Symptom Response to Low-Dose Naltrexone in Fibromyalgia: An Exploratory Analysis of the Randomized Placebo-Controlled FINAL Trial, 2026, Nielsen et al

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Symptom Response to Low-Dose Naltrexone in Fibromyalgia: An Exploratory Analysis of the Randomized Placebo-Controlled FINAL Trial

Nielsen, Maria Juul; Vaegter, Henrik Bjarke; Bruun, Karin Due

Abstract

Background: Fibromyalgia (FM) remains difficult to manage due to a highly variable symptom profile. The "FINAL" randomized, placebo-controlled trial examined the efficacy of low-dose naltrexone (LDN) on pain in women with FM, showing no significant difference in pain reduction at the group level but potentially higher 30% pain response rates. Analysis of secondary outcomes showed potential improvements in memory problems.

Objectives: This exploratory analysis aimed to further investigate individual responses to LDN treatment by analyzing 30% responder rates for six secondary FM outcomes.

Methods: The FINAL trial included 99 women with FM who were randomized 1:1 to treatment with LDN or placebo for 12 weeks. Based on original data from this trial, 30% response rates were assessed for the six selected secondary outcomes: tenderness, fatigue, sleep disturbances, depression, memory problems, and stiffness. Risk ratios (RR) with 95% confidence intervals (CI) were calculated to assess differences between groups.

Results: No significant differences were found between treatment groups for any of the symptom response categories. The highest RR was observed for memory (RR = 1.67, 95% CI: 0.82-2.95), followed by sleep (RR = 1.28, 95% CI: 0.92-2.64), stiffness (RR = 1.26, 95% CI: 0.84-2.89, p = .47), tenderness (RR = 1.16, 95% CI: 0.88-2.67), fatigue (RR = 1.10, 95% CI: (0.78-3.13) and depression (RR = 0.96, 95% CI: 0.92-2.66).

Conclusions: Response rates for 30% improvement in six selected nonpain outcomes were similar after 12 weeks treatment with LDN or placebo in women with FM. Larger studies investigating 30% response rates are warranted.

Keywords: Depression; Exploratory analysis; Fatigue; Fibromyalgia; Low dose Naltrexone; Memory problems; Naltrexone; Sleep disturbances; Stiffness; Tenderness.

Web | DOI | Pain Management Nursing
 
I'm glad they did this analysis. Yes, they're trying to salvage something from a negative trial, but applying the 30% rule of thumb for improvement in pain research to non-pain outcomes is something I'd like to see more of.

It's better than the statistically derived minimum important differences that have been used in the UK studies of GET/CBT, for example, where we get things like 8 points on a scale of 0-100 being considered clinically important.
 
Evergreen said:
I'm glad they did this analysis. Yes, they're trying to salvage something from a negative trial, but applying the 30% rule of thumb for improvement in pain research to non-pain outcomes is something I'd like to see more of.

It's better than the statistically derived minimum important differences that have been used in the UK studies of GET/CBT, for example, where we get things like 8 points on a scale of 0-100 being considered clinically important.
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30 % of what? The baseline value or the scale?

30 % more of 30 would be 9, which is lower than the usual 10 % threshold for the 100 point scales.
 
Utsikt said:
30 % of what? The baseline value or the scale?

30 % more of 30 would be 9, which is lower than the usual 10 % threshold for the 100 point scales.
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I'd prefer it to be 30% of the scale, but in pain studies, it's of your own baseline value. So if you have a VAS pain of 7, then to be considered improved, you'd need to move down to 5 or less. I'd quite like to move down that much.

If your baseline pain level is 5, you'd have to move down to 3.5 or lower.

People with low baseline pain aren't usually included in pain studies.

So if that were applied to the SF36 physical function scale, to be considered improved, the average person with moderate ME/CFS with a baseline of 45 would have to improve by at least 13.5 points to be considered improved, rather than 8 or 10.

To make this work, I think you'd need the scales to be like pain scales, where lower scores are better. Otherwise the more severe would be considered improved with trifling changes.
 
Utsikt said:
The PRT study was on low lever pain, and I think that applies to most BPS pain studies I’ve seen.
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Which study is that?

In the 2021 Asher, Gordon, Schubiner study, for example:
Participants aged 21 to 70 years with back pain for at least half the days of the last 6 months and 1-week average pain intensity score of 4 of 10 or greater at screening were recruited from the community in Boulder, Colorado.
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People with negligible or mild pain are excluded from pain studies I've seen.
 
Evergreen said:
Which study is that?

In the 2021 Asher, Gordon, Schubiner study, for example:


People with negligible or mild pain are excluded from pain studies I've seen.
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For example that. The median baseline pain was 4.1 with the Brief Pain Inventory Short Form. That’s fairly low levels of pain in my book.

Different scales from 1-10 use different cutoffs, and the threshold for mild is usually between 3 and 5.
 
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