Speaker
Matthew Shun-Shin, BMBCh, PhD
Imperial College London
Topic
The SAMSON Trial: An N-of-1 Trial of Statin, Placebo, and No Treatment to Assess Patient Symptoms
Keywords
Statins; SAMSON; N-of-1 study design; Side effects; Placebo; Nocebo effect
Key Points
- Studies have shown that more than half of patients abandon statin medications completely within 2 years. Yet, placebo-controlled trials do not show excess withdrawals in the statin arm.
- The SAMSON trial was a double-blind, three-group, N-of-1 trial in which participants were randomized to receive 12 one-month medication bottles in a computer-generated sequence. Four bottles contained statin tablets, 4 contained placebo tablets, and 4 were empty. The aim was to determine, for an individual participant, to what extent their symptoms were associated with the statin. Participants used a smartphone to rate the severity of their symptoms every day.
- After 1 year, personalized study results were shared with each participant (n=60). Six months later, the study team evaluated whether participants were able to restart a statin.
Discussion Themes
The most important message from the SAMSON trial is that side effects from statin tablets are very real, but they are mainly caused by the act of taking the tablets, not the statin contained within them.
Because this N-of-1 design incorporated a period with no medication, participants could see as clearly as the study team the powerful magnitude of the “nocebo effect.” This resulted in half the participants successfully restarting statins.
Read more about the SAMSON trial in a letter from study investigators in the New England Journal of Medicine and an interview in Medscape.
Tags
#pctGR, @Collaboratory1