Clinical Significance versus Statistical Significance in Manual Lymphatic Drainage on Stereotyped behavior for children with Autism Spectrum Disorder – A Critical Review

 

Dr. Sampoornam. W¹, Dr. Padmavathi. P², Mrs. Salomi Sangeetha. J³

¹Professor, Dhanvantri College of Nursing, Pallakkapalayam.

²Principal, Dhanvantri College of Nursing, Pallakkapalayam.

³Associate Professor, Karpaga Vinayaga College of Nursing, Pudukkottai.

 

ABSTRACT:

Context: Treatment options directed to the reduction of stereotypies, in individuals with Autism Spectrum Disorder, are often highly intrusive. Psychotropic medication and intensive behavioral interventions are the most common treatments. The impact of the treatments in the reduction of stereotypical behavior is assessed based on the number of stereotypical episodes occurring over a period of time. By exploring pitfalls in statistical analysis clarifies the importance of differentiating between statistical significance and clinical significance. Critical Review Analysis: Hitherto clinical significance portrayed positive outcome in course of intervening manual lymphatic drainage on stereotyped behavior for children with autism. Besides, statistical significance failed to prove the significant results after implementation of manual lymphatic drainage for stereotyped behavior probably owing to existing effect size relationship. Further research must be carried out and replicated for understanding its statistical significance.

 

 

INTRODUCTION:

Autism spectrum disorder (ASD) is an important cause of developmental disability worldwide.  ASD is a complex developmental disorder characterized by impaired social interaction and communication and restrictive and repetitive behavior. Once thought to be relatively rare, there has been a worldwide increase in the prevalence of children diagnosed with ASD with figures rising from 2 to 6/10,000 in epidemiological studies prior to the 1990s to current estimates of up to 260/10,000 or 2.6% (Waugh I, 2016). It has been estimated that more than 2 million people might be affected with ASD in India (Krishnamurthy V, 2008).

 

According to new research, Allopregnanolone a hormone made by the placenta late in pregnancy is such a potent neurosteroid that disrupting its steady supply to the developing fetus can leave it vulnerable to brain injuries associated with autism spectrum disorder (Children's National Health System, 2019).

 

Repetitive and stereotyped behaviors are one of the core features of autism spectrum disorders (ASD; American Psychiatric Association 2000). The most common stereotypical behaviors are rocking motion of the hands, nodding or shaking arms, sudden runs, body balance forward and backward, repeated manipulation of objects and finger movements (Hattier, M.A, 2013). These movements are involuntary, with an exclusive function of producing physical and sensorial self-regulation, limiting individual’s interaction with the environment (Freeman, R.D, 2010).

 

In clinical research, study results, which are statistically significant, are often interpreted as being clinically important. While statistical significance indicates the reliability of the study results, clinical significance reflects its impact on clinical practice. Although the results may be statistically significant, they may not be clinically important. Having a good notion of what real clinical significance is or could be is crucial for correct interpretation of the modern medical literature. In clinical practice, the clinical significance of a result is dependent on its implications on existing practice-treatment effect size being one of the most important factors that drives treatment decisions.

 

Statistical significance is heavily dependent on the study's sample size, with large sample sizes, even small treatment effects (which are clinically inconsequential) can appear statistically significant; henceforth, the reader has to interpret carefully whether this significance is clinically meaningful.

 

Clinical significance versus statistical significance based on case report:

In this critical review significance of Manual lymphatic drainage is remarkably figured out. Hitherto paucity of nursing literatures abounded on intervention like manual lymphatic drainage for autism. Antonucci N, 2018 operated case report with 3 patients diagnosed to have autism spectrum disorder clinically presenting significant features of bizarre behaviors, motor stereotypies, temper tantrums, delay in learning & loss of eye contact. After intervening manual lymphatic drainage for the cases, results delineated clinically significant betterment in disappearance of stereotyped behavior, faster and easier learning & progress in speech output.  The response to manual lymphatic drainage protocol was robust.

 

Manual lymphatic drainage is a therapeutic approach that has been successfully utilized in several conditions where lymphatic circulation is obstructed by obstacles at the level of nodes.   The massage is performed using a novel, petroleum free, cosmetic cream endowed with specific rheological and sensory properties.

 

The therapist or a parent operates the massage with both hands, gently stroking the surface of the neck on the sides of the trachea with open palms and extended fingers. Manual lymphatic massage at the level of deep cervical nodes improves brain lymphatic drainage possibly resulting in decrease of neuroinflammation that is a hallmark of autism (Antonucci N, 2018). An approach for improving brain lymphatic flow in autism through lymphatic drainage massage that is a strategy successfully utilized in a variety of neurological conditions where lymph coming from the brain finds obstacles at the level of deep cervical nodes.

 

In addition to stimulating lymphatic drainage, researchers theorize that such an approach may work also as vagus nerve stimulation with the additional benefit of targeting the larynx in a manner similar to that outlined for laryngeal manual therapy. This therapy is utilized for the treatment of dysphonia, and its effects on speech, a function that is typically altered in autism, may contribute to the overall improvement of symptoms.

 

A Critical Analysis:

Hitherto clinical significance depicted positive outcome in course of intervening manual lymphatic drainage on stereotyped behavior for autism. Besides, statistical significance failed to prove the significant results after implementation of manual lymphatic drainage for stereotyped behavior probably owing to existing effect size relationship.  This research gap can be bridged by replicating the same study with large sample size based on power analysis.

 

Since this clinical case report is an open-label, non- controlled, retrospective analysis, caution must be exercised when ascribing cause and effect to any treatment outcome. Future studies will evaluate changes of markers of neuroinflammation and how they relate to symptom improvement following manual lymphatic drainage of the deep cervical nodes.

 

CONCLUSION:

The results of a protocol for improving brain lymphatic flow in autism through lymphatic drainage massage, a technique successfully used in a variety of conditions where intracranial lymphatic circulation is hampered by obstacles at the level of deep cervical nodes. This type of inexpensive, safe and accessible approach can be beneficial to autistic subjects and constitute a new and promising treatment. Researcher convinced that the described approach will play a pivotal role in future options for autism treatment, possibly in combination with other therapeutic approaches such as behavioral therapies or nutritional supplementation.

 

REFERENCES:

1.     Houle TT, Stump DA. Statistical significance versus clinical significance. Semin Cardiothorac Vasc Anesth. 2008;12(1):5-6.

2.     Antonucci N, Pacini S, Ruggiero M. Manual Lymphatic Drainage in Autism Treatment. Madridge J Immunol. 2018; 3(1): 69-72.

3.     Krishnamurthy V. A clinical experience of autism in India. J Dev Behav Pediatr 2008; 29:331-3.

4.     Hattier, M.A.; Matson, J.L.; Macmillan, K.; Williams, L. Stereotyped Behaviours in Children with Autism Spectrum Disorders and Atypical Development as Measured by the BPI-01. Dev. Neurorehabil. 2013, 16, 291–300.

5.     Freeman, R.D.; Soltanifar, A.; Baer, S. Stereotypic Movement Disorder: Easily Missed. Dev. Med. Child Neurol. 2010, 52, 733–738.

 

 

Received on 09.04.2020          Modified on 23.04.2020

Accepted on 04.05.2020     © AandV Publications all right reserved