Page 81 - The clinical aspects and management of chronic migraine Judith Anne Pijpers

Table 4. Blinding results: assumptions of participants on the received treatment.
Withdrawal and botulinum toxin A: a double blind RCT
Satisfaction with treatment after 12-weeks was 7/10 (median, interquartile range=3). Treatment was rated as very good (≥8/10) by 44.7% of BTA and 47.5% of placebo treated participants. Furthermore, 61.8% of BTA and 72.5% of placebo treated patients would recommend their treatment to friends or family, 25% and 17.5% didn’t know, and 13.2% and 10% would not.
In total 59, presumably treatment-related adverse events were reported in the double blind phase by 52 participants: 25 on BTA and 27 on placebo (Supplementary Table 1). Adverse events were mild (92%) or moderate (8%). Most frequently reported adverse events were pain (37%) and small hematoma (31%) at injection sites. Ptosis was reported by six participants (BTA n=2, placebo n=4).
Blinding appeared successful (Table 4). Assumptions about received (participants) or given (investigators) treatments were equally distributed and participants nor investigators significantly more often guessed the correct treatment. At 12 weeks, investigators correctly identified treatment in 54.3% of BTA-treated patients and 55.0% of placebo-treated patients. For participants these proportions were 38.2% and 44.0%.
4
Actually received BTA
Actually received placebo
P value
.81 .90
Assumption At 3 days*
At 12 weeks**
BTA
29 (33.0%) 29 (38.2%)
Placebo 59 (67.0%) 35 (46.1%)
Don’t know 0 (0.0%)
12 (15.8%)
BTA
29 (33.7%) 30 (37.0%)
Placebo 56 (65.1%) 36 (44.0%)
Don’t know 1 (1.2%)
15 (18.8%)
Values are n (%)
* N BTA = 88, N Placebo = 86 ** N BTA = 76, N Placebo = 81
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