Table 2. Premature Study Termination, Patient Safety, and Treatment Compliance by Treatment Group (N = 125)
CharacteristicTreatment GroupP
Control (n = 61)Intervention (n = 64)
Premature study termination
    Number reported8 (13.1)6 (9.4).51
    Primary reason.12*
        A (Unable to contact)4 (6.6)6 (9.4)
        B (Dropped out)3 (4.9)0 (0.0)
        C (Uncooperative or nonadherent)1 (1.6)0 (0.0)
Patient safety
    Reported study-related serious AEs (n)22
        No22
        Yes00
        Unknown00
    Reported study-related AEs (n)
        No65
        Yes01
        Unknown30
Treatment compliance
    Treatments received during the study.13*
        01 (1.6)0 (0.0)
        14 (6.6)1 (1.6)
        23 (4.9)2 (3.1)
        31 (1.6)7 (10.9)
        412 (19.7)9 (14.1)
        5 (All)40 (65.6)45 (70.3)
    Surveys completed during the study.93*
        00 (0.0)0 (0.0)
        13 (4.9)3 (4.7)
        26 (9.8)8 (12.5)
        3 (All)52 (85.3)53 (82.8)
1Patient satisfaction with control/auriculotherapy.13*
    1 (Waste of time)3 (5.9)1 (1.8)
    2 (Poor)4 (7.8)2 (3.6)
    3 (Fair)11 (21.6)10 (18.2)
    4 (Good)10 (19.6)23 (41.8)
    5 (Excellent)23 (45.1)19 (34.6)
Patient recommends auriculotherapy for family/friends†46 (75.4)52 (81.3).45

  • Continuous variables are reported as (mean ± SD); categorical variables represent number of patients (%).

  • ↵* Fisher exact test.

  • ↵† Of the 125 randomized participants, 89 provided study satisfaction and blinding assessment data at week 6.

  • AE, adverse event.