Western Medicine

Posts featuring my personal commentary on controversial topics in western medicine and how Chinese medicine can help

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.

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This is… interesting.  I won’t comment, just link and quote… and highlight…

http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000258

Abstract

Background

In late spring 2009, concern was raised in Canada that prior vaccination with the 2008–09 trivalent inactivated influenza vaccine (TIV) was associated with increased risk of pandemic influenza A (H1N1) (pH1N1) illness. Several epidemiologic investigations were conducted through the summer to assess this putative association.

Methods and Findings

Studies included: (1) test-negative case-control design based on Canada’s sentinel vaccine effectiveness monitoring system in British Columbia, Alberta, Ontario, and Quebec; (2) conventional case-control design using population controls in Quebec; (3) test-negative case-control design in Ontario; and (4) prospective household transmission (cohort) study in Quebec. Logistic regression was used to estimate odds ratios for TIV effect on community- or hospital-based laboratory-confirmed seasonal or pH1N1 influenza cases compared to controls with restriction, stratification, and adjustment for covariates including combinations of age, sex, comorbidity, timeliness of medical visit, prior physician visits, and/or health care worker (HCW) status. For the prospective study risk ratios were computed. Based on the sentinel study of 672 cases and 857 controls, 2008–09 TIV was associated with statistically significant protection against seasonal influenza (odds ratio 0.44, 95% CI 0.33–0.59). In contrast, estimates from the sentinel and three other observational studies, involving a total of 1,226 laboratory-confirmed pH1N1 cases and 1,505 controls, indicated that prior receipt of 2008–09 TIV was associated with increased risk of medically attended pH1N1 illness during the spring–summer 2009, with estimated risk or odds ratios ranging from 1.4 to 2.5. Risk of pH1N1 hospitalization was not further increased among vaccinated people when comparing hospitalized to community cases.

Conclusions

Prior receipt of 2008–09 TIV was associated with increased risk of medically attended pH1N1 illness during the spring–summer 2009 in Canada. The occurrence of bias (selection, information) or confounding cannot be ruled out. Further experimental and epidemiological assessment is warranted. Possible biological mechanisms and immunoepidemiologic implications are considered.

 No...Comment.  Flu Vaccine linked with Swine Flu Incidence?

You'll never see a headline saying "Vaccination Spreads Disease"

Background

Every winter, millions of people catch influenza—a viral infection of the airways—and hundreds of thousands of people die as a result. These seasonal epidemics occur because small but frequent changes in the influenza virus mean that an immune response produced one year through infection or vaccination provides only partial protection against influenza the next year. Annual vaccination with killed influenza viruses of the major circulating strains can greatly reduce a person’s risk of catching influenza. Consequently, many countries run seasonal influenza vaccination programs. In most of Canada, vaccination with a mixture of three inactivated viruses (a trivalent inactivated vaccine or TIV) is provided free to children aged 6–23 months, to elderly people, to people with long-term conditions that increase their risk of influenza-related complications, and those who provide care for them; in Ontario, free vaccination is offered to everyone older than 6 months.

In addition, influenza viruses occasionally emerge that are very different and to which human populations have virtually no immunity. These viruses can start global epidemics (pandemics) that can kill millions of people. Experts have been warning for some time that an influenza pandemic is long overdue and, in March 2009, the first cases of influenza caused by a new virus called pandemic A/H1N1 2009 (pH1N1; swine flu) occurred in Mexico. The virus spread rapidly and on 11 June 2009, the World Health Organization declared that a global pandemic of pH1N1 influenza was underway. By the end of February 2010, more than 16,000 people around the world had died from pH1N1.

Why Was This Study Done?

During an investigation of a school outbreak of pH1N1 in the late spring 2009 in Canada, investigators noted that people with illness characterized by fever and coughing had been vaccinated against seasonal influenza more often than individuals without such illness. To assess whether this association between prior vaccination with seasonal 2008–09 TIV and subsequent pH1N1 illness was evident in other settings, researchers in Canada therefore conducted additional studies using different methods. In this paper, the researchers report the results of four additional studies conducted in Canada during the summer of 2009 to assess this possible association.

What Did the Researchers Do and Find?

The researchers conducted four epidemiologic studies. Epidemiology is the study of the causes, distribution, and control of diseases in populations.

Three of the four studies were case-control studies in which the researchers assessed the frequency of prior vaccination with the 2008–09 TIV in people with pH1N1 influenza compared to the frequency among healthy members of the general population or among individuals who had an influenza-like illness but no sign of infection with an influenza virus. The researchers also did a household transmission study in which they collected information about vaccination with TIV among the additional cases of influenza that were identified in 47 households in which a case of laboratory-confirmed pH1N1 influenza had occurred. The first of the case-control studies, which was based on Canada’s vaccine effectiveness monitoring system, showed that, as expected, the 2008–09 TIV provided protection against seasonal influenza. However, estimates from all four studies (which included about 1,200 laboratory-confirmed pH1N1 cases and 1,500 controls) showed that prior recipients of the 2008–09 TIV had approximately 1.4–2.5 times increased chances of developing pH1N1 illness that needed medical attention during the spring–summer of 2009 compared to people who had not received the TIV. Prior seasonal vaccination was not associated with an increase in the severity of pH1N1 illness, however. That is, it did not increase the risk of being hospitalized among those with pH1N1 illness.

What Do These Findings Mean?

Because all the investigations in this study are “observational,” the people who had been vaccinated might share another unknown characteristic that is actually responsible for increasing their risk of developing pH1N1 illness (“confounding”). Furthermore, the results reported in this study might have arisen by chance, although the consistency of results across the studies makes this unlikely. Thus, the finding of an association between prior receipt of 2008–09 TIV and an increased risk of pH1N1 illness is not conclusive and needs to be investigated further, particularly since some other observational studies conducted in other countries have reported that seasonal vaccination had no influence or may have been associated with reduced chances of pH1N1 illness. If the findings in the current study are real, however, they raise important questions about the biological interactions between seasonal and pandemic influenza strains and vaccines, and about the best way to prevent and control both types of influenza in future.

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I found this old facebook conversation:

http://www.facebook.com/topic.php?uid=4721625661&topic=3443

Am feeling both tired and lazy today, so I’ll just quote the convo and wait for comments.

308house House, MD and Cordyceps

House, MD would have made a great Chinese doctor.

<blockquote>Philip Tan-Gatue:

Anyone seen the episode “Whatever it takes”? House actually prescribed cordyceps sinesis to a patient.

Debra Hayes:
No, I didn’t, regrettably. Could you elaborate?
Debra Hayes:
I found it…
House’s mistake almost kills the patient, because the patient tells him that he spent 40 days at a festival. House figures out that he was in Brazil eating Brazil nuts for 40 days, and has poisoning (oh, not chestnuts, but so close, and if you have a nut sensitivity anyway…) The treatment is the iodine drip that House has unhooked. Oops. It seems clear that the patient is dying! Unless they try an alternative treatment! House suggests an herbal treatment. Cordyceps Sinesis. with dimercaperol chelation can mediate bone marrow damage of radiation. In monkeys! Can it possibly work? Oh, the suspense!
Philip Tan-Gatue:
who the heck eats brazil nuts for 40 days anyhow… but even if not pathogenic in itself, that many nuts should drive your system batty.
Debra Hayes:
True! In astrnage sense, however, we could look at House using the “exotic” to treat the exotic. We know how Chinese medicine works and in many of his cases it could be used, but it was nice to see it used in this instance.
Philip Tan-Gatue:
It’s too bad that the House character is basically limited to western medicine. If his mind were open to Chinese medicine, he’d be a truly great diagnostician. He already has the propensity to link disease with environmental and occupational influences.
Debra Hayes:
Indeed, he does! That is what makes him phenomenal. Perhpas, he embodies the western ideal of using the shen to see, and that is what makes him unique.
Original convo from January 8, 2008.
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One of the greatest frauds being intentionally perpetuated by some unscrupulous agents on both eastern and western medical “sides” is the idea that the two are mutually exclusive and never shall the two meet.  If one’s motivation is merely to profit from the medicine then it stands to benefit the practitioner to see the other side as “competition” and try to discredit it.  On the other hand, if one has in mind the benefit of the patient, then I believe one must at least be open to what the other side shall contribute.

westvseast 300x187 More Musings on Acupuncture Research

Now THIS kind of West vs East I heartily encourage!

On the “alternative” medicine side in general, there is a conscious effort to paint “Big Pharma” as some evil, money-grubbing organization deliberately poisoning the population.

On the “conventional” or western side, there is an effort by a powerful few to brand alternatives as unscientific, or at the very least, incompatible with conventional medicine.

Both are lurid extremes hurting both sides and ultimately the patient.

I acknowledge that it is difficult to reconcile apparently conflicting ideas.  Some acupuncture instructors, when training western MDs, sometimes begin their didactics by saying that the MD must first “forget” western medicine to appreciate eastern medicine.  Boulderdash.

On the other hand, I remember some of my western medicine professors in university commenting on how “primitive” Chinese medicine seems because of Chinese medicine’s use of “nature” terms in it’s vocabulary such as “wind”, “cold” and “dampness”.  It is conveniently forgotten that the root word for the western medical term “inflammation” is in fact, “flame”.

In a spirited email exchange, I was warned that I, being biased towards acupuncture (and freely admitting it, although I am not biased because of financial reasons – I could make a heckuvalot more money as a pure western MD with all the drug company money and laboratory test kickbacks…) might suffer from “cognitive dissonance” when faced with “evidence” that acupuncture apparently doesn’t work.

So what is “cognitive dissonance”?

Changingminds.org defines it thus:

This is the feeling of uncomfortable tension which comes from holding two conflicting thoughts in the mind at the same time.

Dissonance increases with:

  • The importance of the subject to us.
  • How strongly the dissonant thoughts conflict.
  • Our inability to rationalize and explain away the conflict.

Dissonance is often strong when we believe something about ourselves and then do something against that belief. If I believe I am good but do something bad, then the discomfort I feel as a result is cognitive dissonance.

Cognitive dissonance is a very powerful motivator which will often lead us to change one or other of the conflicting belief or action. The discomfort often feels like a tension between the two opposing thoughts. To release the tension we can take one of three actions:

  • Change our behavior.
  • Justify our behavior by changing the conflicting cognition.
  • Justify our behavior by adding new cognitions.

Unfortunately for skeptics I do not feel any cognitive dissonance in my practice of medicine and with the research.  It is because I realize that I am not God. I do not know everything.  No one knows everything.  What we know are bits and pieces of things, and even how they fit together is subject to personal, collective societal and cultural bias. I adapt the attitude of St. Thomas Aquinas thus, as quoted by William G. Most:

william g most More Musings on Acupuncture Research

Father William G. Most

Let us imagine that this theologian is standing on the circumference of a circle. From each of two or more points on the circumference, he tries to draw a line that will reach the center of the circle, that is, the true solution. If he has done his work well, all lines will come to a focus in the center.What will a good theologian do if not all the lines seem to focus? First, he will recheck his work for possible errors. But what should he do if he finds no error? If he is following theological rather than philosophical method, he will not try to make one line focus with another line. Rather he will say: “Now we are in theology, in lofty divine matters. It is not strange if mysteries appear. Therefore, even though I cannot see how to reconcile two lines, yet I must hold both truths.” And so, he will confess simply that he cannot go further.

(Most, William G. Grace, Predestination and the Salvific Will of God, accessed online  April 3, 2010 http://www.catholicculture.org/culture/library/most/getchap.cfm?WorkNum=214&ChapNum=4)

We are not theologians yes, and we are not dealing with “lofty divine matters”.  However the attitude should be the same. What happens if the lines don’t seem to focus? First we check for errors.

Thousands of years of experience shows that inserting a needle in acupoint Hegu relieves pain in general, and the effects are supposedly different depending on the manipulation and the patient condition.  I am but one physician, but I have duplicated this in the clinic.  I know many others who have.  Acupuncture is now accepted in many conventional hospitals in the United States to assist in childbirth (email correspondence with Dr. Eleonor Lazo, MD) Yet the skeptics who would destroy any possible synergy between the two medical traditions would try to use statistics to bash us. They say research shows that it doesn’t work.  When we show them research that shows acupuncture works, they’ll always find something to put it down, such as sample size, or it’s just a preliminary study etc etc, utterly forgetting their own sins (http://qi-spot.com/2010/02/21/another-big-pharma-cover-up/, http://qi-spot.com/2010/02/22/more-magic-numbers-this-time-its-celebrex/) And now apparently Lipitor causes increase in blood sugar too!  So much for peer review.

Is it too much for me, therefore, to suggest that when statistics apparently contradict clinical experience, we examine the statistics first?   It seems to me that when acupuncture is shown to work, the studies are supposedly “faulty” yet perfectly alright when the opposite is apparently shown.  My last post (http://qi-spot.com/2010/03/30/how-to-research-acupuncture/) shows why I believe current research paradigms for acupuncture are imperfect, thus leading to apparent conflicts.

The second problem is how we perceive if something “works”.  Most studies try to compare a treatment to the placebo effect.  I think the placebo effect is like St. Jude Thaddeus – getting a bad rap because of nomenclature.  Selling something known to be placebo is bad – you’re cheating customers.  Encouraging the placebo effect with good bedside manner – is that bad?  Now the argument is that acupuncture is “just a placebo”.  How can acupuncture be just a placebo when there are many studies (I refer the reader to http://www.acupuncture.com.au/articles/archive.html because I am too lazy to cut and paste them now) that show the specific physiological mechanisms of how it works?  A placebo by definition doesn’t do anything.  Acupuncture does something.  The question is is that something it does good?  As I have blogged before, improved sleep is good.  Easier walking is good.  Regular bowel movement is good. More energy is good. Decreased pain is good.  It had previously been pointed out that western medicine by definition should have a greater “placebo effect” due to cultural bias.  Yet acupuncture can work where western medicine doesn’t.  So much for “placebo”.

I also examine motivation.  What is my end point? To prove acupuncture works? No.  I believe it does.  To prove it doesn’t work?  Well, I’m not OUT to prove it doesn’t work, but I AM on the lookout to see where it works best, and where it sucks.  How? By personal study, reading both eastern and western medical journals (although I ignore 60s and 70s Chinese studies as those are ridiculously biased – hello cultural revolution!) By learning from the experiences of clinicians (I think it’s obvious I am biased towards the clinical experiences of great practitioners – lots of clinical pearls there) and from personal experience (I’ve developed some acupuncture manipulation tricks of my own ha ha).   I put a LOT of value on genuine clinical experience by great thinkers.  Edward Jenner was initially ridiculed for proposing his cowpox innoculation theory to protect against smallpox, because it went against the theory of the time.  Yet he was adamant because he was backed by clinical experience.

jenner 300x222 More Musings on Acupuncture Research

Edward Jenner was ridiculed for his ideas, as seen in this contemporary cartoon. (Click to enlarge)

If one is out on a witch hunt, to prove Chinese medicine doesn’t work, then everything you see will be filtered through that lens.  The same accusation can be made against me, that I see everything differently because I believe Chinese medicine works.  In that sense, we’re all bothered by cognitive dissonance!  Skeptics try to rationalize their position by citing statistics (which we know can be manipulated).  We rationalize our position by citing different statistics (which again, we acknowledge are manipulable).

I guess where I’m going with this is: unless we be like what William G. Most describes: true lovers of knowledge acknowledging our intellect is limited, we’ll be going nowhere.  In the meantime, what I do often (of course not always) works for my patients, the advice I give them based on Chinese medicine principles often (of course not always -THAT would be true placebo) works.  So if it ain’t broke, don’t fix it.

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Acupuncture did wonders for my migraines.  I had it so bad before that i had status migranosus for a week.  Imagine a whole week of having most lights and sounds burn like soldering torches.  Imagine a whole week of misery and pain.  That was the worst, thankfully.  Typically my mood would be trashed, my eyes heavy, and my head pounding.

That was there for years, only mildly relieved by sumatriptan and once I even needed ergotamine given in hospital.  I thought I was doomed to a life of drugs.

Until acupuncture.

One treatment.

Since then, for five years, nothing.  They’ve only began to return mildly recently – time for a “booster treatment”.

Anyway, once can see why I am “biased” towards acupuncture – it worked for me.

It’s also quite nice to see it verified by western medicine:

Acupuncture Eases Migraine Headache Pain
Acupuncture May Be Cost-Effective Option for Treating Chronic Headache

(http://www.webmd.com/migraines-headaches/news/20040315/acupuncture-migraine-headache-pain)

Note the term “cost-effective option”.  This means basically that it’s an option that uses up less money in the long run.  Hence, the patient benefits from the same health effects but at less cost.

By Jennifer Warner

WebMD Health News

Reviewed by Brunilda Nazario, MD

March 15, 2004 — Acupuncture may provide lasting relief from the pain of chronic headaches, such as migraines, according to a new study.

Researchers found that compared with standard medical care, acupuncture offers substantial benefits in preventing headaches and improving the quality of life for people who suffer from frequent headaches, especially migraines.

Acupuncture is commonly used to treat other types of chronic pain, but researchers say this is the first large-scale study to examine the effectiveness of acupuncture under real-life conditions. They say the results indicate that health insurance coverage of acupuncture services should be expanded to include the treatment of chronic headaches and migraine.

Darned right it should.

Pins and Needles Ease Migraine Pain

In the study, published in the March 15 issue of the British Medical Journal, researchers randomly divided 401 adults aged 18-65 years old with chronic headache (at least two headaches a month) — into two treatment groups. Participants had a history of having mostly migraine headaches.

I just found it interesting that six years ago, the BMJ seemed to support articles on acupuncture.  Now it publishes an editorial (not even a news article!) totally biased against it (see previous post).

One group received up to 12 acupuncture sessions during a three-month period in addition to standard medical care, and the other group received standard care alone.

A year later, researchers found those who received acupuncture:

  • Experienced 22 fewer days with headaches
  • Used 15% less medication
  • Made 25% fewer visits to their doctor
  • Took 15% fewer days off sick from work than the control group
  • In my case it was no headaches, 100% less medication, 100% fewer visits and no sick days from work since the acupuncture.

    One session btw.

    Researchers say one limitation of their study is that the control group did not receive a sham acupuncture intervention. Therefore, some of the benefits found among the acupuncture group may have not been caused by the actual treatment but because of the “placebo effect,” which is based on the patient’s expectations of benefit from treatment rather than the effectiveness of the treatment itself.

    But researchers say previous placebo-controlled studies have already shown that acupuncture is superior to placebo in treating migraine.

    In a related study published in the same journal, British researchers found that acupuncture improves the quality of life for people with chronic headaches at a small additional cost. They say the findings show that acupuncture is a relatively cost-effective headache therapy compared with other treatments covered by the National Health Service of the United Kingdom.

    A recent study I found (not online but I have the PDF file) entitled “Efficacy of Acupuncture for the Prophylaxis of Migraine: A multicentre randomised controlled clinical trial” (Lancet Neurology 2006;5:310-16)

    The results were:

    Findings Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2·3 days (95% CI 1·9–2·7) in the verum acupuncture group, 1·5 days (1·1–2·0) in the sham acupuncture group, and 2·1 days (1·5–2·7) in the standard therapy group. These differences were statistically significant compared with baseline (p<0·0001), but not across the treatment groups (p=0·09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0·133).

    The “verum” group was defined as receiving true acupuncture, the sham were placed in random points and standard as… standard western medical care.  Note that the condition for success was “reduction of migraine days”.  Personally I find that some patients can respond by having the same amount of headaches but less intensity and duration – they hurt much less and last shorter.

    Anyway the results still show that real acupuncture works better than either sham or standard treatment.  Not statistically significant, but significant to patients.

    And doctors like me.

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