Use of simple advice and behavioural support
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7436.397 (Published 12 February 2004) Cite this as: BMJ 2004;328:397All rapid responses
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Tim Coleman (BMJ, Feb 14, p398) wrote: “The challenge for those who
advocate complementary therapies in smoking cessation is to provide
evidence for their effectiveness.” One might add that advocates of these
therapies have a responsibility to avoid making misleading claims about
current evidence. A related matter is the potentially misleading promotion
of some smoking cessation devices, which are not regulated as medicines or
medical devices. An instructive case is NicoBloc, a smoking cessation
device currently marketed in the UK, Australia, Ireland and the US. The
product has been available for some years under various brand names but no
clinical trials have been published.
NicoBloc is a corn syrup solution, applied to the filters of
cigarettes. Smokers are instructed to progress from applying one drop to
three drops of the solution over a six-week period, then make a quit
attempt. NicoBloc has prima facie plausibility as way of making cigarettes
less rewarding to smoke. However, the manufacturer makes a very different
claim:
"NicoBloc will be absorbing up to 99% of the tar and nicotine that
would otherwise be entering your lungs each time you inhale without
significantly altering the taste or satisfaction of the cigarette."[1]
What evidence is provided for these paired claims? The NicoBloc
website reports smoking machine tests by Stillwell and Gladding
laboratories, showing approximately 98% reductions in tar and nicotine
yields when Winston and Marlboro were treated with three drops of
NicoBloc.[2] (These were standard yields – what a smoking machine
collects when it takes a 35ml puff over 2 seconds, once per minute).
However, elsewhere in the “Professionals” page, we find that a published
study reported 20% reductions in tar yield and 30% reductions in nicotine
yield when Marlboro full-flavor (16mg tar yield) was treated with three
drops of the solution.[3] Because the Stillwell and Gladding tests were
also conducted on 16mg Marlboro, these are strongly conflicting
results.[4] The manufacturer accepts the favourable results and dismisses
the others as unreliable. More importantly, standard machine smoking
yields are treated as a valid indicator of smokers’ actual intakes,
despite a strong expert consensus that yield figures are practically
useless for this purpose. [5] That is, the "up to 99%" figure is derived
from the wrong test.
Interestingly, the published study included actual intake
measures.[3] It found a 60% reduction in mean nicotine boost when 19
subjects smoked cigarettes treated with three drops on a once-off basis.
The manufacturers could then have claimed that three drops of NicoBloc had
been demonstrated to produce intake reductions of “up to 60%” and at least
been referring to the right kind of test.
Intake reductions approaching 99% would probably not be appealing to
many smokers if accompanied by satisfaction reductions approaching 99%,
hence the motivation to claim that satisfaction is maintained. The
“without significantly altering taste or satisfaction” claim is apparently
based on the fact that the reductions in taste and satisfaction reported
by the 19 subjects in the published study were not statistically
significant.[3] Also, a progress report on a six-week “preliminary open
trial” of NicoBloc/ Accu Drop combined with motivational counselling, also
employing 19 subjects, states:
“With the exception of the three early drop outs, all participants
reported satisfaction and adherence to using the drops as prescribed…”
and
“The participants uniformly reported that while the drops affected the
strength of their cigarette[s] they did not affect the taste of their
cigarettes.”[6]
Being satisfied with the process of using NicoBloc is not the same
as finding treated cigarettes satisfying to smoke so the first sentence
does not support the manufacturer’s claim. The second sentence comes
closer, although it would be interesting to know whether subjects reported
this spontaneously or were cued. However, if subjects could still taste
anything at all when applying three drops, is it credible that their tar
intakes were reduced by anywhere near 99%?
The manufacturers of NicoBloc have been repeatedly informed that
their promotions are potentially misleading but appear impervious to the
arguments. Unless Nicobloc is an isolated case, there is a need for new
regulatory measures to help ensure that consumer choices between available
therapies and products are not adversely affected by misinformation.
REFERENCES.
1. www.nicobloc.com/using.htm Using NicoBloc. Accessed Feb 13, 2004.
2. http://www.nicobloc.com/Professionals/professional_home.asp Summary of
NicoBloc research. Accessed Feb 13, 2004.
3. Pickworth, W.B., Fant, R.V., Nelson, R.A. and Henningfield, J.E.
Effects of smoking through a partially occluded filter. Pharmacology,
Biochemistry and Behaviour vol 60, no 4, pp817-21, 1998.
4. Stillwell and Gladding Testing Laboratories Report of Analysis document
provided to The Cancer Council Australia by Rosen Holdings, Nov 10, 2003.
5. National Cancer Institute. Risks Associated with Smoking Cigarettes
with Low Machine-Measured yields of Tar and Nicotine. Smoking and Tobacco
Control Monograph No.13. Bethesda, MD: US Department of Health and Human
Services, 2001.
6. Gariti, P. “RE: Progress Report – Accu Drop.” Jan 14, 1998. Document
provided to The Cancer Council Australia by Rosen Holdings, Nov 10, 2003.
Competing interests:
None declared
Competing interests: No competing interests
Smoking cessation devices: NicoBloc replies
As the person who compiled the Summary of NicoBloc research [1] (Bill King’s ref. No. 2), I feel that there are some aspects of Bill King’s criticisms which warrant clarification.
References
[1] http://www.nicobloc.com/Professionals/professional_home.asp - Summary of NicoBloc research. Accessed 5 Mar 2004.
[2] Pickworth, W.B., Fant, R.V., Nelson, R.A. and Henningfield, J.E. Effects of smoking through a partially occluded filter. Pharmacology, Biochemistry and Behaviour vol 60, no 4, pp817-21, 1998.
[3] http://www.nicobloc.com/Professionals/professional_home.asp - Capital Doctor, 'NicoBloc, a new drug-free stop-smoking aid'. Accessed 5 Mar 2004.
[4] Silagy, C., Lancaster, T., Stead, L., Mant, D and Fowler, G. Nicotine replacement therapy for smoking cessation (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons, Ltd. (amended 20 Aug 2002)
Competing interests:
Dr Alex Milne, is an independent consultant who was engaged by NicoBloc to summarise published scientific data and is replying on behalf of NicoBloc
Competing interests: No competing interests