Self-Assessment Method for Statin Side-effects Or Nocebo
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.
Timeline
- Start
- 2016-03
- Primary completion
- 2020-10-31
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 20 mg | Oral |