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. 2017 Dec 27:8:304.
doi: 10.4103/sni.sni_266_17. eCollection 2017.

Long-chain omega-3 fatty acids in aneurysmal subarachnoid hemorrhage: A randomized pilot trial of pharmaconutrition

Geisi Saito  1 , Rodrigo Zapata  2 , Rodrigo Rivera  3 , Héctor Zambrano  4 , David Rojas  5   6 , Hernán Acevedo  6 , Franco Ravera  7 , John Mosquera  2 , Juan E Vásquez  2 , Jorge Mura  5   8
Affiliations

Long-chain omega-3 fatty acids in aneurysmal subarachnoid hemorrhage: A randomized pilot trial of pharmaconutrition

Geisi Saito et al. Surg Neurol Int. .

Abstract

Background: Functional recovery after aneurysmal subarachnoid hemorrhage (SAH) remains a significant problem. We tested a novel therapeutic approach with long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) to assess the safety and feasibility of an effectiveness trial.

Methods: We conducted a multicentre, parallel, randomized, open-label pilot trial. Patients admitted within 72 hours after SAH with modified Fisher scale scores of 3 or 4 who were selected for scheduled aneurysm clipping were allocated to receive either n-3 PUFA treatment (parenteral perioperative: 5 days; oral: 8 weeks) plus usual care or usual care alone. Exploratory outcome measures included major postoperative intracranial bleeding complications (PIBCs), cerebral infarction caused by delayed cerebral ischemia, shunt-dependent hydrocephalus, and consent rate. The computed tomography evaluator was blinded to the group assignment.

Results: Forty-one patients were randomized, but one patient had to be excluded after allocation. Twenty patients remained for intention to treat analysis in each trial arm. No PIBs (95% confidence interval [CI]: 0.00 to 0.16) or other unexpected harm were observed in the intervention group (IG). No patient suspended the intervention due to side effects. There was a trend towards improvements in all benefit-related outcomes in the IG. The overall consent rate was 0.91 (95% CI: 0.78 to 0.96), and there was no consent withdrawal.

Conclusions: Although the balance between the benefit and harm of the intervention appears highly favourable, further testing on SAH patients is required. We recommend proceeding with amendments in a dose-finding trial to determine the optimal duration of parenteral treatment.

Keywords: Omega-3 fatty acids; pharmaconutrients; pharmaconutrition; randomized pilot trial; subarachnoid hemorrhage.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Flow diagram of the participants through the clinical trial phases
See this image and copyright information in PMC

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