NEUROPSYCHIATRIC PSEUDOSCIENCE ATTEMPTS TO LEGITIMIZE ACUPRESSURE AND THE SEA-BAND TREATMENT

Insomnia is a disruptive and sometimes debilitating condition. Nearly 30% of adults report experiencing at least one symptom of insomnia^[1]. Though many of us experience situational insomnia to a degree—especially as a grad student—only about 6% of people experience insomnia severe enough to meet clinical criteria.

There are several types of sleep disruptions classified as insomnia. Psychological research of insomnia often focuses on psychophysiological insomnia.^[2]  To be classified as psychophysiological insomnia, the sleep disruption cannot be due to substance use, mental illness, or medical conditions. Diagnosis by the DSM-5^[3] must include dissatisfied sleep and at least one of the following criteria: sleep latency—difficulty initiating sleep; frequent nocturnal waking—difficulty maintaining sleep; prolonged periods of wakefulness; or undesired early waking. The sleep disturbance must also cause significant distress and dysfunction during non-sleep activity, and must occur for at least three nights a week over the course of three months.

A new study^[4] published in the Journal of Neuropsychiatric Disease and Treatment^[5] presents a suspect treatment for psychophysiological insomnia in adolescents. Researchers at the Clinic of Child and Adolescent Neuropsychiatry in Naples, recently concluded acupressure^[6] to be an effective therapy for managing insomnia in adolescents.

How? Unfortunately, I don’t know how. I have read the article a dozen times, and the science and research design are deeply flawed. 

I believe the study intentionally attempted to provide an unsubstantiated legitimacy to acupressure as an alternative therapy^[7]—specifically assisting the interests of the manufacturer of the Sea-Band device used within the study. The researchers used pseudo-scientific conventions to convey the pretense of scientifically valid clinical research. 

I fail to see how how the authors could present the data in the study as research. It is ill structured, even to infer a loose correlation, let alone conclude significance and effect—especially when considering:

• The study employed a flawed research design, vague data collection, and data-dredging^[8] to infer statistical significance.
• The researchers did not clearly define the mechanism of effect for the therapy.
• The study is full of logical fallacies^[9], further compromising the internal validity of the study and contributing to reader confusion.

THE STUDY DESIGN

The researchers explicitly described the study as an assessment of the efficacy and safety of an HT-7 point acupressure system when used to treat insomnia in adolescents. Yet, the study more accurately assessed the Sea-Band device, and does not conclusively treat insomnia.

The study did not examine or reference any established efficacy of Sea-Band as a treatment for insomnia, nor did it provide evidence for the efficacy of Sea-Band device as an acupressure device.

Further, the study inferred—relied on—acupressure as established therapy. Yet it did not provide a clear method of effect for either acupressure or the Sea-Band device.

“Insomnia can be treated with medication, herbal therapy, and psychologic or physical therapy. Commonly used medications include hypnotic/sedative drugs, but may have adverse effects, including impairment of memory, drug resistance, dependency, and addiction. Among the nondrug therapies for insomnia, acupressure, a method used for over 5000 years in Eastern medicine, is becoming increasingly popular worldwide.”

To establish acupressure as a potential therapy for insomnia, the author referred to a single study^[14]. That study reviewed meta-analysis of various studies combining acupuncture, acupressure, and reflexology; it concluded there was no evidence supporting any of these therapies as an effective treatment for insomnia.

Even presuming acupressure is a potential therapy, and stimulating the HT-7 point is the mechanism of effect, the author does not give clear cause for the premise that use of the Sea-Band is acupressure. In fact, while providing not further exploration into how they work, the Sea-Band website FAQ^[15] states the band exerts pressure and stimulates the P6 acupressure point, not the HT-7.

It is also not clear whether the devices were given to subjects with the pretense of improvement, or as a test for therapeutic effect, but the author specifically stated:

“The Sea-Band device was given to the patients in order to improve their symptoms related to difficulty falling asleep.”

This might convey to a potential participant—or an unsuspecting reader of the study—an unwarranted assumption of the established therapeutic ability of the Sea-Band device to diminish insomnia, and may also the confirmation bias of the research team.  

Researchers recruited 25 adolescents affected by psychophysiological insomnia. Subjects were caucasian from a middle-class socioeconomic background. Initial screenings and preliminary diagnoses were made by a neuropsychiatrist, utilizing criteria from the International Classification of Sleep Disorders (ICSD-2)^[10]—criteria from the ICSD-2 closely resembles the above DSM-5 criteria. 

The small sample size and the common locality of the sample subjects might present some concern—and were the only limitations of the study admitted to provided by the researchers—however, the sample size and criteria for diagnosis are not dissimilar to other sleep studies, and seem practical for an initial therapeutic investigation.

Subjects must have reported experiencing at least two of the following symptoms for at least two years prior to the study: fragmented sleep, frequent awakenings, early morning awakenings, or feeling tired due to poor sleep quality. They were given two Sea-Bands devices, to be worn bilaterally on the wrist at the Shen Men point on the wrists during normal bedtime hours.

Two sets of two polysomnographic sleep studies^[11] were performed. The first set established a baseline before acupressure “therapy,” and the second set to establish the effects after six-months of acupressure “therapy.” Researchers did not evaluate the first night of the sleep studies, from each set, in order to remove the first night effect^[12] known to produce unrepresentative sleep data.

The basic research design of the study is weak, and presents more questions than answers.

The study utilized a one-group pretest-posttest design^[13]. A single group—in this case adolescents with insomnia—are tested prior to therapy, provided the therapy, and tested after therapy. This design is generally referred to as a pre-experimental or quasi-experimental design. The internal validity of this type of test is compromised, due to the lack of a control group, and difficulty accounting for the impact of extraneous variables.

The addition of a control group—perhaps wearing a device similar in appearance to the Sea-Band—would have strengthen the validity of the research design.

Further, only two data points were used. A more effective study might have examined the subjects for multiple days during the pretest and posttest, and might have utilized sleep journals during the intervening therapeutic period.

DATA, DATA, EVERYWHERE

The research team collected and analyzed twenty-two separate criteria from sleep studies. Criteria included: Time in bed, total sleep time, sleep latency, percentage of time in specific sleep stages, sleep efficiency percentage (sleep time/time in bed * 100), etc. The team analyzed each data point using an analysis of variance test, and significance at the P value of < 0.05. They found a “significant” change in about half of the values. The significant results included: Increased time in bed, increased total sleep time, and reduced sleep onset latency.

“A strength of the the gold standard polysomnography for assessment of sleep alterations in order to circumvent subjective reporting by patients.”

The data does not support the explicit  hypothesis and relies on non-sequiturs to infer significance.

The researchers data-dredged. There hypothesis was vague, and they did not clearly state what and how they determine a change in sleep difficulty. By examining all 22 categories, the researchers presented a ripe opportunity for false pattern-recognition. This undermines the internal validity of the study—whatever internal validity remained—and severely muddies the conclusions of the study.

The researchers presumed the the device lessened sleep difficulties due to significant differences in only 11 of the 22 categories. They completely failed to acknowledge the p-values of criteria not supporting their hypothesis and the variability within their selected sample. Persons with insomnia do not have to experience all the symptoms to meet the clinical threshold—Instead:

• The study should have provided all clear changes in data values.
• The researchers should have predetermined data criteria, and established the importance of specific criteria for improving sleep quality.
• The researchers might have Instead examined only common values experienced by subjects.

The author used a non-sequitur argument to dismiss qualitative data and increase the perceived value of their quantitative data—researchers could have utilized a well designed qualitative survey to determine treatment efficacy, especially considering the initial criteria for diagnosis of insomnia is a dissatisfaction with sleep quality and an impairment of daily function due to lack of sleep. The change in the data provided presumes the therapy manages insomnia, without explaining how the data translates to insomnia relief, or whether subjects experienced a relief from their symptoms

CONCLUSIONS

“Acupuncture and acupressure are believed to restore equilibrium. Acupressure involves using the fingers, thumbs, palms, heels of the hand, and elbows to apply pressure and stimulate specific points along the meridians (or energy channels) of the body.”

The study concluded that acupressure could be a “safe, effective, and cost-effective therapy for the management of psychophysiological insomnia.” My conclusion: The researchers cherry picked data. The data’s support of hypothesis is vague and not clearly tested by the parameters of the study. Providing such a definitive conclusion, with such shoddy science, leads me to believe the researchers initiated the study with a pre-existing agenda, and intentional fraud, providing a disservice by further adding to public confusion and concern surrounding psychological research.

If a person with insomnia is concerned about the risks associated with sleep-aid medications, alternative therapies, like acupressure, provides a risk free alternative, also free of definitive results. But,

STAY-TUNED — My next post will examine the effectiveness of Cognitive Behavioral Therapy for psychophysiological insomnia.

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