Table 1 Included RCTs of individualised herbal medicine.
| Study | Design (Jadad score) | Participants and indication | Intervention | Outcome measures | Main results | Comments |
|---|---|---|---|---|---|---|
| Bensoussan 19984 | Double‐blind, placebo controlled RCT(5) | n = 116. 18–75 years (99 analysed). Adults with IBS meeting Rome criteria | 16 weeks1) Individualised CHM2) Standardised CHM3) Placebo capsule | 1. 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 CHM | Per 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 20075 | Double‐blind, placebo controlled RCT(3) | n = 20 (14 analysed)Patients with osteoarthritis of the knee | 10 weeks | At baseline week 5 and 10 | 1a, b, c, d. NSD between groups | Per 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 5 | 1. WOMAC knee health (3×100 mm VAS)a. painb. physical functionc. stiffnessd. total | 2a, 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 20076 | Double‐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) Placebo | 1. Haematological toxicity | 1. NSD between groups | Study 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 QoL | 3. 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.