Much of the response to our papers about acupuncture as a treatment for medically unexplained symptoms, some as letters to the Journal and some in other online fora, relates to the headline messages. In the papers we acknowledged the limitations of our work and explained our choice of methods. The trial and accompanying process evaluation was always intended to be a pragmatic real world trial, with all its attendant potential biases, and we have attempted to report its results fully, warts and all. The pragmatic interpretation that Lawson asks for is as we reported: within the limits of the trial, five-element acupuncture is a safe and potentially effective intervention for patients with medically unexplained symptoms that may help some of them to take an active role in their treatment and make cognitive or behavioural lifestyle changes.
The design of the study was a standard waiting list controlled pragmatic trial, that was the best design to answer a pragmatic question. It was also best as a precursor to a cost effectiveness study, that would further inform NHS provision. The effect size was demonstrated on the basis of the preselected primary outcome measure, using standard statistical methods. It was conducted according to its registered protocol with the exception of the sample size that was revised downward because, in common with many trials, recruitment was slower than anticipated. This deviation from protocol was fully reported in the paper. We noted that the results were sensitive to missing data and that the study may have been underpowered.
Devroey and Van DeVijver complain that the sample was a heterogenous group with different diagnoses, but has missed the point that patients in this group all lacked diagnoses. As we explain in the paper, sham acupuncture controls are used to investigate the efficacy of a particular needling protocol, usually for a narrowly defined diagnosis, but are not appropriate for answering the pragmatic question of whether a referral for a series of acupuncture treatments is likely to be beneficial. The reason for doing the trial in the first place is that this group of patients are challenging for their doctors and occupy a considerable amount of their time.
We acknowledge in the paper that the ‘study design precludes assigning the benefits of this complex intervention to any one component of the acupuncture consultations, such as the needling or the amount of time spent with a healthcare professional’, but the suggestion that simply spending more time with physicians would achieve the same effect fails to address the issue, either for doctor or patients. The Measure Yourself Medical Outcome Profile instrument has been validated in settings other than complementary medicine.1,2 In terms of determining clinical significance, we can draw on work done with other seven-point scales, that concludes ‘the smallest difference that patients consider important is often approximately 0.5’.3 Consequently, our finding of a 0.6 mean difference between the groups is likely to be clinically significant — especially as substantial numbers of patients in the trial will have perceived more benefit than this. Adjustment of consultation rates for the extra acupuncture consultations would not change the inference on the within — and between-group inference on consultation rates. All the 41 control patients were offered acupuncture after a period of 6 months, and 35 took up the offer Patients from both the intervention and the control groups were interviewed.
The rationale for offering acupuncture to this group of patients is that medicine seems to have little to offer them; this mixed methods study suggests an acceptable and potentially valuable way out of what is often an impasse for doctors and patients.
- © British Journal of General Practice 2011