Open-Label Placebo Treatment of Women With Premenstrual Syndrome

NCT03547661 | Completed

• 2 other identifiers: ID 2017-02186325130_170117
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Syndrome; Open-Label Placebo Effect; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• PMS symptom intensity assessed by a PMS symptom diary sub sum score

  Symptom intensity will be assessed by an intensity sub scale of the PMS symptom diary. Intensity will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of symptom intensity and 6 the highest.

  Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)

• PMS symptom interference assessed by a PMS symptom diary sub sum score

  Symptom interference will be assessed by an interference sub scale of the PMS symptom diary. Interference will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of interference and 6 the highest.

  Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)

Secondary Outcomes (1)

• Experience of study participation in intervention groups

  One time assessment, up to 2 years after baseline. The interview takes between 30 and 60 minutes

Study Arms (3)

Treatment as Usual

NO INTERVENTION

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

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)

Other: P-Dragees rosa Lichtenstein

Open-Label Placebo

ACTIVE COMPARATOR

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)

Other: P-Dragees rosa Lichtenstein

Interventions

P-Dragees rosa Lichtenstein OTHER

Placebo dragées

Integrative Open-Label Placebo; Open-Label Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jens Gaab: lead

Study Sites (1)

University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy

Basel, Canton of Basel-City, 4055, Switzerland

Location

Related Publications (12)

• Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700.

  PMID: 27755279 BACKGROUND

• Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.

  PMID: 24401940 BACKGROUND

• Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.

  PMID: 21203519 BACKGROUND

• Maharaj S, Trevino K. A Comprehensive Review of Treatment Options for Premenstrual Syndrome and Premenstrual Dysphoric Disorder. J Psychiatr Pract. 2015 Sep;21(5):334-50. doi: 10.1097/PRA.0000000000000099.

  PMID: 26352222 BACKGROUND

• O'Brien, P. S., Rapkin, A., & Schmidt, P. J. (2007). The premenstrual syndromes: PMS and PMDD: CRC Press.

  BACKGROUND

• Sampson GA. Premenstrual syndrome: a double-blind controlled trial of progesterone and placebo. Br J Psychiatry. 1979 Sep;135:209-15. doi: 10.1192/bjp.135.3.209.

  PMID: 385093 BACKGROUND

• Sandler AD, Bodfish JW. Open-label use of placebos in the treatment of ADHD: a pilot study. Child Care Health Dev. 2008 Jan;34(1):104-10. doi: 10.1111/j.1365-2214.2007.00797.x.

  PMID: 18171451 BACKGROUND

• Schaefer M, Harke R, Denke C. Open-Label Placebos Improve Symptoms in Allergic Rhinitis: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(6):373-374. doi: 10.1159/000447242. Epub 2016 Oct 15. No abstract available.

  PMID: 27744433 BACKGROUND

• Van Ree JM, Schagen Van Leeuwen JH, Koppeschaar HP, Te Velde ER. Unexpected placebo response in premenstrual dysphoric disorder: implication of endogenous opioids. Psychopharmacology (Berl). 2005 Oct;182(2):318-9. doi: 10.1007/s00213-005-0090-8. Epub 2005 Oct 19. No abstract available.

  PMID: 16001107 BACKGROUND

• Yonkers KA, O'Brien PM, Eriksson E. Premenstrual syndrome. Lancet. 2008 Apr 5;371(9619):1200-10. doi: 10.1016/S0140-6736(08)60527-9.

  PMID: 18395582 BACKGROUND

• Frey Nascimento A, Gaab J, Degen B, Rytz M, Holder A, Sezer D, Buergler S, Meyer AH, Kirsch I, Kossowsky J, Locher C. Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial. BMJ Evid Based Med. 2025 Mar 25;30(5):295-304. doi: 10.1136/bmjebm-2024-112875. Online ahead of print.

  PMID: 40132912 BACKGROUND

• Frey Nascimento A, Gaab J, Kirsch I, Kossowsky J, Meyer A, Locher C. Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 17;10(2):e032868. doi: 10.1136/bmjopen-2019-032868.

  PMID: 32071176 DERIVED

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Gaab, Prof. Dr.

  University of Basel, Faculty of Psychology, Division for Clinical Psychology and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 6, 2018
• Study Start: August 2, 2018
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)