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

bogus claims

I have just been in Sao Paulo to give a lecture at the opening of a new university institute, ‘Question of Science‘. Under the leadership of Natalia Pasternak, the institute will promote scepticism in Brazil, particularly in the area of alternative medicine. Brazil currently has no less than 29 types of alternative medicine paid for with public money, and even homeopathy is officially being recognised and taught at all Brazilian medical schools.

But the most peculiar case of Brazilian quackery must surely be phosphoethanolamine. Gilberto Chierice, a Chemistry Professor at the University of São Paulo, used resources from a campus laboratory to unofficially manufacture, distribute, and promote the chemical to cancer patients claiming that it was a cheap cure for all cancers without side-effects. Remarkably, this was in the total absence of through clinical testing. In September 2015, university administrators therefore began preventing him from continuing with this practice. However, in October 2015, several courts in Brazil ruled in favour of plaintiffs who wanted the compound to remain available. In an unusual move of defence of common sense, a state court overturned the lower courts’ decision a month later, and the secretary for Brazil’s science and technology ministry promised to fund further research on the compound. In 2016, a law was passed in Brazil allowing the sale of synthetic phosphorylethanolamine for cancer treatment. Due to opposition from the Brazilian Medical Association, the Brazilian Society of Clinical Oncology, and the regulatory agency ANVISA, the country’s Supreme Court then suspended the law. I was told that a stepwise plan of clinical testing had been implemented. As the drug even failed to pass the most preliminary tests, the program had to be aborted.

This story seems like a re-play of many similar tales of bogus cancer cures of the past. They all seem to follow a similar pattern:

  1. Someone dreams up a ‘cure’ for all cancers that is cheap and free of side-effects.
  2. This appeals to many desperate cancer patients who are fighting for their lives.
  3. It also attracts several entrepreneurs who are hoping to make a fast buck.
  4. The story is picked up by the press and consequently a sizable grass-roots movement of support emerges.
  5. Populist politicians jump on the vote-winning band-waggon.
  6. The experts caution that the bogus cancer ‘cure’ is devoid of evidence and might put patients’ lives at risk.
  7. The legislators get involved.
  8. Law suits start left, right and centre.
  9. Eventually, the cancer ‘cure’ is scientifically tested and confirmed to be bogus.
  10. Eventually, the law rules against the bogus ‘cure’.
  11. A conspiracy theory emerges stating that the cancer ‘cure’ was unjustly suppressed to protect the interests of Big Pharma.
  12. A few years later, the subject re-surfaces and the whole cycle starts from the beginning.

Such stories remind us that fighting bogus claims is hugely important, even if it does not always succeed or turns out to be merely an exercise of damage limitation. Every life saved by the struggle against quackery makes it worthwhile.

I wish the new Institute ‘Question of Science‘ all the luck it richly deserves and desperately needs.

In the latest issue of ‘Simile’ (the Faculty of Homeopathy‘s newsletter), the following short article with the above title has been published. I took the liberty of copying it for you:

Members of the Faculty of Homeopathy practising in the UK have the opportunity to take part in a trial of a new homeopathic remedy for treating infant colic. An American manufacturer of homeopathic remedies has made a registration application for the new remedy to the MHRA (Medicines and Healthcare products Regulatory Agency) under the UK “National Rules” scheme. As part of its application the manufacturer is seeking at least two homeopathic doctors who would be willing to trial the product for about a year, then write a short report about using the remedy and its clinical results. If you would like to take part in the trial, further details can be obtained from …

END OF QUOTE

A homeopathic remedy for infant colic?

Yes, indeed!

The British Homeopathic Association and many similar ‘professional’ organisations recommend homeopathy for infant colic: Infantile colic is a common problem in babies, especially up to around sixteen weeks of age. It is characterised by incessant crying, often inconsolable, usually in the evenings and often through the night. Having excluded underlying pathology, the standard advice given by GPs and health visitors is winding technique, Infacol or Gripe Water. These measures are often ineffective but for­tunately there are a number of homeo­pathic medicines that may be effective. In my experience Colocynth is the most successful; alternatives are Carbo Veg, Chamomilla and Nux vomica.

SO, IT MUST BE GOOD!

But hold on, I cannot find a single clinical trial to suggest that homeopathy is effective for infant colic.

Ahhhhhhhhhhhhhhhhhhh, I see, that’s why they now want to conduct a trial!

They want to do the right thing and do some science to see whether their claims are supported by evidence.

How very laudable!

After all, the members of the Faculty of Homeopathy are doctors; they have certain ethical standards!

After all, the Faculty of Homeopathy aims to provide a high level of service to members and members of the public at all times.

Judging from the short text about the ‘homeopathy for infant colic trial’, it will involve a few (at least two) homeopaths prescribing the homeopathic remedy to patients and then writing a report. These reports will unanimously state that, after the remedy had been administered, the symptoms improved considerably. (I know this because they always do improve – with or without treatment.)

These reports will then be put together – perhaps we should call this a meta-analysis? – and the overall finding will be nice, positive and helpful for the American company.

And now, we all understand what homeopaths, more precisely the Faculty of Homeopathy, consider to be evidence.

 

 

The UK media have often disappointed me when reporting about matters related to alternative medicine. Yet, this is ‘small fry’ compared to their coverage of the EU during the last decades. Here I have selected 50 (there are plenty more) headlines from a long list of ‘alternative truths’ and Euromyths of their invented or misleading healthcare-related stories:

  1. New EU sulphur rules will cause problems with oil-fired Aga’s, Dec 2009
  2. EU ‘bans boozing’, Feb 2005
  3. UK diners will face £200m for EU allergen rules, Nov 2014
  4. False alarm over 999 calls, Dec 2006
  5. Ambulances turn yellow for Europe, Mar 2002
  6. EU to force St Johns Ambulances to replace its entire fleet, Apr 2002
  7. Human medicines to be forbidden for use on animals, Feb/Mar 1995
  8. Taxpayers money used to rehabilitate Peruvian drug addicts, Jul 2014
  9. EU bans children from blowing up balloons, Oct 2011
  10. EU health directive to prevent barmaids from showing cleavage, Nov 2005
  11. “EU red tape” is denying cancer patients access to new treatments, Jun 2016
  12. EC rules on levels of listeria threaten British cheeses, Feb 1995
  13. Sales of cigars to fall due to be sold individually with a health warning, Jan 1994
  14. Circus performers required to wear hard hats, Jul 2003
  15. EU responsible for your hay fever, May 2015
  16. Condom dimensions to be harmonised, Mar 2000
  17. Fishing boats obliged to carry condoms, Nov 1992
  18. EU to push for standard condom size, Oct 1994
  19. EU plans to liquify corpses and pour them down the drain, July 2010
  20. Traditional cricket teas will be subjected to random hygiene checks, Apr 1993
  21. EC to ban prawn cocktail crisps, Jan 1993
  22. Smoky bacon crisps to be banned, May 2003
  23. EU outlaws teeth whitening products, Feb 2003
  24. EU blocking vital checks on doctors’ qualifications, Apr 2016
  25. EU doctors in UK a threat to patients, Sep 2016
  26. UK hospital have to employ people who do not speak English, Apr 2012
  27. Hundreds of GPs to be forced to acquire additional qualifications, Sep 1994
  28. 58 hour working week will ground hospitals to a halt, Aug 2004
  29. UK doctors unable to treat off shore patients at night, Feb 1999
  30. HGV drivers not permitted to wear glasses, Feb 1996
  31. Regulators to set maximum heat of electric blankets, leaving pensioners cold, Oct 1993
  32. Organic farmers ordered by EU to use homeopathic medicine, Apr 2015
  33. Small inshore fishing boats to be forced to carry extensive medical kits, Dec 1994
  34. Rare meat to be banned due to “too much bacteria”, Sep 1993
  35. Street vendors face closure due to an EC food hygiene Directive, Nov 1992
  36. EC to stop UK citizens taking extra strong multi-vitamin pills, Feb 1993
  37. EU rights to reside in another member state, EU benefit claimants and NHS treatment entitlement, Feb 2013
  38. Brussels to ban herbal cures, Mar 1999
  39. License to be required to sell herbal medicines, Oct 1994
  40. Update on whether license to be required to sell herbal medicines, Nov 1994
  41. Horses to no longer receive medicine that would make them unsafe for consumption, Jan 1994
  42. Hysteria about listeria, Feb 1995
  43. European Commission approve unsafe high-risk medical devices, Jul 2016
  44. Medicines to receive Latin labelling, May 1999
  45. Soya milk indistinguishable from cow milk and thus to be banned, April 1995
  46. Scotch whisky must be handled as a dangerous chemical, Nov 1995
  47. EC hygiene rules force closure of abattoirs, Nov 1992
  48. EU ban on ciggie breaks? Just hot air, Jun 2007
  49. Brussels to reinstate tobacco subsidies, Feb 2013
  50. EU to ban vitamin supplements, Mar 2002

 

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Yes, some of this is so nonsensically idiotic that it could be quite funny.

But sadly, it is also very annoying, even infuriating. I am sure these relentless lies are partly the cause why Brexit is currently dividing the UK and threatening to become a monumental exercise in self-destruction.

 

The DAILY MAIL is by no means my favourite paper (see, for instance, here, here and here). This week, the Mail published another article which, I thought, is worth mentioning. The Mail apparently asked several UK doctors which dietary supplements they use for their own health (no mention of the number they had to approach to find any fitting into this category). The results remind me of a statement by the Permanent Secretary, Sir Humphrey Appleby in the famous TV series YES MINISTER: “if nobody knows anything then nobody can accuse anybody else of knowing nothing, and so the one thing we do know is that nobody knows anything, and that’s better than us knowing nothing”.

Below, I present the relevant quotes by the doctors who volunteered to be interviewed and add the most up-to date evidence on each subject.

Professor Christopher Eden, 57, is a consultant urological surgeon at the Royal Surrey County Hospital in Guildford.

“I take a 1g supplement of vitamin C daily. (The recommended daily amount, or RDA, is 40mg, which is equivalent to a large orange.) This amount of vitamin C makes the urine mildly acidic and increases the levels of an antimicrobial protein called siderocalin, found naturally in urine, which makes the environment less favourable to bad bacteria and reduces the risk of infection.”

Ascorbic acid (vitamin C) cannot be recommended for the prevention of urinary tract infections.

Louise Newson, 48, is a GP and menopause specialist based in Stratford-upon-Avon.

“Women going through the menopause or perimenopause may get bowel symptoms such as bloating which are due to hormone imbalances affecting the balance of gut bacteria. Probiotic (good bacteria) supplements correct this imbalance and are also linked to levels of the brain chemical serotonin, which can improve mood. This is important during the menopause. I make sure I take a probiotic daily, specifically one with a high bacteria count including Lactobacillus acidophilus. I look for one that has to be kept in the fridge, as this is a sign of a quality product.”

For … probiotics, prebiotics, acupuncture, homeopathy and DHEA-S, randomized, placebo-controlled trials are scarce and the evidence is unconvincing.

Professor Tony Kochhar, 45, is a consultant orthopaedic surgeon at London Bridge Hospital.

“Having taken statins for a couple of years, I developed tendonitis, inflammation in the foot, which caused pain around the outside of it. My GP told me to stop taking the statins, which helped, and I now control my condition with diet. I also take a supplement of collagen (a natural protein found in the tendons) to build up tendon structure and reduce pain. I take two 1,200mg collagen supplements daily and it has really helped. Within two weeks of starting them, my pain had gone.”

it is not possible to draw any definitive raccomendations on the use of nutraceutical supplementation in tendinopathies.

Dr Anne Rigg, 51, is a consultant oncologist at London Bridge Hospital.

“One theory is that vitamin D may help control normal breast cell growth and may even stop breast cancer cells from growing. The body creates vitamin D from sunlight on the skin when we are outdoors, but because of the British weather and the rightful use of sunscreen, it’s easy to become deficient. I take the recommended daily dose of 10mcg. [Fatty fish such as salmon and mackerel are good sources, too, but you’d have to eat them in large amounts to get the recommended daily dosage.] It’s vital not to overdose, as it can increase the risk of kidney stones: the vitamin helps absorb calcium from the diet, which can build up into stones.”

Supplementation with vitamin D did not result in a lower incidence of invasive cancer…

Dr Rob Hogan, 62, is an optometrist at iCare Consulting.

“I’m aware, too, of the increased risk of age-related macular degeneration (AMD), a leading cause of sight loss in people over 60. This is where the small central portion of the retina (the macula) at the back of the eye deteriorates. So I take MacuShield, a supplement which, studies have found, can help improve vision and keep the back of the eye healthy. It contains a mixture of natural compounds — lutein, zeaxanthin and meso-zeaxanthin — which are antioxidants that have been found in studies to improve vision and eye health. I take one a day, usually with a meal.”

In early AMD, macular pigment can be augmented with a variety of supplements, although the inclusion of MZ may confer benefits in terms of panprofile augmentation and in terms of contrast sensitivity enhancement.

Dr Milad Shadrooh, 37, is a dentist in Basingstoke, Hampshire.

“I take a varied supplement daily to maintain good health and, specifically, healthy teeth. It contains calcium (an adult’s RDA is 700mg, which is equivalent to three 200ml cups of milk) as most people, including me, don’t get enough in their diet.”

calciumsupplements that are used to prevent or treat osteoporosis appear to have beneficial effects on tooth retention as well.

Dr Joanna Gach, 49, is a consultant dermatologist at University Hospitals Coventry and Warwickshire NHS Trust.

“Every so often, I take a multivitamin capsule containing zinc, selenium and biotin. These are all helpful for sorting out my brittle nails and maintaining healthy hair.”

 no evidence supports the use of vitamin supplementation with vitamin E, vitamin C (ascorbic acid), vitamin A, retinoids, retinol, retinal, silicon, zinc, iron, copper, selenium, or vitamin B12 (Cyanocobalamin) for improving the nail health of well-nourished patients or improving the appearance of nails affected by pathologic disease.

Luke Cascarini, 47, is a consultant maxillofacial surgeon at Guy’s and St Thomas’ Hospital in London.

“I take a daily vitamin drink containing a high-dose vitamin B complex, which is necessary for good oral health.”

The published research reveals only a possible relationship between vitamins and minerals and periodontal disease. Vitamin E, zinc, lycopene and vitamin B complex may have useful adjunct benefits. However, there is inadequate evidence to link the nutritional status of the host to periodontal inflammation. More randomized controlled trials are needed to explore this association.

Dr Jenni Byrom, 44, is a consultant gynaecologist at Birmingham’s Women’s and Children’s Hospital.

“I take evening primrose oil for premenstrual symptoms such as breast pain. I take 1g of evening primrose oil daily and have found it really makes a difference.”

Evening primrose oil has not been shown to improve breast pain, and has had its licence withdrawn for this indication in the UK owing to lack of efficacy (it is still available to purchase without prescription).

Dr Sarah Myhill, 60, is a GP based in Wales.

“I take 10g of vitamin C dissolved in a glass of water every day before I start my shift — and I never get colds. I believe that high doses of vitamin C can kill bad microbes on contact — or, at least, help reduce the severity of infections such as colds and sore throats.”

 vitamin C has minimal or no impact on the duration of common cold or in the number of days at home or out of work.

Jonathan Dearing, 49, is a consultant orthopaedic surgeon specialising in sports injuries at BMI Carrick Glen Hospital in Ayrshire.

“I carry a vitamin D oral spray and use it after exercise, as it helps improve muscle recovery by regulating various processes that help them repair and grow.”

… supraphysiological dosages of vitamin D3 have potential ergogenic effects on the human metabolic system and lead to multiple physiological enhancements. These dosages could increase aerobic capacity, muscle growth, force and power production, and a decreased recovery time from exercise. These dosages could also improve bone density. However, both deficiency (12.5 to 50 nmol/L) and high levels of vitamin D (>125 nmol/L) can have negative side effects, with the potential for an increased mortality. Thus, maintenance of optimal serum levels between 75 to 100 nmol/L and ensuring adequate amounts of other essential nutrients including vitamin K are consumed, is key to health and performance. Coaches, medical practitioners, and athletic personnel should recommend their patients and athletes to have their plasma 25(OH)D measured, in order to determine if supplementation is needed. Based on the research presented on recovery, force and power production, 4000-5000 IU/day of vitamin D3 in conjunction with a mixture of 50 mcg/day to 1000 mcg/day of vitamin K1 and K2 seems to be a safe dose and has the potential to aid athletic performance. Lastly, no study in the athletic population has increased serum 25(OH)D levels past 100 nmol/L, (the optimal range for skeletal muscle function) using doses of 1000 to 5000 IU/day. Thus, future studies should test the physiological effects of higher dosages (5000 IU to 10,000 IU/day or more) of vitamin D3 in combination with varying dosages of vitamin K1 and vitamin K2 in the athletic population to determine optimal dosages needed to maximize performance.

Dr Glyn Thomas, 46, is a cardiologist and cardiac electrophysiologist at the Bristol Heart Institute.

“I take a magnesium supplement as it can help address an extra heartbeat — something I suffered with for 20 years.”

Whether magnesium supplementation could have a role in the prevention of AF in the community has not been tested.

_____________________________________________________

Firstly, let me congratulate those colleagues who actually might have got it right:

  1. Dr Hogan
  2. Dr Shadrooh
  3. Mr Cascarini
  4. Mr Dearing

I say ‘MIGHT HAVE GOT IT RIGHT’ because, even in their cases, the evidence is far from strong and certainly not convincing.

Secondly, let me commiserate those who spend their money on unproven supplements. I find it sad that this group amounts to two thirds of all the ‘experts’ asked.

Thirdly, let me remind THE DAILY MAIL of what I posted recently:  journalists to be conscious of their responsibility not to mislead the public and do more rigorous research before reporting on matters of health. Surely, the Mail did us no favour in publishing this article. It will undoubtedly motivate lots of gullible consumers to buy useless or even harmful supplements.

And lastly, let me remind all healthcare professionals that promoting unproven treatments to the unsuspecting public is not ethical.

 

The public is often impressed by scenes shown on TV where surgeons in China operate patients apparently with no other anaesthesia than acupuncture. Such films have undoubtedly contributed significantly to the common belief that acupuncture cannot possibly be a placebo (every single time I give a public talk about acupuncture, the issue comes up, and someone asks me: how can you doubt the efficacy of acupuncture when, in China, they use it for major operations?).

Some years ago, I have myself been involved is such a BBC broadcast and had to learn the hard way that such scenes are more than just a bit misleading.

Unfortunately, the experts rarely object to any of this. They seem to have become used to the false claims and overt propaganda that is rife in the promotion of acupuncture, and have resigned to the might of poor journalism.

The laudable exception is a team of French authors of a recent and excellent paper.

This unusual article analysed a clip from the program “Acupuncture, osteopathy, hypnosis: do complementary medicines have superpowers?” about acupuncture as an anaesthetic for surgical procedures in China. Their aim was to propose a rational explanation for the phenomena observed and to describe the processes leading a public service broadcasting channel to offer this type of content at prime time and the potential consequences in terms of public health. For this purpose, they used critical thinking attitudes and skills, along with a bibliographical search of Medline, Google Scholar and Cochrane Library databases.

Their results reveal that the information delivered in the television clip is ambiguous. It did not allow the viewer to form an informed opinion on the relevance of acupuncture as an anaesthetic for surgical procedures. It is reasonable to assume that the clip shows surgery performed with undisclosed epidural anaesthesia coupled with mild intravenous anaesthesia, sometimes performed in other countries.

What needs to be highlighted, the authors of this critique state, is the overestimation of acupuncture added to the protocol. The media tend to exaggerate the risks and expected effects of the treatments they report on, which can lead patients to turn to unproven therapies.

The authors concluded that broadcasting such a clip at prime time underlines the urgent need for the public and all health professionals to be trained in sorting and critically analysing health information.

In my view, broadcasting such misleading films also underlines the urgent need for journalists to be conscious of their responsibility not to mislead the public and do more rigorous research before reporting on matters of health.

The Clinic for Complementary Medicine and Diet in Oncology was opened, in collaboration with the oncology department, at the Hospital of Lucca (Italy) in 2013. It uses a range of alternative therapies aimed at reducing the adverse effects of conventional oncology treatments.

Their latest paper presents the results of complementary medicine (CM) treatment targeted toward reducing the adverse effects of anticancer therapy and cancer symptoms, and improving patient quality of life. Dietary advice was aimed at the reduction of foods that promote inflammation in favour of those with antioxidant and anti-inflammatory properties.

This is a retrospective observational study on 357 patients consecutively visited from September 2013 to December 2017. The intensity of symptoms was evaluated according to a grading system from G0 (absent) to G1 (slight), G2 (moderate), and G3 (strong). The severity of radiodermatitis was evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Almost all the patients (91.6%) were receiving or had just finished some form of conventional anticancer therapy.

The main types of cancer were breast (57.1%), colon (7.3%), lung (5.0%), ovary (3.9%), stomach (2.5%), prostate (2.2%), and uterus (2.5%). Comparison of clinical conditions before and after treatment showed a significant amelioration of all symptoms evaluated: nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy.

The authors concluded that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ demand for a reduction of the adverse effects of anticancer treatments and the symptoms of cancer itself, thus improving patient’s quality of life and combining safety and equity of access within public healthcare systems. It is, therefore, necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs.

Why do I call this ‘wishful thinking’?

I have several reasons:

  1. A retrospective observational study cannot establish cause and effect. It is likely that the findings were due to a range of factors unrelated to the interventions used, including time, extra attention, placebo, social desirability, etc.
  2. Some of the treatments in the therapeutic package were not CM, reasonable and evidence-based. Therefore, it is likely that these interventions had positive effects, while CM might have been totally useless.
  3. To claim that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ is pure fantasy. Firstly, some of the CMs were certainly not evidence-based (the clinic’s prime focus is on homeopathy). Secondly, as already pointed out, the study does not establish cause and effect.
  4. The notion that it is necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs is not what follows from the data. The paper shows, however, that the authors of this study are in need to be appropriately informed about EBM as well as CM.

I stumbled across this paper because a homeopath cited it on Twitter claiming that it proves the effectiveness of homeopathy for cancer patients. This fact highlights why such publications are not just annoyingly useless but acutely dangerous. They mislead many cancer patients to opt for bogus treatments. In turn, this demonstrates why it is important to counterbalance such misinformation, critically evaluate it and minimise the risk of patients getting harmed.

Boiron is the world’s largest manufacturer of homeopathic products. The 2016 sales figures of the company amounted to 614 489 000 Euro. Boiron has recently been very active promoting its products, not least on Twitter where I note about 10 of their promotional tweets every day. I saw the following tweet yesterday:

Acidil temporarily relieves occasional heartburn, acid indigestion, bloating or upset stomach. (link: http://bit.ly/2gCARdu)

This prompted me to look up what this product contains. The ingredients (potencies) are as follows:

  • Abies nigra (4C)
  • Carbo vegetablilis (4C)
  • Nux vomica (4C)
  • Robinia pseudoacacia (4C)

Just to remind you, 4C means the substance is diluted at a rate of 1: 100 000 000. Even the most deadly poison would be ineffective at such a dilution.

So, how can they claim that it is effective?

To find the answer, I did a Medline search and found the only listed trial of Acidil (if anyone knows of further studies, please let me know). Here is its abstract:

BACKGROUND:

It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.

METHODS:

24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.

RESULTS:

There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.

CONCLUSION:

An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.

The question I have is simple: why are they allowed to make false medical claims?

Is there anyone out there who can answer it?

The ‘CANADIAN COLLEGE OF HOMEOPATHIC MEDICINE’ has posted an interesting announcement:

Homeopathic Treatment of Asthma with Homeopath Kim Elia www.wholehealthnow.com/bios/kim-elia

In asthma, bronchial narrowing results in coughing, wheezing, shortness of breath, and a sense of tightness in the chest. Traditional treatments, such as bronchodilator and steroidal inhalers, reasonably control the condition, but cure is elusive. Side effects and long-term use can eventually be quite damaging, including impairment of immune function and growth rate in children. Homeopathy has an excellent track record in treating this debilitating illness, and offers the hope of weaning off of traditional injurious treatments, replacing them with a far gentler and deeper-acting solution.

About Kim Elia

Students from around the world have expressed appreciation and admiration for Kim’s superb knowledge of the history of homeopathy, his deep understanding of homeopathic prescribing, and his extensive knowledge of materia medica. He is known for his dynamic and distinctive teaching methods which reflect his immense knowledge of the remedies and his genuine desire to educate everyone about this affordable and effective healing modality.

END OF QUOTE

There a few facts that the college seems to have forgotten to mention or even deliberately distorted:

  1. Asthma is a potentially lethal disease; each year, hundreds of patients die during acute asthma attacks.
  2. The condition can be controlled with conventional treatments.
  3. The best evidence fails to show that homeopathy is an effective treatment of asthma.
  4. Therefore, encouraging homeopathy as an alternative for asthma, risks the unnecessary, premature death of many patients.

And who is Kim Elia?

Here is some background (from his own website):

  • Apparently, he was inspired to study homeopathy when he read Gandhi’s quote about homeopathy, “Homeopathy cures a greater percentage of cases than any other method of treatment. Homeopathy is the latest and refined method of treating patients economically and non-violently.” He has been studying homeopathy since 1987 and graduated from the New England School of Homeopathy.
  • Kim is the former Director of Nutrition at Heartwood Institute, California.
  • He was the Director of Fasting at Heartwood.
  • Kim was a trainer at a company providing whole food nutritional supplements.
  • Kim serves as CEO of WholeHealthNow, the distributors of OPUS Homeopathic Software and Books in North America.
  • Kim provides and coordinates software training and support, and oversees new software development with an international team of homeopaths and software developers.
  • He was inspired to create the Historic Homeopathic Timeline, and is responsible for a growing library of recorded interviews and presentations with today’s world renowned homeopaths.
  • Kim was the principal instructor and developer of the four year classical homeopathy program at the Hahnemann Academy in Tokyo and Osaka, Japan.
  • He is currently developing new homeopathy projects.

What the site does not reveal is his expertise in treating asthma.

The Canadian College of Homeopathic Medicine claims to be dedicated to the training of homeopaths according to the highest standard of homeopathic education, emphasizing the art and practice of homeopathy as outlined in Hahnemanns’s Organon of the Medical Art. We aim to further the field of homeopathy as a whole through the provision of quality, primary homeopathic care.

If that is what the highest standard of homeopathic education looks like, I would prefer an uneducated homeopath any time!

On this blog, I have repeatedly discussed chiropractic research that, on closer examination, turns out to be some deplorable caricature of science. Today, I have another example of what I would call pseudo-research.

This RCT compared short-term treatment (12 weeks) versus long-term management (36 weeks) of back and neck related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).

Eligible participants were aged 65 and older with back and neck disability for more than 12 weeks. Co-primary outcomes were changes in Oswestry and Neck Disability Index after 36 weeks. An intention to treat approach used linear mixed-model analysis to detect between group differences. Secondary analyses included other self-reported outcomes, adverse events and objective functional measures.

A total of 182 participants were randomized. The short-term and long-term groups demonstrated significant improvements in back and neck disability after 36 weeks, with no difference between groups. The long-term management group experienced greater improvement in neck pain at week 36, self-efficacy at week 36 and 52, functional ability and balance.

The authors concluded that for older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.

What renders this paper particularly fascinating is the fact that its authors include some of the foremost researchers in (and most prominent proponents of) chiropractic today. I therefore find it interesting to critically consider the hypothesis on which this seemingly rigorous study is based.

As far as I can see, it essentially is this:

36 weeks of chiropractic therapy plus exercise leads to better results than 12 weeks of the same treatment.

I find this a most remarkable hypothesis.

Imagine any other form of treatment that is, like SMT, not solidly based on evidence of efficacy. Let’s use a new drug as an example, more precisely a drug for which there is no solid evidence for efficacy or safety. Now let’s assume that the company marketing this drug publishes a trial based on the hypothesis that:

36 weeks of therapy with the new drug plus exercise leads to better results than 12 weeks of the same treatment.

Now let’s assume the authors affiliated with the drug manufacturer concluded from their findings that for patients with chronic back and neck disability, extending drug therapy plus exercise from 12 to 36 weeks did not result in any additional important reduction in disability.

WHAT DO YOU THINK SUCH A TRIAL CAN TELL US?

My answer is ‘next to nothing’.

I think, it merely tells us that

  1. daft hypotheses lead to daft research,
  2. even ‘top’ chiropractors have problems with critical thinking,
  3. SMT might not be the solution to neck and back related disability.

I REST MY CASE.

 

Homeopathy for depression? A previous review concluded that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. But that was 13 years ago. Perhaps the evidence has changed?

A new review aimed to assess the efficacy, effectiveness and safety of homeopathy in depression. Eighteen studies assessing homeopathy in depression were included. Two double-blind placebo-controlled trials of homeopathic medicinal products (HMPs) for depression were assessed.

  • The first trial (N = 91) with high risk of bias found HMPs were non-inferior to fluoxetine at 4 and 8 weeks.
  • The second trial (N = 133), with low risk of bias, found HMPs was comparable to fluoxetine and superior to placebo at 6 weeks.

The remaining research had unclear/high risk of bias. A non-placebo-controlled RCT found standardised treatment by homeopaths comparable to fluvoxamine; a cohort study of patients receiving treatment provided by GPs practising homeopathy reported significantly lower consumption of psychotropic drugs and improved depression; and patient-reported outcomes showed at least moderate improvement in 10 of 12 uncontrolled studies. Fourteen trials provided safety data. All adverse events were mild or moderate, and transient. No evidence suggested treatment was unsafe.

The authors concluded that limited evidence from two placebo-controlled double-blinded trials suggests HMPs might be comparable to antidepressants and superior to placebo in depression, and patients treated by homeopaths report improvement in depression. Overall, the evidence gives a potentially promising risk benefit ratio. There is a need for additional high quality studies.

I beg to differ!

What these data really show amounts to far less than the authors imply:

  • The two ‘double-blind’ trials are next to meaningless. As equivalence studies they were far too small to produce meaningful results. Any decent review should discuss this fact in full detail. Moreover, these studies cannot have been double-blind, because the typical adverse-effects of anti-depressants would have ‘de-blinded’ the trial participants. Therefore, these results are almost certainly false-positive.
  • The other studies are even less rigorous and therefore do also not allow positive conclusions.

This review was authored by known proponents of homeopathy. It is, in my view, an exercise in promotion rather than a piece of research. I very much doubt that a decent journal with a responsible peer-review system would have ever published such a biased paper – it had to appear in the infamous EUROPEAN JOURNAL OF INTEGRATIVE MEDICINE.

So what?

Who cares? No harm done!

Again, I beg to differ.

Why?

The conclusion that homeopathy has a ‘promising risk/benefit profile’ is frightfully dangerous and irresponsible. If seriously depressed patients follow it, many lives might be lost.

Yet again, we see that poor research has the potential to kill vulnerable individuals.

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