Trial Report Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma, 2011, Wechsler et al

Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma

Michael E. Wechsler, John M. Kelley, Ingrid O.E. Boyd, Stefanie Dutile, Gautham Marigowda, Irving Kirsch, Elliot Israel, Ted J. Kaptchuk

Published July 14, 2011

[Line breaks added]

Background
In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma.

Methods
In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention.

Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient).

At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV1) was measured, and patients' self-reported improvement ratings were recorded.

Results
Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV1, as compared with approximately 7% with each of the other three interventions (P<0.001).

However, patients' reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001).

Conclusions
Although albuterol, but not the two placebo interventions, improved FEV1 in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes.

Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine; ClinicalTrials.gov number, NCT01143688.)

Link | PDF (The New England Journal of Medicine) [Open Access]

 

Requested to be posted here.

 

Very useful summary/commentary here:
https://s4me.info/threads/brain-ret...d-discussion-thread.40713/page-19#post-601799

 

@Evergreen would you be able to post your excellent explanation here as well? Including the images?

 

Sure, and thank you, @forestglip for creating the thread. I changed the first sentence minimally so that it would make sense in this thread.

@Joan Crawford directed me to the Wechsler et al. 2011 asthma paper being discussed on this thread. It illustrates the problem with subjective outcomes better than anything else I've seen, and demonstrates that unblinded studies with subjective outcomes are worthless for telling us whether the interventions being trialled are effective or not.

Here's figure 4 from the paper, where the placebo inhaler and sham acupuncture perform nearly as well as the effective albuterol inhaler on subjective outcomes:



And here's figure 3 of the paper, where the objective outcome clarifies that albuterol is effective, while the placebo inhaler and sham acupuncture are revealed to be as useless as no intervention:


In the BPS part of the ME/CFS research world, we are swimming in figure 4s.

 

It's so weird how decades of painful lessons from drug trials have simply not been taken into account, no actual lessons learned here. It's looking to me like the only reason why drug companies have adopted rigorous methodologies is simply because it's more profitable, because putting out drugs that don't work is an easy way to go bankrupt. And it's them adopting it, for financial reasons, that has forced academia to follow along.

To the point where it's actually plausible that if it wasn't for market forces, drug trials would still be run using the same poor methodologies that have ruined everything for us. If it was left as an academic field dominated by professors, none of this would have happened. They would have been happy with the fake results they had, content to trade smug rhetoric. I can't see any reason why it wouldn't be this way.

 

This figure is from Bart Stouten's 2017 contribution to the Journal of Health Psychology's special issue on the PACE trial which you can read here: https://journals.sagepub.com/doi/10.1177/1359105317707531

It's so relevant to the Wechsler discussion that I think it deserves a mention here.