John R. Hughes talks with
ScienceWatch.com and answers a few questions about
this month's Fast Moving Front in the field of Social
Article: A meta-analysis of the efficacy of
over-the-counter, nicotine replacement
JR;Shiffman, S;Callas, P;Zhang, J
Journal: TOB CONTROL, 12 (1): 21-27 MAR 2003
Addresses: Univ Vermont, Dept Psychiat, 38 Fletcher Pl,
Burlington, VT 05401 USA.
Univ Vermont, Dept Psychiat, Burlington, VT 05401
Pinney Associates, Pittsburgh, PA USA.
Univ Pittsburgh, Pittsburgh, PA USA.
Why do you think your paper is highly
Many clinicians believe counseling essential to overcoming a drug
dependency or for a medication treatment to work; however, studies showed
that requiring counseling to obtain nicotine replacement therapy
(NRT)—i.e., nicotine gum, patch, etc.—was a major barrier for
most smokers. Thus, several studies were undertaken to see if
over-the-counter (OTC) NRT would still be effective. The paper showed that
NRT medications used for self-treatment as OTCs were not only effective,
but equally effective as getting NRT by prescription from a doctor.
Does it describe a new discovery, methodology, or
synthesis of knowledge?
"The research encourages national
and global treatment policies to promote the
use of OTC NRT in non-medical
The paper uses a well-accepted statistical method (meta-analysis) to
collate results across studies of whether OTC NRT is more effective than
OTC placebo and as effective as NRT plus brief counseling. The studies
examined were relatively novel "real-world" simulations; i.e., smokers
obtained NRT from a storefront and were given no advice at all.
Would you summarize the significance of your paper
in layman's terms?
The analysis showed that counseling is not essential for the NRT to work.
OTC NRT was not less effective than NRT plus brief counseling from MDs
(probably because such counseling was very minimal). The implication is
that smokers can look to NRT to help them quit, even if they do not
participate in counseling. However, counseling adds further benefit, so
smokers are advised to avail themselves of counseling as well.
How did you become involved in this research and
were there any particular problems encountered along the way?
The initiative to establish the viability of OTC NRT was driven by being
discouraged at the low rates of use of NRT and looking for ways to make it
easier to obtain NRT. Demonstrating that NRT could work on its own in
real-world settings required studies that had minimal requirements but
could still be valid.
Where do you see your research leading in the
We and others are looking at novel ways to use NRT to help smokers; e.g.,
to reduce the total number cigarettes-per-day among smokers not able to
quit, to reduce first and then quit, to use NRT prior to quitting, to use
NRT to decrease craving and withdrawal when smokers cannot smoke, and
combining different NRT products. Others are examining new nicotine
products; e.g., a nicotine product that delivers a rapid bolus of nicotine
to the lung as do cigarettes.
Do you foresee any social or political
implications for your research?
The research encourages national and global treatment policies to promote
the use of OTC NRT in non-medical settings. Our finding that OTC NRT is
effective has been challenged by correlational survey studies in "real
world" settings which concluded that OTC NRT does not work. These studies
found that smokers who choose to use OTC NRT do worse than those who choose
to quit without NRT.
Our recent work suggests OTC NRT looks worse, not because it is not
effective, but because those who feel the need to use OTC NRT to quit are
more addicted to nicotine, have failed more in the past, etc. Our analysis
in this paper shows that OTC NRT can help people quit smoking, which
suggests that public health authorities should promote quitting with NRT,
even when smokers are not willing to enter counseling.
John Hughes, M.D.
Department of Psychiatry
University of Vermont
University Health Center
Burlington, VT, USA
Keywords: nicotine replacement therapy, a
well-accepted statistical method, meta-analysis, real-world