Mingshi Formula （明视方） for Low Myopia in Children with Heart Yang Insufficiency Syndrome： A Multicentre， Double-Blind， Randomised Placebo-Controlled Study
10.13288/j.11-2166/r.2024.06.008
- VernacularTitle:中药明视方干预儿童低度近视心阳不足证的多中心、随机双盲安慰剂对照临床研究
- Author:
Jianquan WANG
1
;
Xinyue HOU
1
;
Zefeng KANG
1
;
Yingxin YANG
2
;
Xinquan LIU
3
;
Zhihua SHEN
4
;
Xiaoyi YU
5
;
Jing YAO
6
;
Fengming LIANG
7
;
Fengmei ZHANG
8
;
Jingsheng YU
9
;
Ningli WANG
10
;
Man SONG
11
;
Hongrui SUN
1
;
Xin YAN
1
Author Information
1. Eye Hospital， China Academy of Chinese Medical Sciences， Beijing ，100040
2. Beijing Hospital of Traditional Chinese Medicine， Capital Medical University
3. Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
4. Shenzhen Traditional Chinese Medicine Hospital
5. The First Affiliated Hospital of Guangzhou University of Chinese Medicine
6. First Affiliated Hospital， Heilongjiang University of Chinese Medicine
7. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
8. Henan Province Hospital of Traditional Chinese Medicine
9. The First Hospital of Hunan University of Chinese Medicine
10. Beijing Tongren Hospital， Capital Medical University
11. Fuzhou Hospital of Traditional Chinese Medicine， Fujian University of Traditional Chinese Medicine
- Publication Type:Journal Article
- Keywords:
low myopia;
children;
Mingshi Formula （明视方）;
imbalance of essence and sinew;
heart yang insufficiency syndrome
- From:
Journal of Traditional Chinese Medicine
2024;65(6):587-593
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the effectiveness and safety of the Chinese herbal medicine Mingshi Granules （明视方颗粒） for low myopia in children with heart yang insufficiency. MethodsA multicentre， prospective， double-blind randomised controlled study was conducted， in which 290 children with low myopia from 8 centres were randomly divided into 145 cases in the treatment group and 145 cases in the control group， and the treatment group was given education， dispensing glasses， and Chinese herbal medicine Mingshi Granules， while the control group was given education， dispensing glasses， and granules placebo. Both Mingshi Granules and placebo granules were taken orally， 1 bag each time， twice daily， 4 weeks of oral intake and 2 weeks of rest as 1 course of treatment， a total of 4 courses of treatment （24 weeks）. Equivalent spherical lenses， best naked-eye distance visual acuity， ocular axis， corneal curvature K1， adjustment amplitude， traditional Chinese medicine （TCM） symptom scores， calculate the amount of progression of equivalent spherical lenses， were observed at the 12th and the 24th week of treatment， at the 36th week and 48th week of follow-up， resectively， the control rate of myopia progression was evaluated at the 24th week， and safety indexes were observed before treatment. ResultsThe amount of progression of equivalent spherical lenses was lower in the treatment group than in the control group at the 48-week follow-up （P＜0.05）. The control rate of myopia progression at 24 weeks after treatment in the treatment group was higher （57.60%， 72/125） than that in the control group （44.63%， 54/121） （P＜0.05）. The best naked-eye distance visual acuity at 36-week follow-up in the treatment group was higher than that in the control group （P＜0.05）. Equivalent spherical lenses were significantly lower in both groups at all observation time points compared with pre-treatment （P＜0.05）， and were higher in the treatment group than in the control group at the 48-week follow-up （P＜0.05）. The ocular axes of both groups were significantly higher at each observation time point after treatment and at follow-up compared with before treatment （P＜0.05）. The amount of eye axis growth in the treatment group was lower than that in the control group at 24 weeks after treatment and at the 48-week follow-up （P＜0.05）. Corneal curvature K1 was significantly lower in the treatment group at the 24th week of treatment compared to pre-treatment （P＜0.05）. The magnitude of adjustment in the treatment group was significantly higher at the 36-week follow-up and at the 48-week follow-up than before treatment （P＜0.05）. The scores of white/dark complexion， white coating thin pulse， fatigue and total TCM symptom scores of children in both groups at the 12th， 24th， 36th and 48th weeks of follow-up were significantly lower than those before treatment （P＜0.05）； the scores of blurred vision at the 24th and 36th weeks of follow-up were significantly lower than those before treatment （P＜0.05）； and the scores of blurred vision in the treatment group at the 48th week of follow-up were signi-ficantly lower than those before treatment （P＜0.05）. In the treatment group， the score of fatigue was higher than that of the control group at the 36-week follow-up， and the score of blurred vision was lower than that of the control group at the 48-week follow-up （P＜0.05）. No adverse reactions or obvious abnormalities of the safety indexes were observed of the two groups during the treatment. ConclusionChinese herbal medicine Mingshi Granules showed the effect of controlling the progression of low myopia， improving the best naked eye distance visual acuity， slowing down the growth of the eye axis， improving some of the TCM symptoms， with good safety.
