The mean values of VAS assessing physician's overall opinion of improvement were significantly different in favor of THC compared with TM at every time point (week 1–3), but there were no statistical significances between the remaining pairs of the three groups. On the other hand, the mean values of VAS assessing patient's overall opinion of improvement over the entire treatment period were generally comparable among the three groups, except for the end of week 1 in which THC group demonstrated significantly greater VAS than TM group (Table 7). On the basis of the number of responders whose VAS assessing total pain decreased at least by 80% compared with the baseline, the proportion of responders at the end of the study was comparable among the three groups (the response rate was 14 out of 20 patients or 70.0% in each group).
100-mm VAS assessing physician's and patient's overall opinions of improvement evaluated during treatment.
According to the reported adverse events, gastrointestinal adverse effects (nausea or abdominal pain) were significantly found in the ibuprofen group compared with TM and THC groups (8:0:0 events). Notably, two patients experienced severe abdominal pain and needed to be withdrawn from the study during the first week after initiation of oral ibuprofen. In addition, two events of skin rash and one event of edema were also found in ibuprofen group. In the TM group, three events of muscle aches over the treated area following the first massage session were reported. The adverse symptom was self-limited within a few days. In contrast, there was no reported adverse event in THC group.