Given the study that I’m going to discuss, I can’t help but start out with a brief (for me) reminiscence. Longtime readers know that I graduated from the University of Michigan Medical School in the late 1980s. Back when I attended U. of M., its medical school was considered stodgy and hard core even by 1980s standards. No organ systems approach to education for U. of M.! Oh, no. It didn’t matter that the organ systems approach, in which all classes are organized by organ systems and teach the same organ systems at roughly the same time (e.g., biochemistry teaching the biochemistry of the heart while physiology class teaches the physiology of the heart while anatomy teaches the anatomy of the heart, etc.) was sweeping medical education. Then, just to be hardcore, U. of M. would administer three examinations and a final every term, each of which would be one test testing students on every topic that term. One of the classes spanned the first two years and culminated with a final exam that covered all the material from all two years. Meanwhile, the Department of Internal Medicine was chaired by William Kelley, a hard core academic internist who had been recruited to Michigan in 1975 at age 36 as the youngest chair of medicine in history at the time. While on my internal medicine rotation I remember the trepidation we all felt preparing to present to Dr. Kelly when he did chairman rounds. The Department of Surgery was just as hard core in its dedication to science and the scientific basis of medicine.
There was no “complementary and alternative medicine” (CAM) or “integrative medicine.” There was no “quackademic medicine” (the infiltration of quackery into medical academia).
Of course, I graduated from medical school about a decade before the wave of pseudoscience known as “integrative medicine” swept through medical school, annihilating the line between science and pseudoscience in its wake. Even so, I have a hard time imagining any reaction to the sort of pseudoscience routinely found in medical school other than derision.
How the culture has changed at U. of M. since I was there. For example, there is a program in anthroposophic medicine there. Yes, we’re talking about Rudolf Steiner. There’s also a very active program in integrative medicine there. There’s even a naturopath on staff, Suzanna Zick, ND, MPH. (I can’t help but shake my head at how far my alma mater has fallen.) We’ve met her before, specifically as a co-author of the Society for Integrative Oncology’s clinical practice guidelines for breast cancer care. Here, she is the first author of a study of acupressure for cancer-related fatigue in JAMA Oncology hot off the presses last week.
When I think of acupressure, I like to think of it as acupuncture, only without the needles. It’s based on the same vitalistic concepts as acupuncture, in which qi, or life energy, flows through meridians. Instead of sticking thin needles into specific points along these “meridians” (which, remember, have never been demonstrated to exist and have no anatomical correlates), though, acupressure involves applying physical pressure to these same “acupoints” (which also have never been shown to exist and have no anatomic correlates). Basically, because acupressure is based on the same concepts from traditional Chinese medicine that acupuncture is, it’s just as much a load of prescientific mystical BS as acupuncture. It’s popular, though, probably because it promises the benefits of acupuncture without all those nasty needles. I know I’d rather just hold pressure on a couple of acupoints than have some guy (or woman) whose dedication to sterile technique is questionable stick several needles into my body.
In this case, Zick studies the effect of a self-administered acupressure technique for its effect on fatigue in breast cancer survivors. Fatigue, of course, can be a serious, debilitating problem during treatment for breast cancer (or any cancer). The disease, chemotherapy, radiation therapy, they all conspire to sap a patient’s energy, often leaving them feeling tired all the time. However, persistent fatigue can also be a problem after the successful treatment of breast cancer, and it’s unfortunately common. Zick et al note that approximately one-third of women experience moderate to severe persistent fatigue up to 10 years after the end of their treatment for breast cancer and then justify this study thusly:
Acupressure, a method derived from traditional Chinese medicine (TCM), is a treatment in which pressure is applied with fingers, thumbs, or a device to acupoints on the body. Acupressure has shown promise for treating fatigue in patients with cancer, and in a study of 43 cancer survivors with persistent fatigue, our group found that acupressure decreased fatigue by approximately 45% to 70%. Furthermore, acupressure points termed relaxing (for their use in TCM to treat insomnia) were significantly better at improving fatigue than another distinct set of acupressure points termed stimulating (used in TCM to increase energy). Despite such promise, only 5 small studies have examined the effect of acupressure for cancer fatigue.
One can’t help but wonder if acupressure is so promising if there have only been five small studies on it, but that’s just me channeling Mark Crislip. In any case, you can see where this is going. Zick et al decided to do a three-pronged single-blind randomized trial of:
- “Relaxing” acupressure
- “Stimulating” acupressure
- Usual care.
Now, before I tell you a single other thing about this study, I’m going to ask you to predict the outcome of this study. Go on. Think about it. Take as much time as you like. Try not to scroll down any further. Now, I was tempted to end the post here and then post the rest of my analysis tomorrow, but fortunately for you (and unfortunately for me) that’s not how I roll. So I’ll just have to trust you to have thought about it before making my prediction, and you’ll have to trust me that I made this prediction while reading the methods, all before I looked at a single result.
Think about it. You have usual care. That’s easy to predict. They won’t get better, or, if they do, they’ll only get slightly better. Then you have two forms of acupressure. It doesn’t really matter much in terms of my precition, but the specific points they used were:
Relaxing acupressure points consisted of yin tang, anmian, heart 7, spleen 6, and liver 3. Four acupoints were performed bilaterally, with yin tang done centrally. Stimulating acupressure points consisted of du 20, conception vessel 6, large intestine 4, stomach 36, spleen 6, and kidney 3. Points were administered bilaterally except for du 20 and conception vessel 6, which were done centrally (eFigure in Supplement 2). Women were told to perform acupressure once per day and to stimulate each point in a circular motion for 3 minutes.
So, you have a study with unblinded patients with a control group with no treatment other than usual plus two different acupressure treatments. Do you see where I’m going? Yes, my prediction was that there would be significant improvement in both acupressure groups and that there would be little or no improvement in the control group. I don’t even have to know what the outcome measures are to predict this, but for the sake of completeness, I’ll note that, to measure fatigue, the investigators used the Brief Fatigue Inventory (BFI), a scale that, according to the authors, correlates well with other fatigue measures.The instrument consists of 9 items, each measuring fatigue on a scale of 0 to 10, and the score is calculated from the mean of completed items. Scores of 4 or higher indicate clinically relevant fatigue. A 3-point change or a drop below 4 is considered a clinically meaningful change. Sleep quality was measured by an instrument called the PSQI, for which a score of 8 or higher suggests poor sleep quality and a 3-point change or a drop below 8 is considered clinically meaningful. Quality of life was measured by the LTQL, which is composed of 4 subscales, including somatic, spiritual and philosophical, fitness, and social support.
The rest of the design is as follows. 288 patients were randomized, with 270 receiving relaxing acupressure (n = 94), stimulating acupressure (n = 90), or usual care (n = 86). Women did acupressure for six weeks. One woman withdrew owing to bruising at the acupoints. Outcomes were assessed at 6 weeks and then, after acupressure was stopped, four weeks later at 10 weeks.
So what were the results with respect to fatigue? Here you go:
Yep, with respect to the primary outcome measure, fatigue, I appear to have corrected quite well. Both acupressure arms improved, but there was no difference between them, as I predicted.
What about the other outcome measures? The authors report:
At week 6, participants randomized to relaxing acupressure had significantly lower PSQI scores compared with usual care but were not significantly different from those randomized to stimulating acupressure. The stimulating acupressure arm was not significantly different from the usual care arm. There was no significant difference between the 3 study arms at week 10 (Table).
In other words, there was a small transient benefit to relaxing acupressure that didn’t last and could easily have been the result of placebo effects. So I was sort of wrong there, but not quite. Basically, for sleep, the results were worse than I predicted.
What about quality of life? The authors report:
Participants in the relaxing acupressure arm improved significantly compared with the usual care arm for 3 of the 4 quality-of-life subscales, including somatic, fitness, and social support at both 6 and 10 weeks. Stimulating acupressure was not significantly different from usual care for any subscale at either time point. There were no significant differences between the relaxing and stimulating acupressure arms for any subscale at either week 6 or 10.
What the authors fail to note is that these differences observed were quite small and that it could easily be questioned whether they were clinically significant.
What amused me in the discussion was how the authors tried to explain why both acupressure arms showed improvement in the BFI (fatigue). Basically, instead of accepting the the most obvious and likely explanation, they do a bit of woo handwaving:
Why might both acupressure arms significantly improve fatigue? In our group’s previous work, we had seen that cancer fatigue may arise through multiple distinct mechanisms.15 Similarly, it is also known in the acupuncture literature that true and sham acupuncture can improve symptoms equally, but they appear to work via different mechanisms. Therefore, relaxing acupressure and stimulating acupressure could elicit improvements in symptoms through distinct mechanisms, including both specific and nonspecific effects. These results are also consistent with TCM theory for these 2 acupoint formulas, whereby the relaxing acupressure acupoints were selected to treat insomnia by providing more restorative sleep and improving fatigue and the stimulating acupressure acupoints were chosen to improve daytime activity levels by targeting alertness.
Well, at least they got the nonspecific effects right. There is, however, nothing in this study that suggests any specific effects of acupressure on fatigue, sleep, or quality of life. This study is completely consistent with nonspecific effects.
So why did they choose such a poor control, usual care, that doesn’t account for placebo effects? Who knows? A far better design would have been to use a control akin to the ones used in acupuncture studies to produce a “sham acupressure” group. In acupuncture, the best placebo controls are either (1) retractable needles that don’t actually puncture the skin and whose tips are hidden so that the patient and acupuncturist can’t see where the needle meets skin or (2) using the “incorrect” acupuncture points. Now, #1 is not possible in acupressure, but #2 certainly is. Zick et al could have used “sham” acupressure in which the patients were taught to apply acupressure to the “wrong” acupuncture points. This control wasn’t used, hence the seemingly positive result.
This study is basically yet another example of a CAM study that fails to use the correct controls and therefore ends up with a result that seems positive but probably is not. Of course, we can’t know for sure because the correct control wasn’t used. Keeping an open mind demands that I at least consider the possibility that the improvement in, for instance, fatigue is greater than placebo, but we don’t know how much placebo effects there were. My suspicion is that both acupressure groups represent no more than placebo, but I could be rong. I doubt that I am, though. After all, in the absence of a plausible mechanism by which pressing special magic points on the body for a few minutes a day can alleviate serious fatigue, the prior plausibility for this study was very low, which means that the unimpressive results of this study are far more likely to be due to chance, placebo effects, and hidden biases in the study than they are to be due to a real, biological phenomenon.
Whenever I see a study like this coming from my alma mater, I can’t help but cringe. One wonders what the Bill Kelley of the late 1980s would think of the U. of M. Medical School of 2016 for cranking studies like this. I suspect he wouldn’t be pleased. Quackademia continues to expand.