Five studies, described as RCTs, were included in the review (n=406 patients, range 54 to 128). None of the authors of these studies could be contacted to check randomisation methods, and the review authors noted that some were probably non-randomised. None of the studies reported their method of randomisation or allocation concealment. One study apparently blinded outcomes assessment, but otherwise no blinding was used.
TCM plus conventional treatment versus conventional treatment only
Mortality/survival (two studies): One study reported significantly lower mortality in the intervention group for up to five years (RR at five years 0.14, 95% CI 0.03 to 0.65). The other study reported significantly higher survival rates in the intervention group for up to two years (RR at two years 2.0, 95% CI 1.15 to 3.46), but found no statistically significant difference between the groups at three years.
Quality of life (three studies): Two studies suggested a reduction in the number and severity of radio-chemotherapy side-effects in the intervention group.
Treatment response (two studies): One study reported a significantly lower rate of relapse or metastasis in the intervention group (RR 0.35, 95% CI 0.14 to 0.88).
Immune response (three studies): All studies reported statistically significant improvements in the intervention group in at least one measure of immune function: effect sizes were reported in the review.
Adverse events: No studies reported any adverse events associated with traditional Chinese medicine.