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SAMSON trial

  • Research type

    Research Study

  • Full title

    Self-Assessment Method for Statin side-effects Or Nocebo (SAMSON) trial.

  • IRAS ID

    165971

  • Contact name

    Darrel Francis

  • Contact email

    Darrel@DrFrancis.org

  • Eudract number

    2015-004109-18

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Cardiovascular disease remains the main cause of death world-wide. Medical advances have brought forward effective preventative regimes but despite this many people outside trials do not persist with medicines because of adverse symptoms attributed to medication. Yet analysis of the 83,880 patients who have received statin versus placebo in double-blinded randomised controlled trials show no sign of a tendency for greater adverse symptom rates on statins versus placebo (leaving aside the known propensity to increased glucose). This project will develop, test and deliver a method for determining within an individual patient to what extent symptoms are associated with the statin or merely the taking of a medication (the nocebo effect). We will also make available an open-source hardware and software tool that enables any patient to establish for themselves whether the side-effects are truly caused by the drug or are nocebo.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    15/LO/1761

  • Date of REC Opinion

    4 Nov 2015

  • REC opinion

    Favourable Opinion