PMID- 32185949
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200318
IS  - 2589-451X (Electronic)
IS  - 0255-2922 (Linking)
VI  - 38
IP  - 1
DP  - 2018 Feb
TI  - Effect of Zuogui pill and Yougui pill on osteoporosis: a randomized controlled 
      trial.
PG  - 33-42
AB  - OBJECTIVE: To evaluate the effect and safety of Zuogui pill and Yougui pill, 
      classic Yin and Yang tonic formula (CYYTF), in the treatment of osteoporosis and 
      the underlying mechanism. METHODS: Participants aged 55 to 75 with osteoporosis 
      and Kidney deficiency in Traditional Chinese Medicine (TCM) will be included and 
      randomly allocated into two groups: treatment group and control group. 
      Participants in the treatment group were treated with Zuogui pill or Yougui pill 
      TCM formula granule, while the control group received placebo. Primary outcomes 
      are the lumbar spine on bone mineral density (BMD) (L1-4) and femoral BMD. 
      Secondary outcomes include pain intensity, health-related quality of life 
      (HRQoL), bone turnover markers and safety. RESULTS: Totally 200 patients were 
      enrolled from December 2014 to April 2016 from four hospitals. There were no 
      statistically significant differences between the two groups at baseline (P > 
      0.05) and it was good to comparability. Statistically significant differences 
      between the two groups were observed for the lumbar BMD (L1-4), pain VAS scores 
      and HRQoL at six months and twelve months and femoral BMD at twelve months (P < 
      0.05), but no significant differences for femoral BMD and bone turnover markers 
      at six months (P > 0.05). Moreover, significant difference was observed at 
      different time before and after treatment in terms of lumbar spine (L1-4) BMD, 
      femoral BMD, pain VAS scores and health-related quality of life, and there was an 
      crossover effect between the time and groups before and after treatment. In 
      additional, in the treatment group, 8 patients lost to follow-up and 3 patients 
      had adverse events (AEs) and in the control group, 10 patients lost to follow-up 
      and 2 patients had AEs. No remarkable differences were observed between the two 
      groups with regard to AEs, lost rate and safety (P > 0.05). CONCLUSION: Zuogui 
      pill or Yougui pill could improve BMD, ease pain, relieve Kidney deficiency 
      syndrome, improve the quality of life osteoporosis patients, inhibit bone 
      conversion and regulate the coupling balance of bone formation and bone 
      resorption, but long-term efficacy should be confirmed by a longer term follow-up 
      and larger of samples clinical randomized controlled trials.
FAU - Li, Wenxiong
AU  - Li W
AD  - Institute of Orthopedics, Shaanxi University of Traditional Chinese Medicine, 
      Xi?an 712000, China.
FAU - Liu, Zhu
AU  - Liu Z
AD  - Institute of Orthopedics, Shaanxi University of Traditional Chinese Medicine, 
      Xi?an 712000, China.
FAU - Liu, Li
AU  - Liu L
AD  - Institute of Orthopedics, Shaanxi University of Traditional Chinese Medicine, 
      Xi?an 712000, China.
FAU - Yang, Feng
AU  - Yang F
AD  - Institute of Orthopedics, Shaanxi University of Traditional Chinese Medicine, 
      Xi?an 712000, China.
FAU - Li, Wenxiong
AU  - Li W
AD  - Department of Orthopedics, Affiliated Hospital of Shaanxi University of 
      Traditional Chinese Medicine, Xi?an 712083, China.
FAU - Zhang, Kuaiqiang
AU  - Zhang K
AD  - Department of Orthopedics, Affiliated Hospital of Shaanxi University of 
      Traditional Chinese Medicine, Xi?an 712083, China.
FAU - Liu, Zhu
AU  - Liu Z
AD  - Department of Orthopedics, Affiliated Hospital of Shaanxi University of 
      Traditional Chinese Medicine, Xi?an 712083, China.
FAU - Cheng, Yan
AU  - Cheng Y
AD  - Department of Orthopedics, Shaanxi Province Hospital of TCM, Xi?an 710021, China.
FAU - Yin, Jichao
AU  - Yin J
AD  - Department of Orthopedics, Xi?an Hospital of TCM, Xi?an 710021, China.
FAU - Sun, Yindi
AU  - Sun Y
AD  - Department of Orthopedics, Xi?an Honghui Hospital, Xi?an 710021, China.
LA  - eng
GR  - 81473711/National Natural Science Foundation of China/
GR  - 201507006-01/Special Fund for TCM Research in the Public Interest/
GR  - 2015SF072/the Shaanxi Program of Science and Technology/
PT  - Journal Article
PL  - China
TA  - J Tradit Chin Med
JT  - Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan
JID - 8211546
SB  - IM
OTO - NOTNLM
OT  - Bone resorption
OT  - Osteoporosis
OT  - Quality of life
OT  - Treatment outcome
OT  - You Gui Wan
OT  - Zuo Gui Wan
EDAT- 2018/02/01 00:00
MHDA- 2018/02/01 00:01
CRDT- 2020/03/19 06:00
PHST- 2020/03/19 06:00 [entrez]
PHST- 2018/02/01 00:00 [pubmed]
PHST- 2018/02/01 00:01 [medline]
AID - 2742 [pii]
PST - ppublish
SO  - J Tradit Chin Med. 2018 Feb;38(1):33-42.