patient choice
During the coronavirus disease 2019 pandemic, Ayurvedic herbal supplements and homeopathic remedies were promoted as immune boosters (IBs) and disease-preventive agents. This happened in most parts of the world but nowhere more intensely than in India.
The present study examined the clinical outcomes among patients with chronic liver disease who presented with complications of portal hypertension or liver dysfunction temporally associated with the use of IBs in the absence of other competing causes. This Indian single-center retrospective observational cohort study included patients with chronic liver disease admitted for the evaluation and management of jaundice, ascites, or hepatic encephalopathy temporally associated with the consumption of IBs and followed up for 180 days. Chemical analysis was performed on the retrieved IBs.
From April 2020 to May 2021, 1022 patients with cirrhosis were screened, and 178 (19.8%) were found to have consumed complementary and alternative medicines. Nineteen patients with cirrhosis (10.7%), jaundice, ascites, hepatic encephalopathy, or their combination related to IBs use were included. The patients were predominantly male (89.5%). At admission, 14 (73.75%) patients had jaundice, 9 (47.4%) had ascites, 2 (10.5%) presented with acute kidney injury, and 1 (5.3%) had overt encephalopathy. Eight patients (42.1%) died at the end of the follow-up period. Hepatic necrosis and portal-based neutrophilic inflammation were the predominant features of liver biopsies.
Ten samples of IBs, including locally made ashwagandha powder, giloy juice, Indian gooseberry extracts, pure giloy tablets, multiherbal immune-boosting powder, other multiherbal tablets, and the homeopathic remedy, Arsenicum album 30C, were retrieved from our study patients. Samples were analyzed for potential hepatotoxic prescription drugs, known hepatotoxic adulterants, pesticides, and insecticides, which were not present in any of the samples. Detectable levels of arsenic (40%), lead (60%), and mercury (60%) were found in the samples analyzed. A host of other plant-derived compounds, industrial solvents, chemicals, and anticoagulants was identified using GC–MS/MS. These include glycosides, terpenoids, phytosteroids, and sterols, such as sitosterol, lupeol, trilinolein, hydroxy menthol, methoxyphenol, butyl alcohol, and coumaran derivatives.
The authors concluded that Ayurvedic and Homeopathic supplements sold as IBs potentially cause the worsening of preexisting liver disease. Responsible dissemination of scientifically validated, evidence-based medical health information from regulatory bodies and media may help ameliorate this modifiable liver health burden.
The authors comment that Ayurvedic herbal supplements and homeopathic remedies sold as IBs, potentially induce idiosyncratic liver injury in patients with preexisting liver disease. Using such untested advertised products can lead to the worsening of CLD in the form of liver failure or portal hypertension events, which are associated with a high risk of mortality compared to those with severe AH-related liver decompensation in the absence of timely liver transplantation. Severe mixed portal inflammation and varying levels of hepatic necrosis are common findings on liver histopathology in IB-related liver injury. Health regulatory authorities and print and visual media must ensure the dissemination of responsible and factual scientific evidence-based information on herbal and homeopathic “immune boosters” and health supplements to the public, specifically to the at-risk patient population.
Menopausal symptoms are a domaine of so-called alternative medicine (SCAM), not least because many women are worried about hormone treatments and therefore want ‘something natural’. TCM practitioners are only too keen to offer their services. But do their treatments really work?
This study aimed to analyze the effectiveness of acupuncture combined with Chinese herbal medicine (CHM) on mood disorder symptoms for menopausal women.
A total of 95 qualified Chinese participants were randomly assigned to one of three groups:
- 31 in the acupuncture combined with CHM group (combined group),
- 32 in the acupuncture combined with CHM placebo group (acupuncture group),
- 32 in the CHM combined with sham acupuncture group (CHM group).
The patients were treated for 8 weeks and followed up for 4 weeks. The data were collected using the Greene Climacteric Scale (GCS), self-rating depression scale (SDS), self-rating anxiety scale (SAS), and safety index.
The three groups each showed significant decreases in the GCS, SDS, and SAS after treatment (p < 0.05). Furthermore, the effect on the GCS total score and the anxiety domain lasted until the follow-up period in the combined group (p < 0.05). Within the three groups, there was no difference in GCS and SAS between the three groups after treatment (p > 0.05). However, the combined group showed significant improvement in the SDS, compared with both the acupuncture group and the CHM group at 8 weeks and 12 weeks (p < 0.05). No obvious abnormal cases were found in any of the safety indexes.
The authors concluded that the results suggest that either acupuncture, or CHM or combined therapy offer safe improvement of mood disorder symptoms for menopausal women. However, the combination therapy was associated with more stable effects in the follow-up period and a superior effect on improving depression symptoms.
Previous reviews have drawn conclusions that are far less positive, e.g.:
- the observed clinical benefit associated with acupuncture may be due, in part, or in whole to nonspecific effects.
- the evidence gathered was not sufficient to affirm the effectiveness of traditional acupuncture compared with sham acupuncture.
- For natural menopause, one large study has shown acupuncture to be superior to self-care alone in reducing the number of hot flushes and improving the quality of life; five small studies have been unable to demonstrate that the effect of acupuncture is limited to any particular points, as traditional theory would suggest; and one study showed acupuncture was superior to blunt needle for flash frequency but not intensity.
- Sham-controlled RCTs fail to show specific effects of acupuncture for control of menopausal hot flushes.
It seems therefore wise to take the conclusions of the new study with a pinch of salt. The intergroup difference observed in this trial may well be due to residual biases, multiple testing, or coincidence. And the reported intragroup differences are in complete accord with the fact that the employed therapies are mere placebos.
This, of course, begs the question of whether SCAM has anything else to offer for women suffering from menopausal symptoms. To answer it, I can refer you to one of our systematic reviews:
Some evidence exists in favour of phytosterols and phytostanols for diminishing LDL and total cholesterol in postmenopausal women. Similarly, regular fiber intake is effective in reducing serum total cholesterol in hypercholesterolemic postmenopausal women. Clinical evidence also exists on the effectiveness of vitamin K, a combination of calcium and vitamin D or a combination of walking with other weight-bearing exercise in reducing bone mineral density loss and the incidence of fractures in postmenopausal women. Black cohosh appears to be effective therapy for relieving menopausal symptoms, primarily hot flashes, in early menopause. Phytoestrogen extracts, including isoflavones and lignans, appear to have only minimal effect on hot flashes but have other positive health effects, e.g. on plasma lipid levels and bone loss. For other commonly used CAMs, e.g. probiotics, prebiotics, acupuncture, homeopathy and DHEA-S, randomized, placebo-controlled trials are scarce and the evidence is unconvincing. More and better RCTs testing the effectiveness of these treatments are needed.
It has been reported that Goop founder Gwyneth Paltrow now has taken to promoting the weirdest wellness thing she’s ever done: rectal ozone therapy. ‘I have used ozone therapy, rectally. Can I say that?’ she told Dear Media podcast The Art of Being Well. ‘It’s pretty weird. It’s pretty weird, yeah. But it’s been very helpful.’
The benefits of rectal ozone therapy are said to be reduced pain/inflammation, increased energy, improved metabolism/circulation, stimulated immune system, detoxification, anti-aging, and fighting bacterial/viral infections.
But who am I to criticize an authority like Gwyneth?
Therefore, I better look up the evidence! And if you had speculated that there is none, you would have been mistaken. Here are some of the more recent clinical studies listed in Medline:
Objective: Fibromyalgia is a chronic disorder with a very complex symptomatology. Although generalized severe pain is considered to be the cardinal symptom of the disease, many other associated symptoms, especially non-restorative sleep, chronic fatigue, anxiety, and depressive symptoms also play a relevant role in the degree of disability characteristic of the disease. Ozone therapy, which is used to treat a wide range of diseases and seems to be particularly useful in the treatment of many chronic diseases, is thought to act by exerting a mild, transient, and controlled oxidative stress that promotes an up-regulation of the antioxidant system and a modulation of the immune system. According to these mechanisms of action, it was hypothesized that ozone therapy could be useful in fibromyalgia management, where the employed therapies are very often ineffective.
Patients and methods: Sixty-five patients with fibromyalgia, according to the definition of the American College of Rheumatology (Arthritis Rheum 1990; 33: 160-172), were treated at the MEDE Clinic (Sacile, Pordenone, Italy) from February 2016 to October 2018. Females were 55 and males were 10; age ranged from 30 to 72 years, and the time from fibromyalgia diagnosis ranged from 0.5 to 33 years. Treatment was made by autohemotransfusion in 55 patients and by ozone rectal insufflations in 10 patients, according to SIOOT (Scientific Society of Oxygen Ozone Therapy) protocols, twice a week for one month and then twice a month as maintenance therapy.
Results: We found a significative improvement (>50% of symptoms) in 45 patients (70%). No patient reported important side effects. In conclusion, at our knowledge, this is the largest study of patients with fibromyalgia treated with ozone therapy reported in the literature and it demonstrates that the ozone therapy is an effective treatment for fibromyalgia patients without significant side effects.
Conclusions: At the moment, ozone therapy seems a treatment that, also because without any side effect, is possible to be proposed to patients with fibromyalgia that are not obtaining adequate results from other available treatments and it can be considered as complementary/integrative medicine.
No2:
Introduction: The Corona virus disease 19 (COVID-19) has accounted for multiple deaths and economic woes.While the entire medical fraternity and scientists are putting their best feet forward to find a solution to contain this deadly pandemic, there is a growing interest in integrating other known alternative therapies in to standard care. This study is aimed at evaluating the safety and efficacy of ozone therapy (OT), as an adjuvant to the standard of care (SOC).
Methods: In the current randomized control trial, 60 patients with mild to moderate score NEWS score were included in two parallel groups (n = 30/group). The interventional group (OZ) received ozonized rectal insufflation and minor auto haemotherapy, daily along with SOC, while the control group (ST) received SOC alone. The main outcome measures included changes in clinical features, oxygenation index (SpO2), NEWS score, Reverse transcription polymerase chain reaction(RT-PCR), inflammatory markers, requirement of advanced care, and metabolic profiles.
Results: The OZ group has shown clinically significant improvement in the mean values of all the parameters tested compared to ST Group. However, statistical significance were only observed in RT-PCR negative reaction (P = 0.01), changes in clinical symptoms (P < 0.05) and requirement for Intensive care (P < 0.05). No adverse events were reported in OZ group, as against 2 deaths reported in ST group.
Conclusion: OT when integrated with SOC can improve the clinical status and rapidly reduce the viral load compared to SOC alone, which facilitate early recovery and check the need for advanced care and mortality as demonstrated in this study.
Introduction: IgA deficiency is a primary immunodeficiency predominantly due to an antibody defect, for which there is no replacement therapy. Treatment consists of prevention and treatment of infections and other associated conditions. Given the immunomodulatory and regulatory properties of the redox balance of ozone therapy in infectious and inflammatory conditions, evaluation of its effect on IgA deficiency is of interest.
Objective: Assess the benefits and possible adverse effects of ozone treatment in patients with IgA deficiency.
Methods: A monocentric randomized controlled phase 2 clinical trial (RPCEC 00000236) was carried out, after approval by the Institutional Ethics Committee of the Roberto Rodríguez Fernández Provincial General Teaching Hospital in Morón, Ciego de Ávila Province, Cuba. Included were 40 patients aged 5-50 years, distributed in 2 groups of 20, after agreeing to participate and signing informed consent. The experimental group received 2 cycles of ozone by rectal insufflation for 20 days (5 times a week for 4 weeks each cycle) with a 3-month interval between cycles, for a total of 40 doses, with age-adjusted dose ranges. The control group was treated with leukocyte transfer factor (Hebertrans), 1 U per m2 of body surface area subcutaneously, once weekly for 12 weeks. Frequency of appearance and severity of clinical symptoms and signs of associated diseases, serum immunoglobulin concentrations and balance of pro-oxidant and antioxidant biomarkers were recorded at treatment initiation and one month after treatment completion. Therapeutic response was defined as complete, partial, stable disease or progressive disease. Descriptive statistics and significance were calculated to compare groups and assess effect size.
Results: One month after treatment completion, 70% of patients in the experimental group experienced significant increases in IgG(p = 0.000) and IgM (p = 0.033). The experimental group also displayed decreased pro-oxidation biomarkers, glutathione modulation and increased antioxidant enzymes, with reduced oxidative stress; none of these occurred in the control group. Complete therapeutic response was achieved in 85% of patients in the experimental group and only 45% in the control group. Mild, transient adverse events were reported in both groups.
Conclusions: Ozone therapy by rectal insufflation is a suitable therapeutic option for treating IgA deficiency because it produces antioxidant and immunomodulatory effects and is feasible, safe and minimally invasive.
Background: Ozone therapy may stimulate antioxidant systems and protect against free radicals. It has not been used formerly in patients with pulmonary emphysema.
Aim: To assess the effects of rectal ozone therapy in patients with pulmonary emphysema.
Material and methods: Sixty four patients with pulmonary emphysema, aged between 40 and 69 years, were randomly assigned to receive rectal ozone in 20 daily sessions, rectal medicinal oxygen or no treatment. Treatments were repeated three months later in the first two groups. At baseline and at the end of the study, spirometry and a clinical assessment were performed.
Results: fifty patients completed the protocol, 20 receiving ozone therapy, 20 receiving rectal oxygen and 10 not receiving any therapy. At baseline, patients on ozone therapy had significantly lower values of forced expiratory volume in the first second (fEV1) and fEV1/forced vital capacity. At the end of the treatment period, these parameters were similar in the three treatment groups, therefore they only improved significantly in the group on ozone therapy. No differences were observed in other spirometric parameters.
Conclusions: Rectal ozone therapy may be useful in patients with pulmonary emphysema.
Background: Pain secondary to chemotherapy-induced peripheral neuropathy (CIPN) can limit the administration of chemotherapy, cancer-treatment outcomes, and the quality of life of patients. Oxidative stress and inflammation are some of the key mechanisms involved in CIPN. Successful treatments for CIPN are limited. This report shows our preliminary experience using ozone treatment as a modulator of oxidative stress in chronic pain secondary to CIPN. Methods: Ozone treatment, by rectal insufflation, was administered in seven patients suffering from pain secondary to grade II or III CIPN. Pain was assessed by the visual analog scale (VAS). Results: All patients, except one, showed clinically relevant pain improvement. Median pain score according to the VAS was 7 (range: 5-8) before ozone treatment, 4 (range: 2-6) at the end of ozone treatment (p = 0.004), 5.5 (range: 1.8-6.3) 3 months after the end of ozone treatment (p = 0.008), and 6 (range: 2.6-6.6) 6 months after the end of ozone treatment (p = 0.008). The toxicity grade, according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0), improved in half of the patients. Conclusion: This report shows that most patients obtained clinically relevant and long-lasting improvement in chronic pain secondary to CIPN after treatment with ozone. These observed effects merit further research and support our ongoing randomized clinical trial.
Background: Medical ozone is more bactericidal, fungicidal, and virucidal than any other natural substance. Some studies proved that ozone infused into donated blood samples can kill viruses 100% of the time. Ozone, because of its special biologic properties, has theoretical and practical attributes to make it a potent hepatitis C virus (HCV) inactivator, which suggests an important role in the therapy for hepatitis C.
Aim: The study aim is to evaluate the role of ozone therapy in decreasing HCV ribonucleic acid (HCV RNA) load and its effect on the liver enzymes among patients with chronic hepatitis C.
Methods: This study included 52 patients with chronic hepatitis C (positive polymerase chain reaction [PCR] for HCV RNA and raised serum alanine transaminase [ALT] for more than 6 months). All patients were subjected to meticulous history taking and clinical examination. Complete blood count, liver function tests, and abdominal ultrasonography were requested for all patients. The ozone group included 40 patients who received major autohemotherapy, minor autohemotherapy, and rectal ozone insufflation. The other 12 patients (conventional group) received silymarin and/or multivitamins.
Results: There were significant improvements of most of the presenting symptoms of the patients in the ozone group in comparison to the conventional group. ALT and aspartate transaminase (AST) levels normalized in 57.5% and 60% in the ozone group, respectively, in comparison to 16.7% and 8% in the conventional group, respectively. Polymerase chain reaction (PCR) for HCV RNA was negative among 25% and 44.4% after 30 and 60 sessions of ozone therapy, respectively, in comparison to 8% among the conventional group.
Conclusions: Ozone therapy significantly improves the clinical symptoms associated with chronic hepatitis C and is associated with normalized ALT and AST levels among a significant number of patients. Ozone therapy is associated with disappearance of HCV RNA from the serum (-ve PCR for HCV RNA) in 25%-45% of patients with chronic hepatitis C.
Oxidative stress is suggested to have an important role in the development of complications in diabetes. Because ozone therapy can activate the antioxidant system, influencing the level of glycemia and some markers of endothelial cell damage, the aim of this study was to investigate the therapeutic efficacy of ozone in the treatment of patients with type 2 diabetes and diabetic feet and to compare ozone with antibiotic therapy. A randomized controlled clinical trial was performed with 101 patients divided into two groups: one (n = 52) treated with ozone (local and rectal insufflation of the gas) and the other (n = 49) treated with topical and systemic antibiotics. The efficacy of the treatments was evaluated by comparing the glycemic index, the area and perimeter of the lesions and biochemical markers of oxidative stress and endothelial damage in both groups after 20 days of treatment. Ozone treatment improved glycemic control, prevented oxidative stress, normalized levels of organic peroxides, and activated superoxide dismutase. The pharmacodynamic effect of ozone in the treatment of patients with neuroinfectious diabetic foot can be ascribed to the possibility of it being a superoxide scavenger. Superoxide is considered a link between the four metabolic routes associated with diabetes pathology and its complications. Furthermore, the healing of the lesions improved, resulting in fewer amputations than in control group. There were no side effects. These results show that medical ozone treatment could be an alternative therapy in the treatment of diabetes and its complications.
___________________________
What does that tell us?
That rectal ozone therapy is a panacea?
No, I don’t think so.
In my view, it tells us that strange journals publish a lot of dodgy research from strange research groups that use dodgy methodologies to confirm their odd belief that bogus treatments work for everything.
PS
I wonder which orifice Gwyneth will employ next to get the attention of the public.
So-called alternative medicine (SCAM) is widely used in Arabia. One of the commonly used methods is camel urine alone or mixed with camel milk. Camel urine is a liquid by-product of camel metabolism. Urine from camels has been used as prophetic medicine for centuries, being a part of ancient Bedouin practices. Camel urine comes out as a concentrated, viscous syrup because the kidneys and intestines of a camel are very efficient at reabsorbing water. 
Camel urine is consumed and used for treating numerous ailments. Some employ it as a treatment for hair loss, for instance. The camel urine from a virgin camel is priced at twenty dollars per liter, with herders saying that it has curative powers.
A recent paper offers more information:
Camel is one of the important livestock species which plays a major role in the pastoral mode of life by fulfilling basic demands of livelihood. Traditionally, camel urine has been used in the treatment of human diseases. With regard to the health benefits of drinking the urine of camels, it has been proven by modern scientific researches. Camel urine has an unusual and unique biochemical composition that contributes to medicinal values. The chemical composition of camel urine showed the presence of purine bases, hypoxanthine, sodium, potassium, creatinine, urea, uric acid, and phosphates. The nano-particles in the camel’s urine can be used to fight cancer. Camel urine has antimicrobial activity against pathogenic bacteria. Its chemical and organic constituents have also inhibitory properties against fungal growth, human platelets, and parasitic diseases mainly fasciollosis in calves. The healthy status of the liver can be restored through ingestion of diet and minerals in camel urine. Camel urine is used by the camel owners and Bedouins as medicine in different ways. The Bedouin in the Arab desert used to mix camel urine with milk. Recently; the WHO has warned against drinking camel urine due to the modern attempt to limit Outbreaks of Respiratory Syndrome (MRS) in the Middle East. There is no scientific dosage for camel urine to be applied as medicine for different diseases and the ways of camel urine formulation and utilization for the care of patients varies from country to country. Therefore, the purposes of the present review describe the biochemical composition of camel urine will be scientifically extracted and formulated as a therapy rather than drinking raw urine and people’s health impact.
Researchers from the Medical Oncology Department, Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia wanted to determine whether camel urine shows promise in the treatment of cancer. The aim of their study was to observe cancer patients who insisted on using camel urine and to devise some clinically relevant recommendations.
The authors observed 20 cancer patients (15 male, 5 female) from September 2020 to January 2022 who insisted on using camel urine. They documented the demographics of each patient, the method of administering camel urine, the reasons for refusing conventional treatment, the period of follow-up, and the outcome and side effects.
All the patients had radiological investigations before and after finishing treatment with camel urine. All patients used a combination of camel urine and milk, and treatment ranged from a few days up to 6 months. The average amount of urine/milk consumed was 60 ml/day. No clinical benefit was observed and two patients developed brucellosis. Eleven patients changed their minds and eventually accepted conventional antineoplastic treatments but 7 were too weak to receive further treatment and died from their disease.
The authors concluded that camel urine had no clinical benefits in cancer patients, and may even have caused zoonotic infection. The promotion of camel urine as a traditional medicine should be stopped because there is no scientific evidence to support it.
I fear that, yet again, ‘ancient wisdom’ turns out to be just ‘old bullshit’.
I recently came across this editorial from the NEJM. I find it extremely relevant to the many discussions we have about so-called alternative medicine (SCAM) we have on this blog. I, therefore, take the liberty to copy a small section of it here without further comment, and encourage everyone to read the full paper:
…expertise and authority are increasingly seen as means for elites to establish and support existing hierarchies. There is, of course, some substance to this argument: although orthodox doctors may believe that their dominance and privilege are attributable to the rigor of the methods they use and that other schools of medicine were vanquished because of the superior results achieved by science-based practice, another version of the story sees the suppression of other approaches to healing (e.g., naturopathy, homeopathy, or chiropractic) as the result of ruthless actions by the American Medical Association and other forms of organized medicine. These critiques aren’t new; as Lewis Grossman writes in Choose Your Medicine, “medical freedom” arguments have long been used to oppose institutions intended to protect consumers, such as medical licensure and the FDA.3 The difference today is that the antiexpertise perspective has moved into the mainstream. With Google and Amazon having created a world in which people can frictionlessly obtain both information and nearly any product they want, it’s not hard to portray expert gatekeepers as barriers to patients’ ability to exercise choice.
Perhaps the most substantial threat to expertise is that members of the public are coming to believe that facts don’t exist — that all facts are political and therefore a matter of opinion. This mindset is fundamentally incompatible with the scientific practice of medicine, which depends on a shared commitment to backing up hypotheses with empirical evidence. Indeed, modern medicine owes much of its privileged position to a broad acceptance that the methods it uses can be relied on to make medical choices that are likely to do more good than harm.
A 1902 Supreme Court case, American School of Magnetic Healing v. McAnnulty, offers an instructive example of what could happen if all medical facts were seen as purely matters of opinion. The American School of Magnetic Healing in Nevada, Missouri, received 3000 pieces of mail every day, largely consisting of checks, money orders, and cash to purchase the healing services that the school advertised in newspapers throughout the United States. Patients who sent payments were instructed to lie down at a specified time wherever they were, and the healers at the magnetic school would, from Nevada, channel the healing energy of the universe into their bodies to heal them.3 The Post Office Department (which predated the Postal Service) concluded that this practice was a fraudulent operation using the mail and, after a hearing conducted by the postmaster general, stopped delivering mail to the school. The school sued, and the case went to the Supreme Court, which found in its favor.
Writing for the Court, Justice Rufus Peckham essentially rejected the existence of medical facts. “Just exactly to what extent the mental condition affects the body,” he wrote, “no one can accurately and definitely say.… Because the [school] might or did claim to be able to effect cures by reason of working upon and affecting the mental powers of the individual… who can say that it is a fraud?… Those who might deny the existence or virtue of the remedy would only differ in opinion from those who assert it. There is no exact standard of absolute truth by which to prove the assertion false and a fraud.”4 Although this decision was never expressly overruled, both Congress and the courts have since rejected the premise that the efficacy of treatments is purely a matter of opinion.
Differences of opinion within medicine are necessary for progress, and both licensing and certifying boards must therefore be careful to leave room for the expression of divergent views. Moreover, there is ongoing debate regarding the extent to which free-speech protections cover professional speech. But despite the existence of divergent views and areas for legitimate debate, there are some opinions that have been so thoroughly repudiated by existing evidence as to be considered definitively wrong.5 Constructive debates are possible only within a shared epistemic framework and with a commitment to the idea of verifiable facts. It’s incumbent on licensing and certifying boards to defend the existence of facts and to give the public a way to know when practitioners are making claims that are incompatible with reality.
When it comes to disciplining doctors, boards haven’t always lived up to public expectations — but that’s not a reason they should fall short yet again, especially during a lethal pandemic. Although there are many gray areas in medicine, some propositions are objectively wrong. For example, when a licensed physician insists that viruses don’t cause disease or that Covid-19 vaccines magnetize people or connect them to cell towers, professional bodies must be able to take action in support of fact- and evidence-based practice.
The public relies on the medical profession in times of grievous vulnerability and need. For the profession to earn and maintain the public’s trust — along with the privileges associated with the status of being licensed practitioners — medical boards must be able to differentiate practitioners who are providing fact-based advice from those who are not.
This happens with such a regularity that I have decided to write about it; in fact, I shall do that in the form of an ‘open letter‘ to all concerned.
Background
A person or group of persons compose a complaint about my work in which they allege that I am engaged in a decade-long vendetta specifically against their particular form of so-called alternative medicine (SCAM). This letter is sent to me, or to a publisher of my articles/books, or to my peers at the university, or to anyone else they consider appropriate. Such interventions can at times be quite entertaining or even hilariously funny, but if they occur too often, they are also mildly irritating and wasteful. Foremost, they are based on a fundamental misunderstanding that might be worth clearing up with this …
Open Letter
Dear advocate of the specific SCAM in question,
Dear professional organization of the specific SCAM in question,
I am sorry that my lecture/article/blog post/book/interview caused concern and led you to feel that I am running a long-term campaign or vendetta against the specific SCAM that you advocate. This letter is to assure you that your feeling is entirely erroneous: I am in no way targeting your specific SCAM.
If you have a look at my most recent book, for instance, you will see that, in it, I discuss a total of 202 different forms of SCAM and that – with good reason – I am highly critical of the vast majority of these methods. Imagine what it would mean to run a vendetta or campaign against all of these specific SCAMs. I would need a sizable team of co-workers involving lawyers, researchers, administrators, etc. to manage the task. I would also need plenty of funds to support the campaign, and I would most likely have more legal cases going than I have hair on my head.
The truth is that, since my retirement ~10 years ago, I do my research with no assistance whatsoever, I get no financial support or compensation for my work, and I am in contact with lawyers only when they ask me to serve as an expert witness. There simply is no evidence for the campaign that you feel does exist and you evidently misjudge my motives for criticizing your specific SCAM.
My aim is not to defame your specific SCAM or SCAM in general. I have no reason to do this. My aim is simply to inform the public responsibly and to prevent vulnerable people from getting harmed or ripped off. As I have studied the subject systematically for three decades, I feel I am competent, entitles, and duty-bound to try and do this.
I sincerely hope you are able to see the difference: you seem to think that I am destructively out to get you or your SCAM, while in truth I am constructively doing what responsible healthcare professionals (should) do.
Now that this misunderstanding has been cleared up, I thank you for reconsidering your position and stopping to claim things about me that are not true.
Best regards
Edzard Ernst
Turnera diffusa, known as damiana is a shrub native to southern Texas in the United States, Central America, Mexico, South America, and the Caribbean that produces small, aromatic flowers. Damiana is an ingredient in a traditional Mexican liqueur, which is sometimes used in lieu of triple sec in margaritas. Damiana was included in several 19th-century patent medicines, such as Pemberton’s French Wine Coca. The leaves were omitted from that product’s non-alcoholic counterpart, Coca-Cola.
In folklore, the plant was believed to be an aphrodisiac. I looked for evidence from clinical trials but was unable to find any. However, that does not seem to bother PharmaSGP GmbH which produces a drug called Neradin.
The German advertisement of Neradin tells us that:
Bei sexueller Schwäche wie Erektionsstörungen können auch traditionelle Mittel helfen – ohne die Nebenwirkungen mancher chemischer Potenzmittel. Das pflanzliche Arzneimittel Neradin® nutzt dazu erfolgreich Wirkstoffe der mexikanischen Heilpflanze Damiana (Turnera Diffusa).
Die Vorteile von Neradin® auf einen Blick: Fördert die Potenz des Mannes bei sexueller Schwäche
I translated this into English:
Traditional remedies can also help with sexual weakness such as erectile dysfunction – without the side effects of some chemical sexual enhancers. The herbal medicine Neradin® successfully uses active ingredients from the Mexican medicinal plant Damiana (Turnera Diffusa).
The advantages of Neradin® at a glance: Promotes male potency in case of sexual weakness
The patient information leaflet states that “Niradin is a homeopathic drug” and “one tablet Niradin contains 100mg Turnera Diffusa Trit. D4”.
English language sites concur:
Neradin is a homeopathic medicine. Homeopathy is understood as a regulatory therapy for acute and chronic diseases. The areas of application are derived from the homeopathic drug pictures. The following indications are authorised for this medicinal product: Discomfort caused by sexual weakness
So, what we seem to have here is the following:
- A pharma firm that advertises a homeopathic product as a herbal drug.
- A homeopathic remedy that is based on a plant for which there is not a jot of evidence.
- If there were evidence that the plant helps against erectile dysfunction, its homeopathic dilution would, according to the homeopathic ‘like cures like’ axiom, bring about erectile dysfunction.
- A dilution (1:10000) that is too low to have any effect, even if it were made of Viagra.
Am I the only one to think that something is not quite right here?
But don’t let it spoil your HAPPY VALENTINE!
I recently came across a truly baffling article. As it is in German, I translated it for you:
Supply shortages have kept pharmacies on tenterhooks for months, with more than 400 common medicines missing. The German Central Association of Homeopathic Doctors (DZVhÄ) suggests switching to alternative medicine as a solution: “We have homeopathic medicines that have been tried and tested in practice for more than 200 years and can replace many medicines that are currently not available,” says the president of the DZVhÄ , Dr Michaela Geiger.
The DZVhÄ is convinced that homeopathic medical practices can replace fever-reducing medicines, but in many cases also antibiotics and much more. However, Geiger qualifies: “Due to our medical training, we also know that cancer drugs such as the often cited Tamoxifen cannot be replaced by homeopathy”.
The homeopathic doctors respond directly to the sharpest argument of their critics: “But let’s assume that homeopathy only works via the placebo effect, as is being rumored, even then it would be an option, especially if other options are lacking,” says DZVhÄ vice-president Dr. Ulf Riker. Since homeopathically trained doctors can judge the general course of a disease, they can also distinguish a placebo effect from a medicinal effect.
…
If fever medication for children is lacking, parents should not be deprived of another “therapy option”, Riker said. “If you do not get your conventional fever medication in the coming weeks, visit a specialist pharmacy for naturopathy and homeopathy. If you are due for a medical consultation, experienced homeopathic doctors can prescribe a suitable homeopathic medicine for you,” he says.
Why do I find this so intriguing?
Essentially, what we have learned from the article is the following:
- “Tried and tested in practice for more than 200 years” is ‘homeopathy speak’ for “effective”, even if the evidence tells us otherwise.
- Homeopathic remedies can replace many evidence-based conventional medications such as fever-reducing medicines, antibiotics, and much more, even if the evidence tells us otherwise.
- Homeopaths know that cancer drugs cannot be replaced by homeopathy – except for those homeopaths who seem to have forgotten this simple lesson.
- Homeopathic placebos are a realistic option when there is a supply problem with effective drugs, even if the evidence tells us otherwise.
- Homeopathically trained doctors can distinguish a placebo effect from a medicinal effect, even if there is no evidence that any clinician can reliably do this.
- Homeopathic doctors prescribe suitable homeopathic medicine. Suitable for whom? As it is ineffective, it is unsuitable for the patient. Therefore, Riker is probably talking about the homeopath.
So, what have we really learned from this article? I don’t know about you, but I got the impression that the president and the vice president of the DZVhÄ do not seem to mind putting patients in danger, as long as they can promote homeopathy.
The All-Party Parliamentary Group (APPG) on Beauty and Wellbeing, UK, has undertaken an investigation into the ‘complementary therapies sector’, to consider how the sector can support everyone’s physical health, mental health, and well-being and take pressure off the NHS. In their recent document, they state:
The complementary therapies industry is an integral part of the Personal Care sector, which includes beauty, wellbeing, and alternative therapies. These therapies can be key to supporting everyone’s health and mental wellbeing…
To ensure complementary therapies can adequately support the NHS, we need to attract more talent into the sector and ensure all therapists receive the right training to become highly skilled professionals.
We also need to enhance the perception of the professionalism within the sector, so that it is no longer seen as ‘frivolous and fluffy’ and non-essential. Building awareness and understanding of its value in supporting our nation’s health is one step. However, it also important to crack down on any bad practice and the ‘underground market’ of poor treatment…
The committee makes the following recommendations:
1. The Government must work with NHS England to better promote the benefits of social prescribing with GPs, nurses and other health and care professionals, and how they can refer people to non-clinical complementary therapy services.
2. The Personal Care sector team in the Department for Business, Energy, Industry and Strategy must work with officials within the Department for Health and Social Care responsible for social prescribing to better integrate complementary therapy services into the NHS, and produce guidance to support health professionals and therapists in doing so.
3. The Department for Health and Social Care must undertake or fund research studies to demonstrate the value of integrating complementary therapy services into the NHS through social prescribing.
4. The Department for Education must revisit the gap between the apprentice wage and minimum wage for apprentices aged 19+, and provide financial incentives for employers to take on learners on any ‘job ready ‘qualification.
5. The Government must give Environmental health officers (EHOs) greater powers to act quickly to deal with bad practice and lead a crack-down on tax evading businesses that are driving down prices and undermining legitimate businesses under pressure.
…
…
…
Conclusions
The evidence that we have received during this investigation clearly demonstrate that greater support
and recognition is needed for the complementary therapies sector to ensure that they are able support
everyone’s physical health, mental health and wellbeing and take pressure off the NHS.
We hope the Government will review our recommendations in order to support the complementary
therapies sector and ensure they have adequate funding and acknowledgement.
In case you are wondering what therapies they refer to, here is their complete list of the treatments (including links to what they seem to think about them):
This could have made me laugh, had it not been so serious. The committee is composed of MPs who might be full of goodwill. Yet, they seem utterly clueless regarding the ‘complementary therapies sector’. For instance, they seem to be unaware of the evidence for some of the treatments they want to promote, e.g. craniosacral therapy, aromatherapy, Reiki, shiatsu, energy healing, or reflexology (which is far less positive than they seem to assume); and they aim at enhancing the “perception of the professionalism” instead of improving the PROFESSIONALISM of the therapists (which obviously would include adherence to evidence-based practice). And perhaps the committee might have given some thought to the question of whether it is ethical to push dubious therapies onto the unsuspecting public.
I could go on, but the perplexing wooliness of the document speaks for itself, I think.
And in case you are wondering who the MP members of the committee are, here is the list of its members:
• Carolyn Harris MP – Co-Chair
• Judith Cummins MP – Co-Chair
• Jessica Morden MP – Vice-Chair
• Jackie Doyle-Price MP – Vice-Chair
• Peter Dowd MP – Treasurer
• Nick Smith MP – Secretary
• Caroline Nokes MP – Member
• Sarah Champion MP – Member
• Alex Davies-Jones MP – Member
• Kate Osamor MP – Member
• John McNally MP – Member
• Kevan Jones MP – Member
• Gagan Mohindra MP- Member
The Secretariat for this APPG is Dentons Global Advisors with support from the National Hair and Beauty Federation, the Federation of Holistic Therapists and spabreaks.com.
PS
Two hours after having posted this, I begin to feel bad about being so dismissive. Let me thus try to do something constructive: I herewith offer to give one or more lectures to the committee about the evidence as it pertains to the therapies they included in their report.
Drip IV is “Australia’s first and leading mobile healthcare company specialising in assisting with nutritional deficiencies”. They claim to provide a mobile IV service that is prescribed and tailored individually to your nutritional needs. Treatment plans and customised infusions are determined by a medical team to suit individual requirements. They deliver vitamins, minerals and amino acids directly to the body via the bloodstream, a method they state allows for optimal bioavailability.
These claims are a little puzzling to me, not least because vitamins, minerals and amino acids tailored individually to the nutritional needs of the vast majority of people would mean administering nothing at all. But I guess that virtually every person who consults the service will get an infusion [and pay dearly for it].
The Australian Therapeutic Goods Administration (TGA) seems to have a similarly dim view on Drip IV. The TGA has just issued 20 infringement notices totalling $159,840 to the company and to one of its executive officers. The reason: unlawful advertising of intravenous infusion products to Australian consumers on a company website and social media. Ten notices totalling $133,200 were issued to the company and ten notices totalling $26,640 were issued to an executive officer. The TGA considers the intravenous infusion products to be therapeutic goods because of the claims made about them, and the advertising to be unlawful because the advertisements allegedly:
- contained prohibited representations, such as claims regarding cancer.
- contained restricted representations such as that the products would alleviate fatigue caused by COVID-19, assist in the treatment of Graves’ Disease and Alzheimer’s Disease, and support the treatment of autoimmune diseases such as Multiple Sclerosis. No TGA approval had been given to make such claims.
- referred to ingredients that are prescription only, such as glutathione. Prescription medicines cannot be advertised directly to the public in Australia.
- contained a statement or picture suggesting or implying the products were ‘TGA Approved’. Advertising of therapeutic goods cannot include a government endorsement.
- contained a statement or picture expressing that the goods were ‘miraculous’.
Vitamin infusions have become very popular around the globe. There are now thousands of clinics offering this service, and many of them advertise aggressively with claims that are questionable. Here is just one example from the UK:
Modern life is hectic. If you are looking to boost your wellbeing, increase your energy levels, lift your mood and hydrate your body, Vitamin IV Infusions are ideal. Favoured by celebrities such as Madonna, Simon Cowell and Rihanna, Vitamin IV Infusions are an easy, effective way of delivering vitamins, minerals and amino acids directly into your bloodstream via an IV (intravenous) drip. Vitamins are essential for normal growth and staying healthy – but our bodies can’t produce all of the nutrients we need to function and thrive. That’s why more than one in three people take daily vitamin supplements – often without realising that only 15% of the active nutrients consumed orally actually find their way into their bloodstream. With Vitamin IV Infusions, the nutrients enter your bloodstream directly and immediately, and are delivered straight to your cells. We offer four different Vitamin IV Infusions, so you can choose the best combination for your personal needs, while boosting your general health, energy and wellbeing.
My advice to consumers is a little different and considerably less costly:
- to ensure you get enough vitamins, minerals, and amino acids, eat a balanced diet;
- to boost your well-being, sit down and calculate the savings you made by NOT using such a service;
- to increase your energy levels, take a nap;
- to lift your mood, recount the money you saved and think of what nice things you might buy with it;
- to hydrate your body drink a glass of water.
Perhaps it is time the authorities in all countries had a look at what these clinics are offering and what health claims they are making. Perhaps it is time they act as the TGA just did.
