D.D. Palmer, the father of chiropractic, died in 1913. Over a century later, his ideas have never been properly tested with placebo controls – until now.
The research on chiropractic has been far from rigorous. One of the problems is that studies of spinal manipulation therapy (SMT) can’t be double blinded, and it is very difficult to even do single blinding. So most studies resort to non-manipulation control groups like “usual care” or “wait list” or “pain medication.” Those studies are practically guaranteed to lead to false positive conclusions: they make SMT look more effective than it would look if you could provide a control that patients couldn’t distinguish from real SMT.
In a study just published in the European Journal of Neurology, Chaibi et al. successfully used a credible placebo manipulation on patients with migraine. It showed that SMT doesn’t work for migraine, but that’s not news. The news is that it showed how to improve the methodology of SMT studies to get more reliable results. (more…)
Image credit: Wellcome Images, Wellcome Library, London, via Wikimedia Commons.
Last week I gave a quick overview of standard treatment options for migraine, a severe form of recurrent headaches. As promised, this week I will address some common treatments for migraine that I don’t think are supported by the evidence.
Acupuncture is the CAM modality that, it seems to me, has infiltrated the furthest into mainstream medicine, including for the treatment of migraine. In fact the The American Headache Society includes acupuncture on its list of recommended treatments. The reason for this is that acupuncture proponents have been able to change the rules of clinical research so that essentially negative or worthless studies of acupuncture are presented as positive.
I reviewed the evidence for acupuncture and migraine previously, demonstrating the multiple problems with the acupuncture literature in general, and specifically acupuncture in migraines. Most studies suffer from at least one fatal flaw: they are not properly blinded, they do not include a control, they mix acupuncture with non-acupuncture variables (mostly including electrical stimulation in the treatment group), comparison groups are not adequately treated, they make multiple comparisons to maximize chance outcomes, or they are simply too small making them susceptible to all the usual problems of bias in research.
What we don’t see is a consistent and clinically-relevant effect in properly-controlled double-blind trials where the variables of acupuncture are isolated.
I am a headache specialist and so I receive many questions, through SBM, NeuroLogica or listeners of the Skeptic’s Guide to the Universe, about how to best treat headaches, or about a specific, often unusual, treatment. Migraines and severe headaches are very common. According to the latest statistics:
14.2% of US adults 18 or older reported having migraine or severe headache in the previous 3 months in the 2012 NHIS. The overall age-adjusted 3-month prevalence of migraine in females was 19.1% and in males 9.0%, but varied substantially depending on age. The prevalence of migraine was highest in females 18-44, where the 3-month prevalence of migraine or severe headache was 23.5%.
That means about 28 million Americans suffer from migraines. Percentages do vary from continent to continent, but not dramatically. Migraine, therefore, is a huge burden. Headaches can be debilitating when severe, and so also are a major source of lost productivity.
This will be a two-part series reviewing some of the options for treating migraines, focusing on science-based treatments in part I, and non-science-based treatments in part II. None of this is intended to give specific medical advice for any individual. If you have severe headaches you should consult your physician. I will simply be reviewing the evidence for various options, focusing on migraine specifically.
Caffeine, a common trigger for migraines and headaches
A recent editorial entitled “CAM in the Real World: You May Practice Evidence-Based Medicine, But Your Patients Don’t” published in Headache: The Journal of Head and Face Pain by Robert Cowan, a headache specialist, addresses the use of complementary and alternative medicine (CAM) in the treatment of headaches. Unfortunately he propagates many common misconceptions about CAM in the article.
I do agree with one point – physicians need to be more aware of CAM treatments and their patients’ use of them. We should be directly asking our patients about such use, in a non-judgmental way, and we should be familiar enough with common CAM treatments so that we can provide knowledgeable guidance to our patients.
Cowan begins by, in my opinion, grossly exaggerating the current popularity of CAM. He writes:
As much as 82% of headache sufferers use complementary and alternative approaches.
The reference he cites, however, states:
Adults with migraines/severe headaches used CAM more frequently than those without (49.5% vs 33.9%, P < .0001); differences persisted after adjustment (adjusted odds ratio = 1.29, 95% confidence interval [1.15, 1.45]). Mind–body therapies (eg, deep breathing exercises, meditation, yoga) were used most commonly.
Only 4.5% of adults with migraines/severe headaches reported using CAM to specifically treat their migraines/severe headaches.
A recent study looking at acupuncture for the prevention of migraine attacks demonstrates all of the problems with acupuncture and acupuncture research that we have touched on over the years at SBM. Migraine is one indication for which there seems to be some support among mainstream practitioners. In fact the American Headache Society recently recommended acupuncture for migraines. Yet, the evidence is simply not there to support this recommendation, which, in my opinion, is a failure to understand a science-based assessment of the clinical evidence.
The recent study, like many acupuncture studies, was problematic, and was also negative. It showed that acupuncture does not work for migraines, but of course also contains the seeds of denial for those who want to believe in acupuncture. From the abstract:
We performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5-8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life.
Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5-8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13-16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference -1.06 [95% confidence interval (CI) -1.77 to -0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference -1.22 [95% CI -1.92 to -0.52], p < 0.001; Yangming-specific acupuncture v. control: difference -0.91 [95% CI -1.61 to -0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups.