Basic information from the ME Association on Naltrexone
Naltrexone:
1 is an unproven and highly speculative form of drug treatment for ME/CFS and for all the other conditions like MS - where it is sometimes being used in the private medical sector
2 is unlikely to be prescribed by an NHS doctor for ME/CFS
3 could cause adverse effects, some of which are similar to, or the same as, ME/CFS symptoms - see below
We receive very mixed reports regarding both efficacy and safety. So in our current state of knowledge this is not a drug that we recommend or endorse
I would however point out that there has been one small clinical trial involving the use of naltrexone in fibromylagia, a condition that has some overlapping features with ME/CFS
Abstract, as published on MEA website:
From Arthritis and Rheumatism, 28 January 2013.
Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels†
Jarred Younger*, Noorulain Noor, Rebecca McCue, Sean Mackey
Department of Anesthesia, Stanford University School of Medicine, 780 Welch Road, Suite 207F, Palo Alto, CA 94304-1573
Abstract
OBJECTIVE
To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily
self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.
METHODS
Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.
RESULTS
When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P =
0.039), but not improved fatigue or sleep.
Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.
CONCLUSION
The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication.
POTENTIAL SIDE-EFFECTS OF NALTREXONE:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Skin rash
Rare
- Abdominal or stomach pain (severe)
- blurred vision, aching, burning, or swollen eyes
- chest pain
- confusion
- discomfort while urinating or frequent urination
- fever
- hallucinations or seeing, hearing, or feeling things that are not there
- itching
- mental depression or other mood or mental changes
- ringing or buzzing in the ears
- shortness of breath
- swelling of the face, feet, or lower legs
- weight gain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Abdominal or stomach cramping or pain (mild or moderate)
- anxiety, nervousness, restlessness or trouble sleeping
- headache
- joint or muscle pain
- nausea or vomiting
- unusual tiredness
Less common
- Chills
- constipation
- cough, hoarseness, runny or stuffy nose, sinus problems, sneezing, or sore throat
- diarrhea
- dizziness
- fast or pounding heartbeat
- increased thirst
- irritability
- loss of appetite
- sexual problems in males
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Dr Charles Shepherd
Hon Medical Adviser, MEA