Open-Label Placebo Treatment of Women With Premenstrual Syndrome

Premenstrual Syndrome Clinical Trial

— OLPPMS_1  

Official title:

Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547661
• Other study ID #: ID 2017-02186
• Secondary ID: 325130_170117
• Status: Completed
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: June 28, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• P-Dragees rosa Lichtenstein
Placebo dragées

Locations

Country	Name	City	State
Switzerland	University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
Jens Gaab

Country where clinical trial is conducted

Switzerland, 

References & Publications (10)

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. Erratum in: Pain. 2017 Feb;158(2):365. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

Sampson GA. Premenstrual syndrome: a double-blind controlled trial of progesterone and placebo. Br J Psychiatry. 1979 Sep;135:209-15. — View Citation

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. — View Citation

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. Epub 2016 Oct 15. — View Citation

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. Epub 2005 Oct 19. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Experience of study participation in intervention groups	By means of semi-structured interviews, participants experience of participation in interventions groups of 10 women of the open-label placebo without treatment rationale group and of 10 women of the open-label placebo with treatment rationale group, who are randomly chosen out of the 50 participants of each of the intervention study groups will be assessed.	One time assessment, up to 2 years after baseline. The interview takes between 30 and 60 minutes