Use of simple advice and behavioural supportBMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7436.397 (Published 12 February 2004) Cite this as: BMJ 2004;328:397
All rapid responses
As the person who compiled the Summary of NicoBloc research  (Bill King’s ref. No. 2), I feel that there are some aspects of Bill King’s criticisms which warrant clarification.
- Machine smoking tests: ‘The manufacturer accepts the favourable results and dismisses the others as unreliable’. There are three independent sets of results in existence . Two of these are in close agreement, with tar and nicotine reductions in the 88–99% range. The third shows (tar) 20% and (nicotine) 30% reductions, the latter being insufficient to account for the physiological reductions in nicotine (60%) reported in the same paper , particularly as the main complaint is that in extrapolating from standard smoking machine tests to human smokers, humans tend to get more out of their cigarettes than the machines do. These latter results must, therefore, be treated with caution, and the balance of evidence is in favour of the two sets of results which broadly agree.
- ‘the "up to 99%" figure is derived from the wrong test’ (i) Tar: as there is no ready physiological measurement for tar derived from cigarettes by human smokers, smoking machines supply the only data available. (ii) Nicotine: the only physiological data currently published (see below) are the ~60% reductions reported in ; these are very encouraging in their own right in terms of the reduction in nicotine blood plasma boosts. However, the machine tests, which conform to ISO standards and are used by Government-appointed laboratories, determine the differences between brands of cigarettes in terms of nicotine and tar yield. Therefore the tests are valid for what they objectively measure which is the differences between NicoBloc-treated and -untreated cigarettes in tar and nicotine yield.
- ‘it would be interesting to know whether subjects reported this spontaneously or were cued’ This point would have to be raised with the author of the study. However, these subjects’ reports are in line with anecdotal reports from quitters using the Rosen Programme (a forerunner to NicoBloc).
- ‘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 only argument here is anecdotal, but a would-be quitter will be predisposed to find any quitting aid acceptable. Using NicoBloc, they begin with a single drop, which is far less drastic than three. It has been likened to reducing sugar in tea, or salt on food; the initial apparent change in taste is transient and quickly becomes acceptable. The relevant point is not whether there is any perceptible change in taste, but whether such change as is perceived can be tolerated and adjusted to. The anecdotal answer, from large numbers of Rosen Programme quitters, is ‘yes’. In this context, it is important to realise that the effectiveness of NicoBloc as a quitting aid rests on more than just the reduction in tar and nicotine inhaled. The behavioural modification, goal-setting and other aspects are important, too .
- ‘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.” . . . The product has been available for some years under various brand names but no clinical trials have been published’ Ideally, research needs to be funded and carried out by people who do not stand to gain or lose by the result; furthermore, small companies cannot tie up the hundreds of thousands of pounds needed to fund even a single trial when the report will not be published for at least a couple of years. NicoBloc and any similar product faces an additional problem: what if it is exactly as effective as as Nicotine Replacement Therapy (NRT)? The Cochrane Review of NRT  found that over half the 110 trials reviewed failed to show a significant (95% confidence) benefit of NRT over no treatment. A company with a single product as effective as NRT thus runs a 50-50 chance that the first study published shows it to be ineffective, and could be commercially damaged as a result, and yet NRT, with the backing of the pharmaceutics industry, has survived and is now the pre-eminent quitting aid. NicoBloc has considerable documented evidence from the Rosen Programme of its effectiveness as a quitting aid, sufficient to encourage those who developed it to bring it to market as an over-the-counter product, but is dependent on the scientific community for research. On a positive note, there is one study using NicoBloc under way and another applying for funding; beyond offering encouragement, information and supplies of NicoBloc, the company has no involvement.
- ‘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’ The quality of consumer information is what matters here, however it is achieved. The previous point revealed an inherent problem for would-be quitters: a small company with a good product has a slimmer chance of commercial success than a huge company with one; the huge companies are the pharmaceuticals, so the commercially successful products are likely to be pharmaceutical, however good the other products are. Currently, those smokers for whom NRT is contraindicated (e.g. pregnant, diabetic, age-related macular degeneration) have little choice and less independent information. What all quitters need is greater and more informed choice about quitting aids; NicoBloc’s own data from nearly 2000 respondents using NicoBloc indicate that more than two-thirds of them have failed to quit with NRT and are looking for something different to try. Surely it would be rational to spend public money on independent research into non-pharmaceutical quitting methods. A miniscule share of tobacco tax would fund a very useful range and number of studies.
 http://www.nicobloc.com/Professionals/professional_home.asp - Summary of NicoBloc research. Accessed 5 Mar 2004.
 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.
 http://www.nicobloc.com/Professionals/professional_home.asp - Capital Doctor, 'NicoBloc, a new drug-free stop-smoking aid'. Accessed 5 Mar 2004.
 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)
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
Smoking cessation devices: does lack of regulation encourage misleading claims about evidence of effectiveness?
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
"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."
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. (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. Because the Stillwell and Gladding tests were
also conducted on 16mg Marlboro, these are strongly conflicting
results. 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.  That is, the "up to 99%" figure is derived
from the wrong test.
Interestingly, the published study included actual intake
measures. 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. 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…”
“The participants uniformly reported that while the drops affected the
strength of their cigarette[s] they did not affect the taste of their
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.
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
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: No competing interests