Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part II: validation study

Ear, Nose & Throat Journal, Oct, 2005 by Shlomo Silman, Daniel S. Arick, Michele B. Emmer

Table 1. Mean (standard deviation) pre- and posttest air-conduction
thresholds (dB HL) in the former control group in the current study
and in the active-treatment group in the previous study

Group             Test   Ear   n   500 Hz  1,000 Hz  2,000 Hz  4,000 Hz

Current study:    Pre   Right  30   31.0     32.0      22.2      28.8
Former control                      (8.9)    (9.2)    (10.6)    (11.7)
  group *               Left   30   30.7     32.7      23.0      28.7
                                   (10.1)   (12.7)    (11.6)    (14.7)

Previous study:   Pre   Right  43   33.0     32.1      23.8      29.4
Active-treatment                   (10.9)   (10.1)    (11.0)    (12.1)
                        Left   45   35.3     37.7      26.0      31.4
                                   (11.4)   (10.8)    (12.2)    (11.7)

Current study:    Post  Right  30   18.5     18.2      11.8      15.0
Former control                     (12.3)   (12.8)    (11.3)    (11.6)
  group                 Left   30   18.7     16.3      11.0      14.2
                                    (8.2)    (9.7)     (9.9)    (11.8)

Previous study:   Post  Right  43   18.3     15.5       7.9      12.0
Active-treatment                   (76.0)    (8.4)    (79.0)     (9.8)
  group                 Left   45   19.0     17.3       8.7      14.7
                                   (10.3)   (11.0)     (8.2)     (8.1)

* The former control group was made up of 30 patients who had served as
untreated controls in the previous clinical trial. (1) Upon conclusion
of their participation in that study, they elected to receive active
treatment.

([dagger]) Data from the active-treatment group in the previous study'
are presented for comparison purposes.

Table 2. Mean (95% confidence interval) differences (posttest minus
pretest) in air-conduction thresholds (dB HL) in the 30 former
controls *

Ear        500 Hz         1,000 Hz       2,000 Hz       4,000 Hz

Right       -12.8          -13.8           -10.3          -13.8
        (-17.5, -8.1)  (-18.5, -9.2)   (-14.3, -6.4)  (-19.1, -8.5)

Left        -12.0          -16.3           -12.0          -14.5
        (-15.6, -8.4)  (-21.2, -11.5)   (-170, -70)   (-20.0, -9.0)

* All differences are statistically, significant (p < 0.001) according
to the Student's paired t test. The negative values represent
improvements in hearing sensitivity following treatment.

Table 3. Mean (95% confidence interval) differences
between groups (values for the previous study's
active-treatment group minus values for the current
study's former control group) in the changes (post-test
minus pretest) in air-conduction thresholds (dB
HQ *

Ear         500 Hz       1,000 Hz       2,000 Hz       4,000 Hz

Right        -1.9          -2.8           -5.6           -3.6
          (-7.4, 3.5)   (-8.5, 2.9)   (-11.3, 0.1)   (-10.2, 2.9)
           p = 0.48      p = 0.33      p = 0.053       p = 0.28

Left         -4.3          -2.0           -5.3           -2.3
          (-9.3, 0.6)   (-7.4, 3.5)   (-11.1, 0.4)   (-8.5, 3.9)
           p = 0.09      p = 0.46       p = 0.07       p = 0.47

Statistical significance was determined according to an independent
samples t test (assuming equal variances). The negative values
represent improvements in hearing sensitivity following treatment.

Table 4. Pure-tone thresholds for 500 through 4,000 Hz in 8 patients
following initial treatment and following extended treatment

                                             Frequency (Hz)

                                                Right ear

Pt.   Test                            500   1,000   2,000   4,000

1     After 7 wks of initial Tx *     30     25      15      25
      After extended Tx ([dagger])    10     10      15      10

2     After 7 wks of initial Tx       15      5       5       5
      After extended Tx               10     10       0       5

3     After 7 wks of initial Tx       25     30      25      20
      After extended Tx               20     15      15      10

4     After 7 wks of initial Tx       30     25      30      25
      After extended Tx               10     15      15      10

5     After 7 wks of initial Tx       30     30      10      10
      After extended Tx               25     15      15      15

6     After 7 wks of initial Tx       10     20      10      10
      After extended Tx               15     15       5      10

7     After 7 wks of initial Tx       15     25      20      10
      After extended Tx               10      0      10      10

8     After 7 wks of initial Tx       35     30      20      20
      After extended Tx               20     20       0      15

                                             Frequency (Hz)

                                                Left ear

Pt.   Test                            500   1,000   2,000   4,000

1     After 7 wks of initial Tx *     25     25       5      25
      After extended Tx ([dagger])    10     10       5       0

2     After 7 wks of initial Tx       35     25      15      30
      After extended Tx               20     15       5      15

3     After 7 wks of initial Tx       25     20      10      15
      After extended Tx               15     15      15      10

4     After 7 wks of initial Tx       15     10      10      15
      After extended Tx               10     10      10      10

5     After 7 wks of initial Tx       15     15       5      15
      After extended Tx               25     20       5      15

6     After 7 wks of initial Tx       25     30      20      25
      After extended Tx               15     15      15      10

7     After 7 wks of initial Tx       55     60      45      40
      After extended Tx               35     45      30      15

8     After 7 wks of initial Tx       35     35      20      15
      After extended Tx               15     10      10       0

* Previous study. Posttest was performed 4 weeks following the
conclusion of the 7-week treatment course. Note that these patients
had been treated for 7 weeks in the previous clinical trial, but they
did not reach the criteria, for complete recovery. Their pure-tone
thresholds upon initial enrollment in the previous clinical trial
were poorer than those indicated in this table.

([dagger]) Current study. Posttest was performed 2 weeks following
the conclusion of extended treatment.