CLINICAL APPLICATIONS

* Traumatic injuries including external and physical injuries with bruises, contusions, and sprains

* Broken bones or fractures with severe pain, inflammation and swelling

* Post-surgical recovery: prevents adhesion and scar tissue formations

 

WESTERN THERAPEUTIC ACTIONS

* Analgesic effect to alleviate pain

* Anti-inflammatory action to reduce inflammation and swelling

* Antispasmodic function to relieve muscle spasms and cramps

* Hemostatic effect to stop bleeding from trauma and injuries

* Circulatory effect to invigorates blood circulation to facilitate healing

 

CHINESE THERAPEUTIC ACTIONS

* Invigorates blood circulation

* Removes blood stagnation

* Relieves pain

* Helps regenerate bones and soft tissues

 

DOSAGE

Take 5 to 6 capsules every six hours at the initial stage of injury. After the condition stabilizes, reduce the dosage to 3 to 4 capsules three times daily. For maximum effectiveness, take the herbs on an empty stomach with warm water. The herbs can be taken after meals if stomach discomfort should occur.

 

INGREDIENTS

Bai Shao (Radix Paeoniae Alba)

Chuan Mu Xiang (Radix Vladimiriae)

Da Huang (Radix et Rhizoma Rhei)

Dang Gui Wei (Extremitas Radix Angelicae Sinensis)

Er Cha (Catechu)

Fu Ling (Poria)

Gan Cao (Radix et Rhizoma Glycyrrhizae)

Hong Hua (Flos Carthami)

Mo Yao (Myrrha)

Mu Dan Pi (Cortex Moutan)

Ru Xiang (Gummi Olibanum)

Su Mu (Lignum Sappan)

Tao Ren (Semen Persicae)

Yan Hu Suo (Rhizoma Corydalis)

 

BACKGROUND

Musculoskeletal and connective tissue injuries lead to over 10 million clinic visits per year in the United States.[1] Causes of these injuries may be external (sports injuries, car accidents, trauma), internal (chronic wear and tear of muscles, ligaments and tendons; bones weakened by osteoporosis), or both. Acute injuries are characterized by severe pain, swelling and inflammation, and in some cases, internal bleeding. Treatment of acute injuries should focus on relieving pain, reducing swelling and inflammation, and stopping bleeding. Chronic injuries are characterized by dull pain, stiffness and numbness, and decreased muscle mass and strength. Treatment of chronic injuries includes relief of pain and restoration of physical and physiological functions.

 

FORMULA EXPLANATION

Flex (TMX) is formulated to treat both internal and external injuries, such as broken bones, bone fractures, sports injuries, bruises, contusions, and sprains. It can be used to enhance recovery and prevent scarring. This is an excellent formula to activate qi and blood circulation, remove qi and blood stagnation, relieve pain, and facilitate healing by regenerating bone and soft tissues.

        Yan Hu Suo (Rhizoma Corydalis) and Su Mu (Lignum Sappan) dispel blood stasis and alleviate pain. Er Cha (Catechu) reduces swelling, drains dampness and absorbs seepage from sores or wounds. Ru Xiang (Gummi Olibanum), Mo Yao (Myrrha), Chuan Mu Xiang (Radix Vladimiriae), Dang Gui Wei (Extremitas Radix Angelicae Sinensis), Hong Hua (Flos Carthami) and Tao Ren (Semen Persicae) promote the healing of wounds and relieve pain by invigorating blood circulation. Da Huang (Radix et Rhizoma Rhei) and Mu Dan Pi (Cortex Moutan) reduce inflammation by clearing heat. Bai Shao (Radix Paeoniae Alba) has strong analgesic, antispasmodic and anti-inflammatory effects. Fu Ling (Poria) tonifies the Spleen and indirectly promotes the regeneration of muscles. Gan Cao (Radix et Rhizoma Glycyrrhizae) relaxes the tendons and muscles and harmonizes the formula.

        Together, Flex (TMX) effectively treats trauma injuries by using herbs that relieve pain, reduce inflammation, alleviate spasms and cramps, and speed up recovery.

 

CAUTIONS & CONTRAINDICATIONS

* This formula is contraindicated during pregnancy and nursing.

* In cases of concussions, send the patient to the hospital immediately. Do not use Flex (TMX) until the condition is stabilized (usually 7-10 days later).

* Do not use this formula if the patient has serious internal hemorrhage. Flex (TMX) has many herbs that activate blood circulation and may delay coagulation.

* This formula is not designed for long-term use. It should be used only during the acute phases of injuries, and discontinued when the desired effects are achieved.

* This herbal formula contains herbs that invigorate blood circulation, such as Dang Gui Wei (Extremitas 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.[2]^,[3],[4]

* This formula may cause mild gastrointestinal discomfort, which can be minimized by taking the herbs with food or decreasing the dosage.

* The following warning statement is required by the State of California: ¡§This product contains Da Huang (Radix et Rhizoma Rhei). Read and follow directions carefully. Do not use if you have or develop diarrhea, loose stools, or abdominal pain because Da Huang (Radix et Rhizoma Rhei) may worsen these conditions and be harmful to your health. Consult your physician if you have frequent diarrhea or if you are pregnant, nursing, taking medication, or have a medical condition.¡¨

 

CLINICAL NOTES

* Flex (TMX) is an herbal formula originally used by kung fu [gong fu] masters and monks in the Shaolin temple to treat various internal and external injuries. It has excellent functions to relieve pain, treat soft tissue injuries, and facilitate the healing of broken bones or bone fractures.

* 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.

* In cases of concussions, use a lancet needle and bleed the area that was injured and squeeze out some blood. Send the patient to the hospital and advise the patient not to eat anything greasy for at least 1 month. It is best if their diet only includes porridge and completely cooked and soft vegetables. Do not use this formula until the condition has stabilized in 7 to 10 days to avoid bleeding.

* The following is a folk remedy to treat acute back pain from sprain and strain. Crack open 2 crabs (ocean) with a wooden stick (do not use a knife or any metal instruments) and put then into a clay pot with enough vodka or whiskey to cover both crabs. Place the clay pot into another bigger pot with water and steam it for one hour. Serve the crab meat along with the soup.

 

SUPPLEMENTARY FORMULAS

* To stop bleeding, add Notoginseng 9 .

* For severe pain, use with Herbal ANG.

* With severe inflammation, combine with Astringent Complex.

* For headache, use with Corydalin (AC) or Corydalin (CR).

* For neck and shoulder pain, add Neck & Shoulder (AC) or Neck & Shoulder (CR).

* For lower back pain, combine with Back Support (AC) or Back Support (CR).

* For pain in the arm (shoulder, elbow, wrist, and hand), add Arm Support.

* For severe pain due to herniated disk, add Back Support (HD).

* For pain due to knee injuries, add Knee & Ankle (AC) or Knee & Ankle (CR).

* For chronic pain due to damaged soft tissues (muscles, ligaments, tendons, and cartilages), add Flex (MLT).

* For muscle spasms and cramps, combine with Flex (SC).

* For chronic arthritic pain that worsens during cold and rainy weather, combine with Flex (CD).

* For inflammation of joints with redness and swelling, consider using Flex (Heat) instead.

* For bone spurs, use with Flex (SPR).

* For external injury with open wound and/or infection, use with Herbal ABX.

* During the recovery phase of bone fractures or broken bones, use with Osteo 8.

* For post-surgical constipation, add Gentle Lax (Deficient).

* For severe blood stagnation and bruising, add Circulation (SJ).

* For signs and symptoms of excess fire, add Gardenia Complex.

 

ACUPUNCTURE TREATMENT

Traditional Points:

* Ah shi points

 

Classic Master Tung's Points:

* Head: Zhengjin (T 77.01), Zhengzong (T 77.02) with strong stimulation, Yizhong (T 77.05), Erzhong (T 77.06), Sanzhong (T 77.07), Zhengshi (T 77.03). Bleed dark veins nearby the medial malleolus or Shuijing (T 66.13). Bleed before needling for best result.

 

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

* Trauma, broken bones, post-surgical rehab: Needle bilaterally Tianhuangfu [shenguan] (T 77.18), Minghuang (T 88.12), Tianhuang (T 88.13), Qihuang (T 88.14).

 

Balance Method by Dr. Richard Tan:

* The treatment protocol is different for each case, depending on the location and severity of injuries.

 

Ear Acupuncture:

* Knee injuries: Knees, Adrenal Gland, Pituitary Gland

* Post-operative pain: Needle the reflective location of the surgery, Subcortex, Shenmen, and Lung. Needle twice a day with strong stimulation and leave the needles in for one to two hours. These points are more effective to relieve sharp pain associated with surgery and not as well for distension and pain as the result of abdominal surgery.

* Post-operative flatulence: Select and needle the sensitive points along the Large Intestine and Small Intestine, Stomach, Sympathetic, and Spleen. Strongly stimulate for one to two hours to help alleviate distension and promote passage of gas.

 

Auricular Medicine by Dr. Li-Chun Huang:

* Acute sprain and contusion: corresponding points (to the area of injury)

¡± For pain, add Large Auricular Nerve, Lesser Occipital Nerve. Bleed Ear Apex.

¡± For tranquilizing the mind, add Shenmen.

 

NUTRITION

* Advise the patients to eat half of a fresh pineapple on an empty stomach daily. Pineapple is rich in bromelain and will reduce swelling and inflammation.

* Patients with broken bones or fractures should consume an adequate amount of calcium during recovery.

* Patients with broken bones or fractures should avoid foods with preservatives because phosphorus in preservatives can lead to bone loss.

* Patients are advised to avoid cold food and drinks, as cold will cause more stagnation. They should also avoid spicy food to prevent aggravating the inflammatory condition.

 

LIFESTYLE INSTRUCTIONS

* Avoid exercise with a high risk of injury, especially during the recovery phase.

* For external injury with open wounds, be sure to clean the affected area thoroughly to prevent infection.

* Vitamin E oil can be applied to the wounds to minimize scarring. However, vitamin E oil should be applied only after the open wounds have closed or healed.

 

CASE STUDIES

* A.S., a 45-year-old female, presented with a right lateral ankle sprain that had occurred three days prior. Objective findings included purplish color and swelling around the ankle. The practitioner diagnosed this condition as local blood stagnation. For treatment, Flex (TMX) and Knee & Ankle (AC) were prescribed. After taking the herbs for three days, the patient reported her ankle was feeling 50% better. She discontinued taking the Flex (TMX) after eight days since her ankle was then 90% better. For an additional week she continued to take the Knee & Ankle (CR) and her ankle was 100% better. Submitted by S.L., Yuma, Arizona.

* D.G., a 59-year-old male, presented with an acute ankle sprain on the left ankle due to a recent fall. Objective findings included swelling, black and blue coloring, and abrasions around the left ankle. The TCM diagnosis was qi and blood stagnation. For treatment, Flex (TMX) was prescribed at 3 capsules three times per day. As a result of taking the herbs, the patient reported that the swelling had resolved in four days and the bruising resolved in one week. Overall, the herbs helped his pain decrease within two days of taking the herbs. Submitted by M.P., Muskego, Wisconsin.

* S.P., a 32-year-old male, presented with pain located on his neck and back due to an injury while working out. The practitioner diagnosed this condition as qi and blood stagnation. Flex (TMX) was prescribed at 4 capsules three times a day, while also taking Neck & Shoulder (AC) at 6 capsules three times a day. After taking the herbs, there was an immediate decrease in pain. The patient discontinued taking Flex (TMX) after two weeks and continued taking Neck & Shoulder (AC) for an additional four weeks until the pain was gone. Submitted by S.L., Yuma, Arizona.

* C.K., a 12-year-old boy, presented with a painful and swollen elbow, with bruises due to a go-cart accident in which he was pinned under the roll bar. The patient was asked to take three capsules of Flex (TMX), four times a day, with food to avoid stomach upset. The accident happened on Thursday. The boy was able to return to school on Monday with 100% recovery, and experienced no stomach upset. A topical herbal tincture Po Sum On, along with acupuncture, massage and homeopathic remedies, were all part of the treatment regimen. Submitted by M.C., Sarasota, Florida.

* D.D., a 41-year-old nurse, presented with a work-related injury. She had severe back pain that was the result of a fall from lifting a patient. She said she heard a popping sound in her back when she fell. MRI confirmed her diagnosis of a herniated lumbar disc. She was nine weeks post-injury and had scheduled for steroid epidurals. She refused injections and came to our clinic for ¡¥safe and non-invasive care.¡¦ Her blood pressure was 140/80 mmHg and the heart rate was 80 beats per minute. The TCM diagnoses included qi and blood stagnation and soft tissue damage. Back Support (AC), Flex (SC) and Flex (TMX) were prescribed at 3 capsules each three times a day. After the herbs, the patient was able to reduce Vicodin (APAP/hydrocodone) use from 2 to 0.5 tablets per day, and none at all on some days. She had increased blood pressure from stress over the injury, which was up to 170/110 mmHg. After the herbs and massage, the blood pressure came down to normal and is staying down. She had received no additional physical therapy. She did remarkably well in a short period of time. Submitted by M.H., West Palm Beach, Florida.

* An 18-year-old male chef presented with neck and shoulder pain from a skateboard fall. X-rays revealed a diminished cervical curvature as well as a hypokyphotic curve at T2 to T3. The practitioner diagnosed the condition as a cervical sprain/strain. The patient was treated with Neck & Shoulder (AC) and Flex (TMX), which produced a reduction in pain. The patient found it necessary to take the herbs with food to avoid stomach discomfort. Submitted by M.H., Jupiter, Florida.

* J.M., a 36-year-old female massage therapist, presented with pain from a recent automobile accident (second accident in 6 months). She exhibited neck, back, arm and leg pain. Airbags bent her right thumb. Her blood pressure was 120/70 mmHg and her heart rate was 72 beats per minute. X-rays showed herniation and soft tissue damage. She also complained of muscle spasms, hot sensation on trigger points, inability to move the right thumb and the range of motion for the neck and trunk were both decreased. Flex (TMX), Neck & Shoulder (AC) and Back Support (AC) were all prescribed at 2 capsules each three times daily. She responded quickly to these formulas and acupuncture treatments. Pain levels were reduced by half in a short period of time. Submitted by M.H., West Palm Beach, Florida.

* L.P., a 77-year-old female, presented with severe pain in the left wrist and right rib cage after a fall. She had numbness of the wrist and palm where she landed on the cement. The patient showed bruises on the right eye. The right wrist was painful to light movement and palpation. There were tender points on the right subclavicular area. There were no visible contusions on the right rib cage. The diagnoses were qi and blood stagnation with soft tissue damage. Flex (TMX), Neck & Shoulder (AC) and Flex (SC) were prescribed at 2 capsules of each formula three times daily. The patient reported daily lowering of pain levels. Numbness was reduced to a light tingling after two days. She reported continuous and steady improvement each day. She was instructed to reduce the dosage to 2 capsules of each formula twice a day when the pain subsided. After the swelling was reduced, the patient was referred to a chiropractor for cervical and occipital adjustments. Submitted by M. H., West Palm Beach, Florida.

 

PHARMACOLOGICAL AND CLINICAL RESEARCH

Flex (TMX) is formulated specifically to treat both internal and external injuries, such as muscle aches and pain, bruises, sprains, contusions, and in severe cases, bone fractures or broken bones. Pharmacologically, herbs in this formula have an analgesic effect to relieve pain, anti-inflammatory action to reduce inflammation and swelling, and antispasmodic function to relieve muscle spasms and cramps.

        Yan Hu Suo (Rhizoma Corydalis) is one of the strongest and most potent herbs for treatment of pain. Its effects are well documented in both historical references and modern research studies. According to classical texts, Yan Hu Suo (Rhizoma Corydalis) has been shown to treat chest and hypochondriac pain, epigastric and abdominal pain, hernial pain, amenorrhea or menstrual pain, and pain of the extremities. According to laboratory studies, the extract of Yan Hu Suo (Rhizoma Corydalis) has been found to be effective in both acute and chronic phases of inflammation. The mechanism of its anti-inflammatory effect is attributed to its effect to inhibit the release of histamine and pro-inflammatory mediators.[5]^,[6] Furthermore, it has a strong analgesic effect. With adjustment in dosage, the potency of Yan Hu Suo (Rhizoma Corydalis) has been compared to that of morphine. In fact, the analgesic effect of Yan Hu Suo (Rhizoma Corydalis) is so strong and reliable that it has been used with a satisfactory anesthetic effect in 98 out of 105 patients (93.4%) who underwent surgery.[7] The analgesic effect can be potentiated further with concurrent acupuncture therapy. In one research study, it is demonstrated that the analgesic effect is increased significantly with concurrent treatments using Yan Hu Suo (Rhizoma Corydalis) and electro-acupuncture, when compared to a control group, which received electro-acupuncture only.[8] Overall, it is well understood that Yan Hu Suo (Rhizoma Corydalis) has a marked effect to treat pain. Though the maximum analgesic effect of Yan Hu Suo (Rhizoma Corydalis) is not as strong as morphine, it has been determined that the herb is much safer, with significantly less side effects, less risk of tolerance, and no evidence of physical dependence even with long-term use.[9]

        In addition to Yan Hu Suo (Rhizoma Corydalis), there are many herbs with analgesic effect to alleviate pain. Ru Xiang (Gummi Olibanum) and Mo Yao (Myrrha) have an analgesic effect to relieve pain and an anti-inflammatory effect to reduce swelling and inflammation.[10],[11] Clinically, they have been used effectively to treat pain associated with various types of trauma and external injuries.[12] Furthermore, use of Ru Xiang (Gummi Olibanum) and Mo Yao (Myrrha) is also beneficial to facilitate wound healing by stimulating maturation and differentiation of white blood cells.[13] The combination of Bai Shao (Radix Paeoniae Alba) and Gan Cao (Radix et Rhizoma Glycyrrhizae) also has a marked analgesic effect to relieve pain. The effectiveness is increased significantly when combined with acupuncture.[14] Clinically, these two herbs have been used successfully to treat conditions such as pain,[15] neuralgia,[16] trigeminal neuralgia,[17]^,[18] neck pain, [19] acute back pain,[20] heel pain,[21] pain in the lower back and legs,[22] sciatica,[23] gastric and abdominal pain,[24] and dysmenorrhea.[25]

        Flex (TMX) contains many herbs with excellent anti-inflammatory effects to reduce swelling and inflammation. Dang Gui (Radix Angelicae Sinensis) exerts both analgesic and anti-inflammatory effects through the inhibition of pro-inflammatory mediators, including nitric oxide and prostaglandin E2 in peritoneal macrophages.[26]^,[27] In comparison with acetylsalicylic acid, the anti-inflammatory effect of Dang Gui (Radix Angelicae Sinensis) is approximately 1.1 times stronger, and its analgesic effect is approximately 1.7 times stronger.[28] Er Cha (Catechu) exerts a remarkable anti-inflammatory effect via dual inhibition of cyclo-oxygenase and 5-lipoxygenase enzymes to reduce production of pro-inflammatory eicosanoids and attenuate edema.[29] Mu Dan Pi (Cortex Moutan) has demonstrated strong anti-inflammatory actions through inhibition of prostaglandin synthesis and decreased permeability of the blood vessels.[30]^,[31] Chuan Mu Xiang (Radix Vladimiriae) exhibited an anti-inflammatory effect through significant inhibitory effects on INF-£^-induced nitric oxide production.[32] Su Mu (Lignum Sappan) has both anti-inflammatory and antiarthritic effects. It suppresses inflammation through the inhibition of nitric oxide activity,[33] and attenuates collagen-induced arthritis by decreasing the levels of IL-1£], IL-6, TNF-£\ and PGE2 in serum and the expression of cyclo-oxygenase-2 and transcription factor NF-£eB.[34] Finally, Gan Cao (Radix et Rhizoma Glycyrrhizae) has demonstrated marked anti-inflammatory effects by enhancing the effect of glucocorticoid through increased production and secretion as well as decreased metabolism by the liver.[35] In terms of anti-inflammatory actions, the comparison of cortisone to glycyrrhizin and glycyrrhetinic acid, two compounds from Gan Cao (Radix et Rhizoma Glycyrrhizae), is approximately 10:1.[36] Clinical applications of Gan Cao (Radix et Rhizoma Glycyrrhizae) include pain, inflammation, edema, arthritis, spasms, cramps and others.[37]^,[38]

        To relieve spasms and cramps, Flex (TMX) utilizes the muscle-relaxant effect of Bai Shao (Radix Paeoniae Alba) and Gan Cao (Radix et Rhizoma Glycyrrhizae) to relax both smooth and skeletal muscles.[39]^,[40] Clinically, these two herbs have been used successfully to treat conditions such as leg cramps in the calf,[41] muscle cramps in hemodialysis,[42] restless leg syndrome,[43] intestinal spasm,[44] facial spasms and twitching,[45] and menstrual cramps and pain.[46]

        In addition to all the functions listed above, Flex (TMX) contains other herbs with supportive functions. Tao Ren (Semen Persicae) and Hong Hua (Flos Carthami) have excellent functions to invigorate blood circulation and facilitate healing. It was demonstrated in a clinical study with 775 cases of swelling and subcutaneous hemorrhage due to acute sprains that Hong Hua (Flos Carthami) can effectively improve and/or cure the condition within three to five days. Da Huang (Radix et Rhizoma Rhei) has a wide range of effects on the treatment of sports or traumatic injuries. Taken internally, it shortens coagulation time or stops bleeding. Used externally (as powder or paste), it treats traumatic hemorrhage with no adverse reactions or side effects. Lastly, Dang Gui (Radix Angelicae Sinensis) is an effective herb to promote the generation of bones. According to one study, the water extract of Dang Gui (Radix Angelicae Sinensis) is found 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.[47]

        In summary, Flex (TMX) is not only effective for treating acute pain and inflammation associated with trauma and external injuries, it also contains herbs to facilitate healing and recovery.

 

COMPARATIVE ANALYSIS

Trauma injuries are generally treated with drugs that reduce inflammation and relieve pain. Two classes of drugs commonly used for treatment include non-steroidal anti-inflammatory agents (NSAID) and opioid analgesics. NSAID¡¦s [such as Motrin (ibuprofen) and Voltaren (diclofenac)] are generally used for mild to moderate pain, and are most effective to reduce inflammation and swelling. Though effective, they may cause such serious side effects as gastric ulcer, duodenal ulcer, gastrointestinal bleeding, tinnitus, blurred vision, dizziness and headache. Furthermore, newer NSAID¡¦s, also known as COX-2 inhibitors [such as Celebrex (celecoxib)], are associated with significantly higher risk of cardiovascular events, including heart attack and stroke. Opioid analgesics [such as Vicodin (APAP/hydrocodone) and morphine] are usually used for severe to excruciating pain. While they may be the most potent agents for pain, they also have the most serious risks and side effects, including but not limited to dizziness, lightheadedness, drowsiness, upset stomach, vomiting, constipation, stomach pain, rash, difficult urination, and respiratory depression resulting in difficult breathing. Furthermore, long-term use of these drugs leads to tolerance and addiction. In brief, it is important to remember that while drugs offer reliable and potent symptomatic pain relief, they should be used only if and when needed. Frequent use and abuse leads to unnecessary side effects and complications.

        In TCM, treatment of trauma injuries is focused on relieving acute symptoms and promoting long-term recovery. Symptoms of pain, inflammation and swelling are usually treated with herbs that activate qi and blood circulation, as these herbs have excellent analgesic and anti-inflammatory effects. Furthermore, herbs that activate qi and blood also promote blood circulation to the affected area to facilitate and speed up the recovery process. In other words, by relieving symptoms and promoting recovery, use of herbs achieves both immediate and prolonged benefits.

        Both drugs and herbs are effective and play slightly different roles in trauma management. In mild to moderate cases, drugs and herbs are approximately equally effective. In severe cases, such as bone fractures or severe physical injuries, drugs have a stronger analgesic effect. After the acute condition stabilizes, herbs should definitely be used as they facilitate and shorten the recovery process. In short, drugs and herbs have contrasting benefits, and may be utilize in different stages of trauma recovery for optimal care.