AIM:

To summarise and critically evaluate the evidence from randomised clinical trials for the effectiveness of individualised herbal medicine in any indication.

METHODS:

Search of electronic databases and approaches to experts in the field to identify randomised, controlled clinical trials of individualised herbal medicine in any indication. Independent data extraction and assessment of methodological quality by two authors and best evidence synthesis.

RESULTS:

Three randomised clinical trials of individualised herbal medicine were identified. Statistically non-significant trends favouring active over placebo treatment in osteoarthritis of the knee probably result from large baseline differences and regression to the mean. Individualised treatment was superior to placebo in four of five outcome measures in the treatment of irritable bowel syndrome, but was inferior to standardised herbal treatment in all outcomes. Individualised herbal treatment was no better than placebo in the prevention of chemotherapy-induced toxicity.

CONCLUSIONS:

There is a sparsity of evidence regarding the effectiveness of individualised herbal medicine and no convincing evidence to support the use of individualised herbal medicine in any indication.