scholarly journals Effect of Metformin on Cigarette Withdrawal Syndrome and Abstinence in Lung Cancer Patients; A Double-blind Placebo-controlled Trial

2021 ◽  
Vol 14 (5) ◽  
Author(s):  
Bijan Pirnia ◽  
Raheleh Masoudi ◽  
Melika Sefidrood ◽  
Elham Zarghami ◽  
Kambiz Pirnia ◽  
...  
Keyword(s):  
Withdrawal Syndrome ◽  
Controlled Trial ◽  
Nicotine Withdrawal ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Urinary Cotinine ◽  
Metformin Group ◽  
Secondary Outcomes ◽  
Cigarette Withdrawal

Background: Lung cancer (LC) is a leading cause of cancer morbidity and mortality worldwide. One of the predisposing factors for LC is smoking. Metformin is the first line for diabetes treatment and is shown that it can be used for nicotine withdrawal syndrome reduction. Objectives: This study was conducted to evaluate the effects of metformin on reducing the nicotine withdrawal syndrome and increasing nicotine abstinence in patients with LC. Methods: In a randomized double-blind placebo-controlled trial from February 2018 to May 2019, 53 patients with LC were selected by respondent-driven sampling (RDS), and were assigned into two experimental and wait-list control (WLC) group through block randomization (BR). After 3 weeks of baseline assessment, metformin or placebo was prescribed in the form of escalating doses. Cigarette Withdrawal Scale (CWS-21), urinary cotinine levels, and exhaled carbon monoxide (eCO) levels were evaluated in 16 steps by the repeated measures. The primary outcomes include metformin efficacy on cigarette withdrawal syndrome and secondary outcomes include urinary cotinine levels and eCO level. The data were analyzed by generalized estimation equation (GEE), chi-square, and Atlas-Ti5. Results: The primary outcomes showed that the metformin group had significant effects on the improvement of depression, anxiety, craving, irritability, and appetite, difficulty in concentrating, appetite-weight, and insomnia during the 12-weeks treatment period (all P's < 0.05). In addition, only cravings scores remained constant until the 6-month follow-up (P < 0.05). Secondary outcomes demonstrated that urinary cotinine levels and eCO level significantly decreased in the metformin group (all P's < 0.05). However, this decrease did not remain constant at both levels until the 6-month follow-up (P > 0.05). Conclusions: Metformin had a clinical potential for reducing nicotine withdrawal. However, more studies are needed.

Double-Blind, Placebo-Controlled Trial of Oral Immunotherapy (OIT) in Peanut (PN) Allergic Children: A Follow-up

2010 ◽  
Vol 125 (2) ◽  
pp. AB58 ◽  
Author(s):  
S.M. Jones ◽  
A.M. Scurlock ◽  
L. Pons ◽  
T.T. Perry ◽  
A.R. Morgan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Oral Immunotherapy ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Primary Prophylaxis to Prevent Tuberculosis Infection in Prison Inmates:A Randomized, Double-Blind, Placebo-Controlled Trial

2019 ◽  
Author(s):  
Roberto Dias de Oliveira ◽  
Andrea da Silva Santos ◽  
Cassia Barbosa Reis ◽  
Alessandra de Cássia Leite ◽  
Flávia Patussi Correia Sacchi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Primary Prophylaxis ◽  
Tuberculosis Infection ◽  
Secondary Outcome ◽  
Double Blind ◽  
Middle Income ◽  
High Exposure ◽  
Double Blind Placebo ◽  
Clinical Benefits

Abstract Background. In many low- and middle-income countries, tuberculosis incidence in prisons is high, exposing incarcerated populations to an elevated risk of tuberculosis infection. Methods. We conducted a randomized, double-blind, placebo-controlled trial among HIV-negative male inmates of a high tuberculosis burden prison to determine whether twice-weekly isoniazid (900 mg) for 12 months prevents tuberculosis infection. The primary outcome was QuantiFERON–TB Gold Plus (QFT) conversion to ≥0.35 IU/ml at 6 months; the secondary outcome was conversion at any time point. Alternative QFT positivity thresholds (≥0.7, ≥2.0, and ≥4.0 IU/ml) were investigated as exploratory endpoints. Results. In total, 467 participants were randomly assigned to isoniazid (N=258) or placebo (N=209). In an interim analysis of participants who had completed six months of follow-up (N=171), QFT conversion occurred in 20.7% (19/92) and 21.5% (17/79) of participants in isoniazid and placebo arms (efficacy: 4.0%; P=0.88). The trial was then stopped for futility, and the remaining participants underwent QFT testing. Among all participants with a second QFT test at 6-months, conversion occurred in 19.7% (26/132) and 30.3% (37/122) of participants in isoniazid and placebo arms (efficacy: 35.1%; P=0.04). Protection was also seen among all individuals with a follow-up QFT (5/132 [3.8%] vs 14/122 [11.5%]; efficacy: 67.0%, P=0.01). In exploratory analyses, the isoniazid arm had significantly lower rates of conversion at ≥2.0 IU/ml (67.0% efficacy, P=0.01), but not at other cutoff values. Discontinuations and losses to follow-up were high in both arms (isoniazid, 126/258 [48.8%]; placebo, 87/209 [41.6%]; P=0.14), due to elective withdrawal (24.0% vs 21.5%; P=0.60) and transfer or release from prison (19.0% vs 18.2%; P=0.92). Conclusions. Our results suggest that 900 milligrams of isoniazid given twice weekly may confer partial protection against QFT conversion in high exposure environments; however, discontinuation rates in both arms were high, which would limit the clinical benefits of this prevention method.

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