Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

The Betel Nut Intervention Trial (BENIT). A Randomized Clinical Trial for Areca Nut and Betel Quid Cessation: Primary Outcomes

Thaddeus A Herzog
* ORCID logo ,
Lynne R Wilkens
,
Grazyna Badowski
ORCID logo ,
Ana Joy Pacilan Mendez
,
Adrian A Franke
,
Pallav Pokhrel
,
Jade S.N. Chennaux
,
Lynnette F Tenorio
,
Patrick P Sotto
,
Crissy T Kawamoto
ORCID logo ,
Yvette C Paulino
Version 1 : Received: 20 June 2023 / Approved: 20 June 2023 / Online: 20 June 2023 (10:01:15 CEST)

A peer-reviewed article of this Preprint also exists.

Herzog, T.A.; Wilkens, L.R.; Badowski, G.; Mendez, A.J.P.; Franke, A.A.; Pokhrel, P.; Chennaux, J.S.N.; Tenorio, L.F.; Sotto, P.P.; Kawamoto, C.T.; Paulino, Y.C. The Betel Nut Intervention Trial (BENIT)—A Randomized Clinical Trial for Areca Nut and Betel Quid Cessation: Primary Outcomes. Int. J. Environ. Res. Public Health 2023, 20, 6622. Herzog, T.A.; Wilkens, L.R.; Badowski, G.; Mendez, A.J.P.; Franke, A.A.; Pokhrel, P.; Chennaux, J.S.N.; Tenorio, L.F.; Sotto, P.P.; Kawamoto, C.T.; Paulino, Y.C. The Betel Nut Intervention Trial (BENIT)—A Randomized Clinical Trial for Areca Nut and Betel Quid Cessation: Primary Outcomes. Int. J. Environ. Res. Public Health 2023, 20, 6622.

Abstract

Background: Areca nut and betel quid (ANBQ) chewing is a widespread carcinogenic habit. The BENIT (ClinicalTrials.gov - NCT02942745) is the first known randomized trial designed for ANBQ chewers. Methods: We compared intensive behavioral treatment intervention condition (IC) with control condition (CC) in the BENIT and included a 5-stage early stopping rule. We report the primary analysis at stage 3. English literate adults in Guam and Saipan who self-identified as ANBQ chewers with tobacco were enrolled between August 2016 and August 2020. IC participants (n=88) received five in-person sessions over 22 days and a brochure containing quitting advice. CC participants (n=88) received only the brochure. Participants were assessed at baseline and day-22 follow-up. Self-reported chewing status at day-22 was determined by a composite of two survey items with disparate wording and response options for cross-verification. Results: Cessation rates were 38.6% (IC) and 9.1% (CC). Proportional hazards regression revealed a p=0.0058, which met the Stage 3 criteria for significance and an estimated reduction in ANBQ chewing for IC compared to the CC of 71% (95% CI: 41%-88%). Conclusion: Robust self-reported intervention effects at day-22 suggests that intensive cessation programs such as BENIT should be further developed and implemented on a larger scale.

Keywords

Betel Nut Intervention Trial; areca nut; betel quid; clinical trial; cessation; oral cancer

Subject

Public Health and Healthcare, Public Health and Health Services

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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