CLINICAL APPLICATIONS

* Osteoporosis with decreased bone strength, mass, and density 

* Individuals with risk factors of osteoporosis, such as menopause, old age, and use of tobacco, alcohol, and drugs

* Maintenance for healthy and strong bones

* Soreness, weakness and pain in the bones, lower back and knees

* Inability to stand for a prolonged period of time

* Pain or soreness that is aggravated by weight-bearing activities

* Recovery from bone fracture and broken bones

 

WESTERN THERAPEUTIC ACTIONS

* Osteogenic effect to stimulate osteoblast proliferation and differentiation

* Osteoprotective effect to prevent and treat osteoporosis

* Increases absorption and utilization of calcium

* Increases bone mass and density

* Angiogenic effect to stimulate blood vessel formation, invigorate blood circulation, facilitate wound healing, enhance tissue regeneration, and facilitate healing of bone fractures

 

CHINESE THERAPEUTIC ACTIONS

* Replenishes Kidney jing (essence)

* Tonifies Kidney yang and yin

* Tonifies qi and blood

 

DOSAGE

Take 3 to 4 capsules three times daily on an empty stomach with warm water. For prevention in patients with higher risk of osteoporosis, take 2 capsules daily.

 

INGREDIENTS

Dang Gui (Radix Angelicae Sinensis)

E Jiao (Colla Corii Asini)

Gou Qi Zi (Fructus Lycii)

Gu Sui Bu (Rhizoma Drynariae)

Gui Ban (Plastrum Testudinis)

Lu Jiao (Cornu Cervi)

Ren Shen (Radix et Rhizoma Ginseng)

Xu Duan (Radix Dipsaci)

 

BACKGROUND

Osteoporosis is a disorder characterized by a reduction of bone mass density, leading to fractures after minimal trauma.[1] Osteoporosis is becoming one of the more common disorders as the population continues to age and life expectancies continue to increase. Osteoporosis occurs mostly in individuals between 51 to 75 years of age, and is six times more common in women than men.[2] There are numerous risk factors, including but not limited to aging, dietary habits, lifestyles, and family history. Chronic use of drugs also increases the risk of osteoporosis, with such examples as thyroid supplements, corticosteroids, ethanol, tobacco, and heparin. Therefore, optimal prevention and treatment of osteoporosis require modification to diet and exercise, and use of herbal medicine.

 

FORMULA EXPLANATION

Osteo 8 is a well-balanced formula designed for women and men of all ages who want to maintain healthy bones. It contains herbs that tonify qi, blood, yin and yang. The main function of the formula is to replenish the vital jing (essence) of the Kidney to strengthen bones, increase bone density, and promote healing.

        Most herbs in Osteo 8 enter the Kidney to revitalize the body and replenish jing (essence). Osteoporosis or weakness of sinews and bones are the result of Kidney and Liver deficiencies. According to traditional Chinese medicine, the Kidney stores the jing (essence) that is vital for strong bones, and the Liver stores blood and controls the sinews and tendons. If the Liver and Kidney are deficient, bone, sinews and joints become weak. Therefore, treatment of bone disorders requires tonification of the Liver and Kidney.

        Lu Jiao (Cornu Cervi), one of the most effective and precious herbs, is the principle herb in Osteo 8. It tonifies Kidney yang, replenishes Kidney jing (essence), nourishes blood and strengthens sinews and bones. Gu Sui Bu (Rhizoma Drynariae) and Xu Duan (Radix Dipsaci) are two herbs that tonify Kidney yang. Gu Sui Bu (Rhizoma Drynariae) and Xu Duan (Radix Dipsaci) strengthen the bones and are often used together to promote mending of bones and relieve soreness, weakness and pain of the bones. They are the best pair used to heal fractured bones and other injuries such as contusions, sprains, and ligament injuries due to trauma.

        Gui Ban (Plastrum Testudinis), Gou Qi Zi (Fructus Lycii) and E Jiao (Colla Corii Asini) are used to tonify the Kidney yin and jing (essence). Gui Ban (Plastrum Testudinis) nourishes Kidney yin and strengthens the bones by filling the marrow with jing (essence). Gou Qi Zi (Fructus Lycii) tonifies the Liver and the Kidney yin to treat secondary symptoms such as dizziness, dryness, blurred vision, tinnitus, thirst, and night sweats. Neutral in property, it has a unique function to effectively nourish the different parts of the body without creating any stagnation. E Jiao (Colla Corii Asini), one of the essential herbs used in most antiaging formulas, tonifies blood and nourishes yin. Together, these three herbs replenish Kidney yin and jing (essence) to maintain healthy bones and treat weakness and soreness of the back, hips and knees.

        Finally, to enhance the overall wellness of the body, Ren Shen (Radix et Rhizoma Ginseng) and Dang Gui (Radix Angelicae Sinensis) are added to tonify qi and blood.

 

CAUTIONS & CONTRAINDICATIONS

* This formula should be used with caution in patients with an excess condition or heat accumulation.

* This formula should be used with caution in patients with damp-heat in the lower jiao.

* This herbal formula contains herbs that invigorate blood circulation, such as Dang Gui (Radix Angelicae Sinensis). Therefore, patients who are on anticoagulant or antiplatelet therapies, such as Coumadin (warfarin), should use this formula with caution, or not at all, as there may be a higher risk of bleeding and bruising.[3]^,[4],[5]

* The safety status of using Dang Gui (Radix Angelicae Sinensis) in individuals with hormone-dependent cancer is unclear.[6]^,[7],[8] According to one reference, use of Dang Gui (Radix Angelicae Sinensis) is not associated with thickening of the endometrium or vaginal cell maturation, both of which would indicate an estrogenic effect. Furthermore, there is no confirmation of the presence of a phytoestrogen component or affect on hormone-dependent cancer, when ferulic acid is evaluated as the main component of Dang Gui (Radix Angelicae Sinensis).[9] According to another reference, the water extract of Dang Gui (Radix Angelicae Sinensis) has a weak estrogen-agonistic activity to stimulate the growth of breast cancer cells (MCF-7).[10] In summary, due to conflicting and insufficient data, use of Dang Gui (Radix Angelicae Sinensis) in patients with hormone-dependent cancer warrants caution pending further study.

 

CLINICAL NOTES

* Osteoporosis is six times more common in women than in men because a tremendous amount of jing (essence) is lost during the process of pregnancy and delivery. Post-menopausal osteoporosis is most common and happens between 51 to 75 years of age. Women who have children may see signs and symptoms of osteoporosis earlier than those who have fewer or no children.

* Men may not experience osteoporosis in the same way as women. Men lose jing (essence) with excessive sexual activities, and may show symptoms and signs of Kidney deficiency, such as hair loss, loose teeth, weakness and soreness of the back and knees.

* There are three excellent formulas for post-surgical recovery. Flex (TMX) should be taken after the surgery for 5 to 10 days to facilitate the immediate healing of wounds. Continue herbal treatment with Flex (MLT) and Osteo 8 for one month to facilitate healing and recovery of soft tissues and bones, respectively.

 

SUPPLEMENTARY FORMULAS

* For soreness and pain of the low back and knees, use with Back Support (CR).

* For neck and shoulder pain, use with Neck & Shoulder (CR).

* For arm pain, add Arm Support.

* For bone spurs, add Flex (SPR).

* For arthritis due to heat with redness, swelling and burning of joints, use with Flex (Heat).

* For arthritis due to coldness, with pain that worsens during cold and rainy weather, use with Flex (CD).

* For gout, add Flex (GT).

* For bone fractures, use with Flex (TMX).

* For recovery from bone fracture with soft tissue injuries, use with Flex (MLT).

* For fatigue and overall deficiency, use with Imperial Tonic.

* For menopause with hot flashes and night sweats, use with Balance (Heat).

* For menopause with dryness or yin deficiency, use with Nourish.

* For vaginal dryness, add Balance Spring.

* For menopause with irritability and insomnia, use with Calm, Calm ZZZ, or Calm (ES).

* For hair loss or premature gray hair, use with Polygonum 14.

* For blood deficiency, insomnia and excessive dreams, use with Schisandra ZZZ.

* For Kidney yang deficiency, add Kidney Tonic (Yang).

* For Kidney yin deficiency, add Kidney Tonic (Yin).

* For visual disturbances, blurriness, redness or pain, add Lycium Support.

 

ACUPUNCTURE TREATMENT

Traditional Points:

* Mingmen (GV 4), Dashu (BL 11), Shenshu (BL 23)

* Sanyinjiao (SP 6), Shenshu (BL 23), Guanyuan (CV 4), Pishu (BL 20)

 

Classic Master Tung's Points:

* Tianhuang (T 77.17), Dihuang (T 77.19), Renhuang (T 77.21), Tianhuang (T 88.13), Minghuang (T 88.12), Qihuang (T 88.14), Fuke (T 11.24), Zhengji (T 44.24)*

 

Master Tung’s Points by Dr. Chuan-Min Wang:

* Osteoporosis: Linggu (T 22.05), Tianhuang (T 77.17), Dihuang (T 77.19), Renhuang (T 77.21)

* Osteoarthritis

§ Knee: Needle contralaterally Jianzhong (T 44.06). Needle ipsilaterally medial knee eye and lateral knee eye.

§ Hip: Needle contralaterally Jianzhong (T 44.06), Naoshu (SI 10). Needle ipsilaterally Huantiao (GB 30).

 

Balance Method by Dr. Richard Tan:

* Left side: Shenmai (BL 62), Weizhong (BL 40), Tongli (HT 5), Shaohai (HT 3)

* Right side: Taixi (KI 3), Yingu (KI 10), Houxi (SI 3), Xiaohai (SI 8)

* Left and right sides can be alternated from treatment to treatment.

 

Auricular Medicine by Dr. Li-Chun Huang:

* Osteoporosis and cervical vertebral degeneration: corresponding points (to the area of degeneration), Triangle Area of Cervical Vertebra (back of ear), C6, C7, C3, C4; Large Auricular Nerve.

§ For dizziness, add Dizziness Area.

§ For shoulder pain, add Shoulder Joint.

§ For finger numbness, add Finger, Coronary Subcortex, and Large Auricular Nerve.

§ For back headache, add Occiput and Lesser Auricular Nerve. Bleed Ear Apex.

 

NUTRITION

* Consume a sufficient amount of calcium, either from diet or supplements. Make sure the supplement is of good quality so it breaks down and absorbs in the body. Calcium supplementation is most effective if it is combined with vitamin D and other minerals.

* Consumption of foods rich in plant estrogen is also beneficial, such as soybeans and yam.

* Consumption of oxtail, ox neck or bone-based soup with tomato and ginger is highly recommended.

 

The Tao of Nutrition by Dr. Maoshing Ni and Cathy McNease:

* Make hummus with black beans and goat milk yogurt. Eat as a snack in between meals regularly.

 

LIFESTYLE INSTRUCTIONS

* Patients are advised stop drinking alcohol, smoking tobacco, and limit sexual activities to prevent loss of jing (essence).

* Patients with osteoporosis have higher risk of bone fractures. They should refrain from activities with high risk of injury, such as lifting heavy objects or overexertion from strenuous exercises.

* Walking, tai chi chuan [tai ji chuan], qi gong, and other mild exercises are recommended in order to strengthen the bones and joints without increased risk of injury. Weight-bearing exercise is especially effective to improve bone strength.

 

CASE STUDIES

* A 49-year-old female practitioner of Oriental medicine has family history of osteoporosis in maternal grandmother and mother. While her grandmother did not have any incidence of physical injury leading to bone fracture, her mother had an ankle fracture on the right side, and lost three inches in height. The patient sought treatment for prevention and treatment of osteoporosis. Upon evaluation, the diagnosis was blood deficiency without visible signs of bone loss. The patient started on Osteo 8 at a dosage of 3 to 6 capsules per day. In addition, she also took a supplement of calcium, magnesium, and potassium (2 to 4 capsules per day). She exercised aerobically with weights three times a week. She also lowered her intake of high-fat foods and avoided caffeine. No other changes were made with the lifestyle. Prior to treatment, her baseline bone mass density (BMD) was 0.448 (on 9/19/01). After four month of treatment, her bone mass density (BMD) increased to 0.7 (1/16/02). The patient improved from “low normal” to “low risk” for osteoporosis. The practitioner commented that the “increase in bone density was remarkable.” Submitted by C.C., Middletown, Connecticut.

* B.D., a 68-year-old female, wanted a natural alternative to Evista (raloxifene) for osteoporosis prevention. She appeared thin and pale. She had a history of osteoporosis in her mother’s side of the family. The TCM diagnosis was Kidney qi, jing (essence), yin and yang deficiencies. Osteo 8 was prescribed at 2 capsules a day. She had a bone mass density test done two years ago and it was slightly low, and was therefore placed on Evista (raloxifene). After one year on Osteo 8, the bone density tested normal. She repeated the test one year later and the density tested normal again. Her medical doctor was quite impressed. [Note: This patient had a sensitive stomach. She started with 4 capsules daily but had to be reduced to 2 caps because of gastrointestinal discomfort.] Submitted by M.H., West Palm Beach, Florida.

* C.M., a 48-year-old female, presented with joint pain (hands, feet, knees) that worsened in cold and rainy weather, reporting a family history of arthritis and osteoporosis. She also suffered from tendonitis of both forearms. She had decreased range of motion, with calcification of joints in her fingers. Her Western diagnosis was rheumatoid arthritis; the TCM diagnosis was cold and damp obstruction. Osteo 8 and Flex (CD) were prescribed at four capsules each, twice daily. Within one day, the symptoms began improving. After one week, joints and tendons were not stiff, and almost pain-free. During the winter (the season in which her condition usually deteriorated), the symptoms even improved. The patient reported later that if she stopped taking the herbs, the symptoms returned. Submitted by C.D., Phoenix, Oregon.

 

PHARMACOLOGICAL AND CLINICAL RESEARCH

Osteo 8 is an herbal formula specifically for osteoporosis and other bone-related disorders. It contains herbs that increase the utilization of calcium, strengthen the bones, prevent fractures, and promote healing.

        Calcium is the most abundant mineral in the bones and the body. Therefore, health of the bones is directly associated with proper intake and absorption of calcium. However, most forms of calcium (i.e., calcium carbonate) are hard to digest, and there are many other factors that impede the absorption, such as caffeine, fat, excess dietary fiber, alcohol, cocoa (chocolate), and excessive amounts of protein. Therefore, efforts must be made to enhance the bioavailability of calcium through proper intake and absorption. Lu Jiao (Cornu Cervi) and Gui Ban (Plastrum Testudinis) are both rich in numerous minerals, including calcium and magnesium, which are essential for bone health.[11] Gu Sui Bu (Rhizoma Drynariae), traditionally used to treat patients with bone fractures, has been shown to increase the absorption of calcium.[12] Furthermore, daily ingestion of E Jiao (Colla Corii Asini) is associated with increased absorption and utilization of calcium, as well as elevated levels of calcium in the blood.[13] Thus, ingestion of Osteo 8 will increase the intake, absorption, and utilization of calcium.

        Osteo 8 contains many herbs that promote the generation of new bones. Dang Gui (Radix Angelicae Sinensis) has a marked effect on osteoblast proliferation and differentiation systems, as well as in a fibroblast-secreted hyaluronic acid assay. It enhances the deposition of hyaluronic acid and proliferation of osteoblasts in vitro, as well as bone regeneration.[14] Furthermore, Dang Gui (Radix Angelicae Sinensis) has been shown to contribute to the formation of bones and treatment of bone injuries. It directly stimulates the proliferation, alkaline phosphatase activity, protein secretion and particularly type I collagen synthesis of human osteoprecursor cells in a dose-dependent manner.[15] Xu Duan (Radix Dipsaci), another herb in this formula, shows a potential effect to increase the proliferation and differentiation of the osteoblasts, and it does not affect osteoclast activity. The researchers concluded that these herbs can effectively increase the rate of tissue regeneration of damaged bones.[16] Gu Sui Bu (Rhizoma Drynariae) has a marked osteoprotective effect, and has been shown to effectively prevent and treat osteoporosis. According to in vivo and in vitro studies, the extract of Gu Sui Bu (Rhizoma Drynariae) exerts significant activity on both the proliferation of osteoblastic cells and promotion of bone mineral density (BMD).[17]^,[18] In addition, in vitro and in vivo studies have shown Gu Sui Bu (Rhizoma Drynariae) to significantly influence both osteoblast and osteoclast activity to safely and effectively accelerate bone regeneration and enhance bone healing. Gu Sui Bu (Rhizoma Drynariae) increased osteoblast numbers, intracellular alkaline phosphatase (ALP) levels and nodule numbers without influencing osteoclast activity.[19] Gu Sui Bu (Rhizoma Drynariae) promotes osteoblast maturation by regulating bone differentiation-related gene expression and defending against nitrosative stress-induced apoptotic insults.[20] Clinically, Gu Sui Bu (Rhizoma Drynariae) has marked physiological effect to treat many bone-related disorders, including but not limited to postmenopausal osteoporosis, [21] osteoarthritis,[22] and periodontal diseases.[23]^,[24] Another study showed that herbs that strengthen both the bones and the tendons, such as Gu Sui Bu (Rhizoma Drynariae), Gou Qi Zi (Fructus Lycii) and Xu Duan (Radix Dipsaci), have a positive effect in treating osteoporosis, with results better than that of calcium alone. The researchers in this study concluded that the use of herbs that tonify the Kidney is an “optimal method for osteoporotic treatment.” [25] Finally, oral administration of polypeptides from Lu Rong (Cornu Cervi Pantotrichum) has been shown to reverse osteoporosis and prevent bone loss. The mechanisms of actions are attributed to the promotion of mitosis and the inhibition of interleukin-1 (IL-1) and interleukin-6 (IL-6). The researchers state that Lu Rong (Cornu Cervi Pantotrichum) can be a therapeutic agent for the treatment of postmenopausal osteoporosis.[26]

        Ren Shen (Radix et Rhizoma Ginseng) and Dang Gui (Radix Angelicae Sinensis) are two representative herbs that tonify qi and blood in Chinese herbal medicine. As they improve the “function” and the “substance” aspects of the body, they lead to an increase in overall health and well-being. From a biomedical perspective, these two herbs both have an angiogenic effect to promote blood vessel formation, invigorate blood circulation, facilitate wound healing and enhance tissue regeneration.[27]^,[28],[29]

        Overall, Osteo 8 contains herbs that are rich in calcium, increase adsorption of calcium into bones, and promote the growth and healing of bones. It is an ideal formula for both the prevention and the treatment of decreased bone density, bone fractures, or other bone-related disorders.

 

COMPARATIVE ANALYSIS

Osteoporosis is a bone disorder that primarily affects elderly individuals as they gradually lose bone mass density. As a result of osteoporosis, their bones become weak and fragile, and they have a much higher risk of bone fracture from minor injuries. Furthermore, individuals with osteoporosis often require an extended period of time for recovery, which is often complicated by infection.

        The drugs of choice for treating osteoporosis are bisphosphonates

, a category of drugs that include Fosamax (alendronate), Actonel (risedronate), Didronel (etidronate), Aredia (pamidronate), and Skelid (tiludronate). On average, these drugs may increase bone mass density by 3 to 5% after continuous use for three years. However, they cause numerous side effects, such as stomach irritation, and may increase the risk of cancer (thyroid adenoma and adrenal pheochromocytoma) and fertility impairment (inhibition of ovulation, and testicular and epididymal atrophy).

 

Furthermore, there is evidence that use of these drugs do not decrease the incidence of bone fracture. Though these drugs increase bone mass density, the bones remain brittle and are susceptible to fracture. This is evident as the use of biphosphonates is linked with increased risks of osteonecrosis of the jaw (1 in 952 cases) and subtrochanteric or femoral shaft fractures (274% increased risk).[30]^,[31] In women with menopause, hormone replacement therapy may be used to decrease the loss of bone mass density. These drugs, however, must be prescribed and monitored very carefully, as use of these hormone substances have been shown to significantly increase risk of cancer, such as breast cancer (by 20 to 30%), endometrial cancer (by six to eight fold), and ovarian cancer (by 10 to 20%). Other side effects and adverse reactions of hormone replacement therapy include gallbladder disease, thromboembolitic disease, and photosensitivity.[32] In brief, treatment of osteoporosis requires careful evaluation of risks versus benefits by both practitioners and patients.

        Herbs have been used with great success to nourish underlying deficiencies, and prevent and treat osteoporosis. In fact, according to one clinical study, use of herbs that tonifies Kidney jing (essence) for one year was associated with an average increase of 3.4% in bone mass density among 28 women in menopause (average age of 48.8 years). Furthermore, few or no side effects were reported throughout the study.

        Drugs and herbs are both effective for the prevention and treatment of osteoporosis. However, herbs are safe and natural, and should be considered the treatment of choice. Furthermore, patients are encouraged to adopt the dietary and lifestyle recommendations described above to maximize the overall efficacy of their treatment program.