Dr Dimitrios N' Gelis

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CONSERVATIVE TREATMENT OF OTOSCLEROSISBy    
Dr Dimitrios N. Gelis, MD, DDS, Dr of
Med.,OtorhinolaryngologistTel
0030-741-26631FAX [phone]e-mail
pharmage_at_otenet.grwww.gelis.gr1
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Dr Dimitrios N. Gelis

• Researcher in Otorhinolaryngological Clinical
  Pharmacology and Therapeutics, ORL Allergy,
  Neurootology
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TREATMENT OF OTOSCLEROSIS

• THERE ARE 4 OPTIONS FOR THE TREATMENT OF
  OTOSCLEROSIS

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TREATMENT OF OTOSCLEROSIS

• THERE ARE 4 OPTIONS FOR THE TREATMENT OF
  OTOSCLEROSIS
• 3

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  Do nothing Otosclerosis does not have to be
treated. It is usually advisable to have a
hearing test repeated once a year, or more often
if hearing lessens.
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  Hearing aid

• Hearing aids are usually effective for conductive
  hearing loss.

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Medical treatment

•   To date the only proposed medical treatment
  has been sodium fluoride which is a dietary
  supplement, not a drug in association with
  calcium and vitamin D. Some investigators have
  also proposed bisphosphonates (e.g. etidronate)
  as inhibitor agents of bone resorption.

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Surgical treatment

• The current standard surgical technique, the
  stapedectomy, produces excellent hearing result,
  that remain for many years after the surgery.
  This procedure may allow avoidance of hearing
  aids. However, it does not help the sensory
  component of the hearing loss and at best may
  close the air-bone gap.

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MEDICAL TREATMENT
 .
The acceptable medical treatment of otosclerosis
today continues to be the administration of
sodium fluoride in combination with calcium
carbonate
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ACTION OF FLUORIDE

• Fluoride reduces osteoclastic bone resorption and
  increases osteoblastic bone formation. Cause and
  Chevance (1) (1973)

 
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ANTIENZYMATIC ACTIONOF FLUORIDE

• Fluoride acts anti-enzymatically on proteolytic
  enzymes that are cytotoxic to the cochlea and
  produce sensorineural hearing loss.

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Fluoride reduces the levels of acid-phenylphosphat
ase
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CALCIUM UPTAKE

• The uptake of radioactive calcium is
• a measure of osteoblastic new bone
• formation

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• Calcium uptake from otosclerotic bone
• otosclerotic bone shows a greater uptake than
  normal bone, but if the lesion is immature i.e.
  active otosclerosis-the uptake is far greater
  than in the case of an inactive focus or mature
  otosclerosis.

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)

• FLUORIDE PREVENTS SENSORINEURAL DEAFNESS
• fluoride therapy reduces the enzyme activity of
  the focus, and so is of value in prevention of
  sensorineural deafness, (Causse et al,1989)

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PROTEOLYTIC ENZYMES

• untreated otosclerotic patients, with
  preoperative progressive sensorineural hearing
  loss have proteolytic enzymes in the perilymph in
  a high proportion of cases

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INDICATIONS FOR SODIUM FLUORIDE THERAPY

• 1.  Patients with surgically confirmed
  otosclerosis which has shown progressive
  sensorineural deafness disproportionate with age.

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INDICATIONS FOR SODIUM FLUORIDE THERAPY

• 1.  Patients with surgically confirmed
  otosclerosis which has shown progressive
  sensorineural deafness disproportionate with age.

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•   Patients with pure sensorineural deafness whose
  family history, age of onset, audiometric pattern
  and good auditory discrimination indicate the
  possibility of cochlear otosclerosis.

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Patients with radiological demonstration by
polytomography of spongiotic changes in the
cochlear capsule.
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  Patients with positiveSchwartze sign.
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Pre-operative administration. Fluoride induces
a substantial reduction in the vascularity and
remodelling of the otosclerotic focus.

• An active focus of otosclerosis ( positive
  Schwartze sign)
• Progressive sensorineural hearing loss observed
  by an audiometry over a period of twelve months.
• Polytomographic radiological evidence of a
  demineralized focus in the cochlear capsule.,

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FLUORIDE AND STAPEDECTOMY

• Generally the patients with otoscleorosis are
  followed up by audiometry for one or two years
  before stapedectomy. If there is progression of
  the cochlear component of hearing loss, fluoride
  therapy is given before operation.

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Post operative treatment

• When patients are found to have an active focus
  at operation, fluoride therapy is prescribed for
  two years or more.

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EARLY STAGES OF OTOSCLEROSIS 

• NaF has a stabilizing effect on early
  otosclerosis. This drug, in fact, arrests the
  disease process in more than 60 percent of ears
  at the 2-year follow up and in more than 50
  percent at 5 years. A program of secondary
  prevention of otosclerosis by NaF was suggested.

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Treatment of early cases

• According to Colleti and Fiorino (1991) the dose
  of 6 to 16 mg of NaF according to age, daily
  administered for two year is sufficient for the
  treatment of early cases of otosclerosis .

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EXPERIENCE WITH SODIUM FLUORIDE

• Sodium fluoride has now been used for 34 years in
  an effort to slow down or arrest sensorineural
  hearing nerve deterioration in patients with
  stapedial otosclerosis or after spapedectomy as
  well as in patient with pure cochlear
  otosclerosis.

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VALUE OF SODIUM FLUORIDE

• Extensive clinical experience in thousands, of
  patients with this therapy has demonstrated its
  value in arresting previously progressive
  sensorineural hearing loss.

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OBJECTIONS AGAINST SODIUM FLUORIDEF

• For a long time there were those who objected to
  this therapy on the basis that it had not been
  adequately proven by double-blind,
  placebo-controlled studies.

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CONTRAINDICATIONS OF SODIUM FLUORIDE

• In spite the fact that there is no reason to
  hesitate in prescribing this useful, effective,
  and safe medication to promote maturation of
  otospongiotic lesions, and thus to slow down or
  to arrest progression in sensorineural hearing
  loss, Sodium Fluoride treatment has some
  contraindications.

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1.     Patients with chronic nephritis with
nitrogen retention.2.     Patient, with
chronic rheumatoid arthritis who may
experience joint pains during treatment
and subside after cessation of the
treatment.3.     Pregnant or lactating
women.4.     In children before skeletal growth
has been achieved. 5.     Allergic to
fluoride which induces itching rash
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DOSAGDOSAGE AND ADMINISTRATIONOF SODIUM FLUORIDE

• Clinical experience suggests that a somewhat
  smaller dose of 50 mg daily achieved by taking
  two capsules with each meal, may be as effective
  as the larger dose

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DOSAGE AND DOSAGE AND ADMINISTRATIONOF
SODIUM FLUORIDE According to Shambaugh and
Glasscock (8) . When there is evidence of an
active lesion a daily dose of 50mg sodium
fluoride has been given for two years.
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DOSAGE AND ADMINISTRATIONOF SODIUM FLUORIDE 
 

• In a very active case with a positive Schwartze
  sign the dose is increased to 75mg daily. When
  there is evidence of stabilization of hearing,
  fading of the Schwartze sign and radiological
  sign of recalcification of the focus, a daily
  maintenance dose of 16-25mg is given for the rest
  of the patient' s life

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Dietary supplements

• During the winter time, one multivitamin tablet
  is taken to supply 400 units of vitamin D to
  ensure intestinal absorption of the calcium.

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Sodium Fluoride prescription

• Sodium fluoride 8.3 mg
• Calcium Carbonate (as oyester shell) 364mg
• m.f. caps 274
• S. One caps every 8 hours after meals

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• RESULTS OF TREATMENT WITH SODIUM FLUORIDE
• Otosclerosis of more than 1000 patients over a
  ten years period. (Shambauch and Cause 1980).
• Pure cochlear otosclerosis, were fairly uniform
  and showed that in about 80 of cases the
  sensorineural component of the hearing loss was
  stabilized.
• There were a few patients who showed a slight
  but significant recovery of sensorineural hearing
  loss.
• The remainder continued to show slow progress of
  the sensorineural deafness.
• There was a smaller control group of cases, who
  did not receive the treatment, where the
  progression of the sensorineural hearing loss
  occurred in a much higher percentage than in the
  treated cases.

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 .
The acceptable medical treatment of otosclerosis
today continues to be the administration of
sodium fluoride in combination with calcium
carbonate
MEDICAL TREATMENT
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The authors noticed that there were a few
patients who responded favorably to sodium
fluoride, with stabilization of the demineralized
focus, but a few years after discontinuing the
fluoride there was reappearance of a
demineralized focus and an increase of the
sensorineural hearing loss, indicating
reactivation of the lesion. In order to prevent
this phenomenon they prescribe a maintenance dose
of 20 mg daily for the rest of the patient's life
once the focus has become nature and inactive.
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Causse and Chevance (1) demonstrated that in
addition to the known effects of sodium fluoride
on the calcification of the focus there may also
be an antienzymatic effect which neutralizes the
cytotoxic enzyme, or enzymes, which may produce
sensorineural hearing loss. According to the
author among 300 patients treated with sodium
fluoride, The drug in fact arrests the disease
process in more than 75 percent of the ears at
the 2-year follow-up and in more thats 50 at 5
years.
41
The authors noticed that there were a few
patients who responded favorably to sodium
fluoride, with stabilization of the demineralized
focus, but a few years after discontinuing the
fluoride there was reappearance of a
demineralized focus and an increase of the
sensorineural hearing loss, indicating
reactivation of the lesion. In order to prevent
this phenomenon they prescribe a maintenance dose
of 20 mg daily for the rest of the patient's life
once the focus has become nature and inactive.
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Unfortunately there is still widespread prejudice
and almost an emotional dislike of fluoride
therapy by many members of the medical
profession, which is not justified and due to
ignorance about the facts of this form of
treatment.
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SIDE EFFECTS OF SODIUM FLUORIDE

• Side effects occur about as frequently as with
  aspirin a single very large dose of 5000mg can
  be fatal and drug should therefore be kept out of
  the reach of children (9

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The experts in sodium fluoride treatment of
otosclerosis suggest a skeletal survey of the
patient which should be made at the beginning of
treatment and repeated every two years, for there
is the remote possibility of skeletal fluorosis
being produced. Shambauch has observed
radiological evidence of early fluorosis, of the
spine in 0,25 of his cases and this condition is
reversible when therapy was discontinued.
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Gastric disturbance
Gastric disturbance, as a result of the
production of hydrofluoric acid in the stomach,
is the most common side effect and this is
largely prevented by enteric coated tablets of
sodium fluoride. Patients with peptic ulcer may
rarely complain of a flare-up of their symptoms
and the treatment must be stopped.
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Increase of the joint symptoms
In some patients with chronic arthritis there may
be an increase of the joint symptoms but with
cessation of treatment a return to the previous
state occurs within a few weeks.
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W.H.O. report 1979
According to W.H.O. 1979 there has not been a
single case reported of permanent harm to a
patient from moderate dosage of sodium fluoride
therapy.
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Sodium fluoride therapy without permanent harm
Permanent harm to the patient has never resulted
from sodium fluoride therapy and a desirable side
effect, in the older age group, is a reduction in
the incidence of osteoporosis and the occurrence
of fractures.
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TREATMENT OF OTOSCLEROSIS WITH DIPHOSPHONATES  Sev
eral investigators suggest diphosphonates for the
treatment of Otosclerosis as inhibitor agents of
bone resorption (e.g. etidronate). The efficacy
of etidronate, was assessed as a treatment for
the inner ear symptoms, of otosclerosis in a
retrospective study, with primary complain of
dizziness, hearing loss, tinnitus or Menier'
syndrome (10).
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Etidronate protocol
The diagnosis of otosclerosis was based no
small-pixel computed tomography of the temporal
bones. Of the 896 patients on an etidronate
protocol, 545 were followed for more than sic
months and were analyzed. The symptomatic
responses to etidronate, as well as audiologic
and computerized rotary chair results were used
in the assessment. Patients who were previously
on Sodium Fluoride were separately analyzed. In
this preliminary study etidronate appeared to be
ant effective treatment for the new neurotologic
symptoms of otosclerosis. Prospective blinded
efficacy studies of the bisphosphonates in the
treatment of otosclerosis should be undertaken.