ANODYNE study: A double-blind randomized trial of greater occipital nerve block of methylprednisolone and lignocaine versus placebo as a transitional preventive treatment for episodic cluster headache

ANODYNE Study Overview

This study investigates the effectiveness of greater occipital nerve block (GONB) using methylprednisolone and lignocaine for preventing episodic cluster headaches.

Background

There is limited evidence on how well GONB works for treating cluster headaches. This study aimed to evaluate its effectiveness and safety as a transitional preventive treatment.

Methods

Conducted in New Delhi, India, the trial involved patients aged 18-65 diagnosed with episodic cluster headaches. Participants were either not on preventive medications or had stable doses for at least three months. They were randomly assigned to receive either:

  • Active Treatment: GONB with 2 ml of methylprednisolone and 2 ml of lignocaine
  • Placebo: 4 ml saline injections

Before the injection, lignocaine jelly was applied to reduce numbness. The main goal was to measure the change in weekly headache frequency from baseline to Week 4.

Results

Forty patients participated between December 2021 and January 2023. The results showed:

  • Active Group: Average reduction of 11.1 attacks per week
  • Placebo Group: Average reduction of 7.7 attacks per week
  • Mean Difference: 3.4 attacks (p < 0.001)

Adverse effects were mild and temporary, with no serious events reported.

Conclusion

The study concluded that GONB significantly reduces the frequency of cluster headache attacks and is well tolerated by patients.

Value of Clinical Trials

Clinical trials are essential for developing safe and effective treatments. They help integrate new findings into everyday medical practice.

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