# A Continuous Oral Regimen of High-Dose Cromolyn Sodium Is Effective for Some Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Patients With Mast Cell Activation Syndrome

## TL;DR

High-dose cromolyn sodium taken continuously throughout the day may help some ME/CFS patients with mast cell activation syndrome.

## Contribution

A new continuous high-dose oral regimen for cromolyn sodium is proposed and shown to be effective in some ME/CFS patients with MCAS.

## Key findings

- A continuous dosing regimen of 1600-2400 mg cromolyn daily improved symptoms in five MCAS patients.
- Higher-than-usual cromolyn doses were well-tolerated and effective within FDA safety guidelines.
- The continuous regimen may offer better compliance and symptom control than traditional dosing.

## Abstract

Our clinical experience in the last four years using oral cromolyn in patients with mast cell activation syndrome (MCAS) suggests that a continuous oral regimen of high-dose cromolyn may enhance compliance with the medication. The five patients described in this retrospective case series were given instructions to take oral cromolyn using a continuous dosing regimen, placing the entire day’s dose in an opaque bottle that is then filled with water, and sipping the solution throughout the day. If a conventional maximum dose of eight vials daily (800 mg) was tolerated but ineffective after a week, the patients were instructed to increase to 1600-2400 mg daily until reaching an optimal effect. We report that a cromolyn dose of 1600-2400 mg daily, administered using the continuous oral dosing regimen during the day, was effective in controlling signs and symptoms of mast cell activation. All five patients benefitted from a dose of cromolyn that is higher than usual and customary recommendations, but within the safety guidelines of the original Food and Drug Administration (FDA) application. The continuous oral regimen has some theoretical advantages over four discrete doses per day, though further study is needed.