(Reuters Health) – Current and previous registered clinical trials on e-cigarettes are often too small, too short, and lack the behavioral support that might help people quit smoking, a new study suggests.
An analysis of 66 completed and ongoing registered trials examining the effects of e-cigarettes on smoking cessation or reduction also revealed that few included outcomes at 6 months or longer, or reported on e-cigarette flavorings, and none assessed newer pod devices “that are designed to deliver nicotine more similarly to cigarettes,” according to the report in JAMA Psychiatry.
“This is a really important area of research,” said study coauthor Krysten Bold, an assistant professor in the department of psychiatry at the Yale School of Medicine in New Haven, Connecticut. “And a lot more information is needed to understand whether and how these products might help people who want to stop smoking.”
“What we saw in our review is that many of the studies are short term and don’t have a follow-up of six months or longer,” Bold said. “Another thing that is missing is that none of them looked at the newer device types. E-cigarettes have changed rapidly over the past several years.”
There has been some evidence, from a large meta-analysis that is constantly being updated, that e-cigarettes have helped some people quit smoking, Bold said. The meta-analysis suggests “that e-cigarettes do work for some people who want to quit and perhaps work better than some other methods, but there is still a lot we do not know in terms of what devices, nicotine concentrations, or flavors may be important to help someone quit smoking.”
Moreover, “we don’t know enough about who may benefit or even how best to use them,” Bold said. “We don’t know the nicotine concentrations, how long people should plan to use them and how they should taper off.”
To take a closer look at the quality of evidence being gathered, Bold and her colleagues searched all registries under the World Health Organization Registry Network, from inception through January 11, 2021 to identify trials studying the effects of e-cigarettes on smoking cessation or reduction with primary or secondary outcomes of smoking cessation, reduction, or related biomarkers.
The researchers identified 29 completed and 37 ongoing trials on four registries. Thirty-five of the 66 trials (53%) were recruiting individuals motivated to quit smoking, and only 23 (35%) included behavioral support for cessation.
Smoking abstinence was a primary or secondary outcome in 49 trials (74%), while 17 (26%) assessed smoking reduction only. Completed and ongoing trials had similar sample sizes (median 140), durations (median 12 weeks), and comparators – for example, 35% compared e-cigarettes with nicotine replacement therapy. But ongoing trials were less likely (38%) to assess outcomes at 6 months or longer than completed trials (72%).
None of the completed trials reported studying newer pod devices and only a small proportion of ongoing trials did (16%). Nicotine concentration was reported in about half (55%) of completed and ongoing trials, but e-cigarette flavors were reported rarely (8%).
Dr. Panagis Galliatsatos doesn’t believe there is “robust research” showing that these products have value as smoking cessation tools.
“There could be a benefit, but I don’t know,” said Dr. Galliatsatos, an assistant professor in the division of pulmonary and critical care medicine and director of the Tobacco Treatment Clinic at Johns Hopkins Medicine in Baltimore. “And you won’t be able to unless they are willing to go all in and be regulated,” he added.
“They are putting the cart before the horse,” Dr. Galliatsatos said. “They’re making a product meant to be enjoyable like combustible cigarettes but then they want to raise medical findings that haven’t been proven. If you want to tout medical benefits, you need to go through FDA approval. We have FDA approved products that get the job done.”
SOURCE: https://bit.ly/3mSh6C1 JAMA Psychiatry, online September 1, 2021.
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