When Less Treatment is More

An article worth reading in its entirety discussing the new guidelines for breast cancer treatment. We've discussed breast cancer treatment a few times, for example, here and here. A few excerpts will follow. In the case of cancer, I can't help but wonder if our language is too clumsy. Perhaps a small "cancer" would be allowed to just be if it was called "a lump of abnormal cells." I posted about this earlier, here. The term cancer, from the word crab, (Latin?) implies that it keeps eating away. But some of these "cancers" go away on their own, or won't cause any further damage. Incredibly difficult to change the thinking of patients or doctors at this stage of the game. It is a conversation well worth having, however. "Less is More" is the name of Dr. Redberg's blog in Annals of Internal Medicine, we've discussed here, and here,

March 29, 2012, 1:23 pm

When Less Treatment Is More

By PAULINE W. CHEN, M.D.

Michele Constantini
The path of less, versus more, treatment has met with resistance...

“Sometimes the hardest thing for us doctors to do,” her surgeon said to me, “is to know when not to do anything.”

I was reminded of the relevance of his remark for both doctors and patients when I read a study on breast cancer treatment published this month in The Journal of Clinical Oncology.

For years, the standard treatment for most women with early-stage invasive breast cancer has been to cut out the tumor and then administer radiation. But eight years ago in a major study, that approach was re-evaluated for women over age 70. It turned out that putting older women with less aggressive early cancers through the additional rigors and complications of radiation — fatigue, rash and the need to visit a radiation center daily for a month or more — had no effect on their survival rates.

A year later, the findings were incorporated into a widely accepted series of cancer treatment guidelines that recommended surgery — but rendered radiation optional — for women over 70 with more favorable early forms of breast cancer.

But in the latest study, researchers from Yale University’s School of Medicine discovered that the earlier study and resulting recommendations have had little effect on what treatments older breast cancer patients are receiving. ..

“We’ve become increasingly concerned about the overuse of screening tests or excessive treatments with little benefit,” said Dr. Cary P. Gross, associate professor of medicine at Yale and senior author of the study. “But these concerns aren’t reflected in changes in how we are caring for patients...”

Patients, too, may feel the same way and insist on proceeding with treatment. Convincing them otherwise can require lengthy discussions that many doctors don’t have the time for. “It’s almost simpler to present a ‘plan of action’ than convince a patient that doing nothing is a reasonable course,” said Dr. Kenneth B. Roberts, another one of the authors and an associate professor of therapeutic radiology at Yale.

“Our system’s ability to find new treatments has far outpaced its ability to understand the limits of those treatments or to communicate with patients about the best strategies for those treatments,” Dr. Gross said. “What we need to do is step back and figure out how we can design our health system so that the right patient gets the right care at the right time, rather than all patients getting more care all the time.”

For more info on my practice click here.

Auricular Acupuncture for Epilepsy, a Case for Vagal Stim

(No posting due to travel the last two weeks, thought I could do some but I didn't see too much in the news and my schedule chaotic.)
I did a series of posts about Litscher's work here, here and here. The abstract doesn't mention if he's looking at HRV, but I would suspect he is from his previous work. I will try to get a copy of his paper. (Sometimes it isn't possible because the abstract is out before the paper is ready.) More on my acupuncture practice here.

Evid Based Complement Alternat Med. 2012;2012:615476. Epub 2012 Feb 1.

Auricular Acupuncture May Suppress Epileptic Seizures via Activating the Parasympathetic Nervous System: A Hypothesis Based on Innovative Methods.
He W, Rong PJ, Li L, Ben H, Zhu B, Litscher G.
Source

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Abstract

Auricular acupuncture is a diagnostic and treatment system based on normalizing the body's dysfunction. An increasing number of studies have demonstrated that auricular acupuncture has a significant effect on inducing parasympathetic tone. Epilepsy is a neurological disorder consisting of recurrent seizures resulting from excessive, uncontrolled electrical activity in the brain. Autonomic imbalance demonstrating an increased sympathetic activity and a reduced parasympathetic activation is involved in the development and progress of epileptic seizures. Activation of the parasympathetic nervous system such as vagus nerve stimulation has been used for the treatment of intractable epilepsy. Here, we propose that auricular acupuncture may suppress epileptic seizures via activating the parasympathetic nervous system.

Fewer Pap Smears Recommended

I offer this up as part of an emerging trend in the prevention world. It seems that there is a dawning realization that more treatment, more intervention, does not always lead to better outcomes. It might shock many patients to realize that, for example, HPV (human papilloma virus) is eliminated in most cases by the patient's own immune system and won't cause any problems. Just as some breast cancers are small and will go away and the treatment might be worse than any outcome of letting the cancers be. This is a "hard sell" after so many years of admonishing people to get screened for all sorts of conditions. More on my practice, here.

March 14, 2012, 5:58 pm
New Guidelines Advise Less Frequent Pap Smears
By TARA PARKER-POPE

The annual Pap smear, a cornerstone of women’s health for at least 60 years, is now officially a thing of the past, as new national guidelines recommend cervical cancer screening no more often than every three years.

In recent years, some doctors and medical groups, including the American College of Obstetricians and Gynecologists in 2009, began urging less frequent screening for cervical cancer. Even so, annual Pap smear testing is still common because many women are reluctant to give up frequent screening for cervical cancer...

“We achieve essentially the same effectiveness in the reduction of cancer deaths, but we reduce potential harm of false positive tests,” said Dr. Wanda Nicholson, a task force member and an associate professor of obstetrics and gynecology at the University of North Carolina at Chapel Hill. “It’s a win-win for women.”

Cost is not a factor in the task force recommendations. Instead, its members focus on the effectiveness of a screening test to reduce cancer deaths, balanced against the potential harms that accompany the screening. The worry about frequent Pap smear screening is that tests can result in a large number of false positives that lead to sometimes painful biopsies and put women at risk for pregnancy complications in the future, like preterm labor and low-birth-weight infants...

Finally, the group also recommends against regular HPV screening for anyone under 30. In 2003, the task force said it did not have enough evidence to make a recommendation about HPV testing. It now says the test is unnecessary because many women exposed to the virus will eventually eliminate the virus without any intervention.

“HPV in women under 30 is highly prevalent but also highly transient,” Dr. Nicholson said. “Women under 30 may get infected with HPV, but they have a high likelihood of clearing that infection on their own, and it not causing any long-term change to their cervical tissue.”

Do Statins Make It Tough to Exercise?: More Statin Problems

To be tossed into the "First Do No Harm" file. I don't know what to make of the rat study, but it still amazes me that statins are the most widely prescribed drugs in the world. I've discussed some of the problems with statins, diabetes risk here, cognition problems here, and here. Link to the article if you are on statins, or know someone who is.

March 14, 2012, 12:01 am
Do Statins Make It Tough to Exercise?
By GRETCHEN REYNOLDS

For years, physicians and scientists have been aware that statins, the most widely prescribed drugs in the world, can cause muscle aches and fatigue in some patients. What many people don’t know is that these side effects are especially pronounced in people who exercise.

To learn more about the effect statins have on exercising muscles, scientists in Strasbourg, France, recently gave the cholesterol-lowering drug Lipitor to a group of rats for two weeks, while a separate control group was not medicated. Some of the rats from both groups ran on little treadmills until they were exhausted.

It was immediately obvious that the medicated animals couldn’t run as far. They became exhausted much earlier than the rats that had not been given statins...


Statins’ safety has come under considerable scrutiny in recent weeks. Last month, the Food and Drug Administration added safety alerts to prescribing information for statins, warning of risks for memory loss and diabetes, as well as muscle pain.

More than 20 million Americans are taking statins, and by most estimates, at least 10 percent of them will experience some degree of muscle achiness or fatigue. That proportion rises to at least 25 percent among people taking statins who regularly exercise, and may be 75 percent or higher among competitive athletes...

“Statins are anti-aging for arteries,” he says. “If you take them, you’ll have younger arteries. Unfortunately,” he adds, “they are not anti-aging for muscles.”

More information about my practice here.

Exercise Fueling the Brain

From the NYTimes an article on how exercise improves brain functioning. This could be part of the anti-aging aspect to exercise. (More info on my practice here.)

How Exercise Fuels the Brain
By GRETCHEN REYNOLDS
Moving the body demands a lot from the brain...
This increase in brain activity naturally increases the brain’s need for nutrients, but until recently, scientists hadn’t fully understood how neurons fuel themselves during exercise. Now a series of animal studies from Japan suggest that the exercising brain has unique methods of keeping itself fueled. What’s more, the finely honed energy balance that occurs in the brain appears to have implications not only for how well the brain functions during exercise, but also for how well our thinking and memory work the rest of the time...
But about 10 years ago, some neuroscientists found that specialized cells in the brain, known as astrocytes, that act as support cells for neurons actually contained small stores of glycogen, or stored carbohydrates. And glycogen, as it turns out, is critical for the health of cells throughout the brain.

While a brain with more fuel reserves is potentially a brain that can sustain and direct movement longer, it also “may be a key mechanism underlying exercise-enhanced cognitive function,” says Hideaki Soya, a professor of exercise biochemistry at the University of Tsukuba and senior author of the studies, since supercompensation occurs most strikingly in the parts of the brain that allow us better to think and to remember. As a result, Dr. Soya says, “it is tempting to suggest that increased storage and utility of brain glycogen in the cortex and hippocampus might be involved in the development” of a better, sharper brain...
He and his colleagues have found that “glycogen supercompensation in some brain loci” is “enhanced in rats receiving carbohydrates immediately after exhaustive exercise.” So for people, that might mean that after a run or other exercise that is prolonged or strenuous enough to leave you tired, a bottle of chocolate milk or a banana might be just the thing your brain is needing.

Electroacupuncture, Immunity and Autonomic Nervous System in Rats

We've seen a number of studies on acupuncture and the immune system and its effect on cellular immunity(Nerve growth factor and electroacupuncture), moxabustion and cytokine production, basophils and acupuncture for eczema, and some theoretical studies on stress and immunity but I don't recall seeing a paper drawing the specific connection between the autonomic nervous system and improved immunity. In rats no less... (Information about my practice here.)

Anesthesiology. 2012 Feb;116(2):406-14.
Electroacupuncture improves survival in rats with lethal endotoxemia via the autonomic nervous system.
Song JG, Li HH, Cao YF, Lv X, Zhang P, Li YS, Zheng YJ, Li Q, Yin PH, Song SL, Wang HY, Wang XR.
Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Recent advances have indicated a complex interplay between the autonomic nervous system and the innate immune system. Targeting neural networks for the treatment of sepsis is being developed as a therapeutic strategy. Because electroacupuncture at select acupoints can modulate activities of the autonomic nervous system, we tested the hypothesis that electroacupuncture at specific acupoints could modulate systemic inflammatory responses and improve survival via its impact on the autonomic nervous system in a rat model of sepsis.
METHODS:

Sprague-Dawley male rats received electroacupuncture for 45 min before and at 1, 2, or 4 h after a lethal dose of intraperitoneal lipopolysaccharide injection (6 mg/kg). Outcomes included survival and systemic cytokine responses. Also, the possible roles of neural circuitry, including the hypothalamic-pituitary-adrenal axis and the autonomic nervous system, were evaluated.
RESULTS:
Electroacupuncture pretreatment at the Hegu acupoints significantly attenuate systemic inflammatory responses and improve survival rate from 20% to 80% in rats with lethal endotoxemia. Such a site-specific effect requires the activation of muscarinic receptors in the central nervous system, but not increasing central sympathetic tone. In the periphery synergistic, rather than independent, action of the sympathetic and parasympathetic systems is also necessary.
CONCLUSIONS:
Electroacupuncture pretreatment has a dramatic survival-enhancing effect in rats with lethal endotoxemia, which involves the activation of efferent neural circuits of the autonomic nervous system (e.g., cholinergic antiinflammatory pathway). This approach could be developed as a prophylactic treatment for sepsis or perioperative conditions related to excessive inflammation.

More Acupuncture and HRV: Systems Level Approach

To be filed under "Couldn't Have Said It Better Myself." I'm pleased that there is more interest in HRV and acupuncture since I've been studying this topic for 10 years. I've ordered a new HRV monitoring system from Vivonoetics (vivonoetics.com) which should be arriving this coming week. Yay! I was struggling to get my J and J system to work, so am hopeful that a new system should make data gathering much easier. More information about my practice here.

Explore (NY). 2012 Mar;8(2):99-106.
Acupuncture and heart rate variability: a systems level approach to understanding mechanism.
Anderson B, Nielsen A, McKee D, Jeffres A, Kligler B.
Pacific College of Oriental Medicine, New York, NY; Albert Einstein College of Medicine, Yeshiva University, Bronx, NY.
Abstract

Recent research has elucidated several different mechanisms for acupuncture. However, the interrelationship between these mechanisms and how acupuncture affects complex physiological systems is still not understood. Heart rate Variability (HRV), the beat-to-beat fluctuations in the rhythm of the heart, results from the regulation of the heart by the autonomic nervous system (ANS). Low HRV is associated with increased risk of all-cause mortality and is a marker for a wide range of diseases. Coherent HRV patterns are associated with increased synchronization between the two branches of the ANS, and when sustained for long periods of time result in increased synchronization and entrainment between multiple body systems. There is strong evidence from randomized placebo controlled trials that acupuncture modulates HRV. This may represent a mechanistic pathway for global physiological regulation, which is congruent with East Asian medical theory. The ability of acupuncture to improve HRV could be used as a tool in acupuncture research and practice to monitor treatment effectiveness and the impact on quality of life.

HRV and Acupuncture Study: ISAMS Huang

This is the published article from this presentation from ISAMS. I'm confused about their conclusions, i.e. that heart rate variability increases in disease, when it's the opposite. They also found that the LFR/HFR was unchanged, and that HRV decreased with acupuncture which does not correspond with most studies. The finding that Sample Entropy increased corroborates my findings. (Info on my practice here.)

J Acupunct Meridian Stud. 2012 Feb;5(1):15-20. Epub 2011 Dec 9.
A naturalistic study of the effect of acupuncture on heart-rate variability.
Fasmer OB, Liao H, Huang Y, Berle JØ, Wu J, Oedegaard KJ, Wik G, Zhang Z.
Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Norway; Haukeland University Hospital, Department of Psychiatry, Bergen, Norway.
OBJECTIVES:
To study the effect of acupuncture on heart rate variability (HRV) by using linear and non-linear methods of analysis.
METHODS:
40 patients were recruited consecutively, including patients with insomnia, stomachache, diarrhea, dizziness, cervical syndrome, lower back pain, gonarthritis, peripheral facial paralysis, post-traumatic organic brain syndrome and urinary retention... HRV was recorded before, during, and after acupuncture.
RESULTS:
Acupuncture substantially reduced variability, causing a 41% reduction in the standard deviation. Using a Fourier analysis, the variances both in the low frequency (LF) and the high frequency (HF) ranges were markedly reduced, but the LF/HF ratio (an indication of sympatho-vagal balance) was not altered. The HR was unchanged. The sample entropy, which is a measure of the complexity of time series, was significantly increased (+35%).
CONCLUSIONS:
Acupuncture produced a pattern of changes different from that seen in pathological conditions, where increased variability and reduced complexity is expected. (???)

Manual Acupuncture at St36 and PC6 shows increase in HRV

One more study showing that acupuncture at 6MC and St36 (the hypertension protocol of Longhurst et al) increases HRV, hence decreases stress response. In this case the stimulation was manual, but they compared "stimulating" versus "nonstimulating." For details on these two methods I would have to see the entire article. (For information on my practice, please click here.)

Stimulation of gastric slow waves with manual acupuncture at acupuncture points ST36 and PC6 - A randomized single blind controlled trial.
Witt CM, Meissner K, Pach D, Thiele C, Lüdtke R, Ghadiyali Z, Deter HC, Zimmermann-Viehoff F.
Neurogastroenterol Motil. 2012 Feb 6.
Background  To investigate the effects of stimulated and non-stimulated manual acupuncture at ST36 and PC6 on gastric myoelectrical activity and autonomic function. Methods  A total of 65 healthy volunteers were randomly assigned to a 1: 1: 2 ratio to receive either 15 min of verum acupuncture (VA) with stimulation followed by 15 min of VA without stimulation (nsVA), or 15 min of nsVA followed by 15 min of VA with stimulation (sVA), or 30 min of sham acupuncture (SA). Measures of autonomic function included electrogastrogram, electrocardiogram, impedance cardiography and assessment of blood pressure, breathing frequency, and electrodermal activity. Outcome parameters were compared between VA and SA, and between sVA and nsVA. The percentage of regular gastric slow waves (normogastria) was defined as the primary outcome. Key Results  The percentage of normogastria was not significantly different between VA and SA. Differences in secondary outcomes such as power spectrum of gastric slow waves and heart rate variability parameters were pronounced in the comparison of sVA and nsVA. During sVA, the percentage of normogastria was lower (P = 0.005), the percentage of bradygastria was higher (P = 0.003) and power ratio was higher (P < 0.001), systolic blood pressure was lower (P = 0.039) and RMSSD was higher (P < 0.001) as compared with nsVA.

Electroacupuncture at St36 prevents stress induced increases in neuropeptide Y in rats

This study confirms the value of electroacupuncture at St36 in reducing one of the sympathetic pathways involved in the stress response and adds some additional evidence. This effect was discussed in different contexts here and here. In the first post electroacupuncture at St36 was used for migraine prophylaxis and was found to decrease the stress response (decrease LFR/HFR.) In the second post, electroacupuncture was used to decrease blood pressure.
Exp Biol Med (Maywood). 2012 Jan 1;237(1):18-23. Epub 2011 Dec 7.

Acupuncture at ST36 prevents chronic stress-induced increases in neuropeptide Y in rat.
Eshkevari L, Egan R, Phillips D, Tilan J, Carney E, Azzam N, Amri H, Mulroney SE.
Department of Nursing, School of Nursing and Health Studies, Georgetown University Medical Center, Washington, DC 20007, USA. eshkevl@georgetown.edu

Chronic stress, as seen in post-traumatic stress disorder, can exacerbate existing diseases. Electroacupuncture (EA) has been proposed to treat chronic stress, although information on its efficacy or mechanism(s) of action is limited. While many factors contribute to the chronic stress response, the sympathetic peptide, neuropeptide Y (NPY), has been shown to be elevated in chronic stress and is hypothesized to contribute to the physiological stress response. Our objective was to determine if EA at acupuncture point stomach 36 (ST(36)) is effective in mitigating cold stress-induced increase in NPY in rats. Both pretreatment and concomitant treatment with EA ST(36) effectively suppressed peripheral and central NPY after 14 d of cold stress (P < 0.05). The effect was specific, as NPY in Sham-EA rats was not different than observed in stress-only rats. Additionally, the effect of EA ST(36) was long-lasting, as NPY levels remained suppressed despite early cessation of EA ST(36), while exposure to cold stress was continued. In the paraventricular nucleus (PVN), it was notable that changes in NPY mirrored plasma NPY levels, and that the significant elevation in PVN Y1 receptor observed with stress was also prevented with EA ST(36). The findings indicate that EA ST(36) is effective in preventing one of the sympathetic pathways stimulated during chronic stress, and thus may be a useful adjunct therapy in stress-related disorders.

Atopic Dermatitis and Acupuncture

Study looking at skin response with acupuncture and cetirizine. Both worked compared to placebo, but the flare was smaller with acupuncture. More info on my practice here.

Acupuncture compared with oral antihistamine for type I hypersensitivity itch and skin response in adults with atopic dermatitis - a patient- and examiner-blinded, randomized, placebo-controlled, crossover trial.
Pfab F, Kirchner MT, Huss-Marp J, Schuster T, Schalock PC, Fuqin J, Athanasiadis GI, Behrendt H, Ring J, Darsow U, Napadow V.Allergy. 2012 Feb 8

Department of Dermatology and Allergy, Technische Universität München, Munich, Germany; Department of Radiology, Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA; Division of Environmental Dermatology and Allergy, Helmholtz Zentrum München/TUM, ZAUM-Center for Allergy and Environment, Munich, Germany; Department of Prevention and Sports Medicine, Klinikum rechts der Isar, Technische Universitaet Muenchen, Munich, Germany.
Abstract
BACKGROUND:

Itch is the major symptom of atopic dermatitis (AD). Acupuncture has been shown to exhibit a significant effect on experimental itch in AD. Our study evaluated acupuncture and antihistamine itch therapy (cetirizine) on type I hypersensitivity itch and skin reaction in AD using a patient and examiner-blinded, randomized, placebo-controlled, crossover trial.
METHODS:

Allergen-induced itch was evaluated in 20 patients with AD after several interventions in separate sessions: preventive (preceding) and abortive (concurrent) verum acupuncture (VAp and VAa), cetirizine (10 mg, VC), corresponding placebo interventions (preventive, PAp, and abortive, PAa, placebo acupuncture; placebo cetirizine pill, PC) and a no-intervention control (NI). Itch was induced on the forearm and temperature modulated over 20 min, using our validated model. Outcome parameters included itch intensity, wheal and flare size and the D2 attention test.
RESULTS:

Mean itch intensity (SE: 0.31 each) was significantly lower following VAa (31.9) compared with all other groups (PAa: 36.5; VC: 36.8; VAp: 37.6; PC: 39.8; PAp: 39.9; NI: 45.7; P < 0.05). There was no significant difference between VAp and VC (P > 0.1), although both therapies were significantly superior to their respective placebo interventions (P < 0.05). Flare size following VAp was significantly smaller (P = 0.034) than that following PAp. D2 attention test score was significantly lower following VC compared with all other groups (P < 0.001).
CONCLUSIONS:

Both VA and cetirizine significantly reduced type I hypersensitivity itch in patients with AD, compared with both placebo and NI. Timing of acupuncture application was important, as VAa had the most significant effect on itch, potentially because of counter-irritation and/or distraction. Itch reduction following cetirizine coincided with reduced attention.

Statins good for you? Think again. FDA issues warning

Long overdue. People have been complaining about the statins for years, finally the FDA takes action. Good for them. I discussed the irrational boosterism about statins here, their link to diabetes here.
More on my practice here.
Maybe one more for the "Follow the Money", and "First Do No Harm" files.

February 28, 2012
Safety Alerts Cite Cholesterol Drugs’ Side Effects
By GARDINER HARRIS

Federal health officials on Tuesday added new safety alerts to the prescribing information for statins, the cholesterol-reducing medications that are among the most widely prescribed drugs in the world, citing rare risks of memory loss, diabetes and muscle pain.

It is the first time that the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years. Among the drugs affected are huge sellers like Lipitor, Zocor, Crestor and Vytorin...

Dr. Sidney M. Wolfe, director of Public Citizen’s health research group, is among those who contend statins are overused. He said the new alerts about risks provided more reasons that otherwise healthy people with cholesterol levels less than 240 “should not be taking these drugs.”..


Reports about memory loss, forgetfulness and confusion span all statin drugs and all age groups of patients, the F.D.A. said. Dozens of well-controlled trials of statins have offered few hints that the drugs cause any kind of cognitive impairment, Dr. Egan said. Still, the F.D.A. has received many reports over the years that some patients felt unfocused or “fuzzy” in their thinking after taking the medicines.

Officials in the F.D.A. debated whether such reports were truly worrisome, Dr. Egan said. But in recent years, the F.D.A. — criticized for waiting too long to issue some safety alerts — has become more willing to be public about possible drug risks, even when the evidence is uncertain...

That statins can cause muscle pain, particularly at high doses, has long been known, but in its new alert the F.D.A. reminded doctors that some other medications increase the likelihood that statins linger in the body longer than normal and increase the risk of muscle pain.

Fibromyalgia and Brain Connectivity

This article by "friend of blog" Vitaly Napadow, looks at resting brain connectivity as a biomarker for pain and pain relief in fibromyalgia patients. He doesn't mention acupuncture as the treatment modality used, but I emailed him and he said acupuncture was the non-medicinal modality.

Decreased intrinsic brain connectivity is associated with reduced clinical pain in fibromyalgia.
Napadow V, Kim J, Clauw DJ, Harris RE.Arthritis Rheum. 2012 Jan 31.
Source

Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Charlestown, MA 02129; Department of Radiology, Logan College of Chiropractic, Chesterfield MO, 63006. vitaly@nmr.mgh.harvard.edu.
Abstract
OBJECTIVE:

A major impediment toward the development of novel treatment strategies for fibromyalgia (FM) is the lack of an objective marker which tracks with spontaneous clinical pain report. Resting state intrinsic brain connectivity in FM has demonstrated increased insular connectivity to the default mode network (DMN), a network whose activity is increased during rest. Moreover increased insular connectivity to the DMN was associated with increased spontaneous pain levels. However as these analyses were cross-sectional in nature, they provided no insight to dynamic changes in connectivity and their relationship with variation in clinical pain report.
METHODS:
17 FM patients underwent resting state fMRI at baseline and following 4 weeks of a non-pharmacological intervention to diminish pain. Intrinsic DMN connectivity was evaluated using probabilistic independent component analysis. A paired analysis evaluated longitudinal changes in intrinsic DMN connectivity and a multiple linear regression investigated correlations between longitudinal changes in clinical pain and changes in intrinsic DMN connectivity. Changes in clinical pain were assessed with the Short Form of the McGill Pain Questionnaire (SF-MPQ).
RESULTS:

Clinical pain was reduced following therapy (SF-MPQ sensory scale: p<0.02). Intrinsic DMN connectivity to the insula was reduced, and this reduction was correlated with reductions in pain (corrected p<0.05).
CONCLUSIONS:
Our findings suggest that intrinsic brain connectivity can be used as a candidate objective marker that tracks intra-subject with changes in spontaneous chronic pain in FM. We propose that intrinsic connectivity measures could potentially be used either in research or clinical settings as a complementary, more objective outcome.

Coronary Stents: No advantage found

To file in the "First, Do No Harm" file. Or the "Follow the Money" file. You decide. I've discussed some of the hesitations about coronary stents here, and here.
We learned that the FDA "endangered countless patients' lives when it stopped enforcing 30-year-old requirements that medical device makers meet federal lab standards before testing their products on humans." We also learned that the procedures could cost $30,000 to $50,000 per procedure, so no one wanted to stop that gravy train. There was a study published in 2007 in NEJM showing that many patients given stents would fare just as well without them. So this is nothing new. There are a number of forces at work here. Following the money is big, but also the tyranny of doing a procedure that makes sense, even though the data doesn't support it. I talked about "believing in treatments that don't work" here.
Talked about better mental models for treatment here.
For information about my practice please click here.

No Extra Benefits Are Seen in Stents for Coronary Artery Disease
The common practice of inserting a stent to repair a narrowed artery has no benefit over standard medical care in treating stable coronary artery disease, according to a new review of randomized controlled trials published on Monday...


Some of these devices, called drug-eluting stents, are coated with medicine that helps to keep the artery open. The cost of the procedure varies from about $30,000 to $50,000, and more than one million are performed every year in the United States.

The procedure has certain risks. According to Dr. David L. Brown, an author of the analysis, the risk for death is about one in a thousand, and complications can include stroke, heart attack, bleeding, kidney damage and serious allergic reactions. But those events are rare, and the review did not detect any increased risk in P.C.I. compared with medical treatment...

The researchers reviewed eight randomized trials comparing P.C.I. with standard medical care. Combining data from all the studies, the researchers found that prescribing beta blockers, ACE inhibitors, statins and daily aspirin — now standard for treatment of stable coronary artery disease — was just as effective as stent implantation for prevention of chest pain, heart attack, the need for a future P.C.I. and death.

More than half of patients with stable coronary artery disease are now implanted with stents without even trying drug treatment, Dr. Brown said. The reason, he believes, is financial.

“In many hospitals, the cardiac service line generates 40 percent of the total hospital revenue, so there’s incredible pressure to do more procedures,” he said.

“When you put in a stent, everyone is happy — the hospital is making more money, the doctor is making more money — everybody is happier except the health care system as a whole, which is paying more money for no better results.”


Angina is often the symptom that convinces doctors and patients that medical therapy is not enough and that a stent is required. But in this analysis, 29 percent of people who had P.C.I. still had angina, compared with 33 percent of those on medicine, an insignificant difference.

These results support the current concept of coronary artery disease, the authors wrote — that it is a systemic inflammatory disease of the arteries that cannot be successfully treated by surgical intervention at a particular site on one artery.

According to Dr. Brown, a professor of medicine at Stony Brook University, many doctors cannot accept this. Instead, he said, “interventional cardiologists use the analogy of a pipe blocked in a house — it’s a terrible analogy, but patients accept it. It’s simplistic and erroneous.”