CLINICAL APPLICATIONS

* Chronic and constant stress, anxiety and depression with underlying deficiency

* Insomnia with difficulty falling or staying asleep in patients who are stressed or have things on their minds

* Type A personality with excessive competitive drive, impatience, sense of urgency without the body strength and constitution to cope with their stress

 

WESTERN THERAPEUTIC ACTIONS

* Anxiolytic effect to relieve stress and anxiety

* Antidepressant function to lift emotions

* Sedative and hypnotic benefits to treat insomnia

* Muscle-relaxant action to alleviate tension and stiffness

 

CHINESE THERAPEUTIC ACTIONS

* Calms the shen (spirit)

* Regulates Liver qi

* Sedates Liver fire

* Tonifies the deficiencies

 

DOSAGE

Take 3 to 4 capsules three times daily for stress, anxiety, emotional instability and similar mental disorders. For insomnia, another dose may be taken 30 minutes before bedtime. This formula is safe for long-term use.

 

INGREDIENTS

Bai Shao (Radix Paeoniae Alba)

Chai Hu (Radix Bupleuri)

Da Zao (Fructus Jujubae)

Deng Xin Cao (Medulla Junci)

Fu Shen (Poria Paradicis)

Gan Cao (Radix et Rhizoma Glycyrrhizae)

Gou Teng (Ramulus Uncariae cum Uncis)

He Huan Hua (Flos Albiziae)

Shou Wu Teng (Caulis Polygoni Multiflori)

Suan Zao Ren (Semen Ziziphi Spinosae)

Xiang Fu (Rhizoma Cyperi)

Xiao Mai (Fructus Tritici)

Zhi Mu (Rhizoma Anemarrhenae)

 

BACKGROUND

Nonstop stress in the modern world places a tremendous burden on the mind and the body to always function in a heightened and alarmed state. Overtime, the mind and the body are unable to relax, leading to a wide variety of dysfunctions throughout the body, including brain (feelings and emotions), heart (hypertension, arrhythmia, atherosclerosis, coronary artery disease), muscles (stiffness and pain), stomach (acid reflux, peptic ulcer disease, irritable bowel syndrome), and immune system (weakened immune system, frequent infection). Therefore, optimal treatment requires use of herbs to rescue the mind from stress and restore the body to its optimal health.

 

FORMULA EXPLANATION

Calm ZZZ is designed to treat individuals who are under constant stress but also have a deficient constitution. This is one of the best formulas to treat shen (spirit) disturbance both during the day and at night. Shen (spirit) disturbance during the day can manifest as stress, anxiety and emotional instability. Shen (spirit) disturbance at night manifests as insomnia with difficulty falling asleep and/or staying asleep. Many of these patients will also have underlying deficiencies as a result of Liver excess consuming yin and body fluids on a long-term basis. Therefore, optimal treatment requires use of herbs to calm the shen (spirit), regulate Liver qi, sedate Liver fire, and tonify the deficiencies.

        In this formula, Chai Hu (Radix Bupleuri) and Xiang Fu (Rhizoma Cyperi) are used to regulate qi circulation and relieve Liver qi stagnation. Gou Teng (Ramulus Uncariae cum Uncis) calms Liver yang, Deng Xin Cao (Medulla Junci) sedates Heart fire, and Zhi Mu (Rhizoma Anemarrhenae) clears deficiency fire. These three herbs treat the excess aspects of shen (spirit) disturbance and relieve irritability.

        In addition, Bai Shao (Radix Paeoniae Alba), Fu Shen (Poria Paradicis), Suan Zao Ren (Semen Ziziphi Spinosae), He Huan Hua (Flos Albiziae), and Shou Wu Teng (Caulis Polygoni Multiflori) calm the shen (spirit) and relieve stress and anxiety by nourishing the Heart. Xiao Mai (Fructus Tritici), Gan Cao (Radix et Rhizoma Glycyrrhizae) and Da Zao (Fructus Jujubae) calm the shen (spirit) and control emotional instability and prevent the drastic shifting of moods. Together, these eight herbs address the deficiency aspects of shen (spirit) disturbance.

        In short, Calm ZZZ uses an integrative approach to treat both the excess and deficient aspects of shen (spirit) disturbance. Clinical applications include stress, anxiety, emotional disturbance, mental disorders, and insomnia.

 

CAUTIONS & CONTRAINDICATIONS

* This herbal formula may cause drowsiness in individuals who are sensitive to herbs. Patients are advised not to drive or operate heavy machinery while taking this herbal formula. Similarly, alcohol is not recommended as it may intensify the effect.

* Calm ZZZ is not to be used as “sleeping pills.” Do not ingest a large amount of this formula, as this will only increase the risk of potential side effects, such as drowsiness.

* Allergy warning: Xiao Mai (Fructus Tritici) used in this product contains wheat. Persons with allergy to wheat should not take this product.

 

CLINICAL NOTES

* Calm ZZZ is an excellent formula to treat insomnia associated with stress and anxiety. However, it will generally take a few days before this formula nourishes the underlying deficiency and restores the normal sleeping patterns accordingly.

 

Pulse Diagnosis by Dr. Jimmy Wei-Yen Chang:

* Outward display of emotional conditions (i.e., patients who express how they feel and do not hold their feelings inside): convex and forceful pulse on the left guan

* Internalized emotional conditions (i.e., patients who hold their feelings inside): concave and deep pulse on the left guan

 

SUPPLEMENTARY FORMULAS

* For mild to moderate cases of stress and anxiety, combine with Calm.

* For moderate to severe cases of stress and anxiety, combine with Calm (ES).

* For severe cases of insomnia, combine with Schisandra ZZZ.

* For headache, add Corydalin (AC) or Corydalin (CR).

* For heartburn or gastric ulcers, add GI Care.

* For depression, add Shine or Shine (DS).

* For constipation, combine with Gentle Lax (Deficient) or Gentle Lax (Excess).

* For irritable bowel syndrome (IBS) due to stress, add GI Harmony.

* For ulcerative colitis due to stress, add GI Care (UC).

* For menopausal symptoms, combine with Balance (Heat).

* For forgetfulness, add Enhance Memory.

* For hypertension, combine with Gastrodia Complex or Gentiana Complex.

* To tonify the overall body constitution, combine with Imperial Tonic.

 

ACUPUNCTURE TREATMENT

Traditional Points:

* Shenmen (HT 7), Sanyinjiao (SP 6), Ganshu (BL 18), Danshu (BL 19), Wangu (GB 12), Anmian, Yintang, ear Shenmen

 

Classic Master Tung's Points:

* Stress, anxiety, irritability, depression and emotional instability: Dizong (T 44.09), Neiguan (PC 6), Huoying (T 66.03), Tongshan (T 88.02), Tongtian (T 88.03), Tianhuangfu [Shenguan] (T 77.18), Huoxi (T 11.16)

* Insomnia: Linggu (T 22.05), Xinling (T 33.17)*, Shenjian (T 44.19), Zhenjing (T 1010.08), Zhenghui (T 1010.01), Tianhuang (T 77.17), Dihuang (T 77.19), Renhuang (T 77.21), Huoying (T 66.03), Tianhuangfu [Shenguan] (T 77.18), Shenmen on the ear. Bleed du (governing) channel and back of the knee area.

 

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

* Anxiety, stress, irritability, insomnia: Zhenjing (T 1010.08), Tianhuangfu [shenguan] (T 77.18), Zhongjiuli (T 88.25)

 

Balance Method by Dr. Richard Tan:

* Left side: Shenmen (HT 7), Shaohai (HT 3), Zulinqi (GB 41), Yanglingquan (GB 34), Weizhong (BL 40), Shugu (BL 65)

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

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

 

Ear Acupuncture:

* Shenmen

 

Auricular Medicine by Dr. Li-Chun Huang:

* Tranquilizing the mind: Nervous Subcortex, Shenmen, Brain Stem, Occiput, Anxious. Bleed Ear Apex.

* Improving sleep: Shenmen, Heart, Kidney, Occiput, Neurasthenia Area, Neurasthenia Point, Nervous Subcortex. Bleed Ear Apex.

* Neurasthenia: Shenmen, Heart, Occiput, Nervous Subcortex, Neurasthenia Area (Front & Back), Neurasthenia Point (Front & Back). Bleed Ear Apex.

* Improving depression, anxiety, stress, nervousness: Shenmen, Heart, Nervous Subcortex, Anxious, Be Happy, Liver, Occiput. Bleed Ear Apex.

 

NUTRITION

* A diet high in calcium, magnesium, phosphorus, potassium, and vitamins B and E is recommended. These vitamins and minerals are easily depleted by stress.

* Encourage the consumption of fruits and vegetables such as apricots, winter melon, asparagus, avocados, bananas and broccoli in addition to brown rice, dried fruit, figs, salmon, garlic, green leafy vegetables, soy products, and yogurt.

* A glass of warm milk with honey before bedtime is helpful for mild insomnia.

* Advise the patient to avoid foods that contain tyramine near bedtime. Tyramine increases the release of the brain stimulant norepinephrine. Food with high tyramine content include: bacon, cheese, chocolate, eggplant, ham, potatoes, sugar, sausage, spinach, and tomatoes.

* Avoid caffeine (coffee, tea, cola, chocolate), tobacco, alcohol and sugar whenever possible.

* Warm and hot natured foods that damage qi and yin should be avoided, such as:

§ certain fruits like mango and durian that produce heat.

§ stimulants like coffee, alcohol, and energy drinks.

§ spicy/pungent/aromatic vegetables such as pepper, garlic, onions, basil, rosemary, cumin, funnel, anise, leeks, chives, scallions, thyme, saffron, wormwood, mustard, chili pepper, and wasabi.

* Avoid food and drinks with artificial coloring.

* Consume as few meat products as possible. Do not eat processed meats, such as lunch meats, hot dogs and sausages, as they contain nitrites that are associated with inflammation and chronic disease.

 

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

* Restlessness and emotional instability: Make a tea of wheat bran, licorice root, and dates. Drink three times daily until symptoms are relieved.

* Insomnia: Boil mulberry tea and drink 1/2 cup.

* Anxiety and/or insomnia: Toast 1/4 cup amaranth in the oven until slightly brown, remove and steep in a cup of hot water for five minutes and sip for immediate relief of anxiety or before bedtime for insomnia.

 

LIFESTYLE INSTRUCTIONS

* Regular exercise, adequate rest, and normal sleep patterns are beneficial for stress reduction.

* Relax the mind and the body through meditation, yoga, breathing exercises, imagery exercises, and other activities such as tai chi chuan [tai ji chuan] and qi gong.

* Get away from the daily routine to do something different and enjoyable to relieve stress whenever possible. Laughter really is the best medicine!

* Noise can be disturbing to mental health and cause stress.

* If insomnia is due to overwork, do not work in the bedroom, and remove anything that may be a reminder of the office or work. A warm bath or light snack before bedtime may also be helpful.

* Advise the patients to not worry and to do their best to prepare for upcoming events they know may be stressful. Try to ask for help from friends, family and colleagues when stress in life becomes intolerable.

* Shift outlook on life and look at changes in a positive way and as challenges rather than threats.

* Sleep by 10 p.m. In TCM, 11 p.m. to 1 a.m. is when the yin shifts to yang. It is crucial for the body to be at rest during this time for optimal health.

 

CASE STUDIES

* C.W., a 39-year-old female, presented with difficulty in both falling and staying asleep, which she believed was due to stress. The practitioner diagnosed this condition as Liver qi stagnation and shen (spirit) disturbance; the Western diagnosis was insomnia. Calm ZZZ was prescribed at three capsules three times a day. After taking the herbs for two weeks, the patient reported being able to sleep for four to six hours undisturbed. She had also mentioned having better personal relationships. Submitted by S.L., Yuma, Arizona.

* M.S., a 49-year-old female, presented with severe muscle spasms on the side of her neck and shoulder area. Objective findings included limited range of motion (ROM). It was mentioned that she had been under a lot of stress and was experiencing difficulty sleeping. Other findings included pale face, low voice, and tension on the trapezius muscle. The practitioner diagnosed this condition as qi and blood deficiencies, along with qi and blood stagnation. Calm ZZZ was prescribed, in which after one week of taking it, the patient had reported a dramatic improvement. Her ROM became 90% normal, and the other symptoms almost diminished. Submitted by N.V., Muir Beach, California.

* A.B., a 22-year-old female, presented with anxiety and fear of failure. Additional symptoms she had been experiencing were depression, insomnia, and poor eating habits. It was noted that her shen (spirit) was not settled and she had dysglycemia. The practitioner diagnosed this condition as Liver qi stagnation and Spleen qi deficiency; Western diagnosis was low self-esteem along with low caloric diet. Calm (ES) was prescribed to take during the day and then Calm ZZZ to take at night. After two weeks she was then instructed to take Schisandra ZZZ at night and Shine during the day. Bu Zhong Yi Qi Tang (Tonify the Middle and Augment the Qi Decoction) was taken as well until she began eating at regular intervals. After one month of taking the herbs, the insomnia had resolved and regular sleeping habits were occurring. In addition, her depression was lifted. She started experiencing major changes in attitude, life purpose and direction. Six weeks later she maintained her results by taking Calm. The anxiety had also reduced, only being anxious during stressful situations, which she had been resolving. She had also established regular eating habits, her energy had improved and her menses became regular without pain. Overall, the patient was very pleased with the outcome of taking the herbs. Submitted by N.T., Bethesda, Maryland.

* S.C., a 62-year-old female, presented with pain in the right wrist due to practicing yoga, along with high stress and insomnia. The patient had not yet seen a Western doctor for this condition, but her TCM diagnosis was qi and blood stagnation in the Lung, Pericardium, and Heart channels. For treatment, Arm Support and Calm ZZZ were prescribed at 3 to 4 capsules three times a day each. After taking the herbs for one week, the wrist pain had completely resolved and did not return. The additional symptoms of stress and sleep had improved during the course of the following two weeks. Afterwards, the patient no longer needed to take the Arm Support and only continued taking the Calm ZZZ. Submitted by B.S., Niceville, Florida.

* R.K., a 55-year-old female, presented with insomnia due to low back pain and stress. The practitioner diagnosed this condition as qi and blood stagnation in the Urinary Bladder channel and Liver qi stagnation. Calm ZZZ and Back Support (AC) were prescribed. After taking the herbs for two weeks, the back pain resolved temporarily. However, it still would come and go due to overuse. Over time, her sleep had improved as her back pain had gotten better. Submitted by B.S., Niceville, Florida.

* J.F., a 38-year-old female, presented with sleep issues, difficulty falling asleep and staying asleep. Premenstrual irritability, mood swings, and anxiety during the day were also present. Other symptoms included palpitations and racing heart beat at night when working at 3:30 a.m. and 5:00 a.m. Blood pressure was 100/62 mmHg and heart rate was 70 beats per minute. Objective findings were pale face, jitteriness and difficulty sitting still. The practitioner diagnosed this condition as Liver blood and yin deficiencies as well as Heart blood and yin deficiencies. The patient was given Calm ZZZ three capsules three times a day. Jia Wei Xiao Yao San (Augmented Rambling Powder) was given at the onset of her PMS symptoms until day three of her period. With Calm ZZZ she was sleeping seven hours in a row consistently with some nights eight to ten hours as well as falling asleep after just 20 minutes vs. one to two hours before she took the herbs. The PMS symptoms also improved dramatically with much more even emotions. Submitted by L.M., Lafayette, Colorado.

 

PHARMACOLOGICAL AND CLINICAL RESEARCH

Calm ZZZ is an excellent formula to treat both the emotional and physical aspects of mental and psychological disorders. Pharmacological effects of this formula include anxiolytic effect to relieve stress and anxiety, antidepressant function to lift emotions, sedative and hypnotic benefits to treat insomnia, and muscle-relaxant action to relieve tension and stiffness. Clinical applications include stress, anxiety, depression and insomnia.

        Calm ZZZ has herbs with anxiolytic, antidepressant, and sedative effects to combat stress, anxiety, depression and insomnia. Suan Zao Ren (Semen Ziziphi Spinosae) has an anxiolytic effect to relieve stress and anxiety.[1] Zhi Mu (Rhizoma Anemarrhenae) has demonstrated significant antidepressant activity on two experimental models of depression.[2] The proposed mechanism of the antidepressant activity of Zhi Mu (Rhizoma Anemarrhenae) involves marked increase of noradrenaline and serotonin levels in both the hypothalamus and the hippocampus.[3] Chai Hu (Radix Bupleuri), Gou Teng (Ramulus Uncariae cum Uncis), Suan Zao Ren (Semen Ziziphi Spinosae) and Da Zao (Fructus Jujubae) have a calming effect on the brain to help the patients manage mental stress by promoting relaxation and improving sleeping.[4]^{,[5],[6],[7],[8]} Clinically, Suan Zao Ren (Semen Ziziphi Spinosae) has been used in many studies to successfully treat insomnia.[9]^,[10]

        Gan Cao (Radix et Rhizoma Glycyrrhizae), Xiao Mai (Fructus Tritici) and Da Zao (Fructus Jujubae) are the three principle herbs in this formula. Together, these three herbs have been shown to have an excellent anxiolytic effect to treat disorders such as neurasthenia, hysteria, and insomnia. For neurasthenia, use of Gan Cao (Radix et Rhizoma Glycyrrhizae), Xiao Mai (Fructus Tritici), Da Zao (Fructus Jujubae) and others was shown to effectively treat 92 out of 100 patients.[11] For hysteria, concurrent use of acupuncture and these herbs effectively stabilized the condition and resolved the clinical signs and symptoms in all 60 patients, with no recurrence in follow-up visits 6 months after the conclusion of treatments.[12] For insomnia, use of Gan Cao (Radix et Rhizoma Glycyrrhizae), Xiao Mai (Fructus Tritici), Da Zao (Fructus Jujubae) and others was associated with a 74.2% overall rate of effectiveness in 110 patients.[13] Furthermore, concurrent use of Da Zao (Fructus Jujubae) and Gan Cao (Radix et Rhizoma Glycyrrhizae) also has a positive cognitive effect to improve mental functions and ameliorate memory impairment.[14]^,[15]

        In addition, Calm ZZZ contains many herbs with analgesic, anti-inflammatory, and muscle-relaxant effects to help the body cope with muscle aches and pain due to stress. Bai Shao (Radix Paeoniae Alba) and Gan Cao (Radix et Rhizoma Glycyrrhizae) have anti-inflammatory and muscle-relaxant functions.[16]^,[17] Clinically, these two herbs have marked effect to treat neck pain,[18] acute back pain,[19] sciatica,[20] pain in the lower back and legs,[21] leg cramps in the calf,[22] restless leg syndrome,[23] heel pain,[24] gastric and abdominal pain,[25] intestinal spasm,[26] menstrual cramps and pain,[27] neuralgia,[28] facial spasms and twitching,[29] trigeminal neuralgia,[30]^,[31] and dysmenorrhea.[32] Xiang Fu (Rhizoma Cyperi) illustrates its anti-inflammatory effect in dose- and time-dependent manners by inhibiting the production of nitric oxide and superoxide (O2-), two important mediators in the pathogenesis of inflammatory diseases.[33] Zhi Mu (Rhizoma Anemarrhenae) exerts significant anti-inflammatory action by inhibiting cyclo-oxygenase-2, inducible nitric oxide synthase, and 5-lipoxygenase.[34] Lastly, Chai Hu (Radix Bupleuri) demonstrates both analgesic and anti-inflammatory functions,[35]^,[36] and the saikosaponins appear to be the main compounds for these actions.[37]

        Lastly, to alleviate the adverse effects of stress on the digestive system, Calm ZZZ contains many herbs with gastroprotective effects. Gan Cao (Radix et Rhizoma Glycyrrhizae) has a proven effect to prevent and treat peptic ulcers. The mechanisms of this action include inhibition of gastric acid secretion, binding and deactivation of gastric acid, and promotion of recovery from ulceration.[38] According to one study, 100 patients with gastric or duodenal ulcers were treated with Gan Cao (Radix et Rhizoma Glycyrrhizae) with a 90% rate of effectiveness.[39] Another study also reported good results using Gan Cao (Radix et Rhizoma Glycyrrhizae) to treat patients with peptic ulcers. The treatment protocol was to administer 2.5 to 5 grams of powdered Gan Cao (Radix et Rhizoma Glycyrrhizae) three times daily for three to four weeks.[40]

        In summary, Calm ZZZ is an excellent formula that treats both the emotional and physical aspects of mental and psychological disorders. Treatment of the emotional aspects of mental disorder includes use of herbs with anxiolytic effects to relieve stress and anxiety, and sedative and hypnotic effects to treat insomnia. Furthermore, treatment of the physical aspects of mental disorder includes use of herbs with muscle-relaxant effects to relieve tension and stiffness.

 

COMPARATIVE ANALYSIS

Stress, anxiety, and insomnia are three conditions that often contribute to and aggravate each other. Clinical signs and symptoms include intrusive thoughts, illusions, hallucinations, difficulty concentrating, hypervigilance, restlessness, anger, irritability, and inability to fall and/or stay asleep.

        Pharmaceutical drug treatments for stress, anxiety, and insomnia focus primarily on use of benzodiazepines such as Valium (diazepam), Ativan (lorazepam), Halcion (triazolam), Restoril (temazepam), and Dalmane (flurazepam). Though these drugs are very potent and have an immediate effect to sedate patients, they do not address the underlying conditions. Furthermore, long-term use of these medications are associated with many side effects, including drowsiness, dizziness, tiredness, blurred vision, changes in sex drive or ability, shuffling walk, persistent, fine tremor or inability to sit still, difficulty breathing or swallowing, severe skin rash, yellowing of the skin or eyes, irregular heartbeat, and addiction. Therefore, these drugs should only be used when necessary, and only for a short period of time.

        Use of herbs is extremely effective to treat stress, anxiety, and insomnia. Herbs regulate mood and emotions, and alleviate stress and anxiety by enhancing the body’s own ability to deal with these external factors. Furthermore, many herbs calm the shen (spirit) and help to restore normal sleeping patterns. Unlike benzodiazepine drugs that have immediate and potent sedative effects, herbs are moderate in potency, and may require one to two weeks to relieve stress, anxiety, and insomnia. In contrast, one of the main advantages of herbs is they are safe and natural, and do not have negative side effects like drugs.

        Stress, anxiety, and insomnia are very common disorders. While drugs and herbs are both effective, they have contrasting differences of benefits and risks. While drugs are more effective for short-term treatment, herbs are more successful for long-term management. Furthermore, counseling (behavioral and psychotherapy) is extremely important toward the understanding of, and complete recovery from, these conditions.