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Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS) Post Treatment Lyme Disease Syndrome (PTLDS), Fibromyalgia Leading Research. Delivering Hope.Open Medicine Foundation® Canada

SIMPLE Study: Impact of Saline Infusion on ME/CFS, POTS and Long COVID

Study Aim

The study will compare the effectiveness of different saline formulations, including a placebo, in individuals with ME/CFS, Long COVID, and POTS, to determine the most beneficial types and understand their impact on patient improvement.

Investigators

  • David Fineberg, MBBS, FRACGP, DCH
  • Elena Schneider-Futschik, PhD
  • Kristin Brown, PhD
  • Christopher Armstrong, PhD

Updates and Potential

  • The most commonly reported treatment that improves ME/CFS is IV saline.
  • Intervention trial where patients will each be provided with a mock saline infusion, a saline infusion, saline with dextrose infusion and a Hartmann’s solution.
  • This will form the basis for future trials to be used in conjunction with saline.
  • Recruitment to begin later 2024.
  • Submitted mechanistic paper on Metformin for ME/CFS and LC.
STUDY HYPOTHESIS AND DESCRIPTION

Several trial treatments for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have utilized saline, with the placebo within those trials also being saline. Consequently, these placebos have shown high improvement levels, suggesting a significant placebo effect. Additionally, many patients, including those with ME/CFS, Long COVID, and Postural Orthostatic Tachycardia Syndrome (POTS), respond positively to saline infusion. Therefore, investigating the impact of saline on these conditions is valuable.

Saline’s rapid improvement in these patients allows for the observation of objective measures of improvement within a short timeframe. This study proposes to trial different saline formulations, including a placebo sham saline, saline alone, saline with dextrose, and Hartmann’s solution, in the same individuals. By comparing their effectiveness beyond placebo, we aim to understand which types of saline or treatments are most beneficial for individuals and why.

Detailing the impact of saline infusion can elucidate its efficacy, identify patient populations most likely to benefit, and characterize its effects for future trials involving saline. This study has the potential to inform clinical practice and improve treatment strategies for individuals with ME/CFS, Long COVID, and POTS.

OBJECTIVES

The image displays an IV bag, attached to a metal stand, indicating a medical or clinical setting.

  1. Assess impact of volume expansion in ME/CFS and LC.
  2. Assess outcome markers against the rapid improvement in symptoms experienced from saline solution.
  3. Determine which type of saline is most effective.
  4. Match effective saline to patient using data collected prior to infusions.