Hyperbaric Oxygen for Ulcerative Colitis: Evidence Update

Sometimes a good small study is enough to merit serious attention, help prove a concept, and inspire others to expand the investigation.

The last and only time we reported on hyperbaric oxygen therapy (HBOT) for inflammatory bowel disease (IBD), the subject was a 2012 systematic review of the medical literature. IBD, or chronic inflammation of the digestive tract, includes Crohn's disease and ulcerative colitis. The author selected just 19 human studies for his analysis but showed promise for future research. Dozens of papers have been published since, and it's a pretty mixed bag.

Now comes an interesting little study on HBOT for ulcerative colitis. Including only 18 patients, but quite well designed, the randomized, double-blind, sham-controlled trial was conducted by gastroenterologists at Dartmouth, the Mayo Clinic, University of Pittsburgh, and University of California San Diego. They presented their findings at the 12th Congress of the European Crohn's and Colitis Organisation (ECCO) in February.

Follow this link to the Study Abstract. Then read this helpful Summary and Perspective, which closes with a caveat:

This trial had a very small sample size, and while it produced a suggestive signal of efficacy, more research is clearly needed to determine the optimal dose, how often the therapy should be administered, and how quickly it works. Hyperbaric oxygen therapy is also very expensive, so if it does work, it has to work well to be worth the high cost. 

Hear, hear. Still, clinicians who have have been following the research on hyperbaric oxygen in IBD may find this work newly encouraging. Its careful design, authorship by leading physicians at major academic centers, and presentation at a leading medical conference set it apart from the growing medical literature on this topic.

People living with these chronic diseases should understand these results mark the very first stages of human clinical trials. We will be waiting and watching for more evidence and trends in clinical practice in the months and years ahead. As we see more activity we may add inflammatory bowel disease, including Crohn's and ulcerative colitis, to our directory of diseases and conditions treated with hyperbaric oxygen therapy.

We think it is vitally important that patients and referring physicians get information about the state of clinical evidence, for both approved and off-label conditions, so they can jointly make the best healthcare decisions. Learn more about our Editorial Policy for selecting the information we publish on HyperbaricLink.

Keepers: Our Top 10 Favorite Posts of 2011

In 2011 we posted 136 blog entries. Every day we scour the hyperbaric business and science news. Often we're inspired to share the news with you. Sometimes we hit on a topic, share a video, or link to a story that really reminds us why we do this. Here's a quick selection of favorites you may have missed or may wish to read again.

Quad Cities Homeless Man Gets HBOT for Frostbite

FDA Urges Caution in Negative Pressure Wound Therapy

Evidence-based HBOT: Trust It or Trash It?

Evidence-based HBOT Is Not CAM

Mixing Hyperbaric Oxygen with Other Prescription Drugs

HyperbaricLink: The Only HONcode Certified Website Focused Exclusively on Hyperbaric Oxygen Therapy

HBOT Program Oversight: Exposé Makes Good Points

VIDEO: Fire Suppression Test of USC Catalina Chamber, Avalon, California

CRAO: Fast Intervention with Hyperbaric Oxygen Helps Save Student's Eyesight

Serious Carbon Monoxide Poisoning Risk from Ice Resurfacing Equipment at Indoor Rinks

We thank you for your readership and participation in the year past, and we look forward to bringing you even more evidence-based hyperbaric oxygen therapy news in the year ahead.

On the Retraction Watch

Readers interested in the reliability of scientific papers, and the reliability of news reports based on them, will appreciate a couple segments from New York Public Radio’s weekly program, On the Media. Scientific Retractions on the Rise and Retraction Watch both look at what happens when scientific papers go bad, typically a slow motion process that always begins with doubt and sometimes ends with the dismantling of cherished theories.

Regular readers of O2.0 will know we caution against relying on a single clinical study and advocate checking sources. These stories illuminate some of the reasons why.

Both segments aired September 2 and are available for download or listening online at the On the Media website, about two-thirds of the way down the page.

If you haven't heard of it before, On the Media is a weekly radio program in which journalists and their guests examine the business of news, entertainment, and advertising. The results are engaging, informative, and sometimes surprising. We hear the show makes great listening during a hyperbaric dive, and it's available as a podcast from your favorite purveyor.

Hyperbaric Oxygen as Medical Gas: New Online Journal

We are excited to see Medical Gas Research, a new online journal focused on neurobiology and neurological diseases, join PLoS ONE and other open-access journals designed to ensure fast publication times without sacrificing rigorous peer review. The journal will cover

anesthesiology, hyperbaric oxygen medicine, diving medicine, internal medicine, emergency medicine, surgery, and many basic sciences disciplines such as physiology, pharmacology, biochemistry, microbiology and neurosciences.

Already a search for "hyperbaric" yields 6 articles on stroke, traumatic brain injury, and other neurologic issues. Here's looking forward to more evidence and accelerated hyperbaric medical research in this fascinating and important field.

O2.0 is the news blog of HyperbaricLink, the independent web guide to hyperbaric oxygen therapy.

Evidence-based HBOT Is Not CAM

In our May 16 post we gently admonished integrative medicine guru Andrew Weil, MD, for misstating the clinical evidence on HBOT for stroke. Our criticism pales by comparison to Orac's on the Respectful Insolence blog. In "Dr. Andrew Weil versus evidence-based medicine" the pseudonymous Orac writes:

... no physician that I can think of has over the course of his lifetime done more to promote the rise of quackademic medicine than Dr. Weil. The only forces greater than Dr. Weil in promoting the infiltration of pseudoscience into academic medicine have been the Bravewell Collaborative and the National Center for Complementary and Alternative Medicine (NCCAM).

The swipe at NCCAM seems harsh to us. The National Institutes of Health (NIH) has just launched its NCCAM online portal. We're only too happy there's a new home for evidence-based CAM on the web. Visitors should be impressed by the website's complete and helpful information. They should also be enlightened or frightened by the scarcity of high-quality, supporting clinical evidence on natural products, mind-body medicine, manipulative and body-based practices, and other CAM practices. Just hosting this community will challenge CAM proponents to deliver the goods if they can.

Nowhere on NCCAM's list of Health Topics A-Z will you find hyperbaric oxygen therapy. Evidence-based HBOT is neither complementary nor alternative medicine. It's not integrative, holistic, natural, traditional, new age, or unconventional. Let's keep it that way.

O2.0 is the news blog of HyperbaricLink, the independent web guide to hyperbaric oxygen therapy.

Evidence-based HBOT: Trust It Or Trash It?

Newspapers, magazines, television, radio, the web—you're showered with health news and views 24/7. How do you know who to believe? One elegant new tool has boiled the challenge down to three simple questions. Who said it? When did they say it? How did they know? Trust It or Trash It? is a tool to help you think critically about health information. Developed by Genetic Alliance in cooperation with the CDC National Center on Birth Defects and Developmental Disabilities and others, the simple interactive guide also urges you to dig deeper using a Content Scale, Quality Scale, and Usability Scale. We think you'll find Trust It or Trash It? fun and informative. We've found it inspiring, and maybe a bit intimidating, as we work to make HyperbaricLink one health information resource you can always trust.

O2.0 is the news blog of HyperbaricLink, the independent web guide to hyperbaric oxygen therapy.

Restorix Health Mixes It Up In Greater Seattle

Suddenly one ambitious new HBOT clinic in Issaquah WA has become the darling of the local newspaper and the chamber of commerce, and raised the hackles of one leading authority in hyperbaric medicine. Restorix Health opened in December with "the largest collection of large monoplace chambers in the country" (6 Perry Sigma 40s) and plans "to lead the country in research using hyperbaric chambers to treat soldiers with traumatic brain injuries" and other investigational conditions by opening "15 to 20 new clinics along the West Coast in the next five years." Followup coverage last week ballyhoos the center's Innovation in Issaquah award for "space-age medical research."

UHMS past president Dr Neil Hampson is having none of it. Read his letter to editor of the Issaquah Reporter (see also our appreciation of his Virginia Mason program). Hampson casts doubt on Restorix's business model and its clinicians' research credentials, concluding:

I am skeptical that the Restorix Foundation will be capable of underwriting the expense of quality research in hyperbaric medicine, as I would be about most foundations in this country. My strongest hope is that they do not plan to charge patients for experimental treatment.

Restorix Research Institute chief medical officer Tommy Love shot off a quick rebuttal, insisting his studies (4 in the works) will be IRB-approved and peer-reviewed, adding:

Our research studies will never charge patients to participate.  Dr. Hampson’s claim that only large institutions can do credible research is simply untrue.

We're captivated by the debate and eager to learn more about the privately funded research Restorix has in the works.

O2.0 is the news blog of HyperbaricLink, the independent web guide to hyperbaric oxygen therapy.

Clinical Evidence: Is Any Of It Any Good?

Last week Newsweek told us "Why Almost Everything You Hear About Medicine Is Wrong," and goodness knows there have been times we have wanted to say the same. Facts and skepticism, not commerce or politics, not hopes and dreams, should drive evidence-based medicine. We're all about facts and skepticism. And so we also seriously doubt the article's chief claim, based on some pretty flimsy-sounding mathematical modeling, that the majority of clinical trial results are wrong.

Yet the article's main point strikes home. Human clinical trials are conducted by human beings, all with personal motivations and biases, on human beings, all with minds and bodies wide open to all sorts of suggestions and stimuli. The human experiment is messy. Life is messy. Even the finest, largest randomized prospective trials, using gold-standard placebo controls, may fall to shreds upon closer scrutiny.

One of our favorite scientific papers last year sheds a little light. Kaptchuk et al, publishing in the online journal PLoS ONE, found that "placebos administered without deception may be an effective treatment for IBS" (irritable bowel syndrome). That's right. Patients who were told they were being given "...placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes," did significantly better than patients who received no treatment at all.

Maybe it was the mere act of caring and caregiving, the human touch, that made the difference. We don't know.

So we do the best we can, and we keep our wits about us when we read and interpret (yes, interpret) study results. And here at HyperbaricLink, on our Diseases and Conditions pages, we always provide thoughtfully curated facts and clicks for you to study the state of the HBOT evidence yourself.

In hyperbaric medicine we're used to scathing headlines that make Newsweek's look tame. Who could forget this September gem from Slate: "Don't listen to Tim Tebow: Hyperbaric oxygen chambers are mostly useless." At least the author was kind enough to provide a link to hyperbaric oxygen search results in the Cochrane Reviews, where (equally messy and suspect) meta-analytical techniques abound but domain expertise and independence rule. Surely we're fortunate that HBOT has won the attention of The Cochrane Collaborative. We're also fortunate to have the UHMS, the ACHM, and other professional organizations with peer-reviewed meetings and publications to keep investigators and authors honest.

We'll keep consulting such reliable sources and keep placing our trust in the scientific method. And let's take those papers one at a time, please, and spare the sweeping generalizations.

O2.0 is the news blog of HyperbaricLink, the independent web guide to hyperbaric oxygen therapy.

What Does Money Have To Do With It?

While we're on the subject of research and the healthy skepticism with which a single study should usually be regarded, we wanted to make mention of a good book from last fall's reading list. White Coat, Black Hat: Adventures on the Dark Side of Medicine takes a hard look at the corrupting influence of corporate money on medical research. To us, the disparity in research funding between pharmaceuticals and hyperbaric medicine is striking. We can't help but observe that the pace of adoption of hyperbaric oxygen therapy in new areas of medicine may be related to the fact that hyperbaric chamber manufacturers and HBOT providers have nowhere near the financial resources of drug companies.

Maybe that's a good thing in the long term. If research into new uses for hyperbaric oxygen therapy isn't driven by manufacturer dollars study results may be more enduring. As a therapy with multiple applications, perhaps new HBOT research will serve as a guiding example for uncoupling research underwriting from its financial beneficiaries. In the meantime, we'll regard research with the potential to be hugely beneficial to a specific organization with a healthy dose of skepticism.

Problems with the system may make us advocates for improvement, but we're not motivated to question the essential value of peer reviewed scientific research. Science may be fallible, but it's a lot less fallible than non-science.

Autism Study Invalidated: No Link to Vaccines

Many news sources have picked up the report by Brian Deer in BMJ.com, the online arm of the British Medical Journal, that the 1988 study linking autism and the measels, mumps, and rubella (MMR) vaccine contained numerous instances of altered clinical data. Highlights from the report include:

• Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism.

• Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns.

• Some children were reported to have experienced first behavioral symptoms within days of MMR, but the records documented these as starting some months after vaccination.

Numerous other subsequent studies have shown no link between the vaccine and autism spectrum disorders, and the original paper was withdrawn by the Lancet. Unfortunately, in the time since the publication of the bogus study the scare it started has caused needless illnesses and deaths and a resurgence of the diseases the vaccine prevents.

This latest development underscores the vital importance of well designed clinical studies of any diagnosis--or treatment. Although a number of studies have been conducted to evaluate the effectiveness of hyperbaric oxygen therapy in treating patients with autism, there is currently not a sufficient body of evidence to conclude scientifically that HBOT is effective.

Tai Chi For Fibromyalgia: How Evidence Is Done

Aspiring hyperbaric medicine clinical investigators take note. In last month's New England Journal of Medicine, "A Randomized Trial of Tai Chi for Fibromyalgia" put the lie to the myth that it's next to impossible to produce first-class evidence for alternative medicine. Still, it takes money, plenty of money. Big Pharma didn't fund this study, Big Government did—the National Center for Complementary and Alternative Medicine, to be precise, a section of the National Institutes of Health. The results should be motivating for HBOT researchers, who could secure like funding if they tried harder, and especially welcome news for people living with fibromyalgia.

O2.O is the news blog of HyperbaricLink, the independent web guide to hyperbaric oxygen therapy.

Natural Health: Science, Business, Politics, Law

Probably we're preaching to the choir at the Alliance for Natural Health, an organization "dedicated to promoting sustainable health and freedom of choice in healthcare through good science and good law." Too many drugs pushed by too powerful a medical establishment? Agreed. More wisdom in prescribing diet and exercise? Definitely. A conspiracy against natural health by Big Pharma, the FDA, and the AMA? Meh. Better health through holistic medicine and supplements? Not so fast.

Nutraceuticals are drugs, too, and frighteningly untested and unregulated, most of them, except as "medical foods." Holistic providers of all stripes seem free to practice in America as they see fit and make all sorts of wild claims without much fear of retribution. If it's FDA clearance and Medicare reimbursement they want, then let's see the evidence, fully vetted and given due process. Heck, the California Walnut Commission did it, and got the FDA to agree that "eating 1.5 oz of walnuts per day, as part of a low saturated fat and low cholesterol diet, and not resulting in increased caloric intake, may reduce the risk of coronary heart disease."

Before reading our reply to the ANH, below, please leave this post and read the organization's "Memo to Political Leaders: When You Think Job Creation, Think Natural Health (If You Don't, Other Countries Will)."

Our reply:

Yes, let’s do embrace natural and ancient remedies and holistic approaches to health and healing. But let’s not pretend Western medicine isn’t on to something BIG with its pesky Scientific Method and evidence-based practice. Call it Conventional if you want. I call it Modern. Sometimes it pretends it knows more than it knows, and like Freedom it requires our constant struggle, yet it’s one of the marvels of our Age. And it should include more alternative thinking for sure.

As for hyperbaric oxygen therapy, the US leads the world, business is brisk, and growth is steady and strong. Thank goodness we have a medical establishment and government regulation to make sure we don’t jump willy-nilly into treatments for which there is no assurance of safety and efficacy. These are pretty low bars for entry.

On my site, HyperbaricLink, you’ll find us championing FDA approval of HBOT indications like traumatic brain injury and stroke, where we find the evidence especially compelling. Where the evidence is scant or merely interesting, we urge investigators to do the clinical trials and publish the findings or shut up.

Our comment is awaiting moderation.

O_2.0 is the news blog of HyperbaricLink, the independent guide to hyperbaric oxygen therapy treatment centers, physicians and clinicians, diseases and conditions.

HBOT For Autism: Junk Science?

Yesterday "hyperbaric oxygen chambers to cure autism" made the Junk Science Week shortlist in a major Canadian newspaper. National Post financial columnist Terance Corcoran, darting about from fear to hype to hope, fails to build much of a case for such harsh judgment. And his entire tirade stems from a pretty finely balanced television story on CBC's The National.

We're on record, in this blog and on the HyperbaricLink autism page, in favor of more well-designed clinical investigations to build on last year's interesting work by Rossignol, et al, using mild HBOT. The UHMS December 2009 position statement on "The Treatment of Autism Spectrum Disorder with Hyperbaric Oxygen Therapy" concurs:

... there is a strong case for further trials to be done in this area. Any future trials would need to be well planned, appropriately powered and include several relevant treatment arms.... These clinical efforts should be combined with efforts to elucidate the basic mechanisms by which mild hyperbaric therapy might exert a therapeutic effect.

Now does that sound like Junk Science to you? Let's be ever mindful of the canyon that lies between "unstudied" and "disproven" medical claims, especially when seeking effective treatments for such a poorly misunderstood condition as autism.

CO Poisoning: Is HBOT Still The Gold Standard?

One of our chief missions is to raise awareness and help increase 24/7 access to HBOT chambers at emergency rooms for victims of thermal burns, smoke inhalation, and carbon monoxide poisoning. (Review our past coverage here.) So we were especially pleased to discover a new posting of a 2007 talk by Dr Fred Fiesseler of Morristown (NJ) Memorial Hospital. Drawn from case studies and a review of the medical literature, Fiesseler's presentation reaffirms our commitment to this mission. To listen to the audio file follow this link:

Is Hyperbaric Oxygen Still the Standard for Carbon Monoxide Poisoning?

Going forward we will be identifying ER-accessible chambers in our treatment center directory and partnering with emergency medical associations and innovative companies like Healthagen to spread this lifesaving information far and wide.

Of course some political activism may be in order, too, and count on HyperbaricLink to be there.

TBI: Pentagon Study To Commence 2011

A clinical trial to include 300 soldiers at 5 sites over 18 months, all coordinated by the Defense Centers of Excellence (DCoE) for Psychological Health & Brain Injury, is more good news for military veterans suffering traumatic brain injury (TBI) and another shot in the arm for evidence-based hyperbaric medicine. Read more about the study at Army Times.

P.S. Please accept this short PSA as our apology for neglecting to celebrate Brain Injury Awareness month in March.

PatientsLikeMe: Fanned, Followed, Fast Companied

Fast Company magazine just recognized what we've long known about PatientsLikeMe, naming the company among its most innovative of 2010. Innovative indeed—and right up our alley. A beautifully conceived website "committed to providing a better, more effective way to capture valuable results and share them with patients, healthcare professionals, and industry organizations that are trying to treat the disease," PatientsLikeMe ingeniously balances patients' desire for privacy with their need for openness.

For patients (maybe like you) this important site represents the highest and best use of the Internet we can imagine, and as it expands we're eager to see our HyperbaricLink online community participate and benefit. Especially popular is PatientsLikeMe's fibromyalgia and chronic fatigue syndrome section, some 12,000 strong and growing. But there's nobody home in the hyperbaric oxygen therapy room, which O2.0 readers will find in move-in condition. And it's free to join.

OxyHeal Wins DoD Contract To Support TBI Study

We're happy to report it's getting difficult for us to keep score of all the good HBOT research now under way for our military troops and veterans recovering from traumatic brain injury (TBI). The US Department of Defense just awarded OxyHeal Health Group a major contract to support its Centers of Excellence (DCoE) for Psychological Health and TBI. In preparation for the trial, entitled "Hyperbaric Oxygen Applied Late after Mild to Moderate Traumatic Brain Injury," the company will fabricate, install, lease, and staff multiplace hyperbaric chamber systems at four military sites. The DCoE:

assesses, validates, oversees and facilitates prevention, resilience, identification, treatment, outreach, rehabilitation, and reintegration programs for psychological health (PH) and traumatic brain injury (TBI) to ensure the Department of Defense meets the needs of the nation's military communities, warriors, and families.

Well, alright, then. Lock and load! And with over 40 years of experience in chamber design, manufacturing, and contract management, OxyHeal stands ready and able to serve.

Read the full press release here.

Carbon Monoxide Poisoning: A Public Health Crisis

We bring you yet more deadly stats for the cold and "flue" season. Carbon monoxide poisoning accounts for some 50,000 emergency room visits annually in the US. Every year about 450 Americans die from accidental exposure alone. Death rates peak in December and January. Almost all survivors experience serious immediate and lasting neuropsychological effects.

Autism: HBOT Among "Risky Alternative Therapies"?

Strong words from the recent Chicago Tribune autism treatment series. At the risk of offending some parents and physicians of children with autism, we recommend it as required reading. Not that we'd lump hyperbaric oxygen in with "risky alternative therapies," but perhaps an HBOT researcher or two can honestly be said to have "hijacked" science to suit their objectives.

Still, individual successes and powerful anecdotes do matter. Medicine invented higher education by case study, after all. O2.0 simply won't view skepticism and hope as mutually exclusive principles but, rather, as equally strong motivators for good evidence-based medicine. So let's get on with it. Once more we urge researchers to raise the pressure from mild to true HBOT and raise the stakes by organizing larger prospective trials and observational studies.

(Baltimore Sun photo by Algerina Perna of Dr Carlos Pardo at Johns Hopkins.)

Off-Label HBOT: Autism

As promised (see our November 9 post), we've read the CARD study, we've spoken with one of its authors, and we're downgrading our Evidence Index score on hyperbaric oxygen therapy for autism. Indeed the early results using room air at mild pressures are now decidedly mixed.

Far be it for us to deny that real children with autism are enjoying real benefits from their hyperbaric oxygen therapy. It would be hasty to dismiss Rossignol's hypotheses and findings altogether. And O2.0 loudly repeats its call for physicians' responsible off-label usage and continuing investigations at higher pressures and 100% oxygen. But from where we sit, that's the sad state of the evidence on HBOT for autism in today's published medical literature: scant.

We've nothing to add but praise for any investigators who bemoan

...the lack of publication of studies with null results. Studies showing a lack of evidence for treatment efficacy are as important as studies demonstrating positive results because they provide important information about treatment approaches with only spurious or anecdotal evidence.

Hear, hear! Jump to our updated autism page learn more and to use our HyperbaricLink Evidence Index to guide your personal research.