Richard James Clark, Uni of Plymouth, Peninsula School of Medicine
29 April 2013
I can offer two comments to help you avoid future criticism of your study:
1. Model validity? As I am sure you know, moxibustion is a technique used within traditional acupuncture, and its use would not normally be decided on the basis of a named anatomico-pathalogical condition (such as OA). Instead it would be used specifically in Yin, Cold or Deficiency states, to disperse the cold, tonify the yang, and replenish deficiencies. While the local points around the knee may be good for the first of these, the other two aims might be better fulfilled by applying the moxibustion at other locations (such as the relevant Yu or Shu points). While OA generally does fit this description (Yin, cold, deficient) this is not always the case (eg some patients have acute Yang exacerbations) so your study would be improved if you took this into account.
2. Confounding factors. Your rationale for a comparison-with-usual-care study is clear but even so there is a risk that aspects of usual care will vary in such a way as to undermine your study. It is important that your outcome measures should include any variation in the `usual treatment¿. For example, consider two patients taking conventional NSAIDs, one in the treatment group and one in the control group ¿ the patient in the treatment group gains benefit from the moxa and so reduces their medication, the control patient maintains their consumption of NSAIDs. Thus the scores on your various outcome measures may be similar for these two patients, but the vital piece of information (that the first patient is now taking less medication) will be ignored.
I hope you find this helpful and I look forward to seeing what you come up with in due course.
A very useful and thorough study, but ...
29 April 2013
I can offer two comments to help you avoid future criticism of your study:
1. Model validity? As I am sure you know, moxibustion is a technique used within traditional acupuncture, and its use would not normally be decided on the basis of a named anatomico-pathalogical condition (such as OA). Instead it would be used specifically in Yin, Cold or Deficiency states, to disperse the cold, tonify the yang, and replenish deficiencies. While the local points around the knee may be good for the first of these, the other two aims might be better fulfilled by applying the moxibustion at other locations (such as the relevant Yu or Shu points). While OA generally does fit this description (Yin, cold, deficient) this is not always the case (eg some patients have acute Yang exacerbations) so your study would be improved if you took this into account.
2. Confounding factors. Your rationale for a comparison-with-usual-care study is clear but even so there is a risk that aspects of usual care will vary in such a way as to undermine your study. It is important that your outcome measures should include any variation in the `usual treatment¿. For example, consider two patients taking conventional NSAIDs, one in the treatment group and one in the control group ¿ the patient in the treatment group gains benefit from the moxa and so reduces their medication, the control patient maintains their consumption of NSAIDs. Thus the scores on your various outcome measures may be similar for these two patients, but the vital piece of information (that the first patient is now taking less medication) will be ignored.
I hope you find this helpful and I look forward to seeing what you come up with in due course.
Competing interests
None