A Phase II study of St. John's Wort for smoking cessation.
OBJECTIVE
To examine the feasibility and efficacy of St. John's Wort (SJW) for smoking cessation.


METHODS
This one-arm Phase II study utilized an exact two-stage group sequential design with a 1-week run-in period between the start of SJW treatment and the designated quit date. A total of 37 smokers (ages 18-65 years, smoking > or = 10 cigarettes/day) were started on SJW. Thirteen failed to make a verified quit attempt on the predesignated date and were taken off study resulting in 24 evaluable subjects.


METHODS
Smokers completed clinic visits at a cancer center with interval telephone calls and mailings.


METHODS
Standardized SJW, 450 mg capsules taken orally twice daily along with cessation counseling messages.


METHODS
Subjects completed validated surveys and a focused physical examination at baseline. Evaluable subjects were defined as those subjects who made a confirmed quit attempt on their "quit date" 1 week following initiation of SJW. Smoking status was determined through self-report and bioverification using carbon monoxide (CO) testing.


RESULTS
Among evaluable subjects, the 12-week quit rate was 37.5% (9/24). Quitters had no significant change in weight from baseline to 12-weeks cessation. Use of SJW was generally well tolerated.


CONCLUSIONS
Based upon these results (which suggest that SJW may be effective in maintaining smoking cessation) and the high compliance and few AEs, we conclude that SJW demonstrates feasibility for use in smoking cessation. If SJW proves to be effective in larger controlled studies, it could represent a less expensive, more readily accessible and well-tolerated agent to promote tobacco cessation.
Lawvere
Silvana
S
Division of Cancer Prevention & Population Sciences, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
Mahoney
Martin C
MC
Cummings
K Michael
KM
Kepner
James L
JL
Hyland
Andrew
A
Lawrence
David D
DD
Murphy
Jill M
JM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use*; D006801:Humans; D020902:Hypericum; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use; D016540:Smoking Cessation / Q000379:methods*
D000928:Antidepressive Agents; D010936:Plant Extracts