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When n=1, it’s easy to jump to conclusions about a therapy working

Rating

4 Star

Hyperbaric oxygen: The mysterious therapy that saved a cancer survivor from radiation side effects

Our Review Summary

This well-written article discusses a patient suffering from delayed effects of radiation who received hyperbaric therapy treatment. The patient noticed improvements in pain levels and mobility, but doctors in the story warn that this treatment is unproven to help patients with delayed radiation injury and that this type of therapy tends to be overused.

Though it is gratifying to hear the patient’s words and the hope that this treatment has provided him, it actually isn’t clear whether the hyperbaric oxygen itself was the reason he got better. The “placebo” effect is well described in the medical literature and refers to sham treatments (fake surgery or pills) leading to benefit. It may also be that the treatment really did help but not for the reasons cited–maybe simply sitting still for hours helped tissues to heal. We do wish the story had explored this aspect more.

 

Why This Matters

Overuse of unproven medical technologies poses risks to patients and adds to rising healthcare costs. An N of 1 does not prove that a technology works since there are so many other factors that could contribute to a patient seeing improvement over time.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The article discussed that Medicare covers the treatment at $450 for a two-hour session. There wasn’t a discussion about whether other insurance programs covered the treatment. It would have been helpful to know how much the entire treatment plan for the profiled patient cost and whether it was covered by his insurance.

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

Not Satisfactory

The article was about one patient’s subjective account of pain relief. The only mention of evidence is by one of the doctors quoted, saying he did a literature search and found the evidence supporting this treatment to be “grim.” A quantitative assessment of that evidence would have been useful to include.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

Although the article mentioned overuse of the treatment, there wasn’t an explicit mention of the type of harms associated with using hyperbaric therapy.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The article cautioned about the lack of evidence and rigorous medical studies supporting the use of hyperbaric chamber therapy outside of common uses (e.g., decompression sickness, burn healing). The article also mentioned how the results seen with the patient profiled are not commonly seen in patients with chronic late radiation effects.

Does the story commit disease-mongering?

Satisfactory

The article did not commit disease mongering. It highlights the story of a desperate patient in a balanced way.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Besides the one reference to Kaiser Health News, all the sources had connections to the patient.

Does the story compare the new approach with existing alternatives?

Satisfactory

The article mentioned physical therapy and pain medication as standard treatment for delayed radiation effects on muscles and joints. It did a good job describing how challenging it can be to manage.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The article mentioned hyperbaric chambers are located in about 1,400 hospitals across the US. Given that Medicare also reimburses for hyperbaric therapy, access is probably relatively easy.

Does the story establish the true novelty of the approach?

Satisfactory

The article described that this is not a novel procedure and that hyperbaric therapy has been around since the 1900s.

Does the story appear to rely solely or largely on a news release?

Satisfactory

It does not appear this story relied on a news release.

Total Score: 7 of 10 Satisfactory

Comments (3)

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Vincenzo Zanon

August 11, 2018 at 2:44 pm

That is surely a well-written article, where Authors are presenting just the case treated at their Unit.

If they’re jumping to conclusions, if any, it is probably on the basis of other literature they have previously extensively read on the topic, a literature stronger in numbers (with ‘n’ value surely greater than 1) and stronger evidence as well … i.e., and among various available great paper on this issue: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3185897/ (2011), or https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00534-3/fulltext (Evidence is needed!, 2015), or https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD005005.pub4/full (2016).

These other conclusions I’m proposing to consider, even if suggesting further studies and economic evaluation of each case, are nevertheless confirming a justified application of Hyperbaric Oxygen Therapy (HBOT) in selected patients and tissues.

Vincenzo Zanon, FUHM

Reply

Richard Gustavson

August 11, 2018 at 11:08 pm

There is plenty of evidence of the benefit of Hyperbaric oxygen therapy and radiation tissue damage. The primary benefit is the angiogenesis a effect of Hyperbaric Oxygen Therapy therapy. I highly recommend the Hyperbaric Oxygen Therapy Indications 13th edition chapter 8 For a discussion and peer reviewed evidence-based support

Reply

    Kevin Lomangino

    August 12, 2018 at 12:02 pm

    Richard,

    Thanks for weighing in. However, you and other commenters seem to miss the thrust of our critique, which is directed at the news story for failing to back up its claims. If there is “plenty of evidence” that hyperbaric oxygen therapy helps radiation tissue damage as you state, that certainly wasn’t established in the article, which describes the evidence supporting the therapy for this use as “grim.” And if the evidence is as limited as the article suggests, then it’s misleading to suggest that therapy “saved” the patient from radiation-related pain.

    Best regards,

    Kevin Lomangino

    Reply