Discussion
cough, RE, COPD, Cancer
INFECTIOUS DISEASES, ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, RECRUITMENT, COPD, DEL, CANCER
HTP use elicited a marked reduction in cigarette consumption, resulting in almost 40% abstinence from smoking by the end of the study. When present, adverse events were mild and transitory. This is the first study to directly compare ECs to HTPs, showing comparable effectiveness and tolerability between the JustFog-EC and IQOS-HTP study groups.RCT findings for IQOS-HTP are in agreement with the findings of an American Cancer Society analysis that found a substantial decline in cigarette sales after the introduction of IQOS in Japan [Multiple factors contributed to the high quit rate observed among IQOS-HTP and JustFog-EC users: (1) participants were keen to switch to combustion-free NDAs; (2) personalized motivational counseling was administered by psychologists proficient in both smoking cessation and harm reduction at each study visit; (3) top selling products in their respective category (ie, JustFog for ECs and IQOS for HTPs) were given for free in the study and most participants found these products appealing; (4) study products had a pharmacokinetic profile of nicotine uptake mimicking that of conventional cigarettes [The same factors might have contributed to the comparable effectiveness between ECs and HTPs and to the progressive transition from dual use to solo use by the end of the intervention phase. Dual use is known for being a common transitory state, with transitions to solo use taking variable time to occur [For this study, we selected the top selling products in their respective category (ie, ECs and HTPs). Both IQOS-HTP and JustFog-EC performed well in the study, as technical issues (eg, malfunctions) were relatively uncommon. Participants enjoyed using both study products, with mCEQ scores showing mild to moderate positive responses in terms of product acceptability, cigarette craving reduction, and physical and psychological reward; mSCAS scores indicating a moderately pleasant user experience; and consumption data revealing regular constant product use throughout the study. This is consistent with the notion that a positive sensorial experience and product enjoyment can contribute to the effectiveness of combustion-free products in terms of cessation outcomes [Adverse events were mild and did not led to discontinuation of product use in either study group. None of the participants abused the products under investigation in terms of excessive daily consumption. In some participants, HTP use was associated with mild cough and reduced physical fitness in line with previous observations [A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation as early as 4 weeks. Greater improvement was observed at 12 weeks as there was a much higher prevalence of quitters by the end of the intervention phase compared to 4 weeks. This is in agreement with the improvement in the level of exercise tolerance shown in prospective studies of COPD patients who switched to ECs [The trial had strengths and limitations. First, among the innovative features of this randomized controlled switching study, adherence to the study products was enhanced by offering a selection of different products to choose from according to preference/liking. Three aromas of tobacco sticks and three e-liquid flavors were provided to best match participants’ sensorial experiences. Nonetheless, these choices remain limited (ie, only 3 different flavors for each class of products) and product specific, thus reducing the generalizability of the study findings. In addition, multiple flavor use is common among e-cigarette users, and switching between flavors is frequently reported even during daily use [Second, after close scrutiny, we chose to offer the best vaping devices and HTPs available on the Italian market at the time of the study. More details about the selection process have been published previously [Third, study products were provided in combination with personalized motivational counseling administered by psychologists proficient in both smoking cessation and harm reduction. Provision of expert guidance in the context of a switching trial conducted at specialized smoking cessation services may limit the generalizability of the study findings. Changes in tobacco/nicotine use behavior and product use will be investigated in a separate follow-up study under real-life conditions.In conclusion, this study confirmed the effectiveness of ECs for cigarette substitution and smoking cessation [The authors would like to thank the staff at Centro Prevenzione Cura Tabagismo (CPCT) for their invaluable assistance with subject recruitment. We are also grateful to Fabio Cibella for the fruitful scientific advice about the statistical analysis plan and Adrian Shalivari for the refinement of the electronic data capture system. The authors’ thoughts and prayers go out to all the victims of the Russia-Ukraine conflict. This research was supported by an investigator-initiated study award by Philip Morris Products SA (PMI.IIS.2016.006). Philip Morris Products SA had no role in the design of the study and will not have any role during its execution, data analysis, or data interpretation, or during writing of the manuscript.Conflicts of Interest: PC, DC, MS, M Migliore, and M Caruso are full-time employees of the University of Catania, Italy. RE is a fixed-term researcher at BIOMETEC, University of Catania, Italy. M Maglia and FB are fixed-term researchers at Centro per la Prevenzione e Cura del Tabagismo, University of Catania, Italy. BB is a full-time employee of ARNAS Garibaldi, Catania, Italy. AP is a full-time employee of Casa di Cura Musumeci-Gecas, Gravina di Catania, Italy. GC is a full-time employee of the Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Messina, Italy. M Ceracchi is an employee at FullCRO, Roma, Italy.Study diagram.Study schedule and assessments.Detailed technical issues.Summary of the measures of product preference, acceptability, and risk perception.Risk perception.Consumption data for study participants (per protocol population).Average daily consumption.Summary of the measures of participant well-being.Adverse Events.CONSORT 2010 checklist.