The RCT, conducted by researchers from The University of Sydney and Southern Medical University from Guangzhou, used complementary medicines manufactured by Bod Australia.
Writing in the journal Osteoarthritis and Cartilage, the researchers pointed out that there were no significant differences in symptomatic relief between the intervention and placebo group during the 12-week study.
During the study, 106 subjects over the age of 40 and are suffering from symptomatic hand osteoarthritis were randomised into two groups.
Two supplements were given to the intervention group. They are 1) Flexofytol – a liquid capsule containing curcumin, with 168mg given per day and 2) a combination of 250mg of Indian frankincense (Boswellia serrata) extract trademarked Boswellin Super, 100mg of pine bark extract trademarked Fenoprolic, and 1,500mg of MSM.
The four ingredients were selected as they were identified as having the largest effects for treating osteoarthritis in a systematic review conducted by Liu X, et al.
The effects of the four ingredients on hand osteoarthritis were compared against the placebo using visual analogue scale (VAS) during the 6th and 12th week of the study.
Said to be the first RCT studying the effects of supplements on hand osteoarthritis, the trial was entirely conducted online, with the participants screened and recruited online as well.
Their symptoms were also assessed by the study physician remotely, based on their uploaded hand photos, x-rays, and self-reported questionnaires.
Results
Both the intervention and placebo groups reported a reduction in pain VAS by the end of the study. However, there was no significant difference between the two groups.
At week 12, the mean of pain VAS was 50.67 in the intervention group – which was a mean reduction of 8.64. For the placebo group, the mean of pain VAS was 45.61 – which was a mean reduction of 14.63.
Hand function, as measured by the Functional Index of Hand Osteoarthritis (FIHOA), also decreased in both groups.
There was also no difference between the two groups in terms of the number of subjects who needed to take pain killers. In this case, 70 per cent of the placebo group and 67.3 per cent of the intervention group took pain killers during the study. Also, the median total amount of paracetamol taken by subjects in the intervention group was 9.3g, while that of the placebo was 6.5g.
“The results indicate that there is no clinical relevance in terms of the supplement combination for treating people with hand osteoarthritis when compared with placebo.
“These findings do not support the use of the supplement combination for treating hand pain in people with hand osteoarthritis,” the researchers said.
They added that previous studies which yielded positive results were all focused on mild knee osteoarthritis, which could be a reason for the disparity in results in this study.
This is because not only did this study focused on hand osteoarthritis, most of the participants were also at more advanced stage of the disease as determined by radiography results.
Another reason could be because the study material used in this RCT were from different manufacturers and IP, hence leading to variation in results.
Adverse events
Adverse events were reported by both groups during the study but were deemed unrelated to the study treatments.
In both groups, 7 in 10 subjects reported experiencing adverse events, with gastrointestinal symptoms the most common symptom.
Eventually, five in the intervention group and four in the placebo group discontinued the study halfway due to adverse events.
One of the adverse events reported was a subject from the intervention group developing starvation ketoacidosis.
A case from the placebo group developed renal abscess and was hospitalised, and another two more had gallbladder infection and sciatic pain that required surgery.
Unmet needs
The researchers noted that there has been a lack of effective treatment or supplementation for alleviating hand osteoarthritis.
At the moment, chondroitin sulfate is a promising candidate for treating hand osteoarthritis, based on the latest guidelines from The American College of Rheumatology.
However, the researchers pointed out that the evidence for using chondroitin sulfate has been limited.
The study was funded by Australia’s National Health and Medical Research Council (NHMRC) Program Grant.
"Bod Australia is proud to collaborate with and support our partners in the industry with the vision of developing existing research to provide accessible solutions to a range of health problems. In this spirit, Bod is pleased to have been approached for support in the RADIANT study and to have had the opportunity to participate by providing the necessary ingredients for the study to be conducted. We look forward to continued involvement with our industry partners in the future.
"The objective of the RADIANT study was to build upon the established body of evidence on Flexofytol in osteoarthritis with interest in the possibility of extending the applications of its therapeutic use to hand osteoarthritis. Flexofytol is currently available for purchase in Australia from Bod Australia and other suppliers. Bod is additionally seeking opportunities to tap into potential overseas markets, recognising the potential in its therapeutic applications.
"Bod will continue to pursue its R&D interests in the field of medical cannabis, a field we believe has much potential for development. We will continue partnering and collaborating with renowned research institutions and universities globally to facilitate research in the field and the development of quality products," Adele Hosseini, chief scientific officer at Bod Australia said in response to the findings.
Source: Osteoarthritis and Cartilage
Efficacy and Safety of a Supplement Combination on Hand Pain Among People with Symptomatic Hand Osteoarthritis An Internet-based, Randomised Clinical Trial The RADIANT Study
https://doi.org/10.1016/j.joca.2021.01.011
Authors: Liu X, et al
