Efficacy of Fufang E'jiao Jiang in the Treatment of Patients with Qi and Blood Deficiency Syndrome: A Real-World Prospective Multicenter Study with a Patient Registry

Mengjie Zhao; Mengli Xiao; Jiake Ying; Panbo Qiu; Hongxian Wu; Qin Tan; Shiliang Chen; Lulu Zhang; Sanfei Shi; Guida Li; Yang Zhao; Fang Lu

doi:10.1155/2023/3179489

Efficacy of Fufang E'jiao Jiang in the Treatment of Patients with Qi and Blood Deficiency Syndrome: A Real-World Prospective Multicenter Study with a Patient Registry

Evid Based Complement Alternat Med. 2023 Feb 3:2023:3179489. doi: 10.1155/2023/3179489. eCollection 2023.

Authors

Mengjie Zhao^{1

2

3}, Mengli Xiao², Jiake Ying², Panbo Qiu², Hongxian Wu⁴, Qin Tan², Shiliang Chen⁵, Lulu Zhang⁶, Sanfei Shi⁷, Guida Li⁸, Yang Zhao², Fang Lu^{2

3}

Affiliations

¹ Graduate School of Beijing University of Chinese Medicine, Beijing 100029, China.
² NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Xiyuan Hospital, China Academy of Chinese Medicine Sciences, Beijing 100091, China.
³ National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medicine Sciences, Beijing 100091, China.
⁴ Zhongshan Hospital, Fudan University, Shanghai 200032, China.
⁵ Shucheng Hospital of Traditional Chinese Medicine, Shucheng, Anhui 231300, China.
⁶ Liaocheng People's Hospital, Liaocheng, Shandong 252000, China.
⁷ Pan'an County TCM Hospital, Panan, Zhejiang 322300, China.
⁸ Feixian People's Hospital, Feixian, Shandong 273400, China.

Abstract

Objective: This nationwide, multicenter prospective observational study with a patient registry was designed to evaluate the efficacy of Fufang E'jiao Jiang (FEJ) in Chinese patients with Qi and blood deficiency syndrome (QBDS).

Methods: QBDS patients were consecutively recruited from 81 investigational sites in China from July, 2019, to December, 2020. Patients who met the eligibility criteria were enrolled in a prospective registry database. Baseline characteristics and changes in scores on the traditional Chinese medicine (TCM) symptom evaluation scale for Qi and blood deficiency, the clinical global impression (CGI) scale, the fatigue scale-14 (FS-14), and the Pittsburgh sleep quality index (PSQI) were analyzed to determine the clinical efficacy of FEJ.

Results: A total of 3,203 patients were recruited. The average remission rate (i.e., the sum of the cure rate and improvement rate) of the 20 symptoms of QBDS was 92.49% after 4 weeks of FEJ treatment, which was higher than at baseline; the rate increased to 94.69% at 8 weeks. The CGI scale revealed that the number of total remissions at 4 and 8 weeks was 3,120 (97.41%) and 415 (100%), respectively. The total FS-14 scores decreased by 1.67 ± 4.11 (p < 0.001) at 4 weeks and 1.72 ± 3.09 (p < 0.001) at 8 weeks of treatment. The PSQI scores were 6.6 ± 4.7 and 6.52 ± 3.07 at 4 and 8 weeks, respectively, which were significantly lower than the baseline scores (p < 0.001; p = 0.0033). Both the subhealth fatigue (SF) and iron deficiency anemia (IDA) groups showed significantly improved clinical symptoms of QBDS (p < 0.01). Between-group comparisons revealed significantly greater improvements in FS-14 and PSQI scores in the SF group than in the IDA group (p < 0.05). A multivariate logistic regression analysis showed that disease course, FS-14 score at baseline, and four-week FEJ doses were independent risk factors for the degree of symptom relief in QBDS patients (p < 0.05).

Conclusion: In real-world settings, FEJ has a promising effect in treating QBDS and can significantly improve the severity of its symptoms.