1 Strategies for acupuncture research Hugh MacPherson Research Director Foundation for Traditional Chinese Medicine York Senior Research Fellow Department of Health Sciences University of York

2 Strategies for the clinical evaluation of acupuncture Acupuncture as a simple intervention Route maps to evidence …. Acupuncture as a complex intervention - a whole system approach

3 Problems with acupuncture research so far Mostly built on assumption that acupuncture is a simple intervention Inexperienced acupuncturists Inadequate acupuncture Over-emphasis on internal validity Compounded by poor reporting of the acupuncture trials

4 mechanism -month follow-up Responses= 146 (92%) 12-month follow-up Responses= 147 (92%) 24-month follow-up Responses= 123 (77%) Route maps to evidence … safety efficacy effectiveness Drug model

5 Acupuncture as a simple intervention Is there a single active ingredient? If so can it be isolated? Or if multiple active ingredients, can we divide up the intervention and measure each active ingredient separately? If so, then easier to attribute acupuncture to outcome - showing cause and effect (internal validity)

6 Bandolier 1999

7 Internal validity score out of 9 Garvey et al7 Duplan et al6 Mendelson et al5 Edelist et al4 Gunn et al4 MacDonald et al4 Lehmann et al3 Lopacz & Gralewski3 Thomas & Lundberg3 Von Menke et al3 Coan et al2 Internal validity of low back pain trials – Cochrane/van Tulder 1999

8 Coan et al 1980 paper: Aim: to evaluate the impact of acupuncture for low back pain Mode of therapy – “acupuncture was performed according to the classical Oriental meridian theory of promoting healing by stimulating the energy flow in the body”.

9 Internal validity score out of 9 Garvey et al7 Duplan et al6 Mendelson et al5 Edelist et al4 Gunn et al4 MacDonald et al4 Lehmann et al3 Lopacz & Gralewski3 Thomas & Lundberg3 Von Menke et al3 Coan et al2 Internal validity of low back pain trials – Cochrane/van Tulder 1999

10 Garvey et al 1989 paper: Aim: to evaluate impact of a single steroid injection for low back pain Improved Lidocaine40% Lidocaine plus steroid45% Single dry needle (acupuncture)61% Vapocoolant spray with acupressure67%

11 Balancing internal and external validity Internal validity The degree to which the design establishes cause- and-effect between treatment and observed outcome, i.e. attribution External validity The degree to which the design and intervention can be generalised, i.e. real world applicability

12 mechanism safety -month follow-up Responses= 146 (92%) effectiveness 12-month follow-up Responses= 147 (92%) Responses= 68 (85%) 24-month follow-up Responses= 123 (77%) 24-month follow-up Responses = 59 (73%) 12 – month follow-up Route maps to evidence … efficacy safetymechanism efficacy effectiveness Drug modelCAM model

13 Acupuncture as a complex intervention 1 Medical Research Council: “the greater the difficulty in …. defining precisely what are the active ingredients …. the greater the likelihood you are dealing with a complex intervention.” 1 1 MRC: A framework for the development and evaluation of RTCs for complex interventions, 2000

14 Acupuncture as a complex intervention 2 Reducing a complex intervention from its whole to its parts will result in an “irretrievable loss” 1 1 MRC: 2000

15 Whole system research: key features 1 treatment individualization, multiple components, patient-practitioner interaction, importance of therapeutic setting, patient-determined outcome values 1 Ritenbaugh C, Verhoef M, Fleishman S, Boon H, Leis A. Whole systems research: a discipline for studying complementary and alternative medicine. Altern Ther Health Med. 2003; 9(4):32-6.

16 Whole system research: challenges and opportunities defining scope of treatment impact of practitioner active patient participation synergy between components long-term follow up optimising internal and external validity

17 Strategic directions …. Acupuncture as a complex intervention Evaluation of acupuncture as a whole system