Qi Spot

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.

Worth mentioning: Acupuncture recommended by John Bartleson, MD, of the Mayo Clinic for low back pain as evidenced on their website:

(http://www.mayoclinic.com/health/acupuncture-for-back-pain/AN02055)

From wikipedia, the Mayo Clinic  ”is a non-profit organization and an internationally renowned group of medical practice headquartered in Rochester, Minnesota. Its headquarters consist of the Mayo Medical School, the Mayo Graduate School, the Mayo School of Graduate Medical Education, and several other health science Mayo Clinic partners with a number of smaller clinics and hospitals in Minnesota, Iowa, and Wisconsin, an organization known as the “Mayo Health System.” Mayo also provides medical treatment and performs research in its facilities in Arizona and Florida.”

So what does it have to say?

“When performed properly by trained practitioners, acupuncture has proved to be an effective therapy for back pain. Several studies have found that acupuncture can help reduce chronic back pain and improve daily function.”

Very very important: when performed PROPERLY by TRAINED practitioners.  Why do I emphasize this? Time and time again I say that acupuncture is not a pill but a procedure.  It’s not just sticking a needle in, but practitioner skill is vital in the selection of acupoints and proper manipulation depending on the patient’s particular condition.  In fact, I am giving a lecture later on low back pain and will be emphasizing on several “kinds” of lumbago such as Blood Stasis (trauma), Damp-Cold, Kidney Yin Deficiency, etc etc…

The point is that not all back pains are created equal, and each must be met at their own terms.

Oh but what about the studies showing sham acupuncture also works? Doesn’t that debunk acupuncture?  And how the heck does it work anyway?

Scientists don’t fully understand how or why acupuncture affects the amount of pain you feel. Several studies have found that acupuncture causes the same effects as sham (minimal or simulated) acupuncture used in some studies for comparison. Sham acupuncture involves tapping the skin with a toothpick at the same strategic points used in acupuncture to simulate the insertion of a needle. Sham acupuncture may not be an accurate way of studying the benefits of acupuncture, however, because it’s possible that acupuncture points can be stimulated by even surface pressure. Both acupuncture and sham acupuncture showed improvement over usual medical treatments. (emphasis mine)

If only I had a penny for every time I’ve said this.

And now to complete the cycle:

Acupuncture is generally recognized as safe if done by a competent, certified acupuncture practitioner. Possible side effects and complications can occur, which include soreness, bleeding, infection or bruising at the needle sites.

Acupuncture isn’t a cure and not everyone responds to acupuncture for back pain. If your back pain doesn’t begin to improve within a few weeks, acupuncture may not be the right treatment for you. If you’re considering acupuncture for back pain, talk with your doctor, who can refer you to an acupuncturist.

Acupuncture is generally recognized as safe if done by a competent, certified acupuncture practitioner. Possible side effects and complications can occur, which include soreness, bleeding, infection or bruising at the needle sites.
Acupuncture isn’t a cure and not everyone responds to acupuncture for back pain. If your back pain doesn’t begin to improve within a few weeks, acupuncture may not be the right treatment for you. If you’re considering acupuncture for back pain, talk with your doctor, who can refer you to an acupuncturist.

There you have it folks:

a) acupuncture is a procedure, not a pill

b) sham acupuncture seems to work because it is still stimulating the acupoints, albeit less directly and less strongly

c) we may now know exactly how it works, but would that stop you from trying it if it does work?

and d) like ANY other treatment, it may not work for everyone.

This last point requires me to point out a certain bias.  If a western medicine treatment doesn’t work for a particular patient, we’ll say that it just didn’t work for a particular patient.  No one questions western medicine in general if a pill didn’t lower someone’s blood pressure.  Yet we in the so-called “alternative” field have to overcome a tendency by people to dismiss acupuncture and herbal medicine if it didn’t work for a particular person.  Know what I mean?

Well, off to University to enlighten some minds.

Remember how I wrote about biased headlines? (http://qi-spot.com/2010/02/09/another-biased-headline/)  In that previous article, I had mentioned that one can subtly affect comprehension by careful(?) selection of words to use in a headline.  The headline in question then read “Researcher Warns on Herbal Medicines”.  Only when you read the article itself will you see that it actually warns against misuse of herbal medicines or potential side effects from mixing with western meds.  The typical reaction, however, is to just glance over the headline – giving one the impression that herbal medicines PER SE are something generally unsafe and thus there is a need to warn the public about it.

Compare that with this headline: “Mixing medicine with herbal remedies can be risky.” (http://news.medill.northwestern.edu/chicago/news.aspx?id=158237)  This is much better and not misleading at all.

A few quotes from the article proves the spirit of the writer’s intent.  Allow me to refresh you:

Dr. Arshad Jahangir, a cardiologist at the Mayo Clinic in Phoenix/Scottsdale Arizona, who wrote the review, said the main reason patients look to herbal remedies is because they want to preserve their health.

“They think it’s natural and probably safe to use,” he said. “We’re not saying anywhere in the review that people should not take these products. But they should, at the very least, consult with their doctors who can look at their other medications and identify the potential for harm.”Herbal medications readily found over-the-counter can adversely affect the way prescription drugs are absorbed by the body by either enhancing or reducing their effectiveness.” (emphasis mine)

Yes! The article fits the headline!  And for the record, I perfectly agree. Next we see that integration between “eastern” and “western” medicine is promoted.  (albeit in a method I don’t agree with 100%, but I’ll take what is given.)

Christina Ferrari-Noonan, an acupuncturist and herbalist at Ancient Healing Chicago downtown, said patients who want to take herbal remedies should consult their doctors first.

“Patients should definitely go by the physician’s recommendation and see what they’re comfortable with,” she said. “There are definitely a lot of over-the-counter herbs that can be considered dangerous.”

Ferrari-Noonan, who has a background in Eastern and Western medicine, said herbalists should work in conjunction with doctors “We’re diagnosticians in traditional medicine not in western medicine,” she said. “Patients need to go their doctor first to get diagnosed. That diagnosis needs to be in place, and then as herbalists, we can go from there. Blood tests are especially valuable as a starting point.”

What I don’t agree with is the last sentence.  At times, people present with discomforts that cannot be classified in western medicine (how do you translate “Spleen Qi deficiency leading to weakness of the four limbs” into western medicine?  It isn’t CFS, it isn’t a movement disorder, etc etc) or do not appear in blood tests.

Jahangir agreed that herbalists and physicians should work together. “We’re not at war with herbalists and they are not against what we do,” he said. “Our goals are common, which is to serve our patients and to give them medicine or products that will do the job it’s supposed to do without causing harm.”

Tell that to the skeptics who insist that only commercial pharmaceuticals are worthwhile.

Mary Helen Lee, an herbalist at Chicago’s White Moon Healing Center, said herbal supplements could be beneficial as a compliment to chemical-based drugs, if taken correctly. “It’s definitely possible to take herbs to reverse the toxic side effects and lessen the harm the chemicals medications can have on your body,” she said. (I do this a lot with cancer patients on chemotherapy – Phil)

Lee said incorrect dosage amounts could also cause problems. “Either people are taking too much or too little, which can have a major effect,” she said. “Obviously, there are some dangerous herbs out there and people should be cautious. Patients should see a professional and get the correct herb and the correct dose for their problem.”

Experts agree that the biggest mistake people make is to self-diagnose on the Internet and treat themselves with over-the-counter herbal remedies without consulting doctors first. (emphasis mine)

“The Internet can be very helpful in educating yourself about herbs and possible effects, but it can also be very dangerous,” Ferrari-Noonan said.

So there you have it – a more balanced view that can be summarized thus:

a) herbs can work if used properly

b) always tell any healthcare professional about everything you’re doing for your health.  If they become biased against you because of that, then it’s time to find another provider.

c) never self medicate – there ARE herbal scammers out there who are only out to sell you stuff.

d) physicians of all traditions CAN and SHOULD work together.

Sweet Mother of God.  How can anyone have the gall to accuse Traditional Chinese Medicine of having little or no “evidence” to back it up when the “evidence” for some western medicine is even more immaterial than how these skeptics perceive qi.  Qi is hardly immaterial, by the way.

Doc Accused of Faking Celebrex Study from nbcconnecticut.com states that a physician was able to publish a clinical study saying that the drug had post surgical benefits…with NO patients enrolled in the study.

All of a sudden “evidence based” and “peer review” lose their luster.

These skeptics say Chinese medicine relies more on anecdotal evidence or small sample size.  Right now I’ll take small sample size over NO sample size.

Here’s the article:

A Massachusetts doc, who is also a former member of Pfizer Inc.’s speakers’ bureau, is accused of launching what is being called “one of the biggest research frauds in medical history,” according to The Day of New London.  And he has agreed to plead guilty, according to a Massachusetts newspaper.

Dr. Scott Reuben, who is accused of faking medical research studies, including some that were published in medical journals, was charged with health care fraud Thursday in federal court in Boston, according to the U.S. Department of Justice.

He’s accused of accepting a $75,000 grant from Pfizer to research the effectiveness of the pain medication Celebrex for a 2005 study, the Day reports.

His research, which the Day reports was pioneering at the the time, indicated that there are post-surgery benefits from painkillers. But no patients were actually enrolled in the study, according to a U.S. Department of Justice news release.

Health care fraud.  $75,000 grant.  For the nth time, I recall a famous comment by “some guy who knows some guy”… I’ve quoted that comment in the post previous to this one so forgive me if I’m too tired of copying and pasting it.

The Wall Street Journal reports that he also falsified information about Pfizer’s Bextra and on Merck’s Vioxx.

“Anesthesia & Analgesia” had to retract 10 papers Reuben wrote and medical experts say at least 21 journal articles by the anesthesiologist appear to be fabricated, the Day reports.

Reuben was the chief of acute pain at Baystate Medical Center inSpringfield, Massachusetts, and The Day reports that the hospital let him go last March, after an audit revealed he had been inventing data for as many as 13 years.

Reuben has reached an agreement in which he will plead guilty and prosecutors will recommend a more lenient sentence…

He would also have to forfeit assets of at least $50,000 he got from allegedly fake research, the Journal reports.

The Republican, of Springfield, Massachusetts, reports that Reuben has signed a plea agreement and must return $420,000 to pharmaceutical companies.

Here’s how I see it.  We can say that this guy is just ONE bad apple and should not be used as a basis to judge western medicine as a whole.  In that case we can also say that cases of Chinese medicine causing problems are also due to isolated bad apples.  On the other hand if we are to accept these events as being representative of the pharmaceutical industry in general, then such industry has no right to accuse Chinese medicine for being wanting of evidence.  Either way, the truth is somewhere in the middle: be critical, be wary.  Caveat Emptor, it is said.

And people wonder why I, despite being an MD, no longer am able to fully trust “peer reviewed” journals and “evidence based” medicine.

From cnbc.com: Senate Report: Avandia Maker Knew of Cardiac Risks (http://www.cnbc.com/id/35498711)

NEW YORK – A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.

Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee’s ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

The agency ordered a warning to be included on Avandia’s label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive.

Soon afterwards Sen. Grassley, one of the FDA’s toughest critics in Congress, disclosed that the agency’s internal safety experts came within one vote of recommending a withdrawal of Avandia.

These guys are so quick to approve new drugs, and so reluctant to withdraw them.  I guess they don’t want to blemish their record too much.

The Senate report suggests sharp disagreements remain at the FDA over how to handle Avandia’s risks.

In a letter to FDA Commissioner Margaret Hamburg that was also released Saturday, the senators said the committee’s report was based on researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents. They said committee investigators had interviewed GlaxoSmithKline and agency employees as well as what it called anonymous whistleblowers.

Based on its knowledge of the heart attack risks, GlaxoSmithKline “had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner,” the report said.

I guess people haven’t learned from the debacles concerning Bextra and Vioxx (Vioxx and Bextra Studies allegedly fabricated)

Instead, the company tried to downplay findings that the drug could increase cardiovascular risks while also working to downplay findings that a rival medication might reduce such risks, it said.

GlaxoSmithKline said in a statement the drug is safe. It said the committee report took data out of context from analyses of Avandia.

Going back to my favorite comment (from http://qi-spot.com/2010/01/27/some-guy-no-evidence-for-acupuncture-real-world-lots-of-evidence/): “the company that did the testing probably is in the work of acupuncture. You think they’re gonna release something that says anything EXCEPT “acupuncture works”?”

It could just as easily read, “the company that did the testing probably is in the work of acupuncture manufacturing a particular drug.  You think they’re gonna release something that says anything except “acupuncture works”? “this drug works and is safe”?

In May 2007, the New England Journal of Medicine published an analysis of dozens of studies on nearly 28,000 people who had taken Avandia. The journal said there was a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication. The findings raised concerns because two-thirds of the people with Type 2 diabetes, the most common form, die of heart problems.

And in true Spin Doctoring fashion:

“Contrary to the assertions in the report, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events,” GlaxoSmithKline said.

…okay.

In their letter to Hamburg, the senators said the documents the committee reviewed included an analysis conducted by two safety officials at the agency. The analysis compared Avandia to Takeda Pharmaceutical’s diabetes drug Actos, and found that Avandia has an increased risk of heart attack and heart failure. Actos is co-promoted by Pfizer Inc.

Here’s a thought.  Maybe Avandia IS safe but the other drug company just wants to shut it down so it can sell it’s own drug.  Yeah that’s it!  Still doesn’t bode well for the trust factor, eh.

So what is being done?  Is the drug being withdrawn like Bextra or Vioxx?

At FDA’s request, Glaxo agreed in 2007 to conduct a six-year study between its drug and Actos, to give a definitive picture of Avandia’s safety. The study, which will involve 16,000 participants, is still enrolling patients.

But FDA researchers quoted in the report called the study “unethical and exploitative,” since patients will continue taking Avandia, a drug with known risks, over Actos, which has not shown any links to heart prblems (sic).

All together now: “oooooookay…”

DA spokesman George Strait said the FDA is reviewing new data on Avandia and will present those findings to an advisory committee this summer.

“Meanwhile, Commissioner Hamburg is reaching out to ensure that she has a complete understanding and awareness of all of the data and issues concerning this drug,” Strait said.

Avandia was Glaxo’s third best-selling drug in 2006 with revenue of $2.2 billion. But the safety concerns disclosed the following year slashed revenue to $1.2 billion by the end of 2008.

*wink and snicker*

And people wonder why I trust herbal formulas in use in China for 2000 years over these newfangled “scientific” drugs.  The only science that’s obvious is spinning, number crunching, and marketing.