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FDA warning: hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes

24 Aug

The FDA issued a warning yesterday about hyperbaric oxygen treatment (HBOT) that includes autism. HBOT has not been shown to cure or be an effective treatment for autism, among the myriad conditions for which HBOT is touted.

The warning is quoted below.

No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you’ll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.

HBOT involves breathing oxygen in a pressurized chamber. The Food and Drug Administration (FDA) has cleared hyperbaric chambers for certain medical uses, such as treating decompression sickness suffered by divers.

HBOT has not, however, been proven to be the kind of universal treatment it has been touted to be on some Internet sites. FDA is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health.

“Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by FDA, which may cause them to delay or forgo proven medical therapies,” says Nayan Patel, a biomedical engineer in FDA’s Anesthesiology Devices Branch. “In doing so, they may experience a lack of improvement and/or worsening of their existing condition(s).”

Patients may be unaware that the safety and effectiveness of HBOT has not been established for these diseases and conditions, including:

AIDS/HIV
Alzheimer’s Disease
Asthma
Bell’s Palsy
Brain Injury
Cerebral Palsy
Depression
Heart Disease
Hepatitis
Migraine
Multiple Sclerosis
Parkinson’s Disease
Spinal Cord Injury
Sport’s Injury
Stroke
Patel says that FDA has received 27 complaints from consumers and health care professionals over the past three years about treatment centers promoting the hyperbaric chamber for uses not cleared by the agency.

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How HBOT Works
HBOT involves breathing oxygen in a pressurized chamber in which the atmospheric pressure is raised up to three times higher than normal. Under these conditions, your lungs can gather up to three times more oxygen than would be possible breathing oxygen at normal air pressure.

Patel explains that your body’s tissues need an adequate supply of oxygen to function. When tissue is injured, it may require more oxygen to heal. “Hyperbaric oxygen therapy increases the amount of oxygen dissolved in your blood,” says Patel. An increase in blood oxygen may improve oxygen delivery for vital tissue function to help fight infection or minimize injury.

Hyperbaric chambers are medical devices that require FDA clearance. FDA clearance of a device for a specific use means FDA has reviewed valid scientific evidence supporting that use and determined that the device is at least as safe and effective as another legally U.S.-marketed device.

Thirteen uses of a hyperbaric chamber for HBOT have been cleared by FDA. They include treatment of air or gas embolism (dangerous “bubbles” in the bloodstream that obstruct circulation), carbon monoxide poisoning, decompression sickness (often known by divers as “the bends”), and thermal burns (caused by heat or fire).

What are the Risks?
Patients receiving HBOT are at risk of suffering an injury that can be mild (such as sinus pain, ear pressure, painful joints) or serious (such as paralysis, air embolism). Since hyperbaric chambers are oxygen rich environments, there is also a risk of fire.

“If you’re considering using HBOT, it’s essential that you first discuss all possible options with your health care professional,” Patel says. “Whatever treatment you’re getting, you need to understand its benefits and risks. Your health care professional can help you determine which treatment is your best option.”

In addition, any problems experienced with these devices can be reported to MedWatch, the FDA safety information and adverse events reporting program.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

August 22, 2013

More discussion at Forbes from Emily Willingham

—
By Matt Carey

Hyperbaric oxygen in the treatment of childhood autism: a randomised controlled trial

24 Oct

Hyperbaric Oxygen therapy (HBOT) has risen in recent years as an “alternative” therapy for many conditions, autism included. The logic behind HBOT is rather fuzzy. For example, there was some discussion of using HBOT to reduce oxidative stress a few years back. How increasing oxygen in the body would decrease oxidative stress was not clear. Some other discussions focused on oxygen perfusion. Basically, some studies have shown that some areas of the brain may be getting less oxygen in autistics than in non-autistics. The idea was that increasing the oxygen to those areas might result in some improvement in some measure or another.

This begs the question: are there areas of higher perfusion (hyperperfusion) in the brains of autistics? Seems an important question to pose when proposing increasing perfusion. But one can not find the term “hyperperfusion” in this review promoting HBOT and autism, for example. But the answer is, yes, people have measured hyperperfusion in autistic’s brains:

Brain perfusion SPECT and EEG findings in children with autism spectrum disorders and medically intractable epilepsy

In specific, they found

The areas of hypoperfusion and EEG focus were highly related in seven of 12 children, while the areas of hyperperfusion were highly related to EEG focus in six of 12 children. The areas of hypoperfusion were highly related to the focus observed on EEG, but were not always related.

Using the simplistic logic of HBOT/autism promotors, one then is left with the question of whether could HBOT make seizure activity worse? I wouldn’t put too much weight on this question other than to point out that it isn’t 100% clear that there can be no downside to HBOT. The logic “there is hypoperfusion therefore HBOT should benefit” isn’t strong; the idea that “there are areas of hyperperfusion, therefore HBOT could have a downside” is also not strong. There are three other studies mentioning hyperperfusion and autism. And, I was interested to see that there are 350 hits for a search of hyperperfusion and epilepsy in pubmed. Compare this to 30 hits for autism and hypoperfusion.

Back to HBOT. There isn’t much science for HBOT, to be frank. Most of the momentum, at least in publications, is from one source: Dan Rossignol. An early paper: Hyperbaric oxygen therapy may improve symptoms in autistic children. by Dr. Rossignol was published in Medical Hypotheses–a pseudo medical journal. I believe Dr. Rossignol’s clinic in Florida provides HBOT.

While there have been articles like the above and some small open label study reports, true randomized trials have been lacking. A recent review Hyperbaric oxygen therapy for treatment of children with autism: a systematic review of randomized trials reported

While some uncontrolled and controlled studies suggested that HBO therapy is effective for the treatment of autism, these promising effects are not replicated. Therefore, sham-controlled studies with rigorous methodology are required to be conducted in order to provide scientific evidence-based HBO therapy for autism treatment.

Also worth noting is that HBOT is currently rated as “non-accepted” by the European Committee for Hyperbaric Medicine. An indication that there was not good evidence either way at the time they prepared their statement.

Two recent studies (the one which is the focus of this article and another) have used a more randomized/blind methodology and one has looked at biomarkers considered important in HBOT and autism (cytokines). The results have not been encouraging.

First the more biomarker based study. This group studied autistic children given HBOT and looked at cytokine levels (Brief report: Hyperbaric oxygen therapy (HBOT) in children with autism spectrum disorder: a clinical trial.) Per that study,

Ten children completed 80 sessions of HBOT and all improved by 2 points on the clinician-rated CGI-I scale (much improved) as well as several parent-completed measures of behavior. The lack of a control group limits the ability to determine if improvements were related to HBOT.

and also:

“Although this study was limited by the small sample size and by the variable nature of cytokines, we found no evidence that HBOT affects cytokine levels or that cytokine levels were associated with behavioral changes”

So, if there is a benefit from HBOT, it isn’t due to changes in cytokines. Which HBOT doesn’t seem to affect.

Another somewhat recent study attempted a clinical trial as well
Controlled evaluation of the effects of hyperbaric oxygen therapy on the behavior of 16 children with autism spectrum disorders. This study, out of the old “Thoughtful House” including Andrew Wakefield as an author found ” No consistent effects were observed across any group or within any individual participant, demonstrating that HBOT was not an effective treatment for the participants in this study. This study represents the first relatively large-scale controlled study evaluating the effects of HBOT at the level of the individual participant, on a wide array of behaviors.”

Finally, a study out in the past couple of months again attempts a randomized controlled study: “Hyperbaric oxygen in the treatment of childhood autism: a randomised controlled trial.” The study is out of Thailand. One factor of note is the attempt to do a real control using a “sham” air group. Obviously HBOT studies are complicated in that study subjects can easily detect the changes in pressure. Of note, HBOT in this case is 100% oxygen:

This study was a prospective, randomised, double-blind, controlled trial of HBOT at 153 kPa (1.5 ATA) with 100% oxygen for one hour daily, weekdays to a total of 20 sessions, versus a sham air treatment consisting of pressurised room air at 116 kPa (1.15 ATA) on the same schedule.

While some reports have used 100% oxygen at 1.5ATA, many have used either air or enriched air and sometimes lower pressure (1.3ATA). I.e. this study involves higher oxygen exposure than in many studies. Air is about 21% oxygen. So, a 1.5 atmospheres of pure oxygen is about 7.5 times the oxygen partial pressure in air. Many reports in early studies were about 1.3 ATA air or slightly enriched air. 1.3 ATA (atmospheres absolute) at 25% O2 is about 32% oxygen. For divers, these levels of oxygen are comparable to Nitrox or enriched air. One can get a higher oxygen level from a mask at 1 atmosphere. Which has been a critique of HBOT from the start. Early anecdotal reports from HBOT practitioners claimed that oxygen delivered by mask was not effective. Only high pressures gave whatever results were claimed. Which is counter intuitive to the simple explanations of how HBOT should work.

But, with both high pressure and pure O2, the Thailand study should provide clarity in these questions. Which begs the question, what are those results? The full paper is online and the abstract is below.

BACKGROUND:
Promising results with hyperbaric therapy for children with autism have been reported, but most involved the use of only mild pressure with oxygen supplementation. To date, there has been no randomised, blinded trial of 100% oxygen administered at hyperbaric pressure. This study evaluated the efficacy of hyperbaric oxygen therapy (HBOT).

METHODS:
Sixty Thai children with autism, aged three to nine years, were randomly assigned to receive 20 one-hour sessions of either HBOT at 153 kPa (1.5 ATA) or sham air at 116 kPa (1.15 ATA). Effects on behaviour were measured using the Autism Treatment Evaluation Checklist score (ATEC) and clinical improvement was measured with the Clinical Global Impression (CGI) system; in particular the clinical change (CGIC) and severity (CGIS) sub-scores. These were evaluated by parents and clinicians, both of whom were blinded to the actual exposure.

RESULTS:
The mean total ATEC scores by both parents and clinicians were significantly improved after intervention in both arms of the study compared to the score before intervention (P <; 0.001 in both groups by parents, P = 0.015 in HBOT group and P = 0.004 in sham group by clinician). There were no statistically significant differences in average percentage changes of total ATEC score and all subscales scores when comparing the HBOT and sham air groups, either by parents or clinicians. Changes in the CGI scores following intervention were inconsistent between parents and clinicians. For severity scores (CGIS), parents rated their children as more improved following HBOT (P = 0.005), while the clinicians found no significant differences (P = 0.10). On the other hand, for change scores (CGIC) the clinicians indicated greater improvement following HBOT (P = 0.03), but the parents found no such difference (P = 0.28).

CONCLUSIONS:
Children with autism who received 20 sessions of either HBOT or a sham air exposure had significant improvements in overall behaviour but there were no significant differences in improvement between groups. The inconsistent changes on CGI sub-scores between parents and clinicians are difficult to interpret, but no overall clinically significant benefit from HBOT could be shown. Both interventions were safe and well tolerated with minimal side effect from middle ear barotraumas.

Repeat for emphasis: “Children with autism who received 20 sessions of either HBOT or a sham air exposure had significant improvements in overall behaviour but there were no significant differences in improvement between groups”

Reports from parents and clinicians did not agree and the authors conclude “no overall clinically significant benefit from HBOT could be shown”.

HBOT is not cheap. A single “dive” can cost in the neighborhood of $100. Parents have purchased portable chambers which run in the $10-20k range (depending on model and whether new). And have modified these to provide O2 enriched air, outside the manufacturer’s specifications. There is a resale value in these chambers so far, so the net cost is not going to be as high. But, all told, there is substantial outlay of funds and time in HBOT. The science pro is shaky at best. And now there are two negative controlled trials.

These results will likely do little to dampen the enthusiasm for HBOT. All studies of HBOT and autism in clinicaltrials.gov are completed, so future data may not be forthcoming.

—
By Matt Carey

Controversial issues in hyperbaric oxygen therapy: a European Committee for Hyperbaric Medicine Workshop

22 Aug

After writing the post on the University of California HBOT paper (Brief Report: Hyperbaric Oxygen Therapy (HBOT) in Children with Autism Spectrum Disorder: A Clinical Trial) this new abstract came out: Controversial issues in hyperbaric oxygen therapy: a European Committee for Hyperbaric Medicine Workshop.

It covers a discussion of applications of HBOT which were not yet considered in their previous workshop. This includes autism as a condition to treat with HBOT. Their conclusion: rate HBOT for autism as “not-accepted”.

Every few years, the European Committee for Hyperbaric Medicine (ECHM) publishes its recommendations concerning the clinical indications for hyperbaric oxygen therapy (HBOT). The last recommendations were issued during the 7th European Consensus Conference on Hyperbaric Medicine in 2004. Since then, several publications have reported on the use of HBOT in some indications in which it has not yet been recommended routinely, namely aseptic bone necrosis, global brain ischaemia and autism. Patients or their families push physicians and staff of hyperbaric facilities to use hyperbaric treatment regardless of the quality of the scientific evidence. Therefore, the ECHM Workshop “Controversial issues in hyperbaric oxygen therapy” was convened as a satellite meeting of the 2010 European Underwater and Baromedical Society Annual Scientific Meeting in Istanbul, Turkey in 2010. For each topic, a set procedure was used: first came a general report by specialists in the topic, incorporating a review of current pathophysiological, experimental and clinical evidence. Then, there were reports from hyperbaric facilities that had gained clinical experience in that condition, followed by a general discussion with specialists present in the audience. Finally, statements regarding each topic were proposed and voted on by the audience and these were presented to the ECHM Executive Board for consideration and possible approval. In conclusion, the use of HBOT in femoral head necrosis will be proposed during the next ECHM Consensus Conference to become an ‘accepted’ indication; whilst the use of HBOT in global brain ischaemia and autism should retain its current ECHM recommendations, that it should be ‘optional’ and ‘non-accepted’ respectively.

Brief Report: Hyperbaric Oxygen Therapy (HBOT) in Children with Autism Spectrum Disorder: A Clinical Trial

22 Aug

Hyperbaric Oxygen Therapy (HBOT) is a popular offering in the alternative medical community. It is a therapy that has proven and approved uses (most notably treatment for decompression sickness or carbon monoxide poisoning). It has been proposed as a therapy for autism, and there is already a mixed body of literature on the subject, most with small and/or uncontrolled studies. The most recent study found no benefit.

Another study has now been released, this time from the University of California (UC San Francisco and UC Davis). Brief Report: Hyperbaric Oxygen Therapy (HBOT) in Children with Autism Spectrum Disorder: A Clinical Trial is a small, uncontrolled study. The measure of benefit, at least by the abstract, is the CGI-I (Clinical Global Impression, Improvement scale), which is not particularly objective. Measures of cytokine levels were made, and no changes were observed. So, if any behavioral changes were derived from the HBOT, they were not correlated with cytokine levels.

We sought to determine whether HBOT leads to parental reported behavioral changes and alterations in cytokines in children with ASD. Ten children completed 80 sessions of HBOT and all improved by 2 points on the clinician-rated CGI-I scale (much improved) as well as several parent-completed measures of behavior. The lack of a control group limits the ability to determine if improvements were related to HBOT. Enrolled children did not exhibit abnormal cytokine levels at baseline and no significant changes in mean cytokine levels were observed. Although this study was limited by the small sample size and by the variable nature of cytokines, we found no evidence that HBOT affects cytokine levels or that cytokine levels were associated with behavioral changes.

In general, not a particularly strong study. I’ll note that UCSF’s recent MB12 study put a rather positive spin on a negative result. The fact that these researchers rated the children as improved is not really impressive to me. We don’t need more weak studies on alternative medicine. Those will never really answer any questions.

What’s up with Fox News and promoting bad autism science and medicine

15 Jul

OK, it’s anecdotal. But from my perspective of all the networks, Fox just seems to be the most open to bad science and medicine reporting. CBS has Sharyl Attkisson, and her work has been far from excellent over the years. But Fox just seems to be the “go-to” news outlet for those pushing vaccine causation and unproven medical treatments.

Case in point, Fox 9 in the Twin Cities. A recent story: Investigators: Hyperbaric Autism Care.

http://www.myfoxtwincities.com/video/videoplayer.swf?dppversion=10588

Investigators: Hyperbaric Autism Care: MyFoxTWINCITIES.com

There just isn’t any evidence that HBOT works for autism. There isn’t even a good theory for why it would work. Listen to the story, they basically have it right: the brain will absorb more oxygen. In turn this will help treat autism.

That’s about it for the theory: oxygen should be good. More should be better. I.e. hyperbarics will treat autism. When it goes by fast, it sounds like they have some idea what they are talking about. But there isn’t anything there.

Controlled Evaluation of the Effects of Hyperbaric Oxygen Therapy on the Behavior of 16 Children with Autism Spectrum Disorders

21 Apr

Hyperbaric oxygen treatment (HBOT) has become a big topic in the world of CAM (complementary and alternative medicine) and autism. An upcoming parent convention with a focus on CAM is even sponsored by an HBOT company. A few papers have come out, without much clear evidence of benefit.

A recent paper looks again at HBOT. This paper has a few limitations. Amongst these: there were only 16 participants and, well, I consider papers by Thoughtful House and by Andrew Wakefield in particular to be somewhat problematic.

Here is the abstract:

Controlled evaluation of the effects of hyperbaric oxygen therapy on the behavior of 16 children with autism spectrum disorders.

Jepson B, Granpeesheh D, Tarbox J, Olive ML, Stott C, Braud S, Yoo JH, Wakefield A, Allen MS.

Thoughtful House Center for Children, Austin, TX, USA.
Abstract

Hyperbaric oxygen therapy (HBOT) has been used to treat individuals with autism. However, few studies of its effectiveness have been completed. The current study examined the effects of 40 HBOT sessions at 24% oxygen at 1.3 ATA on 11 topographies of directly observed behavior. Five replications of multiple baselines were completed across a total of 16 participants with autism spectrum disorders. No consistent effects were observed across any group or within any individual participant, demonstrating that HBOT was not an effective treatment for the participants in this study. This study represents the first relatively large-scale controlled study evaluating the effects of HBOT at the level of the individual participant, on a wide array of behaviors.

One problem with HBOT studies in the past is the attempt to use a placebo like therapy. It seems to this observer at least that it would be quite easy to distinguish placebo vs. real HBOT. The current study avoids that. They took data during a baseline period, during the HBOT therapy weeks and a post-HBOT period. They found that there was no benefit.

These findings diverge considerably from those of Rossignol et al. (2009). The current study controls for the potential ‘‘washing out’’ of the effect when group data are averaged (as must be done in a between-groups design) by carefully measuring potential changes in 11 topographies of behavior over time across 16 individuals. If there was a subgroup for which HBOT was effective, it seems likely that at least one such child would have participated in the current study. The lack of an effect for any participant in the current study makes the existence of such a subgroup seem implausible.

The paper concludes:

News programs and community blogs report that many families of children with autism are using HBOT therapy. The cost of such treatment may range up to $150 per hour. Families report using anywhere from 40 to 120 h of HBOT. These hours are in lieu of other therapies such as applied behavior analysis, speech therapy, and occupational therapy and do not include travel time to the medical center where the therapy is provided. Some families purchase the chambers in order to provide therapy in their home. A number of websites focus on renting ($1,395 per month) and selling ($8,495–27,995) chambers to families. Given the financial and time-investment required for HBOT and the conflicting study outcomes to date, we cannot recommend HBOT as a treatment for autism until such time as more conclusive favorable results are demonstrated.

This is consistent with a previous study which included one of the above authors, Randomized trial of hyperbaric oxygen therapy for children with autism, which concluded:

This study found HBOT to have no significant beneficial effect on ASD symptoms. The experimental design of the current study is of a higher rigor than those employed in previous studies which have suggested that HBOT is effective. Further, the dependent measures included were far more comprehensive than those included in previous studies; therefore it is unlikely that an effect was present which was not detected. Based upon the findings of the current study, HBOT delivered at 24% oxygen at 1.3 atmospheric is not recommended for the treatment of ASD symptoms.

Do’C over at the AutismStreet blog has followed the HBOT research pretty closely. Here is his list of articles skeptical about HBOT.

My own view:
HBOT is expensive, time consuming, not effective for treating autism and will continue to be promoted heavily to parents looking for a way to help their children. There is something profoundly wrong with the world of CAM and autism if they don’t move away from therapies like HBOT.

Autism treatment: Science hijacked to support alternative therapies

23 Nov

Such is the title of the latest article in the Chicago Tribune by Trine Tsouderos and Patricia Callahan.

The article is subtitled: ‘Researchers’ fears about misuse of their work come true’.

Go now and read it. I’ll pull some examples here, but read the article. Send it to your friends. When a writer tells you to stop reading his own piece and go read something else, he means it.

The article reports on how the alternative medical community in autism has clearly misused some research to create and promote supposed therapies.

The prime example, the misuse of work by a John’s Hopkins team on neuroinflammation in autopsied brains of autistics (e.g. Neuroglial activation and neuroinflammation in the brain of patients with autism. by Vargas , Nascimbene , Krishnan, Zimmerman, and Pardo.)

The John’s Hopkins team showed that neuroinflammation was present in the brains of recently deceased autistics. What they did not show was that this was a cause of autism or that this was injurious to the autistics. As Dr. Pardo told the Tribune:

“We were concerned that the study would raise a lot of controversy and be misused,” Pardo said. “We were right.”

In one example from the article, Dr. Rossignol, one of the luminaries of the autism alternative medicine movement wrote a letter to support the use of intravenous immunoglobulin (IVIG) to treat an autistic child. He cites the Pardo study.

From the Tribune story:

Rossignol did not mention that Pardo’s team had written in its online primer, using capital letters for emphasis, that intravenous immunoglobulin “WOULD NOT HAVE a significant effect” on what they saw in the brains of people with autism.

“THERE IS NO indication for using anti-inflammatory medications in patients with autism,” the team wrote.

Another of the Hopkins team, Dr. Zimmerman is quoted:

Meddling with neuroinflammation could actually be a terrible mistake, said co-author Dr. Andrew Zimmerman, director of medical research at the Center for Autism and Related Disorders at the Kennedy Krieger Institute in Baltimore.

“It may actually be an attempt of the brain to repair itself,” said Zimmerman, a pediatric neurologist. Suppressing the immune response “could be doing harm.”

Another alternative-medical practitioner, and colleague of Dr. Rossignol, Dr. Bradstreet is not deterred by the experts in the field who warn him off of applying this experimental and possibly (likely?) useless treatment.

“Every kid with autism should have a trial of IVIG if money was not an option and IVIG was abundant,” Bradstreet said. “It makes sense to try and would be ideal to give every young child a chance at it.”

The Pardo paper has also been used to promote hyperbaric oxygen therapy (HBOT). Another big name in the alt-med world, Dr. Neubrander uses the Pardo study in his presentations and claims that HBOT will reduce inflamation.

Dr. Neubrander appears to acknowlege the slim backing he has on science. In the Tribune article:

“Science is slow,” he said. “I will use the safety of the science and, no, I will not throw the science out the window. But the science has to be balanced against the wisdom. And science says, ‘There is no wisdom from you, the mothers or fathers of the world, who depend on anecdote. Only science has wisdom.’ “

I am at a loss as to how to respond to that statement other than to point out that Dr. Neubrander (and Dr. Bradstreet and Dr. Rossignol) will never, ever be allowed to treat my child.

Again from the Tribune:

Few treatments are completely benign, said Dr. Steven Goodman of the Johns Hopkins Berman Institute of Bioethics. “Even an ineffective therapy is rarely harmless,” he said, “and sometimes that harm is worse than the disease.”

As an example, the Tribune article discusses how pure oxygen, assumed to be only beneficial, was given to premature babies. That is, until it was shown that it was causing blindness in a significant number of children.

The Tribune article concludes by acknowledging the fact that there is not a complete description of what is autism, or how or if it can be treated.

Research into autism has yet to find solid answers, but there is reason for hope, said Zimmerman, a co-author on Pardo’s paper.

“In the last five years, there has been a tremendous upsurge of activity,” he said. “It gives us a lot of new prospects. I think we will solve this problem in the next 10 to 15 years.”

And though autism advocates in the movement say they cannot wait that long for answers, a lack of options isn’t a valid reason to try something, bioethicists say.

“You have a duty to make sure there is good reason to believe it might work and not hurt your child,” said Douglas Diekema, a bioethicist at Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute.

It is difficult to be patient while science does its work, Zimmerman said. But, he added: “Above all, do no harm.”

This is one in a series of articles on alternative medicine and autism from the Tribune. I hope to backtrack and discuss the previous articles soon. But, the responses are already coming in. Many frame the Tribune as anti-parent, anti-progress, biased…all sorts of things that the article is clearly not. The Tribune obviously took a lot of time to prepare these articles. They cite the experts in the field.

Let’s face it, the supposed experts in the alternative medical “treatment” of autism are clearly misunderstanding or misrepresenting the research they rely upon. The Tribune did the work, talked to the experts and clearly showed this.

Hyperbaric Oxygen Therapy Ineffective Treatment for Children with Autism

13 Nov

Hyperbaric Oxygen Therapy (HBOT) has grown in popularity over the last few years. This growth has occurred without any evidence that HBOT is at all beneficial.

A recent study, published in the journal Research in Autism Spectrum Disorders entitled Randomized trial of hyperbaric oxygen therapy for children with autism, explores this question.

The study was performed by CARD, the Center for Autism and Related Disorders and ICDRC the International Child Development Resource Center. CARD is a very large ABA provider run by Doreen Granpeesheh. Dr. Granpeesheh is also associated with Thoughful House, the Clinic founded by Dr. Andrew Wakefield. Dr. Wakefield, is the prime proponent of the notion that the MMR vaccine causes autism. ICDRC is the clinic run by Dr. Jeffrey Bradstreet, a prominent name in the autism alternative medical community.

As you might surmise from their press release, Center for Autism and Related Disorders Study Finds Hyperbaric Oxygen Therapy Ineffective Treatment for Children with Autism, they did not find HBOT to be effective.

Children were given 80 1 hour sessions in a Vitaeris 320 inflatable chamber (a model used commonly in HBOT treatment). 6-10 sessions/week were performed. Children were split into two groups matched by age and number of ABA hours already received. Parameters like supplement use and diets remained unchanged during the time of the study. For the treatment group the chambers were inflated to 1.3 atm, with enriched oxygen air (24-28% O2, compared to 21% for regular air).

The children were given multiple assessments:

All assessments were conducted by trained assessors who were blind to group assignment. To maximize the study’s ability to detect change in any symptom area relevant to autism, a large variety of assessments were used, including the following: the ABC (Aman & Singh, 1994), ADOS (Lord et al., 1999), Behavior Rating Inventory of Executive Functioning (BRIEF; Gioia, Isquith, Guy, & Kenworthy, 2000), Clinical Global Impression Scale (CGI; Guy, 1976), Parent Stress Index (PSI; Abidin, 1995), Peabody Picture Vocabulary Test (PPVT-III; Dunn & Dunn, 1997), Repetitive Behavior Scale (RBS; Bodfish, Symons, & Lewis, 1999), SRS, Vineland Adaptive Behavior Scales—Second Edition (VABS-II; Sparrow, Cicchetti, & Balla, 2005), and the Beery-Buktenica Developmental Test of Visual-Motor Integration—5th edition (VMI-5; Berry and Berry, 2004 K.E. Berry and N.A. Berry, The Berry-Buktenica developmental test of visual-motor integration: Administration, score, and teaching manual, NCS Pearson, Minneapolis, MN (2004).Berry & Berry, 2004). The ADOS, BRIEF, PPVT-III, SRS, VABS, and VMI-5 were administered pre and post-treatment. The ABC, CGI, and RBS were administered weekly. The PSI was administered four times, once at baseline, twice during treatment, and once at completion.

The study was relatively small, with 46 participants.

Forty six participants began the study and 12 withdrew, resulting in 18 previous HBOT participants and 16 placebo participants completing all 80 sessions and follow-up measures. The primary reason reported for withdrawal was the travel required to the clinic. One participant in the placebo group withdrew after having a seizure for the first time. Mean participant age was 6.18 (previous HBOT 6.11; placebo 6.25) and mean number of ABA treatment hours per month was 109 (previous HBOT 114.7; placebo 103.3).

I won’t go into details about the specific outcomes, but the conclusion was pretty straightforward: HBOT had no effect.

No significant differences between the previous tHBOT and placebo groups were found on any of the outcome measures. Thus, the results of this study indicate that previous HBOT delivering 24% oxygen at 1.3 atm did not produce a therapeutic effect for the children who participated in our study. Therefore, previous HBOT at this dose is not recommended for the treatment of ASD symptoms.

I found it interesting how they referred to a previous HBOT study by Rossignal (another prominent member of the autism alternative medical community):

The results of this study corroborate the findings of the only other published study on previous termHBOTnext term which included a control group (Rossignol et al., 2009 D.A. Rossignol, L.W. Rossignol, S. Smith, C. Schneider, S. Logerquist and A. Usman et al., Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial, BMC Pediatrics 9 (2009) 10.1186/1471-2431-9-21.Rossignol et al., 2009)—albeit, not the study authors’ interpretations of their findings. In both the Rossignol et al. (2009) study and the current study, both treatment and control groups improved over time, but the difference in improvement between groups appeared insignificant. In addition, the current study employed dependent measures which were far more comprehensive than in previous research on previous HBOT for ASDs, thereby increasing the probability that a therapeutic effect would have been detected if indeed one had been present.

Yes, the current study is consistent with the Rossignol group’s results, just not their interpretation.

Commentary:

There was much discussion and excitement earlier this year when the Rossignol group study came out. Do’C at the Autism Street blog compiled a list of many of the skeptical discussions. There has not been anywhere near the interest in the newer CARD study.

Will this mean the end of HBOT treatments for Autism? I sincerely doubt it. Take a look at Dr. Bradstreet’s website (Dr. Bradstreet being one of the coauthors of the current study showing no effect). The first page of the site still links to the older study by Dr. Rossignol’s group (claiming that HBOT is effective) and not his own study (which shows HBOT to be not effective).

Of course, it is all the more complicated since Dr. Rossignol is also one of the ICDRC doctors. The alternative-medical community is a pretty small pond, isn’t it?

Back to the question: will this mean the end of HBOT in autism? I wish I could make bets this safe. Of course not. No alternative therapy is abandoned. As shown above, one of the authors of this study showing that HBOT is not effective for treating autism and he hasn’t stopped.

2-Fatality HBOT Fire

14 Jun

Admittedly, the future for Francesco Martinizi (the boy who was very badly burned in a fire/explosion in a Florida HBOT clinic while apparently being “treated” for Cerebral Palsy), looked quite uncertain.

As I wrote previously:

Yes, this accident (fire/explosion) is tragic, very tragic. If Francesco indeed survives the injuries he’s apparently sustained, the next couple of months are likely to be very very rough. The situation certainly isn’t helped by the fact that there probably isn’t much in the way of good scientific evidence to support the notion that little 4 year-old Francesco should have ever been in such a facility in the first place.

His future is certain now. Francesco died Thursday.

Media reports:

Child Hurt In Chamber Explosion Dies In Hospital

Boy critically burned in Broward oxygen chamber explosion dies

Boy dies from injuries in hyperbaric chamber blast in Lauderdale-by-the-Sea

Boy injured in hyperbaric chamber blast dies

Previous entries at LBRB:

Fire, Fatal Injury, and Claims of Certification in an Independent HBOT Clinic

HBOT quackery maims 4 year old

Woman and child hurt in HBOT explosion

In Pace Requiescat, Francesco.

Question for commenters: What do you think about the mainstream media’s coverage of this fatality?

Jenny Mcarthy on HBOT

6 May

Given the recent death of a woman and serious injury of a child in a hyperbaric chamber. It is perhaps worth highlighting Jenny McCarthy’s recent “tweet”.

Im inside a hyperbaric chamber. This thing makes me feel amazing.

If a vaccine “exploded” killing one person and critically injuring another with such clear causality, one can imagine McCarthy would be the first to stand up and denounce it. Instead, as one commentator says it’s “All risk, no benefit” when it comes to the quackery surrounding autism, and that’s before you risk dreadful gluten-free and casein-free cup cakes. Meanwhile, despite having no evidence, McCarthy suggests vaccines are dangerous toxic products and may be responsible for the start of an explosion of preventable childhood diseases.

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