Non-inferiority trial comparing cigarette consumption, adoption rates, acceptability, tolerability, and tobacco harm reduction potential in smokers switching to Heated Tobacco Products or electronic cigarettes: Study protocol for a randomized controlled trial.

BACKGROUND: Despite the introduction of tobacco control measures, smoking remains highly prevalent in most EU countries. In Italy, one in four adults were still regular smokers in 2017. Increasing use of combustion-free delivering nicotine technologies for cigarette substitution may accelerate the current downward trends in smoking prevalence. Whether Heated Tobacco Products (HTPs) are more effective tobacco smoking substitutes that may potentially facilitate adoption and full conversion compared to e-cigarettes (ECs) is not known.We have designed a prospective study to compare changes in cigarette consumption and adoption rates among smokers randomized to either HTPs or ECs. Product acceptability, tolerability, and their tobacco harm reduction potential will be also compared. METHODS: 220 healthy smokers, not motivated to quit, will be randomized into a 12-weeks single-center, open label, non-inferiority trial comparing study outcomes from HTPs vs. ECs use. The primary outcome will be biochemically verified self-reported continuous abstinence at 12-weeks from the previous visit. Secondary outcomes will include: smoking reduction from baseline, adoption rates and product acceptability, tolerability, changes in step test values and in the level of selected biomarkers of exposure in exhaled breath (i.e. eCO) and in spot urine samples. A follow-up visit will be also included at 24-weeks to review product usage and smoking behavior under naturalistic condition of use.Recruitment of participants started in May 2019 and enrolment is expected to be completed in November 2019. DISCUSSION: This will be the first study directly comparing Heated Tobacco Products with Electronic Cigarettes in term of reduction in cigarette consumption, adoption rates, product acceptability, tolerability, and tobacco harm reduction potential. This knowledge can contribute to a better understanding of the potential role of this new technology in the evolving nicotine consumer market. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03569748.Registered June 25, 2018.https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4.

Lack of Substantial Post-Cessation Weight Increase in Electronic Cigarettes Users.

Minimization of post-cessation weight gain in quitters is important, but existing approaches (e.g., antismoking medications) shows only limited success. We investigated changes in body weight in smokers who quit or reduced substantially their cigarette consumption by switching to electronic cigarettes (ECs) use. Body weight and smoking/vaping history were extracted from medical records of smokers and ex-smokers to match three study groups: (1) regular EC users on at least two consecutive follow-up visits; (2) regular smokers (and not using ECs); (3) subjects who reported sustained smoking abstinence after completing a cessation program. Review of their medical records was conducted at two follow-up visits at 6- (F/U 6m) and 12-months (F/U 12m). A total of 86 EC users, 93 regular smokers, and 44 quitters were studied. In the EC users study group, cigarettes/day use decreased from 21.1 at baseline to 1.8 at F/U 12m (p < 0.0001). Dual usage was reported by approximately 50% of EC users. Both within factor (time, p < 0.0001) and between factor (study groups, p < 0.0001) produced significant effect on weight (% change from baseline), with a significant 4.8% weight gain from baseline in the quitters study group at F/U 12m. For the EC users, weight gain at F/U 12m was only 1.5% of baseline. There was no evidence of post-cessation weight increase in those who reduced substantially cigarette consumption by switching to ECs (i.e., dual users) and only modest post-cessation weight increase was reported in exclusive EC users at F/U 12m. By reducing weight gain and tobacco consumption, EC-based interventions may promote an overall improvement in quality of life.

Evaluation of Post Cessation Weight Gain in a 1-Year Randomized Smoking Cessation Trial of Electronic Cigarettes.

Stop smoking it is often associated to weight gain that is one of the most important causes for relapse. This is the first study to describe long-term changes in body weight in smokers invited to quit or reduce smoking by switching to ECs. Conventional cigarettes consumption and body weight were measured prospectively in a randomized controlled trial of smokers invited to switch to ECs. Post cessation weight changes from baseline at week-12, -24 and -52 were compared among 1) high, medium and zero nicotine strength products and 2) pooled continuous smoking failure, smoking reduction and abstinence phenotypes. Saliva cotinine levels and appetite levels were also measured. No significant changes in body weight were observed among high, medium and zero nicotine strength products. Differences among continuous smoking phenotypes were significant only at week-12 (p = 0.010) and week-24 (p = 0.012) with quitters gaining 2.4{plus minus}4.3 Kg and 2.9{plus minus}4.4 Kg respectively. However, weight gain at week-52 (1.5{plus minus}5.0 Kg) was no longer significant compared to Failures and Reducers. No confounding factors could explain the significant changes in body weight. Smokers who quit smoking by switching to ECs may limit their post-cessation weight gain, with substantial reversal in weight gain being manifest at late time points.

Losartan vs. amlodipine treatment in elderly oncologic hypertensive patients: a randomized clinical trial.

Elderly neoplastic patients frequently may show hypertension and hyperuricemia, before and after chemotherapeutic treatments. The purpose of this study was to evaluate the efficacy of losartan which is an antihypertensive drug with uricosuric properties vs. amlodipine in hypertensive neoplastic elderly patients. This was an open-labeled, randomized, comparative trial. The study was performed as a 30-day study. Seventy patients with cancer were randomly assigned to receive losartan or amlodipine. Blood pressure (BP), blood urea nitrogen (BUN) levels, creatinine, serum and urinary uric acid, creatinine and uric acid clearance were determined before and after chemotherapy. One day after chemotherapy in losartan group vs. amlodipine group we observed a significant difference in urinary uric acid (p<0.001) of 18 mg/24 h vs. 40 mg/24 h. Thirty days after chemotherapy we observed a significant difference in azotemia of 0.0 mg/dl vs. 3.8 mg/dl (p<0.001), serum uric acid of 0.05 mg/dl vs. 0.49 mg/dl (p<0.001), urinary uric acid (p<0.001) of 23 mg/24 h vs. 0.0 mg/24 h, GFR of 2 ml/min/1.73 m(2) vs. -8 ml/min/1.73 m(2) (p<0.05) and systolic BP (SBP) of 3.6 mmHg vs. 0.8 mmHg (p<0.05). The findings of the present study support the effective role of losartan compared to amlodipine in treating hypertension and hyperuricemia in elderly patients under chemotherapeutic treatment.

Eighteen needles to forget...an unnamed past.

Lasthénie de Ferjol syndrome is a very rare psychiatric illness that occurs mainly in women. It is characterized by severe recurrent iron-deficiency anemia caused be repeated episodes self-induced blood-letting. We report the case of a young homosexual male repeatedly admitted to various hospitals for severe hypochromic anemia. We discovered that the anemia was indeed due to psychotic self-provoked hemorrhages. Based on this experience and a review of the few cases reported in the literature, we discuss issues of early diagnosis, management and treatment of Lasthénie de Ferjol patients.

Two clinical cases of insulinoma misdiagnosed as psychiatric conditions.

We describe the clinical cases of two male subjects, respectively 73 and 41 years old, affected with insulinoma, misdiagnosed for many years as psychiatric subjects and scarcely responsive to therapy with benzodiazepins, antidepressants and antiepileptics. Although Whipple's triad was satisfied in both subjects since the onset of symptoms, they had to wait a long time for the correct diagnosis and appropriate treatment. Once the surgical therapy was carried out, our subjects recovered totally and ended the psycho-drugs.

A catastrophic case of skin gangrene.

We describe the case of a 70-year-old male with the catastrophic antiphospholipid syndrome admitted for skin gangrene of the fingers. The initial diagnosis was antiphospholipid antibody syndrome in a patient with rheumatoid arthritis and a history of deep vein thrombosis of the lower limbs. Liver involvement, the characteristic skin gangrene, pneumonia and worsening severe renal failure were determinant to make the final diagnosis of catastrophic antiphospholipid syndrome that led the patient to death.

Six clinical cases of Mandragora autumnalis poisoning: diagnosis and treatment.

A multiple case of Mandragora autumnalis poisoning is described. Mandragora autumnalis, a solanaceous plant that is common in the Sicilian countryside, contains a variable concentration of solanum alkaloids, which cause gastrointestinal irritation, and tropane alkaloids, which have anticholinergic properties and produce typical and sometimes severe atropine-like symptoms. Vital function support, decontamination, symptomatic treatment and, in severe cases, antidote therapy with physostigmine are useful to control acute poisoning.