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Figure. Flow chart of literature selection
“Sudden Deafness Hearing Loss” AND “Therapy”
search in PubMed database from January 1976
to December 31 2016
1908
1376
1099
221
Inclusion:
Published in a peer-reviewed
journal in English language
Inclusion:
Articles filtered with keyword
“Human”
Exclusion:
Articles without available abstract
Inclusion
We checked whether papers
stated treatment or not.
779
Inclusion:
Full text
Fetterman BL,
Saunders JE,
Luxford WM
Prognosis and treatment of
sudden sensorineural hearing
loss
Am J
Otol.
1996
Jul;17(4):5
29-36.
Retrospective
single
institute
3 837
Rahko T, Kotti V.
Comparison of carbogen
inhalation and intravenous
heparin infusion therapies in
idiopathic sudden sensorineural
hearing loss.
Acta
Otolary
ngol
Suppl.
1997;529:
86-7.
Retrospective
single
institute
3 87
Suckfüll M, Thiery J,
Schorn K,
Kastenbauer E,
Seidel D.
Clinical utility of LDL-apheresis
in the treatment of sudden
hearing loss: a prospective,
randomized study.
Acta
Otolary
ngol.
1999;119(
7):763-6.
Prospective
single
institute
RCT 1b 27
Stokroos RJ, Albers
FW, Tenvergert EM.
Antiviral treatment of idiopathic
sudden sensorineural hearing
loss: a prospective, randomized,
double-blind clinical trial.
Acta
Otolary
ngol.
1998
1998
Jul;118(4):
488-95.
Prospective
single
institute
RCT 1b 44
Minoda R1,
Masuyama K, Habu
K, Yumoto E.
Initial steroid hormone dose in
the treatment of idiopathic
sudden deafness.
Am J
Otol.
2000
Nov;21(6):
819-25.
Retrospective
single
institute
5 250
Fujino M1, Hisashi
K, Yashima N,
Takeshita M,
Fujiwara Y, Chujo K,
Nakagawa T,
Komune S,
Komiyama S.
Treatment of sudden
sensorineural hearing loss with
a continuous epidural block.
Eur Arch
Otorhin
olaryng
ol.
1999;256
Suppl
1:S18-21.
Retrospective
single
institute
5 20
Kallinen J1,
Laurikainen E,
Laippala P,
Grénman R.
Sudden deafness: a comparison
of anticoagulant therapy and
carbogen inhalation therapy.
Ann
Otol
Rhinol
Laryngol
.
1997
Jan;106(1)
:22-6.
Prospective
single
institute
2a 168
Am J Otol. 2000 Nov;21(6):819-25.
Initial steroid hormone dose in the treatment of idiopathic sudden deafness.
Minoda R , Masuyama K, Habu K, Yumoto E.
• The purpose of this study was to clarify whether higher doses of steroids improve the prognosis of idiopathic
sensorineural hearing loss (ISHL) and the suitable dose of steroid hormone.
• The study was a retrospective statistical analysis.
• This study was performed at the Department of Otolaryngology, Head Neck Surgery, Kumamoto University
School of Medicine. Two hundred fifty patients with ISHL were analyzed in this study. They were divided into two
groups: those receiving less than a specified daily dose of steroid and those receiving a daily dose greater than
or equal to the specified dose.
• The patients received systemic steroid therapy combined with adenosine triphosphate, vitamins, diuretics,
vasodilators, hyperbaric oxygen therapy, stellate ganglion block, or volume expander.
• The correlation between the initial dose of steroid hormone and the improvement rate was analyzed.
• Spearman's correlation coefficients and partial correlation coefficients between the initial dose and the
prognosis were all significantly negative.
• On the other hand, the correlations between the initial dose and the prognosis were positive in the group
receiving <30 mg/day, whereas they were negative in the group receiving > or =30 mg/day, although these
correlations were not significant.
• The general use of steroid hormone to treat ISHL is not recommended. Furthermore, if steroid hormone is used
for treatment, the use of <30 mg/day of prednisolone is preferable.
Minoda R1,
Masuyama K,
Habu K,
Yumoto E.
Initial steroid
hormone dose in the
treatment of
idiopathic sudden
deafness.
Am J Otol.
2000
Nov;21(6):819-25.
Retrospective single institute 5 250
Evidence Level
1a ランダム化比較試験のメタアナリシス
1b 少なくとも一つのランダム化比較試験
2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど)
2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど)
3 ケース・コントロール研究(後ろ向き研究)
4 処置前後の比較などの前後比較,対照群を伴わない研究
5 case report case series
6 expert’s opinion(専門家委員会報告を含む)
Review
Am J Otol. 1999 Sep;20(5):587-92; discussion 593-5.
Management of idiopathic sudden sensorineural hearing loss.
Haberkamp TJ, Tanyeri HM.
OBJECTIVE:
To determine if any consensus exists regarding the efficacy of treatment in idiopathic sudden
sensorineural hearing loss syndrome (ISSNHL).
DATA SOURCES:
A review of the literature from 1966 to the present on Medline database was performed with the
following search criteria: Hearing loss, sensorineural (MeSH terms), sensorineural hearing loss (text
word), deafness (MeSH), and idiopathic or sudden (all fields). Further limiting search terms were
treatment outcomes or controlled studies.
DATA EXTRACTION:
The articles were then analyzed searching for randomized, prospective, controlled studies of single
treatment modalities. Both human and animal studies were included for discussion because of the
paucity of human studies.
CONCLUSION:
No consensus exists on the effective treatment of ISSNHL. Randomized, controlled studies have
demonstrated the effectiveness of systemic steroids, however, follow up studies have questioned the
benefit of steroid therapy.
Acta Otolaryngol. 1999;119(7):763-6.
Clinical utility of LDL-apheresis in the treatment of sudden hearing loss: a prospective, randomized study.
Suckfüll M, Thiery J, Schorn K, Kastenbauer E, Seidel D.
Although the pathogenesis of sudden hearing loss (SHL) is not as yet known, the clinical picture and the frequent association with
vascular risk factors make an ischaemic event likely. This study aimed to assess the effect of an extracorporeal procedure (H.E.L.P.) in
removing LDL-cholesterol, fibrinogen and lipoprotein (a) from the plasma, on the recovery of hearing SHL. This procedure using the
HELP-system was compared with the usual standard treatment with prednisolone, dextranes and pentoxifyllin.
We undertook a single centre, prospective, randomized study in which 18 patients were assigned to H.E.L.P.-apheresis and 9 patients
were assigned to standard treatment (2:1 randomization). Audiometric and laboratory testing was performed at baseline, 24 h and 6
weeks after start of treatment. Primary endpoint was the improvement of the average pure-tone threshold between 0.125 and 8 kHz
after 24 h. Twenty-four hours after H.E.L.P. treatment average pure-tone threshold recovered by 10.4 dB and by 26.4 dB after 6 weeks.
The recovery of hearing of the standard treated patients was 5.8 dB and 16.8 dB after 24 h and 6 weeks respectively. LDL-cholesterol,
fibrinogen and lipoprotein (a) were significantly reduced in the HELP treated patients compared with standard therapy, resulting in a
significant improve in plasma viscosity, erythrocyte aggregation and resistance to oxidative stress of LDL particles.
Our results suggest that the clinical outcome of SHL after a single extracorporeal LDL-apheresis is superior or at least equal to the more
expensive standard treatment with prednisolone, dextranes and pentoxifyllin. Re-establishment of vascular endothelial function and
improved blood rheology may be the underlying cause. These results must be confirmed in larger-scale trials.
Suckfüll M,
Thiery J,
Schorn K,
Kastenbauer
E, Seidel D.
Clinical utility of LDL-
apheresis in the
treatment of sudden
hearing loss: a
prospective,
randomized study.
Acta
Otolaryngol
.
1999;119(7):763-6.Prospective single institute RCT 1b 27
Evidence Level
1a ランダム化比較試験のメタアナリシス
1b 少なくとも一つのランダム化比較試験
2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど)
2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど)
3 ケース・コントロール研究(後ろ向き研究)
4 処置前後の比較などの前後比較,対照群を伴わない研究
5 case report case series
6 expert’s opinion(専門家委員会報告を含む)
Eur Arch Otorhinolaryngol. 1999;256 Suppl 1:S18-21.
Treatment of sudden sensorineural hearing loss with a continuous epidural block.
Fujino M, Hisashi K, Yashima N, Takeshita M, Fujiwara Y, Chujo K, Nakagawa T, Komune S, Komiyama S.
The efficacy of a continuous epidural block was evaluated in the treatment of 20 patients with sudden sensorineural
hearing loss (SNHL).
Ten patients were treated with continuous cervicothoracic epidural block (group A) and the other 10 were treated with
stellate ganglion block (group B).
No significant difference in factors affecting prognosis was noted between the groups. In the epidural block group 70%
achieved substantial hearing improvement, while this occurred in only 30% of patients undergoing stellate ganglion
block. These findings suggest that continuous epidural block can be effective in the treatment of sudden SNHL.
Fujino M1,
Hisashi K,
Yashima N,
Takeshita M,
Fujiwara Y,
Chujo K,
Nakagawa T,
Komune S,
Komiyama S.
Treatment of sudden
sensorineural hearing
loss with a continuous
epidural block.
Eur Arch
Otorhinolar
yngol.
1999;256 Suppl
1:S18-21.
Retrospective single institute 5 20
Evidence Level
1a ランダム化比較試験のメタアナリシス
1b 少なくとも一つのランダム化比較試験
2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど)
2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど)
3 ケース・コントロール研究(後ろ向き研究)
4 処置前後の比較などの前後比較,対照群を伴わない研究
5 case report case series
6 expert’s opinion(専門家委員会報告を含む)
Am J Otol. 1998 Sep;19(5):579-83.
What kind of patients are suitable for evaluating the therapeutic effect of sudden deafness?
Sano H, Okamoto M, Shitara T, Hirayama M.
OBJECTIVE:
This study aimed to find out appropriate patients to evaluate the therapeutic effect of sudden deafness.
STUDY DESIGN:
The study design was a retrospective case review.
SETTING:
The study was performed at a university hospital.
PATIENTS:
A series of 443 patients with idiopathic sudden sensorineural hearing loss who visited the authors within 1 week from
the onset participated.
INTERVENTIONS:
Relationship between interval from the onset and treatment prognosis was investigated.
RESULTS:
The significant difference in prognosis related to the days from the onset to the initial visit was noted only in the
patients with the initial hearing level from 50-65 dB. The prognosis of the patients who visited the authors on the
next day from the onset was excellent. Whereas, in the patients with initial hearing level worse than 70 dB, no
significant difference in prognosis was noted among the days of visit.
CONCLUSIONS:
The patients with the initial hearing level worse than 70 dB and who visited the authors within 8 days from the onset
were appropriate for candidates in evaluating the therapeutic effect of sudden deafness.
Acta Otolaryngol. 1998 Jul;118(4):488-95.
Antiviral treatment of idiopathic sudden sensorineural hearing loss: a prospective, randomized, double-blind clinical
trial.
Stokroos RJ, Albers FW, Tenvergert EM.
A subclinical viral labyrinthitis has been postulated in the literature to elicit Idiopathic Sudden Sensorineural Hearing
Loss. An etiological role for the herpes virus family is assumed. Corticosteroids possess a limited beneficial effect on
hearing recovery in ISSHL. In this study, the therapeutic value of the antiherpetic drug aciclovir (Zovirax) on hearing
recovery in 44 ISSHL patients receiving prednisolone is evaluated in a multicentre clinical trial.
The study is designed prospectively, randomized, double-blind and placebo-controlled. Subjective parameters include
hearing recovery, a pressure sensation on the affected ear, disequilibrium or vertigo and tinnitus. Audiometric
parameters include pure tone and speech audiometry. A one-year follow up is obtained.
Both the pressure sensation and disequilibrium or vertigo have a good prognosis, but tinnitus, occurring in most
patients, has a poor prognosis. Hearing recovery prognosis depends on the severity of initial hearing loss, and not on
vestibular involvement. No beneficial effect from combining aciclovir with prednisolone can be established in ISSHL.
Stokroos RJ,
Albers FW,
Tenvergert
EM.
Antiviral treatment of
idiopathic sudden
sensorineural hearing
loss: a prospective,
randomized, double-
blind clinical trial.
Acta
Otolaryngol
. 1998
1998
Jul;118(4):488-95.
Prospective single institute RCT 1b 44
Evidence Level
1a ランダム化比較試験のメタアナリシス
1b 少なくとも一つのランダム化比較試験
2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど)
2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど)
3 ケース・コントロール研究(後ろ向き研究)
4 処置前後の比較などの前後比較,対照群を伴わない研究
5 case report case series
6 expert’s opinion(専門家委員会報告を含む)
Acta Otolaryngol Suppl. 1997;529:86-7.
Comparison of carbogen inhalation and intravenous heparin infusion therapies in idiopathic
sudden sensorineural hearing loss.
Rahko T, Kotti V.
The effect of carbogen (5% carbon dioxide and 95% oxygen) inhalation and intravenous
heparin on sudden sensorineural hearing loss was compared. Forty-four patients received
the former, 43 the latter treatment, respectively. The patients were unselected patients of
the clinic. The PTA (0.5-2.0 kHz) at the pretreatment stage was 62 dB in the heparin and 55
dB in the carbogen group. One month later the corresponding figures were 34 and 32 dB,
the difference being statistically not significant. Thus neither of these methods proved
superior in the treatment of sudden sensorineural hearing loss.
Rahko T, Kotti
V.
Comparison of
carbogen inhalation
and intravenous
heparin infusion
therapies in idiopathic
sudden sensorineural
hearing loss.
Acta
Otolaryngol
Suppl.
1997;529:86-7. Retrospective single institute 3 87
Evidence Level
1a ランダム化比較試験のメタアナリシス
1b 少なくとも一つのランダム化比較試験
2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど)
2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど)
3 ケース・コントロール研究(後ろ向き研究)
4 処置前後の比較などの前後比較,対照群を伴わない研究
5 case report case series
6 expert’s opinion(専門家委員会報告を含む)
Ann Otol Rhinol Laryngol. 1997 Jan;106(1):22-6.
Sudden deafness: a comparison of anticoagulant therapy and carbogen inhalation therapy.
Kallinen J, Laurikainen E, Laippala P, Grénman R.
Sudden deafness (SD) is a sudden or rapidly progressive, partial or complete, typically unilateral
sensorineural hearing impairment that has no known specific etiologic factor. This study was designed
to compare, in a group of 168 consecutive patients with SD, the effect of anticoagulant therapy and
carbogen inhalation therapy.
Special attention was paid to the shape of the audiogram relative to the clinical outcome and the
treatment modality. We found that the configuration of the audiogram of SD patients is prognostic of
the outcome, and that patients with a low-frequency-sloping hearing impairment have a better
prognosis compared to the patients with a high-sloping loss. Anticoagulant treatment was most
effective in low-sloping hearing losses, while carbogen inhalation may be more effective for patients
with high-sloping hearing losses.
Kallinen J1,
Laurikainen E,
Laippala P,
Grénman R.
Sudden deafness: a
comparison of
anticoagulant therapy
and carbogen
inhalation therapy.
Ann Otol
Rhinol
Laryngol.
1997
Jan;106(1):22-6.
Prospective single institute 2a 168
Evidence Level
1a ランダム化比較試験のメタアナリシス
1b 少なくとも一つのランダム化比較試験
2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど)
2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど)
3 ケース・コントロール研究(後ろ向き研究)
4 処置前後の比較などの前後比較,対照群を伴わない研究
5 case report case series
6 expert’s opinion(専門家委員会報告を含む)
Am J Otol. 1996 Jul;17(4):529-36.
Prognosis and treatment of sudden sensorineural hearing loss.
Fetterman BL, Saunders JE, Luxford WM.
Most cases of sudden sensorineural hearing loss (SHL) are idiopathic. Consequently, the otologist may
be asked to predict hearing recovery and select a treatment strategy without fully understanding the
disease process. We retrospectively reviewed the charts of 837 patients with SHL to evaluate the
prognostic value of specific clinical parameters and the effectiveness of steroid and vasodilator
treatments. Treatment response was defined by the patient's subjective response and audiological
criteria.
Patients who were treated with steroids and/or vasodilators were more likely to improve. Patients who
improved had a worse initial pure-tone average (PTA) than those who did not improve. In addition,
those with poorer initial speech discrimination scores, worse initial thresholds at 4,000 Hz, younger age,
and greater number of treatments were more likely to improve. Neither the electronystagmogram
results nor the initial audiogram shape were valuable indicators. Recognition of prognostic indicators
can help in counselling patients and in the evaluation of treatment response.
Fetterman BL,
Saunders JE,
Luxford WM
Prognosis and
treatment of sudden
sensorineural hearing
loss
Am J Otol.
1996
Jul;17(4):529-36.
Retrospective single institute 3 837
Evidence Level
1a ランダム化比較試験のメタアナリシス
1b 少なくとも一つのランダム化比較試験
2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど)
2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど)
3 ケース・コントロール研究(後ろ向き研究)
4 処置前後の比較などの前後比較,対照群を伴わない研究
5 case report case series
6 expert’s opinion(専門家委員会報告を含む)
2000_1996_review of SD pre-review

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2000_1996_review of SD pre-review

  • 1. Figure. Flow chart of literature selection “Sudden Deafness Hearing Loss” AND “Therapy” search in PubMed database from January 1976 to December 31 2016 1908 1376 1099 221 Inclusion: Published in a peer-reviewed journal in English language Inclusion: Articles filtered with keyword “Human” Exclusion: Articles without available abstract Inclusion We checked whether papers stated treatment or not. 779 Inclusion: Full text
  • 2. Fetterman BL, Saunders JE, Luxford WM Prognosis and treatment of sudden sensorineural hearing loss Am J Otol. 1996 Jul;17(4):5 29-36. Retrospective single institute 3 837 Rahko T, Kotti V. Comparison of carbogen inhalation and intravenous heparin infusion therapies in idiopathic sudden sensorineural hearing loss. Acta Otolary ngol Suppl. 1997;529: 86-7. Retrospective single institute 3 87 Suckfüll M, Thiery J, Schorn K, Kastenbauer E, Seidel D. Clinical utility of LDL-apheresis in the treatment of sudden hearing loss: a prospective, randomized study. Acta Otolary ngol. 1999;119( 7):763-6. Prospective single institute RCT 1b 27 Stokroos RJ, Albers FW, Tenvergert EM. Antiviral treatment of idiopathic sudden sensorineural hearing loss: a prospective, randomized, double-blind clinical trial. Acta Otolary ngol. 1998 1998 Jul;118(4): 488-95. Prospective single institute RCT 1b 44 Minoda R1, Masuyama K, Habu K, Yumoto E. Initial steroid hormone dose in the treatment of idiopathic sudden deafness. Am J Otol. 2000 Nov;21(6): 819-25. Retrospective single institute 5 250 Fujino M1, Hisashi K, Yashima N, Takeshita M, Fujiwara Y, Chujo K, Nakagawa T, Komune S, Komiyama S. Treatment of sudden sensorineural hearing loss with a continuous epidural block. Eur Arch Otorhin olaryng ol. 1999;256 Suppl 1:S18-21. Retrospective single institute 5 20 Kallinen J1, Laurikainen E, Laippala P, Grénman R. Sudden deafness: a comparison of anticoagulant therapy and carbogen inhalation therapy. Ann Otol Rhinol Laryngol . 1997 Jan;106(1) :22-6. Prospective single institute 2a 168
  • 3. Am J Otol. 2000 Nov;21(6):819-25. Initial steroid hormone dose in the treatment of idiopathic sudden deafness. Minoda R , Masuyama K, Habu K, Yumoto E. • The purpose of this study was to clarify whether higher doses of steroids improve the prognosis of idiopathic sensorineural hearing loss (ISHL) and the suitable dose of steroid hormone. • The study was a retrospective statistical analysis. • This study was performed at the Department of Otolaryngology, Head Neck Surgery, Kumamoto University School of Medicine. Two hundred fifty patients with ISHL were analyzed in this study. They were divided into two groups: those receiving less than a specified daily dose of steroid and those receiving a daily dose greater than or equal to the specified dose. • The patients received systemic steroid therapy combined with adenosine triphosphate, vitamins, diuretics, vasodilators, hyperbaric oxygen therapy, stellate ganglion block, or volume expander. • The correlation between the initial dose of steroid hormone and the improvement rate was analyzed. • Spearman's correlation coefficients and partial correlation coefficients between the initial dose and the prognosis were all significantly negative. • On the other hand, the correlations between the initial dose and the prognosis were positive in the group receiving <30 mg/day, whereas they were negative in the group receiving > or =30 mg/day, although these correlations were not significant. • The general use of steroid hormone to treat ISHL is not recommended. Furthermore, if steroid hormone is used for treatment, the use of <30 mg/day of prednisolone is preferable. Minoda R1, Masuyama K, Habu K, Yumoto E. Initial steroid hormone dose in the treatment of idiopathic sudden deafness. Am J Otol. 2000 Nov;21(6):819-25. Retrospective single institute 5 250 Evidence Level 1a ランダム化比較試験のメタアナリシス 1b 少なくとも一つのランダム化比較試験 2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど) 2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど) 3 ケース・コントロール研究(後ろ向き研究) 4 処置前後の比較などの前後比較,対照群を伴わない研究 5 case report case series 6 expert’s opinion(専門家委員会報告を含む)
  • 4. Review Am J Otol. 1999 Sep;20(5):587-92; discussion 593-5. Management of idiopathic sudden sensorineural hearing loss. Haberkamp TJ, Tanyeri HM. OBJECTIVE: To determine if any consensus exists regarding the efficacy of treatment in idiopathic sudden sensorineural hearing loss syndrome (ISSNHL). DATA SOURCES: A review of the literature from 1966 to the present on Medline database was performed with the following search criteria: Hearing loss, sensorineural (MeSH terms), sensorineural hearing loss (text word), deafness (MeSH), and idiopathic or sudden (all fields). Further limiting search terms were treatment outcomes or controlled studies. DATA EXTRACTION: The articles were then analyzed searching for randomized, prospective, controlled studies of single treatment modalities. Both human and animal studies were included for discussion because of the paucity of human studies. CONCLUSION: No consensus exists on the effective treatment of ISSNHL. Randomized, controlled studies have demonstrated the effectiveness of systemic steroids, however, follow up studies have questioned the benefit of steroid therapy.
  • 5. Acta Otolaryngol. 1999;119(7):763-6. Clinical utility of LDL-apheresis in the treatment of sudden hearing loss: a prospective, randomized study. Suckfüll M, Thiery J, Schorn K, Kastenbauer E, Seidel D. Although the pathogenesis of sudden hearing loss (SHL) is not as yet known, the clinical picture and the frequent association with vascular risk factors make an ischaemic event likely. This study aimed to assess the effect of an extracorporeal procedure (H.E.L.P.) in removing LDL-cholesterol, fibrinogen and lipoprotein (a) from the plasma, on the recovery of hearing SHL. This procedure using the HELP-system was compared with the usual standard treatment with prednisolone, dextranes and pentoxifyllin. We undertook a single centre, prospective, randomized study in which 18 patients were assigned to H.E.L.P.-apheresis and 9 patients were assigned to standard treatment (2:1 randomization). Audiometric and laboratory testing was performed at baseline, 24 h and 6 weeks after start of treatment. Primary endpoint was the improvement of the average pure-tone threshold between 0.125 and 8 kHz after 24 h. Twenty-four hours after H.E.L.P. treatment average pure-tone threshold recovered by 10.4 dB and by 26.4 dB after 6 weeks. The recovery of hearing of the standard treated patients was 5.8 dB and 16.8 dB after 24 h and 6 weeks respectively. LDL-cholesterol, fibrinogen and lipoprotein (a) were significantly reduced in the HELP treated patients compared with standard therapy, resulting in a significant improve in plasma viscosity, erythrocyte aggregation and resistance to oxidative stress of LDL particles. Our results suggest that the clinical outcome of SHL after a single extracorporeal LDL-apheresis is superior or at least equal to the more expensive standard treatment with prednisolone, dextranes and pentoxifyllin. Re-establishment of vascular endothelial function and improved blood rheology may be the underlying cause. These results must be confirmed in larger-scale trials. Suckfüll M, Thiery J, Schorn K, Kastenbauer E, Seidel D. Clinical utility of LDL- apheresis in the treatment of sudden hearing loss: a prospective, randomized study. Acta Otolaryngol . 1999;119(7):763-6.Prospective single institute RCT 1b 27 Evidence Level 1a ランダム化比較試験のメタアナリシス 1b 少なくとも一つのランダム化比較試験 2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど) 2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど) 3 ケース・コントロール研究(後ろ向き研究) 4 処置前後の比較などの前後比較,対照群を伴わない研究 5 case report case series 6 expert’s opinion(専門家委員会報告を含む)
  • 6. Eur Arch Otorhinolaryngol. 1999;256 Suppl 1:S18-21. Treatment of sudden sensorineural hearing loss with a continuous epidural block. Fujino M, Hisashi K, Yashima N, Takeshita M, Fujiwara Y, Chujo K, Nakagawa T, Komune S, Komiyama S. The efficacy of a continuous epidural block was evaluated in the treatment of 20 patients with sudden sensorineural hearing loss (SNHL). Ten patients were treated with continuous cervicothoracic epidural block (group A) and the other 10 were treated with stellate ganglion block (group B). No significant difference in factors affecting prognosis was noted between the groups. In the epidural block group 70% achieved substantial hearing improvement, while this occurred in only 30% of patients undergoing stellate ganglion block. These findings suggest that continuous epidural block can be effective in the treatment of sudden SNHL. Fujino M1, Hisashi K, Yashima N, Takeshita M, Fujiwara Y, Chujo K, Nakagawa T, Komune S, Komiyama S. Treatment of sudden sensorineural hearing loss with a continuous epidural block. Eur Arch Otorhinolar yngol. 1999;256 Suppl 1:S18-21. Retrospective single institute 5 20 Evidence Level 1a ランダム化比較試験のメタアナリシス 1b 少なくとも一つのランダム化比較試験 2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど) 2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど) 3 ケース・コントロール研究(後ろ向き研究) 4 処置前後の比較などの前後比較,対照群を伴わない研究 5 case report case series 6 expert’s opinion(専門家委員会報告を含む)
  • 7. Am J Otol. 1998 Sep;19(5):579-83. What kind of patients are suitable for evaluating the therapeutic effect of sudden deafness? Sano H, Okamoto M, Shitara T, Hirayama M. OBJECTIVE: This study aimed to find out appropriate patients to evaluate the therapeutic effect of sudden deafness. STUDY DESIGN: The study design was a retrospective case review. SETTING: The study was performed at a university hospital. PATIENTS: A series of 443 patients with idiopathic sudden sensorineural hearing loss who visited the authors within 1 week from the onset participated. INTERVENTIONS: Relationship between interval from the onset and treatment prognosis was investigated. RESULTS: The significant difference in prognosis related to the days from the onset to the initial visit was noted only in the patients with the initial hearing level from 50-65 dB. The prognosis of the patients who visited the authors on the next day from the onset was excellent. Whereas, in the patients with initial hearing level worse than 70 dB, no significant difference in prognosis was noted among the days of visit. CONCLUSIONS: The patients with the initial hearing level worse than 70 dB and who visited the authors within 8 days from the onset were appropriate for candidates in evaluating the therapeutic effect of sudden deafness.
  • 8. Acta Otolaryngol. 1998 Jul;118(4):488-95. Antiviral treatment of idiopathic sudden sensorineural hearing loss: a prospective, randomized, double-blind clinical trial. Stokroos RJ, Albers FW, Tenvergert EM. A subclinical viral labyrinthitis has been postulated in the literature to elicit Idiopathic Sudden Sensorineural Hearing Loss. An etiological role for the herpes virus family is assumed. Corticosteroids possess a limited beneficial effect on hearing recovery in ISSHL. In this study, the therapeutic value of the antiherpetic drug aciclovir (Zovirax) on hearing recovery in 44 ISSHL patients receiving prednisolone is evaluated in a multicentre clinical trial. The study is designed prospectively, randomized, double-blind and placebo-controlled. Subjective parameters include hearing recovery, a pressure sensation on the affected ear, disequilibrium or vertigo and tinnitus. Audiometric parameters include pure tone and speech audiometry. A one-year follow up is obtained. Both the pressure sensation and disequilibrium or vertigo have a good prognosis, but tinnitus, occurring in most patients, has a poor prognosis. Hearing recovery prognosis depends on the severity of initial hearing loss, and not on vestibular involvement. No beneficial effect from combining aciclovir with prednisolone can be established in ISSHL. Stokroos RJ, Albers FW, Tenvergert EM. Antiviral treatment of idiopathic sudden sensorineural hearing loss: a prospective, randomized, double- blind clinical trial. Acta Otolaryngol . 1998 1998 Jul;118(4):488-95. Prospective single institute RCT 1b 44 Evidence Level 1a ランダム化比較試験のメタアナリシス 1b 少なくとも一つのランダム化比較試験 2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど) 2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど) 3 ケース・コントロール研究(後ろ向き研究) 4 処置前後の比較などの前後比較,対照群を伴わない研究 5 case report case series 6 expert’s opinion(専門家委員会報告を含む)
  • 9. Acta Otolaryngol Suppl. 1997;529:86-7. Comparison of carbogen inhalation and intravenous heparin infusion therapies in idiopathic sudden sensorineural hearing loss. Rahko T, Kotti V. The effect of carbogen (5% carbon dioxide and 95% oxygen) inhalation and intravenous heparin on sudden sensorineural hearing loss was compared. Forty-four patients received the former, 43 the latter treatment, respectively. The patients were unselected patients of the clinic. The PTA (0.5-2.0 kHz) at the pretreatment stage was 62 dB in the heparin and 55 dB in the carbogen group. One month later the corresponding figures were 34 and 32 dB, the difference being statistically not significant. Thus neither of these methods proved superior in the treatment of sudden sensorineural hearing loss. Rahko T, Kotti V. Comparison of carbogen inhalation and intravenous heparin infusion therapies in idiopathic sudden sensorineural hearing loss. Acta Otolaryngol Suppl. 1997;529:86-7. Retrospective single institute 3 87 Evidence Level 1a ランダム化比較試験のメタアナリシス 1b 少なくとも一つのランダム化比較試験 2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど) 2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど) 3 ケース・コントロール研究(後ろ向き研究) 4 処置前後の比較などの前後比較,対照群を伴わない研究 5 case report case series 6 expert’s opinion(専門家委員会報告を含む)
  • 10. Ann Otol Rhinol Laryngol. 1997 Jan;106(1):22-6. Sudden deafness: a comparison of anticoagulant therapy and carbogen inhalation therapy. Kallinen J, Laurikainen E, Laippala P, Grénman R. Sudden deafness (SD) is a sudden or rapidly progressive, partial or complete, typically unilateral sensorineural hearing impairment that has no known specific etiologic factor. This study was designed to compare, in a group of 168 consecutive patients with SD, the effect of anticoagulant therapy and carbogen inhalation therapy. Special attention was paid to the shape of the audiogram relative to the clinical outcome and the treatment modality. We found that the configuration of the audiogram of SD patients is prognostic of the outcome, and that patients with a low-frequency-sloping hearing impairment have a better prognosis compared to the patients with a high-sloping loss. Anticoagulant treatment was most effective in low-sloping hearing losses, while carbogen inhalation may be more effective for patients with high-sloping hearing losses. Kallinen J1, Laurikainen E, Laippala P, Grénman R. Sudden deafness: a comparison of anticoagulant therapy and carbogen inhalation therapy. Ann Otol Rhinol Laryngol. 1997 Jan;106(1):22-6. Prospective single institute 2a 168 Evidence Level 1a ランダム化比較試験のメタアナリシス 1b 少なくとも一つのランダム化比較試験 2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど) 2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど) 3 ケース・コントロール研究(後ろ向き研究) 4 処置前後の比較などの前後比較,対照群を伴わない研究 5 case report case series 6 expert’s opinion(専門家委員会報告を含む)
  • 11. Am J Otol. 1996 Jul;17(4):529-36. Prognosis and treatment of sudden sensorineural hearing loss. Fetterman BL, Saunders JE, Luxford WM. Most cases of sudden sensorineural hearing loss (SHL) are idiopathic. Consequently, the otologist may be asked to predict hearing recovery and select a treatment strategy without fully understanding the disease process. We retrospectively reviewed the charts of 837 patients with SHL to evaluate the prognostic value of specific clinical parameters and the effectiveness of steroid and vasodilator treatments. Treatment response was defined by the patient's subjective response and audiological criteria. Patients who were treated with steroids and/or vasodilators were more likely to improve. Patients who improved had a worse initial pure-tone average (PTA) than those who did not improve. In addition, those with poorer initial speech discrimination scores, worse initial thresholds at 4,000 Hz, younger age, and greater number of treatments were more likely to improve. Neither the electronystagmogram results nor the initial audiogram shape were valuable indicators. Recognition of prognostic indicators can help in counselling patients and in the evaluation of treatment response. Fetterman BL, Saunders JE, Luxford WM Prognosis and treatment of sudden sensorineural hearing loss Am J Otol. 1996 Jul;17(4):529-36. Retrospective single institute 3 837 Evidence Level 1a ランダム化比較試験のメタアナリシス 1b 少なくとも一つのランダム化比較試験 2a ランダム割付を伴わない同時コントロールを伴うコホート研究(prospective study,concurrent cohort studyなど) 2b ランダム割付を伴わない過去のコントロールを伴うコホート研究(historical cohort study,retrospective cohort studyなど) 3 ケース・コントロール研究(後ろ向き研究) 4 処置前後の比較などの前後比較,対照群を伴わない研究 5 case report case series 6 expert’s opinion(専門家委員会報告を含む)