Cefanorm

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Active ingredient Dry extract from Devils claw
root
Indications Rheumatism, arthrosis
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Botany
Harpagophytum procumbens (Burch.) De Candolle

• Family Pedaliaceae (sesame plants)
• Synonyms Devils claw Wood Spider Grapple
  plant
• Origin Endemic in South and South-West Africa
  (Namibia, Kalahari desert).
• In sandy steppe regions, savannahs with few
  trees or by waysides.

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Botany
Medicinal drug Dried secondary tuber
(Harpagophyti radix), cut up into slices or
pieces.
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Brief profile

• Enduring, weed-like plant.
• Up to 1.5 m long sprouts, lying on the ground.
• Water storage capacity of storage roots up to
  90.
• Stalked leaves with deep lobes.
• Flowers bright violet-red in colour,
  funnel-shaped.
• Widely branched system of primary and secondary
  roots.
• Secondary storage roots can develop several
  tubers with a diameter of up to 6 cm.
• Fruits lignifying capsules with grapnel-like
  outgrowths containing about 50 seeds.

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Drug
Spectrum of ingredients the same in both main
and side roots Concentration of ingredients
higher in the side roots
side roots are used for drug preparation
ProcessingCrushing of the secondary storage
roots (tubers of the side roots) Root
fragments Colour yellowish grey or pale
pink Consistency hard like horn Taste
bitter
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Traditional medical use

• Africa - indigestion - blood diseases -
  fever - pains - migraine
• Europe - metabolic diseases - arthritis -
  diseases in liver, gall-bladder, kidney and
  bladder
• Further research towards the end of the 1950s
  gradually led to Devils claw being applied
  mainly for treating rheumatic diseases.

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Phytochemistry

• Extract from Devil's claw root Mixture of
  substances (just like any typical
  phytopharmaceutical)
• Most important ingredients Iridoid glycosides
• Active component Full extract

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Ingredients

• iridoid glycosides (1.1-3.6) among others
  harpagoside (at least 1.2, very bitter),
  harpagide, procumbide
• phenylethanol derivatives verbascoside,
  isoacteoside
• carbohydrates among others stachyose, raffinose
• flavonoids kaempferol, luteolin
• pharmacologically irrelevant are, among others,
  sterols, alkanes, fats, waxes, gum resin,
  essential oils

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Iridoid glycosides
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Mechanism of action

• Up to now, there are no consistent research
  results as to the actual active ingredient(s)
  contained in the extract from Devil's claw root.
• Possibility of a dual action profile with an
  inhibition of the cyclooxygenase or lipooxygenase
  way within the arachidonic acid metabolism is
  being discussed.
• Results of an in vitro studyDevil's claw root
  extract contains additional substances besides
  harpagoside that act to selectively inhibit the
  lipooxygenase way and consequently the
  biosynthesis of leukotrienes.

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Mechanism of action

• Harpagoside seems to contribute to the analgesic
  but not the antiphlogistic effect
• If rheumatism is considered to be a system
  disease ? another action approach via the
  metabolism-regulating properties of Devil's
  claw might be possible

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Inflammation cascade
Noxa
Cell membranephospholipids
phospholipase
arachidonic acid
lipooxygenase
cyclooxygenase
leukotrienes
prostaglandins
immunocompetent cells (monocytes, T-cells)
cytokinesTNF-a, interleukins
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Toxicology
LD50 (Harpagophytum procumbens, full
extract) 13.5 g/kg body weight p.o. (tests
conducted on mice)
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Tolerability

• Side effects In rare cases nausea, diarrhea,
  vomiting, dizziness and headache have been
  observed.Hypersensitivity reactions (skin
  rashes, urticaria, facial edema even including
  circulatory collapse (anaphylactic shock) have
  been described very rarely. When suffering from
  insulin-dependent diabetes mellitus, a
  blood-sugar increase - which decreased after
  stopping the intake - has been observed very
  rarely.
• Contra-indications Patients suffering from
  gastric and duodenal ulcers (Devils claw root
  extract contains bitter substances that increase
  gastric secretion).

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Pharmacology
Devil's claw has become a scientifically
excellently researched and documented medicinal
plant. Tests demonstrated the analgesic,
antiedematic and antiphlogistic effects of the
full extract. These findings could be confirmed
in practice by clinical studies and physicians'
empiric reports. For the most part, the
conducted studies revealed a distinct
antirheumatic potential.
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Effects

• antiphlogistic by COX- and LOX-inhibition
• analgetic
• muscle-relaxing

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Application for treating rheumatic diseases

• non-specific chronic backache (cervical spine
  area, neck-shoulder-arm syndrome, lumbar spine
  area, lumbago, ischialgia)
• arthrosis (e.g. osteoarthrosis of the hip,
  osteoarthrosis of the knee, degenerative
  changes of the spine such as spondylosis,
  spondylarthrosis)
• active muscle hardening caused by unbalanced
  postures, e.g. at computer workstations or due to
  athletic exertion

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Application for treating rheumatic diseases

• chronic arthritis (primary chronic
  polyarthritis, pcp)
• non-articular rheumatism syndrome (affecting
  musculature, ligaments and tendons), e.g.
  fibromyalgia syndrome

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Alternative to non-steroidal anti-inflammatory
drugs

• Devils claw has a similar principle of effect
  about the COX-/LOX-inhibition (reduction of
  prostaglandins and leukotrienes).
• in contrast to the potential spectrum of side
  effects of the NSAIDs, Cefatec 480 is
  excellently tolerable.
• No interaction in concentration or driving a car.
• Onset of effect after few days to two weeks in
  case of intense, acute pains possibly overlapping
  start of therapy.

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Proven therapeutic success with Cefatec 480
effervescent tablets
Multicentre practice study
Centres 196 practices Indication Degenerative
disorders of the locomotor system Examination
period 8 weeks Patient collective 614
patients (65.1 of the patients were female and
34.0 male,average age of the patients 60.8
years) Medication The daily dosage was 2
effervescent tablets of Cefatec 480

• Especially suitable for a long-term treatment
• Reasonable alternative or accompanying therapy to
  non-steroidal antirheumatic agents

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Proven therapeutic success with Cefatec 480
effervescent tablets
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Proven therapeutic success with Cefatec 480
effervescent tablets
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Cefatec 480 - advantages at a glance

• highly concentrated extract from Devils claw
  root for a gentle therapy of inflammatory and
  wear-caused diseases of the locomotor system
• analgetic, antiphlogistic, muscle-relaxing
• increases the flexibility of the joints
• easy dosing and application2 x 1 film coated
  tablet a day
• good tolerability

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Basic information
Fields of application For supportive treatment of
degenerative disorders of the locomotor system.
Note In acute conditions with reddening,
swelling or hyperthermia of joints and if
complaints persist, a physician should be
consulted. Composition Active ingredient 1 film
coated tablet contains Dry extract from Devil's
claw root (4.4 - 5.01) 480 mg. Extraction
solvent Ethanol 60 (v/v). Excipients Maize
starch, microcrystalline cellulose, lactose
monohydrate, colloidal anhydrous silica,
magnesium stearate, hypromellose, macrogol, talc,
titanium dioxide E 171. The quantity of
carbohydrates taken in with a daily dose equals a
white bread exchange of 0.05.
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Basic information
Contra-indications This medicine may not be taken
in cases of hypersensitivity to Devil's claw or
one of the excipients or in cases of gastric or
duodenal ulcers. In case of cholelithiasis, a
physician should be consulted. There has not been
sufficient research for the use of this medicine
during pregnancy and lactation. Therefore, it
should not be used during this period. Cefatec
480 FT has not been researched for children's
use. Therefore, please refrain from giving
Cefatec 480 FT to children under 12 years of
age. Warning None known. Dosage, kind and
duration of application Adults and children over
12 years take 1 film coated tablet twice
daily. The film coated tablets should be taken in
the morning and the evening with the meals with
some liquid. Take Cefatec 480 FT until you are
free of pain.
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Basic information
Side effects In rare cases diarrhea, nausea,
vomiting, dizziness and headache have been
observed. Hypersensitivity reactions (skin
rashes, urticaria, facial edema even including
circulatory collapse (anaphylactic shock) have
been described very rarely. When suffering from
insulin-dependent diabetes mellitus, a
blood-sugar increase - which decreased after
stopping the intake - has been observed very
rarely. Commercial forms Film coated tablets 20
pcs., 50 pcs.
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Monograph
Devils Claw root, Harpagophyti radix Official
Monograph of the Bundesinstitut für Arzneimittel
und Medizin-produkte (BfArM) (German Federal
Institute for Drugs and Medical
Devices) Commission E (Phytotherapy), BAnz.-No.
43 dated March 02, 1989 (corr. BAnz.-No. 164,
dated September 01, 1990) Name of
Drug Harpagophyti radix, devils claw
root. Composition of Drug Devils Claw root
consists of the dried, secondary tubers of
Harpagophytum procumbens (Burchell) de Candolle
Fam. Pedaliaceae, as well as their preparations
in effective dosage. The drug contains bitter
substances. Uses Loss of appetite, dyspepsia,
supportive therapy of degenerative disorders of
the locomotor system.
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Monograph
Contraindications Gastric and duodenal ulcers.
With gallstones, use only after consultation
with a physician. Side Effects None
known. Interaction with Other Drugs None
known. Dosage Unless otherwise prescribed Daily
dosage For loss of appetite 1.5 g of drug
preparations of equivalent bitter
value Otherwise 4.5 g drug equivalent
preparations. Mode of Administration Comminuted
drug for teas and other preparations for internal
use. Actions Appetite-stimulating Choleretic Anti
phlogistic Mildly analgesic
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