Open-Label Placebo Treatment of Women With Premenstrual Syndrome
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      This study aims to investigate the effect of an open-label placebo intervention on
      premenstrual syndrome (PMS) complaints. Women who suffer from moderate to severe PMS will be
      randomly allocated to three groups: to a treatment as usual group, an open-label placebo
      group, and an integrative open-label placebo group. Participants of all groups will conclude
      a prospective PMS screening for one menstrual cycle. Thereafter, participants of both
      intervention groups will obtain an openly administered placebo intervention for six weeks.
      Participants of the treatment as usual group will have the chance to obtain the same
      open-label placebo intervention after study conduct. Diverse measures will be assessed by
      means of a PMS symptom diary and questionnaires. Furthermore, we assess participants
      experiences of study participation qualitatively by means of semi-structured interviews.
    

Detailed description: 
      Recent evidence suggests that in certain clinical conditions - such as chronic low-back pain,
      migraine, irritable bowel syndrome, attention deficit hyperactivity disorder, and rhinitis -
      placebos improve clinical outcomes even without deception. Premenstrual syndrome (PMS) is
      defined as clinically significant symptoms, comprising at least one emotional or physical
      symptom in the premenstrual phase of the menstrual cycle and which cause substantial distress
      or functional impairment. To date, there exists no study examining open-label placebo
      responses on PMS. However, PMS seems to be considerably susceptible to placebo effects: The
      Royal College of Obstetricians and Gynaecologists alerts to substantial placebo responses in
      randomized-controlled PMS trials and studies showed considerable placebo effects on PMS
      without any specific effect for the medication under examination. Furthermore, a myriad of
      distinctive therapies is described for PMS (including pharmacological and phytopharmaceutical
      drugs as well as complementary non-pharmacological interventions), yet partially mixed
      evidence is reported. Besides being considered as placebogenic, PMS symptoms are timely
      well-defined and delimited which further makes this condition attractive for an investigation
      of open-label placebo responses, as a possible amelioration can be measured in a delimited
      time frame. To sum up, a randomized controlled trial of an open-label placebo treatment of
      women with PMS allows to investigate ways to harness placebo effects ethically in clinical
      practice for syndromes with somatic and psychologically described characteristics.
    

Intervention name(s): P-Dragees rosa Lichtenstein
Intervention type(s): Other
Intervention description(s): Placebo dragées
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Premenstrual Syndrome; Open-Label Placebo Effect; randomized controlled trial