Table 4 Profiles of adverse events.

From: Effect of desalted Salicornia europaea L. ethanol extract (PM-EE) on the subjects complaining memory dysfunction without dementia: a 12 week, randomized, double-blind, placebo-controlled clinical trial

  

PM-EE

(n = 32)

Placebo

(n = 31)

P value

Severity

Mild

7*

6§

1.000

Moderate

0

0

Severe

0

0

Causality

Definite

0

0

0.070

Probable

0

0

Possible

0

0

Unlikely

0

3

Unrelated

7

3

  1. *1 tinnitus event, 2 dyspepsia events, 1 gastroesophageal reflux disease event, 1 irritable bowel syndrome event, 1 herpes zoster skin infection, and 1 trigeminal neuralgia event. §1 dyspepsia event, 1 skin polyp event, 1 herpes zoster skin infection, 1 cervical cyst in the uterus, 1 alopecia areata event, and 1 pruritus event.