The literature search identified 1345 references. This includes one completed but unpublished trial and two ongoing trials identified through contacts with professional bodies and experts in the field. The initial screening of the titles and abstracts identified 15 potentially relevant references, for which full text articles were obtained for further evaluation. Only three trials were finally included in our review.4,5,6
Figure 1 describes the results of the search and inclusion/exclusion process. Agreement between reviewers about study inclusion was 100%.
Figure 1Flow chart of the study selection process. RCTs, randomised controlled trials.
All three included studies are randomised, double‐blind, placebo‐controlled RCTs of moderate to good methodological quality. Jadad scores for the three studies were 5,4
Studies compared: individualised Chinese herbal medicine, standardised Chinese herbal medicine and placebo in irritable bowel syndrome4
; European individualised herbalism and placebo for osteoarthritis of the knee5
; and individualised Chinese medical herbalism with placebo for prevention of chemotherapy‐induced toxicity in cancer patients.6
Each RCT is described below and summarised in table 1.
Table 1Included RCTs of individualised herbal medicine
compared individualised Chinese herbal medicine, standardised Chinese herbal medicine and placebo in 116 patients with irritable bowel syndrome (IBS). Treatment lasted 16 weeks and in the individualised group, the prescription could be adjusted by the herbalist at regular intervals. Herbs were administered as encapsulated powders and the standardised treatment was a combination of 20 different herbs. Outcome measures were change in total Bowel Symptom Score (BSS) and global improvement, each assessed separately by the patient and a gastroenterologist, and patient‐assessed interference with life. The findings presented in the abstract and results section of this paper differ. The abstract reports statistically significant findings favouring herbal treatment over placebo, but this refers to data derived from standardised and individualised herbal treatment combined together. The results section indicates that there were statistically significant differences favouring standardised treatment over placebo in all five outcome measures, but only four of the five showed significant intergroup differences favouring individualised herbal treatment over placebo. The gastroenterologist's assessments for the main outcome measure, the BSS, were not significantly better than placebo in the individualised group. Overall, changes from baseline and responder rates were larger in the standardised than in the individualised group in all measures. Patient‐assessed BSS at a follow up 14 weeks after the end of the trial favoured individualised over standardised treatment, but this difference was not statistically significant.
The data for Hamblin5
was extracted from a pre‐publication draft kindly made available to us by the authors. This study compared 10 weeks of individualised herbal medicine with a placebo tincture in 20 patients diagnosed with osteoarthritis of the knee. The herbal treatments were prescribed by two herbal practitioners each based in a different London general practice surgery. Prescriptions drew upon a formulary of 11 herbs based upon responses to a questionnaire completed by 20 established herbalists. Patients continued with existing pain‐killing and anti‐inflammatory drugs for the period of the trial and, in addition to the active or placebo treatments, also received dietary advice and daily nutritional supplements consisting of multivitamins and minerals, vitamin C and omega‐3 fish oils. Outcome measures were subscale scores and total score for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Measure Yourself Outcome Profile (MYMOP) scores for two symptoms and a daily activity chosen by each patient. Fourteen of the 20 patients enrolled in the study completed the 10 week trial and data analysis is based on these completers. There were no significant differences between groups in changes from baseline for either outcome or their component scores. The authors do report several within‐group changes confined to the active treatment group but the only one of these within‐group changes to reach statistical significance were the WOMAC stiffness score at 5 weeks and symptom 2 on the MYMOP at both time intervals.
compared the effect of individualised Chinese herbal medicine with that of placebo upon chemotherapy‐induced toxicity in patients with early‐stage breast and colon cancer. Individualised treatment was prescribed by one of three qualified Chinese herbalists drawing on a stock of 125 different commonly used herbs. Treatments, including the placebo, were dispensed in the form of a herbal tea. Treatment could be adjusted by the herbalist on day 1 and 14 of each cycle of chemotherapy. Chemotherapy was standardised as four 21 day cycles for breast cancer and six 28 day cycles for colon cancer. The trial was terminated early when 50% of the target sample size had been recruited. This was because of a slow accrual rate. Many potential recruits refused the possibility of being randomised to placebo or were already receiving Chinese herbal medicine. Data analysis for 111 patients showed no statistically significant differences between groups for the primary outcome measure of haematological toxicity. There were no significant differences between groups for responses to a quality of life questionnaire, and only one of 16 items measuring non‐haematological toxicity showed a significant difference favouring the active treatment. This one difference related to nausea, but a similar difference between groups was not observed in the item relating to nausea in the quality of life questionnaire.