Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:
The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).
Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.
Let us be clear about what has happened here. I think, the events can be summarised as follows:
- the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
- they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
- the question raises, what should the researchers give to the control group?
- someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
- the researchers are impressed and ask: but what precisely could we use?
- let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
- another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
- the team is in agreement,
- Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
- a protocol is written,
- ethics approval is obtained,
- the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.
And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.
BOB’S YOUR UNCLE!
EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.
Proponents of alternative medicine regularly stress the notion that their treatments are either risk-free or much safer than conventional medicine. This assumption may be excellent for marketing bogus treatments, however, it neglects that even a relatively harmless therapy can become dangerous, if it is ineffective. Here is yet again a tragic reminder of this undeniable fact.
Japanese doctors reported the case of 2-year-old girl who died of precursor B-cell acute lymphoblastic leukaemia (ALL), the most common cancer in children.
She had no remarkable medical history. She was transferred to a hospital because of respiratory distress and died 4 hours after arrival. Two weeks before her death, she had developed a fever of 39 degrees C, which subsided after the administration of a naturopathic herbal remedy. One week before death, she developed jaundice, and her condition worsened on the day of death.
Laboratory test results on admission to hospital showed a markedly elevated white blood cell count. Accordingly, the cause of death was suspected to be acute leukaemia. Forensic autopsy revealed the cause of death to be precursor B-cell ALL.
With the current advancements in medical technology, the 5-year survival rate of children with ALL is nearly 90%. However, in this case, the child’s parents had opted for naturopathy instead of evidence-based medicine. They had not taken her to a hospital for a medical check-up or immunisation since she was an infant. If the child had received routine medical care, she would have a more than 60% chance of being alive 5 years after diagnosis of ALL.
The authors of this case-report concluded that the parents should be accused of medical neglect regardless of their motives.
Such cases are tragic and infuriating in equal measure. There is no way of knowing how often this sort of thing happens; we rely entirely on anecdotes because systematic research is hardly feasible.
While anecdotes of this nature have their obvious limitations, they are nevertheless important. They can serve as poignant reminders that alternative remedies might be relatively harmless, but this does not necessarily apply to all alternative practitioners. Moreover, they should make us redouble our efforts to inform the public responsibly about the all too often trivialized risks of alternative medicine.
Discussions about the dietary supplements are often far too general to be truly useful, in my view. For a meaningful debate, we need to define what supplement we are talking about and make clear what condition it is used for. A recent paper meets these criteria well and is therefore worth a mention.
The review was aimed at addressing the controversy regarding the optimal intake, and the role of calcium supplements in the treatment and prevention of osteoporosis. The authors demonstrate that most studies on the subject show little evidence of a relationship between calcium intake and bone density, or the rate of bone loss. Re-analysis of data from the placebo group from the Auckland Calcium Study demonstrates no relationship between dietary calcium intake and rate of bone loss over 5 years in healthy older women with intakes varying from <400 to >1500 mg per day .
The authors argue that supplements are therefore not needed within this range of intakes to compensate for a demonstrable dietary deficiency, but might be acting as weak anti-resorptive agents via effects on parathyroid hormone and calcitonin. Consistent with this, supplements do acutely reduce bone resorption and produce small short-term effects on bone density, without evidence of a cumulative density benefit. As a result, anti-fracture efficacy remains unproven, with no evidence to support hip fracture prevention (other than in a cohort with severe vitamin D deficiency) and total fracture numbers are reduced by 0-10%, depending on which meta-analysis is considered. Five recent large studies have failed to demonstrate fracture prevention in their primary analyses.
These facts, the authors argue, must be balanced against the possible harm. The risks of regularly taking calcium supplements include an increase in gastrointestinal side effects (including a doubling of hospital admissions for these problems), a 17% increase in renal calculi and a 20-40% increase in risk of myocardial infarction. Each of these adverse events alone neutralizes any possible benefit in fracture prevention.
The authors draw the following detailed conclusions: “Concern regarding the safety of calcium supplements has led to recommendations that dietary calcium should be the primary source, and supplements reserved only for those who are unable to achieve an adequate dietary intake. The current recommendations for intakes of 1000–1200 mg day−1 are not firmly based on evidence. The longitudinal bone densitometry studies reviewed here, together with the new data included in this review relating to total body calcium, suggest that intakes in women consuming only half these quantities are satisfactory and thus, they do not require additional supplementation. The continuing preoccupation with calcium nutrition has its origin in a period when calcium balance was the only technique available to assess dietary or other therapeutic effects on bone health. We now have persuasive evidence from direct measurements of changes in bone density that calcium balance does not reflect bone balance. Bone balance is determined by the relative activities of bone formation and bone resorption, both of which are cellular processes. The mineralization of newly formed bone utilizes calcium as a substrate, but there is no suggestion that provision of excess substrate has any positive effect on either bone formation or subsequent mineralization.
Based on the evidence reviewed here, it seems sensible to maintain calcium intakes in the region of 500–1000 mg day−1 in older individuals at risk of osteoporosis, but there seems to be little need for calcium supplements except in individuals with major malabsorption problems or substantial abnormalities of calcium metabolism. Because of their formulation, costs and probable safety issues, calcium supplements should be regarded as pharmaceutical agents rather than as part of a standard diet. As such, they do not meet the standard cost–benefit criteria for pharmaceutical use and are not cost-effective. If an individual’s fracture risk is sufficient to require pharmaceutical intervention, then safer and more effective measures are available which have been subjected to rigorous clinical trials and careful cost–benefit analyses. Calcium supplements have very little role to play in the prevention or treatment of osteoporosis.”
Clear and useful words indeed! I wish there were more articles like this in the never-ending discussion about the complex subject of dietary supplements.
If you talk to advocates of homeopathy, you are bound to hear claims that are false or misleading; in fact, you hear them so regularly that you might begin to doubt the truth. For those who have such doubts or are in need of some correct counter-arguments, I have listed here those 12 bogus claims which, in my experience, are most common together with short, suitable, and factual rebuttals.
1) THERE IS NOTHING MYSTERIOUS ABOUT HOMEOPATHY’S MODE OF ACTION, IT WORKS LIKE VACCINATIONS
This argument is used by enthusiasts in response the fact that most homeopathic remedies are too highly diluted to have pharmacological effects. Vaccines are also highly diluted and they are, of course, very effective; therefore, so the bogus notion, there is nothing odd about homeopathy.
The argument is wrong on several levels; the easiest way to refute, I think, it is to point out that vaccines contain measurable amounts of material and lead to measurable changes in the immune system. By contrast, the typical homeopathic remedy (beyond the C12 potency) contains not a single molecule of an active substance and leads to no measurable changes in any system.
2) SIGNIFICANTLY MORE CONTROLLED CLINICAL TRIALS OF HOMEOPATHY ARE POSITIVE THAN NEGATIVE
Several websites of homeopathic organisations make this claim and even provide simple statistics to back it up. Consequently, many homeopathy fans have adopted it.
The statistics they present show that x % of studies are positive, y % are negative and z % are neutral; the whole point is that x is larger than y. The percentage figures may even be correct but they rely on the spurious definitions used: positive = superior to placebo, negative = placebo superior to homeopathy, neutral = no difference between homeopathy and placebo. The latter category was created so that homeopathy comes out trumps.
For all intents and purposes, a study where the experimental treatment is no better than placebo is not a study neutral but a negative result. Thus the negative category in such statistics must be y + z which is, of course, larger than x. In other words, the majority of trials is, in truth, negative.
3) HOMEOPATHY IS SUPPORTED BY NOBEL PRIZE WINNERS
I don’t know of a single Nobel Prize winner who has stated or implied that homeopathy works better than a placebo. Some have tried to find a mechanism of action for homeopathy by doing some basic research and have published theories about it. None of those has been accepted by science.
And if there ever should be a Nobel Prize winner or similarly brilliant person who supports homeopathy, this would merely show that even bright individuals can make mistakes!
4) HOMEOPATHY IS SAFE
Tell that to the child that has just been reported to have died because her parents used homeopathy for an ear infection which (could have been easily treated with antibiotics but) degenerated into a brain abscess with homeopathic therapy. There are many more such tragic cases than I care to remember.
The risks of homeopathy are, of course, minor compared to many conventional treatments, but the risk/benefit balance of homeopathy can never be positive because, unlike those high risk conventional treatments, it has no benefit.
5) HOMEOPATHY DOES NOT LEND ITSELF TO BEING TESTED IN CLINICAL TRIALS
The best way to disprove this argument is to point out that ~ 250 controlled clinical trials are currently available. Every homeopath on the planet boasts about clinical trials – provided they are positive.
6) HOMEOPATHY WORKS VIA QUANTUM ENTANGLEMENT
I do not understand quantum mechanics and, I suspect, neither do the homeopaths who use this argument. But physicists who do understand this subject well are keen to stress that homeopathy cannot be explained in this way.
7) THERE IS NO PROOF THAT HOMEOPATHY DOES NOT WORK
The absence of evidence is not the same as evidence of absence, homeopaths like to exclaim. And they are, of course, correct! However, they forget that, science cannot prove a negative and that, in routine health care, we do not even look for a proof of ineffectiveness. We use those treatments that have a positive proof of effectiveness – everything else is irresponsible.
8) EVEN IF HOMEOPATHY WERE JUST A PLACEBO, IT STILL HELPS PATIENTS AND IS THEREFORE A USEFUL TREATMENT
It is true, of course, that placebo effects can help patients. But it is not true that, for generating a placebo response, we need a placebo. If a clinician administers an effective treatment with compassion, the patient will benefit from a placebo response plus from the specific effects of the treatment. Only giving placebos is therefore tantamount to cheating the patient.
9) THERE IS A WORLDWIDE CONSPIRACY AGAINST HOMEOPATHY
In a way, this argument merely suggests that homeopathic remedies are ineffective in treating paranoia. I have not ever seen a jot of evidence for it – and neither can anyone who uses this claim produce any.
10) YOU NEED TO BE A HOMEOPATH TO BE ABLE TO UNDERSTAND AND ADEQUATELY JUDGE THE VALUE OF HOMEOPATHY
With this notion, homeopaths want to claim that the critics of homeopathy are incompetent. It is like saying that only people who believe in god are allowed to criticise religion. By definition, homeopaths are believers, and therefore they are unlikely to be free of bias when judging the value of homeopathy. Homeopathy is a health technology that must be evaluated like all other health technologies: by independent scientists who know their job.
11) HOMEOPATHY HAS BEEN PROVEN TO WORK FOR LITTLE CHILDREN AND ANIMALS
The argument here is that animals and children cannot possibly respond to placebo. Therefore homeopathy must be more than a placebo.
This notion is twice wrong. Firstly, both animals and children can respond to placebo, if only ‘by proxy’, i.e. via their carers. Secondly, if we consider the totality of the reliable data, we find that neither for children nor for animals is the evidence convincingly positive.
12) HOMEOPATHY HAS BEEN USED VERY SUCCESSFULLY IN MAJOR EPIDEMICS, AND THAT FACT IS PROOF ENOUGH FOR ITS EFFICACY
Yes, there are some rather fascinating historical accounts which homeopaths interpret in this fashion. But if we look a little closer, we invariably find explanations which are much more plausible than the assumption of homeopathy’s effectiveness. Epidemiological observations of this nature can almost never establish cause and effect, and the clinical outcome could have been due to a myriad of confounders unrelated to homeopathy.
If you ask a chiropractor, you will probably be told that chiropractic spinal manipulation is a safe treatment. Unfortunately this is not quite true, as regular readers of this blog will appreciate. About half of all patients suffer mild to moderate adverse effects after chiropractic treatments and, in addition, many instances of much more serious complications have been documented, including rare cases of Horner syndrome. It results from an interruption of the sympathetic nerve supply to the eye and is characterized by the classic triad of miosis (ie, constricted pupil), partial ptosis, and loss of hemifacial sweating (ie, anhidrosis).
Danish neurologists recently reported the case of a 60-year-old man with no relevant medical history who was admitted to the Department of Neurology with drooping of his right upper eyelid and an ipsilateral contracted pupil, combined with pain, weakness, and numbness in his upper right limb.
The patient had experienced thoracic back pain of moderate intensity with radiating right-sided belt-like chest pain for 7 days. When the discomfort suddenly intensified, he sought chiropractic treatment. Following manipulations of the thoracic and cervical spine, the pain intensity initially lessened. Approximately one hour after chiropractic treatment, the patient experienced the eye and upper limb symptoms described above, for which he sought medical assistance three days later.
A detailed neurologic examination revealed moderate right-sided ptosis and miosis, no facial anhidrosis, decreased strength of the intrinsic and opponens muscles of the right hand, and reduced cutaneous sensation corresponding to the T1 dermatome, with inability to discriminate pain and light touch. The remaining clinical examination, routine blood tests, and vital parameters were unremarkable.
Brain CT scan and CT angiography including the aortic arch and neck vessels were performed and ruled out cerebral stroke and carotid artery dissection, respectively. As clinical signs of Horner syndrome and a concomitant radiating pain to the medial arm were considered suggestive of either a lower brachial plexopathy, i.e., due to a Pancoast tumor, or a radiculopathy, chest X-ray and electroneurography (ENG) were performed. No apical pulmonary pathology was detected. ENG of the right medial cutaneous antebrachial nerve demonstrated a normal sensory action potential (SAP), consistent with the lesion being located proximally to the dorsal spinal root ganglion, thus suggestive of a spinal nerve root lesion. A subsequent MRI of the thoracic spine showed a para-median herniation of the T1-T2 intervertebral disc compressing the right T1 spinal nerve root.
The patient received no surgery, and follow-up examination 6 months later revealed near-complete recovery, with only mild paraesthesia in the T1 segment of his right arm and a subtle ptosis remaining.
Horner syndrome due to a herniated thoracic disc has only been reported 6 times in the English language literature, though never preceded by chiropractic manipulation.
One of the most frequent causes of Horner syndrome is carotid artery dissection, which may occur spontaneously or due to local trauma to the neck region. Chiropractic manipulation as an independent risk factor for neck artery dissection and a consequent stroke is a controversial topic, though multiple cases of Horner syndrome due to ICA dissections subsequent to chiropractic manipulation have been reported. In the patient described here, an ICA dissection was considered unlikely due to the concomitant prominent radiating medial brachialgia and was furthermore ruled out by a CT angiogram of the neck vessels.
This patient experienced the onset of a Horner syndrome and ipsilateral upper limb symptoms shortly after chiropractic treatment, suggesting the cervico-thoracic manipulation as the cause of or at least worsening factor in the T1-T2 disc herniation. Several cases of disc herniations following chiropractic treatment have been reported.
While the definite pathophysiologic mechanism to explain this patient’s Horner syndrome remains unclear, it seems, according to the authors of this case-report, evident that manipulations as a minimum altered the configuration of an already existing disc protrusion.
The purpose of this study was to evaluate the impact of early and guideline adherent physical therapy for low back pain on utilization and costs within the Military Health System (MHS).
Patients presenting to a primary care setting with a new complaint of LBP from January 1, 2007 to December 31, 2009 were identified from the MHS Management Analysis and Reporting Tool. Descriptive statistics, utilization, and costs were examined on the basis of timing of referral to physical therapy and adherence to practice guidelines over a 2-year period. Utilization outcomes (advanced imaging, lumbar injections or surgery, and opioid use) were compared using adjusted odds ratios with 99% confidence intervals. Total LBP-related health care costs over the 2-year follow-up were compared using linear regression models.
753,450 eligible patients with a primary care visit for LBP between 18-60 years of age were considered. Physical therapy was utilized by 16.3% (n = 122,723) of patients, with 24.0% (n = 17,175) of those receiving early physical therapy that was adherent to recommendations for active treatment. Early referral to guideline adherent physical therapy was associated with significantly lower utilization for all outcomes and 60% lower total LBP-related costs.
The authors concluded that the potential for cost savings in the MHS from early guideline adherent physical therapy may be substantial. These results also extend the findings from similar studies in civilian settings by demonstrating an association between early guideline adherent care and utilization and costs in a single payer health system. Future research is necessary to examine which patients with LBP benefit early physical therapy and determine strategies for providing early guideline adherent care.
These are certainly interesting data. Because LBP is such a common condition, it costs us all dearly. Measures to reduce this burden in suffering and expense are urgently needed. The question is whether early referral to a physiotherapist is such a measure. The present data show that this is possible but they do not prove it.
I applaud the authors for realising this point and discussing it at length: The results of this study should be examined in light of the following limitations. Given the favorable natural history of LBP, many patients improve regardless of treatment. Those referred to physical therapy early are also more likely to have a shorter duration of pain, thus the potential for selection bias to have influenced these results. We accounted for a number of co-morbidities available in the data set and excluded patients with prior visits for LBP to mitigate against this possibility. However, the retrospective observational design of this study imposes limitations on extending the associations we observed to causation. Although we attempted to exclude patients with a specific spinal pathology, it is possible that a few patients may have been inadvertently included in the data set, in which case advanced imaging may be indicated. Additionally, although our results support that early physical therapy which adheres to practice guidelines may be less resource intense, we cannot conclude without patient-centered clinical outcomes (i.e., pain, function, disability, satisfaction, etc.) that the care was more cost effective. Further, it may be that the standard we used to judge adherence to practice guidelines (CPT codes) was not sufficiently sensitive to determine whether care is consistent with clinical practice guidelines. We also did not account for indirect or out-of-pocket costs for treatments such as complementary care, which is common for LBP. However, it is likely that the observed effects on total costs would have been even larger had these costs been considered.
I was originally alerted to this paper through a tweet claiming that these results demonstrate that chiropractic has an important role in LBP. However, the study does not even imply such a conclusion. It is, of course, true that many chiropractors use physical therapies. But they do not have the same training as physiotherapists and they tend to use spinal manipulations far more frequently. Virtually every LBP-patient consulting a chiropractor would be treated with spinal manipulations. As this approach is neither based on sound evidence nor free of risks, the conclusion, in my view, cannot be to see chiropractors for LBP; it must be to consult a physiotherapist.
I have repeatedly stressed that herbal remedies can cause harm in a range of ways. Indian rheumatologists recently enforced this point by publishing a case-report of adrenal suppression caused by herbal remedies.
A 49-year-old male presented with polyarthritis from which he had suffered for more than 10 years. His serum cortisol levels were extremely low, he had vitamin D deficiency, and his rheumatoid factor was negative. He revealed symptoms of adrenal suppression, mainly muscle weakness and suicidal tendency, and few other psychiatric disturbances.
The patient eventually discontinued his herbal medicine. Then, he was put on deflazacort for 12 weeks at 12 mg twice daily and later the dose was tapered to 6 mg/day. Deflazocort, an intermediate-acting corticosteroid, was prescribed to minimize the probable withdrawal symptoms due to the probable presence of dexamethasone or betamethasone (long-acting steroids) presumably from the herbal medication.
The herbal samples of used by the patient was analysed by mass spectrometry. It showed the presence of steroidal compounds by the mass 393.81, which may be dexamethasone or betamethasone.
The authors of this paper believe that the symptoms of adrenal suppression could have precipitated or exacerbated the neuropsychiatric disturbances due to Hypothalamus-Pituitary-Adrenal (HPA) suppression. In their view, adrenal suppression following ingestion of herbal remedies is of major concern. Abrupt withdrawal of such products could precipitate adrenal failure which can be fatal.
It should be added, I think, that such illegal adulterations of herbal remedies have been reported with some regularity, particularly in Indian (and Chinese) preparations. Our systematic review showed that this problem has caused serious harm. The most severe documented adverse effects include agranulocytosis, meningitis, multi-organ failure, perinatal stroke, arsenic, lead or mercury poisoning, malignancies or carcinomas, hepatic encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral edema, coma, intracerebral haemorrhage, and death.
As under-reporting can be suspected to be huge, we do currently not know how frequent these events are.
There are things that cannot be said too often. In medicine, these are often related to issues that can save lives. In alternative medicine, it is worth remembering that there is nothing that can save more lives than the following rule: EVEN AN APPARENTLY HARMLESS REMEDY WILL BECOME LIFE-THREATENING, IF IT IS USED AS AN ALTERNATIVE TO AN EFFECTIVE THERAPY FOR A SERIOUS CONDITION.
Here is a publication that serves as a very sad reminder of this important axiom.
Japanese physicians recently published a case-report of 2-year-old girl who died of precursor B-cell acute lymphoblastic leukaemia (ALL), the most common cancer in children. She had no remarkable medical history. She was transferred to a hospital because of respiratory distress and died 4 hours after arrival.
Two weeks before her death, she had developed a fever of 39°C, which subsided after the administration of a naturopathic herbal remedy. Subsequently, she developed jaundice one week before death, and her condition worsened on the day of death.
Laboratory test results on admission showed a markedly elevated white blood cell count. Accordingly, the cause of death was suspected to be acute leukaemia. Forensic autopsy revealed the cause of death to be precursor B-cell ALL.
With advancements in medical technology, the 5-year survival rate of children with ALL is nearly 90%. However, in this case, the deceased’s parents preferred alternative medicine to evidence-based medicine and had not taken her to a hospital for a medical check-up or immunisation since she was an infant. The authors state that, if she had received routine medical care, she would have a more than 60% chance of being alive 5 years after diagnosis. Therefore, we conclude that the parents should be accused of medical neglect regardless of their motives.
Alternative practitioners who treat their patients in this way, are in my experience often full of good intentions. They remind me of something Bert Brecht one wrote: THE OPPOSITE OF GOOD IS NOT EVIL, IT IS GOOD INTENTIONS.
Ayurvedic medicine has become highly popular in Western countries; it originates, of course, from India, and is considered to be one of the world’s oldest health care systems. Its adherents claim to create harmony between the body, mind, and spirit, maintaining that this balance prevents illness, treats acute conditions, and contributes to a long and healthy life. In India Ayurveda is mainstream and more than 90% of the population are said to use it. Outside India, Ayurveda is usually classified as an alternative therapy.
Ayurvedic treatments can consist of a range of modalities, including herbal remedies taken by mouth. These preparations have often been reported to be contaminated with toxic metals. Despite several case reports of poisoning from such contamination, the epidemiological evidence is still limited. A new paper on this important topic is therefore welcome. It reports on a cluster of lead and mercury toxicity cases which occurred 2011 among a community of users of Ayurvedic remedies in the US.
Following the identification of the index case, adherents of Ayurveda were offered heavy metals screening. The results showed that 46 of 115 participants (40%) had elevated blood lead levels (BLLs) of 10 μg/dl or above, with 9.6% of BLLs at or above 50 μg/dl.
The authors issued the following warning: this is the largest cluster of lead and mercury toxicity following use of Ayurvedic supplements described in the literature in the US. Contamination of herbal products is a public health issue of global significance. There are few regulations addressing contamination of “natural” products or supplements.
Rasa shastra, the practice of adding metals, minerals or gems to herbal preparations, is a well-documented part of Ayurveda. Adverse reactions to herbs are described in traditional Ayurvedic texts, but practitioners tend to be reluctant to admit that their remedies could be toxic and that reliable information on their risks is not readily available.
Already in 1990, a study on Ayurvedic medicines in India found that 41% of the products tested contained arsenic, and that 64% contained lead and mercury. A 2004 study found toxic levels of heavy metals in 20% of Ayurvedic preparations sold in the Boston area. A 2008 study of more than 230 products found that approximately 20% of remedies (and 40% of rasa shastra medicines) purchased over the Internet from U.S. and Indian suppliers contained lead, mercury or arsenic.
My 2002 systematic review summarised all the available evidence and concluded that heavy metals, particularly lead, have been a regular constituent of traditional Indian remedies. This has repeatedly caused serious harm to patients taking such remedies. The incidence of heavy metal contamination is not known, but one study shows that 64% of samples collected in India contained significant amounts of lead (64% mercury, 41% arsenic and 9% cadmium). These findings should alert us to the possibility of heavy metal content in traditional Indian remedies and motivate us to consider means of protecting consumers from such risks.
Despite these concerns, Ayurveda-fans continue to believe that the toxicity of these remedies is reduced through the purification processes of Ayurvedic remedy preparation. Bizarrely, they may involve prayers as well as physical pharmacy techniques.
The Indian government ruled that Ayurvedic products must be labelled with their metallic content. However, one Indian expert, has been quoted claiming that “the absence of post-market surveillance and the paucity of test laboratory facilities [in India] make the quality control of Ayurvedic medicines exceedingly difficult at this time”. In the US, most Ayurvedic products are marketed without having been approved by the FDA. Since 2007, the FDA has placed an import alert on some Ayurvedic products in order to prevent them from entering the US.
Protecting consumers from heavy metal poisoning by Ayurvedic remedies is certainly not easy – but, in the interest of public health, it is a task that we must tackle with some ungency.
Yoga is a popular form of alternative medicine. Evidence for its effectiveness is scarce and generally far from convincing. But at least it is safe! At least this is what yoga enthusiasts would claim. Unfortunately, this is not entirely true; adverse events have also been reported with some regularity. Their frequency is, however, not known.
A new study was aimed at filling this gap. It was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.
The subjects were 2508 people taking yoga classes and 271 yoga therapists conducting the classes. A survey for yoga class attendees was performed on adverse events that occurred during a yoga class on the survey day. A survey for yoga therapists was performed on adverse events that the therapists had observed in their students to date. Adverse events were defined as “undesirable symptoms or responses that occurred during a yoga class”.
Among 2508 yoga class attendees, 1343 (53.5%) had chronic diseases and 1063 (42.3%) were receiving medication at hospitals. There were 687 class attendees (27.8%) who reported some type of undesirable symptoms after taking a yoga class. Musculoskeletal symptoms such as myalgia were the most common symptoms, involving 297 cases, followed by neurological symptoms and respiratory symptoms. Most adverse events (63.8%) were mild and did not interfere with class participation. The risk factors for adverse events were examined, and the odds ratios for adverse events were significantly higher in attendees with chronic disease, poor physical condition on the survey day, or a feeling that the class was physically and mentally stressful. In particular, the occurrence of severe adverse events that interfered with subsequent yoga practice was high among elderly participants (70 years or older) and those with chronic musculoskeletal diseases.
The authors concluded that the results of this large-scale survey demonstrated that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.
I find these findings interesting and thought-provoking. The main question that they raise is, I think, the flowing: ARE THERE ANY CONDITIONS FOR WHICH YOGA DEMONSTRABLY GENERATES MORE GOOD THAN HARM?