Cistanche Deserticola Anti-osteoporosis Via Regulates Bone Formation And Bone Resorption
Mar 17, 2022
Contact: joanna.jia@wecistanche.com / WhatsApp: 008618081934791
Clinical observation of Chinese medicine Cistanche deserticola in treating osteoporosis and regulating bone metabolomics
Wu Yang, Zhang Xiang, Zhang Hongzhen, Wang Xiaofeng, Zhao Xiaoying, Yao Jing,
[Abstract] Objective: To investigate the clinical mechanism and clinical application of Cistanche deserticola in the treatment of osteoporosis by observing the clinical efficacy of Cistanche deserticola in the treatment of osteoporosis and the related research on the regulation of osteo metabolism. Methods 70 patients with primary osteoporosis who were diagnosed and treated in our department of Traditional Chinese Medicine and Traditional Chinese Medicine and Orthopedics in our hospital from June 2015 to June 2017 were randomly divided into treatment groups (35 cases) and control group (35 cases). The treatment group was treated with single-flavored Cistanche 15 g decoction orally twice a day; and the control group was treated with oral Calcium D tablets,600 mg/time, once a day.Osteocalcin(BGP) and type I collagen carboxy-terminal peptide (ICTP)levels, serum alkaline phosphatase(ALP), calcium(Ca), phosphorus(P) were measured before treatment, at 3 months and 6 months of treatment. The level of bone density was simultaneously detected. The classification and score of TCM symptoms were recorded, and the clinical efficacy was assessed. Results The BMD values of the treatment group were(0.76±0.04)g/em²(L2),(0.69 ±0.06) g/em²femoral neck), and (0.51±0.07) g/cm²(large trochanter). The difference between the two groups before treatment was not statistically significant(P>0.05). The improvement of the above indicators was more obvious than before and was better than that of the control group After 3 months of treatment, the ALP in the treatment group was (58.50±18.27 )mmol/L,c(Ca) was (2.51±0.51) mmol/L, and c ( P) was(1.23±0.01)mmol/L. After 6 months of treatment, the ALP was(69.23±16.11)mmol/L. c(Ca) was (2.94±0.53)mmol/L, and c(P) was(1.30±0.38)mmol/L, which were significantly improved compared with those of the control group (P<0.05). After 3 months and 6months of treatment, the BGP was (5.48±0.25)ug/L and (7.68±0.10)ug/L respectively, which was higher than that before treatment, and it was more significant than that of the control group(P<0.05). After treatment for 3 months and 6 months, ICTP was (6.16±0.37) ug/L and (5.40±0.18 )Jug/L, which was lower than that before treatment, and it was significantly lower than that of the control group (P<0.05). After 6 months of treatment, the treatment group achieved a significant effect of 57.1%, with a total effective rate of 91.4%. Conclusion: Cistanche deserticola has two-way regulation of bone formation and bone resorption, which can improve serum alkaline phosphatase, calcium and phosphorus metabolism, increase bone density, and effectively resist osteoporosis.
[Key words] Cistanche deserticola; Osteoporosis; Bone metabolomics; Osteocalcin; Type I collagen carboxy-terminal peptide

Cistanche deserticola anti- osteoporosis
Osteoporosis (OP) is a disease characterized by bone loss and destruction of bone structure, which causes increased bone fragility and increased fracture risk, resulting in abnormal bone metabolism, increased bone formation, and bone resorption. The formation of reduced [. Traditional medicine pays attention to the connection between the liver and kidney and muscles and bones. Among them, there is the theory of "kidney governs bones" and "liver governs tendons". Osteoporosis. It is recorded in the medical classics of the motherland that Cistanche has the effects of nourishing kidney yang, nourishing essence and blood, moistening the intestines and laxative, nourishing blood, and moisturizing dryness. Its modern pharmacological effects include improving immune function, anti-aging, anti-oxidation, promoting growth and development, protecting nerves, and so on. In this study, the use of Cistanche in the prevention and treatment of osteoporosis has achieved satisfactory results, and related studies on its regulation of bone metabolomics have been reported as follows.
1 Material and methods
1.1 Clinical data
Selected patients with primary osteoporosis who visited our hospital from June 2015 to June 2017 in the TCM Internal Medicine, TCM Orthopedics and Traumatology Outpatient Clinic, and selected 70 eligible patients. Randomly divided into 35 cases in the treatment group and 35 cases in the control group. There was no statistically significant difference in general data between the two groups ((P>0.05), see Table 1.
Table 1 Comparison of general data between the two groups

1.2 Inclusion criteria (3-4)
①In line with the diagnosis of primary low-conversion osteoporosis; ②Check bone formation and bone resorption indicators before treatment, among which osteocalcin (BGP) is normal, type I collagen carboxy-terminal peptide (I CTP) is normal or increased to a certain extent High; ③50-80 years old; ④Bone density test to diagnose osteoporosis.

1.3 Exclusion criteria (3-4)
①Patients with secondary osteoporosis; ②Patients with severe primary diseases such as cardiovascular and cerebrovascular diseases or with fresh fractures; ③Patients who cannot tolerate this medicine; ④Use other medicines for the treatment of this disease within the past 3 months, Those who have other special medications; ⑤Those who are mentally abnormal; ⑥Those who refuse to receive treatment; ⑦ Those who have difficulty or cannot strictly follow the treatment time for treatment.
1.4 Exit criteria
Cases where the 6-month treatment plan cannot be completed, adverse reactions occur during the treatment, or the treatment plan is changed midway.
1.5 Method
The 70 selected patients were randomly grouped according to the random number table method, and divided into 35 cases in the treatment group and 35 cases in the control group.
1.5.1 Treatment group: Take 15g of single-flavor Cistanche (identified by Huang Weijie, clinical pharmacist of the Pharmacy Department of Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine), decoction orally, 2 times a day;
1.5.2 Control group: Oral Calci D600 mg (Wyeth Pharmaceutical Co., Ltd., National Medicine Standard H10950029, 600 mg/tablet), once a day, 1 capsule each time, orally. Both groups took 6 months as a course of treatment. During the treatment period, no other calcium supplementation and Chinese and Western medical treatment were given.
1.6 Observation indicators
1.6.1 Bone Mineral Density (BMD) detection: Using Dove3000 dual-energy X-ray bone mineral density measuring instrument, the relevant data of bone mineral density measurement before treatment, 3 months of treatment, and 6 months after treatment are recorded respectively.
1.6.2 Serum alkaline phosphatase (alkaline phoSphatase, ALP), blood calcium (Ca), blood phosphorus (phosphorus, P) level detection: Record relevant data before treatment, 3 months of treatment, and 6 months after treatment, respectively. The two groups used fasting venous blood draw 5 mL at the time node respectively, using ELISA method, using Beckman AU5800 automatic biochemical analyzer to detect ALP, Ca, P levels, and the kit was purchased from Beckman Coulter Experimental System Co., Ltd. Strictly follow the steps in the instructions.
1.6.3 Detection of osteocalcin (BGP) and type I collagen carboxy-terminal peptide (ICTP) levels: ELISA method is used to detect the relevant data before, 3 months, and 6 months after treatment.
1.6.4 TCM Symptom Grading: Refer to the "Guiding Principles of Clinical Research on New Chinese Medicines for the Treatment of Osteoporosis" for TCM symptom grading and scoring; the pain grade is divided into 10 degrees according to the simplified McGee pain scale method: ①Low back pain; Normal, the pain disappears, score 0; mild, pain 1-3 degrees, 2 points; moderate, 4-6 degrees, 4 points; severe, 7-9 degrees, 6 points. ②Aches and weakness in the waist and knees; normal, the symptoms disappear, score 0; mild, a slight soreness in the waist and knees after walking, 1 point; moderate, between mild and severe, 2 points; severe, weakness in the waist and knees Continue to occur, do not want to stand or walk, 3 points. ③Lower limb pain: normal, the symptoms disappear, score 0; mild pain, 1-3 degrees, 2 points; moderate, pain 4-6 degrees, 4 points; severe, pain 7-9 degrees, 6 points. ④ Weakness of lower limbs: normal, the symptoms disappeared, score 0; mild, occasional lower limb soreness after walking, 1 point; moderate, between mild and severe, 2 points; severe, standing and walking means feeling the soreness of lower limbs Weakness, 3 points. ⑤Difficult walking: normal, walking freely, score 0; mild, occasional walking inconvenience, no discomfort within 100 meters, 1 point; moderate, between mild and severe, 2 points; severe, Difficulty in standing and walking, can not walk more than 10 m, 3 points. ⑥ Tongue quality: If the tongue quality is purple, crimson, dark red, or there are ecchymosis, petechiae, and other abnormalities on the tongue, it will be 1 point; normal 0 point. ⑦Tongue coating: If you see abnormalities such as yellow greasy or dryness, score 1 point; normal 0 points. ⑧ Pulse condition; 1 point for abnormalities such as string, tightness, flood, astringency, sinking, lateness or floating or slippery; normal, 0 points. The total score is less than 8 as mild, 8-18 is moderate, and >18 is severe. Relevant data were recorded before treatment, 3 months after treatment, and 6 months after treatment.
1.7 Statistical analysis
SPSS 21.0 statistical software was used for analysis, measurement data was expressed as (x±s), using t-test; counting data was expressed as [n (%)], using x2 test. P<0.05 indicates that the difference is statistically significant.

2 results
2.1 Comparison of BMD before treatment, 3 months after treatment, and 6 months after treatment (see Table 2). There was no statistically significant difference in indicators between the two groups before treatment (P>0.05). After 6 months of treatment, the BMD values of the treatment groups were respectively
It is (0.76±0.04) g/cm² (L2-4), (0.69±0.06) g/em² (femoral neck), (0.51±0.07) g/cm² (greater trochanter), each index is significantly improved compared with before treatment, and at the same time. The improvement effect is better than that of the control group after 6 months of treatment.
Table 2 Comparison of BMD before treatment, 3 months of treatment and 6 months of treatment

Note: "Compared with the control group before treatment, t=0.012, 0.0018, 0.0097; P=4.299, 7.815, 5.423;
compared with the control group for 3 months, t=4.625, 2.671, 4.862; P=0.0252, 0.0310, 0.0105;
Compared with the control group for 6 months, t=2.414, 3.097, 2.018, P=0.0143, 0.0025, 0.0276
2.2 Comparison of biochemical indexes between the two groups before treatment, 3 months after treatment and 6 months after treatment (see Table 3). The biochemical indexes ALP, c((Ca), c(P) indexes of the two groups after treatment for 3 months and 6 months were improved to different degrees compared with those before treatment (P<0.05), indicating that the anti-osteogenesis of the two groups The treatment of porosity has a certain effect, and the treatment group has a significant improvement in various indicators compared with the control group after 6 months of treatment (P<0.05), indicating that Cistanche has a clear therapeutic effect.
Table 3 Comparison of biochemical indexes before treatment, 3 months after treatment and 6 months after treatment

Note:Compared with the control group before treatment, t=0.084, 0.012, 0.003; P=2.531, 6.980, 7.877;
Compared with the control group for 3 months, t=2.490, 2.570, 2.701; P-0.0222, 0.0163, 0.0128;
Compared with the control group for 6 months, t=2.591, 2.520, 2.602, P=0.0183, 0.0201, 0.0157
2.3 Changes in the levels of osteocalcin (BGP) and type I collagen carboxy-terminal peptide (I CTP) (see Table 4). BGP in the treatment group was (5.48±0.25) μg/L and (7.68±0.10) μg/L respectively after 3 months of treatment and (7.68±0.10) μg/L, which were significantly higher than before treatment, and improved more significantly than the control group during the same period (P<0.05) ). The ICTP of the treatment group was (6.16±0.37) μg/L and (5.40±0.18) μg/L after 3 months and 6 months of treatment, which were lower than before treatment, and at the same time, the decrease was more significant than that of the control group in the same period (P<0.05).
Table 4 Changes in the levels of osteocalcin (BGP) and type I collagen carboxy-terminal peptide (ICTP) (de, Hg/L) treatment group (n=35) control group (n=35)

2.4 Comparison of TCM syndrome scores and curative effects between the two groups
See Table 5 and Table 6. The TCM symptom scores collected for 3 months and 6 months of treatment in the two groups showed significant improvement (P<0.05), and the improvement in the treatment group was better than that in the control group, indicating the definite effect. After 6 months of treatment, the treatment group achieved a significant effect of 57.1%, and the total effective rate was 91.4%, which was more effective than the control group.
Table 5 Comparison of TCM syndrome scores and curative effects between the two groups

Table 6 Comparison of curative effect between the two groups after 6 months of treatment

3 Discussion
According to statistics, there are at least 200 million patients with osteoporosis in my country, accounting for more than 15% of the total population, and the number has been increasing year by year in recent years. Chinese medicine believes that the growth and decline of musculoskeletal is closely related to the surplus and loss of liver and kidney-if the kidney (essence) qi is sufficient, the bones grow normally; the kidney essence (qi) is deficient, the bones grow without roots, the marrow sea is empty, and the bones are weak. As a result, osteoporosis occurs. It is generally believed that factors such as advanced age, postmenopausal women, lack of movement or immobility, and coffee can increase the risk of OP(Osteoporosis). At the same time, certain drugs (such as antiepileptic drugs, glucocorticoids, heparin, etc.) can also increase the prevalence of OP7- 8. Throughout the current clinical medications, the treatment of OP(Osteoporosis) is mainly based on western medicine, such as senile osteoporosis, calcium preparations, vitamin D, and bone resorption inhibitors (alendronate sodium) are generally used in combination; postmenopausal bone Porosity can be combined with hormone replacement therapy (HRT) on the basis of conventional treatment [. However, most of these western medicines have certain side effects. For example, calcitonin can cause nausea, vomiting, facial flushing, hand tingling, hypocalcemia, and cause tetany and other adverse reactions; bisphosphonates can cause nausea, vomiting, abdominal pain Severe adverse reactions such as musculoskeletal pain, osteonecrosis of the jaw, esophageal cancer and renal failure1; There are reports that salmon calcitonin can cause nausea, facial flushing, allergies and other adverse reactions I2; continuous use of large amounts of vitamin D can cause poisoning1; Chinese patent medicine preparations can cause adverse reactions such as constipation and allergies1. Traditional medicine pays attention to the connection between the liver and kidney and bones and bones. The prevention and treatment of osteoporosis mostly start with replenishing the liver and kidney, exerting the multi-target and all-around overall effect of traditional Chinese medicine to combat osteoporosis. At the same time, the single traditional Chinese medicine has clear properties and few toxic side effects.
Cistanche deserticola (Cistanche deserticola Y.C.Ma), classified as top grade 15 in Shennong's Materia Medica, is mainly produced in Inner Mongolia, Xinjiang, Ningxia, Gansu, and other places. Cistanche is sweet and has the effects of nourishing kidney yang, nourishing essence and blood, nourishing the intestines and laxative, nourishing blood, and moisturizing dryness. Modern pharmacological studies have shown that its main chemical components are phenylethanoid glycosides, sugars, etc.14. Some scholars observed that Cistanche induces bone marrow mesenchymal stem cells (BMSCs) to differentiate into osteoblasts, and proposed that Cistanche has the effect of fighting osteoporosis. Xu Xiaoxue 18 et al. observed the treatment of cistanche in ovariectomized rats, and after treatment, the bone mass of the rats increased and pointed out that cistanche can effectively fight osteoporosis. Huang Zongluo and other 1% of clinical drug safety experiments showed that the acute toxicity test of Cistanche was negative, indicating that the clinical medication of Cistanche is relatively safe. Wei Zhenzhen et al. [2] Through experiments with Cistanche phenylethanoid glycosides on perimenopausal rats, they found that the bone density of rats increased, and pointed out that the estrogen-like effect in Cistanche can effectively combat osteoporosis.
Bone mineral density (BMD) examination is a commonly used index for clinical diagnosis of osteoporosis in patients, which can directly reflect the degree of bone mass in patients. In this study, a dual-energy X-ray bone density measuring instrument was used for data examination, which is accurate and has small errors. Features P. In this study, after 6 months of continuous medication, the patient's BMD content increased significantly, indicating that Cistanche can effectively increase the patient's BMD content. The main cause of osteoporosis is the change in the relationship between osteoblasts and osteoclasts, which leads to the loss of cancellous bone trabeculae. 2, Osteocalcin (BGP) and type I collagen carboxy-terminal peptide (I CTP) reflect An important sign of bone transformation, bone transformation is mainly manifested in bone resorption and bone formation. Among them, BGP indicates bone formation, and I CTP indicates bone resorption. Generally speaking, an increase in BGP indicates an increase in bone formation activity and vice versa; an increase in ICTP indicates an increase in bone dissolution and vice versa. It has been reported that after 12 weeks of treatment with Cistanche extract in postmenopausal rats, the weight of the rats increased, the number of bone trabeculae increased significantly, and the bone loss was significantly improved, indicating that the extract of Cistanche can promote the reconstruction of trabecular bone. In this study, after 6 months of administration of Cistanche, the patient's I CTP level decreased, indicating that Cistanche can effectively delay bone resorption and fight the decline of bone cell function; at the same time, BGP was significantly improved, suggesting an increase in bone formation activity, indicating that Cistanche can regulate bone The two-way effect of absorption and generation. ALP, c(Ca), c(P) are electrolytes closely related to bone content, which can directly reflect the bone formation and reduction; ALP is an important indicator reflecting bone formation, and Ca and P are typical markers reflecting bone tissue formation ②. In this study, we observed the biochemical and electrolyte indicators of the patients. We found that the ALP, c(Ca), c(P) of Cistanche was improved to varying degrees from before the treatment for 3 months, and were better than the control group; after 6 months of treatment, ALP, C(Ca), c(P) are significantly increased. It proves that Cistanche can effectively increase the content of ALP, c(Ca), and c(P) in patients, and then play an anti-osteoporosis effect.
In recent years, with the increasing scientific research of Chinese medicine in modern medicine, more and more achievements have shown the superiority of Chinese medicine. Traditional Chinese medicine and Western medicine have different perspectives for understanding and treating diseases. Compared with the many adverse reactions of western medicine in the treatment of osteoporosis, traditional Chinese medicine has advantages that cannot be ignored. In the current clinical application, traditional Chinese medicines are mostly in the form of prescriptions and drug counterparts. The use and clinical observations of single Chinese medicines are relatively rare. Therefore, this study focuses on the clinical efficacy observations of single Chinese medicines, improving clinical experimental methods, and operating It is convenient, highly compatible with patients, and has achieved good results. It is worthy of promotion.

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