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Use of LDN As A Potential Treatment For Multiple Sclerosis

Dr. Maira Gironi
November 01, 2009
Interview with Dr. Maira Gironi, Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Milan, Italy
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What gave you the initial idea that LDN might be effective in multiple sclerosis?

LDN has been thought to trigger prolonged release of beta-endorphins (BE) - endogenous opioids exerting several influences on the immune system. In addition, this opioid has shown to interact at different levels with the endocannabinoid system. This finding drove us to speculate that both the symptomatic effect (i.e. on spasticity) and the cannabinoid-mediated neuroprotection (extensively documented by literature) could be co-shared by BE and by a drug increasing their level, such as LDN.

Could you tell us a little about your clinical work with LDN in multiple sclerosis?

We ran an open-label trial of LDN (4 mg/day) in 40 patients with a diagnosis of primary progressive multiple sclerosis (MS). Five drop-outs occurred and only two major adverse events were reported, the remaining side effects being mild and transitory. Although the study was not powered specifically to assess efficacy, a significant effect on spasticity, and some positive influence on fatigue and depression were observed. However the most striking result was the beta-endorphin increase, which began 3 months after the start of therapy and was still evident one month after therapy discontinuation. This confirmed that the drug is at least biological active.

How have you found patient satisfaction with LDN compared with other therapies?

The subjective satisfaction of patients wasn't specifically investigated, but the rate of response to some of the symptoms evaluated (i.e. spasticity, fatigue, depression and some items of quality of life) suggest a high level of satisfaction.

Is patient compliance with LDN better than with other therapies?

Considering the rate of drop-outs (12 percent), we believe that this drug could be well tolerated.

What side effects have your patients encountered?

Most side effects documented were mild and reversible (i.e. a moderate increase in spasticity, urinary infections or mild liver enzymes increase). Very few were severe such as hepatic steatosis , or worsening disease.

What are the main benefits of using LDN compared with other standard therapies for multiple sclerosis?

The cost/effectiveness ratio is strongly in favour of LDN. On the negative side, LDN causes mild and transient adverse effects; on the positive side, it offers the convenience of oral administration, with low cost, good compliance and some effect on spasticity.

Do you believe LDN should be used widely in all patients with multiple sclerosis?

In order to address this question we are designing a second study aimed at investigating the objective effectiveness of the drug. A randomized, controlled, double-blind trial will clarify whether or not the effects reported are just placebo-triggered. We believe this hypothesis is unlikely because of the objective increase detected in BE.