MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Monthly Archives: December 2019

There are no representative studies using a probability sample examining whether US physicians recommend so-called alternative medicines (SCAMs) to their patients. This article fills a void in the current literature for robust data on recommendations for SCAMs by office-based physicians in the US.

Descriptive statistics and multivariable regression analyses of physician-level data were from the 2012 Physician Induction Interview of the National Ambulatory Medical Care Survey (NAMCS PII), a nationally representative survey of office-based physicians. Weighted response rate among eligible physicians sampled for the 2012 NAMCS PII was 59.7%.

Recommendations by physicians to their patients were recorded for any SCAM, and the following individual SCAMs: massage therapy, herbs/nonvitamin supplements, chiropractic/osteopathic manipulation, yoga, acupuncture, and mind–body therapies.

Massage therapy was the most commonly recommended SCAM (30.4%), followed by chiropractic/osteopathic manipulation (27.1%), herbs/nonvitamin supplements (26.5%), yoga (25.6%), and acupuncture (22.4%). The most commonly recommended SCAMs by general/family practice physicians were chiropractic/osteopathic manipulation (54.0%) and massage therapy (52.6%). Of all U.S. physicians, 53.1% recommended at least one SCAM to patients during the previous 12 months. Multivariable analyses found physician’s sex, race, specialty, and U.S. region to be significant predictors of SCAMrecommendations. Female physicians were more likely than male physicians to recommend massage therapy, herbs/nonvitamin supplements, yoga, acupuncture, and mind–body therapies to patients. Psychiatrists, OB/GYNs, and paediatricians were all less likely to recommend chiropractic/osteopathic manipulation than general and family practitioners.

The authors concluded that, overall, more than half of office-based physicians recommended at least one SCAM to their patients. Female physicians recommended every individual SCAM at a higher rate than male physicians except for chiropractic and osteopathic manipulation. These findings may enable consumers, physicians, and medical schools to better understand potential differences in use of SCAMs with patients.

Yes, I know!

Who cares what type of SCAMs US physicians recommended to their patients 7 years ago?

And who knows what the true figures would have looked like, if the ~40% who did not respond would have been included?

Such surveys usually tell us little of relevance. What is worse, they are misused for exploiting the ‘appeal to authority’ fallacy which hold that, if physicians recommend SCAMs, they must be fine. That this is a fallacy becomes obvious, if we remind ourselves that US physicians also are the main cause for the current opioid crisis in the US (if physicians recommend opioids, they must be fine???).

More importantly, I think, this survey also suggests the following:

  1. 73% of US physicians do NOT recommend chiropractic/osteopathic manipulations.
  2. 73% of them do NOT recommend herbal medicine.
  3. 74% of them do NOT recommend yoga.
  4. 77% of them do NOT recommend acupuncture.

I wonder why!

 

Carbon 60 has recently been promoted by some commentators on this blog. Their claim seems to be that it is the best thing since sliced bread. So, what should we make of carbon 60 as a dietary supplement?

Here is my attempt to provide a brief summary:

The endogenous production of reactive oxygen species (ROS) is a consequence of basal cellular respiration. At a moderate level, ROS are involved in cell signalling and required for biochemical energetics of life. When ROS overwhelm the cellular anti-oxidant defence system, oxidative stress can cause damage to cellular proteins, lipids and nucleic acids. Oxidative stress has been implicated in the pathogenesis of atherosclerosis, neurodegeneration, cancer and musculoskeletal conditions. Therefore, it might be of therapeutic value to relieve the oxidative stress by neutralising ROS with extrinsic anti-oxidants. One potentially potent anti-oxidants is ‘carbon 60’ (also called Fullerene 60).

But what exactly is carbon 60?

Carbon 60 is a molecule composed of 60 carbon atoms arranged in a sphere, and is also known as a buckyball, a cluster of sixty carbon atoms in the shape of a ball, also known as buckminsterfullerene. The carbon atoms in C60 fullerene are linked to three adjacent carbon atoms by strong covalent bonds, and form a spherical pattern of 20 hexagons and 12 pentagons, also known as a truncated icosahedron. The C60 molecule is around 0.7 to 1 nanometres in diameter. Most carbon 60 is manufactured in the laboratory, using an electric arc between two carbon electrodes to create a soot from which the carbon 60 fullerene molecules can be extracted. Tweaking the soot-creating conditions also allows carbon nanotubes to be created instead of C60 buckyballs.

The medicinal properties of carbon 60 currently are the subject of much hype. One website lists 12 amazing health benefits of carbon 60.

#1 May Increase Longevity

#2 Scavenges Free Radicals

#3 May Promote Less Bodily Stiffness and Happier Joints

#4 Seems to Improve Immune Function

#5 Possibly Supports Brain Health

#7 Promotes Cleanliness & Supports Good Hygiene

#8 Might Help You Maintain an Even Waistline

#9 Might Be Useful As A Chemo Support Supplement

#10 Possible UV Protection

#11 Might Enhance Your Skincare Routine

#12 Could Prove Helpful As A Support for Male Infertility Treatments

Is there any evidence to justify these claims? My ‘rough and ready’ searches found just two clinical trials:

Trial No 1

Highly purified and organic solvent-free fullerene-C60 was dissolved, at nearly saturated concentration of 278 ppm, in squalane prepared from olive oil, which is designated as LipoFullerene (LF-SQ) and was examined for usage as a cosmetic ingredient with antioxidant ability. The aim of this study was to assess the anti-wrinkle formation efficacy of LF-SQ in subjects. A total of 23 Japanese women (group I: age 38.9 +/- 3.8, n = 11, group II; age 39.4 +/- 4.3, n = 12) were enrolled in an 8-week trial of LF-SQ blended cream in a randomized, matched pair double-blind study. The LF-SQ cream was applied twice daily on the right or left half of the face, and squalane blended cream (without fullerene-C60) was applied as the placebo on another half of the face. As clinical evaluations of wrinkle grades, visual observation and photographs, and silicone replicas of both crow’s feet areas were taken at baseline (0 week) and at 4th and 8th weeks. Skin replicas were analyzed using an optical profilometry technique. The wrinkle and skin-surface roughness features were calculated and statistically analyzed. Subsequently, trans-epidermal water loss (TEWL), moisture levels of the stratum corneum, and visco-elasticity (suppleness: RO and elasticity: R7) were measured on cheeks by instrumental analysis. LF-SQ cream enhanced the skin moisture and the anti-wrinkle formation. LF-SQ cream that was applied on a face twice daily was not effective at 4th week, but significantly more effective than the placebo at 8th week (p < 0.05) without severe side effects. The roughness-area ratio showed significant improvement (p < 0.05) at 8th week with LF-SQ cream as compared to 0 week with LF-SQ cream, but no significant difference was detected between LF-SQ cream and the placebo. We suggest that LF-SQ could be used as an active ingredient for wrinkle-care cosmetics.

Trial No 2

Oxidative stress plays a major role in acne formation, suggesting that oxygen radical scavengers are potential therapeutic agents. Fullerene is a spherical carbon molecule with strong radical sponge activity; therefore, we studied the effectiveness of fullerene gel in treating acne vulgaris. We performed an open trial using a fullerene gel twice a day; at 4 and 8 weeks, the mean number of inflammatory lesions (erythematous papules and pustules) significantly (P < 0.05) decreased from 16.09 ± 9.08 to 12.36 ± 7.03 (reduction rate 23.2%) and 10.0 ± 5.62 (reduction rate 37.8%), respectively. The number of pustules, consisting of accumulation of neutrophils, was significantly (P < 0.05) decreased from 1.45 ± 1.13 to 0.18 ± 0.60 (reduction rate 87.6%), and further in vitro assays of sebum production in hamster sebocytes revealed that 75 μM polyvinylpyrrolidone-fullerene inhibits sebum production, suggesting that fullerene suppresses acne through decreasing neutrophil infiltration and sebum production. After treatment for 8 weeks, the water content of the skin significantly (P < 0.05) increased from 51.7 ± 7.9 to 60.4 ± 10.3 instrumental units. Therefore, the fullerene gel may help in controlling acne vulgaris with skin care benefit.

So, would you buy a supplement of carbon 60? There are many products to chose from. Yet, many readers of this blog might hesitate: not only is the evidence hardly anything to write home about, but also the price tags are eye-watering (~£40/100ml of oil enriched with carbon 60).

According to WebMed, the shark cartilage (tough elastic tissue that provides support, much as bone does) used for medicine comes primarily from sharks caught in the Pacific Ocean. Several types of extracts are made from shark cartilage including squalamine lactate, AE-941, and U-995.

Shark cartilage is most famously used for cancer. Shark cartilage is also used for osteoarthritis, plaque psoriasis, age-related vision loss, wound healing, damage to the retina of the eye due to diabetes, and inflammation of the intestine (enteritis).

A more realistic picture is pained by this abstract:

The promotion of crude shark cartilage extracts as a cure for cancer has contributed to at least two significant negative outcomes: a dramatic decline in shark populations and a diversion of patients from effective cancer treatments. An alleged lack of cancer in sharks constitutes a key justification for its use. Herein, both malignant and benign neoplasms of sharks and their relatives are described, including previously unreported cases from the Registry of Tumors in Lower Animals, and two sharks with two cancers each. Additional justifications for using shark cartilage are illogical extensions of the finding of antiangiogenic and anti-invasive substances in cartilage. Scientific evidence to date supports neither the efficacy of crude cartilage extracts nor the ability of effective components to reach and eradicate cancer cells. The fact that people think shark cartilage consumption can cure cancer illustrates the serious potential impacts of pseudoscience. Although components of shark cartilage may work as a cancer retardant, crude extracts are ineffective. Efficiencies of technology (e.g., fish harvesting), the power of mass media to reach the lay public, and the susceptibility of the public to pseudoscience amplifies the negative impacts of shark cartilage use. To facilitate the use of reason as the basis of public and private decision-making, the evidence-based mechanisms of evaluation used daily by the scientific community should be added to the training of media and governmental professionals. Increased use of logical, collaborative discussion will be necessary to ensure a sustainable future for man and the biosphere.

To be clear: there is no good evidence that the supplements commercially available currently are effective for any condition.

Now, there is more news on this topic:

The objective of this study was to analyse labelling practices and compliance with regulatory standards for shark cartilage supplements sold in the United States. The product labels of 29 commercial shark cartilage supplements were assessed for compliance with U.S. regulations. Claims, including nutrient content, prohibited disease, and nutritional support statements, were examined for compliance and substantiation.

Overall, 48% of the samples had at least one instance of non-compliance with labelling regulations. The most common labelling violations observed were:

  • missing a domestic address/phone number,
  • non-compliant nutrient content claim,
  • missing/incomplete disclaimer,
  • missing statement of identity,
  • prohibited disease claims,
  • incomplete “Supplement Facts” label.

The use of prohibited disease claims and nutritional support statements without the required disclaimer is concerning from a public health standpoint because consumers may delay seeking professional treatment for a disease.

The authors concluded that the results of this study indicate a need for improved labelling compliance among shark cartilage supplements.

In summary, it seems that shark cartilage supplements are bad for all concerned:

  • Patients who rely on them might hasten their death.
  • Sharks are becoming an endangered species.
  • Consumers are being mislead and misinformed.

There is just one party smiling: the supplement manufacturers who make a healthy profit destroying the health of gullible consumers and patients.

Carl Sagan was a giant in critical thinking and has inspired many, including myself. His book THE DEMON HAUTED WORLD is a classic. In it, he published his ‘BALONEY DETECTION KIT’. As it relates to SCAM and so much more that troubles us today, I today take the liberty of citing it here.

  1. Wherever possible there must be independent confirmation of the “facts.”
  2. Encourage substantive debate on the evidence by knowledgeable proponents of all points of view.
  3. Arguments from authority carry little weight — “authorities” have made mistakes in the past. They will do so again in the future. Perhaps a better way to say it is that in science there are no authorities; at most, there are experts.
  4. Spin more than one hypothesis. If there’s something to be explained, think of all the different ways in which it could be explained. Then think of tests by which you might systematically disprove each of the alternatives. What survives, the hypothesis that resists disproof in this Darwinian selection among “multiple working hypotheses,” has a much better chance of being the right answer than if you had simply run with the first idea that caught your fancy.
  5. Try not to get overly attached to a hypothesis just because it’s yours. It’s only a way station in the pursuit of knowledge. Ask yourself why you like the idea. Compare it fairly with the alternatives. See if you can find reasons for rejecting it. If you don’t, others will.
  6. Quantify. If whatever it is you’re explaining has some measure, some numerical quantity attached to it, you’ll be much better able to discriminate among competing hypotheses. What is vague and qualitative is open to many explanations. Of course there are truths to be sought in the many qualitative issues we are obliged to confront, but finding them is more challenging.
  7. If there’s a chain of argument, every link in the chain must work (including the premise) — not just most of them.
  8. Occam’s Razor. This convenient rule-of-thumb urges us when faced with two hypotheses that explain the data equally well to choose the simpler.
  9. Always ask whether the hypothesis can be, at least in principle, falsified. Propositions that are untestable, unfalsifiable are not worth much. Consider the grand idea that our Universe and everything in it is just an elementary particle — an electron, say — in a much bigger Cosmos. But if we can never acquire information from outside our Universe, is not the idea incapable of disproof? You must be able to check assertions out. Inveterate skeptics must be given the chance to follow your reasoning, to duplicate your experiments and see if they get the same result.

As I said, this is a good book; I warmly recommend it to you.

I have to admit, I only read the DAILY MAIL, if I have to (and certainly not today). This is probably why I missed this article announcing the 1st traditional Chinese medicine to be licensed in the UK.

The plant Sigesbeckia, which has an unpleasant smell, is renowned for its ability to treat aches and pains – including those caused by arthritis.  It is the active ingredient in Phynova Joint and Muscle Relief Tablets, which have just been licensed by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency.

The directive also made it more difficult for medicines to get a licence as it demanded they had to have been in use for 30 years, of which at least 15 years had to be in the EU. Some Western herbal medicines have managed to gain licences in a process costing thousands of pounds to verify their ingredients. But the Phynova tablets are the first traditional Chinese medicine to be approved.

Robert Miller, chief executive of Oxford-based Phynova, said he was ‘extremely proud’, adding: ‘This has come from years of working with our Chinese colleagues. ‘Britain can now benefit from having access to high quality, regulated Chinese medicines.’ He also said that the company is planning to apply for a licence for a second traditional Chinese medicine, a cold and flu remedy.

Dr Chris Etheridge, a medical herbalist and adviser to Potter’s Herbals, celebrated the ‘good news’, adding that Sigesbeckia, which is not commonly used in the West, ‘offers an alternative to those who prefer not to take non-steroidal anti-inflammatory drugs for muscle and joint pain’.

But Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, warned that the new product demonstrates the difficulties the EU rules created for supplying herbal products safely to the public.  He said it is ‘almost impossible to satisfy the licensing conditions’.  He added that some people have therefore turned to the internet to buy unlicensed products, but this means they have ‘no idea whether they are safe or effective’.

How exciting!

Exciting enough to do a quick search for the evidence. Are there any clinical trials to show or suggest that this herbal remedy does anything other than filling the bank account of the manufacturer? Sadly, the answer seems to be NO! At least, I could not find a single such study (if anyone knows more, I’d be pleased to stand corrected).

Frustrated I looked at the website of the manufacturer. Here I found this:

Exclusively containing Sigesbeckia extract, Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic, joint and muscle pain as well as minor sports injuries. Sigesbeckia has been used for thousands of years around the world to relieve painful joints and muscles.

Benefits

– Relief from joint & muscle pain
– Gentle on the stomach
– No known side effects
– No known drug indications or contraindications
– Can be taken with or without food

And this:

What can Sigesbeckia be used to treat?

Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;

Backache

Back pain can occur through a sprain or strain, spasms, nerve compression, herniated discs and other problems in your lower, middle and upper back.

Poor posture, lifting and stretching, sudden movements placing strain on your lower back and sports injuries, are amongst the main culprits for causing back pain.

Minor sports injuries

Minor sports injuries can be caused by an accident such as a fall or blow, not warming up properly before exercise, pushing yourself too hard and not using the appropriate equipment or perhaps poor technique.

Rheumatic and muscular pain

Common causes of rheumatic and muscle pain can be due to; tension and stress, lack of minerals, certain medication, dehydration, sprains and strains, sleep deficiency, too much physical activity and sometimes other underlying health conditions and diseases.

General aches and pains in muscles and joints

Overexertion due to a new exercise routine or from a sprain or strain can cause general aches and pains in muscles and joints. But so too can modern day busy life. The impact on our bodies can trigger aches and pains in your muscles and joints and lower your resistance to illness and disease.

The Benefit of Sigesbeckia extract

One of the benefits of Sigesbeckia extract, as used in approved licensed products, is that it has no known side effects or interactions with other medications according to the Summary of Product Characteristics (SmPC). Always check that the product you purchase is an approved Traditional Herbal Medicine Product in the UK.

In summary: Look after your joints and muscles with Sigesbeckia

Our bodies are all different, and our approach and tolerances will vary. Used for over a thousand years and known for its anti-inflammatory and mobility benefits alongside being used for joint and muscle pain; Sigesbeckia is a herbal medicine that works best when used over time.

Looking for a traditional remedy for joint and muscle relief? Why not try Sigesbeckia?

But again no sign of a clinical trial to back up this plethora of therapeutic claims. How can this be? The answer lies in the directive mentioned in the Mail article. To obtain a licence that enables the manufacturer to make therapeutic claims, a herbal remedy merely needs to demonstrate that it has been in use for 30 years, of which at least 15 years had to be in the EU.

I think I understand the intention of the directive. But I would nevertheless have thought that, 4 years after obtaining a license, the manufacturer could have conducted a study to test whether the product works. In my view this should be a moral and ethical, if not legal obligation. The ‘test of time’ is woefully insufficient and unreliable and no basis for generating progress or securing the best interests of patients.

Considering the total lack of efficacy and safety data, do you agree that the above comment by Michael McIntyre are ironic to the extreme? And do you agree that manufacturers who manage to obtain such a license should be obliged to deliver a proof of efficacy within a reasonable period of time?

Many patients with chronic pain (CP) are prescribed opioids, a situation which has led to the much-discussed opioid crisis. Integrative medicine (IM), which combines pharmacological and so-called alternative medicine (SCAM), has been proposed as a solution. Yet, the role of SCAM therapies in reducing opioid use remains unclear.

This systematic review explored the effectiveness of the IM approach or any of the SCAM therapies to reduce or cease opioid use in CP patients. Electronic searches yielded 5,200 citations. Twenty-three studies were selected. Eight studies were randomized controlled trials, seven were retrospective studies, four studies were prospective observational, three were cross-sectional, and one was quasi-experimental. The majority of the studies showed that opioid use was reduced significantly after using IM/SCAM. Cannabinoids were among the most commonly investigated approaches in reducing opioid use, followed by multidisciplinary approaches, cognitive-behavioral therapy, and acupuncture. The majority of the studies had limitations related to sample size, duration, and study design.

The authors concluded that there is a small but defined body of literature demonstrating positive preliminary evidence that the IM approach including SCAM therapies can help in reducing opioid use. As the opioid crisis continues to grow, it is vital that clinicians and patients be adequately informed regarding the evidence and opportunities for IM/SCAM therapies for CP.

I am unimpressed by this review.

And here is why:

  1. Because of their design, most of the included studies do not allow any conclusions about cause and effect.
  2. The 8 RCTs that would allow such conclusions are mostly of poor quality.
  3. Some of the 8 RCTs are not even what the review authors claim to be. Here is just one example:

Background: Current levels and dangers of opioid use in the U.S. warrant the investigation of harm-reducing treatment alternatives.

Purpose: A preliminary, historical, cohort study was used to examine the association between enrollment in the New Mexico Medical Cannabis Program (MCP) and opioid prescription use.

Methods: Thirty-seven habitual opioid using, chronic pain patients (mean age = 54 years; 54% male; 86% chronic back pain) enrolled in the MCP between 4/1/2010 and 10/3/2015 were compared to 29 non-enrolled patients (mean age = 60 years; 69% male; 100% chronic back pain). We used Prescription Monitoring Program opioid records over a 21 month period (first three months prior to enrollment for the MCP patients) to measure cessation (defined as the absence of opioid prescriptions activity during the last three months of observation) and reduction (calculated in average daily intravenous [IV] morphine dosages). MCP patient-reported benefits and side effects of using cannabis one year after enrollment were also collected.

Results: By the end of the 21 month observation period, MCP enrollment was associated with 17.27 higher age- and gender-adjusted odds of ceasing opioid prescriptions (CI 1.89 to 157.36, p = 0.012), 5.12 higher odds of reducing daily prescription opioid dosages (CI 1.56 to 16.88, p = 0.007), and a 47 percentage point reduction in daily opioid dosages relative to a mean change of positive 10.4 percentage points in the comparison group (CI -90.68 to -3.59, p = 0.034). The monthly trend in opioid prescriptions over time was negative among MCP patients (-0.64mg IV morphine, CI -1.10 to -0.18, p = 0.008), but not statistically different from zero in the comparison group (0.18mg IV morphine, CI -0.02 to 0.39, p = 0.081). Survey responses indicated improvements in pain reduction, quality of life, social life, activity levels, and concentration, and few side effects from using cannabis one year after enrollment in the MCP (ps<0.001).

Conclusions: The clinically and statistically significant evidence of an association between MCP enrollment and opioid prescription cessation and reductions and improved quality of life warrants further investigations on cannabis as a potential alternative to prescription opioids for treating chronic pain.

This study is evidently NOT an RCT!

Most of the 8 RCTs investigate whether SCAM is useful for weaning opioid-dependent patients off their drug. To equate this with the question whether IM/SCAM can reduce or cease opioid use in CP patients is, I think, wrong. The way to reduce opioid use in CP patients is to prescribe less opioids. And for prescribing less opioids, we need no SCAM but we need to remember what we learned in medical school: opioids are not for routine treatment of CP!

So, why do the authors of this review try to mislead us?

Could it have something to do with some of their affiliations and the bias that goes with it?

  • Canadian College of Naturopathic Medicine, North York, Ontario, Canada.
  • Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, Australia.
  • Pacific College of Oriental Medicine, San Diego, California, USA.

What do you think?

Realgar, α-As4S4, is an arsenic sulfide mineral, also known as “ruby sulphur” or “ruby of arsenic”. It is a soft, sectile mineral occurring in monoclinic crystals, or in granular, compact, or powdery form, often in association with the related mineral, orpiment (As2S3).

In Traditional Chinese Medicine (TCM), realgar is often used in combination with herbs. An investigation found a total of 191 different, realgar-containing traditional Chinese patent medicines, and about 87% of them were for oral application. Realgar is said to: 

counteract toxic pathogen both externally and internally. For abscess swelling and sores, it can be used singly or in compound prescription for external application mostly. When taken internally, it is combined with blood-activating and abscess-curing herbs to obtain the action of activating blood to relieve swelling, removing toxicity to cure sores. For example, it is combined with Ru Xiang, Mo Yao and She Xiang in Xing Xiao Wan from Wai Ke Quan Sheng Ji. For itching of skin due to scabies and ringworm, it is often combined with dampness-astringing and itching-relieving herbs to obtain actions of killing parasites and curing ringworm, astringing dampness and relieving itching. For instance, it is combined with the same dose of Bai Fan in powder mixed with clear tea for external application in Er Wei Ba Du San from Yi Zong Jin Jian. For poisonous insect bite, it is mixed with sesame oil and then applied on the afflicted sites.

This herb can kill parasites so it is indicated for intestine track parasites. For roundworm induced abdominal pain, it is often combined with other roundworm-killing herbs to reinforce action. For instance, it is combined with Qian Niu Zi and Bing Lang, etc. in Qian Niu Wan from Shen Shi Zun Sheng Shu. For anus pruritus caused by pinworm, it can be made into gauze strip by mixing with vaseline, and then inserted into the anus.

In addition, according to some ancient formulas, this herb can dispel phlegm and check malaria for internal application, so it can also be indicated for epilepsy, asthma and malaria.

Longtime topical over-dose or oral intake of realgar can cause chronic arsenic poisoning and even death. Chinese authors recently published the case of a 35-year-old Chinese man, who was diagnosed with severe psoriasis and died of fatal acute arsenic poisoning after he applied a local folk prescription ointment containing mainly realgar to the affected skin for about 4 days. The autopsy showed multiple punctate haemorrhages over the limbs, pleural effusion, oedematous lungs with consolidation, mild myocardial hypertrophy and normal-looking kidneys. The histopathological examination of renal tissue showed severe degeneration, necrosis and desquamation of renal tubular epithelial cells, presence of protein cast and a widened oedematous interstitium with interstitial fibrosis. The presence of arsenic in large amount in the ointment (about 6%), in blood (1.76 μg/mL), and in skin (4.71 μg/g), were confirmed analytically. The authors also review 7 similar cases in literature.

My advice is that, when you see recommendations by TCM practitioners like this one

the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically

you think again and consider that TCM really is not a form of healthcare that can be trusted to be safe.

So-called alternative medicine (SCAM) could easily be described as a business that exists mainly because it profits from the flaws of conventional medicine. I know, this is not a good definition, and I don’t want to suggest it as one, but I think it highlights an important aspect of SCAM.

Let me explain.

If we ask ourselves why consumers feel attracted to SCAM, we can identify a range of reasons, and several of them relate to the weaknesses of conventional medicine as it is practised today. For instance:

  1.  People feel the need to have more time with their clinician in order to discuss their problems more fully. This means that their GP does not offer them sufficient time, empathy and compassion they crave.
  2.  Patients are weary of the side-effects of drugs and prefer treatments that are gentle and safe. This shows that they realise that conventional medicine can cause harm and they hope to avoid this risk.
  3.  Patients find it often hard to accept that their symptoms are ‘nothing to worry about’ and does not require any treatment at all. They prefer to hear that the clinician knows exactly what is wrong and can offer a therapy that puts it right.

Conventional medicine and the professionals who administer it have many flaws. Most doctors have such busy schedules that there is little time for building an empathetic therapeutic relationship with their patients. Thus they often palm them off with a prescription and fail to discuss the risks in sufficient detail. Even worse, they sometimes prescribe drugs in situations where none are needed and where a reassuring discussion would be more helpful. It is too easy to excuse such behaviours with work pressures; such flaws are serious and cannot be brushed under the carpet in this way.

Recently, the flawed behaviour of doctors has become the focus of media attention in the form of

  • opioid over-prescribing
  • over-use of anti-biotics.

In both cases, SCAM providers were quick to offer the solution.

  • Acupuncturists and chiropractors claim that their treatments are sensible alternatives to opioids. Yet, there is no good evidence that either acupuncture or chiropractic have analgesic effects that are remotely comparable to those of opioids. They only are seemingly successful in cases where opioids were not needed in the first place.
  • Homeopaths claim that their remedies can easily replace antibiotics. Yet, there is not a jot of evidence that homeopathics have antibiotic activity. They only are seemingly successful in cases where the antibiotic was not needed in the first place.

In both instances, SCAM is trying to profit from the weaknesses of conventional medicine. In both cases, the offered solutions are clearly bogus. Yet, in both cases, scientifically illiterate politicians are seriously considering the alleged solutions. Few seem to be smart enough to take a step backwards and contemplate the only viable solution to these problems. If doctors over-prescribe, they need to be stopped; and the best way to stop them is to give them adequate support, more time with their patients and adequate recognition of the importance of reassuring and talking to patients when they need it.

To put it differently:

The best way to reduce the use of bogus SCAMs is to make conventional medicine less flawed.

Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit. Acupuncture is often recommended, but does it work? This study was aimed at finding out whether acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy.

The 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centres in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019. Either TA or SA using a validated acupuncture placebo device were performed 3 times per week during a 6- to 7-week course of radiation therapy. The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes.

Of 399 patients randomized, 339 were included in the final analysis, including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).

The authors concluded that this randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China.

In essence this two-centre study shows that:

  • real acupuncture is better than usual care, but the effect size is small and of doubtful clinical relevance;
  • real acupuncture is not significantly better than sham acupuncture;
  • the findings differ remarkably between the US and the Chinese centre.

I find the last point the most interesting one. We know from previous research that acupuncture studies from China are notoriously unreliable; they never report a negative result and there is evidence that data fabrication is rife in China. The new findings seems to throw more light on this notion. In the US centre, real and sham acupuncture generated practically identical results. By contrast, in the Chinese centre, real acupuncture generated significantly better results than sham. The authors offer several hypotheses to explain this remarkable phenomenon. Yet, in my view, the most likely one is that Chinese researchers are determined to show that acupuncture is effective. Thus all sorts of unconscious or even conscious biases might get introduced into such studies.

In essence, trial therefore confirms that acupuncture is little more than a theatrical placebo, particularly if we consider the US data which, in my opinion, are more trustworthy.

Lorenzo Cohen, Professor of Palliative, Rehabilitation, and Integrative Medicine and director of the Integrative Medicine Program as well as senior author of the paper unsurprisingly disagrees. He was quoted saying: “The evidence is to a point where patients should incorporate acupuncture alongside radiation treatment as a way to prevent the severity of dry mouth symptoms. I think with this study we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”

Who do you think is closer to the truth?

Recently, we discussed the findings of a meta-analysis which concluded that walking, which is easy to perform and highly accessible, can be recommended in the management of chronic LBP to reduce pain and disability.

At the time, I commented that

this will hardly please the legions of therapists who earn their daily bread with pretending their therapy is the best for LBP. But healthcare is clearly not about the welfare of the therapists, it is/should be about patients. And patients should surely welcome this evidence. I know, walking is not always easy for people with severe LBP, but it seems effective and it is safe, free and available to everyone.

My advice to patients is therefore to walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

Now, there is new evidence that seems to confirm what I wrote. An international team of researchers requested individual participant data (IPD) from high-quality randomised clinical trials of patients suffering from persistent low back pain. They conducted descriptive analyses and one-stage IPD meta-analysis. They received IPD for 27 trials with a total of 3514 participants.

For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) -10.7 (-14.1 to -7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) -10.2 (-13.2 to -7.3)) at short-term follow-up.

Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers-these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care.

But you cannot dismiss so-called alternative medicine (SCAM), just like that, I hear my chiropractic and other manipulating friends exclaim – at the very minimum, we need direct comparisons of the two approaches!!!

Alright, you convinced me; here you go:

The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with chronic low back pain (CLBP). Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review. Only three RCTs met the inclusion criteria. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term. The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.

Convinced?

No?

But I am!

Exercise is preferable to chiropractic and other manipulating SCAMs because:

  1. It is cheaper.
  2. It is safer.
  3. It is readily available to anyone.
  4. And you don’t have to listen to the bizarre and often dangerous advice many chiros offer their clients.
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