Issue #22 - #23

Updated March 20, 1999

Update on the project “Subtle energy Healing in Spastic Quadriplegia or Diplegia”

Michael F. Cantwell, MD, MPH - Principal Investigator Complementary Medicine Research Institute, California Pacific Medical Center, San Francisco

The Protocol of the study was published in the previous issue of MISAHA Newsletter. The project was submitted in mid-November 1998 for grant support to the United Cerebral Palsy Research and Educational Foundation (USPR&EF). After consultation with two reviewers, USPR&EF decided not to fund the project, citing several aspects of its scientific design.

Abstract of our Proposal

Among the most controversial and least studied modalities of alternative therapies is subtle-energy/psi healing, in other words, healing by the biofields interaction, where a gifted healer brings about clinical improvement in a patient through mental intent with or without direct physical contact. The Monterey Institute for the Study of Alternative Healing Arts organized a physician-supervised clinical trial of the Russian husband/wife healers team, the Maykovs, to assess the efficacy of these healers in St. Petersburg, in 1994. All 14 children with severe neurological disorders, including spastic quadriplegia or diplegia, enrolled in this uncontrolled trial showed “significant improvement” in motor and/or emotional functioning after treatment by the healers. Treatment consisted of four weeks of thrice-weekly sessions, with each session incorporating a brief initial assessment period followed by a series of static hand placements and light massage, lasting ¾ - 1 hour. A double-blind controlled crossover trial was proposed to determine whether treatments by these same Russian healers will affect the clinical status of 20 children with severe cerebral palsy who have had little significant clinical improvement over the preceding year. Children would be randomized to one of two groups: 1) one month of treatment by the Maykovs followed by one month of treatment by "sham" healers. This identical-appearing Russian imitators couple without healing experience will also speak only Russian, dress similarly to the healer couple, and will have been trained by the Maykovs to mimic their hand positions and massage techniques or 2) one month of “sham” treatment followed by one month of treatment by the healers. Outcome measures would include parameters of motor and cognitive/emotional function as assessed by neurological examinations performed by two independent pediatric neurologists (e.g. degree of spasticity, range of motion, muscle strength, speech and language levels, ability to follow commands, and response to social overtures) and by the Vineland Adaptive Behavior Scale. Outcome measures will be assessed at the beginning and end of the month preceding initiation of treatments, to establish each child’s baseline rate of change, and again at the beginning and end of each of the two treatment months. If significant improvement is noted at the end of treatment, outcome measures will be assessed again six months after the last treatment month. The parents and pediatric neurologists will be blinded as to the children’s randomization status. If the trial demonstrates that treatment by the healers improves the children’s baseline rate of change and are more effective than sham (placebo) treatment, this should stimulate further discussion and research into the efficacy of psi healing, mechanisms of the phenomenon underlying this form of therapy, and potential application of it.

The principal points of the critique were as follows:

1) Multiple outcome measures: The project, as written, would have evaluated changes in the patients’ neurological exams (e.g. degree of spasticity, muscle strength, joint range of motion), gross motor and cognitive functional ability, and the Vineland Adaptive Behavior Scales. The reviewers recommended using a single outcome measure the Gross Motor Function Scales instrument.
Comment: There are over 20 scales in the literature designed to measure function of children with CP. The Vineland scale that we initially chose is an accepted research instrument in this field and was recommended by developmental psychologists at the Child Developmental Center at California Pacific Medical Center, the largest child development center in the Bay Area. This study is an explorational pilot study. The data from Russia suggest that the healers can have an impact on many different aspects of the gross motor and cognitive functioning of the treated children. At present, too little is known regarding which domain(s) of functioning would be most affected by the healing to narrow the outcome measures to a singlemeasure of gross motor function.
Plan: We will continue with our current outcome measures and add the Gross Motor Function Scales as our primary outcome measure.
2) Use of “sham” healers for the control/placebo group: The reviewers did not state their specific concerns regarding the use of “sham” healers or give recommendations regarding what would constitute acceptable alternative control groups but, rather, felt uncomfortable in a general way with this aspect of the study design.
Comment: The ideal principal of a controlled clinical trial is that the placebo/control group is identical to the treatment group in all aspects except for the therapy being tested. In this case, there are two aspects of the healers’ treatments that could influence the patients’ clinical condition. The first aspect is the expectation associated with such a novel treatment modality and second is the efficacy of the treatment itself, independent of the expectation associated with it. After discussions with many individuals with experience in designing clinical trials, we decided to employ a placebo/control group that included the expectation of healing with a novel treatment modality but did not contain actual treatment. A number of potential novel treatments for the control/placebo group were advanced and eventually discarded since they did not qualitatively approximate the expectation that would be associated with the healing modality utilized by the healers. “Sham” healers, if properly trained so that their treatments were indistinguishable from those of the healers, would be able to engender an expectation of the treatment modality that would be qualitatively and, presumably, quantitatively similar to that of the healers.
Plan: No change, continue with the “sham” healers as the control/placebo group.
3) Lack of a “washout” period between the two treatment months: As submitted, the children would have one month of baseline observation followed by two consecutive months of treatment (alternating between healers and sham healers). The reviewers felt that lack of a waiting interval (“washout” period) between the two treatment months would make it difficult to distinguish possible carry-over effects of the first month’s treatment from the effects of the second month’s treatment. Comment: The design took into account the practicalities of having the Russian healers stay on visa in the United States. We were aware of this methodological difficulty, but were trying to complete the study with 3 months’ stay for the healers.
Plan: We will add a one-month “washout” period between the two treatment months. This will require one additional set of neurological examinations per child and prolong the Russians’ stay by one month.

The additional expenses resulting from adding the “washout” period combined with the lack of institutional or foundation funding for the project will require decreasing the number of children enrolled from 20 to 12. Otherwise, and except for the changes noted above, the project stands ready to move ahead and enroll subjects and should begin in the Spring of 1999.

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