Aim
To determine whether cytisine was at least as effective as varenicline in supporting smoking abstinence for ≥ 6 months in New Zealand indigenous Māori or whānau (extended‐family) of Māori, given the high smoking prevalence in this population.
Design
Pragmatic, open‐label, randomized, community‐based non‐inferiority trial.
Setting
Bay of Plenty, Tokoroa and Lakes District Health Board regions of New Zealand.
Participants
Adult daily smokers who identified as Māori or whānau of Māori, were motivated to quit in the next 2 weeks, were aged ≥ 18 years and were eligible for subsidized varenicline. Recruitment used multi‐media advertising.
Interventions
A total of 679 people were randomly assigned (1 : 1) to receive a prescription for 12 weeks of cytisine or varenicline, plus low‐intensity cessation behavioural support from the prescribing doctor and community stop‐smoking services or a research assistant. Day 5 of treatment was the designated quit date.
Measurements
The primary outcome was carbon monoxide‐verified continuous abstinence at 6 months, analysed as intention‐to‐treat (with multiple imputation for missing data). Secondary outcomes measured at 1, 3, 6 and 12 months post‐quit date included: self‐reported continuous abstinence, 7‐day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance and acceptability, nicotine withdrawal/urge to smoke and health‐care utilization/health‐related quality of life.
Findings
Verified continuous abstinence rates at 6 months post‐quit date were 12.1% (41 of 337) for cytisine versus 7.9% (27 of 342) for varenicline [risk difference 4.29%, 95% confidence interval (CI) = –0.22 to 8.79; relative risk 1.55; 95% CI = 0.97–2.46]. Sensitivity analyses confirmed that the findings were robust. Self‐reported adverse events over 6 months occurred significantly more frequently in the varenicline group (cytisine: 313 events in 111 participants; varenicline: 509 events in 138 participants, incidence rate ratio 0.56, 95% CI = 0.49–0.65, P < 0.001) compared with the cytisine group. Common adverse events were headache, nausea and difficulty sleeping.
Conclusion
A randomized controlled trial found that cytisine was at least as effective as varenicline at supporting smoking abstinence in New Zealand indigenous Māori or whānau (extended‐family) of Māori, with significantly fewer adverse events.
The ductal flow velocities in 37 newborns (group 1: persistent pulmonary hypertension [n = 16], transient tachypnea [n = 3], other [n = 2]; group 2: respiratory distress syndrome [n = 16]) were prospectively evaluated by Doppler ultrasound for the purpose of deriving systolic pulmonary artery pressures. Maximal tricuspid regurgitant Doppler velocity in 21 of these patients was used to validate the pulmonary artery pressures derived from ductal flow velocities. There was a significant linear correlation between tricuspid regurgitant Doppler velocity and pulmonary artery systolic pressure derived from ductal Doppler velocities in patients with unidirectional (pure left to right or pure right to left) ductal shunting (p less than 0.001, r = 0.95, SEE 8) and in those with bidirectional shunting (p less than 0.001, r = 0.95, SEE 4.5). Systolic pulmonary artery pressure in group 1 (67 +/- 13 mm Hg) was significantly higher than that in group 2 (39 +/- 10 mm Hg) (p less than 0.001). In those with bidirectional shunting, duration of right to left shunting less than 60% of systole was found when pulmonary artery pressure was systemic or less, whereas duration greater than or equal to 60% was associated with suprasystemic pulmonary artery pressures. Serial changes in pulmonary artery systolic pressure, reflected by changes in ductal Doppler velocities, correlated with clinical status in persistent pulmonary hypertension of the newborn. Persistently suprasystemic pulmonary artery pressure was associated with death in five group 1 patients. It is concluded that ductal Doppler velocities can be reliably utilized to monitor the course of pulmonary artery systolic pressures in newborns.
Compared a group of 25 postpartum depressed mothers and 25 control mothers with respect to the level and quality of stimulation they provided for their newborn infants during a feeding session. Observer measures of maternal behavior included visual, auditory and kinesthetic stimulation and levels of unconditional positive regard. Results did not indicate any differences between the two groups in levels of stimulation. However, depressed mothers provided significantly lower levels of unconditional positive regard and exhibited less continuity of rocking behavior with their infants. A post hoc analysis that compared the extremes of the two S groups (N = 22) revealed significant differences in gazing behavior, with more depressed mothers gazing less at their infant's faces. Depressed mothers exhibited significantly lower levels of marital adjustment and had more extensive postpartum concerns. Contrary to expectations, no relationship was demonstrated between level of marital adjustment and maternal behavior toward the infant.
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