When A Study Is Withdrawn From Publication

Recently, the Journal of the Podiatric Medical Association (JAPMA) withdrew an article scheduled for publication in August 2015.¹ This paper reported the results of a study testing the Vibram FiveFingers Bikila minimalist shoe and its effects on strengthening the abductor hallucis muscle of the foot.

The article was apparently withdrawn after the editors of JAPMA were notified that the authors of the paper had not disclosed a conflict of interest. It turns out that the lead author, Nicholas Campitelli, DPM, was on the Board of Advisors for Vibram FiveFingers, the manufacturer of the footwear, which was tested in the clinical trial.²

Aside from the lack of appropriate disclosure by the authors, the validity of the study itself has drawn the attention of Craig Payne, PhD, a respected podiatrist in Australia, who writes a newsletter known as the  “Running Research Junkie.” Dr. Payne made many valid criticisms of the recently withdrawn study.³

According to Dr. Payne, the study authors did not follow the CONSORT Statement guidelines — evidence-based recommendations for reporting randomized trials — in many areas including: lack of true randomization; lack of validating reliability of measurement; and performance of a within group analysis instead of a between groups analysis.^1,4

I have found that biased or flawed research articles often ignore previously published studies that may refute the findings of the new paper. After reviewing other published articles on the subject of strengthening the intrinsic muscles of the foot, I found a study that showed a significant increase in the cross sectional area of the abductor hallucis muscle using foot orthoses alone and even more of an increase when foot orthoses were combined with foot exercises.⁵ This study, which did follow CONSORT recommendations, refutes any claims by those who condemn foot orthoses for reducing recruitment of intrinsic muscle activity in the foot. Unfortunately, this study was not discussed in the aforementioned paper by Campitelli and colleagues.

Comparing the data from both studies, the increase in the cross-sectional area of the abductor hallucis muscle was ten times greater with foot orthoses alone in just eight weeks than the increase in thickness of the abductor hallucis using the Vibram FiveFingers shoes over a period of 24 weeks.^1,5

In addition to the study design flaws and lack of appropriate conflict of interest, the real problem with the paper submitted by Campitelli and colleagues was failing to report their findings in the context of previous research published on the same subject. It is gratifying to see that the editors of JAPMA made the proper decision to withdraw the paper from publication.

References

1. Campitelli NA, Bernhard KN, Kidon A, Heard K, Spencer SA, Kawalec JS. Effect of Vibram FiveFingers minimalist shoes on the abductor hallucis muscle. J Am Podiatr Med Assoc. 2015 Aug 6. [Epub ahead of print]

2. https://www.vibramfivefingers.it/advisory-board.aspx

3. https://www.runresearchjunkie.com

4.  https://www.consort-statement.org

5. Jung DY, Koh EK, Kwon OY. Effect of foot orthoses and short-foot exercise on the cross-sectional area of the abductor hallucis muscle in subjects with pes planus: A randomized controlled trial. J Back Musculoskeletal Rehabil. 2011;24(4):225–231.