Self-Assessment Method for Statin Side-effects Or Nocebo
Status:
Active, not recruiting
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
Front-line clinicians cannot currently test for an individual participant whether symptoms
experienced are the pharmacological result of a statin or due to other phenomena. In this
trial, participants who have previously ceased statins due to side effects will be offered
the opportunity to undergo twelve randomly ordered 1-month periods. There will be four
periods of no medication, four periods of placebo and four periods of statin. The placebo and
the statin pills will be identical in appearance. Participants will record on a daily basis
side-effects experienced. At the end of the study, the one-month sessions are sorted into the
order shown above. The participant can then observe directly how much of the increase in
symptoms seen with statin is also seen with placebo.
1. Hypothesis 1: that >30% of participants enrolling for the study will complete it.
2. Hypothesis 2: Overall >50% of symptom burden is nocebo rather than pharmacological
3. The investigators will define the Nocebo proportion of side effects.
4. Hypothesis 3: that the majority of participants, at 6 months after completion, will
either be taking statins or have declined statins for reasons other than perceived side
effects.