The Biota orientalis, oil extract Epiitalis®, is efficacious at reducing the symptoms of knee osteoarthritis: a pilot, multi-site, dose-ranging, randomized, blinded, placebo-controlled trial

Peter G Mitchell, Corina A Bright, Daniel R Bright, Shalini N Srivastava, Sonal S Raote, Santosh Kumar, Peter G Mitchell, Corina A Bright, Daniel R Bright, Shalini N Srivastava, Sonal S Raote, Santosh Kumar

Abstract

Objective: To explore the safety, and efficacy of a proprietary hydrolyzed oil extract from seeds of Biota orientalis (hBO/Epiitalis®, Interpath Pty Ltd) in patients with knee pain due to osteoarthritis (OA).

Methods: Patients aged 40-65 with X-ray diagnosed knee OA and knee pain ≥ 60 on a 100-point VAS (visual analog scale) were enrolled and randomized into four groups to receive daily hBO for 56 days as high (hBO-HD, 640 mg), mid (hBO-MD, 320 mg) or low (hBO-LD, 160 mg) doses, or a matched placebo oil. The primary outcome was change in VAS knee pain from baseline to 56 days in the mITT (modified intention to treat) population. Exploratory outcomes were the mWOMAC (modified Western Ontario and McMaster Universities Arthritis Index), and the SF-36 QoL (quality of life) questionnaire. The OMERACT-OARSI (Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International) responder index was also calculated.

Results: 223 patients were included in the mITT population. Reductions in VAS scores between baseline and day 56 [Least square mean (LS mean) and 95% confidence interval (CI) of LS mean] were 36.4 (31.7-41.0), 37.9 (33.2-42.7), 35.7 (31.2-40.1) and 9.8 (14.5-15.2) for the hBO-HD, hBO-MD, hBO-LD, and placebo groups respectively. The VAS changes in all hBO groups were significantly different (p < 0.0001) vs. changes in the placebo group. hBO treatment led to similar quantitative beneficial changes in mWOMAC, SF-36 and OMERACT-OARSI responder index. There were no SAEs and no adverse events ascribed to the intervention.

Conclusion: In a 56-day trial, hBO was safe, and was efficacious at reducing symptoms in patients with knee OA.

Registration: NCT04117490; Oct 7, 2019.

Keywords: Biota orientalis; Knee osteoarthritis; Randomized placebo-controlled trial; SF-36; VAS knee pain; WOMAC.

Conflict of interest statement

DB and CB have ownership in Interpath Pty LTD. PGM is employed as a consultant for Interpath Pty LTD and also provides consulting to Nordic Bioscience, Boehringer Ingelheim, Cocoon Biotech and MedinCell. PGM holds stock in Pfizer and Eli Lilly. SS and SR are employees of Vedic. SK is an independent consultant biostatistician.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Trial profile. *Withdrawal = participants who withdrew consent during the study. #Dropout = participants who were not contactable or who did not turn up for a follow-up visit. ^Data not considered = any protocol violation or major protocol deviation finding during the study period
Fig. 2
Fig. 2
Pain VAS (mean ± SD) vs. study visit for the MD-BO and Placebo groups

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