Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05434793 |
| Other study ID # |
/CMUH107-REC2-145 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2018 |
| Est. completion date |
October 24, 2019 |
Study information
| Verified date |
June 2022 |
| Source |
China Medical University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Acupuncture has been criticized as a theatrical placebo for the sham effect.
Unfortunately, sham tests used in control groups in acupuncture studies have always ignored
the underlying biophysical factors, including resonance involved in acupuncture points and
meridians.
Methods: In this study, the effects of sham acupuncture at Tsu San Li (St-36) were examined
by analyzing noninvasive 30-sec. recordings of the radial arterial pulses for 3 groups of
patients treated with different probes (blunt, sharp, and patch) on the superficial skin of
the acupuncture point. The 3 groups were then treated with the sharp probe for 3 different
periods (16, 30, and 50 seconds). Then the investigators compared the harmonics of the radial
arterial pulse after Fourier transformation before and after the treatment.
Description:
Acupuncture has been criticized as a theatrical placebo for its sham effect. It is
unfortunate that sham tests designed as the control group in acupuncture studies have always
ignored the biophysical factors, resonance, in acupuncture points, and thus have led to
confusing results. The investigators' previous studies revealed that specific frequency
effects are found at the acupuncture points on the Fourier components of the radial arterial
pulse. The nearby non-acupuncture point also has similar but insignificant effects as the
acupuncture point.
Meridians are the groups of acupuncture points, and can be measured from the harmonics of the
arterial pulse, and thus physicians who practice traditional Chinese Medicine use the pulse
to diagnose disease, to evaluate patients' physical conditions, and even to predict death.
The importance of the information within arterial pulse waves has long been recognized in
clinical medicine. Arterial pulse wave analysis has been widely used in clinical practice,
for example, in cases of hypertension, cardiac failure, and aging. The investigators'
previous studies revealed that the pulse spectrum of the radial arterial pulse could be
highly correlated among patients with abnormal liver function. The specific Fourier
components in the pulse provide more physiologic information than do systolic and diastolic
blood pressure measurements during the process of dying. In addition, pulse spectrum analysis
can be used to differentiate atopic dermatitis with the third harmonic of the radial pulse,
and the fourth harmonic of the radial pulse wave has been shown to predict adverse cardiac
events in asymptomatic patients with type 2 diabetes. Recently, pulse spectrum analysis has
facilitated the diagnosis of coronary artery disease. The investigators can qualitatively and
quantitatively gain physiologic or pathologic information by measuring the harmonics of blood
pressure because the resonance in the cardiovascular system is highly efficient for
hemodynamic evolution design. Each organ and its related meridian are in resonance with a
specific Fourier component of pressure waves.
Meridians present in harmonics are the biophysical design for resonance, showing that the
heart drives the cardiovascular system with less than 2 watts. This tiny factor, including
acupuncture, moxibustion, massage, bian stone, and acupressure, which change resonance, will
redistribute the hemodynamics of the cardiovascular system and then appear in the harmonics
of the arterial pulse. If the investigators do not consider resonance, meridian, and
acupuncture, the investigators will miss the effect when designing a sham test.
This study was derived from the sham test for laser acupuncture, and the results showed that
the sham effect cannot be ignored. Thus, the investigators examined the effect of sham
acupuncture at Tsu San Li (St-36) by noninvasively recording the radial arterial pulses for
patients treated with different types of probes (blunt, sharp, and patch) on the superficial
skin of the acupuncture point for 30 sec. A second group of patients was tested with a sharp
probe for differing amounts of time (16, 30, and 50 sec.). The investigators then compared
the harmonics of the radial arterial pulse after the Fourier transformation before and after
the treatment. The investigators hypothesized that harmonics could be physiologic indicators
corresponding with the resonance on the tiny change of acupuncture point, and could explain
the sham effect found in clinical studies.
