Qi Spot

A buzz topic now is the translation of the government label “No Approved Therapeutic Claims” into Filipino.  The term “No Approved Therapeutic Claims” was used for “food supplements” – a blanket term for non-big pharma produced products, usually “natural” or “herbal” medicine.

“No Approved Therapeutic Claims” thus means – “the claims of these products are not validated by the BFAD/FDA (Bureau of Food and Drugs, now renamed Food and Drug Administration).  What happens then is I can market a “natural” product as a “food supplement” and not as a medicine and it doesn’t have to go through same research as big pharma products.

The problem on this end is that there is a myriad of lousy products out there.  I am an advocate of Chinese herbal medicine but I am also the first to caution against lousy products that only end up harming the patient and the reputation of Chinese medicine.  in China, you see news about companies being penalized for putting out lousy products.  What about us?

Health Secretary Esperanza Cabral has good intentions.  We should be protected from bogus products.  I however, do not agree with the new translation for food supplement “warnings”.  I shan’t print the Filipino version here, but I can tell you it means “this product is not medicine and cannot cure any disease.”

This is obviously where I have a beef.

As a Chinese medicine doctor, I cannot agree that just because something is not produced by Big Pharma, it cannot be considered, “medicine.”  The American Heritage Dictionary defines medicine as “An agent, such as a drug, used to treat disease or injury.”  Note, it says an agent, SUCH AS a drug.  This means that there are other agents, while NOT drugs, that can be used to treat disease or injury.

To the Chinese, one of the most important agents are not just food “supplements”, but food itself.

Sun Simiao is known as the “Yao Wang” or “King of Medicinals”.  He is famous for a book entitled “Prescriptions Worth a Thousand Gold”.  Yet here is this important quote from him:

“Doctors should first understand the cause of disease, then treat it with diet. (Herbal) Medicine should only be used if diet fails” – Sun Simiao

Wow, the “King of Medicinals”, famous for life saving herbal prescriptions… recommends DIETARY therapy?!!  Good luck hearing that from Big Pharma.

Unfortunately this applies to "herbal medicine" product hawkers also. Image by Mike Adams. http://www.naturalnews.com/021638_conventional_medicine_quackery.html

Anyway my final thoughts are these:

1) We should not put down the idea of “food as medicine” as it is actually more effective for a lot of common, everyday problems.

2) The Chinese have this down to a science and I’ll be darned  - the stuff works.  Click http://www.meridianpress.net/intro.html for more info.

3) At the same time, a lot of food supplement products out there are just bunk.  Better not to rely on products made by people who just want your money.  Do your homework.  Pick a tradition of diet therapy (western, Chinese, whatever) and stick to it.

4) Don’t think that one herb or one fruit or one vegetable will solve all your ills.  Make lifestyle adjustments as well.

Now I’m off to get a nice porridge breakfast.  Be well!

http://nephropal.blogspot.com/2010/05/halloween-comes-early.html

Am tired from travel. But this is worth looking into:

A new study by French and British researchers examined 72 new drug therapy studies to evaluate if there was a spin on the conclusions for the benefit of the drug.

“More than 40% of the reports had spin in at least 2 of these sections in the main text.”

Reuters link

Abstract:

Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes

Isabelle Boutron, MD, PhD; Susan Dutton, MSc; Philippe Ravaud, MD, PhD; Douglas G. Altman, DSc
JAMA. 2010;303(20):2058-2064.

Context Previous studies indicate that the interpretation of trial results can be distorted by authors of published reports.

Objective To identify the nature and frequency of distorted presentation or “spin” (ie, specific reporting strategies, whatever their motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes.

Data Sources March 2007 search of MEDLINE via PubMed using the Cochrane Highly Sensitive Search Strategy to identify reports of RCTs published in December 2006.
Study Selection Articles were included if they were parallel-group RCTs with a clearly identified primary outcome showing statistically nonsignificant results (ie, P .05).

Data Extraction Two readers appraised each selected article using a pretested, standardized data abstraction form developed in a pilot test.

Results From the 616 published reports of RCTs examined, 72 were eligible and appraised. The title was reported with spin in 13 articles (18.0%; 95% confidence interval [CI], 10.0%-28.9%). Spin was identified in the Results and Conclusions sections of the abstracts of 27 (37.5%; 95% CI, 26.4%-49.7%) and 42 (58.3%; 95% CI, 46.1%-69.8%) reports, respectively, with the conclusions of 17 (23.6%; 95% CI, 14.4%-35.1%) focusing only on treatment effectiveness. Spin was identified in the main-text Results, Discussion, and Conclusions sections of 21 (29.2%; 95% CI, 19.0%-41.1%), 31 (43.1%; 95% CI, 31.4%-55.3%), and 36 (50.0%; 95% CI, 38.0%-62.0%) reports, respectively. More than 40% of the reports had spin in at least 2 of these sections in the main text.

Conclusion In this representative sample of RCTs published in 2006 with statistically nonsignificant primary outcomes, the reporting and interpretation of findings was frequently inconsistent with the results

Statistical proof of what we’ve been saying all along.  We can make studies say what we want.

Let the good times roll.  Another study, as reported in various articles online, shows evidence that acupuncture works.  Ho hum, what’s new?

The difference is the method of evaluating the effect.  Instead of asking patients, hey does it hurt less?  They did Quantitative sensory testing.

What’s that?

The University of Chicago website defines quantitative sensory testing as:

Quantitative sensory testing (QST) is a method used to assess damage to the small nerve endings, which detect changes in temperature, and the large nerve endings, which detect vibration.

QST is used to diagnose and assess the severity of nerve damage, especially in the small nerve endings. It can also help determine if a neuropathy is responding to treatment. It is used to diagnose many different types of neuropathies, including peripheral neuropathies. It may also be used to identify where the nerves are damaged.

(It) ses a computer testing system to measure how the nerves involved react to vibration and changes in temperature. The test results are compared to a series of “normal” patients as well as to the patient’s unaffected side. (from http://peripheralneuropathycenter.uchicago.edu/

learnaboutpn/evaluation/quant/index.shtml or http://bit.ly/bb7gfC)

Quantitative Sensory Testing

Photo from http://www.neurology.upmc.edu/neuromuscular/patient_info/testing.html

Pretty objective, if you ask me.

So what does the article say?

Dr. Philip Lang and colleagues of the University of Munich used quantitative sensory testing to identify changes in pain sensitivity with acupuncture in 24 healthy volunteers.
After applying acupuncture to the leg, the researchers found that pain thresholds increased by up to 50 per cent. Effects were noted in both the treated leg and the untreated (contralateral) leg.

…It includes tests of both thermal perception (heat and cold), and mechanical perception (pressure applied to the skin).

The patterns of response provide diagnostic information in patients with nerve injury regarding the type of nerve involved, and possible treatments.

Okay, in real life this is how it goes.  Sometimes people have nerve damage.  This obviously leads to decrease in sensations.  A perfect example would be a diabetic with peripheral neuropathy.  Peripheral neuropathy means that the nerve damage occurs at the very ends of the body – fingers and toes.  This test serves to try to measure the nerve response to various external stimuli. In this case, temperature change and pressure, among others.

It is also quantitative, meaning it is measured with numbers.  No more “uh I think it hurts a bit less” here.  Stimulus is given and we see how the nerves respond.

In this case, the body’s threshold of pain is increased – meaning treatment is effective and that a patient can tolerate pain better.

The results pointed to two nerve fibres-the ‘A delta’ pain fibers and the ‘C’ pain fibers-as being specifically affected by acupuncture.

Confirms what Berman, Pomeranz and Stux have been saying for decades.

Although the effects were modest, the researchers believe they provide the basis for future studies in individuals with chronic pain, where the effects might be more dramatic.

Here’s the crazy part.  An objective mind sees it this way, while a skeptic will say the effects are negligible so why bother.  A skeptic will also point out that it’s “just” a pilot study. Excuse me while I go find a toilet to relieve my nausea in.

Oh, and remember how I said that acupuncture can be dependent on the practitioner?

An experienced acupuncturist performed all treatments, applied to acupuncture points commonly used in pain management.

No newbies here who might eff things up!  I’m sure this acupuncturist had good skeeeelz.

And finally,

The results provide a scientific background for the ancient practice of acupuncture, according to Dr. Dominik Irnich, the study’s leading author.

“Our results show that contralateral stimulation leads to a remarkable pain relief. This suggests that acupuncturists should needle contralaterally if the affected side is too painful or not accessible-for example, if the skin is injured or there is a dressing in place,” added Irnich.

Dr. Steven L. Shafer, Editor-in-Chief of Anesthesia & Analgesia and Professor of Anesthesiology at Columbia University, views the results as an important preliminary finding.

“Reproducible findings are the cornerstone of scientific inquiry. The authors have clearly described their methodology, and their findings. If other laboratories can reproduce these results in properly controlled studies, then this provides further support for the scientific basis of acupuncture. Additionally, the ability of quantitative sensory testing to identify specific types of nerves involved in pain transmission may help direct research into the mechanism of acupuncture analgesia,” commented Shafer.

The study has been published in the May issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

Note that the authors mention that contralateral needling works.  This is not a new discovery.  It fits perfectly with the Chinese theory of meridians and collaterals.  According to this, the meridians go up and down and are the big lines you see in point charts.  However, the collaterals also exist that connect one side to another.  While the existence of meridians may be doubted by some, the implication of this belief in meridians and collaterals indicates that what we are verifying scientifically now has been long known by the Chinese since ancient times.  May I also add, that the ancient Chinese put much weight in clinical experience.  They didn’t know how it was happening, but they saw what treatments work through trial and error.  I am glad that, thousands of years later, their hard work is paying off handsomely.

http://timesofindia.indiatimes.com/Life/Health-Fitness/Health/Acupuncture-the-best-bet-to-ease-pain/articleshow/5883083.cms

Enough with answering back at mudslingers.  I get more than enough of that in the local media, with the Philippine elections just around the corner.  Let’s move on to being proactive instead of being defensive.

A common “debunking” technique of anti-acupuncture bigots is to come up with “evidence” that acupuncture is clinical similar to placebo and then “conclude” that acupuncture is therefore useless or irrelevant.  This plays the assumption that placebo = no effect, when in actuality placebo  = the doc does nothing but the patient feels an effect. (http://qi-spot.com/2010/04/28/the-smear-campaign-continues-acupuncture-does-not-relieve-childbirth-pain/)

Of course, even if both acupuncture and sham acupuncture have clinical effects that seem similar (and studies have shown that the real thing beats the fake stuff, even if not by much), the argument the skeptics pose is that if acupuncture is no different than placebo, then what’s the point of doing real acupuncture at all?

Well, a while back, I posted about a study I was looking forward to. (http://qi-spot.com/2010/04/04/a-study-to-look-forward-to-acupuncture-more-than-just-placebo/).  Thanks to Chris, I now have the whole article.   I would like to start by quoting thus:

As long as acupuncture and sham acupuncture treatments produce similar clinical improvements, the results of respective trials can only be taken as evidence against the efficacy of acupuncture. (I don’t think so… – Philip) Only when it can be shown that acupuncture and sham acupuncture effects are mediated differently, this can be taken as evidence that acupuncture effects are different from placebo effects, although both may still be equally effective.

I still can’t help but detect a bit of bias.  When something can be interpreted negatively, it “can only be taken as evidence against…” meaning there is no other way to interpret it, supposedly.

Similar clinical effect, different mechanism of action

Still the point is valid.  If we can show that the real deal triggers physiologic reactions distinct from sham, then that should construe evidence that acupuncture is not only valid, but should be encouraged.

According to the article “Acupuncture, Psyche and the Placebo Response” (the article mentioned above) they HAVE found such physiologic differences.  Why does this matter?  It matters because a) skeptics can’t say it’s like placebo anymore and b) we now have an increased knowledge of acupuncture mechanism of action, which is more than what we can say for such western drugs as lithium.

Take two of these and call me in the morning, even if we don't know how they work

So how does the real thing differ from the fake stuff?  Let’s count the ways as enumerated by Enck et al:

a) “Acupuncture but not sham acupuncture was found to induce both cerebellar as well as limbic cortex activation indicating both motor as well as affective component modulation of the pain matrix.  Acupuncture resp. electroacupuncture at non-acupuncture points and tactile stimulation alone served as controls in early fMRI studies (Wu et al., 2002; Yoo et al.m 2004)

b) Verum (true) acupuncture in contrast to non-penetrating placebo nedles activated cortical centers involved in affective pain modulation (Chae et al., 2009)

c) Greater activation of sensorimotor areas by sham procedure (superficial manipulation at acupuncture points) than by true acupuncture (Napadow et al 2009) – (note that stimulation of true acupuncture points by non-needling methods was considered sham by the authors, whereas in chinese medicine it is a valid method of stimulation)

d) Variances of time of central activation between verum and sham acupuncture, attributed to stronger peripheral actions of true acupuncture

e) PET scans on fibromyalgia patients show that needling at true points elicited significant activation of mu opoid receptor binding capacity in the cingulate, caudate, thalamus and amygdala both after one session and after four weeks, while with sham (insertion into non acupuncture points), small DEactivations were noted, an effect that is seen with placebo analgesia. (Zubieta et al., 2005)

There are more, but these should suffice to prove the point.

All in all I believe this evidence validates my personal belief that real acupuncture has longer lasting effects than sham acupuncture.  This is shown by the fact that real acupuncture has more central (meaning up in the brain, as opposed to just local pain mediation) effects.

Another thing worth noting is that different people have different definitions of sham.  For some, it’s using real points but not inserting.  For others, it’s inserting into non-acupoints.  Logic dictates that both have different effects.  Controls used in acupuncture studies should be standardized!

The crazy thing is that all this has been known by Stux, Berman and others since I was in grammar school in the early 80s!  Jeez!

_________________________

Enck, P., et al., Acupuncture, psyche and the placebo response.  Auton. Neurosci. (2010), http://www.ncbi.nlm.nih.gov/pubmed/20359961

Harris, Zubieta et al. ” Traditional Chinese Acupuncture and placebo (sham) acupuncture are differentiated by their effects on Mu-Opioid Receptors (MORS)” Neuroimage.  2009 Sep; 47(3):1077-85. Epub 2009 Jun 6. http://www.ncbi.nlm.nih.gov/pubmed/19501658

Firstly, I’d like to apologize for not posting for two weeks. I’ve been travelling a lot through Hong Kong and China. I will blog more on some observations I’ve made while in Hong Kong as soon as I get some of my photographs uploaded to my laptop.

Speaking of Hong Kong, I am beginning to wonder if there is some grand plot to discredit acupuncture in Hong Kong. First comes the “letter to the editor” concerning acupuncture spreading disease (http://qi-spot.com/2010/03/20/new-bashing-technique-acupuncture-causes-disease/) and now this.

“Acupuncture does not relieve childbirth pain” (http://www.guardian.co.uk/society/2010/apr/28/acupuncture-childbirth-pain-study)

I am the first person in the world to admit where acupuncture is one big FAIL (such as in colour blindness). But I would like to call the attention of the reader to the weasel wording evident in this smear campaign of a headline.

Look at the title. “Acupuncture does not relieve childbirth pain.” What does this imply to the reader? It implies that acupuncture has no effect at all on the pain felt by mummy.

Yet the sub-title below the headline betrays a hint of the truth:

“Research suggests results from complementary therapy during labour may be placebo effect”

Now, we have no idea, based on this sub-headline if this is a single study or a meta-analysis.  As we have said before, a meta-analysis is a fancy way of saying, “let’s put different studies together just to get the numbers up.  We can always find a way to put the studies together that the sum total numbers can be made to say whatever we want.”

Secondly, it “suggests” (whatever that means) that the results may be placebo effect.  Wait.  Results?  RESULTS?  I thought that acupuncture “does not relieve” childbirth pain?  So if it is useless, why are there “results”?  That means there WAS relief of pain.

So why come up with a headline saying otherwise?  Because the results “may” be placebo effect.

Actually, I wouldn't use those points in pregnancy... but what the heck. Then again, he just might be some really fat guy...

The finding, which has already prompted a vigorous debate about the value of acupuncture, came from British and Korean researchers who examined previous studies of its use in labour.

“The results show that there is little convincing evidence that women who had acupuncture experienced less labour pain than those who received no pain relief, a conventional analgesia, a placebo or sham acupuncture,” researchers told BJOG: An International Journal of Obstetrics and Gynaecology. The journal is owned by the Royal College of Obstetricians and Gynaecologists, which represents most of the UK’s doctors specialising in childbirth and maternity care.

The finding, which has already prompted a vigorous debate about the value of acupuncture, came from British and Korean researchers who examined previous studies of its use in labour.
“The results show that there is little convincing evidence that women who had acupuncture experienced less labour pain than those who received no pain relief, a conventional analgesia, a placebo or sham acupuncture,” researchers told BJOG: An International Journal of Obstetrics and Gynaecology. The journal is owned by the Royal College of Obstetricians and Gynaecologists, which represents most of the UK’s doctors specialising in childbirth and maternity care.

So it IS a meta-analysis.  Strike one.  I wonder what points were used? Hmmm…

Prof Edzard Ernst, of the Peninsula medical school at Exeter and Plymouth Universities and co-author of the report, said: “The effects of acupuncture perceived by women are largely due to placebo. Acupuncture has many qualities that maximise placebo effects: it involves touch and is invasive and, psychologically, is attached to the mysticism of the east.”

Ernst is a known skeptic of acupuncture and makes a living (i.e. buy his book!) by bashing it.  Then again, I make my living healing patients with it, so I guess we cancel each other out.  Still, he admits that acupuncture DOES have an effect, it’s just that he either cannot or will not recognize the evidence that acupuncture DONE PROPERLY is more than placebo. (http://qi-spot.com/2010/04/04/a-study-to-look-forward-to-acupuncture-more-than-just-placebo/)

I would like to point out that even in western medicine, there exist drugs for which the mechanism of action is unknown.  Lithium is used for bipolar disorder and it is not known how it works.  Yet it is given, despite toxicity, because it has been observed to work.  I leave it to the reader to witness where the double standard lies.

Also, I find it disturbing that people will look down (albeit unintentionally) on patients’ experience just to pooh-pooh acupuncture.

Prof Philip Steer, BJOG’s editor-in-chief, said labour pain can be so intense that a women would do anything to minimise it.

Please, by that logic we can get a shaman in pyjamas to conduct ritual chants and that would work.  Yet it doesn’t, and acupuncture does.

“Acupuncture is a drug-free approach and that may explain why some women prefer its use during labour. This review shows that in a very small number of cases acupuncture may be of help, usually for short periods of time after treatment, and this may be down to psychological rather than a physiological effect. Generally the consensus is that the evidence does not support its use.”

The only benefits were 11% less pain in the first 30 minutes after receiving acupuncture and a need for less pharmacological pain relief, the authors say.

Wait wait wait.   The “only” benefits? So “they” begrudgingly admit that there are benefits!  Back to my first question: why the irresponsible headline, then?  The last part of the sentence betrays the answer:

“…a need for less pharmacological pain relief” – in english: LESS DRUGS.

Less drugs, less profit for big pharma.

I will skip to the last part:

Mike O’Farrell, chief executive of the British Acupuncture Council, said: “We’re surprised by these findings as previous trials, along with the evidence that our members see in their practices every day, suggest that acupuncture can be effective in providing pain relief in many different circumstances.”

Again, as I have said before, people not biased by big pharma can see where acupuncture works and it doesn’t.  I am happy to report, both first hand and through correspondence with other OB-Gynecologists even in the US, that acupuncture can work in reducing childbirth pain IF DONE PROPERLY.

My final thoughts: this article should have been entitled “Acupuncture apparently no better than placebo” instead of “Acupuncture doesn’t work”.  News bias, bah humbug.

Campbell, Denis.  ”Acupuncture does not relieve childbirth pain” The Guardian.  28 April 2010.  <http://www.guardian.co.uk/society/2010/apr/28/acupuncture-childbirth-pain-study> Accessed 28 April 2010