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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) |
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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
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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 |
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Digital Object Identifier DOI |
10.1136/bmjopen-2019-032868 |
PubMed ID |
http://www.ncbi.nlm.nih.gov/pubmed/32071176 |
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02/05/2024
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