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The third-generation agent zosuquidar has also failed to show significant benefit in a randomised trial.
However, adding weekly intravenous bolus 5-FU to weekly gemcitabine did not confer a significant survival benefit in a randomised trial (Berlin et al, 2002).
The use of DTIC is largely historical and based on tumour response rates, and DTIC has never demonstrated an OS benefit in a randomised trial.
18 Curcumin has low toxicity and has been shown to benefit the treatment of chronic gut inflammation in animal models, as well as showing benefit in a randomised cross-over trial in the treatment of ulcerative colitis.
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Cyclosporin also appeared to have some benefit in a non-randomised comparison of previously untreated elderly patients, with an improved complete remission (CR) rate for Pgp-positive patients treated with the modulator.
Interestingly the blockage of the renin-angiotensin-system (RAS) revealed a significant benefit in controlled randomised studies in a diabetic population [ 10, 11].
It therefore seems justifiable to analyse the benefit of this scheme in a randomised, prospective study.
Moreover, a combination of gemcitabine and cisplatin displayed benefits over gemcitabine monotherapy in a randomised, phase III trial (Valle et al, 2010).
Adjunctive moxonidine appeared to have benefits versus adjunctive nitrendipine, in a randomised double-blind six-month trial in hypertensive patients with advanced renal failure.
The ultimate test of the usefulness of N-of-1 trials in clinical practice is to compare the outcome of N-of-1 trials in terms of costs and patient benefits to usual care in a randomised design.
Benefits reported by patients in a randomised control trial of hand-held records identified included feelings of increased confidence, personal responsibility and control over their pregnancy; they were also seen to facilitate better communication between women and health professionals [ 40].
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