The proof of its efficacy is based on four randomized, placebo-controlled trials of 853 patients, showing an improvement in functional outcome [32 36].
This finding is based on two randomized controlled trials with in total 148 patients, which is half the population of our study [17, 19].
In recent years, a high concentration (8%%) capsaicin patch has been developed, and approved for PHN based on two randomized controlled studies demonstrating the efficacy and safety of a 1-h application for PHN in non-trigeminal dermatomal distributions [15, 16].
Overall, the quality of the evidence ranged from high to very low, based on seven randomized controlled trials and four observational, or quasi-experimental, studies (see Figure 1).
We have the same best estimate of control group re-operation rate (i.e. 30%) for the saline solution effect, based on two randomized trials [ 31, 35].
FDA approval of clobazam for LGS was based on two randomized controlled trials: OV-1002 11 (NCT00162981) and OV-1012 12 (also known as the CONTAIN trial, NCT00518713).
Sorafenib, an inhibitor of cancer cell proliferation and tumor angiogenesis, has been approved for treatment of advanced HCC based on two randomized, placebo-controlled trials [22], [23].
It is an oral active dual ETA/B receptor antagonist and its approval in 2001 was based on two randomized, double-blind, placebo-controlled trials.
83 Amitriptyline is frequently used in diabetic neuropathy; however, it appears to be less effective in HIV neuropathy based on two randomized, placebo-controlled studies.
