Treating menopausal symptoms with a complex remedy or placebo: a randomized controlled trial

ABSTRACT

Objective To evaluate the efficacy and safety of a complex remedy compared with placebo to treat menopausal symptoms.

Methods A total of 102 peri- and postmenopausal women requiring treatment for menopausal symptoms were randomized to receive a complex anthroposophic remedy prepared in the homeopathic manner (Apis regina tota GL D4, Argentum metallicum D5, Ovaria bovis GL D4), 3 × 10 globuli daily (2 × 12 weeks) and placebo (12 weeks) in different orders of remedy (R) and placebo (P) (1: R/R/P, 2: P/R/R, 3: R/P/R). The primary endpoint was change in climacteric symptoms assessed by the Menopause Rating Scale II (MRS II) after 12 weeks. Secondary endpoints were changes of symptoms and safety throughout the study.

Results Reduction of symptoms after 12 weeks did not differ between remedy and placebo (total score MRS II: –1.4, 95% confidence interval (CI) −2.8 to 0 vs. −2.3, 95% CI −4.4 to −0.3, p = 0.441) and had no clinical relevance (defined as reduction in MRS II ≥ −3.5). Comparison of secondary outcomes at 12 weeks between remedy and placebo or between groups after the 2nd or 3rd period compared to previous periods did not differ. Treatment with remedy for 24 consecutive weeks did not reach clinical relevance either. However, total reduction of symptoms after three periods in Group 1 (R/R/P) (−5.0, 95% CI −7.5 to −2.5) and Group 2 (P/R/R) (−5.9, 95% CI −8.7 to −3.1) reached clinical relevance whereas almost no decrease of symptoms after three periods was seen in Group 3 (R/P/R) (−0.5, 95% CI −2.9 to 1.9).

Conclusions Treatment with the complex remedy for 12 or 24 weeks did not result in clinically significant improvement of menopausal symptoms.

Key words::

• MENOPAUSAL SYMPTOMS
• COMPLEMENTARY THERAPY
• ANTHROPOSOPHICAL MEDICINE
• HOMEOPATHY
• POSTMENOPAUSE
• PERIMENOPAUSE

ACKNOWLEDGEMENTS

We thank U. Mansmann for the statistical planning of the trial and his contribution to the trial protocol, J. Dreyhaupt for his statistical expertise during the ongoing trial, E. Jenetzky for writing the analysis plan and B. Reinhard-Hennch for the contribution of her clinical expertise during the planning and conduct of the trial.

Conflict of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Source of funding WALA Heilmittel GmbH, Bad Boll/ Eckwälden, the manufacturer of the medication, funded the study, provided the properly labelled study medication and weighed the remaining medication to allow determination of adherence to dosing instructions. WALA did neither influence the design, nor conduct data analysis, nor were considered in reporting or publication of the study results.