Double-blinded randomized controlled trial to reveal the effects of Brazilian propolis intake on rheumatoid arthritis disease activity index; BeeDAI

Yoshinari Matsumoto; Kanae Takahashi; Yuko Sugioka; Kentaro Inui; Tadashi Okano; Koji Mandai; Yutaro Yamada; Ayumi Shintani; Tatsuya Koike

doi:10.1371/journal.pone.0252357

Double-blinded randomized controlled trial to reveal the effects of Brazilian propolis intake on rheumatoid arthritis disease activity index; BeeDAI

PLoS One. 2021 May 27;16(5):e0252357. doi: 10.1371/journal.pone.0252357. eCollection 2021.

Authors

Yoshinari Matsumoto^{1

2}, Kanae Takahashi³, Yuko Sugioka⁴, Kentaro Inui⁵, Tadashi Okano⁵, Koji Mandai⁵, Yutaro Yamada⁵, Ayumi Shintani³, Tatsuya Koike^{1

4}

Affiliations

¹ Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare, Wakayama, Japan.
² Department of Medical Nutrition, Osaka City University Graduate School of Human Life Science, Osaka, Japan.
³ Department of Medical Statistics, Osaka City University Medical School, Osaka, Japan.
⁴ Center for Senile Degenerative Disorders (CSDD), Osaka City University Medical School, Osaka, Japan.
⁵ Departments of Orthopaedic Surgery, Osaka City University Medical School, Osaka, Japan.

Abstract

Background and aims: Brazilian propolis reportedly contributed to suppressing disease activity in a mouse model of rheumatoid arthritis (RA), suggesting new treatment options using Brazilian propolis. However, only results from animal experiments have been available, and the suppressive effects of Brazilian propolis on disease activity in humans with RA remain unknown. The purpose of this study was to clinically validate how Brazilian propolis intake changes disease activity in RA patients.

Methods: This study was conducted as a multicenter, double-blinded, randomized, placebo-controlled, parallel-group study of 80 women with RA (median age, 61.5 years; interquartile range, 56.0 to 67.3 years) showing moderate disease activity on Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR). Test tablets containing Brazilian propolis were used in Group P (40 patients), and Brazilian propolis-free placebo tablets were used as control in Group C (40 patients). Group P received 5 tablets of propolis (508.5 mg of propolis) daily, and Group C received 5 tablets of placebo daily. The intervention lasted 24 weeks, with change in DAS28-ESR set as the primary endpoint. As secondary endpoints, other disease activity assessment (DAS28 using C-reactive protein, simplified disease activity index, clinical disease activity index), ultrasonographic evaluation of synovitis, activities of daily living, quality of life, changes in cytokine levels, and adverse events over the course of the study were also assessed. Data were statistically analyzed by analysis of covariance.

Results: No significant differences in the primary endpoint were identified between groups (Group P vs Group C, effect: 0.14, 95% confidence interval: -0.21 to 0.49, p = 0.427). Likewise, no significant differences were seen between groups for any secondary endpoints. The adverse event rate during the study period was 28% in Group P and 33% in Group C.

Conclusions: Brazilian propolis exerted no effects on disease activity in patients with RA.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Antirheumatic Agents / therapeutic use*
Arthritis, Rheumatoid / drug therapy*
Humans
Middle Aged
Propolis / therapeutic use*
Treatment Outcome

Substances

Antirheumatic Agents
Propolis

Grants and funding

Y.M. received Yamada Research Grant (grant No.249YM) from a commercial source: Yamada Bee Company, Inc. (https://www.3838.com). The funders had a role in preparing and blinding propolis and placebo tablets and in decision to publish but had no further role in study design, data collection and analysis, or preparation of the manuscript.