Rapid Responses to:

LETTERS:
George T Lewith
Funding for CAM
BMJ 2007; 335: 951 [Full text]
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[Read Rapid Response] Not accurate
Michael F Vagg   (14 November 2007)
[Read Rapid Response] Re: Not accurate
Hilary Butler   (15 November 2007)
[Read Rapid Response] Re: Not accurate
John P Heptonstall   (16 November 2007)
[Read Rapid Response] Reply
Michael F Vagg   (19 November 2007)
[Read Rapid Response] Re: Reply
John P Heptonstall   (22 November 2007)
[Read Rapid Response] Re: Re: Reply
Michael Faltesek   (23 November 2007)
[Read Rapid Response] To Dr Vagg: wherein does "evidence" start?
Hilary Butler butler@watchdog.net.nz   (23 November 2007)
[Read Rapid Response] Re: Re: Re: Reply
John P Heptonstall   (24 November 2007)

Not accurate 14 November 2007
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Michael F Vagg,
Consultant in Rehabilitation and Pain Medicine
Geelong, Australia 3220

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Re: Not accurate

Lewith's assertion that 'CAM' treatments are used in pain clinics is based on a confusion between 'mind body treatments' and legitimate cognitive-behavioural therapy, which has consistently proven effective in self-management of chronic pain. Similarly, he may be confusing acupuncture (for which there is no rational scientific basis) with dry needling techniques for myofascial pain (for which there is a rationale and in vivo experimental evidence of benefit ).

His assertion that 'Much of our current conventional pharmacopoeia is derived from herbals' is mostly true but irrelevant in the context of the topic under discussion. Is Lewith suggesting that we should use ground fungus instead of cyclosporin ?

The history of the enlightenment would suggest that old knowledge should be discarded in the light of new evidence. Homeopathy, chiropractic and herbalism to name but three adhere to received doctrines which have not changed despite at least a century of evidence that they are ineffective. A sensible approach to the acquisition of knowledge should include a preparedness to accept negative evidence when it is presented .

Competing interests: None declared

Re: Not accurate 15 November 2007
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Hilary Butler,
freelance journalist/mother
home New Zealand 2121

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Re: Re: Not accurate

Michael Vagg's comments including these statements...:

>>>Homeopathy, chiropractic and herbalism to name but three adhere to received doctrines which have not changed despite at least a century of evidence that they are ineffective.<<<

... shows me several things, but first a digression.

Along with millions of people, I have used my own herbs with considerable success. I have a raft of herbals that work very well with the flu for instance. Doctors say that what is needed to stop the flu is a vaccine and when that doesn't work, miserable people are prescribed paracetamol, tamiflu, a cough suppressant, as well as antibiotics, for those secondary infections that might come along.

I've had minimal usage of homeopathy, but when I have, it too has been successful. A chiropractor got rid of a headache that neither the doctor, physio or paracetamol would budge.

These MILLIONS of people who prefer CAM would stop using it if it wasn't working.

What has been notable to me is that when I went to the doctor with various issues, first line "solutions" to problems were expensive prescription drugs, or a steroidal cream, one of the now banned Cox-3 inhibitors, all items designed to remove a wodge out of my wallet.

I declined them all, decided to use CAM and on the back of "negative evidence" got better. Either because of, or in spite of.

I'd say this state of affairs might apply to MILLIONS of other people as well.

If "negative evidence" helps so many people better, what is the rationale for the wholesale prescriptions of potentially toxic, very expensive drugs etc, for conditions, which Dr Vagg will maintain that CAM didn't fix at all? If all I needed was to sit and wait or be given a placebo, why then prescribe unnecessary expensive, potentially toxic drugs?

Is arguing against funding CAM more a cover for making sure that the "just in case" pharmaceutical profits are kept as high as possible, for perhaps "no good reason"?

Vagg says: >>>The history of the enlightenment would suggest that old knowledge should be discarded in the light of new evidence. <<< Yes, I notice that so many people talk about how much safer and preferable caesarians are these days....

Maybe some lessons can be learned by doctors from the realisation that some people are done with the first line "best practice" of being vaccinated, drugged etc, and being expected to comply like automatons for something that feels like supporting a doctor/pharmaceutical partnership. Maybe there is more to "medicine" than that, and just perhaps, CAM sometimes supplies it.

Hilary Butler.

Competing interests: None declared

Re: Not accurate 16 November 2007
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John P Heptonstall,
Director of the Morley Acupuncture Clinic
Leeds LS27 8EG

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Re: Re: Not accurate

Could Michael F Vagg qualify his statement "acupuncture (for which there is no rational scientific basis......)" as it is at odds with multitudinous published research, global demonstrations and anecdote amongst billions of peoples, empirically derived (and recorded in classical texts) evidence over millennia, and World Health Organisation assessments and subsequent recommendations for more than 30 years?

Regards

John H.

Competing interests: Traditional Chinese Medicine Specialist

Reply 19 November 2007
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Michael F Vagg,
Consultant in Rehabilitation and Pain Medicine
Geelong Australia 3220

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I am happy to address John Hepponstall's query to clarify that the basis for acupuncture in TCM is the flow of Chi/Qi through meridians. There is no anatomical or physiological evidence for the existence of these meridians despite much research. The literature on acupuncture's effectiveness has the overall pattern of a non-effective treatment, ie small trials are promising but the higher quality the study, the smaller the treatment effect, with the most rigorous studies being negative. My comment was intended to highlight the logical fallacies used in defence of acupuncture and other such treatments. Anecdotes, cultural appropriateness and small unblinded trials are not the stuff of which a credible treatment is made. Arguments from popularity or authority are also not scientific and rational, as even the wisest authority can be mistaken on any particular issue. Practitoners of TCM cannot simply retreat into their practices whenever negative evidence emerges if they wish to be taken seriously. If they don't wish to follow scientific method like the rest of us, discussions such as this are essentially meaningless.

Competing interests: None declared

Re: Reply 22 November 2007
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John P Heptonstall,
Director of the Morley Acupuncture Clinic
Leeds LS27 8EG

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Rather than detail here for Mr Vagg a necessarily large quantity of examples from an enormous number of studies that inform chronologically on TCM research, practices and principles and generate the scientific evidence that proves the existence of, and many characteristics of, TCM phenomena such as meridians, acupoints and Qi, that Vagg has probably never read, I will now place that data at www.morleyacupunctureclinic.co.uk under ‘Research and General Information on TCM’ article 2 on research developments in China from 70s to 90s for easy access.

To help inform Mr Vagg in this medium I will begin by quoting WANG Xuetai of the Chinese Academy of Traditional Chinese Medicine, Beijing, in his “The Exploration on the Tendency of the Development of Acupuncture- Moxibustion from its History” World Journal of Acupuncture & Moxibustion, Vol 3, No 4, December 1993 and “The Current Situation and Prospects of Acupuncture”, World Journal of Acupuncture & Moxibustion, Vol 7, No 4, December 1997 – comments already 10 years old.

“Since the seventies our researchers have observed the propagated sensation, paresthesia and skin diseases along meridians, transmission of sound information, isotopes, weak illuminance phenomena along meridians, and there has been a new progress in research on the correlation between internal organs and points on the meridians, and the electric characteristics of skin along the meridians. Thus the objective existence of the meridian phenomenon, its specific properties and conditions of appearance have been demonstrated and mastered preliminarily by thoroughgoing investigation…by means of various kinds of new measurements of detection such as the infrared radiometry, energy spectrometry, detection of magnetic information, effect of pressure and electric field and the electrostatic concentration etc. scientific researchers have proved ‘the external Qi’ put out by the master of Qigong, and also observed its influence on living beings and microbio-organisms. The above progress of research indicates that, in the process of exploring life phenomena scientists are making a break through the limitation of experimental methods of reductive analysis in western medicine and introducing directly the newest scientific method, especially the detective measurements of information, into the field of human body science…In the time of flourishing science, people have already recognised that there are three important elements, information, energy and matter, which constitute the universe. Thus the human body can undoubtedly be manifested comprehensively by these three elements. We can not help being sorry to indicate that the human science has been limited much more in the structure and function only with less investigation on the information of the human body up to now…(In 1997 paper he added new advances of the early 90s including…) distribution of Ca ions ++ along meridians and its formative mechanisms, appearance of liquid crystal substance along meridians, relationship between extracellular matrix and meridians etc…and some results from acupuncture clinics and meridian studies have shown the possible close relation of connective tissue with the essence of meridians”.

Ten years ago, by 1997, researchers had also reported numerous studies using electron microscopy of the ‘ultrastructures’ affected and effected by acupuncture, whilst a team at Xian Medical University Research Laboratory of Meridians reported discoveries of neuromastocytic junctions, a junction specifically established between the expanded axon terminal and certain mast cell belonging to type A junction (already reported by ZHANG in 1985), axons approaching the junction run in the direction of the meridian and a link with Substance P activity also strongly suggested association with the meridian phenomenon. A multidisciplinary team in Beijing from the Institute of Biophysics, Hospital of Qinyang, Hospital of TCM, Union Medical College and Institute of Aeronautics and Astronautics, studied the low impedance nature of meridian lines on the epidermis and stratum corneum and its morphology etc. They evidenced the existence of meridian lines/channels, that the Chinese have long known as conduits for Qi, blood and other substances.

The lines/meridians involve cellular structures, including nerve and mast cells and others, communicating energetically at specific frequencies throughout the whole body maintaining equilibrium through feedback from and to every point of consciousness. The meridian lines are characterised by low electrical resistance therefore higher conductivity to facilitate this communication, are generally fixed anatomically, have the ability to override and reroute signals during damage or inhibition of communication at local sites. Each acupoint has its own ‘sound’ identification 'code' for ease of communication with control structures, and meridians that connect with and pertain to certain internal organs were shown to be capable of communication with those organs.

Qi refers to vital energy, energy that is associated with life. In western medical terms energy has a much more limited meaning, ATP is one form understood by medical research chemists looking at the human body. According to TCM there are many forms of Qi, many forms of energy (just like the general physics concept of energy), for example energy derived by through respiration, food and drink, plus that derived at birth from parents, a universality of the concept Qi includes every form known (and as yet unknown) to man.

Meridian energy is characterised by weak bioluminescence identified in Chinese research during the 70s and 80s which evidences electromagnetic signals travelling between cells along meridians; magnetic and electrical signals have been identified along meridian lines, Russian biophysicists identified radiation emission spectra from human cells intracellular structures such as mitochondria and nuclei many decades ago including visible light in HeNe wavelengths, ultra violet, infrared and plasma emissions from various intracellular structures – emissions suggestive of potential for universal intercellular electromagnetic communication.

TCM is founded on empirically derived, well tried and tested, proven research and practices thus illustrating how much safer, and in many cases more powerful, are its forms of intervention than western medicine (WM). It carries an infinitesimal risk of serious injury as compared to WM which is statistically proven to be the most injurious, in terms of mortality and morbidity, cause known to man. For that reason alone one ought to question the protocols and ‘science’ that underpin practices and principles fundamental to WM research that result in such potentially dangerous interventions; one can learn from the Chinese and their evolution of TCM. Every western medical physician ought to become aware of the effectiveness, efficacy, safety and range of disorders treatable successfully by TCM modalities and the enormous wealth of scientific data that underpins TCM. The public deserves no less from those assuming the task of promoting health.

John H.

Competing interests: Traditional Chinese Medicine Specialist

Re: Re: Reply 23 November 2007
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Michael Faltesek,
Self Employed
Self Employed, 98122

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If these tests are so accurate, and meridians and qi do exist. Why is it when studies with extremely good methodology (i.e using control groups along with people thinking they are receiving real acupuncture even though it is sham acupuncture, or the study where there was a sheath around the needle and the needle never even pierced the skin) that it always turns out that either acupuncture shows no efficacy or shows the same efficacy as fake acupuncture.

Fake acupuncture is defined as randomly placing needles in the skin, not deep enough to touch the meridians.

Seeing as how this is the case, it could be argued that there is some mechanism that helps us by the mere simple act of sticking needles in your skin, but that means that we should all save ourselves some money because paying for the expertise doesn't make a difference. Just stick yourself with needles at home.

Also, if you did it at home, it would most likely be MORE hygienic as subscribers to the acupuncture dogma typically don't accept the concept of germ theory (I could be generalizing but this is based off my anecdotal evidence combined with the core beliefs of acupuncture) , so why be hygienic?

Also, do not take in to account studies that group acupuncture in with the practice where they stick needles in your body and send an electric current through the needles. this artificially skews the results because:

A) it is NOT acupuncture

B) electricity already has proven efficacy when it comes to pain. In short, you hurt somewhere, run electricity through it, it will hurt less. But again, this is NOT acupuncture.

It is important to look into the methodology of studies that come out and not rely on their conclusion. A very common pattern for treatments that do not work is that when tests are small, or done poorly with bad methodology, it shows promise. But as the tests become more thorough and have better methodology the effectiveness slowly disappears. This is the case with acupuncture, do not be fooled, it is a sham.

National Council Against Health Fraud : NCAHF Position Paper on Acupuncture http://www.ncahf.org/pp/acu.html.

Acupuncture and Knee Osteoarthritis A Three-Armed Randomized Trial Hanns-Peter Scharf, MD; Ulrich Mansmann, PhD; Konrad Streitberger, MD; Steffen Witte, PhD; Ju ̈ rgen Kra ̈ mer, MD; Christoph Maier, MD; Hans-Joachim Trampisch, PhD; and Norbert Victor, PhD Ann Intern Med. 2006;145:12-20. www.annals.org. Never letting data get in the way of conclusions.

Meta-Analysis: Acupuncture for Low Back Pain Eric Manheimer, MS; Adrian White, MD, BM, BCh; Brian Berman, MD; Kelly Forys, MA; and Edzard Ernst, MD, PhD Intern Med. 2005;142:651-663. www.annals.org. More intellectual dishonesty from what was once a trusted source of medical information.

Competing interests: None declared

To Dr Vagg: wherein does "evidence" start? 23 November 2007
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Hilary Butler butler@watchdog.net.nz,
Freelance journalist.
Home, Tuakau, 2121, New Zealand.

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Re: To Dr Vagg: wherein does "evidence" start?

Dear sir,

If I was head scratchingly bemused at Dr Vagg's first reponse, I was hilariously gobsmacked at his second. For a moment, I thought I had ventured onto a site containing Monty Python scripts:

>>>>Anecdotes, cultural appropriateness and small unblinded trials are not the stuff of which a credible treatment is made. Arguments from popularity or authority are also not scientific and rational, as even the wisest authority can be mistaken on any particular issue.<<<<

Sure he doth jest?

What is evidence? Is it the word of the patient who goes to a doctor and says "I have this big lump here...." thereby the doctor makes a diagnosis?

Is evidence the word of a medical practitioner who says "I think this might work, so lets see if we can prove my opinion?

Was it the "anecdote" that set William Pickering on the trail of Digitalis? Though his 1775 paper is today considered a classic, anyone familiar with medical history of the time is familiar with the expressed fear of his colleagues who considered his protocols outrageous, far too toxic, and who publicly condemned him as a potential murderer or menace.

Even if you fast forward to the 1900's medical literature you see absolute anecdotal classics passed off as wonderful medical advances, such as:

"Preparation of [autologous]diphtheria vaccine", Dr A. Cowan Guthrie, BMJ Sept 28, 1935 pg 602. In Monty Python vein, this could be described as your 'every doctor's guide as to how to make a vaccine for your patient in your kitchen."

Or how about the Lancet, March 23, 1935, Page 703, where Dr W.H. Palmer described how there is no doubt that his "kitchen" vaccine made from daffodil stalks, to prevent lily rash, works a treat.

Those of us who make a habit of looking at "evidence" cannot understand why it is, when you go to a site like www.clinicaltrials.gov and stick in any of the new vaccine trials, you see such a comprehensive list of exlusionary criteria, which have always applied in the past and we have no doubt will apply in the future.

This list usually applies through all phase trials, and yet, when it is declared "safe", parents are then told the vaccine is safe for their perhaps immunosuppressed child who needs it even more than healthy children! Yet said type of child (and many other "fragile" children) never even made the cut for any phase trials whatsoever!

So then, when you look at evidence, what is evidence?

Where is the proof? How much of what is done today is, as Professor Silverman* said in his instructive comments, the "lets try it and see" approach:

>>>>The impatient let's-try-it-and-see approach in the burgeoning field of neonatal medicine has resulted in therapeutic disaster after disaster. It is extremely difficult, I've learned over the years, to convince physicians about the importance of a hard-won modern lesson (the amazing sulfisoxazole incident was the most indelible and instructive example).

Since knowledge in medicine is never complete, the use of concurrent controls in clinical trials of proposed interventions cannot prevent all therapeutic catastrophes. But the precaution can always bring about a substantial reduction in the number of patients maimed and killed as the result of inevitable surprises!<<<<<<

One of the biggest problems in medicine today, is that doctors who only reach for the Merck Manual, behave is if they know it all. And when a patient comes with anecdote and says "Hey, Jeeves, this acupuncture/homeopathy/herbal worked a treat!" they are told "That's not evidence!"

When you look at ALL the treatments available in your doctor's waiting room, how many of them are based on evidence which fulfills the criteria Dr Vagg would have Dr Heptonstall produce?

For those who have had a long hard look into the cupboard on locked away medical history, it looks to us as if "anecdote" can be manipulated to mean "evidence" when it suits a doctor, or a vaccine trial to make it appear so.

Isn't it odd that when it comes to the views of their patients, or any potential treatment protocol which might fall outside technocentric pharmacology, that the standards of 'evidence' required by the Vagg's of this world, from the Heptonstalls of the world, appear not to be the standards of evidence to which, in practice, the Vaggs would adhere themselves!

Which has got to be very strange, don't you think?

Hilary Butler.

* Silverman WA (2003). Personal reflections on lessons learned from randomized trials involving newborn infants, 1951 to 1967. James Lind Library (www.jameslindlibrary.org). Accessed Friday 23 November 2007. http://www.jameslindlibrary.org/essays/cautionary/silverman.html

Competing interests: None declared

Re: Re: Re: Reply 24 November 2007
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John P Heptonstall,
Director of the Morley Acupuncture Clinic
Leeds LS27 8EG

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To respond to Michael Falteseks’ points...

He says

“If these tests are so accurate, and meridians and qi do exist. Why is it when studies with extremely good methodology (i.e. using control groups along with people thinking they are receiving real acupuncture even though it is sham acupuncture, or the study where there was a sheath around the needle and the needle never even pierced the skin) that it always turns out that either acupuncture shows no efficacy or shows the same efficacy as fake acupuncture.”

If you identify such studies I will explain.

There is no such thing as sham, or fake, or pretend acupuncture – these are figments of the imagination of people who neither understand acupuncture nor the principles underpinning the modality – some of whom have attempted acupuncture trials and received criticism from professionals In that regard, perhaps Michael has not read that criticism? Ipsofacto they are an irrelevance and any protocol purporting to use them to evaluate acupuncture cannot be valid.

“Also, if you did it at home, it would most likely be MORE hygienic as subscribers to the acupuncture dogma typically don't accept the concept of germ theory (I could be generalizing but this is based off my anecdotal evidence combined with the core beliefs of acupuncture), so why be hygienic?”

I do not know anyone who practices as an acupuncturist in the UK who fails to adopt hygienic practices; why is acupuncture done at home necessarily more hygienic than at a clinic designed for hygiene?

I know of no ‘core belief of acupuncture’ (which is a technique and not a belief system anyway) that does not accept germ theory. Can Michael explain? I know that people from various disciplines including western medicine do question germ theory; I have heard debate about whether Pasteur plagiarised works of others such as Bechamp (one of the most decorated French research scientists of all time), and if Bechamp’s theory that disease can originate from within (healthy human cells can be caused to mutate into virulent forms given the right pathogenic environment) as well as from without (germ theory of Pasteur) is more accurate. Traditional Chinese Medicine holds a core belief that disease can develop both from within and without – perhaps western medicine can learn from that more comprehensive view of reality.

“Also, do not take in to account studies that group acupuncture in with the practice where they stick needles in your body and send an electric current through the needles. this artificially skews the results because: A) it is NOT acupuncture B) electricity already has proven efficacy when it comes to pain. In short, you hurt somewhere, run electricity through it, it will hurt less. But again, this is NOT acupuncture. “

It is ELECTROACUPUNCTURE when a needle is inserted into an acupoint and an electroacupunctoscope is used to pass a small current through an electrode attached to needles to stimulate the acupoint. Using the wrong current, or the wrong intensity, or the wrong waveform, can INCREASE the pain. Educated use can effect good pain relief. Michael may be confusing the inevitable pain relief of the effects of the punitive electric chair with the qualified use of tiny currents from battery-operated machines used in electroacupuncture for healthy pain relief.

“It is important to look into the methodology of studies that come out and not rely on their conclusion. A very common pattern for treatments that do not work is that when tests are small, or done poorly with bad methodology, it shows promise. But as the tests become more thorough and have better methodology the effectiveness slowly disappears. This is the case with acupuncture, do not be fooled, it is a sham. “

I see Michael has, perhaps unwittingly, appended two studies of the type he describes as his references; neither has a protocol that should used to evaluate acupuncture, and appear to have been designed with very many core misconceptions about acupuncture usage.

Finally, Michael states

“Fake acupuncture is defined as randomly placing needles in the skin, not deep enough to touch the meridians”.

One must wonder whose definition that is, I have neither read not heard that before despite over 20 years in TCM practice, perhaps it was drawn from the notoriously imaginative creations of NCAHF which appears to be Michael’s key source of inspiration?

Competing interests: Traditional Chinese Medicine Specialist