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Background: US mentholated cigarette sales have increased considerably over 50 years. Preference for mentholated cigarettes is markedly higher in Black people. While menthol itself is not genotoxic or carcinogenic, its acute respiratory effects might affect inhalation of cigarette smoke. This possibility seems consistent with the higher lung cancer risk in Black men, despite Black people smoking less and starting smoking later than White people. Despite experimental data suggesting similar carcinogenicity of mentholated and non-mentholated cigarettes, the lack of convincing evidence that mentholation increases puffing, inhalation or smoke uptake, and the similarity of lung cancer rates in Black and White females, a review of cigarette mentholation and lung cancer is timely given current regulatory interest in the topic.Methods: Epidemiological studies comparing lung cancer risk in mentholated and non-mentholated cigarette smokers were identified from MedLine and other sources. Study details were extracted and strengths and weaknesses assessed. Relative risk estimates were extracted, or derived, for ever mentholated use and for long-term use, overall and by gender, race, and current/ever smoking, and meta-analyses conducted.Results: Eight generally good quality studies were identified, with valid cases and controls, and appropriate adjustment for age, gender, race and smoking. The studies afforded good power to detect possible effects. However, only one study presented results by histological type, none adjusted for occupation or diet, and some provided no results by length of mentholated cigarette use.The data do not suggest any effect of mentholation on lung cancer risk. Adjusted relative risk estimates for ever use vary from 0.81 to 1.12, giving a combined estimate of 0.93 (95% confidence interval 0.84-1.02, n = 8), with no increase in males (1.01, 0.84-1.22, n = 5), females (0.80, 0.67-0.95, n = 5), White people (0.87, 0.75-1.03, n = 4) or Black people (0.90, 0.73-1.10, n = 4). Estimates for current and ever smokers are similar. The combined estimate for long-term use (0.95, 0.80-1.13, n = 4) again suggests no effect of mentholation.Conclusion: Higher lung cancer rates in Black males cannot be due to their greater preference for mentholated cigarettes. While some study weaknesses exist, the epidemiological evidence is consistent with mentholation having no effect on the lung carcinogenicity of cigarettes. © 2011 Lee; licensee BioMed Central Ltd.

Lee P.N.,P.N. Lee Statistics and Computing Ltd.
Regulatory Toxicology and Pharmacology | Year: 2014

Reviews show that using snus (Swedish-type moist snuff) is much safer than smoking, with no increased risk from snus of cancer or circulatory disease yet demonstrated, but have not investigated possible health effects from dual use of cigarettes and snus. This review considers studies where health risks can be compared in dual users, those who only use snus or only smoke, and those who use neither product. The interaction RR, the ratio of RRs associated with snus use in smokers and in non-smokers, was used to test for special effects of dual use. Of 51 interaction RRs presented, only one (for gestational hypertension in a study based on the Swedish Medical Register) was significantly (p<. 0.05) above 1.0, and RRs below 1.0 were commoner, perhaps as cigarette consumption is lower in dual users than those who only smoke. Dual users more often initiate tobacco use with cigarettes than snus. Dual use is much commoner in adolescents than adults, possibly because many tobacco users try both products, eventually settling on one. Epidemiological evidence from various sources, though suffering from weaknesses, consistently suggests concomitant snus use increases smoking quit rates, and aligns with evidence from RCTs using snus to aid smoking cessation. © 2013 The Author.

Scherer G.,ABF Analytisch Biologisches Forschungslabor GmbH | Lee P.N.,P.N. Lee Statistics and Computing Ltd.
Regulatory Toxicology and Pharmacology | Year: 2014

The extent of compensation when switching to lower yield cigarettes is important for assessing risk of reduced yield products. Both completeness of and reasons for compensation are judged differently in the scientific and health community. We quantified compensation in a meta-analysis of suitable cross-sectional and brand-switching studies. For each dataset, we derived a compensation index (CI), 1 indicating complete and 0 no compensation. Meta-analyses provided overall estimates. We also reviewed evidence on compensation for nicotine and other factors. The unweighted mean CI (95% confidence interval) was 0.628 (0.513 to 0.742) from 38 estimates from 26 cross-sectional studies, and 0.723 (0.651 to 0.796) from 23 estimates from 19 brand-switching studies. Inverse-variance weighted estimates were 0.781 (0.720 to 0.842) and 0.744 (0.682 to 0.806). Brand-switching data indicate smokers compensate more completely over a narrower yield range. Smokers predominantly compensate by changing puffing volume, and little by changing cigarette consumption. The findings support compensation for nicotine, but other factors may also be relevant. Further investigation is needed using larger studies and different approaches to elucidate their role. We conclude that smokers switching to lower-yield cigarettes only partially compensate. Pharmacological nicotine effects are important, but other factors, including cigarette draw resistance, sensory effects of nicotine and conditioned stimuli may also contribute. © 2014 Elsevier Inc.

Burgess I.F.,Insect Research and Development Ltd | Lee P.N.,P.N. Lee Statistics and Computing Ltd. | Kay K.,Insect Research and Development Ltd | Jones R.,Insect Research and Development Ltd | Brunton E.R.,Insect Research and Development Ltd
PLoS ONE | Year: 2012

Background: Interest in developing physically active pediculicides has identified new active substances. The objective was to evaluate a new treatment for clinical efficacy. Methods and Findings: We describe the selection of 1,2-octanediol as a potential pediculicide. Clinical studies were community based. The main outcome measure was no live lice, after two treatments, with follow up visits over 14 days. Study 1 was a proof of concept with 18/20 (90%) participants cured. Study 2 was a multicentre, parallel, randomised, observer-blind study (520 participants) that compared 0.5% malathion liquid with 1,2-octanediol lotion (20% alcohol) applied 2-2.5 hours or 8 hours/overnight. 1,2-octanediol lotion was significantly (p≤0.0005) more effective with success for 124/175 (70.9%) RR = 1.50 (97.5% CI, 1.22 to 1.85) for 2-2.5 hours, and 153/174 (87.9%) RR = 1.86 (97.5% CI, 1.54 to 2.26) for 8 hours/overnight compared with 81/171 (47.4%) for malathion. Study 3, a two centre, parallel, randomised, observer-blind study (121 participants), compared 1,2-octanediol lotion, 2-2.5 hours with 1,2-octanediol alcohol free mousse applied for 2-2.5 hours or 8 hours/overnight. The mousse applied for 8 hours/overnight cured 31/40 (77.5%), compared with 24/40 (60.0%) for lotion (RR = 1.29, 95% CI, 0.95 to 1.75; NNT = 5.7) but mousse applied for 2-2.5 hours 17/41 (41.5%) was less effective than lotion (RR = 0.69, 95% CI, 0.44 to 1.08). Adverse events were more common using 1,2-octanediol lotion at both 2-2.5 hours (12.0%, p = 0.001) and 8 hours/overnight (14.9%, p≤0.0005), compared with 0.5% malathion (2.3%). Similar reactions were more frequent (p≤0.045) using lotion compared with mousse. Conclusions: 1,2-octanediol was found to eliminate head louse infestation. It is believed to disrupt the insect's cuticular lipid, resulting in dehydration. The alcohol free mousse is more acceptable exhibiting significantly fewer adverse reactions. Trial registrations: Controlled-Trials.com ISRCTN66611560, ISRCTN91870666, ISRCTN28722846 © 2012 Burgess et al.

Lee P.N.,P.N. Lee Statistics and Computing Ltd.
Harm Reduction Journal | Year: 2013

An earlier review summarized evidence relating use of snus (Swedish-type moist snuff) to health and to initiation and cessation of smoking. This update considers the effect recent publications on snus use and health have on the overall evidence. The additional evidence extends the list of neoplastic conditions unassociated with snus use (oropharynx, oesophagus, stomach, lung) to include colorectal cancer and acoustic neuroma, and further undermines the weakly-based argument that snus use increases the risk of pancreatic cancer, although there is a report of poorer cancer survival in users. It remains undemonstrated that " snuff-dipper's lesion" increases risk of oral cancer, and recent publications add to the evidence that snus use has no effect on periodontitis or dental caries. Although onset of acute myocardial infarction is not adversely associated with snus use, there is some evidence of an association with reduced survival. Whether this is a direct effect of snus use or a result of confounding by socioeconomic status or other factors requires further investigation, as does a report of an increased risk of heart failure in snus users. Even if some adverse health effects of snus use do exist, it remains clear that they are far less than those of smoking. © 2013 Lee; licensee BioMed Central Ltd.

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