Gemma C Salter, Mark Roman, Martin J Bland and Hugh MacPherson*
Corresponding author: Hugh MacPherson email@example.com
BMC Musculoskeletal Disorders 2006, 7:99 doi:10.1186/1471-2474-7-99
(2007-03-09 15:32) Université Paris 7, Bichat
I read with great interest this pilot of acupuncture in chronic cervical pain. The
design of the pilot seems correct. For the next step (large-scale randomised trial
to assess acupuncture versus standard GP care), some key points to consider are the
method of randomisation and overall discuss a double blinded study (evoked by the
authors in the discussion). In acupuncture, some methods have been described such
as sham acupuncture interventions that keep the patient unaware of intervention received.
If a sham procedure is not possible, the assessor must absolutely be blinded regarding
the group allocation to minimize bias. Also, one risk is that patients randomized
in the group acupuncture withdraw their consent (beliefs and cultural background).
This would lead to important lost to follow up. A study design such as Zelen design
may be effective in that case to limit lost to follow up. The patients would be randomised
and their consent would be collected after randomisation. If they refuse the strategy
they are randomised for (acupuncture), the adverse strategy (standard GP care) will
be proposed. Regarding randomisation, it is mentioned that several GPs practices will
participate in the large-scale trial. A centralized randomisation would probably be
the better strategy of randomisation. Stratification on GPs practices may be interesting
to limit the effect of each particular physician. The statistical analysis as mentioned
was realized on the principle of intention to treat. I think it would be interesting
(especially in the large-scale trial) to detail methods used to treat missing data
in the chapter analysis.
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