Clinical Research Office. A partnership between Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

Leading research into effective treatment of neuropathic pain could mean improved quality of life for diabetes patients

Researchers at Sheffield Teaching Hospitals NHS Foundation Trust are hopeful that diabetes patients suffering with neuropathic pain could benefit as a result of findings from the largest and longest ever neuropathic pain trial in the world.

Diabetic peripheral neuropathic pain (DPNP) is caused by a type of nerve damage which may result in severe pain in the feet, legs and hands. Neuropathic pain, most commonly described as a burning or electric shock-like sensation, can be intractable and debilitating.

Affecting up to a quarter of people with diabetes, it can cause severe disruption to daily activities and may lead to depression, anxiety, lack of sleep and a poor quality of life.

The OPTION-DM trial, which was funded by the National Institute for Health Research (NIHR), is the largest and longest ever, head-to-head, crossover neuropathic pain trial in the world. Findings will inform future treatment guidelines, not only for neuropathic pain in diabetes patients, but chronic neuropathic pain treatment in general.

Current guidance from the National Institute for Health and Care Excellence (NICE) recommends a choice of four drugs as initial treatment for DPNP, however until now there has been little comparative evidence on which is best, or whether they should be combined.

The trial therefore sought to understand which medication treatment choices work best for patients and whether combination drugs are more effective than single medications at a maximum dose.

Findings from the trial have demonstrated that all treatments provided similar and significant pain reduction for patients. The trial also found that combination treatment, where needed, led to significantly better pain relief and improved quality of life for patients.

Professor Solomon Tesfaye, Research Director of Diabetes and Endocrinology, and Consultant Physician/Endocrinologist at Sheffield Teaching Hospitals NHS Foundation Trust, led the trial which followed 130 patients across 13 centres in the UK for a 51-week period. He said:

“This trial brings focus on the plight of people who suffer from painful neuropathy and will lead to increased awareness and improved treatment for patients. Despite large variations in the cost and availability of each medication, it is reassuring that all three are similar in their effectiveness for relieving pain and so this study has great potential to influence treatment guidelines for DPNP, not only in the UK, but across the world. I would like to thank all the patients who participated in this long and demanding trial”.

Results from the OPTION-DM trial, which have now been published in the world-leading medical journal, the Lancet, will be instrumental in improving treatment and quality of life for patients suffering with DPNP.