RANDOMIZED CONTROLLED TRIAL OF ELECTRO-ACUPUNCTURE FOR AUTISM SPECTRUM DISORDER
 
   

Randomized Controlled Trial of Electro-acupuncture
for Autism Spectrum Disorder

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:
   Frankp@chiro.org
 
   

FROM:   Alternative Medicine Review 2010 (Jul); 15 (2): 136–46 ~ FULL TEXT

Virginia CN Wong, FRCP (London, Glasgow), FRCPCH (UK);
Wen-Xiong Chen, MD, PhD; Wu-Li Liu, BTCM

Department of Paediatrics and Adolescent Medicine,
Queen Mary Hospital,
The University of Hong Kong,
Hong Kong, China.
vcnwong@hku.hk


OBJECTIVE:   To study the efficacy, safety, and compliance of short-term electro-acupuncture for children with autism spectrum disorder (ASD).

DESIGN:   Randomized, double-blind, sham-controlled, clinical trial.

SUBJECTS AND METHODS:   Children with ASD were randomly assigned to an electro-acupuncture (EA) group (n=30) or a sham electro-acupuncture (SEA) group (n=25) matched by age and severity of autism. The EA group received electro-acupuncture for selected acupoints while the SEA group received sham electro-acupuncture to sham acupoints. A total of 12 EA and SEA sessions over four weeks were given. Primary outcome measures included Functional Independence Measure for Children (WeeFIM), Pediatric Evaluation of Disability Inventory (PEDI), Leiter International Performance Scale-Revised (Leiter-R), and Clinical Global Impression-Improvement (CGI-I) scale. Secondary outcome measures consisted of Aberrant Behavior Checklist (ABC), Ritvo-Freeman Real Life Scale (RFRLS), Reynell Developmental Language Scale (RDLS), and a standardized parental report. Data were analyzed by the Mann-Whitney test.

RESULTS:   There were significant improvements in the language comprehension domain of WeeFIM (p=0.02), self-care caregiver assistant domain of PEDI (p=0.028), and CGI-I (p=0.003) in the EA group compared to the SEA group. As for the parental report, the EA group also showed significantly better social initiation (p=0.01), receptive language (p=0.006), motor skills (p=0.034), coordination (p=0.07), and attention span (p=0.003). More than 70 percent of children with ASD adapted to acupuncture easily, while eight percent had poor acupuncture compliance. Mild side effects of minor superficial bleeding or irritability during acupuncture were observed.

CONCLUSION:   A short, four-week (12 sessions) course of electro-acupuncture is useful to improve specific functions in children with ASD, especially for language comprehension and self-care ability.



From the FULL TEXT Article:

Introduction

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by the triad of impairment of social interaction, communication, and stereotypic behavior. [1] There is lack of evidence and consensus about the best treatment for the core features of ASD. [2]

Complementary and alternative medicine (CAM) as defined by Cochrane Collaboration [3] is:

“…a broad domain of healing resources that encompasses all health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. CAM includes all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well being. Boundaries within CAM and between the CAM domain and that of the dominant system are not always sharp or fixed.”

About 40 percent of ASD children have used CAM, with acupuncture being the most common modality. [4] Acupuncture has been widely practiced in China and is being increasingly practiced in many Western countries. [5]



Discussion of Results

      Social Relatedness, Communication, and Stereotypic Behavior

Significant improvement in social initiation as reported in the parental report (Table 3; p=0.01) was seen in the EA group compared to the SEA group, although no significant differences in outcomes of the social domain of RFRLS were observed (Table 2). Non-significant improvement in the domain of eye contact was also detected in the parental report.

Similarly, significant improvement (p=0.006) in receptive language was seen in the EA group compared to the SEA group, based on the parental report. This coincided with the outcome of WeeFIM, in which the ability of language comprehension was significantly improved in the EA group (Table 2; p=0.02), although the RDLS did not detect significant improvement in comprehension (Table 2). A recent RCT21 reported that scalp acupuncture is a safe complementary modality when combined with language therapy and has a significantly positive effect on language development in children with autism.

Significant improvement in attention span was found in subjects treated with acupuncture, as reported by parents (Table 3; p=0.003), although Leiter-R did not find significant differences in this domain (Table 2). A non-significant improvement of expressive language ability, such as more frequency, more words, or being more articulate, was also noted in the parental report. There were no significant effects of acupuncture in improvement of the sub-domains on the Aberrant Behavioral Checklist (Table 2), although non-significant improvement in temper tantrums was noted in the parental report.

      Functional Status

The significant improvement in language comprehension contributes to the significant improvement (Table 2; p=0.028) in self-care in the caregiver assistant domain of the PEDI. Improvements in language comprehension, self-care, and other domains may contribute to the significant improvement of clinical global impression on CGI-I (Table 2; p=0.003) in the EA group.

      Cognition

The presence of mental deficiencies in ASD may be the most important factor for long-term prognosis. [22] It is reported that up to 40 percent of ASD individuals are nonverbal, although nearly 50 percent (27 nonverbal; 28 verbal) of ASD children in this study were nonverbal.

The Leiter-R was adopted as a cognitive assessment tool in the current study, although it might be somewhat biased toward verbal subjects, especially for high functioning verbal ASD individuals. [23]

According to the parental report, a few parents from both groups reported improvement of memory, learning ability, or “craftiness.” No significant between-group differences were found when comparing the Leiter-R reasoning and visualization battery or memory and attention battery.

      Motor Abnormalities

Most ASD subjects lack imitation abilities. In those with praxic deficits, imitation quality as well as quantity is impaired, with movements being awkward and inaccurate. Significantly greater improvements in motor skills (Table 3; p=0.034) and coordination (Table 3; p=0.07) were found in the EA group, although no significant improvement in drooling was found.

Improvements in writing ability – writing words within aligned lines and squares, instead of outside – were reported by some parents, which was also compatible with the outcomes of the pilot study. [6] One case of improvement in swimming ability and in paper cutting was reported in the EA group. Other motor skill improvements reported in patients in the EA group included less clumsiness and improvement in walking posture, speed of walking, or ability to go up and down stairs.

      Acupuncture Compliance and Side Effects

The definition of “acupuncture compliance” is that subjects were able to sit or lie on a couch to accept acupuncture, even if they cried or needed gentle hand or head holding. Good compliance was defined as being able to accomplish this within the first three sessions, while poor compliance meant they were unable to sit or lie on the couch for treatment for nine or more sessions. Table 4 summarizes the categories of acupuncture compliance. There were no significant differences between groups regarding acupuncture compliance, with more than 70 percent of subjects adapting with good compliance, while only eight percent demonstrated poor compliance.

A systematic review of prospective studies of acupuncture safety found the most common adverse events were needle pain, tiredness, and bleeding. Feeling of faintness and syncope were uncommon, and pneumothorax was rare. [24] In this study, the mild side effects of minor superficial bleeding or crying and irritability during acupuncture were experienced by some.



General Discussion

Clearly, existing epidemiological and genetic studies on autism spectrum disorder support a complex etiology. [25] Twin [26, 27] and family aggregation studies [28, 29] strongly support a heritable component to autism etiology. However, the model of inheritance is still not clear, and the identity and number of genes involved remain unknown. [30] In addition, epidemiological studies indicate that environmental factors such as toxic exposures, teratogens, perinatal insults, and prenatal infections such as rubella and cytomegalovirus account for a few cases. [30] It is suggested that autism might result from an interaction between genetic, epigenetic, environmental, and immunological factors, with oxidative stress as a mechanism linking these risk factors. [31] Recently, research has focused on the role of synapse structure and function as central to the development of ASD, suggesting possible targets of intervention. [32]

The effect of acupuncture has been demonstrated in animal and human studies to be due to direct neural stimulation and changes in neurotransmitters such as endorphins, immunological markers, or endocrinological signals. [33] These responses can occur locally or close to the site of application, [34] or at a distance, mediated mainly by sensory neurons to many structures within the central nervous system. [35] This can lead to activation of pathways affecting various physiological systems in the brain as well as in the periphery. [36, 37] In traditional Chinese acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions linked through 14 meridians to various organs or viscera of the human body. [2] By stimulating various meridian points, acupuncture may be able to correct the disharmony and dysregulation of organ systems, which might be involved in various dimensions of ASD, to relieve symptoms and restore the mind and body. [2] The scientific basis of how acupuncture could ameliorate different cognitive and behavioral dimensions of ASD has not been well studied, and the mechanisms of how acupuncture works are likely to be very complex, given the vast number of acupoints involved in the treatment of this complicated disease. [2]

Evidence-based clinical trials of acupuncture for ASD are lacking. [2] Despite a comprehensive search strategy used in our systematic Cochrane review, [2] there had been, prior to this study, no randomized, controlled trial of body-acupuncture for ASD identified in the international peer-reviewed journals, with the exception of three studies using tongue acupuncture (two accepted for publication in J Altern Complement Med) and one using scalp acupuncture. [21]

Since ASD is a heterogeneous disorder with co-morbidities, and there is a lack of a single standardized assessment tool, it is difficult to test the efficacy of a particular therapy. Therefore, this study adopted a comprehensive panel of assessment tools based on the researchers’ 25 years of experience with ASD interventions. In the current study, ABC and RFRLS were used to assess core autistic features, PEDI and WeeFIM examined functional abilities, RDLS assessed language, Leiter-R was used to study cognition, and the CGI scale assessed global impression.

In addition, the parental report, based on the first author’s experience in acupuncture studies in patients with various chronic neurological disorders, [18–20] was used as a complementary tool for parents to record daily observations. Although this tool may be too subjective for analysis in an RCT, parents were blinded to the actual group their child was in.



Traditional Chinese Medicine and Autism Spectrum Disorder:
Rationale for Treatment Protocol


Although no modern diagnosis like ASD was found in the history of traditional Chinese medicine, its origins might date back to ancient China because it might be categorized as one type of “childhood derangement,” [3] noted as a disease category.

According to TCM, the pathogenesis of ASD is the derangement and insufficiency of the brain and mind. [6] The pathological involvement is in the brain, relating to the Heart, Pericardium, Liver, Spleen, and Kidney. The etiology results from an innate lesion or insufficiency of the brain/mind and dysregulation of the Heart, Liver, Spleen, and Kidney after birth. [6]

Acupuncture involves complex theories of regulation of five elements (Fire, Earth, Metal, Water, and Wood), Yin and Yang, Qi, Blood, and body fluids. By stimulating various meridian points, disharmony and dysregulation of organ systems is corrected to relieve symptoms and restore natural internal homeostasis. [38]

The main objective is to “awake,” to “assist,” and to “calm” the mind, as well as enlighten the mentality and improve developmental profile. Consequently, the primary acupoints were selected from head acupoints: Sishencong (EX-HN1) and Yintang (EX-NH3); and ear acupoints: Ear Naodian (AT3) and Ear Shenmen (TF4).

To complement these primary points, other acupoints from the Heart (Shenmen, HT7), Pericardium (Neiguan, PC6), Liver (TaiChong, LR3), and Spleen (Sanyinjiao, SP6) meridians were selected. The intention was to make the heart “unobstructed,” regulate the liver, correct derangements or imbalances, enforce the emotion, dredge stasis, invigorate the spleen and kidney, and facilitate the source of vital function.

Based on the acupoints selected, the primary outcome measures were involved in functional and cognitive domains, while secondary outcome measures concerned other related domains.

The pilot study [6] found that a short, intensive course of electro-acupuncture might improve some core features of children with ASD.



Conclusion

A short, 12–session course of electro-acupuncture at selected acupoints was found to improve some functions in children with ASD, especially language comprehension and self-care ability. Thus, acupuncture might be a useful adjunctive therapy in early interventional programs for children with autism.

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