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Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled

Christien T Klein-Laansma1, Mats Jong2, Cornelia von Hagens3

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Homeopathic treatment (HT) as an add-on to usual care (UC) significantly improved premenstrual syndrome (PMS/PMDD) symptoms compared to UC alone. However, challenges in international trial feasibility suggest further research is needed.

Keywords:
PMS/PMDDhomeopathypragmatic trialspremenstrualrandomized clinical trials

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Area of Science:

  • Integrative medicine
  • Women's health
  • Clinical research methodology

Background:

  • Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) significantly impact women's well-being.
  • Homeopathy presents a potential therapeutic avenue for PMS/PMDD, necessitating rigorous investigation.
  • The feasibility of conducting international pragmatic trials for homeopathic treatments requires evaluation.

Purpose of the Study:

  • To assess the feasibility of an international randomized pragmatic trial comparing homeopathic add-on treatment (UC + HT) with usual care (UC) alone for PMS/PMDD.
  • To evaluate the efficacy of homeopathic treatment as an adjunct to usual care in managing PMS/PMDD symptoms.

Main Methods:

  • A multicenter, randomized, controlled pragmatic trial with parallel groups was conducted in the Netherlands, Sweden, and Germany.
  • Women diagnosed with PMS/PMDD were randomized to receive either UC + HT or UC for 4 months.
  • Symptom severity was assessed using the Daily Record of Severity of Problems (DRSP) and other validated questionnaires before and after treatment.

Main Results:

  • The study faced challenges with legal limitations in Germany and recruitment difficulties in Sweden.
  • In the Netherlands and Sweden, 60 women were randomized, with 47/46 analyzed (ITT/PP).
  • A significant improvement in DRSP scores was observed in the UC + HT group compared to the UC group (p=0.03) after 4 months.

Conclusions:

  • Conducting larger international pragmatic trials for individualized homeopathy in PMS/PMDD is challenging due to recruitment and legal variations.
  • The study demonstrated a significant added value of homeopathic treatment compared to usual care, supporting further investigation.
  • Despite feasibility issues, the positive results warrant continued research into homeopathic interventions for PMS/PMDD.