Fu SF1,
Zhao YQ,
Ren M,
Zhang JH,
Wang YF,
Han LF,
Chang YX,
Fan GW,
Wang H,
Huang YH,
Zhai JB,
Dong JY,
Li X,
Ai JQ,
Zhang H,
Zhu Y,
Zhang BL,
Sun LK,
Fan X,
Gao XM.
Abstract
OBJECTIVE:
The study aims to evaluate the effectiveness and safety of Chinese herbal
medicine granules Danzhi Qing'e formula (DZQE), Erzhi formula (EZ), and
their combination (Combined formula) in the treatment of menopausal
symptoms at different stages of menopause.
METHODS:
Women
between the ages of 40 to 60 years, who met menopausal symptoms
diagnostic criteria and experienced hot flushes at least 14 times/week
in the last 4 weeks, were recruited to participate in a stratified
randomized, double-blind, placebo-controlled clinical trial (n = 389).
They received a treatment period of 8 weeks and were followed up for 4
weeks. Participants were categorized into two subgroups: 197 in the
perimenopausal subgroup (menstrual disorder to 1 y after amenorrhea) and
192 in the early postmenopausal subgroup (1-5 y after amenorrhea).
Participants were randomly assigned to placebo or one of the three herbal formula treatments. The primary outcome instrument was the Menopause-Specific Quality of Life (MENQOL) questionnaire.
RESULTS:
When
analyzing the two subgroups together, DZQE markedly decreased the
MENQOL total score at the end of 12th week with statistical significance
(P = 0.02) and improved vasomotor symptoms after 8 weeks treatment and 4
weeks follow-up (P < 0.05). What is more, the combined formula also
greatly improved the participants' vasomotor symptoms compared with
placebo after the 4 weeks follow-up. No statistically meaningful
difference was observed in any other outcomes among the groups.The
results of subgroup analysis showed that DZQE and Combined formula were
more effective than placebo in improving MENQOL total score for
perimenopausal women at the end of week 12. For typical menopausal
symptoms such as hot flushes and night sweats, DZQE displayed more
favorable effects on early postmenopausal participants. Compared to
placebo, the DZQE both showed statistically significant differences
after 8 weeks treatment and 4 weeks follow-up. Although at the end of
12th week, DZQE also had better effects than placebo in the
perimenopausal subgroup on vasomotor symptoms. Participants in the EZ
group did not show a significant difference of any domains in MENQOL
compared with participants in the placebo group.
CONCLUSIONS:
The
DZQE formula improves the quality of life for menopausal women,
especially for those with vasomotor symptoms during the whole menopausal
period. The DZQE and EZ combination formula is effective only on
perimenopausal symptoms.
