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.

TBI: Should HBOT Be Limited To Clinical Trials?

Occasionally a news reporter surprises us by actually doing her job and doing the hard work of journalism. Take a lesson from Palm Beach Post staff writer Lona O'Connor, who takes the time and effort to help us understand the people, facts, and points-of-view in last week's story: "Therapist using hyperbaric chamber to help Iraq/Afghan vets cope with brain disorder."

Most reporters would have run with the publicity feed and focused exclusively on the injured vets. This story manages to take in all the human drama of their story, while questioning the wisdom of seeking pro bono treatment by a physical therapist, without disrespecting the vets or the physical therapist. She also interviews (1) a local traumatic brain injury expert, who rightly drains some of the feel-good out of the piece by citing the current evidence, and (2) a VA physician, who speaks for the clinical trials now under way. Money quote:

There are many human conditions we don't have the answers for. You don't help people just because you feel bad for them. You have to do something that's safe but isn't going to make them worse. And if something bad happens, what's he going to fall back on?

The article also introduces us to another HBOT center, Crallé Physical Therapy and Oxygen Rescue Care Centers of America (ORCCA), Delray Beach FL. Our best wishes for them and their selfless work. Still, like the VA doc quoted above, we'd much rather see these brave patients in the hands of board-certified physicians conducting peer-reviewed clinical investigations in collaboration with a military or academic medical center.

(Photo credit: Richard Graulich, Palm Beach Post)

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

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.

Jane Brody Prescribes A Healthy Dose Of HBOT Skepticism

The ever trustworthy Jane Brody (we're big fans) strikes the usual fine balance in her Personal Health column on hyperbaric oxygen therapy. She wisely calls on UHMS and the BRF for expert guidance. She also references an article we'd really like to get our hands on, from the November 2008 issue of Emergency Medicine, in which authors Maples and Mendelson "explain the various uses of a 300-year-old treatment that is only now reaching its full potential." Brody cites the proper evidence and acknowledges the approved indications. Then she slams HBOT as one of many "unproven remedies" for cerebral palsy, autism, and more:

...multiple sclerosis, stroke, macular degeneration, spinal cord injury, sports injuries, heart attack, postpolio syndrome, Lyme disease, migraine, cirrhosis, myasthenia gravis, fibromyalgia or chronic fatigue syndrome—among the dozens of conditions that independent clinics claim to treat with hyperbaric oxygen. Not to mention the claims of celebrities like Michael Jackson, who used it in the hope that it will keep him alive to 150, and Keanu Reeves, who used it for insomnia.

Phew.