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Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

BMJ 2014; 348 doi: (Published 11 March 2014) Cite this as: BMJ 2014;348:g1622

Rapid Response:

Re: Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

An accompanying editorial provides several clues regarding both interventions to explain why a randomized controlled trial (RCT) found no improvement in smoking cessation rates when pregnant women receiving behavioral support were given 16 hour delivery nicotine patches (mean dose 18 mg) vs placebo.(1,2)
We are concerned the protocol relied on a planned “quit date” despite the fact that catastrophe theory challenges this hypothesis and it is unsupported by any RCT.(3,4)

The NRT dose and duration were too low, as shown by the enduringly high levels of withdrawal symptoms and craving, which were no different between the placebo and NRT groups. Setting a quit date in these circumstances is too fast and high an expectation - a kind of programmed failure. The highly dependent pregnant women were aware they must not smoke but had to wait until (median) 17 weeks’ gestation to receive an intensive treatment. This predictably would cause very low self esteem. Finally, for a captive population, such a high rate (51%) of loss to follow up suggests women were downhearted by the protocol design.

Can Berlin and colleagues provide information about: a) the delay between inclusion and planned quit date and the delay between the maximum NRT dose and quit date; b) the level of craving for tobacco and of the withdrawal symptoms at the time the quit date was chosen, comparing women who achieved complete abstinence vs the others.

We hypothesise that a quit date may only be relevant and achievable once NRT has relieved the symptoms. Thus accepting a reduction could be a more relevant first target until the dose is adequate.

1 Brose LS. Helping pregnant smokers to quit. BMJ 2014;348:g1808.
2 Berlin I, Grangé G, Jacob N, Tanguy ML. Nicotine patches in pregnant smokers: randomised,placebo controlled, multicentre trial of efficacy. BMJ 2014;348:g1622.
3 West R, Sohal T. "Catastrophic" pathways to smoking cessation: findings from national survey. BMJ 2006 ;332:458-60.
4 Cobb CO, Niaura RS, Donaldson EA, Graham AL. Quit now? Quit soon? Quit when you're ready? Insights about target quit dates for smoking cessation from an online quit date tool. J Med Internet Res 2014;16:e55.

Competing interests: No competing interests

15 April 2014
Alain Braillon
public health
Susan Bewley Women's Health Academic Department, Kings College London, London SE1 7NH, UK England
Northern hospital
80000 Amiens. France