Table 2a. Quality of Randomized Trials of Thyroxine Replacement Therapya
| Study, Year |
Random Assignment? |
Allocation Concealed? |
Groups Similar at Baseline? |
Eligibility Criteria Specified? |
Outcome Assessors Blinded? |
Care Provider Blinded? |
Cooper
et al., 198459
(more details) |
Yes, by individual |
Not stated |
LT4 patients were older (58.2 vs
50.2) and had fewer symptoms (2.1 vs 2.4)
but otherwise similar |
Yes |
Yes |
Probably (1 of 2 investigators is
said to be blinded) |
Meier
et al., 200176
(more details) |
Sequential assignment using a
predefined list; randomized by matched pairs |
No |
LT4 patients had higher TSH (14.4 ± 1.7 vs 11.3 ± 1.0) and
LDLc (4.1 vs 3.7) but were otherwise similar for the whole groups (n = 66);
comparisons were not presented for the analyzed group (n = 63) |
Yes |
Not stated |
Yes |
Caraccio
et al., 200278
(more details) |
Yes, by individual |
Not stated |
Generally yes, but mean TSH (6
vs 4.9) and LDLc (3.6 vs 3.3) were higher in LT4 group |
Yes |
No |
No |
Jaeschke
et al.,
199674
(more details) |
Yes, by individual |
Not stated |
LT4 patients had higher TSH
(12.1 vs 9.4) and slightly more symptoms (14 vs 13) but similar in age |
Yes |
Yes |
1 investigator was not blinded but was not involved in assessment or care |
Kong et
al, 200279
(more details) |
Yes, in blocks of 6 |
Yes |
LT4 patients were older (53 vs
45 yrs), had lower FT4 (0.9 vs 1), and higher TSH (8 vs 7.3) |
Yes |
Yes |
1 was not blinded but was not
involved in care |
Nystrom
et al., 198858
(more details) |
Not stated |
Not stated |
No baseline data were given for
the groups initially assigned LT4 and placebo |
Yes |
Yes |
Yes |
Michalopoulou
et al., 199875
(more details) |
Yes, method not stated |
Not stated |
Inadequately described. LDL was higher in 50 mg group (6.8 vs. 6.2) |
Yes |
Not stated |
Not stated |
Pollock
et al., 200177
(more details) |
Yes, by coin toss in blocks of 4 |
No |
No baseline data were given for
the groups initially assigned LT4 and placebo |
Yes |
Not stated |
Yes |
Table 2b. Quality of Randomized Trials of Thyroxine Replacement Therapya
| Study, Year |
Patient Unaware of Treatment? |
Intention-to-Treat Analysis?b |
Maintenance of Comparable Groups? |
Reporting of Attrition,
Crossovers, Adherence, and Contamination? |
Differential Loss to Followup or
Overall High Loss to Followup? |
Statistical Analysis Appropriate? |
Score (Good/ Fair/ Poor) |
|
Cooper
et al., 198459 |
Yes, not verified |
No |
The number of patients randomized
appears to be 41; 33 patients were analyzed.
It is not clear which group the other 8 belonged to. |
Partially |
Unclear, probably not |
Yes, except it did not address
dropouts |
Good |
| Meier
et al., 200176 |
Yes, not verified |
No |
Yes |
No |
No |
No, analyzed as RCT, but reported
primarily as a before/after study |
Poor |
| Caraccio
et al., 200278 |
Probably were aware, since dosing
and length of followup differed. It
is not clear whether patients were informed of their lipid levels. |
Yes, assuming that completion of
study was not a criterion for inclusion |
Probably |
No |
No |
Yes (when analyzed as an RCT) |
Poor |
| Jaeschke
et al., 199674 |
Yes, not verified |
No |
Probably, 3 dropouts in each
group |
Partially |
Overall 6 out of 40 dropped out |
Yes, except it did not address
dropouts |
Fair |
| Kong et
al, 200279 |
Yes, not verified |
No |
Unknown |
Yes |
Yes, especially for lipid
comparison |
Yes, except it did not address
dropouts |
Poor |
| Nystrom
et al., 198858 |
Probably aware, verified |
No |
Yes |
No |
No |
No, no baseline comparisons or
results provided about the first assignment |
Poor |
| Michalopoulou
et al., 199875 |
Not stated |
Probably |
Yes |
No |
No |
No, analyzed as before/after |
Poor |
| Pollock
et al., 200177 |
Yes, verified |
No |
Probably, but all 3 dropouts were
from the LT4 group |
No |
No |
Yes |
Fair |
a Values reported with
plus/minus signs are means ± SD.
b Symptomatic Group Only.
Note: FT4, serum free thyroxine; LDLc,
low-density lipoprotein cholesterol; LT4, levothryroxine; RCT, randomized
controlled trial; TSH, thyroid-stimulating hormone.
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