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Indication: Micturition problems

Active ingredients: - Sabal fructus - Solidaginis virgaureae herba - Hippocastani semen . Indication: Micturition problems. Saw palmetto. Horse chestnut. Goldenrod. Botany - Saw palmetto. Sabal fructus, syn. Serenoa repens (BARTR.). Family: Arecaceae (palm plants)

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Indication: Micturition problems

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  1. Active ingredients: - Sabal fructus - Solidaginis virgaureae herba- Hippocastani semen Indication: Micturition problems

  2. Saw palmetto Horse chestnut Goldenrod

  3. Botany - Saw palmetto Sabal fructus, syn. Serenoa repens (BARTR.) Family: Arecaceae (palm plants) German names: Amerikanische Säge- oder Zwergpalme Origin: Pine forests and dunes from North Carolina to Florida, grows preferentially on friable, sandy soils

  4. Botany - Saw palmetto Medicinal drug: Saw palmetto berries Sabalis serrulatae fructus Ingredients: - free fatty acids - fatty oil with phytosterols (β-sitosterol derivates) - polysaccharides Therapeutic principle: - antiandrogenic - antiexsudative - antiedematous - anti-inflammatory - antiproliferative - anticongestive

  5. Botany - Saw palmetto Folk medicine: Fruits used to be collected by the Indians as foodstuff Later they were used for medicinal purposes as tonic for sexual organs, as diuretic and sedative The steam of the boiling fruit was inhaled when suffering from diseases of the nose

  6. Brief profile - Saw palmetto • Saw palmetto is a bushy palm tree with a low trunk. Its leaves are fan-shaped and sharply sawed. • Like a lot of palm trees, it prospers at best with warmth and high amounts of rainfall. • The small blossoms bundle to flower spadices from which the fruits are developed in autumn. • They have a size of 2 to 3 cm and are about 1.5 cm thick. • The deep purple, nearly black drupes taste at first sweet, later hot-burning.

  7. Botany - Goldenrod Solidago virgaureae herba Family: Asteraceae (composites) German names: Goldrute, Wundkraut, Heilwundkraut, Heidengoldkraut Origin: Europe, Asia, North Africa, North America. Grows on the edges of forests and clearings as well as in bushes. In the Alps as mountain plant up to 1500 m.

  8. Botany - Goldenrod Medicinal drug: Goldenrod herb Solidaginis virgaureae herba Ingredients: -saponins - essential oil - phenolic compounds Therapeutic principle: - diuretic - slight spasmolytic - antiphlogistic

  9. Botany - Goldenrod Folk medicine: By the Teutons it was appreciated as herb for wounds. For eczema and exanthems, lip herpes, solution for gargling. Further fields of application: Rheumatism, gout, haemorrhoids, diabetes, hepatic engorgement.

  10. Brief profile - Goldenrod • Goldenrod is an enduring plant which can reach a height of up to 1 m. • The upright stem has long-elliptic, acuminate leaves which are toothed. • The golden blossoms are grouped in individual • or combined clusters. • Goldenrod blooms from July to September.

  11. Botany - Horse chestnut Hippocastani semen Family: Hippocastanaceae (horse chestnut plants) German name: Roßkastanie Origin: Mountains of the Balkan, in the Caucasus and Himalaya. In 16th century spread from Vienna over whole Europe.

  12. Botany - Horse chestnut Medicinal drug: Horse chestnut seed, Hippocastani semen Ingredients: -triterpene saponine compound (escin) - flavonoids - tanning agents and mineral substances Therapeutic principle: -anti-inflammatory - antiedematous

  13. Botany - Horse chestnut Folk medicine: In Middle Ages it was used as fodder supplement for horses. In form of ointments for injuries, haematoma, pains in the vertebral column and edema. In form of baths for treatment of venous diseases and haemorrhoids.

  14. Brief profile - Horse chestnut • Regular, dense leafy crown; thick trunk with cracked bark. • Big, finger-shaped 5 to 7-fold leaves with long stem. • Inflorescence, shaped like a candle; panicle-like. • Blooms from April to May, the fruits can be collected from September to October. • Fruits are spiny balls with auburn gleaming seeds. • Not related to the edible Chestnut.

  15. Benign prostatic hyperplasia (BPH) The disease of men elder than sixty

  16. urinary bladder Adenoma of the prostate seminal hillcock Compressed urethra prostatictissue urethra Cowper‘s gland Benign prostatic hyperplasia (BPH) Normale prostate Adenoma of the prostate

  17. Initial stage Problems in connection with urinary evacuation of the bladder (micturition): • weakend urinary stream,decrease in the urinary stream • problem to start micturition (delayed start of micturition) • discontinued micturition • urinary evacuation of the bladder is hardly possible • frequent evacuation of small urine amounts (pollakisuria) • increased nocturnal urinary frequency (nycturia) • sudden strong urinary urgency • after-dripping of urine after micturition

  18. Advanced stage • increase in micturition disorders • complete evacuation of the bladder is no longer possible • continuous urinary urgency • augmented urinary tract infections, formation of bladder stones • pains during micturition

  19. Final stage • urine congestion upwards in both kidneys (overflow bladder) • irreversible injuries of bladder and kidneys • urinary retention • painful extension of the bladder • urinary incontinence

  20. Therapeutic principle

  21. Therapeutic principle Fig.: Antiandrogenic principle of effect of an extract from Saw Palmetto berries in case of BPH

  22. Solidago diuretic, antiseptic (saponins) Sabaldecongestant on the periurethral gland (sitosterols, polysaccharides) a-reductase-blocker Hippocastanumdecongestant on the veins of the small pelvis (escin) antiedematous Points of action

  23. Toxicology • When used as prescribed non-toxic. • Positive monographs of the German Federal Institute for Drugs and Medical Devices (Commission E) for all three components. • In very rare cases complaints resp. irritation of the mucosa of the gastro-intestinal tract. • Contra-indications and interactions have not become known up to now.

  24. Therapeutic success with Cefasabal® Clinical studies 1. Monocentre practice study:Cefasabal®, a therapeutic agent with numerous uses in urology Barsom S, Zeitschrift für Allg. Med. 53, 1311-1313 (1977) Indication: prostatic complaintsExamination period: up to 8 weeksPatient collective: 705 patientsMedication: 20-30 drops, four times daily • Very good success for neurogenic vesical neck disorders

  25. Therapeutic success with Cefasabal® Clinical studies 2. Monocentre practice study: Conservative therapy of mictional disorders Zamfirescu C, Zeitschrift für Allg. Med. 56, 2244 - 2247 (1980) Indication: prostatic complaintsExamination period: 6 yearsPatient collective: 181 patientsMedication: 4 x 1 tablet or 30 drops three times daily • Good therapeutic results for irritable bladder • Successful therapy of chronic vesical neck inflammations

  26. Therapeutic success with Cefasabal® Clinical study on 181 patients Quelle: * Zamfirescu C: Conservative therapy of mictional disorders. Zeitschrift für Allg. Medizin 56, 2244-2247 (1980)

  27. Therapeutic success with Cefasabal® Clinical studies 3. Randomised, double-blind, placebo-controlled study with Cefasabal®: Phytotherapeutic treatment of micturition disorders with benign prostatic hyperplasia (stage I-II)Hess K, Extracta urologica 12, 316 (1989) Indication: prostatic complaintsExamination period: 3 monthsPatient collective: 30 patientsMedication: 4 x 2 tablets daily • Positive effect of Cefasabal® on micturition disorders (BHP stage I-II) • Maintenance dose: 3 x 1 tablet daily

  28. Therapeutic success with Cefasabal® Clinical studies 4. On the conservative treatment of the prostate symptom complexHammer O, Zeitschrift für Allg. Med. 46, 1720 g. (1970) Indication: prostatic disordersExamination period: 4 weeksPatient collective: 380 patientsMedication: 3 times daily 1 tablet (ampoule)

  29. Therapeutic success with Cefasabal® Clinical studies 5. Evaluation on Clinical Efficacy of Cefasabal® in the Treatment with BPHUrological Surgery Dept., Beijing Hospital, (1996) Indication: prostatic complaintsExamination period: 4 weeksPatient collective: 36 patientsMedication: 1 tablet twice to four times daily • Effective and safe preparation for the treatment of BPH

  30. Therapeutic success with Cefasabal® Clinical studies 6. Randomised, double-blind, placebo-controlled study with Cefasabal®:Value of the treatment with natural extract in non complicated BPHNunez Chavez U, Murietta Vela R, Monitor Medico, Vol. 3 No. 10, 31 - 42 (2001) Indication: prostatic complaintsExamination period: 12 weeksPatient collective: 60 patientsMedication: extract (tablets)

  31. Double-blind study Results • relieves typical symptoms associatedwith growth of the prostate • improves urinary flow • improves quality of life • reduces the size of the prostate • does not affect libido or potency • very well tolerated

  32. Double-blind study The scores were obtained by using international Prostate Symptom Score (IPSS), following symptoms: Urinary stream and size of prostate gland in patients with BPH were evaluated.

  33. Double-blind study Variance over time of percentage of patients with positive clinical response as to total symptoms score

  34. Double-blind study Effect of extract over the time on maximum urinary stream (Qmax) rate compared to placebo

  35. Cefasabal® - advantages at a glance • harmonisation of coordination of detrusor and sphincter • tranquilising and invigorating effect on bladder and urethra • reduction of micturition frequency • reinforcement of urinary stream • decrease in the amount of residual urine

  36. Basic information Indications: Adenoma of the prostate (stage 1), micturition disorders, congestive prostatitis, hyperemia of the small pelvis. Composition Active ingredients: 1 tablet contains: Dry extracts from: Sabalis serrulatae fructus (4:1) 1.25 mg, Solidaginis herba (stand. on at least 0.2 mg total flavonoids, calc. as rutoside) 3.75 mg, Hippocastani semen (stand. on at least 0.75 mg escin) 6.25 mg. Excipients: Lactose monohydrate, maize starch, talc, gelatin powder, colloidal anhydrous silica, magnesium stearate. Contra-indications None known. Warning None known.

  37. Basic information Dosage Unless otherwise prescribed, adults take 2 tablets with some liquid 4 times a day. Kind and duration of application Cefasabal® tablets can be swallowed with some liquid e.g. water. Side effects The components Fruct. Sabal. Serr. and Semen Hippocastani shall be able to cause complaints resp. irritation of the mucosa of the gastro-intestinal tract in very rare cases. Up to now, these side effects have not been observed with the finished preparation Cefasabal®. Commercial form Tablets: 100 pcs.

  38. Monograph Saw Palmetto berry, Sabal fructus Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (German Federal Institute for Drugs and Medical Devices) Commission E (Phytotherapy), BAnz.-No. 43 dated March 02, 1989, No. 22a dated Feb. 1, 1990 and No. 11, Jan. 17, 1991 Name of Drug Sabal fructus, saw palmetto berry. Composition of Drug Saw palmetto berry consists of the ripe, dried fruit of Serenoa repens (Bartram) Small (syn. Sabal serrulata (Michaux) Nuttall ex Schultes) [Fam. Arecaceae] as well as its preparations in effective dosage. The drug contains fatty oil with phytosterols and polysaccharides. Uses Urination problems in benign prostatic hyperplasia stages I and II. Contraindications None known.

  39. Monograph Side Effects In rare cases, stomach problems. Interaction with Other Drugs None known. Dosage Daily dosage: 1 – 2 g saw palmetto berry or 320 mg lipophilic ingredients extracted with lipophilic solvents (hexane or ethanol 90 percent v/v); equivalent preparations. Mode of Administration Comminuted herb and other galenical preparations for oral use. Actions Antiandrogenic Anti-exudative Note: This medication relieves only the symptoms associated with an enlarged prostate without reducing the enlargement. Please consult a physician at regular intervals.

  40. Monograph Goldenrod, Solidago Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (German Federal Institute for Drugs and Medical Devices) Commission E (Phytotherapy), BAnz.-No. 193a dated October 15, 1987 and No. 50 dated March 13, 1990 Name of Drug Solidaginis virgaureae herba, European goldenrod herb. Solidaginis herba, goldenrod herb. Composition of Drug European goldenrod herb consists of the above-ground parts of Solidago virgaurea L. [Fam. Asteraceae] gathered during the flowering season and dried carefully, as well as their preparations in effective dosage. Goldenrod herb consists of the above-ground parts of S. serotina Aiton (synonym S. gigantea Willdenow), S. Canadensis L. and hybrids thereof gathered during the flowering season and carefully dried, as well as their preparations in effective dosage. The herb contains flavonoids, saponins, and phenol glycosides.

  41. Monograph Uses As irrigation therapy for inflammatory diseases of the lower urinary tract, urinary calculi and kidney gravel, as prophylaxis for urinary calculi and kidney gravel. Contraindications None known. Note: No irrigation therapy in case of edema due to impaired heart and kidney function. Side Effects None known. Interaction with Other Drugs None known. Dosage Daily dosage: 6 - 12 g herb; equivalent preparations.

  42. Monograph Mode of Administration Comminuted drug for teas and other galencial preparations for internal use. Note: Observe copious intake of fluids. Actions Diuretic Mildly antispasmodic Antiphlogistic

  43. Monograph Horse Chestnut seed, Hippocastani semen Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (German Federal Institute for Drugs and Medical Devices) Commission E (Phytotherapy), BAnz.-No. 228 dated Dec. 5, 1984 Name of Drug Hippocastani semen, horse chestnut seed. Composition of Drug A dry extract manufactured from horse chestnut seeds, Aesculus hippocastanum L. [Fam. Hippocastanaceae], adjusted to a content of 16 – 20 percent triterpene glycosides (calcaluated as anhydrous aescin).

  44. Monograph Pharmacological Properties, Pharmacokinetics, Toxicology As found in different animal experiments, the principal ingredient in horse chestnut seed extract is the triterpene glycoside mixture, aescin (escin), which has an anti-exudative and vascular-tightening effect. There are indications that horse chestnut seed extract reduces the activity of lysosomal enzymes that is increased in chronic pathological conditions of the veins, so that the breakdown of glycoacalyx (mucopolysaccharides) in the region of the capillary walls is inhibited. The filtration of low-molecular proteins, electrolytes and water into the interstitium is inhibited through a reduction of vascular permeability. Using placebo as reference, a significant reduction of transcapillary filtration has been demonstrated in pharmacological studies involving human subjects, and a significant improvement shown in the symptoms of chronic venous insufficiency (sensation of tiredness, heaviness and tension, pruritus, pain and swelling in the legs) in various randomized double-blind studies and/or cross-over studies. Pilot studies are available on the toxicology of horse chestnut seed extract. The oral LD50 of the extract is 990 mg per kg body weight in the mouse, 2150 mg per kg body weight in the rat, 1530 mg per kg body weight in the rabbit, and 130 mg per kg body weight in the dog. In the rat, the “no effect” dose is between 9 and 30 mg per kg body weight after intravenous administration of horse chestnut seed extract over a period of 8 weeks.

  45. Monograph Chronic administration above 80 mg per kg body weight over a period of 34 weeks produced gastric irritation in dogs. In rats, no toxic changes were observed throughout the same period up to an oral dose of 400 mg per kg body weight. Clinical Data 1. Indications Treatment of complaints found in pathological conditions of the veins of the legs (chronic venous insufficiency), for example, pains and a sensation of heaviness in the legs, nocturnal systremma (cramps in the calves), pruritis and swelling of the legs. Note: Other non-invasive treatment measures prescribed by a physician, such as leg compresses, wearing of supportive elastic stockings, or cold water applications, must be observed under all circumstances. 2. Contraindications None known.

  46. Monograph 3. Side Effects Pruritis, nausea, and gastric complaints may occur in isolated cases after oral intake. 4. Special Caution for Use None. 5. Use During Pregnancy and Lactation No restriction known. 6. Interaction with Other Drugs None known. 7. Dosage and Mode of Administration Daily dose: 100 mg aescin (escin) corresponding to 250 – 312.5 mg extract 2 times per day in delayed release form.

  47. Monograph 8. Overdosage None known. 9. Special Warnings None. 10. Effect on Operators of Vehicles and Machinery None.

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