TCTR20180312001

11 evidence topics · 1 source

Objective

Community-pharmacy objective

“smoking cessation” (opens the source at this quote in a new tab)

Location and study date

Country

“Thailand” (opens the source at this quote in a new tab)

Study design

Trial design

“double-blinded randomized placebo-controlled” (opens the source at this quote in a new tab)

Eligibility criteria

Eligibility thresholds

Characteristic	Quoted value
Age, years	“>18”
Daily tobacco consumption	“>10 tobaccos/day”

Treatment

Behavioral intervention

“five sessions of counselling” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using continuous smoking abstinence as the primary endpoint

Primary endpoint

Characteristic	Quoted value
Continuous-abstinence assessment	“week 48”

Statistical analysis description

Number of participants (Planned and analyzed)

Treatment groups

Characteristic	Quoted value
Cytisine participants	“67”
Placebo participants	“65”

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

Continuous abstinence at week 48

“The CARs were determined to be 14.93% and 6.15% for cytisine and placebo, respectively, at week 48.” (opens the source at this quote in a new tab)

Week-48 treatment comparison

Characteristic	Quoted value
Relative risk	“2.41”
95% confidence interval	“0.80-7.35”
P value	“0.102”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Reported adverse-event categories

“gastrointestinal and neurological adverse events” (opens the source at this quote in a new tab)

Study limitations

Summary

The trial included 67 participants receiving cytisine and 65 receiving placebo. The week-48 relative-risk confidence interval included no difference (relative risk 2.41; 95% confidence interval 0.80–7.35; P = 0.102). The small groups limit precision and assessment of uncommon harms.