CLINICAL APPLICATIONS

* Neuropathy: peripheral neuropathy, polyneuropathy, diabetic neuropathy, drug-induced neuropathy

* Neuralgia: trigeminal neuralgia, postherpetic neuralgia

* Peripheral vascular disease

* General pain, numbness, tingling, swelling, and muscle wasting, especially in the extremities

 

WESTERN THERAPEUTIC ACTIONS

* Analgesic function to relieve pain

* Anti-inflammatory function to reduce swelling and inflammation

* Circulatory effect to improve peripheral blood circulation to facilitate healing and recovery

* Treats causes of peripheral neuropathy, such as trauma, infection, and accumulation of drugs and toxic chemicals

 

CHINESE THERAPEUTIC ACTIONS

* Invigorates blood circulation

* Relieves pain

* Opens channels and collaterals

 

DOSAGE

Take 3 to 4 capsules three times daily on an empty stomach, with warm water. Dosage may be increased to 6 to 8 capsules three times daily, if necessary.

 

INGREDIENTS

Bai Shao (Radix Paeoniae Alba)

Chuan Mu Xiang (Radix Vladimiriae)

Chuan Niu Xi (Radix Cyathulae)

Chuan Xiong (Rhizoma Chuanxiong)

Da Huang (Radix et Rhizoma Rhei)

Da Zao (Fructus Jujubae)

Dang Gui (Radix Angelicae Sinensis)

Dang Gui Wei (Extremitas Radix Angelicae Sinensis)

Er Cha (Catechu)

Fu Ling (Poria)

Gan Cao (Radix et Rhizoma Glycyrrhizae)

Hong Hua (Flos Carthami)

Huang Jin Gui (Caulis Vanieriae)

Liu Zhi Huang (Herba Solidaginis)

Lu Lu Tong (Fructus Liquidambaris)

Mo Gu Xiao (Caulis Hyptis Capitatae)

Mo Yao (Myrrha)

Mu Dan Pi (Cortex Moutan)

Qiang Huo (Rhizoma et Radix Notopterygii)

Qin Jiao (Radix Gentianae Macrophyllae)

Ru Xiang (Gummi Olibanum)

Sheng Ma (Rhizoma Cimicifugae)

Tao Ren (Semen Persicae)

Xue Jie (Sanguis Draconis)

Yan Hu Suo (Rhizoma Corydalis)

 

BACKGROUND

Neuropathy is defined as a functional disturbance or pathological change in the peripheral nervous system.[1] Symptoms of neuropathy include sensory loss, muscle weakness and atrophy, and pain. Etiologies of neuropathy include trauma, infection by micro-organisms, drugs, nutritional deficiency, metabolic disorders, malignancy, and unknown causes.[2] Due to the wide range of causes, treatment varies. Herbal treatment of neuropathy focuses on relieving symptoms (pain) and the cause (such as poor circulation, increased cellular pressure, trauma, and infection).

 

FORMULA EXPLANATION

According to traditional Chinese medicine, peripheral neuropathy, polyneuropathy, diabetic neuropathy, distal polyneuropathy, neuralgia, and fibromyalgia have various etiologies. However, they all share one common factor – pain due to blood stagnation. Therefore, Flex (NP) is formulated to treat nerve pain by activating blood circulation and eliminating blood stagnation.

        Tao Ren (Semen Persicae) and Hong Hua (Flos Carthami) are often paired together to synergistically invigorate blood circulation and remove blood stagnation. Ru Xiang (Gummi Olibanum), Mo Yao (Myrrha), Chuan Niu Xi (Radix Cyathulae), and Yan Hu Suo (Rhizoma Corydalis) together invigorate blood circulation and relieve pain. Er Cha (Catechu) and Xue Jie (Sanguis Draconis) promote the generation of new tissues. Mu Dan Pi (Cortex Moutan) moves blood and clears heat associated with local inflammation due to blood stagnation. Dang Gui (Radix Angelicae Sinensis), Dang Gui Wei (Extremitas Radix Angelicae Sinensis), Chuan Xiong (Rhizoma Chuanxiong), and Lu Lu Tong (Fructus Liquidambaris) open the channels and collaterals to relieve pain by invigorating blood circulation to the extremities. Fu Ling (Poria) is used to strengthen the middle jiao to promote absorption of the herbs.

        Da Huang (Radix et Rhizoma Rhei) clears heat, removes blood stasis and helps with blood circulation. Bai Shao (Radix Paeoniae Alba) softens the Liver and benefits the tendons and sinews to relieve tightness, numbness, tingling, and pain. Chuan Mu Xiang (Radix Vladimiriae) invigorates qi circulation in the channels to assist the overall pain-relieving effects of this formula.

        Qin Jiao (Radix Gentianae Macrophyllae), Qiang Huo (Rhizoma et Radix Notopterygii), Huang Jin Gui (Caulis Vanieriae), Mo Gu Xiao (Caulis Hyptis Capitatae), and Liu Zhi Huang (Herba Solidaginis) are used to relieve pain in the joints and extremities. Da Zao (Fructus Jujubae) and Gan Cao (Radix et Rhizoma Glycyrrhizae) are used to harmonize the formula and the middle jiao.

        In summary, Flex (NP) contains herbs that invigorate blood circulation and eliminate blood stasis to treat various presentations of nerve pain.

 

CAUTIONS & CONTRAINDICATIONS

* This formula is contraindicated during pregnancy and nursing.

* This herbal formula contains herbs that invigorate blood circulation, such as Dang Gui (Radix Angelicae Sinensis) and 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.[3]^,[4],[5]

* 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

* It is essential to identify and eliminate the cause(s) of neuropathy, especially if it is induced by drugs or toxic agents. Without elimination of the offending agent, treatment will offer only symptomatic relief.

* Neuropathy due to nutritional deficiency must be identified and treated accordingly. Adequate intake of vitamin B complex is beneficial. Though it is uncommon in developed countries, patients with polyneuropathy due to nutritional deficiency should be put on vitamin B supplementation.

* Neuropathy due to metabolic disorders, such as diabetic neuropathy, must be identified, and the root cause treated accordingly. Blood glucose levels must be monitored to ensure that the patient’s levels stay within an acceptable range.

* Acupuncture is sometimes more effective than herbs in cases of neuropathy. See Acupuncture Treatment for treatment protocols.

 

Pulse Diagnosis by Dr. Jimmy Wei-Yen Chang:

* Yinqiao pulse, a thin, straight, wiry pulse found on or extends proximally to the chi position. Yinqiao pulse is one of the eight extra meridian pulses.

 

SUPPLEMENTARY FORMULAS

* For neuropathy due to chronic exposure to harmful toxins and chemicals, add Herbal DTX.

* For diabetic neuropathy, use with Equilibrium.

* To potentiate the effect to relieve pain, add Herbal ANG.

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

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

* For nerve pain in the lower back, add Back Support (AC) or Back Support (CR).

* For nerve pain in the back from herniated disk, add Back Support (HD).

* For nerve pain in the knees, add Knee & Ankle (AC) or Knee & Ankle (CR).

* For nerve pain with chronic musculoskeletal disorder with damaged soft tissues (muscles, tendons, ligaments), add Flex (MLT).

* With excess heat, add Gardenia Complex.

* With severe blood stagnation, add Circulation (SJ).

* For lymphedema, add Resolve (AI).

 

ACUPUNCTURE TREATMENT

Traditional Points:

* Hua Tou Jia Ji, local ah shi points

* Hegu (LI 4), Shenshu (BL 23), Pishu (BL 20), Sanyinjiao (SP 6), Taichong (LR 3)

 

Classic Master Tung's Points:

* Needle contralateral to the pain. If the pain is in the center, needle bilaterally or the side with the more ah shi points. If the pain is bilateral, needle bilaterally.

* Peripheral neuropathy: Erjiaoming (T 11.12), Wanshunyi (T 22.08), Wanshuner (T 22.09), Tianhuang (T 77.17), Dihuang (T 77.19), Renhuang (T 77.21), Zhengshi (T 77.03), Zhengjin (T 77.01), Zhengzong (T 77.02). Bleed Weizhong (BL 40), Sihuashang (T 77.08), Sihuawai (T 77.14), Sihuazhong (T 77.09), Sihuali (T 77.13), Sihuafu (T 77.10), Sihuaxia (T 77.11) or dark veins nearby. Bleed before needling for best result.

 

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

* Neuropathy: Zhongjiuli (T 88.25), Qili (T 88.51)*, Sizhi (T 77.20), Renhuang (T 77.21)

 

Balance Method by Dr. Richard Tan:

* Use Dr. Tan’s Balance Method accordingly as determined by where the pain is (use mirror or image system).

 

Ear Acupuncture:

* Affected area, Adrenal Gland, Lung

* Embed magnetic balls and switch ears every five days.

 

Auricular Medicine by Dr. Li-Chun Huang:

* Peripheral neuropathy: Large Auricular Nerve, Lesser Occipital Nerve, and corresponding points (fingers, toes). Bleed Ear Apex.

* Intercostal neuralgia: Intercostal Area, Large Auricular Nerve, corresponding points (to the area affected)

§ Supplementary points: Liver, Gallbladder, Chest, Occiput

* Diabetes mellitus: Diabetes Point, Pancreas, Ear Center, Pituitary, Thalamus, San Jiao, Endocrine

§ For numbness in the extremities, add Lesser Occipital Nerve, Large Auricular Nerve

 

NUTRITION

* Nutritional balance is essential in the treatment and prevention of neuropathy. It is important to make sure that there is adequate intake of various nutrients in a well-balanced diet. If necessary, supplement the diet with vitamins and minerals.

* Increase the intake of foods that contain thiamine (vitamin B₁), such as whole grains and green vegetables, to maintain nerve health. Do not consume white sugar and white flour products, as they deplete the body of B vitamins.

 

LIFESTYLE INSTRUCTIONS

* Tight control over blood glucose levels is essential in patients with diabetic neuropathy. Diet, exercise, and herbal treatment will be extremely beneficial in maintaining normal blood glucose levels.

* Nerve pain can be relieved with light massage using a solution of apple cider vinegar water, which is made by mixing ½ cup apple cider vinegar with 2 cups of warm water.

* Application of hot wraps for half an hour is also effective to relieve pain.

* Avoid exposure to toxic agents or industrial poisons that cause nerve damage, such as carbon monoxide, heavy metals (especially lead or mercury), and many chemical solvents.

* Do not take harmful drugs that cause nerve damage, such as antibiotics (sulfonamides, nitrofurantoin, chlorobutanol), antiseizure drugs (phenytoin), sedatives (barbital, hexobarbital) and anticancer drugs (vinca alkaloids).

 

CASE STUDIES

* F.T., a 44-year-old female marathon runner, presented with a Baker’s cyst on her left knee, previously diagnosed by an MRI, measuring out to be 4 cm in diameter. Objective findings were pain and swelling that were limiting her ability to walk and run. The practitioner diagnosed this condition as stagnation of qi and blood within the channels, as well as heat toxin and accumulation of phlegm. Resolve (AI) and Flex (NP) were prescribed at 3 grams three times a day at a 2:1 ratio. After one month of taking the herbs, the cyst was almost completely resolved. The formula was then modified to address the residual inflammation and stagnation in the channels. Thereafter, the client was able to begin long distance running again without further problems. Other than that condition, the patient was in excellent health. She had eliminated coffee from her diet and started eating anti-inflammatory foods while being treated for the cyst. Submitted by E.Z., Portland, Oregon.

* D.A., a 55-year-old female, presented with extreme pain in both heels, radiating up the calf area. Symptoms of night sweats, problems with staying asleep, low energy, and depression were also present. Her pulse was weak and thin, and her tongue was red with thin white coating. The practitioner diagnosed this condition as Liver qi stagnation and Kidney yin deficiency. Upon diagnosis, the patient was prescribed Flex (NP) and Circulation (SJ). The patient reported less pain; however, it was still present especially in the morning and late in the day after standing a lot. Her sleep improved as well to waking up only once during the night. The patient continued to improve; however, effort on her part was necessary to improve more. Submitted by B.L., Fort Myers, Florida.

* J.B., a 55-year-old female, presented with pain located on the right foot, numbness and tingling along the neck, and pain shooting down the back legs. The patient was also complaining about hot flashes and night sweating. Objective findings included pain upon palpation of the joints and red cheeks. The TCM diagnosis was qi and blood stagnation with yin deficiency; her Western diagnosis was RSD (reflex sympathetic dystrophy). Flex (NP) was prescribed at 2 to 3 capsules twice a day. After taking the herbs, the patient experienced less pain in the arm and neck, but pain in the right foot was still present, and she was experiencing slight stomach discomfort. The patient was directed to take a higher dosage if tolerable. Submitted by M.P., Muskego, Wisconsin.

* L.L., a 52-year-old female, presented with body aches over the entire body along with swelling of the legs. Additional symptoms included low grade fever, sore throat, and low energy. The patient had been previously diagnosed with Lyme disease. Her pulse was thin and weak and her tongue was pale and dull with thin white coating. The practitioner diagnosed this condition as general qi and blood stagnation with Spleen qi deficiency. For treatment, patient was instructed to take Resolve (AI) and Flex (NP) in conjunction with acupuncture treatment. As a result, the patient’s energy increased, the pain lessened, and the sore throat was no longer present. Additional treatment the patient had received was lymphatic massage which also had helped her improve. Submitted by B.L., Fort Myers, Florida.

* J.R., a male patient, suffered from intolerable neuropathy after receiving chemotherapy and radiation for throat cancer. He conducted an empirical test on himself in which he took Flex (NP) for one week and did not take it for another. He reported that the week without the Flex (NP) was nearly intolerable. But with it, he is “in the zone” and is able to sleep. Flex (NP) has reduced his neuropathic symptoms by a good 50%. Submitted by C.W., Carpinteria, California.

* A 59-year-old male was stung by a sea urchin while diving in Hawaii four months prior to coming in for treatment. The spines of the sea urchin went into his hand. The black marking of the sting are all gone, but he had difficulty moving his fingers with limited movement of his fingers and hand. His tongue was dusky and swollen with a sticky coat. His pulses were wiry and slippery. After taking Flex (NP) and Astringent Complex for 15 days, in conjunction with acupuncture, the patient was completely healed. Submitted by K.M., Albany, California.

* A 36-year-old diabetic (Type 1) female presented with severe neuropathy of her hands along with chronic fungal and bacterial infections, sores all over her lower limbs, feet numbness, severe fatigue, malaise and weakness. Besides her diabetes, she also was diagnosed with kidney failure as well as immune deficiency due to immuno-suppressants. She had a kidney transplant as a result of her kidney failure. The TCM practitioner diagnosed her condition as severe Kidney jing (essence) deficiency with underlying Spleen qi deficiency, damp-heat, and qi and blood stagnation. Her circulation was severely impaired along with noticeable signs of wasting and thirsting. The patient prescribed an herbal combination of Flex (NP) (3 to 4 capsules three times daily) and a customized special formula to tonify her Spleen qi, move the blood, and circulate the qi. The patient experienced relief from her hand pain within two to three days. Although stinging sensations still persisted, the pain was less in occurrence and intensity. Her sores and warts displayed signs of improvement as well as becoming less visible. Submitted by A.R., Encinitas, California.

* M.F., a 57-year-old female, presented with pain in the leg and big toe with pressure, metallic taste, absence of thirst, heat sensations except in the hands and feet, and upper body sweating. She had been exposed to toxic chemicals and pesticides for six months. The TCM diagnosis was yin deficiency with heat, damp-heat and toxic heat accumulation, and bi zheng (painful obstruction syndrome) of the legs. After six weeks of taking Liver DTX, Balance (Heat) and Flex (NP), she experienced less leg pain, decreased sweating, subsiding heat sensations, and warmer hands. The patient still had a metallic taste in the mouth. The patient was also advised to increase her intake of carrot juice and cucumbers. Submitted by M.C., Sarasota, Florida.

 

PHARMACOLOGICAL AND CLINICAL RESEARCH

Flex (NP) is formulated specifically to treat nerve pain, such as in various presentations of neuropathy and neuralgia. The main signs and symptoms include pain, numbness, sensory loss, and muscle weakness and atrophy. Optimal treatment of neuropathy and neuralgia requires use of herbs to alleviate the symptom (pain) and the cause (poor circulation, increased cellular pressure, trauma, infection, and others).

        Pharmacologically, Flex (NP) utilizes many herbs with excellent analgesic effects to alleviate pain and anti-inflammatory activity to reduce inflammation. Dang Gui (Radix Angelicae Sinensis), Bai Shao (Radix Paeoniae Alba), Gan Cao (Radix et Rhizoma Glycyrrhizae) and Qiang Huo (Rhizoma et Radix Notopterygii) all have an analgesic effect to alleviate pain.[6]^,[7]^,[8]^,[9]^,[10]^,[11] Mu Dan Pi (Cortex Moutan) and Qin Jiao (Radix Gentianae Macrophyllae) have an anti-inflammatory effect to reduce swelling and inflammation.[12]^,[13]^,[14] More specifically, nerve-related pain, such as trigeminal pain, responds remarkably to such herbs as Chuan Xiong (Rhizoma Chuanxiong), Bai Shao (Radix Paeoniae Alba), and Gan Cao (Radix et Rhizoma Glycyrrhizae).[15]^,[16] Injury-related pain, such as pain of the extremities, responds equally well to herbs such as Ru Xiang (Gummi Olibanum), Mo Yao (Myrrha), Yan Hu Suo (Rhizoma Corydalis), Bai Shao (Radix Paeoniae Alba), and Gan Cao (Radix et Rhizoma Glycyrrhizae).[17]^,[18]

        Clinically, many herbs in Flex (NP) have been used successfully to treat various types of nerve pain. The combination of Bai Shao (Radix Paeoniae Alba) and Gan Cao (Radix et Rhizoma Glycyrrhizae) has a marked analgesic effect, and has been used successfully to treat neuralgia,[19] trigeminal neuralgia,[20]^,[21] and sciatica.[22] Chuan Xiong (Rhizoma Chuanxiong) exerts an anti-inflammatory effect via an inhibitory activity on TNF-α production and TNF-α bioactivity,[23] and is used clinically to treat trigeminal nerve pain and trigeminal neuralgia.[24],[25] 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] Lastly, Yan Hu Suo (Rhizoma Corydalis) is one of the strongest and most potent herbs for treatment of pain. 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 pain and inflammation. Furthermore, with appropriate adjustment of dosage, its analgesic effect is comparable to that of morphine.[29] Lastly, it has been demonstrated that the analgesic effect of Yan Hu Suo (Rhizoma Corydalis) is increased significantly with concurrent treatments with electro-acupuncture.[30]

        In addition to relieving the symptoms (pain), Flex (NP) contains many herbs to treat the causes of neuropathy and neuralgia (poor circulation, increased cellular pressure, trauma, infection, and others). Poor circulation is a significant factor contributing to neuropathy and hindering its recovery. Tao Ren (Semen Persicae), Hong Hua (Flos Carthami), Chuan Xiong (Rhizoma Chuanxiong) and Mu Dan Pi (Cortex Moutan) have pronounced influence on improving blood circulation, increasing microcirculation to peripheral parts of the body, eliminating blood stasis, and facilitating recovery.[31]^,[32]^,[33]^,[34] Increased cellular pressure is another contributor to neuropathy. Mu Dan Pi (Cortex Moutan) is used to reduce swelling and pressure in the periphery of the body by inhibiting prostaglandin synthesis and decreasing permeability of the blood vessels.[35]^,[36] Trauma is another common cause of neuropathy. Ru Xiang (Gummi Olibanum), Mo Yao (Myrrha) and Yan Hu Suo (Rhizoma Corydalis) are commonly used in treatment of trauma and sports injuries.[37] Tao Ren (Semen Persicae) is also effective to facilitate recovery from injuries.[38] Certain injuries that damage both nerves and soft tissue, such as frostbite, can be treated with Dang Gui (Radix Angelicae Sinensis), Gan Cao (Radix et Rhizoma Glycyrrhizae), and other herbs.[39]^,[40] Furthermore, infection and its complications also contribute to neuropathy. There are many herbs with remarkable antibiotic properties, such as Er Cha (Catechu),[41] Xue Jie (Sanguis Draconis),[42] and Mu Dan Pi (Cortex Moutan).[43] Lastly, exposure to drugs and toxic agents are two of the main causes of neuropathy. While elimination of these offending agents is the best solution, it is not always possible to discontinue the drugs or completely eliminate exposure to toxic chemicals. Under these circumstances, the drugs and the toxic chemicals accumulate in the body and adversely affect the nerves. Gan Cao (Radix et Rhizoma Glycyrrhizae) is prescribed to remedy these kinds of poisoning. It is one of the most effective detoxifying herbs for treatment of physiological insults, including drug poisoning (chloral hydrate, urethane, cocaine, picrotoxin, caffeine, pilocarpine, nicotine, barbiturates, mercury and lead), food poisoning (tetrodotoxin, snake, and mushrooms), and others (enterotoxin, herbicides, pesticides). The exact mechanism of this action is unclear, but it is thought that it is related to the regulatory effect of Gan Cao (Radix et Rhizoma Glycyrrhizae) on the endocrine or hepatic systems.[44]

        In summary, Flex (NP) is an effective formula for treatment of neuropathy and neuralgia. It contains herbs that relieve the symptoms and the cause, and achieves both short- and long-term improvements.

 

COMPARATIVE ANALYSIS

Pain is a basic bodily sensation induced by a noxious stimulus that causes physical discomfort (such as pricking, throbbing, or aching). Pain may be of acute or chronic state, and may be of nociceptive, neuropathic, or psychogenic origin. For neuropathic pain of acute or chronic origins, the drugs of choice include antiseizure [Dilantin (phenytoin) and Neurontin (gabapentin)] and antidepressant drugs [Elavil (amitriptyline)]. Though effective, these drugs are associated with numerous and significant side effects. Antiseizure drugs cause side effects such as bleeding, burning sensations, clumsiness or unsteadiness, confusion, irregular eye movements, blurred or double vision, swollen glands in neck or underarms, slurred speech, delusions, dementia, bone malformations, and many others. Antidepressant drugs cause blurred vision, confusion or delirium, hallucinations, constipation (especially in the elderly), problems in urinating, decreased sexual ability, difficulty in speaking or swallowing, eye pain, fainting, fast or irregular heartbeat, loss of balance control, mask-like face, nervousness or restlessness, slowed movements, stiffness of arms and legs, and shortness of breath or troubled breathing. In short, these drugs should be prescribed only when benefits significantly outweigh the risks. Furthermore, use of these drugs must be monitored carefully to avoid developing serious side effects and complications.

        Treatment of pain is a sophisticated balance of art and science. Proper treatment of pain requires a careful evaluation of the type of disharmony (excess or deficiency, cold or heat, exterior or interior), characteristics (qi and/or blood stagnations), and location (upper body, lower body, extremities, or internal organs). Furthermore, optimal treatment requires integrative use of herbs, acupuncture and tui-na therapies. All these therapies work together to tonify the underlying deficiencies, strengthen the body, and facilitate recovery from chronic pain. TCM pain management targets both the symptom and the cause of pain, and as such, often achieves immediate and long-term success. Furthermore, TCM pain management is often associated with few or no side effects.

        For treatment of mild to severe pain due to neuropathic causes, TCM pain management offers similar treatment effects to those of pharmaceuticals, with significantly fewer side effects.