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FACT
Focus on Alternative and Complementary Therapies

Bromelain as an adjunctive treatment for moderate-to-severe osteoarthritis of the knee: a randomised placebo-controlled pilot study

Brien S1, Lewith G1, Walker AF2, Middleton D3, Prescott P4, Boyle T1, Bundy R2
1Complementary Medicine Research Unit, Department of Primary Medical Care, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Hampshire, Southampton SO16 5ST, UK
2Hugh Sinclair Unit of Human Nutrition, School of Biosciences, The University of Reading, PO Box 226, Whiteknights, Reading RG6 6AP, UK
3Medic Herb UK Ltd, Brewery Courtyard, Draymans Lane, Bucks, Marlow SL7 2XG, UK
4Faculty of Mathematical Studies, University of Southampton, University Road, Highfield, Southampton SO 17 1BJ, UK

Objective

Current conventional treatment for the most prevalent joint disorder, knee osteoarthritis (OA), is associated with a high incidence of adverse reactions. Bromelain, an extract from the pineapple plant, has purported anti-inflammatory and analgesic properties, and may provide a safer alternative or adjunctive treatment. This pilot is the first double-blind placebo-controlled study to assess bromelain’s specific efficacy and safety profile for this condition.

Materials and methods

Forty-seven subjects with moderate-to-severe knee OA were randomised in this double-blind, randomised placebo-controlled study to receive 12 weeks of treatment intervention (bromelain 800 mg/day or placebo) with a 4-week follow-up. Monthly knee (pain, stiffness and function) and quality of life symptoms were reported using the WOMAC and SF-36 questionnaires. Adverse events were also recorded. The primary outcome measure was the change in total WOMAC score from baseline to the end of treatment. Longitudinal models were used to evaluate outcome.

Results

Thirty-one patients completed the trial (n=14 bromelain; n=17 placebo). Both treatment groups reported an overall relative reduction in mean total WOMAC scores that was clinically significant for the bromelain group (bromelain group 25.2% improvement; placebo 14.2% improvement) although no statistically significant group differences were observed (coefficient = 11.16, P = 0.27, CI −8.86 to 31.18). Clinically relevant reductions in the WOMAC pain and stiffness subscales were also identified in both groups, and the bromelain group demonstrated clinical improvement in the WOMAC disability scores. However, no statistically significant group differences were reported in these WOMAC subscores nor in the quality of life assessment. Adverse events were generally mild in nature.

Conclusion

Bromelain may potentially be effective in the treatment of moderate-to-severe OA in a fully powered study.

Acknowledgements

This study was funded by the Lichtwer Pharma UK Ltd and Boots PLC. Medications were supplied free of charge by Lichtwer Pharma UK Ltd, Marlow, Bucks, UK. Dr Brien’s fellowship was funded by the Hospital Savings Association, Dr Lewith’s post was funded by a grant from the Maurice Laing Foundation, Dr Walker’s post was funded by the University of Reading and Dr Bundy’s fellowship was funded by Lichtwer Pharma UK.

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