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Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial.
Menopause. 2006 Sep-Oct; 13(5):744-59.M

Abstract

OBJECTIVE

To investigate the efficacy and safety of the special extract ERr 731 from the roots of Rheum rhaponticum compared to placebo in perimenopausal women with climacteric complaints.

DESIGN

A multicenter, prospective, randomized, double-blind, placebo-controlled, clinical trial in which 109 women with climacteric complaints received either one enteric-coated tablet of ERr 731 (n = 54) or placebo (n = 55) daily for 12 weeks. Primary outcome criterion for efficacy was the change in Menopause Rating Scale II (MRS II) total score after 12 weeks. Other efficacy assessments analyzed number and severity of hot flushes, menopause-specific quality of life, number of bleeding/spotting days, and treatment outcome.

RESULTS

By 12 weeks, the MRS II total score and each MRS II symptom significantly decreased in the ERr 731 group compared to the placebo group (P < 0.0001). After 4 weeks, ERr 731 also significantly decreased the number and severity of hot flushes (P < 0.0001). After 12 weeks, the overall menopause-specific quality of life was significantly better in women treated with ERr 731 compared with placebo (P < 0.05). Treatment outcome assessed by investigators and participants was better in the ERr 731 group, and ERr 731 was better tolerated than placebo. There were no differences in gynecological findings including endometrial biopsies, bleeding, weight, blood pressure, pulse, and laboratory safety parameters between the treatment groups. No adverse events were classified as being related to the investigational medication.

CONCLUSIONS

Compared to placebo, ERr 731 significantly reduces the occurrence and severity of climacteric complaints in perimenopause. It is also safe and well tolerated.

Authors+Show Affiliations

Health Research Services Ltd., St. Leon-Rot, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16894335

Citation

Heger, Marianne, et al. "Efficacy and Safety of a Special Extract of Rheum Rhaponticum (ERr 731) in Perimenopausal Women With Climacteric Complaints: a 12-week Randomized, Double-blind, Placebo-controlled Trial." Menopause (New York, N.Y.), vol. 13, no. 5, 2006, pp. 744-59.
Heger M, Ventskovskiy BM, Borzenko I, et al. Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial. Menopause. 2006;13(5):744-59.
Heger, M., Ventskovskiy, B. M., Borzenko, I., Kneis, K. C., Rettenberger, R., Kaszkin-Bettag, M., & Heger, P. W. (2006). Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial. Menopause (New York, N.Y.), 13(5), 744-59.
Heger M, et al. Efficacy and Safety of a Special Extract of Rheum Rhaponticum (ERr 731) in Perimenopausal Women With Climacteric Complaints: a 12-week Randomized, Double-blind, Placebo-controlled Trial. Menopause. 2006 Sep-Oct;13(5):744-59. PubMed PMID: 16894335.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial. AU - Heger,Marianne, AU - Ventskovskiy,Boris M, AU - Borzenko,Irina, AU - Kneis,Kyra C, AU - Rettenberger,Reinhard, AU - Kaszkin-Bettag,Marietta, AU - Heger,Peter W, PY - 2006/8/9/pubmed PY - 2007/9/19/medline PY - 2006/8/9/entrez SP - 744 EP - 59 JF - Menopause (New York, N.Y.) JO - Menopause VL - 13 IS - 5 N2 - OBJECTIVE: To investigate the efficacy and safety of the special extract ERr 731 from the roots of Rheum rhaponticum compared to placebo in perimenopausal women with climacteric complaints. DESIGN: A multicenter, prospective, randomized, double-blind, placebo-controlled, clinical trial in which 109 women with climacteric complaints received either one enteric-coated tablet of ERr 731 (n = 54) or placebo (n = 55) daily for 12 weeks. Primary outcome criterion for efficacy was the change in Menopause Rating Scale II (MRS II) total score after 12 weeks. Other efficacy assessments analyzed number and severity of hot flushes, menopause-specific quality of life, number of bleeding/spotting days, and treatment outcome. RESULTS: By 12 weeks, the MRS II total score and each MRS II symptom significantly decreased in the ERr 731 group compared to the placebo group (P < 0.0001). After 4 weeks, ERr 731 also significantly decreased the number and severity of hot flushes (P < 0.0001). After 12 weeks, the overall menopause-specific quality of life was significantly better in women treated with ERr 731 compared with placebo (P < 0.05). Treatment outcome assessed by investigators and participants was better in the ERr 731 group, and ERr 731 was better tolerated than placebo. There were no differences in gynecological findings including endometrial biopsies, bleeding, weight, blood pressure, pulse, and laboratory safety parameters between the treatment groups. No adverse events were classified as being related to the investigational medication. CONCLUSIONS: Compared to placebo, ERr 731 significantly reduces the occurrence and severity of climacteric complaints in perimenopause. It is also safe and well tolerated. SN - 1072-3714 UR - https://www.unboundmedicine.com/medline/citation/16894335/Efficacy_and_safety_of_a_special_extract_of_Rheum_rhaponticum__ERr_731__in_perimenopausal_women_with_climacteric_complaints:_a_12_week_randomized_double_blind_placebo_controlled_trial_ L2 - https://doi.org/10.1097/01.gme.0000240632.08182.e4 DB - PRIME DP - Unbound Medicine ER -