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Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial.
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
 
ID 4610762
Author(s) Frey Nascimento, Antje; Gaab, Jens; Kirsch, Irving; Kossowsky, Joe; Meyer, Andrea; Locher, Cosima
Author(s) at UniBasel Gaab, Jens
Frey Nascimento, Antje
Kossowsky, Joe
Locher, Cosima
Year 2020
Title Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial.
Journal BMJ open
Volume 10
Number 2
Pages / Article-Number e032868
Keywords PMS symptom diary; open-label placebos; premenstrual syndrome; randomised controlled trial; treatment rationale
Abstract

Recent evidence suggests that for certain clinical conditions, placebos can improve clinical outcomes even without deception. These so-called; open-label placebos; (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles. Although premenstrual syndrome (PMS) seems to be considerably susceptible to placebo effects, no study has examined open-OLP responses on PMS.; To test the efficacy of OLPs in women suffering from PMS, a clinical randomised controlled trial including two OLP study groups (with and without treatment rationale) was designed to investigate on the effect on PMS. PMS symptoms are monitored on a daily basis via a symptom diary, adverse events are monitored intermittently. The study started in spring 2018 and patients will be included until a maximum of 150 participants are randomised. Besides the primary outcome PMS symptom intensity and interference, an array of further variables is assessed. Multilevel modelling will be used for data analyses.; Ethics approval was obtained from the Ethics Committee Northwest and Central Switzerland. Results of the main analysis and of secondary analyses will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: (1) ClinicalTrials.gov (NCT03547661); (2) Swiss national registration (SNCTP000002809).

ISSN/ISBN 2044-6055
Full Text on edoc
Digital Object Identifier DOI 10.1136/bmjopen-2019-032868
PubMed ID http://www.ncbi.nlm.nih.gov/pubmed/32071176
   

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