Aim: Complaints about Δ⁹-tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex^®; GW Pharma Ltd, Salisbury, UK) in the management of multiple sclerosis spasticity include unpleasant taste and oral mucosal anomalies. This pilot study assessed the use of sugar-free chewing gum and/or a refrigerated bottle of THC:CBD oromucosal spray to mitigate these effects. Materials & methods: Patients with multiple sclerosis spasticity (n = 52) at six sites in Italy who were receiving THC:CBD oromucosal spray and had associated oral mucosal effects were randomized into Group A (chewing gum; n = 15); Group B (cold bottle; n = 20); and Group C (cold bottle + chewing gum; n = 17). Results: Taste perception in patients receiving chewing gum ± cold bottle intervention (Groups A and C combined) was significantly (p = 0.0001) improved from baseline to week 4 while maintaining spasticity control. Conclusion: Patient comfort, satisfaction and treatment adherence may benefit from these interventions.

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Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 8, No. 2

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History

Received 22 November 2017

Accepted 19 January 2018

Published online 23 April 2018

Published in print April 2018

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Acknowledgements

The study team acknowledge and thanks the collaboration of the participant patients, the staff in the involved centres and the support clinical research organization team (OPIS srl Italy). These data were presented as a poster at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2017, Paris, France, 25–28 October 2017.

Financial & competing interests disclosure

This study was sponsored by Almirall S.A., Barcelona, Spain. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from the compliant and disclosed fees received for the study conduction.

Writing assistance was utilized in the production of this manuscript. Writing assistance was provided by Content Ed Net (Madrid, Spain), with funding from Almirall S.A. (Barcelona, Spain).

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. For investigations involving human subjects, informed consent has been obtained from the participants involved.

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