Related Experiment Video
Updated: Feb 12, 2026
Individualized Reconstitution of Human Milk Microbiota: A Feasible Approach in Real-World Settings
Published on: February 7, 2025
Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled
Christien T Klein-Laansma1, Mats Jong2, Cornelia von Hagens3
11 Department of Health and Nutrition, Louis Bolk Institute , Bunnik, The Netherlands .
Objectives:
Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated.
Design:
A multicenter, randomized, controlled pragmatic trial with parallel groups.
Settings/Location:
The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany.
Subjects:
Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized.
Interventions:
Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences.
Outcome Measures:
Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed.
Results:
In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03).
Conclusions:
With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.
More Related Videos
06:16Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting
Published on: June 6, 2020
09:37Evaluation of Respiratory Muscle Activation Using Respiratory Motor Control Assessment RMCA in Individuals with Chronic Spinal Cord Injury
Published on: July 19, 2013
Related Concept Videos
01:20Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:30Impact of Individuals on Individuals
01:26Varicose Veins II: Diagnostic Studies and Interprofessional Care
01:29Pulmonary Embolism II: Diagnostic Studies and Interprofessional Care
01:04Random Error