This blog is to share the latest research and development of acupuncture and raise the awareness of alternative treatments for your conditions, and is for information only.

Wednesday 31 May 2017

Is sham acupuncture necessary in acupuncture clinical study?

Acupuncture is a therapy through physical stimulation by inserting a sharp, thin needle into the specific point on the body, with mechanical, electrical, or other physical manipulations, which stimulate nerve receptors both directly and indirectly through mechanical coupling via the connective tissue surrounding the needle. In general, the acupuncture stimulation, through the local reflex and central nervous system, induces endocrine, autonomic, and systemic behavioural responses. During past 20 years acupuncture studies have been extensively conducted worldwide, with a mean annual growth rate of 10.7%. It could be said that no other alternative medicines have been through such strict and detailed and scrutinized studies. Even though, the action mechanisms of acupuncture’s analgesic effect have been elucidated and the findings have been published on some top scientific journals.

There is a debate whether acupuncture clinical studies should be subjected to the standard drug therapy clinical trial, because acupuncture is not a medication. We know that efficacy of drug/medication can be assessed under ideal conditions of traditional randomized controlled, double-blinded, sham controlled trials. However, acupuncture is not a kind of medication therapy and is applied in routine circumstance. So the measurement of effectiveness such as comparative effectiveness research (CER), rather than efficacy used in standard drug therapy clinical trial, should be applied to acupuncture clinical studies. CER compares the benefits and harms of the best care options and produces evidence to support decision maker, which is a better option for public health. The real world evidence, more generalizable than the evidence produced by traditional randomized controlled trials, is better suited to inform real-world care decisions. With gradually understanding the nature of acupuncture, recently it was questioned whether it was necessary that sham control should be used in acupuncture clinical studies, because sham controlled study actually complicated result evidence base in some circumstance (Manheimer, 2011). Further, it has been suggested that assessment of the specific effect of acupuncture, by using sham acupuncture in an attempt to blind participants, could produce another limitation for clinical acupuncture trials by potentially attenuating the effects of ‘real’ acupuncture (Kim et al., 2017). Further discussion regarding study design and control interventions for acupuncture clinical trial is necessary.

Reference:
Manheimer E. Selecting a control for in vitro fertilization and acupuncture randomized controlled trials (RCTs): how sham controls may unnecessarily complicate the RCT evidence base. 2011, Fertil Steril. 95(8):2456-61.  https://www.ncbi.nlm.nih.gov/pubmed/21570069 

Kim TH. et al., What is lost in the acupuncture trial when using a sham intervention? Acupunct Med. 2017 Apr 29. pii: acupmed-2016-011333.   https://www.ncbi.nlm.nih.gov/pubmed/28456756

Wednesday 17 May 2017

Acupuncture stimulation improved cognitive function in middle-aged people

Electro-acupuncture with low-frequency stimulation improved cognitive function in middle-aged women and men, reflected by the changes in P300 index. A report of pilot of randomized controlled clinical studies was published in journal of BMC Complementary and Alternative Medicine.

Aging is related to an increase in senile disorders such as Alzheimer’s disease. It has been recently reported that the number of patients with Alzheimer’s dementia is expected to reach 13.5 million by 2050 in the United States alone and will become a major problem worldwide over time. How to improve cognitive function is crucial to prevent senile-related conditions. The P300 is an important index that is used in clinical studies to evaluate reductions in memory and other cognitive functions and has been known to show decreased amplitude and delayed latency with aging. Acupuncture stimulation at some specific acupoints was reported to improve cognitive function and slow down the reduction of memory.

Recently Dr. KH Choi and colleagues conducted a pilot clinical study with randomised double-blinded controlled setting to evaluate the effect of low-frequency electro-acupuncture stimulation at BL62 and KI6 on cognitive function, using P300 index. Fifty-five healthy subjects in their 50s, including 26 males and 29 females were recruited and divided into real acupuncture (n=28) and sham acupuncture (n=27) groups. In real electro-acupuncture at an average of 24μA and 2 Hz stimulation at acupoints BL62 and KI6 lasted 30 mins each session, 12 sessions over one month. Brain activity of each subject was recorded by event related potentials (ERPs) of electroencephalogram before the first session and after the last session of acupuncture, then analysed using P300.

It was found that subjects in the real acupuncture group showed a tendency toward a decreasing P300 latency and increasing P300 amplitude after all 12 sessions of stimulation. In the women, the amplitude significantly increased at many perimeters, compared with sham group.

The authors suggested that the results of this study may serve as a foundation for the treatment of dementia and various brain disorders due to brain aging and impaired cognition. However, because the results of this study are limited to middle-aged women, further studies are necessary to determine the therapeutic effects in different age groups as well as in men and to discover the neurological mechanisms underlying the positive influence of low-frequency electrical stimulation on the brain.

Reference
KH Choi et al., Change in the P300 index–a pilot randomized controlled trial of low-frequency electrical stimulation of acupuncture points in middle-aged men and women. BMC Complementary and Alternative Medicine (2017) 17:246.    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415720/