Prof Catherine Hill

The aim of this randomised, placebo controlled trial is to determine whether a low dose of colchicine is tolerated, and improves pain and function scores amongst participants with osteoarthritis (OA) of the hand, over three months. This pilot study is the first to investigate the use of colchicine in treating hand OA. Colchicine is a medication used to treat joint pain during episodes of gout, working as an anti-inflammatory. Colchicine may provide the first cost-effective pharmaceutical treatment option of participants with hand OA. Participants enrolled in this study are randomly placed into the placebo group, or the colchicine group. Both groups take two identical white tablets per day, one in the morning and one at night. The placebo tablets contain only non-active carbohydrate, while the colchicine tablets provide 1 mg colchicine per day in total. At the beginning and end of the study, participants report their hand pain and function via questionnaires. We assess fluid levels via ultrasound and perform a tender and swollen joint count on both hands. We monitor side-effects throughout the 3 month study. Participants can come off the medication if the side-effects are too severe.  We hope that participants will be able to tolerate the medication without side effects, while receiving some benefit in their hand OA symptoms. So far we have 23 participants enrolled in the study, of a required minimum 62. Recruitment has been slower than expected, however is ongoing. As the participants and staff do not know which group each participant is in, we cannot analyse the results until un-blinding occurs. Two participants have stopped the medication due to suspected side effects, while several have reported a perceived benefit over 3 months.  Osteoarthritis of the hand affects roughly 20% of older adults, and has a negative impact on quality of life. There are no proven drug therapies to help prevent hand OA, or to delay progression. Pain killers and topical anti-inflammatory creams can provide temporary relief only. Some pain-killers have undesirable side effects if used in excess, thus are not a viable option for long term or daily use. Due to its anti-inflammatory properties, theoretically colchicine may help those with inflammation of the joints caused by osteoarthritis. Some previous research has suggested that colchicine may benefit those with knee OA, although it has never been studied for hand OA. This pilot study is the first to try colchicine in the treatment of hand OA. As an anti-inflammatory medication, long term use of colchicine in hand OA may help to reduce not only symptoms such as pain and loss of function, but also reduce the progression of the disease, prolonging quality of life. As the population of Australia ages, treatments for osteoarthritis will become increasingly important to prolong quality of life and reduce costs. The study has been recruiting for approximately 12 months, and we have so far enrolled 23participants, with several more in screening. The target is 62 participants. As the study is double-blinded, that is, neither the participant nor the research staff knows whether the participant is in the placebo group or the active treatment group, analysis of results is impossible until the group allocation is revealed. This is scheduled to happen once the last participant has completed the study.  Although any formal results analysis is impossible at this time, some data can be presented. The average age of the participants currently enrolled is 67 years. We have 6 males and 17 females enrolled. At the half-way point, 7 of a possible 18 have reported a perceived benefit. Two participants reported side effects within 3 weeks of starting the medication and ceased immediately. Otherwise no side effects have been reported. This study may or may not directly benefit participants. If colchicine is effective as a treatment, participants allocated to the colchicine group may benefit directly from being part of the study. If the participants feel they have benefitted from the medication during the study, it can be made available to them at the conclusion of the 16 weeks, through either hospital staff or their GP. If a significant number of participants continue to perceive a benefit after 3 months, we may do an interim analysis to determine whether those participants were receiving colchicine. If there is a suspected benefit, the study will be terminated and colchicine will be made available to all participants. If participants are in the placebo group they will not benefit directly from the study, unless interim analysis suggests a clear benefit of colchicine. If there is a clear distinction between the two groups after the data has been analysed, this pilot study will be strong grounds to perform a larger, longer term study to determine the effects of colchicine on symptoms and progression of hand OA. Further questions will need to be answered, such as the ideal dose of colchicine, whether progression of the disease can be slowed, and whether there are gender or age differences in response. Colchicine may prove to be a cost-effective, low risk drug for sufferers of hand OA, in which case it will be the first pharmaceutical option to help treat OA, beyond pain killers. This research is ongoing. Recruitment will continue until the target of 62 enrolled participants is met. Efforts to recruit, including advertisements in local newspapers/magazines and via web channels will continue. If positive results are found, we will aim to submit for a grant to perform a larger randomised controlled trial over a longer term to confirm the results of the pilot study.