their ART, confirming the need to review continuously the use of SCAM as part of the medication review process.
So, the authors found that half of all PLWHs use some form of SCAM (whether I would classify tea as a SCAM is a different question). They also point out that this might put many PLWHs at risk. What I don’t understand is why they do not take the next logical step and ask what the benefits of the SCAMs for PLWHs are.
Allow me to answer this question: they are zero or very close to zero!
And this means that SCAMs generate a risk for PLWHs without creating any meaningful benefit. In other words the risk-benefit balance fails to be positive.
I think that this is an important point which needs to be stressed clearly in the conclusions. Therefore, I suggest to re-formulate them as follows:
Almost 50% of patients were taking at least one SCAM product. One out of every six patients was at risk of presenting with an interaction between a SCAM and their ART. The SCAMs used convey no appreciatable benefit. Therefore, SCAM use fails to generate more good than harm. It follows that responsible healthcare professionals should discurage SCAM use.
The comment sections of this blog have provided plenty of reason to suspect that chiropractic is a cult, a health cult to be precise. A health cult is defined as a system for the cure of disease based on dogma set forth by its promulgator. The promulgator, in this case, is DD Palmer. As discussed previously, he ‘invented’ chiropractic and promoted many extraordinary claims and ideas, e.g.:
- I was the first to adjust the cause of disease
- Chiropractors adjust causes instead of treating effects
- 95% of all diseases are caused by subluxations of the spine
- Vaccination and inoculation are pathological; chiropractic is physiological
- It was my ingenious brain which discovered [chiropractic’s] first principle; I was its source; I gave it birth; to me all chiropractors trace their chiropractic lineage
- Among the wonderful achievements of this century, the discovery and development of chiropractic is preeminent; it is destined to replace all methods which treat effects
- Dis-ease is a condition of not ease, lack of ease
- His magnetic cure for cancer involved freeing the stomach and spleen of poisons
- Chiropractic is a science of healing without drugs
- Wants to turn chiropractic into a religion (as this would avoid chiropractors being sued for practising medicine without a license)
Since DD Palmer, the chiro-cult has changed. In fact, it has split into two camps. The ‘straights’ have become a Palmer worship cult, while the rest delude themselves of being based on evidence. That the former are cultists is impossible to deny. The latter reject such allegations but, in my mind, they too belong to a cult.
Let me explain.
The criteria for a cult can be defines as follows:
- Charismatic Leader: the ‘mixers’ might no longer worship Palmer, yet they are far from free of his ‘philosophy’; after all, they went to chiro-school where they were educated in the Palmer tradition.
- Isolation: chiropractors seek surprisingly little co-operation with other healthcare professionals and thus tend to be isolated.
- Control: chiropractors are under tight control of their professional bodies, peers, journals, etc. which all make sure that heretic ideas are kept at bay.
- Deception: chiropractors are masters of deception in persuading the public and their patients of the value of spinal manipulations, regardless of the actual evidence.
- Us vs. Them Mentality: chiropractors tend to create an “us vs. them” mentality, demonizing real doctors and promoting group cohesion.
- Exploitation: chiropractors have a long history of exploiting their patients; maintenance care is just one of many examples.
- Fear Tactics: chiropractors are scare mongers, for instance, when they diagnose subluxations even in perfectly healthy people and claim that this invented diagnosis needs urgent adjustments.
What, you don’t agree with these arguments?
In this case let me quote a different set criteria that might help to decide whether chiropractic might be a cult. Here they are:
- Absolute authoritarianism without accountability
- Zero tolerance for criticism or questions
- Lack of meaningful financial disclosure regarding budget
- Unreasonable fears about the outside world that often involve evil conspiracies and persecutions
- A belief that former followers are always wrong for leaving and there is never a legitimate reason for anyone else to leave
- Abuse of members
- Records, books, articles, or programs documenting the abuses of the leader or group
- Followers feeling they are never able to be “good enough”
- A belief that the leader is right at all times
- A belief that the leader is the exclusive means of knowing “truth” or giving validation
Bearing in mind that not all of the 10 criteria need to be fulfilled, I ask you: is chiropractic a cult?
This study aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain.
WalkBack was a two-armed, randomised clinical trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112)
Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60–0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149–295) in the intervention group and 112 days (89–140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group).
The authors concluded that an individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed.
Rigorous clinical trials of excercise therapy are difficult to conceive and conduct because of a range of methodological issues. For instance, there is no obvious placebo and thus it is hardly possible to control for placebo effects. Nonetheless, the benefits of exercise therapy for back pain is undoubted. As previously discussed on this blog, a recent systematic review concluded that “the relative benefit of individualized exercise therapy on chronic low back pain compared to other active treatments is approximately 38% which is of clinical importance.”
I have always been convinced of the health benefits of excercise. In fact, 40 years ago, when I did my inaugural lecture at the University of Munich (LMU), excercise was its topic and I concluded that, if exercise were a pharmaceutical product, it would out-sell any drug. The new study only confirms my view. It adds to our knowledge by suggesting that exercise also reduces the risk of recurrences.
Forget about spinal manipulation, acupuncture, etc., despite the undeniable weaknesses in the evidence, exercise is by far the most promissing treatment for back pain
‘Chiropractic economics’ might be when chiropractors manipulate their bank accounts or tax returns, I thought. But, no, it is a publication! And a weird one at that – it even promotes the crazy idea of maintenance care:
The concept of chiropractic maintenance care has evolved significantly. Initially seen as a method for managing chronic pain, it now includes a broader range of patients and focuses on overall wellness. Modern maintenance care aims to keep patients healthy regardless of their symptoms or history, alleviating and preventing pain through regular, prolonged care. This approach is largely preventive, serving as both secondary and tertiary care. Studies show chiropractic maintenance care often includes diverse treatments such as manual therapy, stress management, nutrition advice and more, with flexible intervals typically around three months. This evolution underscores the importance of evidence-based, individualized patient care. This article shares the evolution of chiropractic maintenance care, looks at what a modern maintenance care appointment can include and explores best practices for DC maintenance care in 2024.
An interview study of Danish chiropractic care showed maintenance care sessions included a range of treatment modalities, including manual treatment and ordinary examinations alongside multiple packages of holistic additions, like stress management, diet, weight loss, advice on ergonomics, exercise and more. In other anecdotal accounts, chiropractic maintenance care seemed to follow a more traditional guideline of lower back pain management and adjustment. The study hypothesized that maintenance care could also help patients from a knowledge perspective, stating, “DCs could obviously play an important role here as ‘back pain coaches,’ as the long-term relationship would ensure knowledge of the patient and trust towards the DC.”
Researchers found that three-month intervals were the most common spacing of maintenance care treatments for patients. Most commonly, patients sought or scheduled chiropractic maintenance care over the course of one to three months.
Chiropractic maintenance care has evolved past simply being a method of ongoing chronic pain management. Today’s patients want to achieve overall wellness, and regular trips to their DC can become a part of that if you work to transition patients into a wellness plan after their acute phase of care is over.
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The author of this article seems to have forgotten two little details:
- Chiropractic maintenance care is not supported by sound evidence, particularly in relation to economics (even the above cited paper stated: “We found no studies of cost-effectiveness of Maintenance Care”).
- Chiropractic maintenance only serves one economic purpose: it boosts the chiropractors’ income.
Yes, easy to forget, particularly if your name is ‘Chiropractic Economics’.
And also easy to forget that maintenance care would, of course, require informed consent. How would that look like?
Chiro (C) to patient (P):
If you agree, we will start a program that we call maintenance care.
P: Can you explain?
C: It consists of regular sessions of spinal manipulations.
P: That’s all?
C: No, I will also give you advice on keeping fit and living healthily.
P: Why do I need that?
C: It’s a bit like servicing your car so that it works reliably when you need it.
P: Is it proven to work?
C: Yes, of course, there are tons of evidence to show that a healthy life style is good for you.
P: I know, but I don’t need a chiro for that – what I meant do the manipulations keep my body healthy even if I have no symptoms?
C: The evidence is not really great.
P: And the risks?
C: Well, yes, if I’m honest, spinal manipulations can cause harm.
P: So, to be clear: you ask me to agree to a program that has no proven benefit and might cause harm?
C: I would not put it like that.
P: And how much would it cost?
C: Not much; just a couple of hundred per year.
P: Thanks – but no thanks.
In response to criticism voiced against Australian chiropractors’ decision to re-commence manipulating children, the Australian Chiropractors Association (ACA) president, David Cahill, welcomed the updated statement on paediatric care by the Chiropractic Board of Australia. “The statement serves to reinforce the confidence the Australian public has in chiropractic care provided by registered ACA member chiropractors,” said Cahill.
The Safer Care Victoria Review has shown chiropractic care for children to be extremely safe. Of the 29,599 online submissions received from across Australia (the largest survey of its kind), there were no reports of harm to a child receiving chiropractic healthcare. Of those submissions, 21,824 responses were from parents who had accessed chiropractic healthcare for their children, and there was not a single report of significant harm in these submissions. “In a particularly strong endorsement, 99.6% of those parental submissions affirmed that chiropractic healthcare benefitted their child highlighting the exemplary safety record of chiropractic healthcare,” Cahill said.
ACA member chiropractors are healthcare professionals who effectively treat a wide range of musculoskeletal disorders. Chiropractors are 5-year university degree educated healthcare professionals, equipped with expertise enabling them to tailor the appropriate care for people of all ages including children. Established in 1938, the Australian Chiropractors Association (ACA) is the peak body representing chiropractors. The ACA promotes the importance of maintaining spinal health to improve musculoskeletal health through non-invasive, drug-free spinal health and lifestyle advice to help Australians of all ages lead and maintain healthy lives.
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Mr Cahill and the Australian Chiropractors Association have thus demonstrated that they fail to understand how one needs to establish the benefits and harms of a therapy. That chiropractic spinal manipulations are “extremely safe” cannot be established by an online survey which might or might not have been manipulated by the chiropractors who have an interest in not loosing the lucrative option of treating children. It cannot even establish “the confidence the Australian public has in chiropractic care”.
Mr Cahill and the Australian Chiropractors Association should know that chiropractic spinal manipulation – just like any other intervention – must be evaluated according to accepted principles of risk-benefit analyses. No proven benefit and a possibility of harm mean that the risk-benefit balance fails to be positive. And this means that it is irresponsible to use chiropractic spinal manipulations.
Mr Cahill and the Australian Chiropractors Association, however, seem to not know even the essentials of ethical healthcare. The obvious conclusion, therefore, is to send the lot of them back to school.
On 8 March 2019, the Council of Australian Governments (COAG) Health Council (CHC) noted community concerns about spinal manipulation on children performed by chiropractors and agreed that there was a need to consider whether public safety was at risk.
On behalf of the CHC, the Victorian Minister for Health, the Hon. Jenny Mikakos MP, instructed Safer Care Victoria (SCV) to undertake an independent review of the practice of chiropractic spinal manipulation on children under 12 years. The findings of this review are to be provided to the Minister for reporting to the CHC. To provide expert guidance and advice to inform the review, SCV established an independent advisory panel. The panel included expertise in chiropractic care, academic allied health, health practitioner regulation, healthcare evidence, governance, paediatrics and paediatric surgery, and musculoskeletal care, and had consumer representation.
The main conclusions were as follows:
- … spinal manipulation in children is not wholly without risk. Any risk associated
with care, no matter how uncommon or minor, must be considered in light of any potential or likely
benefits. This is particularly important in younger children, especially those under the age of 2 years in
whom minor adverse events may be more common. - … the evidence base for spinal manipulation in children is very poor. In particular, no studies have been performed in Australia … The possible, but unlikely, benefits of spinal manipulation in the management of colic or enuresis should be balanced by the possibility, albeit rare, of minor harm.
The main recommendation was straight forward: “Spinal manipulation, as defined in Section 123 of National Law, should not be provided to children under 12 years of age, by any practitioner, for general wellness or for the management of the following conditions: developmental and behavioural disorders, hyperactivity disorders, autism spectrum disorders, asthma, infantile colic, bedwetting, ear infections, digestive problems, headache, cerebral palsy and torticollis.”
The Chiropractic Board of Australia nevertheless decided they would re-start manipulationg babies. On 11/6/2024 The Sydney Morning Harald reported:
Chiropractors have given themselves the green light to resume manipulating the spines of babies following a four-year interim ban supported by the country’s health ministers. In a move slammed by doctors as irresponsible, the Chiropractic Board of Australia has quietly released new guidelines permitting the controversial treatment for children under two. The Royal Australian College of General Practitioners (RACGP) hit out at the decision, saying there was no evidence supporting the spinal manipulation of babies and children and that the practice should be outlawed. ‘‘There is no way in the world I would let anyone manipulate a child’s spine,’’ said Dr James Best, the college’s Specific Interests Child and Young Person’s Health chair. ‘‘The fact that it hasn’t been ruled out by this organisation is very disappointing and concerning. It’s irresponsible.’’ …
Subsequently, it was reported that the federal health minister has intervened in the Chiropractic Board of Australia’s controversial decision to allow practitioners to resume spinal manipulation of children under two and is seeking an urgent explanation.
As pressure mounts on chiropractors to ditch the treatment, federal Health Minister Mark Butler confirmed on Thursday that he would also raise the issue with his state and territory colleagues at a meeting of health ministers in South Australia on Friday.
“The Health Minister is writing to the Chiropractic Board seeking an urgent explanation on its decision to allow a resumption of spinal manipulation of infants under two, in spite of two reviews concluding there was no evidence to support that practice,” a spokeswoman said.
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This course of events can only be surprising to those who are not familiar with the chiropractors’ general attitude. Chiropractors have always put income before ethics and safety. This, I fear, is not a phenomenon confined to Australia or to the care of children but one that beleagues this profession worldwide from the days of DD Palmer to the present.
Whenever I report a case of arterial dissection after spinal manipulation, a defender of the indefensible comments that the case does not prove anything.
Let’s try again, shall we?
It has been reported that Nerissa E. Weeks has filed a negligence complaint against Dr. Jack J. Cacic and his business, Lake Worth Chiropractic & Wellness (LWCW). Weeks, a resident of Lake Worth, alleges that she suffered permanent neurological injuries due to the negligence of Dr. Cacic during chiropractic treatments at LWCW. Weeks initially sought treatment from Cacic on January 12, 2023, for low back pain related to a herniated disc in her lumbar spine. Following this initial visit, she returned to Cacic’s office several months later on June 26, 2023, complaining of neck pain and headaches.
During subsequent visits on June 26 and June 28, Cacic performed cervical manipulations and other treatments without obtaining appropriate informed consent from Weeks regarding the risks involved. On June 30, following another session of cervical manipulations by Cacic, Weeks experienced severe dizziness and vertigo shortly after the procedure. She was subsequently hospitalized and diagnosed with an acute right vertebral artery dissection and an ischemic stroke.
Weeks contends that Cacic failed to recognize symptoms indicative of a vertebral artery dissection and did not provide adequate care consistent with professional standards. The complaint states: “As a direct and proximate result of the negligence of the Defendants, WEEKS suffered permanent neurologic injuries due to an acute thromboembolic cerebrovascular accident.”
The plaintiff is seeking damages exceeding $50,000 for medical expenses, loss of earnings, pain and suffering, mental anguish, disability, impairment, and other related costs incurred due to the alleged negligence. Represented by attorney Hector Buigas from Morgan & Morgan P.A., Weeks demands compensatory damages along with interest, taxable costs, attorneys’ fees, prejudgment interest on medical bills as well as any other relief deemed proper by the court.
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How many more such cases do we need before chiropractors admit that cervical manipulations do more harm than good?
How long until all chiropractors explain to their patients that cervical manipulations do more harm than good?
How long until cervical manipulations become obsolete?
It has been reported that HomeoCare Laboratories Inc. is recalling two batches of Homeopathic StellaLife Oral Care Products citing microbial contamination. The recall involves Homeopathic Stella Life Vega Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse manufactured in 2024, which are marketed to promote oral health, hydrate oral cavities and support healthy gums. The recall is to be performed at the consumer level.
StellaLife VEGA Oral Care, Spray Unflavored comes with NDC 69685-121-01, lot no. 2552 and expiration date of 02-2026. StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse comes with NDC 69685-143-16, lot no. 2550, and expiration date of 02- 2026.
The affected products were manufactured at HomeoCare Laboratories, shipped nationwide, and distributed through various dental practices. As per the FDA, higher than acceptable levels of TAMC was found in the Advanced Formula Peppermint Vega Oral Care Rinse, while Bacillus sp was found in the StellaLife Vega Oral Spray, Unflavored. Bacillus is a common species found in the environment and are generally non-pathogenic, while patients with oral disease, undergoing dental surgical procedures or with compromised immune systems hold potential risks. In the immunocompromised population, the impacted product may cause severe or life-threatening adverse events due to the introduction of bacteria to the disrupted oral mucosa, possibly leading to bacteremia and sepsis. However, the manufacturer of homeopathic products has not received any reports of adverse events related to these two recalled products so far.
Dental practices and consumers, who have the recalled products, are urged to return the impacted products to HomeoCare Laboratories or to the place of purchase or discard them. The company said it is implementing enhanced quality control measures to prevent recurrence.
On the manufacturer’s website, we find the following:
Homeopathy is a safe, gentle, and natural system of healing that works with your body to relieve symptoms, restore itself, and improve your overall health. It is safe to use and has none of the side effects of many traditional medications, because it is made from the natural substances and is FDA regulated. Homeopathic medicines – known as “remedies” – are made from natural sources (e.g., plants, minerals), and are environmentally friendly and cruelty free.
Homeopathic remedies when used as directed, are completely safe for everyone. They are given in such small doses that they don’t cause side effects.* Homeopathy is not a general or “umbrella” term that describes a variety of different natural therapies. Although homeopathic remedies are derived from natural substances, homeopathy should not be confused with herbal medicine, Chinese medicine, or other types of natural medicines. It is its own, unique therapeutic system.
The FDA’s present policy does not require homeopathic medicines to go through the FDA approval process. The homeopathic ingredients monographed in the Homeopathic Pharmacopoeia of the United States have been reviewed for homeopathic efficacy, toxicology, adverse effects and clinical use. The historical safety record with the use of homeopathic drugs, some for close to 200 years. The FDA drug monitoring process does not reveal any significant instances of problems with homeopathic drug products, thus establishing a positive safety profile.
Homeopathy’s Basic Principle: The Law of Similars It is accepted knowledge that every plant, mineral, and chemical can cause in overdose its own unique set of physical, emotional, and mental symptoms. It also is readily acknowledged that individuals, when ill, have their own idiosyncratic physical, emotional, and mental symptom patterns, even when people have the same disease. Homeopathic medicine is a natural pharmaceutical science in which a practitioner seeks to find a substance which would cause in overdose similar symptoms to those a sick person is experiencing. When the match is made, that substance then is given in very small, safe doses, often with dramatic effects.
Homeopaths define the underlying principle for this matching process as the “law of similars.” The “law” is not unknown to conventional medicine. Immunizations are based on the principle of similars. No less a person as Dr. Emil Adolph Von Behring, the “father of immunology,” directly pointed to the origins of immunizations when he asserted, “By what technical term could we more appropriately speak of this influence than by Hahnemann’s word “homeopathy.”
Homeopathy is a natural form of medicine used by over 200 million people worldwide. The holistic nature of homeopathy means each person is treated as a unique individual and their body, mind, spirit and emotions are all considered in the management and prevention of disease. Taking all these factors into account a homeopath will select the most appropriate medicine based on the individual’s specific symptoms and personal level of health to stimulate their own healing ability.
Homeopathic medicines are safe to use as they rarely cause side-effects. This means when used appropriately under the guidance of a qualified homeopath they can be taken by people of all ages*.
* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual results may vary.
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I feel like congratulating the manufacturer: not only have they managed to produce normally harmless products in such a way that they are dangerous, but also they are promoting a plethora of untruth and misleading statements about homeopathy. A most remarkable effort!
