By Glenna Crooks. Full disclosure – I’ve practiced yoga fairly consistently for decades. It’s been good for me.

In grad school it helped me stay focused – and calmer – through killer statistics classes. Later, it was a way to unwind at the end of a workday. Still later, it saved me from surgery to correct fairly severe scoliosis. It’s not cured the deformity but I’m virtually pain free most of the time – no small feat for one who spends 18-24 hours on flights and 8 hours standing to facilitate meetings.

More disclosure – I am certified to teach, though I don’t. The same erratic travel schedule that prevents attending classes on a regular basis precludes committing to teaching them. I trained to be able to practice on the road. It was a good investment of my time and funds.

Yes, my time and funds. Anyone familiar with yoga knows that for the most part, students pay a small amount for a class – or series of classes – out of their own pockets. Sometimes, yoga is offered in schools, hospitals, churches, workplaces and prisons and the cost partially or fully paid by some third party. Sometimes teachers donate their services as part of the ‘selfless service’ that embodies the lifestyle.

Recent weeks presented an interesting confluence of events in my life as a yoga-practicing health policy analyst: health reform passed and Yoga Journal published a major article on methods, issues, controversies and implications of yoga research.

I started a yoga research literature review a few years ago. It was to be the opening chapter of an adaptation of my grantseeking guide (see www.strategichealthpolicy.com for a free download), revised and updated for yoga teachers intending to seek and secure third-party – including health insurance – financing support for classes.

I abandoned the project for many of the issues raised in the Yoga Journal article: research methods were relatively undeveloped, uncontestable positive results were scant and within the yoga community both were controversial. That’s right, even the need for research to demonstrate the value of yoga is controversial. Many thought there was proof enough.

Proof enough for an individual to pay? Yes, that’s been well-demonstrated. Thousands of times each day, people around the world pay out-of-pocket to attend classes. Proof enough for a third-party to pay? Far from it, at least as we have defined proof within the American health care sector.

Now, the health reform era is upon us, some people will press for yoga services as a covered benefit and if a serious discussion takes hold – and succeeds – in adding yoga to American health care armamentarium, yoga teachers will face issues common to other product and service providers. Clearly, not all yoga teachers will want to participate and none will be forced, but those who choose to do so will need to address – at a bare minimum – questions commonplace to physicians, hospitals and drug companies:

First, is yoga effective? Any prevention or treatment modality used in health care is expected to be safe and effective, demonstrating that it performs as advertised, promoted and hoped.

That means prospective research, such as trials comparing yoga against a non-intervention, a placebo or a standard therapy treatment, or a study of a sufficiently large population through ‘natural observation’ to gather similar evidence over many years.

Research such as this will raise questions about whether the ‘style’ of yoga matters, how many sessions might be required to achieve results and whether results last after classes are stopped. People in the study will be carefully selected and ‘assigned’ to each intervention group. They’ll be asked about other aspects of their lifestyle to assure that they’re not confounding the results with other possibly-effective therapies.

Side effects will be monitored. Injuries in class or suicidal thoughts outside of class (if any occur) will be noted so that cautionary warnings and contraindications can be addressed in coverage and reimbursement decisions. Other unintended consequences – weight loss comes to mind – will be documented but can’t be claimed a benefit unless the study was specifically designed to test for it.

Research might also need to tease out yoga’s “mechanism of action” as is the case for medications; for example, by what mechanism does yoga breathing techniques reduce hypertension?

Researchers will be required to seek approval from Institutional Review Boards protecting patients, may be required to vet research methods with regulators or payers, will likely be required to disclose financial interests in yoga and if any are found might be precluded from doing research and/or might be restricted from committees that address yoga policy and financing issues – all to assure research subjects are protected and conflicts-of-interest are prevented. (more…)

Several weeks ago, I wrote about the need for a new paradigm, one that integrates Eastern inductive and Western reductive methodology so that efficacy can truly be measured in alternative medicine trials. In that post, which was part of the DWIHC Comparative Effectiveness Research Series, I argued that Western researchers continue to try to squeeze a square peg into a round hole, and in doing so, ignore the subjective element that is an inherent part of the fabric that we call Eastern medicine.

This past week, I ran across a study in Menopause that not only supports this contention but also challenges us to more closely examine the limitations of current investigations into alternative therapies.

ACUFLASH (the Acupuncture on Hot Flashes among Menopausal Women Study) was a randomized, controlled, parallel study comparing the efficacy of weekly acupuncture plus self-care to self-care alone in 277 menopausal women experiencing, on average, 7 or more hot flashes daily. But here’s the rub: unlike previous trials, ACUFLASH actually estimated the effectiveness of acupuncture in practice, meaning that the study was specifically designed to mimic the basic tenets of Eastern philosophy and incorporate the subjective. Consequently, after agreeing upon expected diagnoses and recommended point selection, licensed Traditional Chinese Medicine acupuncturists were free to diagnose, select acupuncture points and individualize treatment for each study participant.

Not only did the mean frequency of hot flashes decline at least 50% in half of women receiving acupuncture plus self-care, but significant improvements were also noted in hot flash intensity and overall quality of life measures. More importantly, by incorporating a larger study group, and eliminating sham needles and “standardized” (compared to individualized) practice, the researchers were better able to preserve the overall quality of acupuncture and what it strives in achieve, while still remaining true to the tenets of evidence-based scientific methodological standards.

Is this study without flaws? Certainly not. Indeed, the investigators acknowledge that the study participants were not treatment naive, and point out that sham acupuncture, which may be necessary for a true comparative analysis, is hardly “physiologically inert.” Nevertheless, I remain hopeful that the study design and its positive results may open the alternative therapy door a bit wider and lend further credence to its role in treating disease.