University of Iowa Family Practice Handbook, Fourth Edition, Chapter 22
Teresa Bailey Klepser, PharmD and Michael W. Kelly, PharmD, MS
Division of Clinical and Administrative Pharmacy
University of Iowa College of Pharmacy
Peer Review Status: Externally Peer Reviewed by Mosby
| Table 22-2: Herbal Formulary |
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|
Indication |
Efficacy |
Contraindication |
Drug Interactions |
Side Effects |
Dose |
|
Black Cohosh |
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|
PMS symptoms, painful or difficult menstruation, and neurovegetative symptoms (hot flashes) caused by menopause |
Proven in double-blind control trial and 3 open label trials. Shown to be superior to placebo and comparable to estriol, conjugated estrogens, and estrogen-progesterone therapy. |
Pregnancy. Unknown if suitable where HRT is contraindicated such as estrogen-receptor positive breast cancer. German Commission E recommends length of use should not exceed 6 months. |
None known |
Occasional intestinal problems may occur; weight gain possible. Large doses may cause dizziness, nausea, severe headaches, stiffness, and trembling limbs. |
Remifemin: standardized product that contains 40 mg black cohosh to be taken BID. Stand-ardized to 1 mg of 27-deoxyacteine per tablet. |
| Chase Tree Berry (Vitex agnus-castus) |
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|
Disorders of the menstrual cycle, PMS, and mastodynia. |
Proven in open-label trial and one double-blind trial. Efficacy is mild. |
Pregnancy, lactation, and women receiving HRT. Contains progestins, and long-term effects of "natural hormones" on development of various hormone-mediated neoplasms is unknown. |
No drug interactions reported; however, dopamine-receptor antagonists, such as haloperidol, may weaken or block effects. |
eported in a few patients: GI and lower abdominal complaints, allergic reactions (i.e., itching and rash), headache, increased menstrual flow. Early menstruation after delivery rare side effect. |
Available as aqueous- alcoholic extracts (50%-70% V/V) from crushed fruit, tinctures, tea, or capsules. Some preparations formulated to give average daily dose 20-40 mg of berries. Daily dose of crushed fruit may be divided and administered BID or TID. Extract contains 175-225 mg; recommended to be standardized to contain 0.5% agnuside. Unknown why preparations are standardized to 0.5% agnuside since agnuside is an inactive ingredient in Vitex. Herbalists recommend 1-2 ml of tincture TID or 40 drops standardized tincture daily. To make tea, add cup boiling water onto 1 t ripe berries and infuse 10-15 min. Ingest tea TID. Results as early as 4 months or as long as 18 months. |
| Chondroitin |
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|
Nonapproved for visco- elastic agent in ophthal- mic procedures and osteoarthritis. |
Efficacy studies included glucosamine, which may be the active agent. |
Previous hypersen- sitivity to chondroitin sulfate. |
None reported |
Nausea and epigastric pain |
400 mg TID. |
| Coenzyme Q10 |
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|
Nonapproved for CHF, hypertension, stable angina, ventricular arrhythmias, cancer, heart surgery, and periodontal disease. |
Effective for CHF in double-blind, placebo-controlled trial. Efficacy for angina, etc., not yet proven, although studies suggestive |
Biliary obstruction, diabetes mellitus (hypoglycemia), hepatic insufficiency, renal insufficiency |
Hypolipidemic agents lower plasma concentrations of CoQ10. Oral hypoglycemic agents potentially inhibit affects of exogenous administration. |
Rash and GI disturbances (nausea, anorexia, epigastric pain, diarrhea). Elevations of serum aminotransferases occurred with relatively high oral doses. |
100 mg daily, up to 600 mg daily. |
| Dong Quai |
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|
Menstrual disorders, anemia, constipation, insomnia, rheumatism, neuralgia, and hypertension. |
Negative results in placebo-controlled trial. |
Pregnancy (uterine stimulant), lactation, diarrhea, hemorrhagic disease, hypermenorrhea, during colds or flus. Allergy to parsley. |
Unknown if interacts with anticoagulants, such as warfarin, other cardiovascular drugs such as procainamide. |
Photodermatitis may occur in persons collecting plant. Safrole, found in oil of Dong Quai, is carcinogenic and not recommended for ingestion. |
Variety of doses are suggested. No standardized produce available. Most common dose is powdered root 3-4 g divided BID-TID (5.4-12 g/day). |
| Echinacaea |
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|
Internal use: Supportive therapy for URIs (colds) and lower urinary tract. External use: Local application for treatment of hard-to-heal superficial wounds and ulcers. |
Melchart et al reviewed 26 controlled clinical trials evaluating echinacaea's ability to strengthen body's own defense mechanisms. Thirty of 34 echinacaea therapies were more effective compared to controls |
Infectious and autoimmune diseases (tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV, and lupus). Caution should be used in patients who are allergic to members of sunflower family. Effects of echinacaea in pregnancy, lactation, and children are unknown. |
None known. |
None known. |
Variety of doses is recommended. Most common dose is dried powder, 1 g or two 500 mg capsules orally TID. Therapy should not exceed 8 weeks. Some evidence shows that prolonged use of echinacaea may depress the immune system possibly through overstimulation. |
| Feverfew |
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|
Prophylaxis of migraine headaches. |
Proven effective in a double blind, placebo controlled trial. |
Feverfew should be avoided in pregnancy, lactation, and children under 2 years old. |
Feverfew may interact with anticoagulants, increasing the risk of bleeding |
Gastric discomfort. Minor ulcerations of oral mucosa, irritation of tongue, and swelling of lips may occur when fresh leaves are chewed. Heart rate increased by 26 beats/min in two patients. Canadian Health Protection Branch advises consumers not to take feverfew continuously for more than 4 months without medical advice. Discontinuation may produce muscle/joint stiffness and cluster of CNS reactions (rebound of migraines, anxiety, and poor sleep patterns). |
Usual dose is 125 mg daily. Product con- taining at least 0.2% parthenolide is recommended. |
| Garlic |
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|
Support dietary measures for treatment of hyperlipoproteinemia and prevent age-related changes in blood vessels (arteriosclerosis). |
Proven to reduce blood pressure and cholesterol, but data not the best. |
Caution in diabetics and pregnancy (emmenagogue and abortifacient). |
Anticoagulants (increased bleeding). Antiretrovirals (decreased levels). |
GI discomfort (heartburn, flatulence), sweating, lightheadedness, allergic reactions, and menorrhagia. |
0.6-1.2 g dried powder (2-5 mg of allicin) daily or 2-4 g fresh garlic. Alliinase (enzyme that converts alliin to allicin) inactivated by acids. Enteric-coated tablets or capsules allow more absorption because they pass through the stomach and release their contents in alkaline medium of small intestine. |
| Gingko |
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|
Treatment for cerebral circulatory disturbances resulting in reduced functional capacity and vigilance (vertigo, tin- nitus, weakened memory, and mood swings accompanied by anxiety). Treatment of peripheral arterial cir- culatory disturbance such as intermittent claudication. |
7 of 8 well-done trials show positive effect on CNS function (including in Alzheimer's disease). Two well-done trials suggest benefit in claudication. |
None known. |
Antiplatelets--a case report of spontaneous hyphema (bleeding from iris into anterior chamber) from ginkgo and aspirin. |
Gastric disturbances, headache, dizziness, and vertigo. Toxic ingestion may produce tonic-clonic seizures and loss of consciousness. |
Recommended dose is 40 mg TID with meals for at least 4-6 weeks. Standardized prepa- rations containing 6% terpene lactones and 24% ginkgo flavone glycosides are recommended. |
| Ginger |
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|
Dyspepsia and prophy- laxis of symptoms of travel sickness. |
No benefit overall for motion sickness. |
Avoid for postoperative nausea because it may prolong bleeding time and delay immunologic changes. Contraindi-cated for gallstone pain. Recommended in pregnancy only on advice of physician (uterine relaxant [low doses]; uterine stimulant [high doses]). |
None known. |
None reported. |
For travel sickness: Daily dose is 2-4 g. Two 500-mg capsules taken 30 min before travel, then 1-2 more capsule(s) Q4hr as needed. |
| Ginsing (Asian) |
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|
Tonic to combat feel- ings of lassitude and debility, lack of en- ergy and ability to con- centrate, and during convalescence. |
Shown to be of benefit in randomized, double-blind, controlled study for fatigue. |
Pregnancy, children, and patients with hypertension, emotional/psychologic imbalances, headaches, heart palpitations, insomnia, asthma, inflammation, or infections with high fever. |
May interact with phenelzine, producing hallucinations and psychosis. May decrease INR of warfarin. |
Nervousness and excitation first 4 days. Inability to concentrate with long-term use. Diffuse mammary nodularity and vaginal bleeding may be due to estrogen-like effect in women. Hyper- tension, euphoria, restlessness, nervousness, insomnia, skin eruptions, edema, and diarrhea reported with long- term use with average dose of 3 g ginseng root daily. |
1-2 g crude herb daily or 100-300 mg of ginseng extract TID. Standard-ized products that contain at least 4%-5% ginsenosides are recommended. |
| Ginsing (Siberian) |
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|
Tonic for fatigue, conva- lescence, decreased work capacity, or difficulty in concentration. |
No benefit in randomized, placebo controlled study. |
Avoid in hypertension. Not recommended in patients in febrile states, hypertonic crisis, or MI. |
Serum levels of digoxin may increase when taken with Siberian ginseng. Hexobarbital and Siberian ginseng increase sleep latency and duration. |
Mild, transient diarrhea and insomnia. May lower blood glucose. |
2 capsules (each capsule containing 400-500 mg of powdered root) TID. Total of 2-3 g daily. Solid concentrated extract standardized on eleutherosides B and E 300-400 mg daily recommended. |
| Glucosamine |
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|
Nonapproved for osteoarthritis. |
Superior to ibuprofen in a double-blind study. Spared and repaired cartilage. |
Hypersensitivity to glucosamine. Diabetics may have impaired insulin secretion. |
Fluoxetine may increase glucosamine serum concentrations. |
GI side effects such as epigastric pain and tenderness, heartburn, diarrhea, nausea. CNS side effects such as drowsiness, headache, and insomnia. Long-term side effects unknown. |
500 mg TID. |
| Hawthorn |
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|
Mild cardiac conditions such as CHF NYHA stages I or II, uneasiness and oppressed feeling of the heart, not yet digitalized heart, and light forms of bradycardic arrhythmia. |
Proven effective in two double-blind, placebo-controlled studies for symptomatic relief of CHF. |
Pregnancy, lactation. Note for self-treatment. |
Unknown with other cardiovascular drugs such as digoxin, calcium channel blockers, beta-blockers, and antiarrhythmics. |
Large doses may induce hypotension, arrhythmias, and sedation. |
160-900 mg/day divided into BID-TID. |
| Horse Chestnut Seed |
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|
Venous conditions, eczema, leg pains, hemorrhoids, phlebitis, menstruation. |
Shows benefit in double-blind, placebo- controlled studies. |
Renal and hepatic insufficiency. |
Anticoagulants. |
GI irritation, pruritus, giddiness. |
Aescin 30-150 mg daily. Venastat 300 mg (standardized aescin 50 mg). |
| Kava |
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|
Insomnia, nervousness. |
Proven effective in open-label study (weaker evidence than double-blind, placebo- controlled). |
Depression (increased risk of suicide), operating machinery or motor vehicles. Pregnancy, lactation, children. Should not be taken longer than 3 months without doctor's supervision. |
Sedatives, anxiolytics, monoamine oxidase inhibitors, alcohol, antidepressants. Antiplatelets. Levodopa (decreased levels). |
Yellowing skin, nails, hair. Allergic skin reactions; "Kava dermopathy" (dry, scaly skin rash on palms of hands, soles of feet, forearms, back, and shins, swollen face, blood-shot eyes); GI complaints; pupil dilation; disorders of oculomotor equilibrium; morning fatigue, neurologic choreoathetosis, dystonic reactions; dyskinesia. Tolerance: not reported Toxicity: ataxia, muscle weakness, ascending paralysis without loss of consciousness. |
200-250 mg of kava lactones divided into two or three doses. |
| Licorice |
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|
Expectorant and the treatment of ulcers. |
Negative human evidence. |
German Commission E stipulates that duration of use be no longer than 4-6 weeks. Liver cirrhosis, cholestatic liver disorders, hypertonia, kidney diseases, cardiovascular diseases, especially hypertension, hypokalemia, and pregnancy. |
Potassium loss may be increased in the presence of other drugs, e.g., thiazide and loop diuretics. With loss of potassium, sensitivity to digitalis glycosides increases. |
Prolongation of P-R and Q-T intervals. With long-term use or acute toxic ingestion, pseudoaldosteronism (headache, lethargy, sodium and water retention, hypokalemia, high blood pressure, heart failure and cardiac arrest). |
1-2 g licorice root TID or 200-800 mg glycyr-rhizin per day. |
| Ma Huang |
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|
Derivative of ephedrine; CNS stimulant |
Dangerous; should not be used. |
Patients with heart conditions, hypertension, diabetes, or thyroid disease. |
Similar to drug interactions of ephedrine/pseudoephedrine. Avoid consumption with caffeine. |
Nervousness, headache, insomnia, dizziness, palpitations, skin flushing, tingling, vomiting, hypertension, and MI. |
Ephedra herb contains small concentrations of ephedrine (~1%). Maximum ephedrine dose = 100 mg/24 hrs. |
| Melatonin |
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|
Orphan Drug Status. Treatment of circadian rhythm sleep disorders in blind people with no light perception. Nonapproved Indica-tions. Jet lag, insomnia, depression, and cancer. |
Shown effective in jet lag and insomnia but ineffective in preventing fatigue in shift workers. |
Melatonin may aggravate depressive symptoms. |
Vitamin B12 influences melatonin secretion. Low levels of vitamin B12 will produce low levels of melatonin. MAOI may increase melatonin serum concentrations. SSRIs may increase melatonin serum concentrations. Beta-blockers may decrease nocturnal secretion of melatonin. |
Heavy head, headache, and transient depression. Long-term side effects are unknown. |
3 mg HS. |
| Milk Thistle |
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|
upportive treatment for chronic inflammatory liver conditions and cirrhosis. |
Seems to be effective in controlled trials. |
Safety not established in pregnancy. |
None reported. |
Rare: Mild transient diarrhea and rash. |
Daily dose is 200-400 mg per day of silymarin. |
| Saw Palmetto |
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|
Treatment of micturition difficulties associated with benign prostatic hyperplasia |
No difference between saw palmetto and finsateride at 6 months in randomized study. (Draw your own conclusions: Does finasteride work?). |
Pregnancy, children. |
None reported. |
Headache, stomach upset. |
1-2 g saw palmetto or 320 mg lipophilic extract daily, usually given 160 mg BID. Take with food. Standardized products containing 90% free and 7% esterified fatty acids are recommended. |
| St John's Wort |
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|
Anxiety and depression. |
Proven as effective as low dose tricyclics in placebo-controlled studies. |
Caution in fair-skinned persons when exposed to bright sunlight. Caution in pregnancy (emmenagogic and abortifacient). No negative influence on general performance or the ability to drive a car or operate heavy machinery has been reported. |
DRUGS: Antidepressants (serotonin syndrome); antiretrovirals (decreased effect); oral contraceptives (decreased effect); digoxin (decreased levels); the-ophylline (decreased levels); cyclosporine (decreased levels). FOOD: May be similar to MAOIs (tyramine-containing foods: cheeses, beer, wine, herring, and yeast). |
Photodermatitis, GI irritations, allergic reactions, fatigue, restlessness. |
2-4 g daily of herb. Standardized products containing 0.4-2.7 mg hypericin/day or 0.3% hypericin are recommended. Metabolized via cytochrome P450. |
| Valerian |
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|
Restlessness and nervous disturbance of sleep |
Proven double-blind, placebo-controlled studies trial to improve sleep (450 mg dose). |
Caution while driving or performing other tasks requiring alertness and coordination is recommended. |
May potentiate sedative effect of barbiturates, benzodiazepines, opiates, or alcohol. |
Headaches, hangover, excitability, insomnia, uneasiness and cardiac disturbances. Toxicity: ataxia, decreased sensibility, hypothermia, hallucinations, and increased muscle relaxation. |
Dried herb or extract: 2-3 g daily, up to TID. |
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