Treatment: Pharmacological Interventions

1 Polo et al. 2019 — Low Dose Naltrexone for Fibromyalgia

[/ Full Citation:: Polo O, Smith S, Jones DE, Newton JL. Low dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis & Rheumatology. 2019;71(10):1691–1699. (Polo et al. 2019)], DOI:: 10.1002/art.40900 Key Findings::

- Crossover RCT of low-dose naltrexone (LDN) in fibromyalgia
- Assessed daily pain levels as primary outcome

Relevance to Part V:: LDN efficacy data for neuroinflammation treatment modeling; relevant to ME/CFS–fibromyalgia overlap models.

2 White et al. 2011 — PACE Trial

Full Citation:: White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing therapy, cognitive behavior therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized trial. The Lancet. 2011;377(9768):823–836. (White et al. 2011) DOI:: 10.1016/S0140-6736(11)60096-2 Key Findings::

- Largest ME/CFS treatment trial ($n$=641) comparing CBT, GET, APT, and specialist medical care
- Originally reported benefit for CBT and GET; subsequently criticised for methodological flaws
- NICE 2021 reversed GET recommendation based on reanalysis

Relevance to Part V:: Historical benchmark trial; methodological lessons for model validation and outcome measure selection.

References

Polo, Oscar, Sharon Smith, David E Jones, and Julia L Newton. 2019. “Low Dose Naltrexone for the Treatment of Fibromyalgia: Findings of a Small, Randomized, Double-Blind, Placebo-Controlled, Counterbalanced, Crossover Trial Assessing Daily Pain Levels.” Arthritis & Rheumatology 71 (10): 1691–99. https://doi.org/10.1002/art.40900.
White, Peter D, Kimberly A Goldsmith, Anthony L Johnson, Laura Potts, Rebecca Walwyn, Julia C DeCesare, Harriet L Baber, et al. 2011. “Comparison of Adaptive Pacing Therapy, Cognitive Behaviour Therapy, Graded Exercise Therapy, and Specialist Medical Care for Chronic Fatigue Syndrome (PACE): A Randomised Trial.” The Lancet 377 (9768): 823–36. https://doi.org/10.1016/S0140-6736(11)60096-2.