Asthma is an inflammatory disorder of the lungs that affects about 34 million Americans. the number of people with asthma has increased significantly over the past three decades, and by 2025 this number is expected to grow by more than 100 million.

Many people with asthma depend on the use of daily medications to control symptoms. these medications include inhaled steroids, which are not only hugely expensive but can also be associated with significant side effects, including respiratory infections and headaches. given cost and side effects of asthma medications, there is great incentive to identify other means to prevent and treat asthma.

A recent article in the journal Alternative Therapies looked at the cost and benefits of an integrative medicine approach to treating asthma.

This study was conducted at the Continuum Center for Health and Healing, an integrative medicine center at Beth Israel Medical Center in New York City; CCHH has had extensive experience in treating patients with asthma.

In the study, 154 people with mild to severe asthma were randomized into two groups. the first group was continued on its usual prescription meds for asthma.

The second group took its usual asthma meds and those in the group were also trained to incorporate the following integrative medicine practices into their daily routines:

• Attend two nutrition classes where they learned about foods that can trigger asthma and inflammation. They then engaged in an elimination diet for two to four weeks to identify their own particular dietary triggers, and eliminated those foods from their diet.

• Took daily fish oil capsules containing 860 mg of EPA and 580 mg of DHA.

• Took 1,000 mg of vitamin C daily.

• Took a standardized extract of hops, an anti- inflammatory herb.

• Attended two yoga classes and also learned how to practice the healing breath work of yoga known as pranayama; they were encouraged to do this on a daily basis.

• Attended an expressive journaling session where they wrote about the most traumatic stressful event of their lives. (Expressive writing like this has been shown in some studies to decrease symptoms of asthma.)

All participants were followed for six months. At the conclusion of the study, people in the treatment group were found to have significant improvements in quality-of-life measurements compared with the control group, and their overall physical and mental health were also improved.

Pulmonary function tests, however, did not show significant changes in either group over time. the researchers did not measure any changes in the use of prescription asthma medications between the two groups.

The interventions were well tolerated and produced no significant side effects, though several participants in the study group did report mild headache, nausea and fatigue, presumably from the supplements; none of them dropped out of the study, however.

One cautionary note here – hop extracts contain plant estrogens, so people with hormone-sensitive cancer should probably avoid them.

The cost of creating this group program, which was delivered in a community health center, was approximately $260 per participant, which is a bargain considering the cost of medications used to treat asthma, as well as the cost of clinic and emergency room visits for people with asthma.

The authors concluded that this “low-cost, low-risk lifestyle intervention can significantly improve both disease-specific and overall quality of life in adults with asthma over a six-month period.”

While this study had its methodological challenges, it was still an encouraging exploration of the power of lifestyle changes to improve symptoms and self-efficacy in people with a chronic illness like asthma.

Given the cost-effectiveness of these interventions, as well as their overall safety profile, it offers some promising adjunctive treatments to reduce symptoms and improve quality of life in people with asthma.

© Copyright the Sacramento Bee. All rights reserved.

Drs. Kay Judge and Maxine Barish-Wreden are medical directors of Sutter Downtown Integrative Medicine program. Have a question related to alternative medicine? E-mail adrenaline@sacbee.com.

Australian diagnostics firm HealthLinx said this week that it has signed a deal with Seoul Clinical Laboratories for commercial distribution of its OvPlex ovarian cancer diagnostic in South Korea.

With the agreement, HealthLinx now has distribution deals for the protein biomarker-based test in the UK, Australia, Singapore, Israel, and South Korea, with sales of OvPlex currently ongoing in the UK, Australia, and Singapore after launches in those countries earlier this year.

Those launches, along with the start of sales of Vermillion’s ovarian cancer diagnostic OVA1, suggest that, after years of stops and starts, proteomics-based diagnostics – for ovarian cancer, in particular – are at last making headway.

However, while HealthLinx and Vermillion have had success bringing their tests to market, their sales numbers thus far have been rather anemic – indicating that, while these diagnostics have managed to overcome the technology and regulatory hurdles in their way, achieving widespread adoption remains a challenge.

In its annual report for its 2009 fiscal year, ended June 30, 2009, HealthLinx predicted sales of 5,000 OvPlex units in the UK and sales of 500 units in Singapore by the end of its 2010 fiscal year. Such volumes, the company noted, would result in total revenues of more than A$350,000 ($342,000).

However, in its 2010 annual report, the company reported total product and royalty revenues of A$12,757 and noted that OvPlex sales were “modest,” though it did not break out unit sales.

HealthLinx also acknowledged in the 2009 report that sales of OvPlex had “not achieved projected targets within Australia.” Sales of OvPlex in the country began in October 2008 but were temporarily suspended in September 2009 when its domestic distributor, ARL Pathology, was acquired by the healthcare provider Healthscope. Before the pause, the company sold roughly 200 tests. It relaunched the test through Healthscope this June (PM 06/18/2010).

Vermillion has similarly had to back down from overly aggressive predictions regarding its OVA1 ovarian cancer diagnostic. in a document filed with the SEC in December 2009, the company predicted $9.7 million in revenue from sales of OVA1 in 2010 and $34 million in 2011. As of the end of Q3 of 2010, however, it had booked just $159,000 in OVA1 sales, and on a Q3 earnings call, CEO Gail Page lowered the company’s 2010 guidance from a range of 8,000 to 10,000 OVA1 sales to a range of 5,000 to 5,500 sales for the year (PM 11/12/2010).

During the Vermillion earnings call, Page noted that the company had underestimated the effort required to convince doctors of OVA1′s utility and said that it planned to refocus its sales force to concentrate more heavily on educating gynecological oncologists about the test. An article published this July in the Australian newspaper the Age suggested that HealthLinx might be running up against a similar problem.

In the story, several prominent doctors, including Helen Zorbas, CEO of Australia’s National Breast and Ovarian Cancer Centre; Michael Quinn, a gynecological oncologist at the Royal Women’s Hospital and the University of Melbourne; and Peter Grant, head of the department of gynecological oncology at Melbourne’s Mercy Hospital, criticized the lack of data supporting the test, saying that further studies were needed to determine its clinical usefulness.

In September, Quinn, who sat on HealthLinx’s scientific advisory committee until 2008, was ordered by an Australian court to refrain from making any statements regarding the OvPlex test. in an e-mail to ProteoMonitor predating the order, however, he suggested that longitudinal studies following symptomatic women to determine the test’s sensitivity and specificity would be particularly useful in demonstrating its value.

For now, though, HealthLinx is concentrating on a 1,150-subject study to establish the utility of adding two biomarkers to the test’s current five-protein panel. “At the moment we’re just focusing on this particular study,” managing director Nick Gatsios told ProteoMonitor. “We’ve got to get over this study first and then we’ll worry about other studies that might be in the pipeline.”

The OvPlex test currently on the market uses blood levels of C-reactive protein, serum amyloid a, interleukin 6, interleukin 8, and CA125 to aid in the early-stage diagnosis of ovarian cancer in symptomatic women. the company is now evaluating the proteins AGR2 and HTX010 as possible additions to the existing panel. the hope is that the additional markers will boost the test’s sensitivity and specificity from 94 percent to 97 percent.

According to Gatsios, initial data from 450 samples suggest that adding the markers will increase the test’s performance. “[The data] is consistent with what we expected,” he said. “The way we modeled it previously in a small dataset showed that it would increase the performance of the assay. this data looks pretty promising that it will do the same.”

HealthLinx is now collecting samples for the next stage of the study, which will involve 700 subjects. Gatsios said the company hopes to have that stage completed in the next 12 to 14 months, but, he noted, “it’s just a matter of waiting for women [who] present with the symptoms that meet our inclusion criteria to walk in the clinic – and you can’t predict that. Our clinicians have been collecting now for quite a few months.”

The company received an A$750,000 grant from the Victoria government in November 2009 to support the study. It has been obtaining patient samples from the Mater Hospital in Queensland and from several sites in the UK.

HealthLinx is also embarking on trials required by the South Korean Food and Drug Administration for the sale of OvPlex in South Korea. in September it finalized plans for a 220-patient study to be conducted by Byoung-Gie Kim of Samsung Medical Center and Sungkyunkwan University School of Medicine. that study is also anticipated to take 12 to 14 months, after which submissions to the KFDA will begin. according to HealthLinx’s estimates, the South Korean market for OvPlex is roughly 250,000 tests annually.

Have topics you’d like to see covered in ProteoMonitor? Contact the editor at abonislawski [at] genomeweb [.] com.