| ojective:To verify the effectiveness and safety of supplemented six-ingredient rehmannia pill to treat liver and kidney yin deficiency and postmenopausal osteoporosis and provide the train of thought for osteoporosis’s combined treatment of traditional chinese medicine and western medicine. Methods:select120cases of the patients with liver and kidney yin deficiency and postmenopausal osteoporoses, who were treated in the Traditional Chinese Medicine Section of Sichuan Provincial People’s Hospital with complete follow-up visit data, and divide the cases into Group A, Group B and Group C by the method of random number table. Each group has40cases. For Group A, age is62.41±6.48years old, menopause age is10.50±4.11years, weight is57.55±9.14kg, and TCM syndrome integral is19.02±2.37; for Group B, age is64.57±4.62years old, menopause age is11.67±4.08years, weight is58.63±8.76kg, and TCM syndrome integral is18.89±2.18; for Group C, age is63.60±5.89years old, menopause age is9.44±4.36years, weight is59.42±10.1kg and TCM syndrome integral is18.79±2.30. For Group A:Supplemented six-ingredient rehmannia pills (rehmannia glutinosa160g, dogwood80g, moutan bark60g, Chinese yam80g, poria cocos60g, rhizoma alismatis60g, deer-horn glue60g, tortoise-plastron glue60g, medlar60g, radix paeoniae alba30g, fructus psoraleae60g and drynaria rhizome60g) are grinded into fines and each100g of powders are added with100g of honey to make into honeyed pill (include crude drug6g/pill) by the pharmacy department of our hospital, take two pills per day continuously for6months; For Group B:provide5mg of Zoledronic acid injection (Aclasta) for an intravenous drip infusion; Group C:provide supplemented six-ingredient rehmannia honeyed pills and Aclasta for treatment at the same time; the usage method is the same as Group A and Group B. Three groups of patients take Caltrate D (each pill including600mg of elemental calcium, VitD3125U) one pill per time, one time per day for successive six months at the same time, and make observation and follow-up visit for the three groups of cases of illness until the12th month. Select five time observation points, namely prior treatment (zero month), the3rd,6th,9th and12th months and evaluate various traditional Chinese medicine symptoms (including①soreness and weakness of waist and knees;②pain limbs, lumbago and backache or painful heel;③fatigue and lack in strength, light-headedness;④tinnitus and amnesia;⑤dry throat and tongue;⑥hypochondriac pain;⑦insomnia and dreaminess;⑧dysphoria in chestpalms-soles and spontaneous perspiration and night sweat) by4-level scoring method (0-None,1-Light,2-Medium,3-Heavy), evaluate the pain degree of patients by using visual analogue scale (VAS), inspect lumbar vertebra and femur bone density (bone mineral density, BMD) of the patients with dual-energy X-ray bone mineral densimeter and evaluate the patients’life quality by using the life quality evaluation table (short form36questionnaire, SF-36) and take blood to examine estradiol and detect the patient’s changes in estrogen. Results:①By comparing the estradiol inspection results of Group A and Group C in the3rd,6th,9th and12th months with that before treatment, the differences are statistically significant, which indicates that estradiol level has increased obviously after giving drug; By comparing the estradiol inspection results of Group B with that before treatment, the differences aren’t statistically significant; By comparing estradiol level of Group A in the6th and9th months, the difference is statistically significant (t=2.33,P=0.04); By comparing estradiol level of Group C in the6th and9th months, the difference is statistically significant (t=2.9748,P=0.03), it indicates that there is still a certain improvement in estradiol level after drug withdrawal; By comparing the estradiol level of Group A in the9th and12th months, the difference has no statistical significance (t=1.80,p=0.10); By comparing the estradiol level of Group A in the9th and12th months, the difference has no statistical significance; By comparing the estradiol concentrations of Group C in the9th and12th months, the difference has no statistical significance (t=1.39,P=0.26), which indicates that estradiol still can be kept at a certain level and will not go down after drug withdrawal for more than three months;②VAS score:Compared with that before treatment, VAS score of Group A has improved, the difference has statistical significance, it indicates that supplemented six-ingredient rehmannia pill has a certain effect of alleviating pain; by comparing VAS scores of Group A in the9th and12months with that in the6th month, the differences have no statistical significance (t=22.93, P=1.29,t=19.32, P=0.86), which indicates supplemented six-ingredient rehmannia pill can’t further alleviate the patients’ pains; Changes of Group B and Group C at various time points after treatment are more obvious than that of Group A, it indicates that merely using supplemented six-ingredient rehmannia pill isn’t better than bisphosphonates for alleviating pain. By comparing VAS scores of Group C at each time point after treatment with that of Group A (t=9.25,P=0.00,t=7.03,P=0.00,t=4.12,P=0.00t=3.54,P=0.00) and comparing VAS scores of Group C at each time point after treatment with that of Group B (t=10.66,P=0.00,t=8.21,P=0.00, t=6.29,P=0.00,t=5.18,P=0.00), the differences are statistically significant, which indicates that supplemented six-ingredient rehmannia pill combined with bisphosphonates can better alleviate pain compared with merely using supplemented six-ingredient rehmannia pill.③SF-36score:By comparing SF-36scores of Group A at each time point after treatment with that before treatment (t=8.40,P=0.00,t=5.21,P=0.00, t=3.08,P=0.00,t=2.23,P=0.00), the differences are statistically significant, which indicates supplemented six-ingredient rehmannia pill has a certain effect on improving life quality; By comparing SF-36scores of Group A at each time point after treatment with that of Group B, the differences are statistically significant (t=18.40,P=0.00,t=13.73,P=0.00, t=7.84,P=0.00,/=2.17,P=0.00), which indicates that supplemented six-ingredient rehmannia pill can better improve life quality compared with bisphosphonates; By comparing SF-36scores of Group C at each time point after treatment with that of Group A and Group B, the differences are statistically significant, which indicates that supplemented six-ingredient rehmannia pill combined with bisphosphonates has improved life quality significantly; By comparing SF-36scoresof Group A in the9th month with that of the6th month, the difference isn’t statistically significant (t=20.18,P=0.08), which indicates that supplemented six-ingredient rehmannia pill has no obvious difference for improvement of life quality after being suspended for a certain time.④Bone mineral density:By comparing bone mineral densities of Group A at each time point after treatment with that before treatment, the differences are statistically significant (lumbar1-4bone mineral density:t=7.56,p=0.00,t=6.04,p=0.00,t=4.68,p=0.00,t=2.69, p=0.00; Wards bone mineral density:t=8.07, p=0.00,/=6.77,p=0.00, t=5.42,p=0.00,t=3.39,p=0.00; greater trochanter bone mineral density: t=7.43,p=0.00,t=6.58,p=0.00,t=4.90,p=0.00,/=2.97,p=0.00; femur and cervical vertebrae bone mineral density:t=7.67,p=0.00,t=6.32, p=0.00,t=4.66,p=0.00,t=2.98,p=0.00), which indicates that supplemented six-ingredient rehmannia pill has a certain effect of improving bone mineral density; By comparing bone mineral densities of Group C at each time point after treatment with that of Group A (lumbar1-4bone mineral density:t=22.37,p=0.00,t=16.01,p=.00t=8.39,p=0.00,t=5.28,p=0.00, Wards bone mineral density:t=23.92, p=0.00, t=7.42,P=0.00,t=9.10,P=0.00,t=5.72,P=0.00. greater trochanter bone mineral density:t=20.86,P=0.00, t=5.29,p=0.00, t=0.64,P=0.00,t=4.41,P=.00, femur and cervical vertebrae bone mineral density:t=24.55,P=.00, t=8.20,P=0.00,t=11.7.73,P=0.00, t=3.17,P=0.00), and comparing bone mineral densities of Group C at each time point after treatment with that of Group B, the differences are statistically significant (lumbar1-4bone mineral density:t=27.19,P=0.00,t=20.09,P=0.00,t=10.87,P=0.00t=7.24,P=0.00,Wards bone mineral density:t=26.22,P=0.00,t=21.46, P=0.00, t=13.43, P=0.00,t=6.88,P=0.00, greater trochanter bone mineral density:t=29.92,P=0.00,t=22.14,P=0.00, t=4.82,P=0.00,t=6.51, P=0.00, femur and cervical vertebrae bone mineral density:t=28.85, P=0.00,t=20.03,P=0.00, t=3.16,P=0.00,t=7.44,P=0.00), which indicates that supplemented six-ingredient rehmannia pill combined with bisphosphonates has synergistic effect for improving bone mineral density; By comparing bone mineral densities of Group A in the9th month with that in the6th month, the differences are statistically significant (lumbar1-4bone mineral density:t=6.08,P=0.00; Wards bone mineral density:t=6.88,P=000; greater trochanter bone mineral density: t=5.90,P=0.00; femur and cervical vertebrae bone mineral density: t=6.45,P=0.00), which indicates that supplemented six-ingredient rehmannia pill still has a certain effect on improving bone mineral density after stopping; by comparing bone mineral densities of the three groups in the12th month with that in the9th month, the differences have no statistic significance (lumbar1-4bone mineral density:F=14.59,P=0.31, Wards bone mineral density:F=14.26, P=0.29, greater trochanter bone mineral density:F=13.69,P=0.34, femur and cervical vertebrae bone mineral density:F=13.16, P=0.29), which indicates that supplemented six-ingredient rehmannia pill’s effects on bone mineral density of each group are reduced as time goes by.⑤TCM Syndrome Integral:By comparing Chinese medicine syndrome integrals of three groups at each time point with that before treatment, the differences are statistically significant, it indicates that all of the three methods can affect the patient’s Chinese medicine syndrome integrals. By comparing Chinese medicine syndrome integrals of Group A at each time point after treatment with that of Group B (t=13.29,P=0.00,t=7.92,P=0.00,t=4.65, P=0.00,t=3.94,P=0.00) and comparing Chinese medicine syndrome integrals of Group C at each time point after treatment with that of Group B(t=12.90,P=0.00,t=7.11,P=0.00,t=4.33,P=0.00,t=3.89,P=0.00), the differences have no statistic significance, it indicates supplemented six-ingredient rehmannia pill has an advantage in improvement of Chinese medicine syndrome integral. At the end of treatment and during follow-up visit in the12th month, three groups of patients are verified to have no obvious abnormality of hepatorenal function and have no adverse events.Conclusions:1. Supplemented six-ingredient rehmannia pill can alleviate ostalgia of the patients with postmenopausal osteoporosis, improve bone mineral density, enhance their life quality;2. Supplemented six-ingredient rehmannia pill can be used together with bisphosphonates to enhance curative effect; compared with bisphosphonates, six-ingredient rehmannia pill combined with bisphosphonates can better enhance life quality, bone mineral density and estradiol level without occurrence of adverse events. |
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