PRESCRIBING INFORMATION

Actions	Nervine tonic, tonic, mild laxative
Potential Indications	Based on appropriate evaluation of the patient, practitioners should consider prescribing damiana in formulations in the context of: • Nervousness, anxiety, depression (5) • Sexual inadequacy:impotence, frigidity (5,7) • Nervous dyspepsia, constipation (5)

Contraindications None known. Warnings and Precautions None required. Interactions None known. Use in Pregnancy and Lactation No adverse effects expected. Side Effects None expected if taken within the recommended dose range. Dosage Dose per day^* Dose per week^*   3–6 ml of 1:2 liquid extract 20–40 ml of 1:2 liquid extract

* This dose range is extrapolated from the British Pharmaceutical Codex 1934, the British Herbal Pharmacopoeia 1983, the British Herbal Compendium 1992, and the author’s education and experience.

SUPPORTING INFORMATION

Traditional Prescribing	Traditional Western herbal medicine uses include: • Anxiety, depression, nervous dyspepsia, constipation1 • Impotence and frigidity in both sexes,1,2 irritation of the urinary mucous membranes, renal catarrh2
	Native Brazilians and Mexicans used damiana, with early documented use by the Mayan people. Uses by native northern Mexicans included muscular and nervous debility, as an aphrodisiac and emmenagogue, for menstrual disorders, to aid in childbirth, and for spermatorrhea, orchitis, nephritis, and irritable bladder. In addition to the aphrodisiac uses, Hispanic herbalists of Mexico used damiana for sterility, nervous disorders, and diabetes.3–5 Damiana was also consumed in Mexico as a pleasant, stimulating, tonic beverage without the side effects of tea or coffee and was employed therapeutically as a hot drink for suppressed menstruation.6
	Damiana was official in the NF from 1916 to 1942 and was referred to as a stimulant and laxative, with a reputation as an aphrodisiac.7
Pharmacologic Research	• A postulated explanation for the aphrodisiac effect of damiana is that its volatile oil might irritate the urethral mucous membranes.4 • A methanol extract of damiana induced relaxation of isolated smooth muscle from the corpus cavernosum.8 Oral administration of damiana extract (0.25 to 1.0 ml/kg) demonstrated a stimulating effect on the sexual behavior of male rats. Copulatory performance was improved in sexually sluggish or impotent animals, but not in potent animals.9 • Oral administration of damiana infusion resulted in hypoglycemic activity in an experimental model.10 Aqueous alcohol (70%) and 100% alcohol extracts of damiana inhibited the formation of gastric lesions in several experimental models after oral or intragastric administration.11 • Damiana extract decreased psychomotor activity in an experimental model (administered by injection).12
Clinical Studies	No clinical studies using damiana have been found.

PRESCRIBING INFORMATION

Actions

Dandelion leaf and root are considered to have similar actions:bitter tonic, choleretic, diuretic (especially leaf), mild laxative, and antirheumatic.

Potential Indications

Based on appropriate evaluation of the patient, practitioners should consider prescribing dandelion leaf or dandelion root in formulations in the context of: • Cystitis, in combination with uva ursi (2) • Restoration of hepatic and biliary function, dyspepsia (4,5) • Loss of appetite, flatulence, intestinal bloating, to stimulate diuresis (4) • Edema (5,7) • Oliguria, jaundice, gallstones, constipation, muscular rheumatism, chronic skin diseases (5)

Both the traditional prescribing information and the information obtained from pharmacologic research suggest that dandelion leaf has the stronger diuretic activity and dandelion root has the stronger choleretic and cholagogue activities. This data should be reflected in the preferred use of the specific plant parts. Contraindications Dandelion leaf and root are contraindicated in closure of the bile ducts, cholecystitis, intestinal obstruction,¹ and known allergy. (A sesquiter-pene lactone found in both leaf and root is responsible for causing allergic dermatitis. Other constituents within dandelion may also be allergenic.²) Warnings and Precautions Interactions None known. Use in Pregnancy and Lactation No adverse effects expected. Side Effects None expected if taken within the recommended dose range. Dosage Dandelion leaf:     Dose per day^* Dose per week^*   6.0–11.5 ml of 1:1 liquid extract 40–80 ml of 1:1 liquid extract   Dandelion root:     Dose per day^* Dose per week^*   3 to 6 ml of 1:2 liquid extract 20 to 40 ml of 1:2 liquid extract

* This dose range is extrapolated from the British Herbal Pharmacopoeia 1983, the British Herbal Compendium 1992, and the author’s education and experience.

SUPPORTING INFORMATION

Traditional Prescribing	Traditional Western herbal medicine uses of dandelion root include: • Cholecystitis, gallstones, jaundice; atonic dyspepsia with constipation, muscular rheumatism, oliguria4 • Sluggishness and enlargement of the liver or spleen; impaired digestion, constipation5 • Dropsy, uterine obstruction, chronic skin diseases5
	In traditional Western herbal medicine, the uses of dandelion leaf are similar to those of dandelion root, but the leaf was considered to be weaker in activity than the root (except for diuretic activity).4
	Native Americans used dandelion root for heartburn and as a bitter tonic. Dandelion root was official in the USP from 1831 to 1926 and remained official in the NF until 1965. Dandelion root was used as a diuretic, tonic, and mild laxative.6
	Native Americans also used dandelion leaf as a tonic.6
Pharmacologic Research	Dandelion leaf: • In an early experimental study, a decoction of dandelion leaf administered by injection was shown to increase bile secretion.7 • Oral administration of dandelion leaf extract had a strong diuretic effect (even compared with frusemide) in an experimental model. Using high doses, long-term weight loss resulting from diuresis was observed. Because dandelion leaf contains potassium, depletion of this mineral is not a problem. In fact, the diuretic activity may be the result of the potassium content (see later discussion). Dandelion leaf demonstrated stronger activity than did dandelion root.8
	Dandelion root: • Dandelion root decoction increased bile secretion in vivo when administered by injection. The activity was stronger than that observed for dandelion leaf.7 • As previously mentioned, dandelion root extract also demonstrated a mild diuretic effect in an experimental model.8 Diuretic activity was, however, not observed in another study after either oral or intraperitoneal administration during a 2-hour observation period.9 • From the results of their experimental study, the authors concluded that no organic secondary metabolites showing major diuretic activity were present in dandelion root. The high potassium content of dandelion was considered to be the agent responsible for any diuretic activity.10 • Ethanol extract of dandelion root demonstrated analgesic and antiin-flammatory activity when administered by injection.9 • Oral preadministration of an aqueous-ethanolic extract of dandelion root inhibited experimentally induced edema.11 In another experiment, intraperitoneal treatment also demonstrated partial inhibition.9 • An ethanolic extract of dandelion root caused a dose-dependent inhibition of adenosine diphosphate (ADP)–induced aggregation in a preparation of human platelet-rich plasma. Arachidonic acid– and collagen-induced platelet aggregation were not influenced.12
	Dandelion (part undefined or combined): • In an in vitro study, extracts of dandelion reduced enzymatically induced lipid peroxidation and cytochrome c (with and without the reduced form of nicotinamide-adenine dinnucleotide phosphate [NADPH]) in a dose-dependent manner.13 • Dandelion inhibited the production of tumor necrosis factor-alpha (TNF-α) from primary cultures of astrocytes by inhibiting interleukin-1 production.14 In an earlier in vitro study, aqueous solution of dandelion restored the nitric oxide production from γ-interferon-primed peritoneal macrophages as a result of TNF-α secretion.15 • Dandelion extracts were shown to increase bile secretion in experimental models. A choleretic effect was described after administering the dose of dandelion by cannula.16,17 • Oral administration of dandelion root and leaf did not significantly affect glucose homeostasis in either nondiabetic animals or streptozotocin-induced diabetes.18 In another study, oral doses of whole dandelion produced a hypoglycemic effect in normal animals, without a significant response in alloxan-induced diabetes.19 • Dandelion extract increased the activity of cytostatic and surgical treatments in a transplantable tumor model. An independent inhibitory action on the tumor and metastases was also shown. The toxic effect of cyclophosphamide on red blood cells was lessened.20 A hot water extract from dandelion also showed antitumor activity following intraperitoneal administration.21
Clinical Studies	• An herbal preparation containing Calendula, dandelion, St. John’s wort, lemon balm, and fennel reduced intestinal pain in an uncontrolled trial involving patients with chronic colitis. Defecation was normalized in patients with diarrhea syndrome.22 • In a randomized, prospective study, treatment of ureteric calculi with either spasmoanalgesic therapy or an herbal preparation was compared. The preparation contained dandelion root and leaf, golden rod, Rubia tinctorum, Ammi visnaga, and a small amount of escin (a constituent of horsechestnut seed). No significant difference was observed with regard to the transit times of the stones between the two groups, but side effects and treatment costs were less in the herbal therapy group. The strength of the herbal extracts in these capsules was not defined.23 • In a double-blind, placebo-controlled, randomized, clinical trial, 57 women with recurrent cystitis received either herbal treatment (standardized uva ursi extract and dandelion leaf and root extract) or placebo. Treatment for 1 month significantly reduced the recurrence of cystitis during the 1-year follow-up period, with no incidence of cystitis in the herbal group and a 23% occurrence in the placebo group. No side effects were reported. The dose of the individual herbs was not specified.24 • In Germany, the Commission E supports using dandelion leaf to treat loss of appetite, dyspepsia, bloating, and flatulence. Dandelion root with leaf is recommended to treat disturbed bile flow, loss of appetite, and dyspepsia. This combination is also used to stimulate diuresis.3 • ESCOP recommends dandelion leaf as adjuvant therapy for treatments when enhanced urinary output is desirable, for example, in cases of rheumatism and for preventing renal gravel.25 • ESCOP recommends dandelion root for restoring hepatic and biliary function, dyspepsia, and loss of appetite.25

PRESCRIBING INFORMATION

Actions	Antiinflammatory, antirheumatic, analgesic, bitter tonic
Potential Indications	Based on appropriate evaluation of the patient, practitioners should consider prescribing devil’s claw in formulations in the context of: • Rheumatic and arthritic conditions (2,4,5) • Osteoarthritis (2,4) • Chronic back pain (2,5) • Tendinitis (4) • Loss of appetite, dyspepsia (4,6) • Topical treatment for skin lesions, such as wounds and ulcers (6)

Contraindications The Commission E advises the following contraindications:gastric and duodenal ulcers and gallstones. However, any health risks are theoretical in nature, being projected from the bitter tonic activity. Warnings and Precautions None required. Interactions A case of purpurea was reported in a patient taking warfarin and devil’s claw.¹ However, key details of this case, including the patient’s medical condition, other medications, and the doses and duration of the warfarin and devil’s claw ingestion were not reported. Use in Pregnancy and Lactation No adverse effects expected. Side Effects Mild gastrointestinal disturbances may occur in sensitive individuals, especially at the higher dose levels. Dosage Dose per day Dose per week   6.0–11.5 ml of 1:2 liquid extract for analgesic and antirheumatic activity^* 40–80 ml of 1:2 liquid extract for analgesic and antirheumatic activity^*   3 ml of 1:2 liquid extract for gastrointestinal complaints^** 20 ml of 1:2 liquid extract for gastrointestinal complaints^**   Pharmacologic studies have indicated that stomach acidity might decrease the analgesic and antiinflammatory activity. However, a recent study has established that this indication is not the case.²

* This dose range is extrapolated from clinical studies.

** This dosage is extrapolated from the German Commission E.

SUPPORTING INFORMATION

Traditional Prescribing	Traditional Western herbal medicine uses include: • Rheumatism, arthritis, gout, myalgia, fibrositis, lumbago, pleurodynia3 • As a general tonic, loss of appetite, digestive disorders4
	Traditional South African medicinal uses include: • As a purgative and bitter tonic5 • As an analgesic, especially during and after childbirth5 • Febrile diseases, allergic reactions5 • Topically for ulcers, wounds, cutaneous lesions, and after childbirth5
Pharmacologic Research	Key constituents of devil’s claw root include iridoid glycosides (0.5% to 3.0%), primarily harpagoside, which has a bitter taste. • Devil’s claw extract reduced subacute inflammation in an in vivo model of arthritis after oral and intraperitoneal administration. Results were comparable to phenylbutazone. Another study using different but similar models found that devil’s claw did not produce significant effects on either primary or secondary inflammatory reactions. • Oral doses of devil’s claw aqueous extract and harpagoside demonstrated little or no activity in acute models of inflammation, such as carrageenan-induced edema. However, intraperitoneal pretreatment with devil’s claw extract produced significant, dose-dependent, antiin-flammatory effects in this model. Devil’s claw root treated with acid at levels similar to that in the stomach lost all activity (when administered by intraperitoneal injection). However, more recent experiments with simulated stomach conditions found that harpagoside was stable.2 • The iridoids from devil’s claw may possibly be transformed into alkaloids in the gastrointestinal tract. In vitro tests indicate that several of the devil’s claw iridoids, including harpagoside, undergo microbial transformation to form the alkaloid aucubinine B.6 • Both in vitro and in vivo studies have demonstrated that devil’s claw has minimal effect on prostaglandin biosynthesis. These studies indicate that devil’s claw is unlikely to act by a similar mechanism to NSAIDs. Hence the herb will not have the same irritant effects on the stomach. • Injections of devil’s claw extract and harpagoside exhibited dose-dependent peripheral analgesic effects comparable to aspirin. Intraperitoneal administration of harpagoside produced an analgesic effect comparable to phenylbutazone. However, the aglycone of harpagoside was inactive. No consistent analgesic effects were found in an experimental model after oral doses of devil’s claw extract. • Devil’s claw extract inhibited the synthesis of prostaglandins by inhibiting cyclooxygenase-2 and inhibited the release of TNF-α from primary human monocytes (an in vitro model of peripheral inflammation).7 • After oral administration, devil’s claw extract lowered arterial blood pressure dose-dependently, with a concomitant decrease in heart rate, in an experimental model.8 Devil’s claw extract protected against experimentally induced arrhythmia in vitro and in vivo after oral and intraperitoneal administration.8,9
Clinical Studies	• In a randomized, double-blind, controlled, multicenter study, devil’s claw powder taken over a period of 4 months significantly reduced both spontaneous pain and functional disability, and it was as efficacious as was diacerhein (an anthrone analgesic) in patients with osteoarthritis of the knee and hip. The number of patients using NSAIDs and other analgesic drugs at the completion of the study, and the frequency of adverse events, was significantly lower in the devil’s claw group. The daily dose was 2.6 g of freeze-dried powder containing 87 mg of total iridoid and 57 mg of harpagoside.10,11 • In patients with arthrosis and articular pain, devil’s claw extract decreased the severity of pain when compared with placebo in two randomized, double-blind studies. Improvements were more frequent in moderate cases of arthrosis than they were in severe cases. Spinal mobility was also increased compared with placebo in the articular pain trial. The arthrosis patients received 2.4 g per day of an extract (containing 36 mg/day of iridoid glycosides) for 3 to 9 weeks and those with articular pain received 2.0 g per day of an extract (containing 60 mg/day of iridoid glycosides) for 8 weeks. • In another randomized study in patients with chronic back pain, treatment with devil’s claw extract (equivalent to 6 g/day of root and containing 50 mg/day of harpagoside) for 4 weeks demonstrated a greater reduction in a back pain index than did placebo. The reduction in pain, however, was confined almost exclusively to the sub-group of patients whose pain did not radiate to one or both legs. More patients in the treatment group were pain-free compared with the placebo group at the end of the treatment. A subsequent study of similar design confirmed that more patients receiving devil’s claw extract (equivalent to 4.5 g/day or 9 g/day of root and containing 50 mg/day or 100 mg/day of harpagoside, respectively) for 4 weeks were pain-free compared with placebo.12 • In a large, uncontrolled study of patients with various rheumatic ill-nesses, 42% to 85% of patients showed significant improvement after 6 months’ treatment with devil’s claw extract (75 to 225 mg/day of iridoid glycosides). However, one open study of 13 patients with rheumatoid arthritis and psoriatic arthropathy found no benefit from devil’s claw treatment. • In Germany, the Commission E supports using devil’s claw to treat loss of appetite and dyspepsia and as supportive therapy for degenerative disorders of the musculoskeletal system.13 • ESCOP recommends devil’s claw for treating painful arthrosis, tendinitis, loss of appetite, and dyspepsia.14

PRESCRIBING INFORMATION

Actions

Antiinflammatory, antianemic, antiplatelet, female tonic, mild laxative, antiarrhythmic

Potential Indications

Based on appropriate evaluation of the patient, practitioners should consider prescribing dong quai in formulations in the context of: • Dysmenorrhea,* in combination with Corydalis, white peony, and Ligusticum (4) • Female reproductive disorders, irregular menstruation, amenorrhea (5) • Chronic hepatitis and cirrhosis (4) • Constipation, abdominal pain, swellings, bruising (5) • Tinnitus, blurred vision, palpitations (5) • A douche for infertility (4)

Contraindications The following contraindications apply from TCM:diarrhea caused by weak digestion, hemorrhagic disease, bleeding tendency or very heavy periods, first trimester of pregnancy, tendency to spontaneous abortion, and acute viral infections such as the common cold and influenza. Warnings and Precautions None required. Interactions Caution is advised for patients receiving chronic treatment with warfarin. Use in Pregnancy and Lactation Contraindicated in the first trimester of pregnancy, especially in higher doses. Side Effects A case of a man who developed gynecomastia (mammary glandular hyperplasia) after ingestion of dong quai capsules has been reported. The label indicated “100% dong quai (Angelica sinensis) root powder. No fillers or additives.”¹ Dosage Dose per day^** Dose per week^**   4.5–8.5 ml of 1:2 liquid extract 30–60 ml of 1:2 liquid extract

* Dong quai has also been used in TCM for treating dysmenorrhea. (5)

** This dose range is adapted from dried plant doses administered by decoction in TCM.² The author’s experience and the fact that ethanol-water is a more effective solvent than water for many phytochemicals are taken into account.

SUPPORTING INFORMATION

Traditional Prescribing

Uses and properties from TCM include: • Strengthening the heart, lung, and liver meridians, lubricating the bowel, invigorating and harmonizing the blood, treating congealed blood conditions1 • Irregular menstruation, amenorrhea, dysmenorrhea resulting from blood stasis or anemia2–4 • Constipation, abdominal pain; tissue trauma, swellings, bruising, boils, rheumatism; headache, tinnitus, blurred vision, palpitations.2–4

Pharmacologic Research

• The whole root has shown a stimulant effect in vivo. Other studies have shown that dong quai can relax or coordinate uterine contractions, depending on uterine tone. The root is devoid of estrogenic action. • Dong quai can prolong the refractory period and correct experimental atrial fibrillation. Both the aqueous extract of dong quai and ferulic acid inhibited platelet aggregation and serotonin release in vitro. • In experimental models, dong quai was shown to prevent coronary atherosclerosis, lower blood pressure, dilate the coronary vessels, increase coronary flow, reduce blood cholesterol, and reduce respiratory rate. • Dong quai exerted a stimulating effect on hematopoiesis in bone marrow. • Dong quai might somewhat counter the immunosuppressive effects of hydrocortisone in vivo but is not as effective as is Astragalus. • Dong quai had a proliferative effect on muscle cells in vitro. • Dong quai has demonstrated hepatoprotective effects, a stimulating effect on the liver, an antiinflammatory effect, and muscle relaxant properties, all in vivo.

Clinical Studies