Acupuncture and Cancer: Part Two
In the second of this three part series (read part one here and part three here), we continue to follow “Ayo” a head and neck cancer patient. We find out what he does to discover essential questions he needs to ask in order to discern whether or not acupuncture might be a treatment option for dysphagia (difficulty swallowing), a common chemoradiation side effect for head and neck cancer patients.
The first two questions Ayu asked were “What is the existing evidence on acupuncture for dysphagia,” and “Is the research relevant to my particular situation?”
In this post Ayo, on his quest of becoming an informed, proactive participant in his healthcare, Ayo discovers questions 3, 4, and 5.
Question 3: Is active acupuncture responsible for the results?
Ayo might find that Lu et al.1 talk about randomizing and blinding procedures. What does that mean? Let’s say acupuncture for dysphagia is one of the treatments Ayo considers. He finds six papers who report novel research on this subject. Finding out the study population, as he did above, is one of the first things to do.
Next it would be a good idea for Ayo to find out whether or not the studies reported were randomized trials? A randomized controlled trial (RCT) (or randomized comparative trial) is a type of scientific experiment, and the gold standard for a clinical trial. There is one caveat. One word of caution, however. If there were no comparison between groups or utilization of a control group, how could a determination be made that solely the treatment was responsible for the observed effects, rather than other factors, such as mere interaction between clinician and patient? Many studies in the realm of mind-body medicine are considered of poor quality, because investigators did a sloppy job randomizing participants. While this is not the end of the world, a good trial design reduces chance of bias. Just something to keep in mind.
There is also good reason to believe that knowledge of what group a participant belongs to has an impact on the observable outcome. The nomenclature for this phenomenon is “treatment expectancy.” In other words, a cancer patient’s initial belief about the success of a given treatment can affect final treatment outcome. Fascinating really, and something you want to keep in mind if you are a cancer patient or loved one/care provider of a cancer patient! In order to provide an unbiased picture for the treatment of dysphagia by acupuncture, researchers want to eliminate this variable. “Blinding” aids in this process.
Lu et al.1 have a randomization and blinding procedure in place for participants as well as research personnel. This means that participants and most study personnel, including oncologists, speech–language pathologists and study research coordinators will not know who receives active or sham acupuncture.
Question 4: Was there a clearly defined acupuncture treatment protocol in place?
In his evaluation process, Ayo needs to be reasonably certain that every research participant received as identical treatment as possible. For example, Lu et al.1, propose to study 42 participants (21 participants in the active acupuncture group and 21 participants in the sham acupuncture group). Lu et al.1 have a clearly defined protocol in place for the active as well as the sham acupuncture.
Ayo might think about this for a moment. If each patient received different acupuncture treatment, how could anyone discern the acupuncture points necessary to replicate the results in subsequent trials or clinical practice. Following a protocol to the letter will ensure clinicians and researchers hoping to utilize acupuncture for dysphagia have a basis to work from in the future. It also provides Ayo with additional confidence in the results.
Question 5: What did the researchers measure?
This is a question Ayo needs to ask himself for any reports he is reading. If Ayo read the following, sensationalized headline: “Acupuncture, an efficacious treatment for cancer patients!” What questions could cross Ayo’s mind? Did acupuncture cure cancer? Perhaps not? Acupuncture was effective to do exactly what in cancer patients? Reading trial protocols and descriptions Ayo can lear= a lot about what researchers are measuring and how they are wording it. These measures are called “Outcome Measures”.
In this example, Ayo finds that Lu et al.1 are hoping to illuminate about the following outcome measures:
Primary outcome measure is “Change in MD Anderson Dysphagia Inventory (MDADI) from baseline to 12-months from baseline”1(p.707).
Okay, now to the following sub-question Ayo should be asking himself. What is the MDADI? The MDADI is the best measure of Quality of Life for head and neck cancer patients. The MDADI is a questionnaire designed to measure how patients assess their swallowing ability as a result of head and neck cancer treatment and how swallowing dysfunction affects their life1.
Once completed with their research, the only report Lu et al.1 can make about acupuncture and cancer is that acupuncture either improved, worsened or did not change the quality of life as measured by the MDADI.
So Ayo, as a cancer patient, in the course of educating himself about cancer treatments, always needs to inquire about a study’s stated outcome measures. He would be utterly disappointed if his expectations of treatment outcome were at opposite poles of the known clinical efficacy.
Sometimes, if funding and logistics allow, researchers are also investigating secondary outcomes during the course of a study. Lu et al.1 do this by assessing the following “Secondary Outcome Measures.”
- A patient’s history
- A patient’s weight
- Presence and absence of feeding tubes and time to removal FACT-H&N: A multidimensional quality of life instrument, the FACT-G consists of a 28-item core that can be supplemented by site and /or treatment specific subscales, including a HNC specific subscale (FACT-H&N)
- XQ: Xerostomia Questionnaire: The XQ is a validated 8-item questionnaire that specifically measures radiation-induced xerostomia in HNC patients.
- TCS: Treatment Credibility Scale: Monitors patients’ beliefs or expectations regarding the efficacy of acupuncture for treating dysphagia, using a self-administered Treatment Credibility Scale (TCS) (scale 0–4, 4 = greatest expectancy)
- VFSS: Videofluorographic swallowing study.
- Blinding: Assess the treatment blinding effect
- Salivary flow rate: Investigation and measurement include unstimulated, as well as stimulated methods following standard protocols TGF-β1: Plasma TGF-β1 is a cytokine that reflects tissue fibrosis process. Interleukin-6 (IL-6): IL-6 is a major pro- inflammatory cytokine that is especially important in the initiation, development and prognosis of head and neck cancer
Again, to reiterate, after study completion, and after performing all statistical analyses, Lu et al.1 will only be able to elaborate on the findings of what they measured during the course of their investigation. The results sections would include extremely specific statements. For example, instead of saying “acupuncture has been shown to benefit cancer patients” an appropriate statement would read more like:
True acupuncture led to a modestly but significantly higher amount of saliva production. Among the 13 subjects who provided evaluable fMRI data, average salivation in grams during the true and sham acupuncture phases was 2.72 (SD 1.42) and 2.38 (SD 1.43) respectively (two tailed paired t-test p = 0.02)2(p. 4).
If Ayo did not have any basic training in statistics, this statement would probably make relatively little sense to him. The good news is that Ayo can still learn a lot from a study design and research reports without knowing any of the statistics nitty-gritty.
In a couple of days we’ll have a chance to look at the third and final post of this series evaluating the mind-body medicine modality of acupuncture and dysphagia. We’ll read about six additional, basic questions Ayo uncovers.
One of the questions deals a little more with the basics of statistics. The sixth question he borrowed from Mark Twain3 “Question 6: What about the three lies? Lies, damned lies, and statistics!”
See you then—Werner
Continue reading part three…
1. Lu W, Wayne PM, Davis RB, et al. Acupuncture for dysphagia after chemoradiation in head and neck cancer: Rationale and design of a randomized, sham-controlled trial. Contemp. Clin. Trials. 2012;33(4):700–711. doi:10.1016/j.cct.2012.02.017.
2. Deng G, Hou BL, Holodny AI, Cassileth BR. Functional magnetic resonance imaging (fMRI) changes and saliva production associated with acupuncture at LI-2 acupuncture point: a randomized controlled study. Bmc Complement. Altern. Med. 2008;8(1):37. doi:10.1186/1472-6882-8-37.
3. Twain M. Chapters from My Autobiography. Proj. Gutenberg. 1906. Available at: http://www.gutenberg.org/files/19987/19987.txt. Accessed April 15, 2013.