Objective

2

To explore the clinical effect and safety of

Guigui Zhuanggu Tablet

（归龟壮骨片， GZT） in the treatment of low back pain in postmenopausal osteoporosis patients with kidney

yin

and

yang

deficiency syndrome.

Methods

2

A randomized double-blind placebo-controlled trial was designed. Totally 150 postmenopausal osteoporosis women with kidney

yin

and

yang

deficiency syndrome were randomized into treatment group （100 cases） and control group （50 cases）. Both groups were given 600 mg Calci D tablets orally each day. Additionally， the treatment group was given GZT while the control group was given placebo， 1.5 g per time， three times each day， for 3 months. The pain visual analogue scale （VAS） score and the clinical common symptom score were assessed before treatment， at 1-， 2- and 3-month treatment and at 6-month follow-up. The bone mineral density （BMD） and the indexes of bone metabolism including blood calcium （Ca） and phosphorus （P）， procollagen type I N-terminal propeptide （PINP）， C-terminal telopeptide of type I collagen （β-CTx）， 25-hydroxyvitamin D （25-OH-VitD）， alkaline phosphatase （ALP）， and bone gla protein （BGP） were assessed before treatment and at 6-month follow-up.

Results

2

The total effective rate of clinical common symptoms was 96.88% in the treatment group， significantly higher than 59.57% in the control group （

P

＜0.05）. The clinical common symptoms score in both groups significantly decreased at 1-， 2-， and 3-month treatment and at 6-month follow-up compared to that before treatment （

P

＜0.05）. And when compared between different time after treatment， the clinical common symptoms score significantly decreased than the former measurement in the treatment group （

P

＜0.05）. In the control group， the low back pain score and sore waist and knee score significantly decreased at 3-month treatment compared to those at 1-month treatment， also decrease at follow-up compared to those at 1- and 2-month treatment （

P

＜0.05）， while the score on lower extremity cramps， hard walk and heavy objects-lifting difficulty significantly decreased when compared between different treatment time （

P

＜0.05）. The low back pain score， sore waist and knee score and lower extremity cramps score were significantly lower in the treatment group than those in the control group at 2- and 3-month treatment and at 6-month follow up （

P

＜0.05）. The VAS scores in the two groups significantly decreased at 1-， 2-， 3-month treatment and at follow-up compared to those before treatment （

P

＜0.05）. And when compared between different time after treatment， the VAS score significantly decreased than the former measurement in the treatment group （

P

＜0.05）， while the VAS score was significantly lower at 3-month treatment and at 6-month follow-up when compared to the former measurements in the control group （

P

＜0.05）. The VAS scores were significantly lower in the treatment group than those in the control group at 2- and 3-month treatment and at 6-month follow up （

P

＜0.05）. The indexes of bone metabolism were significantly different at 6-month follow up than before treatment in both groups （

P

＜0.05）. The levels of P， PINP， β-CTx and BGP were significantly higher in the treatment group than in the control group at follow-up （

P

＜0.05）.

Conclusion

2

GZT can improve the clinical symptoms of postmenopausal osteoporosis women with low back pain due to kidney

yin

and

yang

deficiency， and can maintain bone mineral density， and has high safety.