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Ray D’Alonzo, Ph.D., is an Associate Director of Research and Development
at Procter & Gamble Pharmaceuticals where he has worked for 29 years and led
research programs in bone metabolism, infectious disease, respiratory
disease, arthritis, and nutrition. He has published scientific papers on a
wide variety of topics from the chemical composition of fats and oils to the
pharmacoeconomics of osteoporosis. Dr. D’Alonzo is the recipient of the
Chancellor’s Medal from the University of Massachusetts, Amherst, in part,
for his contributions to the development of new pharmaceutical agents. As
both a patient and scientist, he has made a personal effort to increase the
awareness of Chiari in the health care sector and to assist others afflicted
with the syndrome. He has published the story of his personal struggle
with Chiari in a book,
Contents Under Pressure,
with 100% of royalties going towards Chiari education, awareness, and
research programs.
August 20, 2006 -- This is a two part article on Reiki, a form of healing
touch belonging to the family of alternative medical treatment approaches.
In part 1 to follow, I will review clinical trials on Reiki that have been
published in the mainstream medical literature. Next month, I will comment
on a much larger set of publications that could be classified as experienced
based.
Reiki is derived from two Japanese words, rei which means God’s wisdom, and
ki which means life force energy. Loosely translated it means spiritually
directed life force energy. Reiki is a form of healing touch and is
administered by masters and practitioners. During Reiki treatment, the
healer extends his/her hands over or on the patient and transfers life force
energy so as to heal the patient. There is no manipulation of the body or
joints and sessions can last an hour or longer. It is offered by many
mainstream healthcare organizations. Because it is unregulated, it is vital
to understand that it can also be offered by anyone who wants to hang a
shingle on their door claiming to be a healer.
Before I review the clinical trials published on Reiki, it is important to
cover the scientific principles employed when designing and executing
clinical studies. Well designed and controlled clinical trials or studies
are required by regulatory authorities to determine if a drug, medical
device or surgical procedure is both safe and effective. There are two basic
types of studies: prospective and retrospective. Prospective trials are
forward looking and thus capable of testing a hypothesis. Retrospective
studies look backwards at data already collected and are useful for forming
hypotheses. Prospective studies are the preferred type for proving if a
treatment actually works.
The design of a prospective clinical study is critical. A study can be
controlled or uncontrolled. When controlled, a placebo group or positive
control group is usually tested in order to compare results against the
group in which the test treatment is being evaluated. Groups can also serve
as their own controls in a cross-over design. Controlled is preferred to
uncontrolled. A study can also be blinded or open. By blinded, it is meant
that participants do not know which group is receiving which treatment until
all the data are collected and verified. A study can be single blinded in
which the patients or subjects are blinded or it can be double blinded in
which both the patients/subjects and investigators are blinded. Blinded
study designs are preferred to eliminate bias. Double blinded is preferred
to single blinded. A well designed study must also state in advance the
hypothesis to be tested as well as the specific measurements to be taken,
often referred to as end-points, and how the data will be analyzed. The type
of patients or subjects must be defined up front. The number of patients or
subjects must be determined by valid statistical modeling. Patients or
subjects must be randomly assigned to placebo and test groups to minimize
the possibility of bias. After patients or subjects are assigned, the groups
must be shown to be balanced with respect to number and other attributes
such as age, gender, and other predefined entry criteria. Other design
attributes can also come into play, but the examples above should give the
reader an idea of the rigor necessary to properly test a treatment in order
to eliminate bias and/or chance from corrupting the results.
When reviewing papers or reports on clinical studies in the literature it is
imperative to look for all the features of good design. It is also important
to take into consideration the journal that the paper is published in as not
all journals are created equal. Some journals require papers to be reviewed
by experts before they can be accepted for publication while others do not.
The credentials of the authors and their institutions must also be
considered before coming to firm conclusions.
A search of PubMed for the term Reiki either in the title or abstract of a
publication produced 67 papers. A more restrictive search requiring that the
publication be a report on a clinical trial produced only 11 papers. Only
six of these papers dealt with clinical trials testing the effectiveness of
Reiki. All six were prospective in design. None of the papers were published
in top journals. Three were published in journals dedicated to alternative
medicine. From a view of eliminating bias, positive results from these
studies would be considered stronger and more reliable if not published in
these journals.
The most recently published clinical trial on Reiki was a paper by Mackay et
al. in the Journal of Alternative & Complementary Medicine in December 2004. The investigators evaluated
45 normal healthy subjects for autonomic nervous system function. Endpoints
included heart rate, cardiac vagal tone, and blood pressure. Subjects were
randomly assigned to one of three groups, one group in which Reiki was
administered, one group in which no treatment was given other than rest, and
one group in which Reiki was mimicked by someone with no knowledge of Reiki.
Significant differences in heart rate and diastolic blood pressure were
observed in favor of the Reiki treatment group. The investigators concluded
that the changes were small and only indicative of a partial effect on the
nervous system and that larger trials would be needed for more definitive
conclusions.
In a study with a similar objective reported in Journal of Advanced Nursing by Wardell in Feb
2001, 23 healthy volunteers were studied where biological correlates of
stress reduction were measured such as salivary cortisol levels and blood
pressure. Thirty minutes of Reiki was administered in a single group
repeated measure design (no control group). The investigator reported that
Reiki was effective however the study did not contain a control group.
Four studies were conducted in patients with psychological or physical
disease. The first was a study in 46 patients with clinical depression
reported in Alternative Therapies in Health and Medicine by Shore. The study measured depression
and self perceived stress by the Beck, Beck Hopelessness, and Perceived
Stress scales. Patients were assigned to one of 3 groups: hands on Reiki,
Distance Reiki, or Distance Reiki placebo. Patients received 1 to 1.5 hours
of treatment a week for 6 weeks. A significant reduction is depression and
self-reported stress was observed in the Reiki treatment groups following
treatment and at one year after treatment.
In a study reported in Journal of Pain Symptom Management involving 24 cancer patients,
Reiki was studied to determine its efficacy in improving quality of life,
relieving pain and reducing the amount of pain medication taken (standard opioid management). Patients were assigned to either Reiki or placebo
groups. Patients in the Reiki treatment group reported improvement in
quality of life and a reduction in the pain which was significantly better
than those in the placebo group. However, the effect was only observed
immediately following Reiki sessions and patients did not reduce the amount
of pain medication they were taking.
A study reporting on post stroke recovery in 50 patients in which depression
and functional independence were evaluated was published by Shiflett et al.
in the Journal of Alternative & Complementary Medicine. In this study patients were assigned to one of
four different groups: a group given Reiki by a master, a group administered
Reiki by practitioners, a group receiving sham Reiki, and a group that
received no treatment. Investigators reported no significant differences
between any of the groups and concluded that Reiki had no clinically
significant effect on stroke recovery.
In a trial evaluating wound healing as published in International Journal of Psychosomatics,
patients served as their own controls in a valid cross-over design. Reiki
was administered in person and reepithelialization rates were measured from
lateral deltoid biopsies. The investigators reported a statistically
significant decrease in healing time in the group receiving Reiki
administered by the mimics.
The following chart summaries the six studies discussed above.
|
Study Population |
Objective |
Overall quality of study design |
Study reported in an alternative medicine
journal |
Result |
|
Normal healthy subjects1 |
Effect of Reiki on autonomic nervous system
function |
Reasonable |
Yes |
Partial effect found in favor of Reiki but larger
studies needed for confirmation |
|
Normal healthy subjects2 |
Effect of Reiki on biological correlates of stress
reduction |
Poor. Study design did not include a control group |
No |
Statistically significant reductions in markers of
stress were observed with Reiki treatment |
|
Patients with clinical depression3 |
Effect of Reiki on reducing depression and self
reported stress |
Reasonable |
Yes |
A significant effect in favor of Reiki was reported |
|
Advanced cancer patients4 |
Effect of Reiki treatment on quality of life, pain
reduction and pain medication use |
Good |
No |
Cancer patients receiving Reiki reported
significant reduction in pain immediately following treatment but did
not reduce their use of pain medication |
|
Post stroke recovery patients5 |
Effect of Reiki on functional independence and
depression |
Good |
Yes |
No effect with Reiki treatment was found |
|
Wound patients6 |
Effect of Reiki on healing rate on full thickness
human dermal wounds |
Reasonable |
No |
Significant benefit in would healing was observed
in group receiving sham Reiki treatment |
The studies above show mixed results and when taken together constitute weak
evidence in favor of Reiki having any effect other than that which can be
accomplished from the touch of an ordinary caring person. The fact that
human touch can induce relaxation is well known. It happens every time a
mother consoles an injured child. Some people are also known to become so
relaxed from getting a hair cut or their teeth cleaned that they fall asleep
during the procedure so it certainly isn’t surprising that Reiki healing
touch can induce biological correlates of relaxation in normal healthy
subjects.
When requesting approval for a new drug from the FDA, 2 large well designed
clinical trials are required both of which must demonstrate a statistically
significant effect in favor of the drug treatment group. The studies
reviewed above do not constitute anything near this standard benchmark
criterion for proof. At best, they formulate a theory that Reiki might be
useful in stress reduction, temporary relief of pain, and mood improvement
but that the level of that improvement may be no better than the caring
touch of an average person.
Next month, in part 2, I will review the literature on non-clinical trial
reports on Reiki to complete my evaluation of the medical literature for
evidence that Reiki is effective. I will also reveal my own experience in
participating in a Reiki healing session.
1J Altern Complement Med. 2004 Dec;10(6):1077-81.
2J Adv Nurs 2001 Feb;33(4):439-45.
3Altern Ther Health Med. 2004 May-Jun;10(3):42-8.
4J Pain Symptom Manage. 2003 Nov;26(5):990-7.
5J Altern Complement Med. 2002 Dec;8(6):755-63.
6Int J Psychosom 1994;41(1-4):61-7.
--Ray D'Alonzo, PhD
** If you
would like to share your comments, thoughts, or ideas with Ray,
please send them to dalonzo.rp@fuse.net.
Due to the volume and nature of email received, individual responses are not
possible. **
[Ed. Note: The opinions expressed above are solely those of the
author. They do not represent the opinions of the editor, publisher,
or this publication. Mr. D'Alonzo is not a medical doctor and does not
give medical advice. Anyone with a medical problem is strongly
encouraged to seek professional medical care.]
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