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Bad Science, Healing Touch And Coronary Bypass

A study published in Alternative Therapies in Health and Medicine is being cited as evidence for the efficacy of healing touch (HT). It enrolled 237 subjects who were scheduled for coronary bypass, randomized them to receive HT, a visitor, or no treatment; and found that HT was associated with a greater decrease in anxiety and shorter hospital stays.

This study is a good example of what I have called “Tooth Fairy Science.” You can study how much money the Tooth Fairy leaves in different situations (first vs. last tooth, age of child, tooth in baggie vs. tooth wrapped in Kleenex, etc.), and your results can be replicable and statistically significant, and you can think you have learned something about the Tooth Fairy; but your results don’t mean what you think they do because you didn’t stop to find out whether the Tooth Fairy was real or whether some more mundane explanation (parents) might account for the phenomenon.

Theoretical underpinnings

According to the study’s introduction:

Healing touch is a biofield- or energy-based therapy that arose out of nursing in the early 1980s…HT aids relaxation and supports the body’s natural healing process, i.e., one’s ability to self-balance and self-heal.” This noninvasive technique involves (1) intention (such as the practitioner centering with the deep, gentle, conscious breath) and (2) placement of hands in specific patterns or sequences either on the body or above it. At its core, the theoretical basis of the work is that a human being is a multi-dimensional energy system (including consciousness) that can be affected by another to promote well-being.

They cite a number of references to theorists who support these ideas. They cite Ochsman; he wrote a book Energy Medicine: The Scientific Basis which I reviewed, showing that despite the book’s title, there is no credible scientific basis and the “evidence” he presents cannot be taken seriously.

They cite Candace Pert, who said in the foreword to Ochsman’s book that Dr. Oschman “pulled” some energy away from her “stagnant” liver. She said the body is “a liquid crystal under tension capable of vibrating at a number of frequencies, some in the range of visible light,” with “different emotional states, each with a predominant peptide ligand-induced ‘tone’ as an energetic pattern which propagates throughout the bodymind.” Does this even mean anything?

They even cite the PEAR study, suggesting that it is still ongoing (it isn’t) and claiming it shows that “actions in one system can potentially influence actions of another on a quantum energetic level.” (It didn’t.)

This is nothing but imaginative speculation based on a misunderstanding of quantum physics and of what physicists mean by “energy.” It is a truism that electromagnetic phenomena are widespread in the human body, but there is a giant gap between that and the idea that a nurse with intention and hand movements can influence electrical, magnetic, or any other physical processes in the body to promote healing. There is no evidence for the alleged “human biofield.”

Previous Research

They cite several randomized controlled studies of HT over the last few years. One showed “better health-related quality of life” in cancer patients. One, the Post-White study, showed no difference between HT and massage. One small study by Ziembroski et al. that I couldn’t find in PubMed apparently showed no significant difference between HT and standard care for hospice patients. One study showed that HT raised secretory IgA concentrations, lowered stress perceptions and relieved pain, and results were greater with more experienced practitioners; but it only compared HT to no treatment and didn’t use any placebo treatment.
A pilot study compared 4 noetic therapies-stress relaxation, imagery, touch therapy, and prayer, and found no difference.

A larger study showed that neither touch therapy nor masked prayer significantly improved clinical outcome after elective catheterisation or percutaneous coronary intervention.

They cite a review of healing touch studies by Wardell and Weymouth It concluded “Over 30 studies have been conducted with healing touch as the independent variable. Although no generalizable results were found, a foundation exists for further research to test its benefits.” Wardell noted that “the question has been raised whether the field of energy research readily lends itself to traditional scientific analysis due to coexisting paradoxical findings.” This is a common excuse of true believers who find that science is not cooperative in validating their beliefs.

Study Design

237 patients undergoing first-time elective coronary artery bypass surgery were randomly assigned to one of 3 groups: an HT group, a visitor group, and a standard care group. All received the same standard care from the hospital. The HT group received preoperative HT education and 3 HT interventions. Practitioners established a relationship with their patients, assessed their energy fields, and performed a variety of HT techniques based on their assessment, including techniques that involved light touch and those that involved no touch (practitioners’ hands held above body). Sessions lasted 20 to 90 minutes; each patient had the same practitioner throughout the study. The “visitor” group patients were visited by a nurse on the same schedule. The visits consisted of general conversation or the visitor remaining quietly in the room with the patient. They mentioned that some visits were shortened at the patient’s request.

Results of the Study

The six outcome measures were postoperative length of stay, incidence of postoperative atrial fibrillation, use of anti-emetic medication, amount of narcotic pain medication, functional status, and anxiety. HT had no effect on atrial fibrillation, anti-emetics, narcotics, or functional status. The only significant differences were for anxiety scores and length of stay. The length of stay for the HT group was 6.9 days, for the visitor group 7.7 days, and for the routine care group 7.2 days, suggesting that the simple presence of a visitor made things worse(!?). Curiously, for the subgroup of inpatients, the length of stay was HT 7.4 days, visitor 7.7 days and routine care 6.8 days, which was non-significant at p=0.26 and suggested that both HT and visitor made things worse.

The mean decreases in anxiety scores were HT 6.3, visitor 5.8, and control 1.8. They said this was significant at the p=0.01 level. But the tables for results broken down by inpatient and outpatient show no significant differences (p=0.32 for outpatients and p=0.10 for inpatients). If it was not significantly different for either subgroup, how could it be significant for the combined group?

These discrepancies are confusing. They suggest that the significant differences found were due to chance rather than to any real effect of HT..

Problems with this Study

Four out of the six outcomes were negative: there was no change in the use of pain medication, anti-emetic medication, incidence of atrial fibrillation, or functional status. The only two outcomes that were significant were hospital stay and anxiety, and these results are problematic and might have other explanations.

It is impossible to interpret what the difference in length of stay means, because they did not record the reasons for delaying discharge. As far as we can tell from the paper, the doctors deciding when to discharge a patient were not blinded as to which study group the patient was in. It’s interesting that the visitor group length of stay was intermediate in the outpatient subgroup, but higher than control for the combined inpatient/outpatient group. They offer no explanation for this. I was puzzled by the bar graph showing these numbers, because the numbers on the graph don’t seem to match the numbers in the text. The numbers were manipulated: they did a logarithm transformation for length of stay “to handle the skewness of the raw data.” I don’t understand that and can’t comment. The range of hospital days is such that the confidence intervals largely overlap. In all, these data are not very robust or convincing and they raise questions.

They interpret the anxiety reduction scores (HT 6.3, visitor 5.8, and control 1.8) as showing a significant efficacy of HT, but it seems more compatible with a placebo response and a slightly better response for the more elaborate placebo.

There were fewer patients (63) in the visitor group than in the HT and control groups (87 each). This was not explained. The comparison of groups appears to show that the control group had significantly higher pre-op anxiety scores than either of the other groups, which would tend to skew the results

They didn’t use a credible control group. A visitor sitting in the room can’t be compared to a charismatic touchy-feely hand-waving practitioner. Other studies have used mock HT where the hand movements were not accompanied by healing thoughts. These researchers rejected that approach because they didn’t think it would be ethical to offer a sham procedure where the practitioner only “pretended” to help. Hmm… One could argue that they have provided no evidence that HT practitioners are ever doing anything more than pretending to help.

They don’t comment on how practitioners were able to “assess the energy fields” of their patients. Emily Rosa’s landmark study showed that practitioners who claimed to be able to sense those fields couldn’t.

The authors consist of 3 RNs (2 of them listed as healing touch therapists and presumably the ones who provided treatment in the study), a statistician with an MS, and two “directors of research” for whom no degrees are listed. The authors are clearly prejudiced in favor of HT.

They interpret this study as supporting the efficacy of HT. I don’t think it does that. I think the results are entirely compatible with a placebo response. With any made-up intervention presented with strong suggestion, one could expect to find one or two statistically significant differences when multiple endpoints are evaluated. And the magnitude of the improvement here is far from robust. This is the kind of result that tends to diminish in magnitude or vanish when better controls are used. I think the study is Tooth Fairy science, purporting to study the effects of a non-existent phenomenon, but actually only demonstrating a placebo response.

I wonder if better results might be obtained by having a patient advocate stay with the patient and offer reassurance, explanations, massage and other comfort measures – something like the doulas who have been shown to improve childbirth outcomes.

The frightening thing is that during the course of this study, patients increasingly bought into the HT belief system and refused to sign up for the study because they wanted HT and didn’t want to risk being assigned to a control group. And hospital staff bought into the belief system, were treated themselves, and became proponents of offering it to patients for other indications.

The paper ends with a rather incoherent statement one would not expect to find in a scientific medical journal: “At the very heart of this study is the movement toward recognizing that the metaphoric and physical heart are both very real, if we allow them to be.”

*This blog post was originally published at Science-Based Medicine*

The Only Way To Decrease Healthcare Costs Is To Ration Care

Those on the left will pretty much sacrifice everything to attain their goal of universal coverage.

But, in this well-reasoned piece by conservative economist Tyler Cowen, expanding coverage won’t necessarily control costs, which is a more imperative issue. The bandied about means of cost control, such as electronic medical records, cutting provider payments, and preventive care, all will have little nor no impact in controlling costs.

Take physician reimbursements, for instance, a favorite target of health reforms. According Princeton economist Uwe Reinhardt, a favorite son among policy wonks, cutting physician pay by 20% would only reduce spending by 2%.

Furthermore, under the current payment system, simply cutting provider reimbursements will only give more of an incentive to do more procedures to make up for lost revenue.

The hard truth is that care will be rationed, and that’s something the Obama administration is unwilling to admit. Indeed, as Mr. Cohen writes, “if we aren’t willing to take even limited steps to conserve resources, we shouldn’t be spending any more money elsewhere.”

Cost control first before universal coverage, and therein lies the central contention of the debate.

And the worst case scenario, as progressive blogger Ezra Klein correctly surmises is, “that the final bill will include a pricey expansion of coverage paired with a speculative and uncertain set of cost controls.”

*This blog post was originally published at KevinMD.com*

Better Health Blogger, Dr. Rob Lamberts, Joins Quick & Dirty Tips

Congratulations to Better Health blogger, Dr. Rob Lamberts, for landing a regular podcasting gig.

Here’s the press release:

***

The HOUSE CALL DOCTOR’S QUICK AND DIRTY TIPS FOR TAKING CHARGE OF YOUR HEALTH, hosted by Dr. Rob Lamberts, joins the highly successful Quick and Dirty Tips iTunes podcasts on July 14, with free content also available for download at www.quickanddirtytips.com.

How can I lower my cholesterol? Is Tylenol really safe? Why do my bruises itch? No topic is off limits for the House Call Doctor—the newest addition to Macmillan’s Quick and Dirty Tips self-improvement franchise. Dr. Rob Lamberts practices full-time in his primary care private practice in the southeastern US.  He is board certified in internal medicine and pediatrics, and has doctored for the past 15 years. Lamberts’ recent involvement in the advocacy of electronic medical records has received national recognition and his popular medical blog, Musings of a Distractible Mind, was named one of Tara Parker-Pope’s “favorite medical blogs” in her New York Times Well blog.

With his trademark sense of humor and straightforward advice, Dr. Lamberts answers a wide variety of questions in this QDT podcast, mixing his extensive experience in the medical field with accessible advice that is both accurate and easy to understand. Filled with friendly and in-depth answers on listeners’ most pressing health issues, House Call Doctor offers progressive and innovative ways to look at medicine and the healthcare industry as a whole.

The House Call Doctor’s first series of podcasts will cover a wide range of health concerns and medical inquiries, including:

What do I really need to know about cholesterol?

How do I talk to my doctor about medical information I’ve found on the Internet?

Where do bruises come from, and how can I get rid of them?

What are the dangers of using popular pain relievers, such as Tylenol?

What should I look out for to prevent the over use of antibiotics?

Dr. Lamberts’ expert tips will give listeners the tools they need to understand their bodies better and improve their health and quality of life. His goal with the House Call Doctor is to “make medical things easier to understand and hopefully to offer a little entertainment in the process.” As Dr. Lamberts says, “People want to understand their health, but unfortunately many of the explanations out there are either confusing or boring.”

Quick and Dirty Tips, known for both its friendly and informative style and its innovative digital content distribution, has already introduced fourteen fascinating experts on a variety of subjects to millions of fans via podcasts, audiobooks, and online interaction. Popular Quick and Dirty Tips shows include: Grammar Girl, Sales Guy, The Dog Trainer, and Money Girl.

Propofol: Will It Become Over-Regulated?

I enjoyed NYC Dr. Kent Sepkowitz’s column in Slate the other day — Paging Dr. Feelgood — where he recaps the careers of some celebrity docs and tries to imagine the pathway to enabling addicts. Key part:

In a strange way, I actually stand in awe of these guys. I have taken care of a few celebs in my career, and for me it was an awful experience. If you f*ck it up, you’re toast. Once I took care of a very important person, a person you have heard of and are very interested in, someone you would be shocked to know had the problem—asthma—that I treated him for. Well, almost treated him for. His complaints and his recollection of near death last time he had the identical symptoms so unnerved me that I asked a colleague to assume his care.

But the Dr. Feelgood experiences no such hesitancy… Perhaps it all starts innocently—a rich, famous guy with a tiny problem walks into the office. He can’t sleep at night. He’s so friendly, sincere, not stuck up like some celebs. Then he comes back a week later because of a sore ankle, wanting a little codeine and bearing an autographed photo or a CD. Other patients notice and figure you must be a pretty good doctor if Mr. Showbiz is coming in….

I once wrote about that concern over VIP complaints, in a medscape column. And, like the author, the only thing that impresses me about these celebrity docs is their creativity — Sepkowitz describes how the first Dr. Feelgood used solubilized placenta. And, while the risks of propofol dosing are drummed into our heads in training, it never occurred to me a doctor-to-the-stars might use propofol outside the hospital on an unmonitored patient.

While it didn’t surprise me that propofol has been considered in
palliative care
and even implicated in a murder, it turns out propofol (diprivan) abuse and dependency is not unheard of and, as this review by Roussin shows, some IRB actually permitted trials:

Normal healthy volunteers (n = 12) were exposed in a blind fashion to acute bolus injections of 0.6 mg/kg of propofol and to a similar volume of soy-based lipid emulsion (similar to the vehicule of propofol) twice. After these sampling sessions, they were asked to choose which drug they preferred to be injected with. Propofol was chosen by 50% of the subjects, and seemed to have been based on the pleasant subjective effects. In contrast, the choice of placebo (Intralipid®) seemed to have been based on either non-intense subjective effects during the propofol sampling session (increased dizziness, confusion) or residual effects (fatigue) after the sessions. These results suggest that, in some healthy volunteers, propofol functioned as a reward.

…From a psychopharmacologists’ standpoint, propofol shares properties in common with many drugs that are abused. In particular, the onset of the effects of propofol are rapid and this drug makes people ‘feel good’ and feel relaxed [45]. The mood-altering effects of subanaesthetic doses of propofol delivered via an infusion or by an acute bolus injection have been assessed in human healthy volunteers [44,52]. Subjects reported feeling high, lightheaded, spaced out and sedated….

I read up on propofol use a lot a year ago, in preparation for a talk on procedural sedation. At that point I think its only foray into pop culture’s collective consciousness was a poem by Karl Kirchwey called “Propofol” that ran a year ago in the New Yorker. It began:

Moly, mandragora, milk of oblivion:
I said to Doctor Day, “You bring on night.”
“But then,” he said, “I bring day back again,”
and smiled; except his smile was thin and slight.

Now everyone’s talking about propofol. The ASA is using this opportunity to reintroduce talk of restricting propofol to their specialty alone (despite abundant and mounting evidence that it’s used safely in ED procedural sedation). Reporters are wondering why propofol administration is not as closely logged as, say, opiates.

All this activity suggests it soon will be. And while keeping this drug out of the hands of abusers and enablers is a worthy goal of regulation, I hope those who’ve demonstrated a safe track record are not prohibited from using this unique medication.

*This blog post was originally published at Blogborygmi*

Physician Burnout Is The Biggest Threat To Healthcare Reform

It was supposed to be delayed gratification.

After all, that’s the American way: work hard, put your nose to the grindstone, get good grades, be obsessively perfectionistic, then you’ll be rewarded if you just stay with it long enough. It’s the myth that perpetuated through medical school, residency and fellowship, and our poor residents, purposefully shielded from the workload they’re about to inherit, march on.

But then they graduate and find that just as the population is aging, chronic and infectious diseases are becoming more challenging, health advances and potential are exploding. Just then, we decide to launch a full scale attack on physicians and their patients with increased documentation requirements, call hours, larger geographic coverage of their specialties, reduced ancillary workforce, and shorter patient vists.

Physicians get it – burn out and dissatisfaction are higher now than ever before. This is probably the greatest real threat to the doctor-patient relationship and health care reform discussions don’t even put it this on the table.

At the same time that we expect our doctors to be devoted, available, enthusiastic, meticulous and at the top of their game with perfect “quality” and “perfect performance,” while simultaneously cutting their pay, increasing documentation reqirements and oversight, limiting independence, questioning their professional judgment, and extending their working hours. We must become more efficient!

Deal?

*This blog post was originally published at Dr. Wes*

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