Front Pharmacol: Traditional Chinese medicine formulation for the treatment of rheumatoid arthritis in women, a study protocol for a double-blind, randomized, placebo-controlled trial

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease that affects women more than men
.
Clinical symptoms, disease activity, and comorbidities are more severe
in women.
In addition, treatment options for women of childbearing age are limited
due to side effects of current medications.
Therefore, there is an urgent need to develop new safer drugs
for women.
Kun Paralysis Granules (KBXG) is a traditional Chinese medicine formula that has been used in the treatment of female RA patients in Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences as a complementary therapy
.
However, there is insufficient evidence to prove its effect
.

Objective: To conduct a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety
of KBXG in the treatment of RA in women.

Methods: The study was a single-center, double-blind, randomized, parallel-group, placebo-controlled clinical trial
.
A total of 90 female RA patients had 28 joint disease activity scores (DAS28) > 3.
2
.
They were randomly assigned to receive KBXG or placebo for 12 weeks
.

Changes in DAS28 based on C-reactive protein (DAS28-CRP) and clinical disease activity index (CDAI) were the primary outcomes
.
Secondary outcomes included improvements in the US College Rheumatology Standard (ACR20, ACR50, ACR70), TCM Syndrome Score, Visual Analogue Score (VAS), mean grip strength, concomitant drug consumption, Hospital Anxiety and Depression Score (HADS), lumbar spine bone density (L-BMD), and 7 joint ultrasound score (US7) of 20%, 50%, and 70%,
respectively.
Any adverse events
will also be recorded.

Discussion: This trial will provide evidence for KBXG in reducing disease activity and improving clinical symptoms and quality of life in women with RA.

The long-term effects of KBXG in women with RA require further follow-up
.

Sources:

Wan Y, Yang J, Ma T, et al.
A Chinese medicine formula (kunbixiao granule) for female rheumatoid arthritis: Study protocol for a double-blind, randomized, placebo-controlled trial.
Front Pharmacol.
2022; 13:945565.
Published 2022 Oct 10.
doi:10.
3389/fphar.
2022.
945565