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Effect of Danlu capsules for the treatment of breast hyperplasia with mastalgia:
a multicenter, double-blind, randomized controlled trial protocol
#MMPMID41195182
Guo Q
; Luo Z
; Huang J
; Xu R
; Dai Y
; Chen Q
Front Med (Lausanne)
2025[]; 12
(?): 1687673
PMID41195182
show ga
BACKGROUND: Mastalgia is a prevalent condition among women. Conservative
treatment is initially recommended, and tamoxifen is considered a second-line
option, but it can cause menopausal-like symptoms. Chinese patent medications are
proposed as alternatives, yet evidence remains insufficient. Danlu capsules,
which are recommended in certain clinical practice guidelines for breast
hyperplasia in China, have demonstrated therapeutic effects on breast pain.
However, high-quality randomized controlled trials are lacking to clarify Danlu
capsules' efficacy in treating breast pain. This study aims to examine the
effectiveness and safety of Danlu capsules for the treatment of mastalgia.
METHODS: This study is a multicenter, randomized, double-blind,
placebo-controlled, and superiority clinical trial involving 264 participants,
which will be randomly assigned in a 1:1 ratio to either receive Danlu capsule or
placebo via a centralized system. All participants will undergo an eight-week
treatment period and an additional 4?weeks of follow-up. The primary outcome will
be the breast pain assessed using the visual analog scale (VAS). Secondary
outcomes will include the evaluation of the quality-of-life questionnaire, the
self-rating anxiety questionnaire, and the self-rating depression questionnaire.
Safety monitoring and adverse event recording will be implemented throughout the
study. Efficacy will be assessed through covariance analysis for primary
endpoints and t-tests for secondary outcomes, with mixed models for repeated
measures comparing breast pain VAS score changes at weeks 4, 8, and 12. All
statistical analyses will be conducted using SAS (9.4), and no interim analyses
will be performed. DISCUSSION: This trial will evaluate the clinical efficacy and
safety of Danlu capsules in treating breast hyperplasia with mastalgia. The
findings are expected to provide an evidence-based treatment option supporting
the potential role of Chinese patent medicine in the management of breast pain.
CLINICAL TRIAL REGISTRATION: http://itmctr.ccebtcm.org.cn/, ITMCTR2025000715.
free
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