Table 1 Included RCTs of individualised herbal medicine
StudyDesign (Jadad score)Participants and indicationInterventionOutcome measuresMain resultsComments
Bensoussan 19984Double-blind, placebo controlled RCT(5)n = 116. 18–75 years (99 analysed). Adults with IBS meeting Rome criteria16 weeks1) Individualised CHM2) Standardised CHM3) Placebo capsule1. Total BSS score (4×100 mm VAS for pain/discomfort, bloating, constipation, diarrhoea)a. patientb. gastroenterologist2. Global improvementa. patientb. gastroenterologist3. Interference with life assessed by patients (no further details reported)1a, 1b, 2a, 2b, 3 favoured standardised CHM over placebo1a, 2a, 2b, 3, 4 favoured individualised CHM over placebo1b NSD between individualised CHM and placebo1a, 1b, 2a, 2b, 3 NSD between standardised and individualised CHMPer protocol analysis for continuous variablesResults reported in abstract combine data for the 2 active treatment groups and are inconsistent with those in results section
Hamblin 20075Double-blind, placebo controlled RCT(3)n = 20 (14 analysed)Patients with osteoarthritis of the knee10 weeksAt baseline week 5 and 101a, b, c, d. NSD between groupsPer protocol analysisSuccess of patient and herbalist blinding not assessedLarge baseline differences between groups in WOMAC scores indicating greater severity of osteoarthritis in the active group
1) Active, individualised herbal medicine prescribed by a herbal practitioner at baseline and week 51. WOMAC knee health (3×100 mm VAS)a. painb. physical functionc. stiffnessd. total2a, b, c NSD between groups
2) Placebo (25% alcohol, caramel colouring, aniseed essential oil flavouring)2. MYMOP (3×7-point scales for the preceding 4 weeks)a. symptom 1b. symptom 2c. daily activity affected(a, b, c chosen by the patient)
Mok 20076Double-blind, placebo-controlled RCT with randomisation stratified for chemotherapy regimen(5)n = 120 (111 assessable)Patients with early stage breast or colon cancer receiving chemotherapy (breast cancer—AC 4×3-week; colon cancer—FUFA 6×28 day cycle treated days 1–5)12 weeks to 6 months1) Individualised CHM2) Placebo1. Haematological toxicity1. NSD between groupsStudy terminated early when 50% of target sample recruited, due to difficulty of recruitment
2. Non-haematological toxicity (16 items)2. 1 of 16 items (nausea) favoured active treatment (p = 0.04)
3. EORTC QoL3. NSD between groups
  • AC, adriamycin and cyclophosphamide; CHM, Chinese herbal medicine; EORTC QoL, European Organisation for Research and Treatment of Cancer Quality of Life questionnaire version 2; FUFA, 5-fluorouracil and folinic acid; IBS, irritable bowel syndrome; MYMOP, Measure Yourself Outcome Profile; NSD, no significant difference; RCT, randomised controlled trial; SS, bowel symptom scale; VAS, visual analogue scale; QoL, quality of life; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.