Phase II trial of LDN results released
1 March 2010
Results of a phase II clinical trial testing the safety and effectiveness of low-dose naltrexone (LDN) as a symptom-relief treatment for people with MS have been published in the journal Annals of Neurology. The journal reported positive outcomes for mental quality of life, but no impact on physical quality of life in people with MS.
The results of the randomised double-blind placebo controlled study suggest that LDN is safe and may have positive effects on mental quality of life in people with MS. The work, led by Dr. Bruce Cree at the University of California in San Francisco, is the first placebo controlled clinical trial to look at the effects of LDN in people with MS.
The Study
The trial enrolled 80 patients with MS who were randomised to receive either LDN or a placebo treatment for an eight week period. At the end of the eight weeks participants were taken off treatment for one week and then put on the other treatment (either placebo or LDN) for a further eight weeks.
Participants were asked to answer questions about their quality of life by filling in surveys at the beginning, half-way through the trial and at the end of the trial.
The Results
Of the original 80 participants enrolled on the trial, data from only 60 were included in the final analysis because of withdrawals, errors in database management, and incomplete survey results, which has limited the ability of researchers to draw firm conclusions about the effectiveness of LDN in people with MS.
The trial did, however, demonstrate that LDN is a relatively safe treatment for MS as vivid dreaming was the only symptom that some people reported as a result of taking LDN.
Researchers analysing the data broke down results of the quality of life survey and found suggestions of an improvement of mental quality of life for people taking LDN, but no improvement in physical quality of life was reported.
Conclusions
Due to the high drop-out rate of participants of the trial, researchers were unable to reach firm conclusions about the effectiveness of LDN on overall quality of life. Researchers concluded that LDN is a relatively safe treatment for MS, but more research will be needed in larger controlled trials to determine its effectiveness.
Dr Susan Kohlhaas, Research Communications Officer at the MS Society said, “We are really pleased to see results of this study published. The next step will be to complete larger, more detailed clinical trials to determine the potential of LDN as a symptom relief therapy for people with MS.”
The Study
The trial enrolled 80 patients with MS who were randomised to receive either LDN or a placebo treatment for an eight week period. At the end of the eight weeks participants were taken off treatment for one week and then put on the other treatment (either placebo or LDN) for a further eight weeks.
Participants were asked to answer questions about their quality of life by filling in surveys at the beginning, half-way through the trial and at the end of the trial.
The Results
Of the original 80 participants enrolled on the trial, data from only 60 were included in the final analysis because of withdrawals, errors in database management, and incomplete survey results, which has limited the ability of researchers to draw firm conclusions about the effectiveness of LDN in people with MS.
The trial did, however, demonstrate that LDN is a relatively safe treatment for MS as vivid dreaming was the only symptom that some people reported as a result of taking LDN.
Researchers analysing the data broke down results of the quality of life survey and found suggestions of an improvement of mental quality of life for people taking LDN, but no improvement in physical quality of life was reported.
Conclusions
Due to the high drop-out rate of participants of the trial, researchers were unable to reach firm conclusions about the effectiveness of LDN on overall quality of life. Researchers concluded that LDN is a relatively safe treatment for MS, but more research will be needed in larger controlled trials to determine its effectiveness.
Dr Susan Kohlhaas, Research Communications Officer at the MS Society said, “We are really pleased to see results of this study published. The next step will be to complete larger, more detailed clinical trials to determine the potential of LDN as a symptom relief therapy for people with MS.”
