Multi-Herb Proprietary Product Monographs

(Alphabetized by Product Name)

Alluna™ Sleep

Manufacturer: GlaxoSmithKline; Pittsburgh, PA. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: Extracts of valerian root (Valeriana officinalis) (500mg) and hops (Humulus lupulus) (120 mg) [extract strength not declared].

Primary Uses: Sleep, insomnia.

DSHEA Structure-Function Claim: “Promotes a Healthy Natural Sleep Pattern.”

Dosage: 2 tablets.

Duration of Administration: 1 month.

Actions: Mild sedative and sleep promoting agent.

Contraindications: None listed.

Pregnancy and Lactation: None listed.

Adverse Effects: None listed.

Drug Interactions: None listed.

Editors’ Note: Product is labeled as an “Herbal Supplement”; tablets are blister packed, each tablet individually sealed. “Not a drug” printed on front panel.

Esberitox ^®

Manufacturer: Schaper & Brümmer; Salzgitter, Germany. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: Esberitox^® (prior to 1985): 5 mg of E. purpurea and E. angustifolia root (1:1), 2 mg of Thuja occidentalis herb, and 10 mg Baptisia tinctoria root plus homeopathic preparations (dilutions) made from additional herbs.

Esberitox^® N1 Tablets (since 1985): 7.5 mg of E. purpurea and E. angustifolia root extract (1:1), 2 mg of Thuja occidentalis herb, and 10 mg Baptisia tinctoria root (without homeopathic dilutions) (Melchart et al., 1994).

Esberitox^® N2 Tablets (since 1990): 7.5 mg of E. purpurea root extract (1:1), 2 mg of Thuja occidentalis herb, and 10 mg Baptisia tinctoria root (changed echinacea material; E. angustifolia no longer used) (Melchart et al., 1994).

Esberitox^®N Tablets (since 1993): 7.5 mg of E. purpurea root and E. pallida root (1:1).

Primary Uses: Acute and chronic infections of the respiratory tract (viral or bacterial); accompanying antibiotics in case of severe bacterial infections such as bronchitis, angina, pharyngitis, otitis media, sinusitis; temporarily weakened immune system with recurring infections; herpes simplex labialis (cold sores); bacterial skin infections; leukopenias after radiation or cytostatic treatment.

DSHEA Structure-Function Claim: Immunomodulator for strengthening the body’s immune system.

Dosage: Adults: 3 tablets, 3 times daily; Infants: 1 tablet, 3 times daily; Children up to 6 years: 1–2 tablets, 3 times daily; Children up to 12 years: 2 tablets, 3 times daily.

Duration of Administration: Not longer than eight weeks.

Actions: Immunostimulation.

Contraindications: Known hypersensitivity to one of the active or inactive ingredients or against composite flowers; for principle reasons not for use in case of progressive systemic diseases such as tuberculosis, leukosis, collagenosis, multiple scleroses, AIDS, HIV infection, and other autoimmune diseases.

Pregnancy and Lactation: None listed.

Adverse Effects: In individual cases, reactions due to a hypersensitivity may occur.

Drug Interactions: None listed.

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monograph for echinacea in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Esberitox Table of Clinical Studies [Please scroll down after clicking as the top half of the page is blank.]

Euvegal^® forte

Manufacturer: Dr. Willmar Schwabe Karlsruhe / Germany. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: Each tablet contains 160 mg valerian root (Valeriana officinalis) extract (4–5:1) and 80 mg lemon balm leaf (Melissa officinalis) extract (4–6:1).

Primary Uses: Restlessness; sleep-induction disturbances due to nervous conditions.

DSHEA Structure-Function Claim: Promotes restful sleep (Valerian Nighttime™, Natures Way).

Dosage: Restlessness: 2x2 tablets per day; as sleep aid: 2 tablets half an hour prior to going to bed.

Duration of Administration: The product is well tolerated. If the symptoms persist, a physician should be consulted.

Actions: Sedative.

Contraindications: None listed.

Pregnancy and Lactation: No known risks subsequent to marketing as a nonprescription drug in Europe. However, results from experimental studies are not available, and the product should therefore not be taken during pregnancy and lactation.

Adverse Effects: None listed.

Drug Interactions: None listed.

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monograph for valerian in this book for more information on the safety of each of the herbs listed in this multi-herb product. However, in some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Euvegal forte Table of Clinical Studies [Please scroll down after clicking as the top half of the page is blank.]

Hochu-ekki-to ^®

Manufacturer: Tsumura & Co., Tokyo, Japan. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: Astragalus root JP (Astragalus membranaceus (Fisch.) Bge., Fabaceae); Asian ginseng root JP (Panax ginseng C.A. Mey., Araliaceae); Atractylodes rhizome JP (Atractylodes lancea (Thunb.) DC, Asteraceae); Japanese angelica root JP (Angelica acutiloba Kitagawa, Apiaceae); Bupleurum root JP (Bupleurum falcatum L., Apiaceae); Jujube fruit JP (Zyzyphus jujuba Mill., Rhamnaceae); Citrus unshiu peel JP (Citrus unshiu Markovich, Rutaceae); Licorice root JP (Glycyrrhiza uralensis Fisch., Fabaceae); Cimicifuga rhizome JP (Cimicifuga simplex Wormskjord, Ranunculaceae); Ginger rhizome JP (Zingiber officinale Roscoe, Zingiberaceae); [JP = Japanese Pharmacopeia].

Primary Uses: Hochu-ekki-to^® is indicated for the following symptoms/conditions of patients having delicate constitution, reduced digestive functions, and severe fatigability of limbs: Summer emaciation, reinforcement of physical strength after illness, tuberculosis, anorexia, gastroptosis (downward stomach displacement), common cold, hemorrhoids, anal prolapse, uterine prolapse, impotence, hemiplegia (paralysis of one side of body), and hyperhidrosis (excessive perspiration).

DSHEA Structure-Function Claim: Not sold in the U.S.

Dosage: 7.5 g per day.

Duration of Administration: Not established. The product could be administered continuously as long as the patient’s symptoms/findings are improved. However the patient should be monitored carefully, and if no improvement is observed, continuous administration should be avoided.

Other Data or Special Instructions:

1. Herb-drug Interaction: The product should be used carefully when co-administered with preparations containing licorice, glycyrrhizinic acid and/or its salts. Pseudo-aldosteronism, myopathy or hypokalemia is likely to occur (if used with licorice).

2. Use in the elderly: Because elderly patients often have reduced physiological function, careful supervision and measures such as reducing the dose are recommended.

3. Pediatric use: The safety of this product in children has not been established (insufficient clinical data).

4. Other precautions: Eczema, dermatitis, etc. may be aggravated.

Actions: Immunostimulant, tonic.

Contraindications: None listed.

Pregnancy and Lactation:The safety of this product in pregnant women has not been established. Therefore, the product should be used only if the expected therapeutic benefits outweigh the possible risks associated with treatment in pregnant women and women who may possibly be pregnant.

Adverse Effects: The incidence rate of adverse reactions of this product has not been investigated yet.

1. Clinically significant adverse reactions

a. Pseudoaldosteronism: Pseudoaldosteronism such as hypokalemia, increased blood pressure, retention of sodium/body fluid, edema, increased body weight, etc. may occur. The patient should be carefully monitored (measurement of serum potassium level, etc.), and if any abnormality is observed, administration should be discontinued and appropriate measures such as administration of potassium preparations should be taken.

b. Myopathy: Myopathy may occur as a result of hypokalemia. The patient should be carefully monitored, and if any abnormality such as weakness, convulsion/ paralysis of limbs, etc. are observed, administration should be discontinued and appropriate measures such as administration of potassium preparations should be taken.

2. Other adverse reactions

a. Hypersensitivity: Rash, urticaria, etc. may occur. If such symptoms are observed, administration should be discontinued.

b. Hepatic: Increases in AST (GOT), ALT (GPT), Al-P, -GTP and bilirubin levels may occur.

c. Gastrointestinal: Anorexia, epigastric distress, nausea, diarrhea, etc. may occur.

Drug Interactions: None listed.

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monographs for ginger and licorice in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Hochu-ekki-to Table of Clinical Studies [Please scroll down after clicking as the top half of the page is blank.]

Hova ^®

Manufacturer: Gebro Broscheck GmbH, Austria. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: Each tablet contains valerian (Valeriana officinalis L.) (60 mg) and hop flower (Humulus lupulus L.) extract (30 mg).

Primary Uses: Sleep, insomnia.

DSHEA Structure-Function Claim: “Promotes a Healthy Natural Sleep Pattern”.

Dosage: 2 tablets.

Duration of Administration: 1 month.

Actions: Mild sedative and sleep promoting agent.

Contraindications: None listed.

Pregnancy and Lactation: None listed.

Adverse Effects: None listed.

Drug Interactions: None listed.

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monograph for valerian in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Hova Table of Clinical Studies [Please scroll down after clicking as the top half of the page is blank.]

Liv.52 ^®

Manufacturer: The Himalaya Drug Company, Bangalore, India. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: Active ingredients in the proprietary formula: capers (Capparis spinosa) (root bark); chicory (Cichorium intybus) (seed); black nightshade (Solanum nigrum) (whole plant); arjuna (Terminalia arjuna) (bark); negro coffee (Cassia occidentalis) (seed); yarrow (Achillea millefolium) (aerial parts); tamarisk (Tamarisk gallica) (whole plant).

Primary Uses: Liver dysfunction.

DSHEA Structure-Function Claim: “Maintenance of optimum liver health” (LiverCare^®, Himalaya USA).

Dosage: 1 or 2 x 500 mg, two to three times per day. Dosage may be adjusted based on body weight and/or severity of the condition.

Duration of Administration: May be used daily for an extended period of time.

Actions: Hepatic stimulant, hepatoprotector.

Contraindications: None listed.

Pregnancy and Lactation: None listed.

Adverse Effects: None listed. No reported Adverse Effects since market entry in 1954.

Drug Interactions: Liv.52^® has been shown to effectively alleviate the hepatotoxicity of drugs.

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monographs in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Liv.52 Table of Clinical Studies

Mastodynon ^®

Manufacturer: Bionorica AG; Neumarkt, Germany. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: 10 g (10.8 ml) Mastodynon^® drops contain as active ingredients 2.0 g Agnus castus ø [chaste tree, Vitex], 1.0 g Caulophyllum thalictroides (HAB 34) Dil. D4 (HAB 1; V.3a), 1.0 g Cyclamen Dil. D4, 1.0 g Ignatia Dil. D6, 2.0 g Iris Dil. D2, 1.0 g Lilium tigrinum Dil. D3. Mastodynon^® drops contain ethanol 53% v/v.

Primary Uses: Disorders associated with premenstrual syndrome (PMS) including: mastodynia (breast pain), psychic lability, constipation, fluid retention/swelling, headache, migraine, and fibrocystic mastopathy.

DSHEA Structure-Function Claim: “For disorders of the menstrual cycle” (in product literature).

Dosage: 30 drops 2x/day (morning and evening) with water.

Duration of Administration: 3 months.

Actions: None listed.

Contraindications: Hypersensitivity to Agnus castus (chaste tree) and/or Caulophyllum thalictroides and/or Cyclamen and/or Ignatia and/or Iris and/or Lilium tigrinum.

Pregnancy and Lactation: None listed.

Adverse Effects: Nausea, gastric complaints, slight weight increase, itching exanthemes, acne, or headache.

Drug Interactions: None listed.

Manufacturer’s Note: “Mastodynon^® drops contain ethanol. It therefore should not be used, if there is a history of successful withdrawal after alcohol abuse.”

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monograph for chaste tree in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Mastodynon Table of Clinical Studies [Please scroll down after clicking as the top half of the page is blank.]

Nutrilite^® Saw Palmetto with Nettle Root

Manufacturer: Access Business Group, Buena Park, California. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: Nutrilite^® Saw Palmetto with Nettle Root; Each softgel contains a blend of 106 mg saw palmetto lipoidal extract (Serenoa repens), 80 mg nettle root extract (Urtica dioica), 160 mg pumpkin seed oil (Cucurbita pepo), 33 mg lemon bioflavonoid concentrate, and 100 IU natural beta-carotene concentrate.

Primary Uses: None listed.

DSHEA Structure-Function Claim: “Both Saw palmetto and Nettle root help support normal urinary flow”.

Dosage: 3 softgels/day.

Duration of Administration: Continuous.

Actions: Helps support normal prostate health.

Contraindications: None listed.

Pregnancy and Lactation: None listed.

Adverse Effects: None listed.

Drug Interactions: None listed.

Editors’ Note: Unlike many other products in this section, this product was developed as a dietary supplement for the U.S., although it may be marketed as a licensed nonprescription drug in selected foreign countries, as required by local regulations. Thus, some of the labeling information found on other products is not listed for this product. However, the 3 ingredients are considered very safe, with few adverse effects (see saw palmetto monograph).

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monograph for saw palmetto in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Nutrilite Saw Palmetto with Nettle Root Table of Clinical Studies [Please scroll down after clicking as the top half of the page is blank.]

Padma^® Basic / Padma^®28

Manufacturer: Padma Inc., Schwerzenbach, Switzerland. Distributed in the U.S. by EcoNugenics, Inc. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: The original Padma 28^® formula contains dried and powdered herbs (403 mg) in a tablet. Those herbs that comprise 30 mg or more include:

costus root (Saussurea costus)

neem fruit (Azadirachta indica)

iceland moss (Cetraria islandica)

chebulic myrobalan fruit (Terminalia chebula)

cardomom fruit (Elettaria cardamomum)

red saunders heart wood (Pterocarpus santalinus)

Other Herbs: allspice fruit (Pimenta dioica), bengal quince fruit (Aegle marmelos), columbine aerial parts (Aquilegiae vulgaris), licorice root (Glycyrrhiza glabra), English plantain aerial parts, (Plantago lanceolata), knotweed aerial part (Polygonum aviculare), golden cinquefoil aerial part (Potentilla aurea), clove flower (Syzygium aromaticum), spiked ginger lily rhizome (Hedychium spicatum), heartleaf sida aerial parts (Sida cordifolia), Valerian root (Valeriana officinalis), lettuce leaf (Lactuca sativa var. capitata), calendula flower (Calendula officinalis), natural camphor (Cinnamomum camphora ), aconite root (Aconitum napellus). Non-herbal ingredient: calcium sulfate.

Note: The formulation of Padma^® Basic differs from Padma 28^® only in the removal of the aconite root (A. napellus) in order to meet regulatory requirements for the U.S. and some European countries. However, it is generally well known that most of the aconite used in Asian traditional medicine is processed in a manner to eliminate or reduce potential toxicity.

Primary Uses: Peripheral arterial occlusive disease (PAOD) stage II (Intermittent claudication) (Drabaek et al., 1993; Mehlsen et al., 1993; Sallon et al., 1998; Samochowiec et al., 1987; Schrader et al., 1985; Smulski and Wójcicki, 1995; Winther et al., 1994). Recurrent respiratory tract infections in children (Jankowski et al., 1991). In Switzerland, the registered indications are the early symptoms of PAOD such as tingling, feeling of heaviness and tension in arms and legs, numbness of hands and feet, cramps in the calf (IOCM, 1999). Other uses include hypercholesterolemia, hypertriglyceridemia (Samochowiec et al., 1992), and angina pectoris (Wójcicki and Samochowiec, 1986).

DSHEA Structure-Function Claim: “Supports the immune system,” “Promotes healthy circulation,” “Supports with antioxidant activity” (Padma Ad, 2000).

Dosage: Two tablets (403 mg), twice daily.*

Duration of Administration: 4–6 months (per clinical studies).

Actions: Preliminary results have found anti-inflammatory (Matzner and Sallon, 1995; Winther et al., 1994), and antioxidative actions (Fishman, 1994; Ginsburg et al., 1999; Suter and Richter, 2000).

Clinical research has also shown the promotion of fibrinolysis (Winther et al., 1994) and the lowering of cholesterol and triglyceride levels (Samochowiec et al., 1992; Samochowiec and Wójcicki, 1987; Wójcicki et al., 1989b; Wójcicki et al., 1988). Experimental research has found effects on the formation of atherosclerosis (Gieldanowski, 1992; Winther, 1994; Wójcicki et al., 1988) and potential hepatoprotective effect in cases of alcohol abuse (Wójcicki et al., 1989a; Nefyodov et al., 2000). In cases of toxic liver injury in rats, Padma 28^® has been shown to normalize the formation of amino acids and related compounds (Nefyodov et al., 2000).

The mechanism of action is still unclear, though the anti-inflammatory action has been linked to the in vitro inhibition of inducible nitric oxide synthesis in macrophage cell line (Moeslinger et al., 2000), the inhibition of the oxidative burst response in neutrophils (Ginsburg et al., 1999, Matzner and Sallon, 1995), the inhibition of neutrophil elastase, and to antioxidant as well as Fe(II)-chelating properties (Ginsburg et al., 1999; Suter and Richter, 2000).

Contraindications: None listed.

Pregnancy and Lactation: None listed. However, a healthcare professional should be consulted before using this product during pregnancy or nursing.

Adverse Effects: Rarely, minor gastric upsets have been reported. In this case, the tablets can be taken along with a meal.

Drug Interactions: Patients should wait 1 1/2 to 2 hours between taking the herb tablets and any medication. This will help ensure that the herbal ingredients do not interfere with the usual absorption of the medication.

Other Data or Special Instructions: Tablets are best taken on an empty stomach, 1/2 hour before mealtime with a glass of warm water. Patients who have difficulty swallowing tablets, may let them dissolve in a glass of warm water before swallowing the mixture.

The tablets are lactose- and gluten-free. They are suitable for diabetics.

* The commercially available products, Padma 28^® and Padma^® Basic have consistently contained the same 403 mg dosage: In order to successfully blind the taste and smell in placebo-controlled, clinical studies, the dosage in studies has varied between 340 mg, 380 mg, and 403 mg.

Note:This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monographs for licorice and valerian in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Padma Basic / Padma 28 Table of Clinical Studies

Phytodolor ^®

Manufacturer: Steigerwald, Darmstadt, Germany. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: 100 ml liquid extract contains: 60 ml (4.5:1) aspen leaves and bark (Populus tremula), 20 ml (4.5:1) common ash bark (Fraxinus excelsior), 20 ml (4.8:1) European goldenrod aerial parts (Solidago virgaurea).

Primary Uses: Rheumatoid arthritis.

DSHEA Structure-Function Claim: “Provides nutritional support for optimal muscle and joint function.”

Dosage: 20 drops (1 ml) mixed in water or other drink, administered 3–4 times daily.

Duration of Administration: While results may be achieved in two weeks, for best results use for a minimum of 4 weeks.

Actions: Anti-inflammatory.

Contraindications: In rare cases, due to salicin and salicylic alcohol content, individuals with a known allergy to salicylates may have an allergic reaction. Due to 45.6% alcohol content, the product should be avoided by pregnant women, children, or anyone with a disease or condition for which alcohol is contraindicated.

Pregnancy and Lactation: Not for use during pregnancy.

Adverse Effects:In rare cases, gastric and intestinal complaints may occur.

Drug Interactions: None listed.

Note:This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monographs in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Phytodolor Table of Clinical Studies

Prostagutt^® forte

Manufacturer: Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: WS^®1473 is an ethanolic (90% w/w) extract containing a minium of 70% fatty acids and esters. 160 mg of saw palmetto (Serenoa repens) extract (WS^® 1473), 10–14.3:1, and 120 mg of stinging nettle root (Urtica dioica) dry extract (WS^® 1031), 8.3–12.5:1.

Primary Uses: Disturbances of micturition in case of benign enlargement of the prostate (prostatic hyperplasia stages I to II according to Alken).

DSHEA Structure-Function Claim: Promotes prostate health (Prostactive^® Plus, Nature’s Way).

Dosage: 2–160 mg capsules per day.

Duration of Administration: Duration of application is not limited in time.

Actions: Inhibitory action on the enzymes 5alpha-reductase and aromatase which are both important for the androgen metabolism in the prostate. As concerns the aromatase inhibition, the combination of both extracts leads to an overadditive effect. Both extracts have antiexudative-decongestive properties. The product increases the maximum urinary flow and improves micturition symptoms.

Contraindications: None listed.

Pregnancy and Lactation: Not applicable.

Adverse Effects: In rare cases, mild gastric disorders may occur.

Drug Interactions: None listed.

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monograph for saw palmetto in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Prostagutt forte Table of Clinical Studies [Please scroll down after clicking as the top half of the page is blank.]

Sinupret ^®

Manufacturer: Bionorica AG; Neumarkt, Germany. (Other brand names for this product, if any, may be found in the table on page 404.)

Contents: Gentian root (Gentiana lutea), primrose flowers with calyx (Primula veris), sorrel herb (Rumex acetosa, R. crispus, R. obtusifolius), elder flowers (Sambucus nigra), vervain herb (Verbena officinalis).

Tablets: Dried powder of gentian 6 mg, primrose flowers 18 mg, common sorrel herb 18 mg, elder flowers 18 mg, vervain herb 18 mg.

Drops: 29 g of aqueous-ethanolic extract (1:11) in the ratio of 1:3:3:3:3 (ethanol 53%).

Primary Uses: Sinusitis, acute or chronic bronchitis. Manufacturer’s literature states, “Acute and chronic inflammation of the paranasal sinuses and of the respiratory tract, also as an additional measure in antibacterial therapy” (Anon., n.d.).

DSHEA Structure-Function Claim: N/A. Not available at this time. Product is scheduled to be available in the U.S. in May 2003.

Dosage: Tablets: Adults: 2 tablets 3 times daily; children of school age: 1 tablet 3 times daily. Drops: Adults: 50 drops 3 times daily; children of school age: 25 drops 3 times daily.

Duration of Administration: Manufacturer’s literature says the preparation is indicated for long-term therapy (Anon., n.d.).

Actions: Secretolytic, anti-inflammatory, anti-infective, immunostimulant, prevents bronchospasm. These actions are of clinical relevance in the established indications, with the primary therapeutic aims to normalize drainage and, especially in the case of sinusitis, to restore ventilation (Anon., n.d.).

Contraindications: None listed.

Pregnancy and Lactation: None listed for pregnancy. Neither the experience from several decades of use nor the known pharmacology and toxicology of the respective herbal ingredients suggest any evidence of risk associated with the use of this formula during pregnancy. A retrospective, multi-center study of Sinupret^® use during all stages of pregnancy by 762 women did not reveal any evidence of adverse effects on the duration of the pregnancies nor on the children (Ismail et al., 2001). In view of the documented relative safety during pregnancy and toxicological studies in animals, the manufacturer’s literature provides a general statement, “Nevertheless, Sinupret^® should be administered during pregnancy and lactation only after medical advice.” (Anon., n.d.) No data was found on effects during lactation.

Adverse Effects: The product is considered safe. Rare cases of gastric intolerance and isolated cases of allergic skin reactions (skin reddening, exanthema up to vesiculation) have been reported (Anon., n.d.). The incidence of ADR-reports (Adverse Drug Reaction) in clinical trials is less than 2% based on 2443 patients. The incidence of spontaneous ADR-reports in the period 1984–1999 is 0.000001%; based on approximately 100 million treated patients in 25 countries.

Drug Interactions: None listed.

Clinical Studies: At least 4 controlled clinical trials have been conducted on the Sinupret^® herbal combination, plus 1 comparative post-market surveillance study. Additional studies have been conducted on the individual ingredients. Only those studies conducted on the proprietary combination are listed in the table below.

Editor’s Comment: Sinupret^® is the top-selling nonprescription medication in Germany; this includes sales for both herbal as well as conventional nonprescription medications.

Note: This information was derived from the label of the manufacturer and consideration of additional safety information is advised. Please consult Brinker, 2001; McGuffin et al., 1997, and the single herb monographs in this book for more information on the safety of each of the herbs listed in this multi-herb product. In some cases, potential toxicity may be reduced or otherwise altered through the combination of herbs into one product.

Sinupret Table of Clinical Studies

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