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

Monthly Archives: January 2019

Slowly, I seem to be turning into a masochist! Yes, I sometimes read publications like ‘HOMEOPATHY 360’. It carries articles that are enragingly ill-informed. But in my defence, I might say that some are truly funny. Here is the abstract of one that I found outstanding in that category:

The article explains about Gangrene and its associated amputations which is a clinically challenging condition, but Homeopathy offers therapy options. The case presented herein, details about how the Homeopathic treatment helped in the prevention of amputation of a body part. Homeopathy stimulates the body’s ability to heal through its immune mechanisms; consequently, it achieves wound healing and establishes circulation to the gangrenous part. Instead of focusing on the local phenomena of gangrene pathology, treatment focuses on the general indications of the immune system, stressing the important role of the immune system as a whole. The aim was to show, through case reports, that Homeopathic therapy can treat gangrene thus preventing amputation of the gangrenous part, and hence has a strong substitution for consideration in treating gangrene.

The paper itself offers no less than 13 different homeopathic treatments for gangrene:

  1. Arsenicum album– Medicine for senile gangrene;gangrene accompanied by foetid diarrhoea; ulcers extremely painful with elevated edges, better by warmth and aggravation from cold; great weakness and emaciation.
  2. Bromium – Hospital gangrene; cancerous ulcers on face; stony hard swelling of glands of lower jaw and throat.
  3. Carbo vegetabilis – Senile and humid gangrene in the persons who are cachectic in appearance; great exhaustion of vital powers; marked prostration; foul smell of secretions; indolent ulcers, burning pain; tendency to gangrene of the margins; varicose ulcers.
  4. Bothrops– Gangrene; swollen, livid, cold with hemorrhagic infiltration; malignant erysipelas.
  5. Echinacea– Enlarged lymphatics; old tibial ulcers; gangrene; recurrent boils; carbuncles.
  6. Lachesis– Gangrenous ulcers; gangrene after injury; bluish or black looking blisters; vesicles appearing here and there, violent itching and burning; swelling and inflammation of the parts; itching pain and painful spots appearing after rubbing.
  7. Crotalus Horridus– Gangrene, skin separated from muscles by a foetid fluid; traumatic gangrene; old scars open again.
  8. Secale cornatum– Pustules on the arms and legs, with tendency to gangrene; in cachectic, scrawny females with rough skin; skin shriveled, numb; mottled dusky-blue tinge; blue color of skin; dry gangrene, developing slowly; varicose ulcers; boils, small, painful with green contents; skin feels too cold to touch yet covering is not tolerated. Great aversion to heat;formication under skin.
  9. Anthracinum– Gangrene; cellular tissues swollen and oedematous; gangrenous parotitis; septicemia; ulceration, and sloughing and intolerable burning.
  10. Cantharis – Tendency to gangrene; vesicular eruptions; burns, scalds, with burning and itching; erysipelas, vesicular type, with marked restlessness.
  11. Mercurius– Gangrene of the lips, cheeks and gums; inflammation and swelling of the glands of neck; pains aggravated by hot or cold applications.
  12. Sulphuric acid– Traumatic gangrene; haemorrhages from wounds; dark pustules; blue spots like suggillations; bedsores.
  13. Phosphoric acid– Medicine for senile gangrene. Gunpowder, calendula are also best medicines.

But the best of all must be the article’s conclusion: “Homeopathy is the best medicine for gangrene.

I know, there are many people who will not be able to find this funny, particularly patients who suffer from gangrene and are offered homeopathy as a cure. This could easily kill the person – not just kill, but kill very painfully. Gangrene is the death of tissue in part of the body, says the naïve little caption. What it does not say is that it is in all likelihood also the death of the patient who is treated purely with homeopathy.

And what about the notion that homeopathy stimulates the body’s ability to heal through its immune mechanisms?

Or the assumption that it might establish circulation to the gangrenous part?

Or the claim that through case reports one can show the effectiveness of an intervention?

Or the notion that any of the 13 homeopathic remedies have a place in the treatment of gangrene?

ALL OF THIS IS TOTALLY BONKERS!

Not only that, it is highly dangerous!

Since many years, I am trying my best to warn people of charlatans who promise bogus cures. Sadly it does not seem to stop the charlatans. This makes me feel rather helpless at times. And it is in those moments that I decide to look at from a different angle. That’s when I try to see the funny side of quacks who defy everything we know about healthcare and just keep on lying to themselves and their victims.

By guest blogger Dr Richard Rawlins (Orthopaedic and trauma surgeon and author of Real Secrets of Alternative Medicine)

The National Center for Complementary and Alternative Medicine (NCCAM) was the US Federal Government’s lead agency, under the auspices of the US National Institutes of Health (NIH), for scientific research on complementary and alternative medicine (CAM). Originally set up in 1991 as the Office for Alternative Medicine (OAM), its first Director, Dr Joseph J. Jacobs had impeccable scientific credentials and intentions but resigned two years later, telling Science he “blasted politicians – especially Senator Tom Harkin…for pressuring his office, promoting certain therapies and attempting an end run around objective science”, and expressing his concern he was expected to “dance to the tune of the alternative medicine lobby.” OAM changed its name to NNCAM in 1998 continuing with a remit “To answer important scientific questions about natural products, mind and body practices and pain management.” It has failed. It has become directed by those who have no intention of enquiring into any scientifically derived evidence as to whether CAMs have a beneficial effect on any specific condition, and is now directed by doctors who believe that they do, and who want to have CAM (SCAM/camistry – by whatever name known), integrated with regular orthodox progressive medical practice. Apparently still dancing to lobbyists’ tunes.

NCCAM even rebranded itself a couple of years ago, dropping any suggestion it might critically consider ‘alternative’ medical approaches such as chiropractic, osteopathy, acupuncture or homeopathy (all of whose founders or original proponents stated that their modalities were ‘alternative’ to the regular medicine of their day) – and is now styled as the ‘National Center for Complementary and Integrated Health’ (NCCIH).

Ad hominem commentary is normally best avoided, but when the NCCIH’s current Director speaks, we should take note. The 2019 New Year’s Message from Dr Helene Langevin M.D. allows us critical insight into her state of mind, her facility with logical fallacies, and her lack of critical thinking. All of which is important considering that the Center has spent $2.5B over the past ten years on research, and found no benefit from the modalities studied beyond the placebo. The Center’s current budget is $142M p.a.

Here follows Dr Langevin’s ‘2019 New Year message’, and a slightly more critical review (in italics) than her own insights and editing offered:

”It has been my longstanding conviction that integrative health care is more than just the sum of conventional and complementary health approaches. When combined, these approaches provide a frontier of new insights into the physiology of health and the pathophysiology underlying diseases and disorders. Dr. Straus, Dr. Briggs, and Dr. Shurtleff have built a strong foundation for NCCIH’s strategic priorities and partnerships.”

Dr Langevin fails to mention her predecessor Dr Josephine Brigg’s opinion when, as Director of the US National Center for Complementary and Alternative Medicine she said: “Integrative medicine represents an invasive rebranding of modern equivalents of ‘snake oil’ by practitioners who raise unrealistic hopes and promote approaches that are not sensible, supported by evidence or proven safe.”

“I plan to help the Center continue to reach beyond its walls and across NIH, encouraging an emphasis on health promotion, whole person care, and nonpharmacologic treatments, especially for pain management.”

What she plans is the integration of implausible pseudo-scientific modalities with regular medical practices. She ignores the wise words of Dr Mark Crislip: “If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.”

“Our current approach to patient care, in general, is fundamentally limited. It often emphasizes the treatment of disease alone, while it many times neglects the promotion, support, and restoration of health.”

That may be a valid critique of ‘our current approach’, but that need not be the case. Orthodox treatment can adopt the other dimensions Dr Langevin identifies without having to ‘integrate’ with CAM modalities.

“Integrative health care can help correct this limitation by giving more consideration to the patient’s long-term recovery and overall health when treating an acute illness or injury.”

But can only do so within a framework of implausible pseudo-science.

“Another limitation of the conventional medical approach is its specialization, based on the basic organization of the body into physiological systems, which can lead not only to fragmented health care, but also fragmented research.”

That is because as ‘medicine’ has advanced since the 16th century Enlightenment, and specialisation has allowed the more focussed scientific consideration and attention to detail that is necessary to advance understanding. The CAM modalities have failed to ‘move on’ and are anachronistic. Any perceived fault of ‘the conventional medical approach’ leading to ‘fragmented health care’ can be remedied by greater co-operation and collaboration amongst conventional doctors. ‘Integration’ with camists (who practice CAMs) is simply not necessary, and proves a distraction.

“In contrast, many traditional healing systems, especially those based on Eastern philosophies, emphasize an understanding of the person as a whole.”

That may be their emphasis – given the lack of scientific endeavour in ‘traditional’ systems, they can hardly do otherwise – they have little else to offer. But conventional medicine is doing all it can to ‘understand the person as a whole’, without the encumbrance of outmoded approaches.

“Further, the widespread role of pharmaceuticals as the default means of medical treatment is an important issue, and nowhere is this more urgent than for pain management.”

So, don’t use them! Conventional medicine can change its ‘default mode’, and does so in the face of scientific evidence.

“NCCIH is playing an increasing role in finding solutions to the current opioid crisis with research on non-drug approaches for pain.”

We must all look forward to published evidence of the benefit arising from NCCIH’s approach to pain management.

Happy New Year, and may the Wu be with you all. (Wu: Chinese, nothingness – wherein CAM resides.)

Lumbar spinal stenosis (LSS) is a common reason for spine surgery. Several non-surgical LSS treatment options are also available, but their effectiveness remains unproven. The objective of this study was to explore the comparative clinical effectiveness of three non-surgical interventions for patients with LSS:

  • medical care,
  • group exercise,
  • individualised exercise plus manual therapy.

All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.

Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. The primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).

A total of 259 participants were allocated to medical care (n = 88), group exercise (n = 84), or manual therapy/individualized exercise (n = 87). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care or group exercise. Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.

The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.

In many ways, this is a fairly rigorous study; in one important way, however, it is odd. One can easily see why one group received the usual standard care (except perhaps for the fact that standard medical care should also include exercise). I also understand why one group attended group exercise. Yet, I fail to see the logic in the third intervention, individualised exercise plus manual therapy.

Individualised exercise is likely to be superior to group exercise. If the researchers wanted to test this hypothesis, they should not have added the manual therapy. If they wanted to find out whether manual therapy is better that the other two treatments, they should not have added individualised exercise. As it stands, they cannot claim that either manual therapy or individualised exercise are effective (yet, I am sure that the chiropractic fraternity will claim that this study shows their treatment to be indicated for LSS [three of the authors are chiropractors and the 1st author seems to have a commercial interest in the matter!]).

Manual therapy procedures used in this trial included:

  • lumbar distraction mobilization,
  • hip joint mobilization,
  • side posture lumbar/sacroiliac joint mobilization,
  • and neural mobilization.

Is there any good reason to assume that these interventions work for LSS? I doubt it!

And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design.

And why do I find such studies objectionable?

Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective). To put it bluntly, such trials

  • could harm patients,
  • might waste money,
  • and hinder progress.

 

Benign prostate hypertrophy (BPH) affects many men aged 50 and older. It is caused by an enlargement of the prostate resulting in difficulties to urinate and to fully empty the bladder. There are several conventional treatment options, including life-style changes that are effective. In addition, a myriad of alternative therapies are being promoted, most of which are of doubtful effectiveness. Recently, a homeopathy-promoter, Dr Jens Behnke, triumphantly tweeted a trial of homeopathy for BPH allegedly proving that homeopathy does work after all. There is no conceivable reason why homeopathic remedies should have any effect on this (or any other) condition. Therefore, I decided to have a closer look at this paper.

The objective of this 5-centre, three-armed, open, randomised study was to evaluate the effectiveness of Homoeopathic Constitutional remedy (HC) and Homoeopathic Constitutional + Organ remedy (HCOM) in comparison to Placebo (PL) in patients suffering from BPH using International Prostate Symptom Score (IPSS), ultrasonographic changes in prostate volume, post-void residual urine, uroflowmetry and in WHO Quality of Life (QOL)-BREF. Patients were randomised into three groups in 2:2:1 ratio and were followed up for 6 months. The statistical analysis was done with modified intention-to-treat principle (mITT).

Of 461 patients screened, 254 patients were enrolled in the study and 241 patients were analysed as per mITT. The mean changes in IPSS and QOL due to urinary symptoms from baseline to end of study showed a positive trend in all the three groups. However, in the HC group, the changes were more prominent as compared to the other two groups. There was no difference between HC and HCOM groups and they were equally effective in terms of managing lower urinary tract symptoms due to BPH. With regard to secondary outcome, there was no difference between the groups. The psychological, social and environmental domains of WHOQOL-BREF have shown positive trend, but there was no statistically significant difference in intervention groups.

The authors concluded that statistical significance was found in the IPSS in all the three groups but only in HC and not in any of the objective parameters.

The paper is so badly written that I struggle to make sense of it. However, the above graph seems clear enough. The changes are perhaps statistically significant (which I find odd and cannot quite understand) but they are certainly not clinically relevant. Most likely, they are due to the fact that this study was not blind, meaning that patients and investigators were aware of the group allocations. This suggests to me that this study

  • is dubious in more than one way,
  • tests a hypothesis that lacks plausibility,
  • yields a result that is clinically irrelevant.

In other words, it does not amount to anything remotely resembling a proof of homeopathy’s efficacy.

Acupressure is the stimulation of specific points, called acupoints, on the body surface by pressure for therapeutic purposes. The required pressure can be applied manually of by a range of devices. Acupressure is based on the same tradition and assumptions as acupuncture. Like acupuncture, it is often promoted as a panacea, a ‘cure all’. While it certainly not a ‘cure all’, one may well ask whether it is good for anything.

The aim of this study was to evaluate the effect of acupressure on pain severity in patients undergoing a coronary artery graft. Seventy patients were selected randomly after coronary artery bypass grafting (CABG) surgery based on inclusion criteria and then assigned to two groups (35 in acupressure and 35 in control) randomly by the minimization method. The intervention group received acupressure at the LI4 point for 20 minutes in 10-second pressure and 2-second resting periods. In the control group, only touching was applied without any pressure in the same pattern as the intervention group. Pain severity was measured before, immediately, and 20 minutes after applying pressure and touch in both groups using the visual analogue scale.

The results of repeated measures analysis of variance showed a decrease in the pain score in the intervention group (group effect) during multiple measurements (time effect) and a reduction in the mean pain score in the various measurements taking into account the groups (the interaction between time and group; P = 0.001).

(1 = after regaining consciousness, 2 = 6 hours later, 3 = 7 hours later)

The authors concluded that acupressure can be used as a complementary and alternative therapeutic approach to relieve post-operative pain in CABG patients.

I find it hard to believe those results.

Why?

For several reasons:

  1. Even though the authors call this study ‘double blind’, it clearly was not. The patients were obviously able to tell whether pressure was applied or not. Similarly, the therapist applying acupressure cannot have been blinded.
  2. All patients received standard care. The control group received more anaesthetics than the acupressure group, according to the authors. I feel that the lack of pain control in the control group is not plausible and needs an explanation.

For me, the most plausible explanation of these (only seemingly impressive) results is that the therapist exerted influence other than acupressure on the patients which made the control group admit to more pain than the experimental group. One possibility is that social desirability made the acupressure group to claim they had less pain than they actually felt.

I came across an embarrassingly poor and uncritical article that essentially seemed to promote a London-based clinic specialised in giving vitamins intravenously. Its website shows the full range of options on offer and it even lists the eye-watering prices they command. Reading this information, my amazement became considerable and I decided to share some of it with you.

Possibly the most remarkable of all the treatments on offer is this one (the following are quotes from the clinic’s website):

Stemcellation injections or placenta lucchini (sheep placenta) treatments are delivered intravenously (via IV), although intramuscular (IM) administration is also possible. Stem cells are reported to possess regenerative biological properties.

We offer two types of Stemcellation injections: a non-vegetarian option and a vegetarian-friendly option. Please enquire for further details.

Alongside placenta lucchini, Stemcellation injections at Vitamin Injections London contain a range of other potent active ingredients, including: physiologically active carbohydrate, nucleic acid, epithelial growth factor, amino acids, hydrolysed collagen, concentrated bioprotein and stem cells.

Please visit our Vitamin 101 section to learn more about the ingredients in Stemcellation sheep placenta injections.

Renowned for their powerful regenerating properties, Stemcellation injections can stimulate collagen production as well as:

  • Remedy cosmetic problems such as wrinkles, discolouration, pigmentation, eye bags and uneven skin tone;
  • Can be undertaken by those who are interested in maintaining their physical activity levels;
  • Can be undertaken alongside other IV/IM injections.

Vitamin Injections London is headed by skilled IV/IM Medical Aesthetician and Skin Specialist Bianca Estelle. Our skilled IV/IM practitioners will conduct a full review of your medical history and advise you regarding your suitability for Stemcellation injections.

END OF QUOTES

The only Medline-listed paper I was able to locate on the subject of placenta lucchini injections was from 1962 and did not substantiate any of the above claims. In my view, all of this begs many questions; here are just seven that spring into my mind:

  1. Is there any evidence at all that any of the intravenous injections/infusions offered at this clinic are effective for any condition other than acute vitamin deficiencies (which are, of course, extremely rare these days)?
  2. Would the staff be adequately trained to diagnose such cases?
  3. How do they justify the price tags for their treatments?
  4. What is a ‘medical aesthetician’ and a ‘skin specialist’?
  5. Is it at all legal for ‘medical aestheticians’ and ‘skin specialists’ (apparently without medical qualifications) to give intravenous injections and infusions?
  6. How many customers have suffered severe allergic reactions after placenta lucchini (or other) treatments?
  7. Is the clinic equipped and its staff adequately trained to deal with medical emergencies?

These are not rhetorical questions; I genuinely do not know the answers. Therefore, I would be obliged, if you could answer them for me, in case you know them.

 

2019 starts well, namely with a comment entitled ‘Unproven medicines a risk to health and wallet’ on the recent statement of the Australian Medical Association (AMA) . As it is remarkable in that it confirms what I have been saying ad nauseam for years, I reproduce it here in full:

Australians are in danger of wasting their money on unproven complementary medicines and therapies, which could not only have serious side effects but could also leave them unable to pay for evidence-based treatments.

The AMA has released its updated Position Statement on Complementary Medicine 2018, which reflects changes to State laws and national monitoring systems that have come into place since the Position Statement was last reviewed in 2011-12.

AMA President, Dr Tony Bartone, said that Australian complementary medicine industry revenue had doubled over the past 10 years to $4.9 billion annually, including $630 million on herbal products and $430 million on weight loss products in 2017.

“While the AMA recognises that evidence-based aspects of complementary medicine can be part of patient care by a doctor, there is little evidence to support the therapeutic claims made for most of these medicines and therapies,” Dr Bartone said.

“The majority of complementary medicines do not meet the same standards of safety, quality, and efficacy as mainstream medicines, as they are not as rigorously tested.

“Some can cause adverse reactions, or interact with conventional medicine. Most just don’t do anything much at all.

“But they do pose a risk to patient health, either directly through misuse, or indirectly if a patient puts off seeking medical advice, or has spent so much on these products that they cannot afford necessary, evidence-based treatment.

“Children are particularly vulnerable, as diagnosing and treating illness in children is complex. A doctor must be involved in any diagnosis and ongoing treatment plan, including the use of complementary medicine.”

Dr Bartone said the AMA had long advocated for better regulation of non-registered health practitioners, such as naturopaths, herbalists, and Ayurveda practitioners.

“We have seen some positive changes over the past six years,” Dr Bartone said.

“All States and Territories now have regulations to protect Australians from unsafe and unethical practitioners.

“All unregistered practitioners must comply with a code of conduct, and they can be sanctioned or banned if they breach the code.

“But we still do not have a national, public register of non-registered practitioners who have been banned from working in their State or Territory, despite all Governments agreeing in 2015 to establish one.

“This register should be established as quickly as possible to alert the public and potential employers of any risks.”

The AMA Position Statement on Complementary Medicine 2018 is at https://ama.com.au/position-statement/ama-position-statement-complementary-medicine-2018

Background

  • Complementary medicine includes a wide range of products and treatments with therapeutic claims that are not presently considered to be part of conventional medicine.
  • These include herbal medicines, some vitamin and mineral supplements, other nutritional supplements, homeopathic formulations, and traditional medicines such as ayurvedic medicines and traditional Chinese medicines.
  • Complementary therapies include acupuncture, chiropractic, osteopathy, naturopathy, and meditation.
  • Registered health practitioners are those who are registered under the Health Practitioner Regulation National Law in force in each State and Territory. They include doctors, nurses, dentists, occupational therapists, and other allied health practitioners.

END OF QUOTE

These are clear and timely words indeed!

One would wish that other national medical associations would have the courage to ignore the numerous and often powerful lobby groups that try to prevent them from following suit and issuing similarly clear, evidence-based and helpful comments. They have a responsibility to protect the public from exploitation and dangers to health, in my view.

“An optimist stays up until midnight to see the New Year in. A pessimist stays up to make sure the old year leaves.” (Bill Vaughan)

Any New Year resolutions?

As far as my blog is concerned, I can think of a few:

  1. Be more polite to people whose opinions differ from mine. I have to admit that I sometimes find it hard to respond politely to offensive or offensively stupid comments. I will try to improve in this respect.
  2. Try harder to keep an open mind (while being careful that my brain does not fall out in the process).
  3. Avoid technical lingo so that all people understand what I am trying to say.
  4. Try to enlarge the readership of my blog (not quite sure how to do this; perhaps by sticking to my resolutions?).
  5. Cover more areas of alternative medicine. I have always strived to include even the most exotic modalities; the problem, however, is that most are not supported by evidence, and in the absence of evidence I don’t know what to discuss.
  6. Report more positive results; the problem is that there are very few sound studies with positive findings – but I will try.
  7. Have fun.

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