Can melatonin help relieve pain in patients with painful diabetic nerve disease?

This study aimed to explore the effects of melatonin in addition to pregabalin (Lyrica) for the management of painful diabetic neuropathy (PDN). The authors concluded that melatonin added to pregabalin may help in reducing pain related to PDN in patients with type 2 diabetes (T2D).

Diabetic neuropathy (DN) or nerve fiber damage is a complication related to DM. Painful diabetic neuropathy (PDN) is debilitating. It is associated with a combination of burning, tingling, electric-like or achy sensations usually in the feet, and skin sensitivity. The exact reason for PDN is not well understood and current treatment is mainly symptomatic. Pregabalin is an anti-seizure medication used as a first-line treatment for PDN.

Studies indicate that agents which prevent inflammation and oxidation are potentially beneficial for PDN management. Melatonin is a neurohormone widely known for its effects on sleep regulation. It also inhibits inflammation, oxidation, and pain sensation. Since there is an association between sleep deprivation and increased pain sensitivity, there is a need to explore the effect of melatonin on PDN management.

This 8-week study included 103 patients with T2D. Patients were randomly assigned to receive either pregabalin and melatonin (52) or pregabalin and placebo (51). At bedtime, patients were given a 150 mg oral dose of pregabalin, once per day. Melatonin was given at 3 mg per day at bedtime for 1 week, followed by 6 mg for 7 weeks. Changes in average pain score and quality of life (QoL) were recorded every day by patients.

The average pain score was reduced by 50% or more in 63.5% of patients that received pregabalin and melatonin after 8 weeks, compared to 43.1% in the placebo group. Patients in the treatment group had a significantly lower pain severity and a better QoL, compared to those given placebo.

There were 49 side effects reported in the melatonin group compared to 32 in the placebo group. The most common side effects were daytime sleepiness and dizziness. Most of these were mild and were resolved with time.

The study showed that melatonin may be a good addition to pregabalin for the improvement of pain and sleep disturbance linked to PDN.

The study included a small number of patients and the follow-up period was short. Moderate doses of melatonin were given to patients. The study relied on self-reporting to evaluate side effects. Further studies using larger patient numbers and longer follow-up visits are needed to confirm results.