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Release on yoga for prostate cancer patients meanders to indecisiveness

More men willing to participate in yoga therapy than expected, Penn study finds

PHILADELPHIA — Men with prostate cancer who are undergoing radiation therapy can benefit from yoga, researchers at the Perelman School of Medicine at the University of Pennsylvania reported at the Society of Integrative Oncology’s 12th International Conference.

The new, first-of-its-kind study, led by Neha Vapiwala, MD, an associate professor in the department of Radiation Oncology at PSOM and Penn’s Abramson Cancer Center, found that general quality of life and measurements of side effects often experienced by prostate cancer patients–including fatigue, sexual health, and urinary incontinence–were stable throughout a course of outpatient radiation therapy among the men participating in an intensive yoga program.

“Data have consistently shown declines in these important measures among prostate cancer patients undergoing cancer therapy without any structured fitness interventions, so the stable scores seen with our yoga program are really good news,” Vapiwala said.

Cancer-related fatigue differs from everyday-life fatigue, which is usually temporary and can be relieved by rest or sleep. Fatigue that stems from cancer or cancer treatments has been found to lower patients’ quality of life even more than pain, and studies have shown that anywhere from 60 to 90 percent of patients receiving radiation therapy report this symptom. Furthermore, erectile dysfunction is reported in 21 to 85 percent of all prostate cancer patients, while urinary incontinence is reported in 24 percent of men with this disease.

The possible explanation for the benefits of yoga seen in the study stems from physiologic data demonstrating its ability to help reduce cancer- as well as treatment- related fatigue and to strengthen pelvic floor muscles and increase blood flow. These latter aspects may in turn improve erectile dysfunction and urinary incontinence, said Vapiwala.

Other studies have demonstrated beneficial health and quality of life effects from yoga interventions in cancer patients. However, yoga has been predominantly evaluated for breast cancer, and research on its role in alleviating prostate cancer patients’ side effects has been lacking, largely due to the perception that men would not be willing to participate in this form of holistic exercise.

“There may also be a psychosocial benefit that derives from participation in a group fitness activity that incorporates meditation and promotes overall healthiness.

National statistics indicate that 72 percent of those who practice yoga are female, and only 18 percent of practitioners are over the age of 55. The median age at diagnosis for cancer of the prostate is 66.

“Despite these figures, we found that a structured yoga intervention in the form of twice-weekly classes is feasible for patients during a six- to nine-week course of outpatient radiotherapy for prostate cancer,” said Vapiwala. “Our participation-rate finding alone is important because it is a caution against making assumptions about patients without proper evidence.”

Specifically, between May 2013 and June 2014, 68 eligible prostate cancer patients were identified and offered study participation, of which 45 consented (66 percent) to attend twice-weekly yoga classes of 75 minutes each, taught by trained Eischens yoga instructors within the Abramson Cancer Center.

Although 18 (40 percent) of these participants were voluntarily withdrawn early due to unavoidable and unanticipated conflicts between radiation treatment times and the yoga class schedule, the remainder were able to participate and the study’s feasibility endpoint was met.

“Eischens yoga incorporates ideas from movement theory and kinesiology and is accessible to all body types and experience levels,” said Tali Mazar Ben-Josef, DMD, a certified Eischens yoga instructor and researcher in the Abramson Cancer Center, who will present the results at the SOI meeting.

Most yoga participants reported a sense of well-being at the end of each class, and upon finishing the yoga program and concluding their study involvement, many patients requested and received an at-home practice routine to fit their needs, Ben-Josef said.

The effect of yoga was measured by participants’ responses to a series of questions that assess overall quality-of-life, cancer-related fatigue, and prevalence of sexual and erectile dysfunction and urinary incontinence. The researchers chose these variables because they affect so many prostate cancer patients.

Severity of fatigue scores demonstrated significant variability over the time of treatment, with increases by week four as expected, but then improving over the course of treatment. Erectile dysfunction, urinary incontinence, and general quality of life scores demonstrated steady trends.

Currently, the team is randomizing prostate cancer patients to participation vs. no participation in this structured yoga program in order to further characterize the potential benefits of yoga in this population.

This trial represents an expansion of the Abramson Cancer Center’s integrative medicine and wellness services that are available to patients and survivors. In addition to yoga, patients can receive training in stress-reduction techniques, meditation, reiki therapy, acupuncture, and massage.

“We offer several ways to enhance quality of life, minimize or reduce side effects of cancer and cancer treatment, and promote healing and recovery,” Vapiwala said. “This study represents one of many research projects we are conducting in an effort to pinpoint the best, most effective practices to help patients with these needs.”

Nearly 240,000 men are diagnosed with prostate cancer each year in the United States, according to the American Cancer Society, which funded the new study.

The full results from the feasibility study are expected to be published early 2016.

Yoga may lessen side effects in men undergoing prostate cancer treatment

Our Review Summary

YogaThis may be a tough release for readers to sort out because, like the headline (“Yoga may lessen side effects in men undergoing prostate cancer treatment”), and the subhead (“More men willing to participate in yoga therapy than expected, Penn study finds”), the messages the release is sending out are wildly divergent, with scant evidence to back up either thesis.

At its core, the release focuses on an unpublished “feasibility study” that was presented at the recently concluded Society for Integrative Oncology annual conference. Researchers from the University of Pennsylvania School of Medicine radiation oncology department claim that levels of fatigue, sexual health, and urinary incontinence remained stable among a small group of men (27) undergoing outpatient radiation therapy who completed an intensive yoga program.

The idea that more men than expected participated in the yoga class seemingly came out of the blue. It’s unclear where that idea came from.

Just as we hold news releases to the same standards as news stories, so do we hold complementary medicine to the same standards as traditional medicine. We need facts.

 

Why This Matters

Interventions, including radiotherapy, intended to treat prostate cancer often cause a host of side effects, including fatigue, impotence and urinary incontinence. If yoga were shown to alleviate those effects, that would be important information for men undergoing radiation therapy to know in making decisions about their treatment and its followup.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Applicable

The news release did not say how much the yoga classes cost, but that is not a fatal flaw, given that the classes are offered daily to millions of downward dog fans in health centers, living rooms and parks around the world. We’ll rate this Not Applicable.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Numbers might have helped the reader decide whether, in fact, the news release was really about how yoga may lessen the side effects associated with prostate cancer treatment, or whether it was about the feasibility of such a study.

But numbers were lacking. “Most yoga participants reported a sense of well-being at the end of each class, and upon finishing the yoga program and concluding their study involvement, many patients requested and received an at-home practice routine to fit their needs,” one researcher says.

Most? 51%? 99%?

Measuring how someone feels is often subjective and can be difficult. In this case, yoga’s effect was measured by participants’ responses to questions about quality of life, cancer-related fatigue and the prevalence of impotence and urinary incontinence.

The comment that scores were variable but then improved suggests that they did not achieve statistical significance.  Even if they did, the question would be whether the differences were considered clinically important — and how they would compare versus other interventions. There was a substantial loss to follow-up (40%), but the investigator seemed most pleased that 27 men completed the study (and that 45 out of 68 eligible men agreed to participate). We would like to have known what the criteria were for eligibility. This is where it would be be wonderful to have a study to look at. Unfortunately, we’re told only that the study will be published sometime in 2016.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The news release does not say whether anyone felt that yoga may have caused any harms. Injuries from the practice of physical yoga (as opposed to meditative) are, in fact, quite common, although most are minor and include pulled muscles and sprains but can extend to more serious injuries such as a ruptured disk in the lower back.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The study apparently did not include a comparison group of men who did not take yoga classes. Historical controls are fine when testing a treatment where the benefits are obvious, as occurred after the discovery of insulin.

But they are less helpful when trying to measure the impact of an intervention like yoga that may exert a more subtle impact on side effects, as described here in the release:

“Severity of fatigue scores demonstrated significant variability over the time of treatment, with increases by week four as expected, but then improving over the course of treatment. Erectile dysfunction, urinary incontinence, and general quality of life scores demonstrated steady trends.”

The researchers appear to be aware of a major drawback to the way the work was structured; the news release notes that “the team is randomizing prostate cancer patients to participation vs. no participation in this structured yoga program in order to further characterize the potential benefits of yoga in this population.”

And the quality of that evidence took a hit when 40% of the participants “were voluntarily withdrawn early due to unavoidable and unanticipated conflicts between radiation treatment times and the yoga class schedule.”

In other words, the validity and importance of findings are uncertain.

Does the news release commit disease-mongering?

Satisfactory

The news release cites American Cancer Society figures on the incidence of prostate cancer in the United States and therefore cannot be accused of disease mongering. However, a substantial proportion of men diagnosed with prostate cancer in a time of widespread use of prostate-specific antigen (PSA) testing are found to have low-risk cancers that do not likely require treatment. The best way to prevent treatment complications is to avoid unnecessary treatments.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The news release makes no mention of funding or possible conflicts of interest. It does say that the oral abstract was presented at the Society of Integrative Oncology’s 12th International Conference.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The news release does not mention any other interventions that might mitigate the side effects associated with prostate cancer treatment.

While the release mentions other services available at the cancer center — stress reduction techniques, meditation, reiki therapy — they are not presented in the context of alternatives for improving quality of life for prostate cancer patients and do seem more in line with marketing the cancer center.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Although the near ubiquity of yoga classes is well-known, it is not clear how available Eischens yoga classes may be. The release also doesn’t tell us what distinguishes Eischens yoga from other forms of yoga.

Does the news release establish the true novelty of the approach?

Satisfactory

The news release said this is the first such effort to assess the potential value of yoga in this setting.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The lead sentence quotes researchers at the University of Pennsylvania stating that men with prostate cancer who are undergoing radiation therapy “can benefit from yoga.”  In her closing quote lead researcher Neha Vapiwala, MD, associate professor at the University states, “We offer several ways to enhance quality of life, minimize or reduce side effects of cancer and cancer treatment, and promote healing and recovery.”

But nowhere in the news release are we given more than anecdotal evidence to support those assertions.

There was no data supporting the claim that more men than expected participated. Where did that idea come from? Given that the population was men with cancer one would expect them to be more  open to alternative therapies.

Total Score: 2 of 9 Satisfactory

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