Dataset Information

Effects of herbal medicine (Danggwijagyaksan) for treating climacteric syndrome with a blood-deficiency-dominant pattern: A randomized, double-blind, placebo-controlled pilot trial.

ABSTRACT:

Background

Danggwijagyaksan (DJS) has been one of the most widely used herbal medicines for gynecological disorders in traditional East Asian medicine. Several clinical studies about DJS have shown improvement in menopausal symptoms. This pilot study aimed to evaluate the efficacy, safety and feasibility of DJS for treating climacteric syndrome with a blood-deficiency-dominant pattern.

Methods

This was a randomized, double-blind, placebo-controlled pilot trial. A group of 45-to 60-year-old women with climacteric syndrome were registered for the trial. The participants received treatment over a 4-week period and were then followed for 4 weeks. The primary outcome measure was the mean change in the Menopause Rating Scale (MRS). Secondary outcome measures included the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Blood-Deficiency Scoring System (BDSS), lean body mass, and serum hormone levels, including follicle-stimulating hormone (FSH) and estradiol (E₂) levels.

Results

The MRS and BDSS scores decreased significantly in both groups, but the differences between two groups were not significant. The WHOQOL-BREF scores increased in the control group. No statistically meaningful differences in serum hormone levels or lean body mass were observed in both groups. There were no serious adverse events, and the laboratory tests were within the normal range. The recruitment rate, completion rate and medication adherence rate were over 90% in both groups, indicating high feasibility.

Conclusions

DJS showed clinical effectiveness in the treatment of climacteric syndrome with a blood-deficiency-dominant pattern. Additionally, DJS was shown to be safe and feasible for a large-scale study to confirm the efficacy of the treatment. Trial registration: Clinical Research Information Service (CRIS, https://cris.nih.go.kr): KCT0002387.

SUBMITTER: Park EJ

PROVIDER: S-EPMC7903340 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Effects of herbal medicine (<i>Danggwijagyaksan)</i> for treating climacteric syndrome with a blood-deficiency-dominant pattern: A randomized, double-blind, placebo-controlled pilot trial.

Park Eun-Ji EJ Baek Seon-Eun SE Kim Mikyung M Kim Ae-Ran AR Park Hyo-Ju HJ Kwon Ojin O Lee Jun-Hwan JH Yoo Jeong-Eun JE

Integrative medicine research 20210109 3

<h4>Background</h4><i>Danggwijagyaksan (DJS)</i> has been one of the most widely used herbal medicines for gynecological disorders in traditional East Asian medicine. Several clinical studies about <i>DJS</i> have shown improvement in menopausal symptoms. This pilot study aimed to evaluate the efficacy, safety and feasibility of <i>DJS</i> for treating climacteric syndrome with a blood-deficiency-dominant pattern.<h4>Methods</h4>This was a randomized, double-blind, placebo-controlled pilot trial ...[more]

PMID: 33665100

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