Open-Label Placebo Treatment of Women With Premenstrual Syndrome (OLPPMS_1)

Jens Gaab

Status: Completed

Conditions: Premenstrual Syndrome

Treatments: Other: P-Dragees rosa Lichtenstein

Study type: Interventional

Funder types: Other

Identifiers

NCT03547661

325130_170117 (Other Grant/Funding Number)

ID 2017-02186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe PMS
• Between 18 and 45 years of age
• A regular menstrual cycle, i.e., max. +/- 3 days of difference of cycle range
• Menstrual cycle range not longer than 31 or shorter than 24 days
• Participants have a general practioner or gynaecologist to consult
• At least one premenstrual symptom causes the desire for a PMS treatment

Exclusion criteria

• Brest feeding at the moment or during the last three months
• Pregnancy
• Failing menstruation onset in the course of two consecutive menstrual cycles
• An essential mental or somatic disease
• Drug or massive alcohol intake or of other psychoactive substances
• Uptake of a new medication within the last 30 days
• Menopause, premenopausal strain or amenorrhoea
• Allergy of one of the ingredients of the placebo dragées (P-Dragees rosa Lichtenstein)
• Women who are surgically sterilised, hysterectomised, or ovariectomised
• BMI above 30
• Actual or recent participation in psychotherapy due to premenstrual symptoms
• Parallel participation in another study with investigational drugs or participation in another PMS study within the last three months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Treatment as Usual

No Intervention group

Description:

The treatment as usual (TAU) group will control for regression to the mean, spontaneous remission, natural course of disease, and the participants-provider interaction. Participants of the TAU group are allowed to continue their usual medication intake, given they are already on a stable dose (at least 30 days of intake) and the medication is not listed in the exclusion criteria.

Integrative Open-Label Placebo

Active Comparator group

Description:

The intervention will encompass an integrative administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000. All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take two dragées a day for six weeks. (Amendment regarding dosage since 08/18)

Treatment:

Other: P-Dragees rosa Lichtenstein

Open-Label Placebo

Active Comparator group

Description:

The intervention will encompass an administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000. All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take two dragées a day for six weeks. (Amendment regarding dosage since 08/18)

Treatment:

Other: P-Dragees rosa Lichtenstein