Assessing the Therapeutic Potential of a Traditional Botanical Remedy for Menstrual Pain: Insights From a Prospective Observational Analysis

Effectiveness of Bryophyllum Pinnatum in the Treatment of Primary Dysmenorrhea: a Prospective Observational Study

Primary dysmenorrhea (PDM) affects round 60 to 90% of women and has a great impact on everyday life of affected women, leading to decreased work productivity, cognitive activity and cuts in social life. The aetiology of pain symptoms mainly results from increased contractile activity. Non-rhythmic and uncoordinated contractions lead to high uterine pressure, which together with vasoconstriction result in reduced blood flow and ultimately in painful uterine ischemia. Conventional treatment options are limited to pain medication such as paracetamol, non-steroidal anti-inflammatory drugs (NSAID) or - especially, but not only, if contraception is also desired - hormonal contraceptives. Due to the frequent occurrence of (sometimes severe) side effects, there has been a lack of effective treatment options that can be taken regularly without hesitation. The succulent herb Bryophyllum pinnatum (BP) (Lam.) Oken. (Crassulaceae) (synonym: Kalanchoe pinnata) originated in Madagascar,but is at present found in wide-ranging (sub)tropical regions of Africa and Asia. In Switzerland, BP is often used in obstetrics and gynaecology, so far mainly for preterm labour (as a tocolytic), and in some cases for overactive bladder syndrome, nocturia and sleeping disorders, but not for dysmenorrhea. Current pharmacological data on the inhibition of myometrial contractile mechanisms by BP preparations as well as its reported use against inflammation and pain in ethnomedicine made us hypothesize that BP might be a new treatment option for PDM.

Primary objective of the study:

Assessment of the PDM - associated menstrual pain

Secondary objectives of the study:

Assessment of the quality of life in PDM Recording of AEs under study medication Compliance

Study Overview

• Status: Active, not recruiting
• Conditions: Dysmenorrhea Primary
• Intervention / Treatment: Drug: Bryophyllum

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8001
    • Paracelsus Zentrum am Grossmünster
  • Aargau
    • Aarau, Aargau, Switzerland, 5000
      • Private Centre for Obstetrics and Gynecology "Geburt und Familie"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Age between 18 and 45 years with regular menstrual cycles (21-35 days)
• Menstrual pain rated 6 or higher on an 11-point PI-NRS during the most painful day
• In good general health
• Provided written informed consent
• Willing to maintain the same personal hygienic product throughout the study (e.g., tampons, pads, menstrual cups; no changes in menstrual hygiene practices allowed during the study)

Exclusion Criteria

• Secondary dysmenorrhea (i.e. in endometriosis, adenomyosis, urogenital malformations)
• Currently taking, or had taken in the past two months, hormonal forms of birth control
• Dysmenorrhea reasonably suspected to be due to a IUD
• Prior or current liver or kidney disease, inflammatory bowel disease, reproductive cancer (uterine, ovarian, etc.)
• Personal history of known hypersensitivity to the used drug or its ingredients or to drugs with a similar chemical structure
• Other diseases that do not allow the subject to assess the nature and scope as well as possible consequences of the clinical study
• Pregnant or breastfeeding women
• Signs that the subject is unlikely to comply with the protocol (e.g., unwillingness to cooperate)
• Alcohol/drug abuse
• Non-German speaking patients (Patient information is only available in German)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group with Bryophyllum Pinnatum; The study group receive Bryophyllum Pinnatum (tablets) for 6 Months	Drug: Bryophyllum; Bryophyllum Pinnatum - tablets, for 6 Months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (Numeric Rating Intensity - NRI)	Measurement of the intensity of the pain during the menstrual periods: a score of 0 means no pain, a score of 10 means the maximal pain	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• Zurfluh L, Spinelli MG, Betschart C, Simoes-Wust AP. Repurposing of Bryophyllum pinnatum for dysmenorrhea treatment: a systematic scoping review and case series. Front Pharmacol. 2023 Dec 1;14:1292919. doi: 10.3389/fphar.2023.1292919. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Primary Dysmenorrhea; Bryophyllum Pinnatum
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea
• Other Study ID Numbers: KEK-2024-01549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share the primary and secondary outcomes of each patients undergone treatment with Bryophyllum Pinnatum
• IPD Sharing Time Frame: from the end of the study (31/12/2028) for 10 years
• IPD Sharing Access Criteria: Researchers who want to reaserch further Bryophyllum Pinnatum in Dysmenorrhea or related research topics. They can contact the PI to receive information. They will receive the row data of the outcomes of each patient.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No