Non-concealed Placebo Treatment for Menopausal Hot Flushes

NCT03838523 | Completed

• 1 other identifier: 1705-100
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

It has been long viewed that placebos cannot be administered in accordance with ethical values because deception is instrumental to the placebo effect. This notion has been shaken up by studies on open-label placebos, showing that placebos can lead to positive effects even though their inert nature is disclosed. Beneficial effects of double-blind placebos were found to be high in hot flush trials. The objective of the study is to determine whether an open-label placebo (OLP) treatment is efficacious in alleviating hot flushes and bother among peri- and postmenopausal women.

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (2)

• Difference in hot flush composite score

  The group difference between OLP and no-treatment regarding frequency x severity of hot flushes as assessed by a portable paper diary in which participants record number and severity of hot flushes in realtime

  4 weeks

• Bother by hot flushes

  The group difference between OLP and no-treatment regarding bother by hot flushes as assessed by the Hot Flush Rating Scale (Hunter \& Liao, 1995). A sum score is calculated which ranges from 3 to 30 with higher scores indicating larger bother by hot flushes.

  4 weeks

Secondary Outcomes (4)

• Hot flush frequency

  4 weeks

• Health-related quality of life

  4 weeks

• Global improvement

  4 weeks

• Number of responders at week 4

  4 weeks

Study Arms (2)

OLP group

EXPERIMENTAL

At baseline, patients are given an explanation about why placebos without deception might be effective. Women allocated to this group receive an 4-week Open Label Placebo treatment. After 4 weeks, they are randomized again to either continue or discontinue the OLP treatment for another 4 weeks.

Other: Open Label Placebo

No-treatment group

NO INTERVENTION

At baseline, patients are given an explanation about why placebos without deception might be effective. Women assigned to the no-treatment group do not receive any treatment as part of the study.

Interventions

Open Label Placebo OTHER

See group description

OLP group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 5 moderate or severe hot flushes per day, including night time
• all hot flushes have at least moderate ratings of bother (sum score ≥ 16 on the bother subscale of the Hot Flush Rating Scale (HFRS) \[41\]
• fluency in German language
• participants are in menopausal transition (irregularities ≥ 60 days in the past year), or postmenopausal (cessation of menstruation ≥ 1 year) \[42\].

You may not qualify if:

• use of hormonal therapy to treat hot flushes within the last 6 weeks before enrolment
• use of herbal remedies to treat hot flushes within the last 6 weeks before enrolment
• intake of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRI) within the last 6 weeks before enrolment
• previous oophorectomy
• severe physical or cognitive impairments which would constitute a barrier to give informed consent
• severe depression and anxiety (≥ 9 sum score or ≥ 5 depression or anxiety subscore on the Patient Health Questionnaire-4)
• medical conditions which might interact with menopausal hot flushes such as untreated hyperthyroidism, alcohol abuse (excluded when ≥4 on AUDIT-C) and cancer

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (6)

• Hunter MS, Liao KL. A psychological analysis of menopausal hot flushes. Br J Clin Psychol. 1995 Nov;34(4):589-99. doi: 10.1111/j.2044-8260.1995.tb01493.x.

  PMID: 8563666 BACKGROUND

• Geisser ME, Clauw DJ, Strand V, Gendreau MR, Palmer R, Williams DA. Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran. Pain. 2010 May;149(2):373-378. doi: 10.1016/j.pain.2010.02.043. Epub 2010 Mar 23.

  PMID: 20332060 BACKGROUND

• Guttuso T Jr, Kurlan R, McDermott MP, Kieburtz K. Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):337-45. doi: 10.1016/s0029-7844(02)02712-6.

  PMID: 12576259 BACKGROUND

• Hunter, M. S. The women's health questionnaire: A measure of mid-aged women's perceptions of their emotional and physical health. Psychology & Health, 7(1), 45-54, 1992.

  BACKGROUND

• Shin H, Shin HS. Measurement of quality of life in menopausal women: a systematic review. West J Nurs Res. 2012 Jun;34(4):475-503. doi: 10.1177/0193945911402848. Epub 2011 Mar 25.

  PMID: 21441417 BACKGROUND

• Pan Y, Meister R, Lowe B, Winkelmann A, Kaptchuk TJ, Buhling KJ, Nestoriuc Y. Non-concealed placebo treatment for menopausal hot flushes: Study protocol of a randomized-controlled trial. Trials. 2019 Aug 16;20(1):508. doi: 10.1186/s13063-019-3575-1.

  PMID: 31420050 DERIVED

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yvonne Nestoriuc, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study, patients and clinicians are aware of group assignment. Assessors are blinded to group assignment of participants. To prevent the breaking of blinding, participants are requested to not communicate their group affiliation when they have questions about the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Women with ≥5 daily moderate to severe hot flushes of at least moderate bother are assigned 1:1 to a 4-week OLP treatment or no treatment. To explore the duration and maintenance of placebo effects, participants in the OLP group are randomized a second time and divided into two subgroups who either discontinue (OLP 4wk) or continue the OLP treatment (OLP 8wk) for another 4 weeks.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 12, 2019
• Study Start: February 12, 2019
• Primary Completion: February 2, 2020
• Study Completion: March 5, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)