Organochalcogens, particularly ebselen, have been used in experimental and clinical trials with borderline efficacy.
In fact, ebselen was used in clinical trials with borderline efficacy [ 19].
Fewer women assigned to oral misoprostol group failed to deliver vaginally within 24 hours, although this finding was of borderline statistical significance (2 trials, 391 participants, 81/196 versus 100/195; RR 0.81, 95% CI 0.65--1.00; NNT = 11).
In the adjuvant setting, the X-ACT trial established borderline superiority to treatment with capecitabine, while a Japanese meta-analysis showed noninferiority when compared to observation alone.
Indeed results from our model with nonoxynol-9 and C31G, and a similar model [ 13] with nonoxynol-9, and cellulose sulfate, have correlated well with significantly harmful (nonoxynol-9, cellulose sulfate) or borderline harmful (C31G) clinical trial results.
However, there was borderline significant heterogeneity among included trials (Cochrane's Q, p = 0.05; I2 = 74%).
This may have led to a few relevant trials that used borderline surrogates being overlooked, but clear cut cases were not likely to have been missed.
Data from the MOSAIC [ 6] and the NSABP protocol C05-C08 trindicatedcated a borderline benefit of 2 3 % in 5-year OS rates when using additional oxaliplatin [ 15].
To inform these management debates, a randomised controlled trial (TOMBOLA, trial of management of borderline and other low grade abnormal smears) was established in the late 1990s.
In this trial, OS was borderline significantly prolonged, with a median of 23.3 months instead of 18.9 months, along with a frequency of serious adverse events of 13%to26%[52]52].
