Medical Device Industry Preemptively Block Regulations

In an unprecedented move, the medical device industry has tried to block a report that examines new regulations on the industry. They are using the usual arguments that there was bias in the scientific report, that industry was not represented, that regulation will slow innovation and kill jobs, and harm patients. Keep in mind that the pro-business group hasn't even seen the report and yet they're attacking it. I've looked at some of the issues with the medical device industry here and here. First, Do No Harm.
Update: Also, it is becoming increasingly difficult to seek redress if you are harmed by a product. See the film Hot Coffee.
July 27, 2011
Study of Medical Device Rules Is Attacked, Unseen
By BARRY MEIER

Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups that examines possible new regulations on the industry.

The scientific group, the Institute of Medicine, is scheduled to release a report on Friday that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators. The report, commissioned by the Food and Drug Administration, comes after several well-publicized recalls in recent years of devices that have failed in thousands of patients, causing numerous injuries.

Case Study: PCOS patient, acupuncture and HRV

So PCOS stands for Polycystic Ovarian Syndrome. And HRV stands for Heart Rate Variability, a measure of autonomic balance, or in layman's terms, the stress response or relaxation response.
I wanted to try to illustrate the gist of my research interest. I will start with this particular patient who is in her late 20's and carries a diagnosis of PCOS and even with clomid does not ovulate. So she has been coming to me for acupuncture. I have done some previous posts on PCOS and HRV and the protocols here, here, here.
What these graphs show are some of the treatments I have her following the protocol using 2Hz strong stimulation electroacupuncture. What I would like to see is a decrease in her LFR/HFR ratio during treatment. As you can see the first three graphs from 6.2.2011, 6.20.2011, and 6.27.2011 all show minimal decrease in her LFR/HFR ratio. So I decided to abandon the protocol and do manual acupuncture with more emphasis on traditional treatment with standard TCM (Traditional Chinese Medicine) points. As you can see, she had a better relaxation response with that treatment as reflected in the decrease in her LFR/HFR ratio. Also notice that in the last graph, she also has a lower value of LFR/HFR more between the 1 and 2 range, which is the lower than in the other graphs. (So sorry for the poor quality of the graphs, will try to work on those and repost.)
I called her after analyzing the data to see how she was doing and she said that she had had some spotting, which was new for her. So we will see how she does with time and I'll try to keep you posted. (For more info on my practice, please click here.)

Blood Pressure Management and Acupuncture

This is another case study. This patient had severe peripheral neuropathy in her feet when she presented to the clinic. She suspected that it was due to a statin she was taking so discontinued it. She also had blood pressure that was out of control and wanted to try another approach.
The graph below shows her Blood Pressure the week before she came in to see me. Her first visit was 6/23/2011. Her last visit was 7/11/2011. The blood pressures for those days I took in my clinic. I didn't end up seeing her after those 4 visits, but contacted her to find out how she was doing and she gave me the last three readings.
So the acupuncture helped her blood pressure, but her blood pressure also was lowered because her feet improved dramatically so she wasn't in so much pain. This obviously helped her blood pressure also. (If I can get it together, I'll try to post her HRV readings in a later post since they were fascinating also.)



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FDA warns against Atrial Fibrillation drug Multaq. Moral? Wait 7 years before taking any newly released drug.

I'm starting to bore myself with reporting on the dangerous drugs that have been approved and set loose on the market, but here's another one. Link below. Please wait to take any new drug for several years, 7 at least, from the time of release. Let other people be the guinea pigs. (info on my practice here)

F.D.A. Issues Alerts on the Heart Drug Multaq
By DUFF WILSON

American and European regulators issued safety alerts on Thursday about Multaq, a drug approved two years ago to treat abnormal heart rhythms...

Cranberry Juice versus Antibiotics: You Decide

An article from the New York Times comparing cranberry juice versus months of low dose antibiotics. No surprise that the antibiotic helped keep the infections away to a larger degree, and also no surprise that it lead to E Coli resistant strains that are harder to treat. I mentioned in a previous post that I have a patient who was treated for months for bladder infections and ended up with Clostridia Dificile infection, a life threatening intestinal infection. She was hospitalized for days with a few of them in the ICU. So, like I said, you decide...

Downside for a Urinary Infection Remedy
By NICHOLAS BAKALAR

Women with recurrent urinary tract infections sometimes must take low-dose antibiotics for months to control the problem. Many prefer to try something less onerous, like cranberry extract or juice, which several studies have suggested can prevent these infections.

But a new study finds that a commonly used antibiotic works much better than cranberry, with one significant drawback: It encourages the development of resistant strains of bacteria.

Dutch researchers randomly assigned 221 women with a history of infections to two groups. The first took a daily dose of 480 milligrams of Bactrim, an antibiotic, and the second took 1,000 milligrams of cranberry extract.

The study, published Monday in The Archives of Internal Medicine, found that by any of three measures — the number of symptomatic infections, the proportion of patients with at least one infection or the average time to the first infection after starting the regimens — antibiotics controlled the infections more effectively in the study participants.

But when the researchers tested the subjects’ urine and feces, they found a large increase in the presence of antibiotic-resistant strains of E. coli, the most common cause of the infections, in those who used the antibiotic.

Dr. Suzanne E. Geerlings, the senior author and an infectious disease specialist at the Academic Medical Center of the University of Amsterdam, said the findings did not rule out using cranberry and noted that antibiotics have risks. “Antibiotics work better,” she said, “but when you get an infection resistant to antibiotics, you have a bigger problem.”

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Looking For Methods to Mitigate Alzheimer's Disease

From today's New York Times, an article looking at various conditions that, if mitigated, will help to avoid Alzheimer's. I won't copy much of the article.
But the following I will file in the "I Did Not Know That" file,(in bold.) I knew there were other reasons to avoid menopausal hormones, but this reason I was unaware of.

The panel found the strongest evidence for only one conclusion: that the herb gingko biloba does not prevent Alzheimer’s. There was moderate evidence that neither vitamin E nor drugs called cholinesterase inhibitors, used to treat dementia symptoms, decrease risk of Alzheimer’s. And there was moderate evidence that the gene ApoE4 significantly increases Alzheimer’s risk, as does menopause therapy with estrogens and progestins.

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The Latest Data on Weight Loss and What Works

A summary of the findings of a new research study, by five nutrition and public health experts at Harvard University. There's a lot in there, so please read the whole thing if diet and weight control is an issue for you. Some of the findings are expected. In the negative column: "French fries led the list: Increased consumption of this food alone was linked to an average weight gain of 3.4 pounds in each four-year period. Other important contributors were potato chips (1.7 pounds), sugar-sweetened drinks (1 pound), red meats and processed meats (0.95 and 0.93 pound, respectively), other forms of potatoes (0.57 pound), sweets and desserts (0.41 pound), refined grains (0.39 pound), other fried foods (0.32 pound), 100-percent fruit juice (0.31 pound) and butter (0.3 pound)." Of course television watching was also in the negative column, as was smoking.
In the positive : "Also not too surprising were most of the foods that resulted in weight loss or no gain when consumed in greater amounts during the study: fruits, vegetables and whole grains. Compared with those who gained the most weight, participants in the Nurses’ Health Study who lost weight consumed 3.1 more servings of vegetables each day.
Furthermore: "But contrary to what many people believe, an increased intake of dairy products, whether low-fat (milk) or full-fat (milk and cheese), had a neutral effect on weight.

And despite conventional advice to eat less fat, weight loss was greatest among people who ate more yogurt and nuts, including peanut butter, over each four-year period."

They also found getting enough sleep was important. In sum, it's the kind of calories you eat more than the actual calorie count. Fascinating. And I'm ecstatic that peanut butter is okay to eat. Yay!

July 18, 2011
Still Counting Calories? Your Weight-Loss Plan May Be Outdated
By JANE E. BRODY

It’s no secret that Americans are fatter today than ever before, and not just those unlucky people who are genetically inclined to gain weight or have been overweight all their lives. Many who were lean as young adults have put on lots of unhealthy pounds as they pass into middle age and beyond.

It’s also no secret that the long-recommended advice to eat less and exercise more has done little to curb the inexorable rise in weight. No one likes to feel deprived or leave the table hungry, and the notion that one generally must eat less to control body weight really doesn’t cut it for the typical American.

So the newest findings on what specific foods people should eat less often — and more importantly, more often — to keep from gaining pounds as they age should be of great interest to tens of millions of Americans...

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Blockbuster Smoking Cessation Drug Linked to Heart Disease

I somehow missed the latest in a series of much-hyped, best-selling drugs turning out to have major problems. This article was released over the July 4th holiday, so I didn't notice it. Long story short, Chantix is still on the market and will be studied further. From the article one critic is quoted as saying, “It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events.” Wow, sounds bad. So why would they leave it on the market? Well maybe because it's "a product that has been prescribed to 13 million people and had $755 million in sales last year." Or this "Chantix is selling well overseas. In Japan, for instance, some pharmacies ran out for a while recently, even as the drug failed to meet expectations in the United States because of health warnings and bad publicity." Another fun fact was that physicians who prescribe the drug can expect to get one new cardiac event in every 28 patients taking the drug. But on the bright side, for every ten patients taking it, one will stop smoking (yes, one in ten) . So there's that.

July 4, 2011
Study Links Smoking Drug to Cardiovascular Problems
By DUFF WILSON

Chantix, the best-selling prescription drug for smoking cessation, was linked to an increased risk of a heart attack, stroke or other serious cardiovascular event for smokers without a history of heart disease compared with smokers who did not use the drug, according to a Canadian medical journal report released on Monday.

The finding added to previous warnings about the pill’s connection to psychiatric problems and cardiovascular risks for people with a history of heart disease...
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Blackburn, a few more quotes from the Atlantic

A month ago, I posted some discussion from the Atlantic Magazine (here) about Alternative Medicine. I didn't excerpt this particular section at the time, but will now since it's pertinent to yesterday's post (here) about telomeres and Dr. Elizabeth Blackburn. She is quoted below. (I would only take slight issue with the claim that she has "no skin in the game," since she now has a for profit company offering telomere testing, but that's small potatoes compared to Big Pharma and the Medical Device industry.) (For more information about my practice please click here.)

You might think the weight of the clinical evidence would close the case on alternative medicine, at least in the eyes of mainstream physicians and scientists who aren’t in a position to make a buck on it. Yet many extremely well-credentialed scientists and physicians with no skin in the game take issue with the black-and-white view espoused by Salzberg and other critics. And on balance, the medical community seems to be growing more open to alternative medicine’s possibilities, not less.

That’s in large part because mainstream medicine itself is failing. “Modern medicine was formed around successes in fighting infectious disease,” says Elizabeth Blackburn, a biologist at the University of California at San Francisco and a Nobel laureate. “Infectious agents were the big sources of disease and mortality, up until the last century. We could find out what the agent was in a sick patient and attack the agent medically.” To a large degree, the medical infrastructure we have today was designed with infectious agents in mind. Physician training and practices, hospitals, the pharmaceutical industry, and health insurance all were built around the model of running tests on sick patients to determine which drug or surgical procedure would best deal with some discrete offending agent. The system works very well for that original purpose, against even the most challenging of these agents—as the taming of the AIDS virus attests.

But medicine’s triumph over infectious disease brought to the fore the so-called chronic, complex diseases—heart disease, cancer, diabetes, Alzheimer’s, and other illnesses without a clear causal agent. Now that we live longer, these typically late-developing diseases have become by far our biggest killers. Heart disease, prostate cancer, breast cancer, diabetes, obesity, and other chronic diseases now account for three-quarters of our health-care spending. “We face an entirely different set of big medical challenges today,” says Blackburn. “But we haven’t rethought the way we fight illness.” That is, the medical establishment still waits for us to develop some sign of one of these illnesses, then seeks to treat us with drugs and surgery. ...
The medical community knows perfectly well what sort of patient-care model would work better against complex diseases than the infectious-disease-inspired approach we’ve inherited. That would be one that doesn’t wait for diseases to take firm hold and then vainly try to manage them with drugs, but that rather focuses on lowering the risk that these diseases will take hold in the first place. “We need to prevent and slow the onset of these diseases,” says Blackburn. “And we know there are ways to do that.” Aside from getting people to stop smoking, the three most effective ways, according to almost any doctor you’d care to speak with, are the promotion of a healthy diet, encouragement of more exercise, and measures to reduce stress.

Acupuncture has been shown in countless studies to reduce stress. So beyond the principle "First Do No Harm," I would add, "Get your acupuncture!" And, yes, in full disclosure, I also have "skin in the game."

Telomeres and Cardiovascular Disease Risk Factore

Dusted off this oldie also. By the same group looking at cardiovascular health and telomeres and stress. (This post is an offshoot of this earlier post.)
*1: *Psychoneuroendocrinology. 2006 Apr;31(3):277-87. Epub 2005 Nov
17.

Cell aging in relation to stress arousal and cardiovascular
disease risk factors.


UCSF Department of Psychiatry, San Francisco, CA, USA.
epele@healthpsych.ucsf.edu

We previously reported that psychological stress is linked to and
possibly accelerates cellular aging, as reflected by lower PBMC
telomerase and shortened telomeres. Psychological stress is a major
risk factor for cardiovascular disease (CVD), with multiple
behavioral and physiological mediators. Telomere shortness has been
associated with CVD, but the relationship between low telomerase
activity, a potential precursor to telomere shortening, and CVD risk
factors has not been examined in humans. Here we examine whether
telomere length and telomerase in leukocytes are associated with
physiological signs of stress arousal and CVD risk factors in 62
healthy women. Low telomerase activity in leukocytes was associated
with exaggerated autonomic reactivity to acute mental stress and
elevated nocturnal epinephrine. Further, low telomerase activity was
associated with the major risk factors for CVD -smoking, poor lipid
profile, high systolic blood pressure, high fasting glucose, greater
abdominal adiposity-as well as to a composite Metabolic Syndrome
variable. Telomere length was related only to elevated stress
hormones (catecholamines and cortisol). Thus, we propose that low
leukocyte telomerase constitutes an early marker of CVD risk,
possibly preceding shortened telomeres, that results in part from
chronic stress arousal. Possible cellular mechanisms by which low
telomerase may link stress and traditional risk factors to CVD are
discussed. These findings may implicate telomerase as a novel and
important mediator of the effects of psychological stress on
physical health and disease.

Original Proceedings of National Academy of Sciences study on telomeres and stress

A bit of background from this earlier post, I had this in the deep freeze of my computer. This was the landmark study showing increased aging in mothers of handicapped children versus mothers of non-handicapped children.
Department of Psychiatry, University of California, 3333 California
Street, Suite 465, San Francisco, CA 94143, USA. elissa@itsa.ucsf.edu

Numerous studies demonstrate links between chronic stress and
indices of poor health, including risk factors for cardiovascular
disease and poorer immune function. Nevertheless, the exact
mechanisms of how stress gets "under the skin" remain elusive. We
investigated the hypothesis that stress impacts health by modulating
the rate of cellular aging. Here we provide evidence that
psychological stress--both perceived stress and chronicity of
stress--is significantly associated with higher oxidative stress,
lower telomerase activity, and shorter telomere length, which are
known determinants of cell senescence and longevity, in peripheral
blood mononuclear cells from healthy premenopausal women. Women with
the highest levels of perceived stress have telomeres shorter on
average by the equivalent of at least one decade of additional aging
compared to low stress women. These findings have implications for
understanding how, at the cellular level, stress may promote earlier
onset of age-related diseases.

Telomeres, Aging and Astragalus

Dr. Elizabeth Blackburn, recent Nobel Prize Winner from UCSF, published groundbreaking work on telomeres, proteins at the end of chromosomes, and how they are a measure of aging. A recent post on the effects of stress on certain chronic diseases is here. This article in the San Francisco Chronicle discusses a new company which will allow telomere testing to the public. There are many topics I would love to riff on about this whole topic, but the main reason I needed to bring this to your attention is a paragraph at the end, where her partner Harvey "Harley offers astragalus root extract, meant to stimulate telomere growth, to any takers." I can't tell you how amazing this is to me. I've been giving Astragalus to my patients, especially the formula Astra Essence from Health Concerns, ever since I set up my practice in 1998. It is a longevity formula and I take it religiously every day. I had no idea it had been implicated with telomere growth. The ancients really knew what they were doing. Astonishing. I'll try to dig up more on the science for later posts. (I'm linking to the whole article so you have context.) (For more info about my practice, please click here.) (For more information about acupuncture and stress please click here.)

Telome Health of Menlo Park tests age of DNA


Nellie Bowles, Chronicle Staff Writer

Monday, July 11, 2011
Lab scientist Saker Karimi (left) and biochemist Cal Harl... Longevity marker Telomeres are the necessary "cap" or end... Nobel laureate Elizabeth Blackburn helped found Telome He... More...

In 1989, biochemist Cal Harley took DNA samples of his entire family, from his 9-year-old daughter to his 74-year-old father.

Before Thanksgiving dinner 20 years later, he repeated the test.

Not only did the family look older (some taller, others grayer), but so did their DNA. Looking at the length of their telomeres, the tiny protective caps on the ends of DNA, Harley could see they had aged, becoming shorter. While his daughter's telomeres were just a little shorter, Harley's had been shrinking drastically.

"I was experiencing accelerated aging," Harley says, shaking his head. "I started exercising after that. And I realized this could be more than just fun with the family. So I called up Liz." Liz happens to be Nobel laureate Elizabeth Blackburn, the UCSF biologist who discovered the telomere and an old colleague of Harley's. "She's hesitant about mixing science and industry, but this was a matter of public health," Harley says.

Thus was born Telome Health Inc., founded by Harley and Blackburn, along with "deal man" CEO Dan Hunt, UCSF social psychologist Elissa Epel and UCSF biologist Jue Lin. The Menlo Park company provides telomere analyses for $199, making it the first to offer affordable, accessible telomere testing for the public.
Consumer-friendly test

Harley knew well that traditional genome science had failed in its grand goal of using DNA to determine everything from personality to disease risk. Scientists, so focused on the individual nucleotides that make up our genetic code, missed something larger: The way we treat our genes may be more important than what those genes might be.

Enter the humble telomere. Once cast aside in textbooks and by genome coders as "junk DNA," these delicate noncoding strings that dangle off the DNA can show how we've lived - how hard we've been drinking, how much we've been eating, smoking and stressing out.

Telomeres shorten each time our cells duplicate, shedding tiny nucleotides off their tips until they become stubby and frayed, and we die. Several studies have shown or suggested that if we lose weight, take Omega-3s or meditate, the telomere shortening process can slow down. Some small observational studies suggest telomeres can even lengthen.

Now, only three years after their discovery, telomere tests may become part of every regular doctor appointment from birth to well-predicted death.

"We want it to be like getting your cholesterol checked," says Blackburn, with her thick Tasmanian accent, "only it's of course much better."

The test is simple and consumer friendly: Ask your doctor to order the test, and a package will be delivered to your doorstep. Spit in the company-provided vial and mail it back to the lab. Two weeks later, you'll receive your TeloAge (your telomere's length compared to that of the general population) and HealthSpan (the number of healthy years you have left), along with a sleek graph showing your projected decline.

Morbid but, for many, fascinating.
2 markets for testing

Many Americans are obsessed with self-monitoring and pseudoscience, clinging to the heart-rate monitor of their Ellipticals, running to the click of a pedometer, watching an agile Dr. Mehmet Oz chastise the obese with elaborate mock-ups of what their organs surely look like. Men's Health magazine, with a worldwide circulation of 15 million, once ran a cancer probability calculator next to sex tips.

In another era, telomeres might have been studied more thoroughly before scientists rolled out what they bill as a stopwatch on your life. But the work on telomeres transpired in San Francisco, not Cambridge, and with Silicon Valley's influence, things move quickly.

At Telome Health Inc.'s Menlo Park office, the atmosphere is jovial. CEO Hunt sees two markets for telomere testing. First, for physicians with seriously ill patients, to determine whether a medical intervention would be worthwhile - in other words, to see if a patient is near death. The second market is for the curious private consumer, and the company plans to eventually sell the kit directly to individuals.

The ideal routine, Blackburn says, is to test every three months to see how rapidly telomeres are shortening and whether the rate is increasing or decreasing.

Some experts are worried, however, that Telome Health Inc. is marketing telomere tests to the public too soon.

"As a matter of overall public benefit, I'm not sure I see that they add societal value," says UC Berkeley bioethicist David Winickoff.

Bruce Ames and Kathleen Collins, aging experts in the department of biochemistry and molecular biology at UC Berkeley, are cautiously optimistic.

"My own suspicion is that telomeres shorten faster with bad nutrition. Americans are eating this god-awful diet," Ames says. "But giving out TeloAge? Seems a little premature. ... Whether or not telomeres actually lengthen has still not definitively been shown."

"But if people had waited to circulate aspirin," Collins counters, "a lot of people would be dead."
Insurance worries

Harley believes that any new information about health is always useful, though he is concerned that life insurance companies might take advantage of the telomere test results to increase premiums. That, he says, "would be a deep perversion of our technology."

In Telome headquarters, Harley offers astragalus root extract, meant to stimulate telomere growth, to any takers. He hasn't managed to lengthen his telomeres yet, but with running and weight loss, he says he has slowed their shrinking. "It's not easy knowing my telomeres are short," Harley leans back in his chair and sighs, "but it's good to know."

Effect of acupuncture on heart rate variability in primary dysmenorrheic women

I feel obliged to link to this study since it combines my interest in HRV, and acupuncture. But it is not as awesome as I would like since it uses a point combination that I don't understand, and it doesn't give any data on the clinical outcome of the patients. At least in the abstract. I will try to get a copy of the entire paper and report back to you. (Info on my practice here.)

Effect of acupuncture on heart rate variability in primary dysmenorrheic women.
Kim E, Cho JH, Jung WS, Lee S, Pak SC.
Am J Chin Med. 2011;39(2):243-9.

Department of Gynecology, College of Oriental Medicine, Kyung Hee University, Seoul, South Korea.

Primary dysmenorrhea is a common gynecological complaint among young women that is related to an autonomic nervous system (ANS) disturbance. Acupuncture is one of several therapeutic approaches for primary dysmenorrhea, since it can modulate ANS function. The heart rate variability (HRV) parameters such as high frequency (HF), low frequency (LF) and LF/HF ratio are generally accepted tools to assess ANS activity. The purpose of this study was to investigate the effects of acupuncture applied at Hegu (LI4) and Sanyinjiao (SP6) points on HRV of women with primary dysmenorrhea during the late luteal phase. The experimental design was a crossover and patient-blinded procedure. All subjects participated in Sham (SA) and Real Acupuncture (RA) procedure, separated by one month, in a crossover sequence. The participants included 38 women (mean age 22.3 years; weight 53.8 kg; height 162.6 cm). HRV measurement was 15 min before and 15 min after an acupuncture procedure. The RA procedure was performed at two bilateral acupoints, but needles were inserted subcutaneously to the acupuncture points for the SA procedure. The RA induced a significant decrease in LF/HF ratio and a significant increase in the HF power, while SA treatment caused a significant increase only in the HF power. Manual acupuncture at bilateral acupoints of LI4 and SP6 may play a role in dysmenorrhea treatment with autonomic nervous system involvement.

Acupuncture and the relaxation response for treating gastrointestinal symptoms in HIV patients on highly active antiretroviral therapy

I bring this study to your attention for a few reasons. It underscores the efficacy of acupuncture for gastrointestinal problems in general by addressing a serious and pernicious problem in HIV patients. The gut is highly innervated, and for that reason is actually easier to affect with acupuncture than one might think. The other interesting part of this study is that they combined the relaxation response with acupuncture to see if there was any difference and it turns out that they had a synergistic effect. The biofeedback device I use in my clinic to monitor Heart Rate Variability (HRV), a measure of the relaxation response, is designed to be used as a device for patients to learn to relax. I use it as a simple monitor, to see what happens during treatment. This makes me think I should go ahead and use it as intended, with patient participation. Who knows how much better my results would be? (For info on my practice, please click here.)

Acupuncture and the relaxation response for treating gastrointestinal symptoms in HIV patients on highly active antiretroviral therapy.
Chang BH, Sommers E.
Acupunct Med. 2011 Jun 24. [Epub ahead of print]

1VA Boston Health Care System, Boston, Massachusetts, USA.
Abstract
OBJECTIVES:

To examine the effect of acupuncture and the relaxation response (RR) for treating gastrointestinal (GI) symptoms in HIV patients who are using highly active antiretroviral therapy (HAART).
METHODS:

The authors conducted a 4-arm 2×2 double-blind randomised controlled trial in an acupuncture clinic in the USA. Sham acupuncture and health education were used as the control conditions of real acupuncture and RR elicitation, respectively. Enrolled patients were randomised to real acupuncture+RR (AR), sham acupuncture+RR (SR), real acupuncture+health education (AE) or sham acupuncture+health education (SE) study arm. Participants listened to CDs with RR-eliciting instructions or health education while receiving acupuncture intervention. Interventions were provided twice weekly for 4 weeks and once weekly for another 4 weeks. Participants used daily diaries to record GI symptom severity ratings (0-10). The authors estimated the intervention effect as the changes in symptom rating per intervention session increase using a mixed-effects regression model.
RESULTS:

A total of 130 people with HIV/AIDS who were on HAART and had persistent GI symptoms were enrolled and 115 started the study intervention. The AR group had greater intervention effects for loose stools symptoms than the other three groups (ß=-0.149, -0.151 and -0.144, p value=0.013, 0.013 and 0.018 comparing AR to AE, SR and SE, respectively). The AR group also had significant intervention effects on reducing nausea symptoms when the intervention was given twice per week (ß=-0.218, p=0.001).
CONCLUSIONS:

Our trial provided preliminary data demonstrating the potential synergistic effects of acupuncture and RR for treating GI symptoms in HIV patients on HAART.

Notes from NGF, Nerve Growth Factor, and Electroacupuncture Article by Manni

Having read the article in full from yesterday's blog post, (link to article here) I wanted to draw attention to a few points. One: they flesh out the concept of acupuncture causing stimulation similar to exercise. I remember reading Anderson's paper a long time ago and was happy to have the citation. Two: It turns out that NGF, nerve growth factor, may be involved en Electroacupuncture's effect on the sympathetic tone of Polycystic Ovarian Syndrome patients(as discussed here.) I discussed PCOS and electroacupuncture here and here. Three: They discuss electroacupuncture's effect on mast cells (MC) and NGF, postulating that acupuncture's effectiveness is due to their modulation of the immune system. I had come to think that the effectiveness of acupuncture for allergy was due to a general decrease in sympathetic tone leading to improved immunity, but they argue pretty convincingly that it may be due to release of these factors. I virtually never use electroacupuncture for allergy, rather manual acupuncture, but I certainly going to try in conjunction with HRV monitoring. Four: They discuss other aspects of NGF on peripheral neuropathy and Central Nervous System insults also, but I didn't include that discussion here.
I have excerpted and highlighted a bit of the article below. (Info on my practice here.)

It has been reported that manual acupuncture and EA
effects can be correlated to activation of all kinds of
type A (alpha, beta, gamma and delta) and C sensory
nerve fibers. However, particular significance has
been given to a group of receptors in the skeletal
muscles, which have both low- and high-threshold
for mechanical stimulation, and are innervated by
A-delta fibers and possibly C-fibers. Physiologically
they are activated by strong muscle contractions and
have been denoted ergoreceptors. Based on this, it
has been suggested that EA with repetitive muscle
contraction results in the activation of physiological
processes similar to those resulting from physical
exercise (Andersson et al., 1995).
Both acupuncture and physical exercise release
endogenous opioids, which seems to be essential
in the induction of acupuncture-mediated functional
changes of different organ systems. However,
other systems may be involved in the acupuncture
modulation of stress, pain, autonomic activity and
immune systems. Indeed, research carried out in
the last 20 years shown that through acupuncture
it is possible to affect synthesis, release and action
of several neurotransmitters (catecholamines, glutamate,
acetylcholine, GABA, serotonin) and neuropeptides
(among others: oxytocin, NPY, CCK,
VIP, SP, CGRP, PACAP) in both CNS and PNS.
It has recently been proposed that at least some of
the effects attributed to acupuncture are mediated
by neurotrophins, particularly NGF (Manni et al.,
2010a).
...The results suggested that EA inhibits
hyperactivity in the sympathetic nervous system (Cao
et al., 1983; Chao et al., 1999), a major pathogenetic
cause of PCO (Barria et al., 1993; Lara et al., 1993;
Lara et al., 2000; Lara et al., 2002). Supporting this
hypothesis, in a following study (Stener-Victorin
et al., 2003) we demonstrated the effect of EA
in reducing ovarian NGF along with ovarian and
hypothalamic sympathetic activation markers...

Neutralization of endogenous NGF reversed most
of these abnormalities (Manni et al., 2006). Almost
identical results were obtained by EA treatment
(Manni et al., 2005c), demonstrating that the results
were probably achieved through the actions of EA
on the NGF system.
Overall, the data on EA/NGF interaction in PCOS models indicated that the
therapeutic potential of EA is exerted via its ability
to modulate the activity of the autonomic nervous
system by inducing a long-lasting depression of the
sympathetic nervous system, with a concomitant
down-regulation of NGF in peripheral organs...

Since MC (mast cells) are critically involved
in allergic responses (Song et al., 2009), these observations
suggest that EA, through the modulation
of MC activity, can influence the release of their
preformed mediators, including NGF, in allergic
reactions.

Nerve Growth Factor and Electroacupuncture

I bring this article to your attention for a few reasons. One: this lab has concentrated on Nerve Growth Factor and acupuncture for quite a few years, and see it as a key link in the cascade of responses between the peripheral nervous system and the Central Nervous System including the autonomic nervous system (my area of interest.) Two: this investigator sees acupuncture's effects as similar to a massage or exercise. This is an interesting take, and the exercise angle is one shared by some Swedish researchers for years. Three: I think this is a direction of inquiry that may prove to be quite fruitful, and one that I don't know much about, so am eager to read more on this topic, and hopefully get some of the original articles to share with you readers. Four: this article has a free full text link! Here's the link. I will copy the abstract in full, as usual, emphases are mine.
Electroacupucture and nerve growth factor: potential clinical applications.
Manni L, Rocco ML, Barbaro Paparo S, Guaragna M

Institute of Neurobiology and Molecular Medicine, CNR, Rome, Italy. luigi.manni@inmm.cnr.it.
Arch Ital Biol. 2011 Jun;149(2):247-55. doi: 10.4449/aib.v149i2.1365.

The nerve growth factor (NGF) is a neurotrophin regulating the survival and function peripheral sensory and sympathetic neurons and of forebrain cholinergic neurons. Both peripheral neuropathies and brain cholinergic dysfunctions could benefit from NGFbased therapies, but the clinical use of NGF has been so far hampered by the development of important side effects, like hyperalgesia and autonomic dysfunctions. Acupuncture is a therapeutic technique and is a part of traditional Chinese medicine. Western descriptions of the clinical efficacy of acupuncture on pain, inflammation, motor dysfunction, mood disorders, and seizures are based on the stimulation of several classes of sensory afferent fibers and the consequent activation of physiological processes similar to those resulting from physical exercise or deep massage. Recently, it has been shown that peripheral sensory stimulation by electroacupuncture (EA) could improve brain NGF availability and utilization, at the same time counteracting the major sideeffects induced by NGF administration. This review focuses on the emerging links between EA and NGF with special emphasis on the work carried out in the last decade in our laboratory, investigating the role of NGF as a mediator of EA effects in the central nervous system and as a modulator of sensory and autonomic activity.

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Genomic Cancer Testing Falls Apart

From today's NYTimes, an article about a technique of using DNA testing to tailor cancer treatment is debunked with law suits ensuing. I flag this article because it falls into the Gold Rush treatment mentality that so pervades the U.S. health care industry. The only way to really make money off of healthcare in our system is to provide treatment once the illness is manifest. (Or to create a condition and then provide treatment for it, i.e. Viagra) There is no money to be made in prevention, so prevention takes a back seat. The only institution with enough heft to counter corporate clout is the government, but with the government itself under attack, and the research and regulatory agencies' budgets being slashed, there's not too much policing going on. So efforts to discover the actual carcinogens involved in the increased cancer rates are meager. The causes of autism are slow to be discovered, and unlikely to be acknowledged if, indeed, a blockbuster drug is implicated. And so it goes. This particular technology also fits into the category of "believing in treatments that don't work." I excerpted parts and highlighted others. (For more info about my practice, please click here.)

July 7, 2011
How Bright Promise in Cancer Testing Fell Apart
By GINA KOLATA

When Juliet Jacobs found out she had lung cancer, she was terrified, but realized that her hope lay in getting the best treatment medicine could offer. So she got a second opinion, then a third. In February of 2010, she ended up at Duke University, where she entered a research study whose promise seemed stunning.

Doctors would assess her tumor cells, looking for gene patterns that would determine which drugs would best attack her particular cancer. She would not waste precious time with ineffective drugs or trial-and-error treatment. The Duke program — considered a breakthrough at the time — was the first fruit of the new genomics, a way of letting a cancer cell’s own genes reveal the cancer’s weaknesses.

But the research at Duke turned out to be wrong. Its gene-based tests proved worthless, and the research behind them was discredited. Ms. Jacobs died a few months after treatment, and her husband and other patients’ relatives are suing Duke.

The episode is a stark illustration of serious problems in a field in which the medical community has placed great hope: using patterns from large groups of genes or other molecules to improve the detection and treatment of cancer.Companies have been formed and products have been introduced that claim to use genetics in this w ay, but assertions have turned out to be unfounded. While researchers agree there is great promise in this science, it has yet to yield many reliable methods for diagnosing cancer or identifying the best treatment.

Instead, as patients and their doctors try to make critical decisions about serious illnesses, they may be getting worthless information that is based on bad science. The scientific world is concerned enough that two prominent groups, the National Cancer Institute and the Institute of Medicine, have begun examining the Duke case; they hope to find new ways to evaluate claims based on emerging and complex analyses of patterns of genes and other molecules.

So far, the Food and Drug Administration “has generally not enforced” its regulation of tests created by individual labs because, until recently, such tests were relatively simple and relied heavily on the expertise of a particular doctor, said Erica Jefferson, a spokeswoman for the agency. But now, with labs offering more complex tests on a large scale, the F.D.A. is taking a new look at enforcement.

Dr. Scott Ramsey, director of cancer outcomes research at the Fred Hutchison Cancer Center in Seattle, says there is already “a mini-gold rush” of companies trying to market tests based on the new techniques, at a time when good science has not caught up with the financial push. “That’s the scariest part of all,” Dr. Ramsey said.



And the Duke researchers continued to publish papers on their genomic signatures in prestigious journals. Meanwhile, they started three trials using the work to decide which drugs to give patients.

Dr. Baggerly and Dr. Coombes tried to sound an alarm. They got the attention of the National Cancer Institute, whose own investigators wanted to use the Duke system in a clinical trial but were dissuaded by the criticisms. Finally, they published their analysis in The Annals of Applied Statistics, a journal that medical scientists rarely read.

The situation finally grabbed the cancer world’s attention last July, not because of the efforts of Dr. Baggerly and Dr. Coombes, but because a trade publication, The Cancer Letter, reported that the lead researcher, Dr. Potti, had falsified parts of his résumé. He claimed, among other things, that he had been a Rhodes scholar.

“It took that to make people sit up and take notice,” said Dr. Steven Goodman, professor of oncology, pediatrics, epidemiology and biostatistics at Johns Hopkins University.

In the end, four gene signature papers were retracted. Duke shut down three trials using the results. Dr. Potti resigned from Duke. He declined to be interviewed for this article. His collaborator and mentor, Dr. Nevins, no longer directs one of Duke’s genomics centers.

The cancer world is reeling.

The Duke researchers had even set up a company — now disbanded — and planned to sell their test to determine cancer treatments. Duke cancer patients and their families, including Mrs. Jacobs’s husband, Walter Jacobs, say they feel angry and betrayed. And medical researchers see the story as a call to action. With such huge data sets and complicated analyses, researchers can no longer trust their hunches that a result does — or does not — make sense.

“Our intuition is pretty darn poor,” Dr. Baggerly said.

HRV and different Electroacupuncture frequencies in Healthy Volunteers

Now we're talking. A study looking at different electroacupuncture freqencies and what happens to Heart Rate Variability. This interests me quite a bit since, I'm planning to look at HRV in PCOS (Polycystic Ovarian Syndrome) patients comparing manual acupuncture with 2Hz electrical stimulation. What they found was an overall increase in HRV with high frequency electroacupuncture (120Hz), but no change in the low frequency electroacupuncture (2Hz) group. This goes against the findings that Stener-Vitorin found in her PCOS patients and various other studies, here. But the study was done in healthy volunteers, and the point selection may not have been optimal to stimulate vagal activity, but it's nice to have some more data points in the acupuncture/HRV realm. (For more information about my practice please click here.)

J Acupunct Meridian Stud. 2011 Jun;4(2):107-15.
Comparison of Electroacupuncture Frequency-related Effects on Heart Rate Variability in Healthy Volunteers: A Randomized Clinical Trial.
Lee JH, Kim KH, Hong JW, Lee WC, Koo S.
Source

Division of Meridian and Structural Medicine, School of Korean Medicine, Pusan National University, Yangsan, Korea.
Abstract

This study aimed to compare the effects of high frequency electroacupuncture (EA) and low-frequency EA on the autonomic nervous system by using a heart rate variability measuring device in normal individuals. Fourteen participants were recruited and each participated in the high-frequency and low-frequency sessions (crossover design). The order of sessions was randomized and the interval between the two sessions was over 2 weeks. Participants received needle insertion with 120-Hz stimulation during the high-frequency session (high-frequency EA group), and with 2-Hz stimulation during the low-frequency session (low-frequency EA group). Acupuncture needles were directly inserted perpendicularly to LI 4 and LI 11 acupoints followed by delivery of electric pulses to these points for 15 minutes. Heart rate variability was measured 5 minutes before and after EA stimulation by a heart rate variability measuring system. We found a significant increase in the standard deviation of the normal-to-normal interval in the high-frequency EA group, with no change in the low-frequency EA group. Both the high-frequency and low-frequency EA groups showed no significant differences in other parameters including high-frequency power, low-frequency power, and the ratio of low-frequency power to high-frequency power. Based on these findings, we concluded that high-frequency EA stimulation is more effective than low-frequency EA stimulation in increasing autonomic nervous activity and there is no difference between the two EA frequencies in enhancing sympathovagal balance.

UCSF, Stanford Study shows that environment plays bigger role in autism

UCSF, Stanford autism study shows surprises

Erin Allday, Chronicle Staff Writer

Tuesday, July 5, 2011

San Francisco -- Environmental factors play a more important role in causing autism than previously assumed and, surprisingly, an even larger role than genetics, according to a new study out of UCSF and Stanford that could force a dramatic swing in the focus of research into the developmental disorder.

The study, published in Monday's issue of the Archives of General Psychiatry, looked at 192 pairs of twins in California and, using a mathematical model, found that genetics account for about 38 percent of the risk of autism, and environmental factors account for about 62 percent.

Previous twin studies had suggested that autism was highly inheritable, with genetics accounting for roughly 90 percent of all cases worldwide. As such, much recent research into autism has focused on tracking down the genes and unlocking the complex genetic codes that are associated with autism...

Earlier beliefs

For decades in the mid-20th century, autism was linked mostly to environmental factors - specifically, poor parenting, with much of the blame falling on mothers. As rates of autism skyrocketed in the '80s and '90s - it's now thought to affect as many as 1 percent of U.S. children - scientists and patient advocates shifted away from blaming families.

Research has focused on obvious genetic factors for the past 10 or 15 years. Now, scientists said, they hope to broaden the study and look at how genetics and environmental influences work together to cause autism...

Antidepressants' role?

One study along those lines, also published in Monday's Archives of General Psychiatry, looked at the possible role of maternal antidepressant use before and during pregnancy. The study of 298 autistic children in the Kaiser Permanente Northern California system found a two-fold increase in risk of the disorder when mothers took antidepressants at some point in the year before giving birth...

It only makes sense that there would be some environmental factor given the dramatic rise in autism in the last 20 years. For some genetic cause to occur so quickly never totally added up. The increase in autism rates certainly does coincide with the liberal use of antidepressants in the general population. I remember reading that Prozac is even found in the ground water in many places. Of course, we can't jump to conclusions about antidepressants or any other environmental factor, but I'm certain that this might influence prospective mothers' choice of whether or not to take the medication. Wow. This is pretty big news.

Just another reason to use acupuncture instead of medications! First Do No Harm!! (For more info on my practice, please click here.)

Toll From Stress: Links to Parkinson's and other Diseases

From Scientific American Mind,( www.ScientificAmerican.com/mind) an article about brain disorders result from a complex interaction between our genes and the environments to which we are exposed. A set of recent studies has just uncovered an important environmental instigator of neurodegenerative disease: stress. It goes on to say that stress has been shown to have an adverse effects on numerous psychological condition The idea that stress may figure into neurodegenerative disease, is relatively new. The research was done on rats and monkeys, but the implications for human disease are pretty clear.
Their Fast Facts:
1. A recent wave of research has unveiled an important environmental player in the genesis of neurodegenerative disease: Stress
2. Pairs of identical twins developed Alzheimer's disease in concert only 40% of the time, showing that factors other than genetics must contribute to the disorder.
3. Stress seems to impede the ability of certain brain cells to recover from insults, triggering aor aggravating the symptoms of disorders such as Parkinson's.

We know from the work of Dr. Elizabeth Blackburn that telomeres show increased cellular aging in patient populations with increased stress, so it is not too surprising that Alzheimer's would be influenced by increased stress levels also.
As readers of this blog know, stress is my particular area of interest especially using acupuncture as a mitigator of the stress response. (I have a page on my website here.)
Be Smart! Relax! And get your acupuncture! (As well as exercise, meditation etc..._
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Studying the Acupuncture Meridians: Collagen Bands and Electrical Impedance

Helene Langevin is a regular at the Society for Acupuncture Research (SAR) gatherings. Her particular interest and expertise is the actual meridians themselves, and the collagen networks that contribute to acupuncture signaling. I was unaware of this study and think it's interesting. The emphases are mine.
Electrical Impedance of Acupuncture Meridians: The Relevance of Subcutaneous Collagenous Bands

The scientific basis for acupuncture meridians is unknown. Past studies have suggested that acupuncture meridians are physiologically characterized by low electrical impedance and anatomically associated with connective tissue planes. We are interested in seeing whether acupuncture meridians are associated with lower electrical impedance and whether ultrasound-derived measures – specifically echogenic collagenous bands - can account for these impedance differences.

In 28 healthy subjects, we assessed electrical impedance of skin and underlying subcutaneous connective tissue using a four needle-electrode approach. The impedances were obtained at 10 kHz and 100 kHz frequencies and at three body sites - upper arm (Large Intestine meridian), thigh (Liver), and lower leg (Bladder). Meridian locations were determined by acupuncturists. Ultrasound images were obtained to characterize the anatomical features at each measured site. We found significantly reduced electrical impedance at the Large Intestine meridian compared to adjacent control for both frequencies. No significant decrease in impedance was found at the Liver or Bladder meridian. Greater subcutaneous echogenic densities were significantly associated with reduced impedances in both within-site (meridian vs. adjacent control) and between-site (arm vs. thigh vs. lower leg) analyses. This relationship remained significant in multivariable analyses which also accounted for gender, needle penetration depth, subcutaneous layer thickness, and other ultrasound-derived measures.

Collagenous bands, represented by increased ultrasound echogenicity, are significantly associated with lower electrical impedance and may account for reduced impedances previously reported at acupuncture meridians. This finding may provide important insights into the nature of acupuncture meridians and the relevance of collagen in bioelectrical measurements.

Andrew C. Ahn1,2*, Min Park3, Jessica R. Shaw4, Claire A. McManus5, Ted J. Kaptchuk2,6, Helene M. Langevin7

1 Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, Massachusetts, United States of America, 2 Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America, 3 P-pro Korea Co., Ltd., Seoul, Korea, 4 AltThera Health, Boston, Massachusetts, United States of America, 5 Department of Research and Training, Spaulding Rehabilitation Hospital, Boston, Massachusetts, United States of America, 6 Division for Research and Education in Complementary and Integrative Medical Therapies, Harvard Medical School, Boston, Massachusetts, United States of America, 7 Department of Neurology, University of Vermont, Burlington, Vermont, United States of America

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