If you wanted to conduct a trial to prove that acupuncture works - not just that sticking needles into people relieved certain symptoms, but that traditional acupuncture, with its theories of qi and meridien, actually works, and therefore that the theories may actually be correct - how will you design the trial?
Well, for a start you might look at what we already know about acupuncture:
1. Acupuncture works best for pain, a condition which is known to be susceptible to the placebo effect.
2. Physician-patient interaction, physician expectation, and patient expectation all affect the magnitude of the placebo effect.
3. 'Fake' or 'mock' acupuncture in the form of needles which retract and do not penetrate the skin stimulates the brain differently from needles which penetrate the skin. Fake acupuncture produces a placebo effect too, although the magnitude may be less than that of 'true' acupuncture.
4. 'Sham' acupuncture in the form of needles which penetrate the skin at sites other than known acupoints produce the same magnitude of pain relief as 'true' acupuncture.
So in order to desgin a trial that will 'prove' that traditional acupuncture works, we should load the design to maximise the placebo effect utilised in traditional acupunture, and avoid mentioning the fact that 'sham' acupuncture will show our 'proof' wrong.
In fact, let's leave 'sham' acupuncture out altogether, won't we?
For our subject let's pick a condition which main symptom is pain, and let's pick for our measure outcome a self-reported scoring system.
To make our trial look legitimate, let's have several arms, including a 'fake' acupuncture arm, but as we mentioned above not a 'sham' acupuncture arm, and let's randomise our patients into these arms.
To maximise on the placebo effect provided by physician-patient interaction, let's not blind our physicians to the intervention.
If we did all that, we should end up with a trial that shows that traditional acupuncture, with the ritual of individualised diagnosis and actual insertion of needles is superior to no treatment, or ritual but no actual insertion of needles, and we can then try to conclude that acupuncture actually works.
That, it seems, is what the investigators in this trial did:
Traditional Acupuncture in Migraine: A Controlled, Randomized Study
Objective.—To check the effectiveness of a true acupuncture treatment according to traditional Chinese medicine (TCM) in migraine without aura, comparing it to a standard mock acupuncture protocol, an accurate mock acupuncture healing ritual, and untreated controls.
Background.—Migraine prevalence is high and affects a relevant rate of adults in the productive phase of their life. Acupuncture has been increasingly advocated and used in Western countries for migraine treatment, but the evidence of its effectiveness still remains weak. A large variability of treatments is present in published studies and no acupoint selection according to TCM has been investigated so far; therefore, the low level of evidence of acupuncture effectiveness might partly depend on inappropriate treatment.
Design and Methods.—A prospective, randomized, controlled study was performed in 160 patients suffering from migraine without aura, assessed according to the ICD-10 classification. The patients were divided into the following 4 groups: (1) group TA, treated with true acupuncture (according to TCM) plus Rizatriptan; (2) group RMA, treated with ritualized mock acupuncture plus Rizatriptan; (3) group SMA, treated with standard mock acupuncture plus Rizatriptan; (4) group R, without prophylactic treatment with relief therapy only (Rizatriptan). The MIDAS Questionnaire was administered before treatment (T0), at 3 (T1) and 6 months (T2) from the beginning of treatment, and the MIDAS Index (MI) was calculated. Rizatriptan intake was also checked in all groups of patients at T0, T1, and T2. Group TA and RMA were evaluated according to TCM as well; then, the former was submitted to true acupuncture and the latter to mock acupuncture treatment resembling the same as TA. The statistical analysis was conducted with factorial ANOVA and multiple tests with a Bonferroni adjustment.
Results.—A total of 127 patients completed the study (33 dropouts): 32 belonged to group TA, 30 to group RMA, 31 to group SMA, and 34 to group R. Before treatment the MI (T0) was moderate to severe with no significant intergroup differences. All groups underwent a decrease of MI at T1 and T2, with a significant group difference at both T1 and T2 compared to T0 (P < .0001). Only TA provided a significant improvement at both T1 and T2 compared to R (P < .0001). RMA underwent a transient improvement of MI at T1. The Rizatriptan intake paralleled the MI in all groups.
Conclusions.—TA was the only treatment able to provide a steady outcome improvement in comparison to the use of only Rizatriptan, while RMA showed a transient placebo effect at T1.
Did you get that?
Here's the MIDAS Index of the various arms over time shown in a graphical form (via Medscape):
On first glance one is tempted to conclude as the authors have that traditional acupuncture is "the only treatment able to provide a steady outcome improvement in comparison to the use of only Rizatriptan"; but of course that is true only because the study had not included an arm - a standard 'true' acupuncture arm - that would most likely show that traditional acupuncture is not the "only" effective treatment.
angry doc looks at the graph, and his conclusion is that Rizatriptan alone seems to provide a great deal of migraine prophylaxis, while the effects of the various forms of acupuncture are modest, and any variation between them small.
The results also suggest that part of the difference between the acupuncture groups can be attributed to the ritual of acupuncture alone (difference between RMA and SMA), and part of it on the actual effect of insertion of needles versus merely tactile stimulation (difference between RMA and TA). However, without a 'sham' acupuncture group, it is impossible to tell if the superiority of TA is due truly to the site of needle insertion, or just the effect of needles penetrating the skin.
But why let that simple fact stop us from saying that traditional acupuncture is the *only* treatment able to provide a steady outcome improvement in migraine comparison to the use of only drugs, right?
Labels: alternative medicine, Clearthought