Use of simple advice and behavioural support

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.

• Machine smoking tests: ‘The manufacturer accepts the favourable results and dismisses the others as unreliable’. There are three independent sets of results in existence [1]. 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 [2], 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 [2]; 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 [3].

• ‘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 [4] 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.

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