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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Recently&#44; Cochrane Library has published three new meta-analyses that address the efficacy and safety of antismoking medications and electronic cigarettes &#40;ECs&#41; for smoking cessation&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">1&#8211;3</span></a> In the first of them the authors conclude that cytisine and varenicline both help more people to quit smoking than placebo and comparing cytisine vs&#46; varenicline there may be a benefit from varenicline for quitting&#44;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">1</span></a> in the second&#44; focused only on ECs&#44; they concludes that there is high-certainty evidence that nicotine ECs increase quit rates compared to nicotine replacement therapy &#40;NRT&#41; and moderate-certainty evidence that they increase quit rates compared to non-nicotine ECs&#44;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">2</span></a> and in the third the conclusion is that varenicline&#44; cytisine and nicotine ECs have similar efficacy in helping smokers to quit and evaluate this conclusion as high certainty&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">With respect to the conclusions of the meta-analysis by Hartmann-Boyce et al&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">2</span></a> on the greater effectiveness of nicotine ECs than NRT&#44; it is important to keep in mind that this conclusion is obtained based on the results of six studies of which two of them contribute with a significant weight&#44; 56&#46;4&#37;&#44; to this statement&#46;<a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">4&#44;5</span></a> It is relevant to point out that both studies have notable methodological limitations&#46; Among them&#44; the following should be highlighted&#58; &#40;a&#41; neither of the two studies is placebo-controlled nor double-blind&#44;<a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">4&#44;5</span></a> &#40;b&#41; in one study the authors acknowledge that they made a mistake when making the calculation to obtain an adequate sample and detects that the way the medication was distributed between the groups benefited the EC groups&#44;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">4</span></a> &#40;c&#41; both studies show notable problems of adherence to nicotine medication with respect to adherence to ECs&#46; &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; In both studies adherence was always superior in the ECs groups than in the NRT groups&#46; In both studies adherence to NRT at first month was lower than adherence to ECs&#46; Nicotine withdrawal syndrome is very intense during the first four weeks and the need for medication to control it is very high&#46; According to adherence data the majority of subjects in the NRT groups were not using adequate medication during this period of time compared with subjects in the ECs groups&#46; All these aspects are important limitations to obtain adequate conclusions&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">Another important problem that was detected in these studies<a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">4&#44;5</span></a> refers to the persistence in the use of ECs beyond the established time&#46; In the study by Bullen et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">4</span></a> 38&#37; of those who were abstinent at six months of follow-up were still using ECs&#44; even 29&#37; of those who had relapsed and were smokers of combustible cigarettes&#44; were still using ECs at that time&#46; It is noteworthy that the authors confess that they did not know whether the study subjects used ECs with or without nicotine&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">4</span></a> In the study by Hajek et al&#46; data on persistence in the use of ECs beyond the established time were also striking&#58; at one year of follow-up there were 79 subjects who had stopped smoking combustible cigarettes in the group that was treated with nicotine ECs&#44; but of them&#44; 63 continued using them&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">5</span></a> This means that around 80&#37; of those who used ECs to quit smoking were still using them after a year&#46; This could make us suspect that the use of ECs could cause addiction&#46; This suspicion has been confirmed by the results of the first metanalysis that analyzes the prevalence of continued ECs use among individuals allocated to ECs conditions in different trials&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">6</span></a> The metanalysis included 19 studies with 7787 participants&#46; The pooled prevalence of continued ECs uses at 6 months or longer was 54&#37; &#40;95&#37; CI&#58; 46&#8211;61&#37;&#41; in participants assigned to ECs conditions&#46; Of participants who had quit combustible cigarettes overall 70&#37; were still using ECs at six months or longer &#40;95&#37; CI&#58; 53&#8211;82&#37;&#41;&#46; Although more people were using nicotine ECs at longer follow up compared to non-nicotine ECs&#44; but CIs included no difference &#40;risk ratio 1&#46;15&#44; 95&#37; CI&#58; 0&#46;94&#8211;1&#46;41&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">6</span></a> All these data strongly suggest that ECs can be addictive and certainly perpetuate the addiction created by combustible cigarettes&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The metanalyses by Lindson et al&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">3</span></a> aims to investigate the comparative benefits&#44; harms and tolerability of different smoking cessation pharmacotherapies and ECs when used to help people stop smoking&#46; Regarding benefits the authors conclude that the most effective interventions were nicotine ECs&#44; varenicline and cytisine &#40;all high certainty&#41;&#44; as well as combination NRT &#40;additive effect&#44; certainty not rated&#41;&#46; There was also high-certainty evidence for the effectiveness of nicotine patch&#44; fast-acting NRT and bupropion&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">3</span></a> However&#44; this meta-analysis has some surprising aspects&#46; It is surprising that the use of nicotine ECs is valued at the same level of effectiveness for smoking cessation as antismoking medications like varenicline or NRT&#44; taking into account that authors only evaluated 16 randomized control trials &#40;RCTs&#41; of nicotine ECs with 3828 participants&#44; but they evaluated 67 RCTs of varenicline with 16&#44;430 participants and 225 RCTs of NRT with 69&#44;075 participants&#46; Moreover&#44; there are many RCTs showing efficacy and safety of varenicline and NRT in smokers with severe controlled diseases&#58; cardiovascular&#44; pulmonary and neuropsychiatric disorders&#46; None RCT using ECs has been carried out in smokers with controlled severe disorders&#46; It is also surprising in this metanalyses that regarding harms and tolerability there are not any conclusions about long term use of nicotine ECs&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">3</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">All these data explain that the claim that nicotine ECs are as effective in helping to quit smoking as antismoking medications should be taken with caution&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The use of ECs also has important security problems that have not yet been resolved&#46; The data on the addiction they could cause has already been pointed out above&#46; But&#44; in addition&#44; other no less important sources of concern have been found&#46; These include&#58; &#40;a&#41; many studies have highlighted that the use of ECs&#44; with and without nicotine&#44; is accompanied by the inhalation of substances with carcinogenic power&#44;<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">7&#8211;9</span></a> &#40;b&#41; it has been shown that the use of ECs can increase the predisposition to suffer from infectious lung diseases&#44; both viral and bacterial&#44;<a class="elsevierStyleCrossRefs" href="#bib0125"><span class="elsevierStyleSup">10&#44;11</span></a> &#40;c&#41; the appearance of e-cigarette or vaping product use-associated lung injury &#40;EVALI&#41; as a new disorder caused by the consumption of ECs is worrying&#44;<a class="elsevierStyleCrossRef" href="#bib0011"><span class="elsevierStyleSup">12</span></a> &#40;d&#41; a recent review of different studies suggest that the long-term use of ECs could produce lesions in the bronchial mucosa very similar to those observed in smokers with COPD<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">13</span></a> and &#40;e&#41; concerns about the addiction that ECs can create have been confirmed in a recent study that analyzes the effectiveness of varenicline in treating a group of ECs users who wanted to stop using them and had difficulty doing so&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">14</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">All these data suggest that ECs&#44; with and without nicotine&#44; are not safe&#44; either in the short&#44; medium or long term&#44; to help smokers to quit&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">In summary&#44; and based on all this data&#44; we can conclude that ECs are neither effective nor safe devices to help smokers quit&#46; The Spanish Society of Pulmonology and Thoracic Surgery &#40;SEPAR&#41; has recently published a Practical Guide for using pharmacological treatment for smoking cessation&#46; This guide shows various smoking treatment protocols&#44; all of them based on scientific evidence&#44; which are effective and safe for helping smokers to quit&#46; None of them contemplates the use of ECs&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">15</span></a></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interests</span><p id="par0045" class="elsevierStylePara elsevierViewall">Dr&#46; Carlos A&#46; Jim&#233;nez-Ruiz has received honoraria for presentations&#44; participation in clinical studies and consultancy from&#58; Aflofarm&#44; Bial&#44; GSK&#44; Menarini and Pfizer&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Dr&#46; Carlos Rabade-Castedo has received honoraria for speaking engagements&#44; sponsored courses&#44; and participation in clinical studies from Aflofarm&#44; GSK&#44; Menarini&#44; Mundipharma&#44; Novartis&#44; Pfizer&#44; and Teva&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Dr&#46; Jose Ignacio de Granda-Orive has received honoraria for speaking&#44; scientific consulting&#44; clinical study participation&#44; or publication writing for the following&#58; Astra-Zeneca&#44; Chiesi&#44; Esteve&#44; Faes&#44; Gebro&#44; Menarini&#44; and Pfizer&#46;</p></span></span>"
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Editorial
Electronic Cigarettes are Neither Effective Nor Safe for Quitting Smoking: A Critical View of the Most Recent Meta-Analyses
Carlos A. Jiménez-Ruiza,
Corresponding author
victorina@separ.es

Corresponding author.
, Carlos Rábade-Castedob, Jose Ignacio de Granda-Orivec
a Madrid, Spain
b Servicio de Neumología, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain
c Servicio de Neumología, Hospital Universitario 12 de octubre, Madrid, Spain

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