Cefasabal

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Active ingredients - Sabal fructus -
Solidaginis virgaureae herba- Hippocastani semen
Indication Micturition problems
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Saw palmetto
Horse chestnut
Goldenrod
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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
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Botany - Saw palmetto
Medicinal drug Saw palmetto berries Sabalis
serrulatae fructus Ingredients - free fatty
acids - fatty oil with phytosterols
(ß-sitosterol derivates) - polysaccharides Th
erapeutic principle - antiandrogenic - antiexs
udative - antiedematous - anti-inflammatory
- antiproliferative - anticongestive
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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
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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.

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

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Botany - Horse chestnut
Hippocastani semen
Family Hippocastanaceae (horse chestnut
plants) German name Roßkastanie Origin Mounta
ins of the Balkan, in the Caucasus and
Himalaya. In 16th century spread from Vienna
over whole Europe.
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Botany - Horse chestnut
Medicinal drug Horse chestnut seed,
Hippocastani semen Ingredients - triterpene
saponine compound (escin) - flavonoids - tann
ing agents and mineral substances Therapeutic
principle - anti-inflammatory
- antiedematous
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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.
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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.

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Benign prostatic hyperplasia (BPH)
The disease of men elder than sixty
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Benign prostatic hyperplasia (BPH)
Normale prostate
Adenoma of the prostate
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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

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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

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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

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

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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

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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

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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)
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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

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Therapeutic success with Cefasabal
Clinical studies
4. On the conservative treatment of the prostate
symptom complex Hammer O, Zeitschrift für Allg.
Med. 46, 1720 g. (1970)
Indication prostatic disordersExamination
period 4 weeksPatient collective 380
patientsMedication 3 times daily 1 tablet
(ampoule)
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Therapeutic success with Cefasabal
Clinical studies
5. Evaluation on Clinical Efficacy of Cefasabal
in the Treatment with BPH Urological 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

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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 BPH
Nunez 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)
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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

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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.
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Double-blind study
Variance over time of percentage of patients with
positive clinical response as to total symptoms
score
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Double-blind study
Effect of extract over the time on maximum
urinary stream (Qmax) rate compared to placebo
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(No Transcript)
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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

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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 (41)
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.
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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. Commerc
ial form Tablets 100 pcs.
39
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.
40
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.
41
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.
42
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. Contraindicat
ions 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.
43
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
44
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).
45
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.
46
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.
47
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.
48
Monograph
8. Overdosage None known. 9. Special
Warnings None. 10. Effect on Operators of
Vehicles and Machinery None.