Reviewed Work: “A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy”
While both Public Health England and the National Academies of Sciences, Engineering and Medicine acknowledge that completely switching from combustible cigarettes to non-combustible products, such as e-cigarettes, exposes users to substantially less toxicants and dangerous chemicals, there remains lacking support
for their use as a quitting tool. For example, NASEM’s report concludes that: “Overall, there is limited evidence that e-cigarettes may be
effective aids to promote smoking cessation.” On the contrary, however, there is evidence to suggest that e-cigarettes
are growing in popularity as a quit tool.
Accordingly,
in an effort to further probe the role of e-cigarettes in initiating cessation
and/or maintaining abstinence, Peter Hajek and colleagues developed a
randomized trial to
compare smoking cessation and abstinence among populations that use traditional
nicotine replacement therapies (NRT) versus those who use e-cigarettes (EC).
In terms
of participant selection, subjects were accepted into the study if they were
currently not using any products and had no strong preference for use of either
nicotine replacement therapies or electronic cigarettes as a quit method. After
being accepted, participants were randomized to receive either an e-cigarette
or an NRT of their choice (the nicotine patch was used by 84 percent of
participants generally along with a fast-acting oral product) and asked simply to
adhere to their treatment group (EC or NRT). Participants were then asked about
smoking status at 4, 26 and between 26-52 weeks—52-week abstinence was
biochemically verified at the final visit.
With
respect to findings, overall, the e-cigarette group had significantly higher
abstinence rates at all time points than those in the nicotine replacement
therapy group. For example, at the conclusion of the study (52 weeks), the
abstinence rate was 18 percent for those in the EC group and only 9.9 percent
for those in the NRT group. At the 4-, 26- and between 26-52-week points, it was
approximately 44, 35 and 21 percent for the EC group and 30, 25 and 12 percent
for NRT.
Moreover,
even participants in the EC group who were unable to achieve abstinence had
higher rates of reduction in cigarettes smoked (biochemically verified as a 50
percent reduction or more) than those in the NRT group (12.8 vs. 7.4 percent
respectively). At the conclusion of the study, participants in the EC group also
had a much higher rate of treatment adherence than those in the NRT group at 39.5
and 4.3 percent respectively.
While
these numbers overwhelmingly suggest that ECs have the potential to be more
effective quitting tools than NRTs, some limitations in the study’s methodology
suggest that their full potential as a cessation tool may not even yet be
realized. For example, at four weeks, 56 percent of participants in the EC
group were not abstinent and although statistically significant, the urge to
smoke in the first four weeks was only marginally lower for those in the EC
group versus those in the NRT group. However, this may have been an
unintentional result of the study’s design. Those in the EC group, were given
an initial supply that consisted of a 30 ml bottle at 18mg/ml and were then encouraged
to experiment with nicotine concentrations in subsequent refills. While
supplementary data indicated that most participants moved to lower and not
higher concentrations as the study progressed, it stands to reason that if a
higher concentration had been delivered initially, it may have prevented drop
out early on.
Likewise,
participants were initially given tobacco flavor but were also encouraged to
experiment with different flavors as the year progressed. At 52 weeks, most
participants were using fruit flavors, followed by tobacco, menthol/mint and
candy flavors. Lower on the list were vanilla, alcohol and coffee flavors. It
is commonly thought that moving away from tobacco flavors is a way to break the
association of nicotine with combustible cigarettes. Accordingly, in a real-world
setting, encouraging the use of non-tobacco flavors early on in the quitting
process may also discourage early dropout rates, increasing overall
effectiveness as a quit tool, particularly for those who have been otherwise
resistant to quitting.
It is
hardly debatable that e-cigarettes are vastly safer than combustible cigarettes—so
much so that, similar to nicotine replacement therapies, the estimate of harm
is no more than 5 percent the harm associated with combustible products.
Current NRT products are endorsed by public health entities, including the FDA,
as a first-line approach to quit smoking. But given that these data show that
e-cigarettes are nearly twice as effective in maintaining abstinence from
combustible products—and that their full potential has not yet been achieved—it
is necessary not only not to discount e-cigarettes and their usefulness but to continue
research to explore their potential as a more effective quitting tool.
