naturopathy
The well-known Dr. Chris van Tulleken recently joined forces with Professor Michael Heinrich and Dr. Anthony Booker from the University College London School of Pharmacy to test a range of herbal products on sale in the UK. They bought over 70 herbal products from various high street stores and internet retailers. Some of the products were ‘THR’ (traditional herbal registration) herbal medicines, and some were marketed as food supplements. They then analyzed their chemistry to see whether each one really contained what the label says. The three popular herbal remedies we tested were:-
- Milk thistle (Silybum marianum),
- Ginkgo (Ginkgo biloba),
- Evening primrose (Oenothera).
The team at UCL used two different methods of analysis to verify the identity of these herbal products and extracts. High-performance thin-layer chromatography (HPTLC) is a sophisticated technique for the analysis of herbal products and is one of the most commonly used methods in the industry. HPTLC analysis creates a chemical fingerprint of the product which the researchers can then compare to an accepted reference standard for the herb. They look for a broad spectrum of ‘marker compounds’ these are the pharmacologically active and/or chemical constituents within a plant that can be used to verify its potency or identity. For complex samples or where additional confirmation is required, researchers often turn to ¹H nuclear magnetic resonance spectroscopy (¹H-NMR) which allows individual samples to be compared in detail against other samples or to the whole group.
In every THR product tested, the product contained what was claimed on the label. However, the food supplements showed a wide range of quality.
- Of the food supplement products labeled as Ginkgo, 8 out of 30 (27%) contained little or no ginkgo extract.
- 36% of the food supplement milk thistle products contained no detectable milk thistle. Although this is quite a small sample size it is still a startling result. Furthermore, in one case of milk thistle, unidentified adulterants suspected to be synthetic compounds were present in place of milk thistle.
- All of the evening primrose food products we tested did contain what the packet claimed.
The researchers concluded that their investigation shows that a regulatory system for herbal products, like the THR scheme, ensures that people have access to safe herbal medicine products. So, if you are considering buying herbal products then do look out for the THR mark– otherwise, you might not just be wasting your money, you might be consuming other, potentially dangerous, ingredients.
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This is an interesting investigation. The researchers should be commended for it! However, I disagree with some of their conclusions. Here is why:
- The investigation merely tested the quality of the products and NOT THEIR SAFETY! To claim that the THR ensures access to safe herbal medicines is incorrect. A product might be of adequate quality but can still be unsafe. The THR only implies safety because the herbal has been used for years without problems being noted. This is not the same as ensuring that it is safe. A direct test of safety is usually not available.
- The recommendation to buy a product with a THR mark is also somewhat misleading. It implies that these products are effective. I fail to see convincing evidence that either MILK THISTLE, GINKGO, or EVENING PRIMROSE are effective for any disease or condition. Thus the responsible recommendation should, in my view, be to NOT buy them regardless of whether they are of good quality or not.
It has recently been reported that a 39-year-old woman (a mother-of-three died) died after immersing herself in a river as part of a cold water therapy session. The woman died after paramedics were called to attend a riverside in Derbyshire. The session was run by Kevin O’Neill of ‘Breatheolution’, whose previous clients include Coleen Rooney and actor Stephen Graham. The woman, who was visiting with two friends after paying up to £200 for a two-hour cold water therapy session, was rushed to hospital where she died.
Mr. O’Neill commented: “I am heartbroken. I’ve not slept and I’m finding it hard to process. I cannot stop thinking about her family. It’s tragic.” An inquest is expected to be opened into the woman’s death. East Midlands Ambulance Service said they were called to Bankside, in Bridgemont. “The caller reported a medical emergency,” a spokesperson said. “We sent a paramedic in a fast response car and a double-crewed ambulance. The air ambulance was also in attendance.”
Derbyshire Fire and Rescue Service, which was called to assist the paramedics, has warned people about the dangers of entering open water. “While we cannot and will not comment or speculate on the circumstances and cause of this tragic death, we would like to remind people of the dangers of entering open water and cold water shock,” said group manager Lee Williams.
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Breatheolution’ has a website where a whole page is dedicated to its leader Kevin O’Neill. I wondered what qualifications Kevin has, but all it tells us about him is this: “I struggled for so long with alcohol and other substance abuse that something had to give, I lost my sister Yvonne in 2019 and I think it was enough trauma to make me think a lot more about my own life”
The website also explains what the cold water sessions are about:
1-2-1 Breath Coaching, practice & Cold water session (river or tank)
2 hours @ £110.00
These sessions are proving popular with those who are not keen on group sessions or just prefer to have a more personal experience. The 2-3 hour sessions will be tailored to you and your breathing and will include potentially life-changing tools and methods to allow you to witness your breathing and physiology differently in the future, its all about feeling and awareness.
Another section of the site is dedicated to celebrities who Kevin seems to have treated. And then there is a video of the treatment. What I did not find anywhere, however, are the conditions that Kevin claims to treat with his cold water therapy.
In any case, it would have been wise for Kevin to read up about the risks of cold water immersion (CWI) before going into business. Perhaps this review would have helped:
In 2012, an estimated 372,000 people (42 per hour) died from immersion, assumed to be drowning. Immersion is the third leading cause of unintentional injury-related death, accounting for 7% of all such deaths (World Health Organization, 2014). These figures are underestimations owing to poor reporting in many Third World countries that have a high number of deaths. The data also do not include life-long morbidity caused by immersion-related injuries, estimated to be a much bigger numerical problem.
There is no strict definition of ‘cold water’. Given that some of the hazardous responses to cold water appear to peak on immersion somewhere between 15 and 10°C, it is reasonable to say that cold water is water <15°C (Tipton et al. 1991). However, the thermoneutral water temperature for a resting naked individual is ∼35°C, so it is possible for individuals to become very cold, with time, on immersion in water below this temperature. The corresponding temperature for those exercising (including shivering) is ∼25°C (Tipton & Golden, 1998).
Historically, the threat associated with CWI was regarded in terms of hypothermia or a reduction in deep body temperature below 35°C. This belief was established as a result of the Titanic disaster and supported by data obtained during maritime conflicts of World War II. However, more recently, a significant body of statistical, anecdotal and experimental evidence has pointed towards other causes of death on immersion. For example, in 1977 a Home Office Report revealed that ∼55% of the annual open water deaths in the UK occurred within 3 m of a safe refuge (42% within 2 m), and two-thirds of those who died were regarded as ‘good swimmers’. This evidence suggests more rapid incapacitation than can occur with whole-body cooling and consequent hypothermia.
The following four stages of immersion have been associated with particular risks (Golden & Hervey, 1981; Golden et al. 1991); the duration of these stages and the magnitude of the responses evoked within them vary significantly, depending on several factors, not least of which is water temperature:
- Initial immersion (first 3 min), skin cooling;
- Short-term immersion (3 min plus), superficial neuromuscular cooling;
- Long-term immersion (30 min plus), deep tissue cooling (hypothermia); and
- Circum-rescue collapse: immediately before, during or soon after rescue.
As a result of laboratory-based research, the initial responses to immersion, or ‘cold shock’, were identified as particularly hazardous (Tipton, 1989), accounting for the majority of immersion deaths (Tipton et al. 2014). These deaths have most often been ascribed to drowning, with the physiological responses of a gasp and uncontrollable hyperventilation, initiated by the dynamic response of the cutaneous cold receptors, resulting in the aspiration of the small volume of water necessary to initiate the drowning process (Bierens et al. 2016). Relatively little is known about the minimal rates of change of cold receptor temperature necessary to cause cold shock. The response has been reported to begin in water as warm as 25°C but is easy to suppress consciously at that temperature. In laboratory conditions, the respiratory frequency response (an indication of respiratory drive) peaks on naked immersion in a water temperature between 15 and 10°C, and is no greater on immersion in water at 5°C (Tipton et al. 1991). The corresponding average rates of change of chest skin temperature over the first 20 s of these immersions was 0.42 (water temperature 15°C), 0.56 (water temperature 10°C) and 0.68°C s−1 (water temperature 5°C). This suggests that an average rate of change in chest skin temperature between 0.42 and 0.56°C s−1 on the first 20 s of immersion is sufficient to evoke a maximal respiratory cold shock response.
More recently, it has been suggested (Shattock & Tipton, 2012) that a larger number of deaths than once thought may be attributable to arrhythmias initiated on immersion by the coincidental activation of the sympathetic and parasympathetic division of the autonomic nervous system by stimulation of cutaneous cold receptors around the body [sympathetic activation (cold shock)] and in the oronasal region on submersion or with wave splash [vagal stimulation (diving response)]. This ‘autonomic conflict’ is a very effective way of producing dysrhythmias and arrhythmias even in otherwise young and healthy individuals, particularly, but not necessarily, if a prolonged breath hold is involved in the immersion (Tipton et al. 1994). It seems that predisposing factors, such as long QT syndrome, ischaemic heart disease or myocardial hypertrophy, are necessary for fatal arrhythmias to evolve (Shattock & Tipton, 2012); many of these factors, including drug-induced long QT syndrome, are acquired. Non-fatal arrhythmias could still indirectly lead to death if they cause incapacitation and thereby drowning (Tipton, 2013). The hazardous responses associated with the cold shock response are presented in Fig. 2.
Figure 2. A contemporary view of the initial responses to immersion and submersion in cold water (‘cold shock’)
The problems encountered in short-term immersions are primarily related to physical incapacitation caused by neuromuscular cooling (Castellani & Tipton, 2015). The arms are particularly susceptible because of their high surface area to mass ratio. Low muscle temperatures affect chemical and physical processes at the cellular level. This includes metabolic rate, enzymatic activity, calcium and acetylcholine release and diffusion rate, as well as the series elastic components of connective tissues (Vincent & Tipton, 1988). Maximal dynamic strength, power output, jumping and sprinting performance are related to muscle temperature, with reductions ranging from 4 to 6% per degree Celsius reduction in muscle temperature down to 30°C (Bergh & Ekblom, 1979). At nerve temperatures below ∼20°C, nerve conduction is slowed and action potential amplitude is decreased (Douglas & Malcolm, 1955). Nerve block may occur after exposure to a local temperature of between 5 and 15°C for 1–15 min. This can lead to dysfunction that is equivalent to peripheral paralysis and can, again, result in drowning owing to the inability to keep the airway clear of the water (Clarke et al. 1958; Basbaum, 1973; Golden & Tipton, 2002; Fig. 3).
Figure 3. The ‘physiological pathways to drowning’ after immersion or submersion in cold water, with possible interventions for partial mitigation (dashed)
Abbreviations: EBA, emergency breathing aid; IS, immersion suit; and LJ, lifejacket. Reproduced with permission, from Tipton (2016b).
Even in ice-cold water, the possibility of hypothermia does not arise for at least 30 min in adults. Hypothermia affects cellular metabolism, blood flow and neural function. In severe hypothermia, the patient will be deeply unconscious. The progressive signs and symptoms (approximate deep body temperature) are shivering (36°C), confusion, disorientation, introversion (35°C), amnesia (34°C), cardiac arrhythmias (33°C), clouding of consciousness (33–30°C), loss of consciousness (30°C), ventricular fibrillation (28°C) and death (25°C) (Bierens et al. 2016). There is great variability between deep body temperature and the signs and symptoms of hypothermia. For example, although the deep body temperature associated with death is often quoted as 25°C, the lowest temperature recorded to date after accidental exposure to cold (air) and with full recovery was 12.7°C in a 28-month-old child (Associated Press, 2014). The coldest adult survivor of CWI followed by submersion had a body temperature of 13.7°C (Gilbert et al. 2000). There is also a large amount of variation in the rate at which people cool on immersion in cold water, owing to a combination of thermal factors (including water temperature and water movement, internal and external insulation) and non-thermal factors (including body size and composition, blood glucose, motion illness, racial and sex differences; Haight & Keatinge, 1973; Gale et al. 1981; White et al. 1992; Mekjavic et al. 2001; Golden & Tipton, 2002).
The most significant practical consequence of hypothermia in water is loss of consciousness; this prevents individuals from undertaking physical activity to maintain a clear airway and avoid drowning. Thus, once again, drowning is often the end-point (Fig. 3).
About 17% of those who die as a result of immersion die immediately before, during or after rescue (Golden et al. 1991). The deaths immediately before rescue are intriguing and probably related to behavioural changes at this time or the relief and psychophysiological alterations associated with imminent rescue, including a reduction in circulating stress hormone concentration and an increase in vagal tone. Death during rescue is most commonly associated with a collapse in arterial pressure when lifted vertical from the water and kept in that position for some time (Golden et al. 1991).
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The tragic death of the woman should perhaps remind us that
- there is no SCAM or wellness treatment that is entirely harmless,
- and there are only few ‘would-be gurus’ who know what they are doing.
‘Spagyric’ is a so-called alternative medicine (SCAM) based on the alchemy of Paracelsus (1493-1541). Paracelsus borrowed the term from “separate” (spao) and “combine” (ageiro) to indicate that spagyric preparations are based on the “separation”, “extraction” and “recombination” of the active ingredients of a substance. Plant, mineral as well as animal source materials are used.
The production of spagyric remedies is based on a complex process of maceration and fermentation of a plant extract in alcohol. It takes place in dark, thick-walled glass flasks that are hermetically sealed and kept at a controlled temperature of 37 °C for 28 days. The tincture thus obtained is then decanted and the drug residue is removed from the solution, completely dried, and burned to ash to recover the inorganic components of the plant material. The ash is subsequently dissolved in the alcoholic solution of maceration, and the finished spagyric preparation is left for 12 days before use.
Spagyric is not the most popular of all SCAMs but it certainly does have a significant following. One enthusiast claims that “spagyric essences work on a vibrational level in their action upon the emotional/mind and physical spheres and can be employed in numerous situations. Most people seek help to relieve physical symptoms. Even so, it is often necessary to address the emotional and psychological aspects which may predispose the illness or imbalance. In an era where many people are experiencing life-changing events, the ability to transition smoothly is essential for well-being and vitality. Guidance and help are required to maintain homeostasis. These medicines can help the patient to understand the root cause of their illness and learn to regain control of their lives. Some medicine systems appear to be less effective than in previous times. It has been suggested that the energetic frequency of both the earth and human organism are changing. Therefore these systems may no longer be a vibrational match for the changing frequencies. Spagyric Medicine is designed to ‘tune in with’ these current frequencies. Research suggests that the Spagyric essences may instigate improved health by energetically influencing DNA.”
After reading such weird statements, I ask myself, is there any evidence that spagyric remedies work? In my search for robust studies, I was unsuccessful. There does not seem to be a single controlled study on the subject. However, there are fragmentary reports of a study initiated and conducted by a now largely unknown healer named Karl Hann von Weyhern.
Von Weyhern (1882 – 1954) had taken a few semesters of pharmacy and medicine in Freiburg but remained without a degree. In 1930, he became a member of the NSDAP (Hitler’s Nazi party) and in 1940 he joined the SS. Around 1935, he settled in Munich as a non-medical practitioner (Heilpraktiker), and Heinrich Himmler who has a soft spot for SCAM enlisted as one of his patients. By then von Weyhern had by then made a steep career in the Nazi hierarchy, and he managed to convince Himmler that his spagyric remedies could cure tuberculosis, which was still rampant at the time. They decided to carry out experiments in this regard in the Dachau concentration camp.
Thus, von Weyhern was allowed to test spagyric remedies on forcibly recruited concentration camp prisoners. These experiments lasted for about one year and included around 150 patients who, according to von Weyhern’s iridology diagnosis, suffered from tuberculosis. Half of them were treated with spagyric remedies and the others with conventional treatments. At the end of the experiment, 27 persons were reportedly released into everyday concentration camp life as ‘fit for work’. How many of the 150 prisoners lost their lives due to these experiments is not known. Von Weyhern never filed a final report. It is to be feared that the death toll was considerable. [1]
After the war, von Weyhern denied belonging to the SS, claimed that he had ‘sacrificed himself’ for his patients in the concentration camp, merely had to pay a fine, and was ‘denazified’ in 1948. Subsequently, he resumed his work as a ‘Heilpraktiker’ in Olching, a village near Dachau. [1]
Of course, these infamous experiments cannot be blamed on spagyric medicine. Yet, I feel they are nevertheless important, not least because they seem to reveal the only thing remotely resembling something like evidence.
[1] Die Ärzte der Nazi-Führer: Karrieren und Netzwerke : Mathias Schmidt (Hg.), Dominik Groß (Hg.), Jens Westemeier (Hg.): Amazon.de: BooksA ‘manifesto’ is not something that I come across often in my area of research, i.e. so-called alternative medicine (SCAM). This one is in German, I, therefore, translated it for you:
Manifesto for healthy medicine
With the Manifesto for healthy medicine, we, the citizens and patients alliance weil’s hilft! (‘BECAUSE IT HELPS’) demand a fundamental change in our healthcare system, towards a diverse medicine that focuses on people and health. Be part of it! Sign the manifesto and become part of the movement.
It’s of paramount importance, the Manifesto for healthy medicine. About the way we live. It’s about our health. It’s about you and it’s about me.
We want our healthcare system to actually focus on health.
We want a medicine that doesn’t ask what’s missing, but what is possible.
We want a medicine that cares about people, that takes care, gets to the bottom of things, and uses innovative technologies to do so.
We want more bio, so that the chemistry is right, and we want naturopathic procedures and naturally effective medicines to be recognized, promoted, and researched further.
We want research that creates knowledge because, in addition to studies, it also takes into account the experience of physicians and the needs of patients.
We want carers and doctors to be able to work in a way that is good for their patients and for themselves.
We want people from all healthcare professions to work together as equals.
We want a medicine that creates awareness for a good and healthy life because climate protection also begins in one’s own body.
We want an integrative medicine that puts people at the center and self-evidently combines conventional and natural healing methods.
And we want this medicine to be accessible and affordable for everyone.
We fight for a healthy medicine of the future.
Be part of it!
(sorry, if some of it might sound badly translated but the German original is in parts pure gibberish)
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Who writes such tosh composed of every thinkable platitude and then pompously calls it a MANIFESTO?
BECAUSE IT HELPS! (weil’s hilft!) is a citizens’ movement that demands a change in the health care system – towards the needs and preferences of patients, towards a holistic view of people, and a focus on health instead of disease. The sensible combination of natural medicine and conventional medicine, an integrative medicine, makes an indispensable contribution to this. This is because it relies fully on the patients and involves them as active partners in the treatment. Modern medicine of the future, therefore, needs the equal cooperation of natural medicine and conventional medicine – in the everyday life of physicians and patients, in the reimbursement by the health insurance companies as well as in research and teaching.
On the information platform www.weils-hilft.de weil’s hilft! informs about current developments in integrative medicine, provides background information, and publishes a podcast once a month. The movement is also active on social media at www.facebook.com/weilshilft and www.instagram.com/weilshilft.
weil’s hilft! is supported by the health and patient organizations GESUNDHEIT AKTIV, KNEIPP-BUND, and NATUR UND MEDIZIN. Together, the alliance represents the interests of more than 220,000 people.
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One could easily disclose the funny side of this, the utter stupidity of the arguments, the platitudes, fallacies, misunderstandings, ignorance, etc. Yes, that would hardly be difficult. But it would ignore how worrying this and similar movements are. They systematically misinform consumers with the sole aim of persuading them that the integration of unproven or disproven treatments into medical routine is in their interest. Yet, if we only scratch the surface of their arguments, we realize that it is exclusively in the interest of those who profit from this type of misinformation.
Social media platforms are frequently used by the general public to access health information, including information relating to complementary and alternative medicine (CAM). The aim of this study was to measure how often naturopathic influencers make evidence-informed recommendations on Instagram, and to examine associations between the level of evidence available or presented, and user engagement.
A retrospective observational study using quantitative content analysis on health-related claims made by naturopathic influencers with 30 000 or more followers on Instagram was conducted. Linear regression was used to measure the association between health-related posts and the number of Likes, and Comments.
A total of 494 health claims were extracted from eight Instagram accounts, of which 242 (49.0%) were supported by evidence and 34 (6.9%) included a link to evidence supporting the claim. Three naturopathic influencers did not provide any evidence to support the health claims they made on Instagram. Posts with links to evidence had fewer Likes (B=-1343.9, 95% CI=-2424.4 to -263.4, X=-0.1, P=0.02) and fewer Comments (B=-82.0, 95% CI=-145.9 to -18.2, X=-0.2, P=0.01), compared to posts without links to evidence. The most common areas of health were claims relating to ‘women’s health’ (n=94; 19.0%), and ‘hair, nail, and skin’ (n=74; 15.0%).
The authors concluded that this study is one of the first to look at the evidence available to support health-related claims by naturopathic influencers on Instagram. Our findings indicate that around half of Instagram posts from popular naturopathic influencers with health claims are supported by high-quality evidence.
At first sight, these findings amazed me; I would have thought that the percentage of supported claims was lower. As it turned out, I was not far off: in the paper, the authors differentiate the results into more categories and state that ” of those with evidence clearly available, approximately 10% of health claims were underpinned by high-quality evidence such as systematic reviews of randomised controlled trials.”
Even though interesting, the study has significant limitations. The authors are well aware of them and explain:
A key limitation was relying on the 10 most relevant retrieved articles in PubMed, rather than conducting an extensive search for evidence, when not provided alongside the claim. It is possible we did not identify existing evidence to support some of the claims; however, it would not have been feasible to construct a comprehensive search strategy and screen articles for every health claim made. Our search strategy served as a proxy measure for the evidence to support the claim and it is unlikely that the 10 most relevant articles on PubMed would systematically fail to identify existing supporting evidence.
The risk of subjectivity in the extraction of interventional health claims from Instagram posts and conversion into a PICO is another limitation. The subjectivity of data extraction was minimised using standards which included extracting specific terms used by the naturopathic influencer to perform database searches on PubMed. If not explicitly stated, the intended target audience of the health claims were made using educated guesses based on the intervention and outcome promoted in the claim. For the claim to be considered supported by evidence, study participants must match the intended audience of the health claim on Instagram(e.g., postmenopausal women, athletes). When the study with the highest level of evidence were inconclusive due to reasons such as inadequate cohort size, conflicting results for different cohort (e.g., male vs. females), heterogeneity between studies and poor quality of studies, it was concluded that the evidence did not support the health claim. When there was considerable uncertainty related to the health intervention or outcome, it was excluded from the study.
So, in the end, I guess, it boils down to whether you are an optimist or a pessimist:
About half of the claims made by prominent naturopaths are supported by at least a bit of evidence.
About half of the claims made by prominent naturopaths are not supported by evidence.
Low back pain (LBP) affects almost all of us at some stage. It is so common that it has become one of the most important indications for most forms of so-called alternative medicine (SCAM). In the discussions about the value (or otherwise) of SCAMs for LBP, we sometimes forget that there are many conventional medical options to treat LBP. It is therefore highly relevant to ask how effective they are. This overview aimed to summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non‐specific LBP.
The Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non‐specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety.
Seven Cochrane Reviews that included 103 studies (22,238 participants) were included. There was high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non‐steroidal anti‐inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub‐acute LBP and five reviews included participants with chronic LBP.
Acute LBP
Paracetamol
There was high‐certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI ‐0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33).
NSAIDs
There was moderate‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo at reducing pain intensity (MD ‐7.29 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.98 to ‐3.61), high‐certainty evidence for a small between‐group difference for reducing disability (MD ‐2.02 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐2.89 to ‐1.15), and very low‐certainty evidence for no evidence of an increased risk of adverse events (RR 0.86, 95% CI 0. 63 to 1.18).
Muscle relaxants and benzodiazepines
There was moderate‐certainty evidence for a small between‐group difference favouring muscle relaxants compared to placebo for a higher chance of pain relief (RR 0.58, 95% CI 0.45 to 0.76), and higher chance of improving physical function (RR 0.55, 95% CI 0.40 to 0.77), and increased risk of adverse events (RR 1.50, 95% CI 1. 14 to 1.98).
Opioids
None of the included Cochrane Reviews aimed to identify evidence for acute LBP.
Antidepressants
No evidence was identified by the included reviews for acute LBP.
Chronic LBP
Paracetamol
No evidence was identified by the included reviews for chronic LBP.
NSAIDs
There was low‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo for reducing pain intensity (MD ‐6.97 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.74 to ‐3.19), reducing disability (MD ‐0.85 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐1.30 to ‐0.40), and no evidence of an increased risk of adverse events (RR 1.04, 95% CI ‐0.92 to 1.17), all at intermediate‐term follow‐up (> 3 months and ≤ 12 months postintervention).
Muscle relaxants and benzodiazepines
There was low‐certainty evidence for a small between‐group difference favouring benzodiazepines compared to placebo for a higher chance of pain relief (RR 0.71, 95% CI 0.54 to 0.93), and low‐certainty evidence for no evidence of difference between muscle relaxants and placebo in the risk of adverse events (RR 1.02, 95% CI 0.67 to 1.57).
Opioids
There was high‐certainty evidence for a small between‐group difference favouring tapentadol compared to placebo at reducing pain intensity (MD ‐8.00 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.22 to ‐0.38), moderate‐certainty evidence for a small between‐group difference favouring strong opioids for reducing pain intensity (SMD ‐0.43, 95% CI ‐0.52 to ‐0.33), low‐certainty evidence for a medium between‐group difference favouring tramadol for reducing pain intensity (SMD ‐0.55, 95% CI ‐0.66 to ‐0.44) and very low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing pain intensity (SMD ‐0.41, 95% CI ‐0.57 to ‐0.26).
There was moderate‐certainty evidence for a small between‐group difference favouring strong opioids compared to placebo for reducing disability (SMD ‐0.26, 95% CI ‐0.37 to ‐0.15), moderate‐certainty evidence for a small between‐group difference favouring tramadol for reducing disability (SMD ‐0.18, 95% CI ‐0.29 to ‐0.07), and low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing disability (SMD ‐0.14, 95% CI ‐0.53 to ‐0.25).
There was low‐certainty evidence for a small between‐group difference for an increased risk of adverse events for opioids (all types) compared to placebo; nausea (RD 0.10, 95% CI 0.07 to 0.14), headaches (RD 0.03, 95% CI 0.01 to 0.05), constipation (RD 0.07, 95% CI 0.04 to 0.11), and dizziness (RD 0.08, 95% CI 0.05 to 0.11).
Antidepressants
There was low‐certainty evidence for no evidence of difference for antidepressants (all types) compared to placebo for reducing pain intensity (SMD ‐0.04, 95% CI ‐0.25 to 0.17) and reducing disability (SMD ‐0.06, 95% CI ‐0.40 to 0.29).
The authors concluded as follows: we found no high‐ or moderate‐certainty evidence that any investigated pharmacological intervention provided a large or medium effect on pain intensity for acute or chronic LBP compared to placebo. For acute LBP, we found moderate‐certainty evidence that NSAIDs and muscle relaxants may provide a small effect on pain, and high‐certainty evidence for no evidence of difference between paracetamol and placebo. For safety, we found very low‐ and high‐certainty evidence for no evidence of difference with NSAIDs and paracetamol compared to placebo for the risk of adverse events, and moderate‐certainty evidence that muscle relaxants may increase the risk of adverse events. For chronic LBP, we found low‐certainty evidence that NSAIDs and very low‐ to high‐certainty evidence that opioids may provide a small effect on pain. For safety, we found low‐certainty evidence for no evidence of difference between NSAIDs and placebo for the risk of adverse events, and low‐certainty evidence that opioids may increase the risk of adverse events.
This is an important overview, in my opinion. It confirms what I and others have been stating for decades: WE CURRENTLY HAVE NO IDEAL SOLUTION TO LBP.
This is regrettable but true. It begs the question of what one should recommend to LBP sufferers. Here too, I have to repeat myself: (apart from staying as active as possible) the optimal therapy is the one that has the most favourable risk/benefit profile (and does not cost a fortune). And this option is not drugs, chiropractic, osteopathy, acupuncture, or any other SCAM – it is (physio)therapeutic exercise which is cheap, safe, and (mildly) effective.
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.
I have been informed by the publisher, that my book has been published yesterday. This is about two months earlier than it was announced on Amazon. It is in German – yes, I have started writing in German again. But not to worry, I translated the preface for you:
Anyone who falls ill in Germany and therefore needs professional assistance has the choice, either to consult a doctor or a non-medical practitioner (Heilpraktiker).
– The doctor has studied and is licensed to practice medicine; the Heilpraktiker is state-recognized and has passed an official medical examination.
– The doctor is usually in a hurry, while the Heilpraktiker takes his time and empathizes with his patient.
– The doctor usually prescribes a drug burdened with side effects, while the Heilpraktiker prefers the gentle methods of alternative medicine.
So who should the sick person turn to? Heilpraktiker or doctor? Many people are confused by the existence of these parallel medical worlds. Quite a few finally decide in favor of the supposedly natural, empathetic, time-tested medicine of the Heilpraktiker. The state recognition gives them the necessary confidence to be in good hands there. The far-reaching freedoms the Heilpraktiker has by law, as well as the coverage of costs by many health insurances, are conducive to further strengthening this trust. “We Heilpraktiker are recognized and respected in politics and society,” writes Elvira Bierbach self-confidently, the publisher of a standard textbook for Heilpraktiker.
The first consultation of our model patient with the Heilpraktiker of his choice is promising. The Heilpraktiker responds to the patient with understanding, usually takes a whole hour for the initial consultation, gives explanations that seem plausible, is determined to get to the root of the problem, promises to stimulate the patient’s self-healing powers naturally, and invokes a colossal body of experience. It almost seems as if our patient’s decision to consult a Heilpraktiker was correct.
However, I have quite significant reservations about this. Heilpraktiker are perhaps recognized in politics and society, but from a medical, scientific, or ethical perspective, they are highly problematic. In this book, I will show in detail and with facts why.
The claim of government recognition undoubtedly gives the appearance that Heilpraktiker are adequately trained and medically competent. In reality, there is no regulated training, and the competence is not high. The official medical examination, which all Heilpraktiker must pass is nothing more than a test to ensure that there is no danger to the general public. The ideas of many Heilpraktiker regarding the function of the human body are often in stark contradiction with the known facts. The majority of Heilpraktiker-typical diagnostics is pure nonsense. The conditions that they diagnose are often based on little more than naive wishful thinking. The treatments that Heilpraktiker use are either disproven or not proven to be effective.
There is no question in my mind that Heilpraktiker are a danger to anyone who is seriously ill. And even if Heilpraktiker do not cause obvious harm, they almost never offer what is optimally possible. In my opinion, patients have the right to receive the most effective treatment for their condition. Consumers should not be misled about health-related issues. Only those who are well-informed will make the right decisions about their health.
My book provides this information in plain language and without mincing words. It is intended to save you from a dangerous misconception of the Heilpraktiker profession. Medical parallel worlds with the radically divergent quality standard – doctor/Heilpraktiker – are not in the interest of the patient and are simply unacceptable for an enlightened society.
Aromatherapy is popular yet it has a problem: there is no indication for it. Yes, it can make you feel better but this is hardly a true medical indication. I know of many things that make me feel better, and I would not call them a THERAPY! But perhaps this new study from Iran offers a solution for the dilemna:
Sleep plays an essential role in infant development. This randomized clinical trial investigated the effect of aromatherapy with rose water on the deep sleep status of premature infants admitted to a neonatal intensive care unit (NICU).
The study was conducted on 64 infants hospitalized in NICUs. In the intervention group, two drops of rose water were poured on gas and placed next to the babies’ heads. The control group was treated in the same way except that distilled water was employed. The ALS scale was used to assess the sleep status.
Of the 66 infants in this study, 30 were female and 36 were male. The average gestational age of the infants was 32.5 ± 1.99 weeks. The results showed that the amount of deep sleep (type A and B) in the intervention group was significantly higher than the control group during and after the intervention (p=0.001).
The authors concluded that, considering the positive impact of rose water in improve of sleep quality in premature babies; it can be used to improve sleeping condition of infants in hospitals, along with main treatment.
The study has many flaws and it is badly written. Yet, I find it interesting. If its results can be confirmed with a more rigorous trial, aromatherapy might finally find a true medical purpose.
Norbert Hofer is the former leader of the Austrian right-wing FPÖ party who almost became Austria’s President. Currently, he is the 3rd member of the National Council. Hofer is a man full of surprises; he stated, for instance, that the Quran was more dangerous than COVID-19 during a speech held at a 2020 campaign event. As a result, he was sued for hate-speech.
Hofer’s latest coup is not political but commercial: Hofer is launching his own dietary supplement on the market. It is called “Formula Fortuna” and contains:
- L-tryptophan; a Cochrane review concluded that “a large number of studies appear to address the research questions, but few are of sufficient quality to be reliable. Available evidence does suggest these substances are better than placebo at alleviating depression. Further studies are needed to evaluate the efficacy and safety of 5‐HTP and tryptophan before their widespread use can be recommended. The possible association between these substances and the potentially fatal Eosinophilia‐Myalgia Syndrome has not been elucidated. Because alternative antidepressants exist which have been proven to be effective and safe the clinical usefulness of 5‐HTP and tryptophan is limited at present.”
- Hydroxypropylmethylcellulose, a common delivery system.
- Rhodiola rosea extracts; human studies evaluating R. rosea did not have sufficient quality to determine whether it has properties affecting fatigue or any other condition.The U.S. Food and Drug Administration (FDA) has issued warning letters to manufacturers of R. rosea dietary supplement products unapproved as new drugs, adulterated, misbranded and in federal violation for not having proof of safety or efficacy for the advertised conditions of alleviating Raynaud syndrome, altitude sickness, depression or cancer.
- Ginseng root extract. Although ginseng has been used in traditional medicine for centuries, modern research is inconclusive about its biological effects. Preliminary clinical research indicates possible effects on memory, fatigue, menopause symptoms, and insulin response in people with mild diabetes. Out of 44 studies examined between 2005–2015, 29 showed positive, limited evidence, and 15 showed no effects. As of 2021, there is insufficient evidence to indicate that ginseng has any health effects. A 2021 review indicated that ginseng had “only trivial effects on erectile function or satisfaction with intercourse compared to placebo”. The constituents include steroid saponins known as ginsenosides, but the effects of these ginseng compounds have not been studied with high-quality clinical research as of 2021, and therefore remain unknown. As of 2019, the United States FDA and Federal Trade Commission have issued numerous warning letters to manufacturers of ginseng dietary supplements for making false claims of health or anti-disease benefits, stating that the “products are not generally recognized as safe and effective for the referenced uses” and are illegal as unauthorized “new drugs” under federal law. Concerns exist when ginseng is used chronically, potentially causing side effects such as headaches, insomnia, and digestive problems. Ginseng may have adverse effects when used with the blood thinner warfarin. Ginseng also has adverse drug reactions with phenelzine, and a potential interaction has been reported with imatinib, resulting in hepatotoxicity, and with lamotrigine. Other side effects may include anxiety, insomnia, fluctuations in blood pressure, breast pain, vaginal bleeding, nausea, or diarrhea.
- Zinc gluconate which has been used in lozenges for treating the common cold. However, controlled trials with lozenges which include zinc acetate have found it has the greatest effect on the duration of coldsInstances of anosmia (loss of smell) have been reported with intranasal use of some products containing zinc gluconate. In September 2003, Zicam faced lawsuits from users who claimed that the product, a nasal gel containing zinc gluconate and several inactive ingredients, negatively affected their sense of smell and sometimes taste. Some plaintiffs alleged experiencing a strong and very painful burning sensation when they used the product. Matrixx Initiatives, Inc., the maker of Zicam, responded that only a small number of people had experienced problems and that anosmia can be caused by the common cold itself. In January 2006, 340 lawsuits were settled for $12 million.
- Pyridoxine hydrochloride (vitamin B6) is usually well tolerated, though overdose toxicity is possible. Occasionally side effects include headache, numbness, and sleepiness. Pyridoxine overdose can cause a peripheral sensory neuropathy characterized by poor coordination, numbness, and decreased sensation to touch, temperature, and vibration.
‘Formula Fortuna’ allegedly is for lifting your mood. If I, however, tell you that you need to pay one Euro per day for the supplement, your mood might even change in the opposite direction.
What next?
I think I might design a dietary supplement against stupidity. It will not carry any of the risks of Hofer’s new invention but, I am afraid, it might be just as ineffective as Hofer’s ‘Formual Fortuna’.
