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Randomized controlled trials in therapeutic apheresis.

Jeffrey L Winters¹

¹Division of Transfusion Medicine, Mayo Clinic, Rochester, MN 55905, USA. winters.jeffrey@mayo.edu

Journal of Clinical Apheresis

|February 2, 2013

Summary

Despite an increase in therapeutic apheresis literature, high-quality randomized controlled trials remain scarce. More robust research is needed to establish apheresis as an effective therapy.

Area of Science:

Medical Science
Clinical Research

Background:

Therapeutic apheresis literature often lacks high-quality evidence.
Previous studies highlighted a deficiency in randomized controlled trials (RCTs) for apheresis.
This study assesses evidence quality trends in therapeutic apheresis research.

Purpose of the Study:

To evaluate the improvement in the quality of evidence for therapeutic apheresis since 1999.
To identify the number of ongoing RCTs in therapeutic apheresis.
To determine if the evidence base for therapeutic apheresis has strengthened.

Main Methods:

Searched MEDLINE for RCTs on therapeutic apheresis published between 2000-2012.
Searched ClinicalTrials.gov for actively recruiting RCTs in therapeutic apheresis.

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Compared findings to literature published between 1976-1999.

Main Results:

Publications on therapeutic apheresis significantly increased from 2000-2012 compared to 1976-1999.
The proportion of RCTs within the total apheresis literature slightly increased but remained low.
Trials continue to involve very small patient numbers, limiting statistical power.
Few RCTs are actively recruiting patients, according to ClinicalTrials.gov.

Conclusions:

The quality of evidence in therapeutic apheresis has not substantially improved.
A significant lack of well-designed, high-quality randomized controlled trials persists.
Further rigorous research is essential to validate the efficacy of therapeutic apheresis.