|Year : 2022 | Volume
| Issue : 1 | Page : 6-11
A comparative study to evaluate the efficacy of an oral Ayurveda compound and Panchakarma procedures in conjunction with physiotherapy in delayed milestones status of cerebral palsy
Vidya Bhushan Pandey1, Abhimanyu Kumar2
1 Department of Kaumarbhritya, Government Ayurveda College and Hospital, Bilaspur, Chhattisgarh, India
2 Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan, India
|Date of Submission||26-Nov-2021|
|Date of Decision||01-Feb-2022|
|Date of Acceptance||07-Feb-2022|
|Date of Web Publication||31-Mar-2022|
Dr. Vidya Bhushan Pandey
Department of Kaumarbhritya, Government Ayurveda College and Hospital, Senior HIG 03, New Housing Board Colony, Deorikhurd, Torwa, Bilaspur 495004, Chhattisgarh.
Source of Support: None, Conflict of Interest: None
Introduction: Cerebral palsy (CP) presents the basic problem of gross delay in the achievement of milestones according to age, especially the motor ones. The study was planned to assess the comparative efficacy of Ayurveda drugs and procedures in the achievement of milestones in conjunction with available standard management physiotherapy (PT). Materials and Methods: Three basic milestones neck holding, sitting, and standing was assessed over statistical parameters with the help of the CDC scale of milestone development. Three groups (Gp.) A B and C were made, Gp. A having PT alone was compared with Gp B with Panchkarma (PK) and PT and Gp. C with PK, PT, and oral drugs. Standard available treatment PT was provided in all the groups. Treatment was provided for 6 months and follow-up after every 2 months. Results within the group were assessed with the Student’s t test and intergroup comparison with ANOVA. Results: Total 51 cases registered and randomly allocated to different groups having 17 cases in each, 6 cases in each group have discontinued and the results were drawn having 11 cases per group. After 6 months, Gp. C presents with maximum improvement 75%, 75%, and 85% for neck holding, sitting, and standing, respectively, and holds statistically better results (P < 0.05) in the neck holding scale in intergroup comparison. Discussion: Multimodal treatment is required for the management of primary and associated problems of CP. No sole treatment plan can result in the expected outcome; however, Ayurveda drugs and procedures with PT can provide safe, effective, and speedy achievement of delayed milestones ultimately gaining functional capacities.
Keywords: Ayurveda, cerebral palsy, delayed milestones, Panchakarma, physiotherapy
|How to cite this article:|
Pandey VB, Kumar A. A comparative study to evaluate the efficacy of an oral Ayurveda compound and Panchakarma procedures in conjunction with physiotherapy in delayed milestones status of cerebral palsy. J Indian Sys Medicine 2022;10:6-11
|How to cite this URL:|
Pandey VB, Kumar A. A comparative study to evaluate the efficacy of an oral Ayurveda compound and Panchakarma procedures in conjunction with physiotherapy in delayed milestones status of cerebral palsy. J Indian Sys Medicine [serial online] 2022 [cited 2022 Aug 12];10:6-11. Available from: https://www.joinsysmed.com/text.asp?2022/10/1/6/342107
| Introduction|| |
Cerebral palsy (CP) is a non-progressive crippling disease of children with an incidence of 2–2.5/1000 international and 2.95 per 1000 in India., It presents with gross delay in the motor milestones according to a particular age. This delay depends on the number, location, and severity of the lesion in the brain. In Ayurveda, however, there is no direct correlation present with CP but its symptoms like spasticity and rigidity have proximity with symptoms explained under the umbrella term of “Vata Vyadhi” (disorders due to vitiation of Vata Dosha and Avarana) as Kunchana (spasticity) and Stambhana (rigidity), respectively. So, This study was planned with the primary objective of enhancing the functional abilities of CP-affected children with speedy gains in their delayed milestones. Second, preventing further complications so as to improve their quality of life and facilitate early rehabilitation. Ayurveda drugs and procedures with an established role in the pacification of vitiated Vata Dosha resulting in improvement in diseased neuromuscular conditions were evaluated for the effect in delayed milestone management in CP.
| Materials and Methods|| |
The study aimed to show the effect of Ayurveda modalities in conjunction with physiotherapy (PT).
The research design was a randomized comparative parallel clinical trial divided into three Groups (Gp). Gp A having PT alone, Gp. B having Panchakarma (PK) along with PT, and Gp. C with oral drug in addition to PT and PK.
Children of age Gp. 1–12 years and diagnosed cases of the spastic type of CP with delayed milestones were included and selected from O.P.D./I.P.D. of Balroga Department in the 2 years of 2009–2011 in a reputed institute of Ayurveda. Patients beyond this age limit, other types of CP, and with progressive neurological were excluded.
PT is the standard rehabilitation procedure; it was allowed to continue in all the Gp.s. In the PT, three basic sets of exercises were used for 20 min/two times a day. These are muscle stretching exercises, muscle strengthening, and range of motion exercises selected methodically to benefit CP patients.
PK procedures used in the trial were Abhyanga (local massage) done with the help of Mash Saindhava Sadhita Taila. Once in a day and direction should be towards the heart. Shashtika Shali Pinda Sweda (SSPS), a variant of sudation therapy, where a cooked bolus of Shashtik Shali (Oryza sativa L.) is tied in a cotton cloth and dipped in a decoction of Dashmool and applied on the body.Shirodhara is done by continuously pouring warm liquids prepared with Balamool decoction and an equal amount of warm milk over the frontal aspect of the head. All these three procedures were administered once a day for 20 min, respectively.Matravasti by administering oil medicated with Prasarni (Paederia foetida L.) will be given through an anorectal route once a day. Dose will be 1–3 years 9 mL, 4–5 years 12 mL, and 6–11 years 24 mL and 12 years and above 48 mL. Dose is calculated according to dose of Snehavasti by Acharya Kahsyapa and dose of Matravasti was calculated by doing 1/4th the dose of Snehavasti as told by Acharya Sushruta.,
Patta Bandhana (PB), done by applying crepe bandage over PVC plastic splint kept bilaterally posterior and over Popliteal fossa to straighten the lower limbs and bilaterally over the cubital fossa to straighten the hand after PK for 3 h. Only that size of the splint was used which will straighten the joints and the rest of the part will be covered with crepe bandage fabric. Every fourth week of the month all PK procedures are stopped to avoid resistance, whereas PT and oral drug were continued.
Syrup-based oral drug prepared with the 8 evidenced-based medicines given in the dose of 1 mL/kg/day in three divided doses for 6 months. Drugs used in the oral Ayurveda compound were the root of Ashwagandha (Withania somniferous L.), the tuber of Vidarikanda (Pueraria tuberose Willd.), and the bark of Sahinjana (Moringa oliferia Lam.) as two parts and roots of Tagara (Valeriana wellichi DC.), fruits of Amalaki (Emblica officinalis Gaertn.), whole plant of Brahmi (Bacopa monnieri L.) and Mandukparni (Centella asciatica L.) as one part and fruits of Pippali (Piper longum L.) as 1/4th part to prepare the syrup form.,,,,,,, This syrup form was an empirical formulation (Anubhuta Yoga) designed according to the evidence-based work of above mentioned drugs in their respective research area. The quantity of raw material for syrup preparation in children was determined by the pharmacy manager of the institute to preserve the taste and required action of the drug.
The expected primary outcome was to identify the changes in milestones followed by secondary outcome to see changes in functional capacities.
Considering the prevalence of disability in India as 3.8% the sample size calculated was 31 with a 90% confidence interval and with a 50% dropout rate due to long durational trial 20 more subjects added and the total sample size is drawn was 51 patients.
Simple randomization is done by using table of random numbers from computer-based randomization software.
Equal number of participants allocated in all the three groups having ratio of 1:1:1 having 17 patients each arm (3 arms = 51 patients).
Mechanism was done by using sequentially numbered opaque sealed envelopes. No blinding was done.
All the ethical considerations along with informed consent related to human participation according to standard guidelines were followed and taken during the study. The effect of the modalities was assessed by the CDC scale of milestones covering three important milestones viz. Neck Holding, Sitting, and Standing.
Student paired t test was applied for statistical analysis within the Gp. results and Intergroup comparison were done by using the ANOVA test.
| Results|| |
At the end, 6 cases in each Gp. (including 2 patients from Gp. A not analyzed for proper interpretation of results) total 18 patients had discontinued might be due to a long durational trial (6 months = 180 days); hence the result was drawn on a total of 33 patients (11 in each group, [Table 1]). As specified in [Figure 1] and [Table 1], the neck holding scale in Gp. A shows a positive change of 15.62% which is statistically significant (P < 0.02) and in Gp. B the result found was 29.41% which is found statistically significant (P < 0.01) whereas in Gp. C changes found were maximum that is 39.39% which is statistically highly significant (P < 0.001). Sitting milestone scale results shows that [Table 1], Gp. A shows 23.81% of changes which is found statistically significant (P < 0.02) and in Gp. B the results found was 38.71% which is also found statistically highly significant (P < 0.001), whereas in Gp. C changes were 55.56% which is statistically highly significant (P < 0.001). In standing milestone scale [Table 1] at the end of trial result in the Gp. A was found 75.00% which is statistically significant (P < 0.05) and in Gp. B the changes were 75.00% which was found statically significant (P < 0.02), whereas in Gp. C the variations found was 85.71% [Figure 2] which was found statistically significant (P < 0.01).
|Figure 2: Showing comparative result of different groups in different Milestone at the end of trial|
Click here to view
Intergroup comparison [Table 2] shows that Gp. C was found statistically significant (P < 0.05) over Gp. A, in the Neck holding, whereas in Sitting Gp. B was found statistically significant (P < 0.05) over Gp. A. Other intergroup comparisons, including the standing scale, were found statistically insignificant (P > 0.05). These statistically proven results reject the null hypothesis favoring no significant changes with the use of multimodal therapies.
| Discussion|| |
In this trial, the aim was set to improve the functional capacities of the child. Gp A ended with statistically significant (P < 0.05) results, being with physical therapy as the only standard method of management. Gp. B having PT and PK procedures shown better results than Gp. A, as PK procedures are easier to perform in all the areas of the body than PT especially in spastic cases, resulting from improved blood circulation and power of muscles. The neck region has richer muscle mass than bone mass, and active PT is a difficult task to perform in this area due to its delicacy.
Abhyanga (local Ayurveda massage) and Swedana (fomentation) increase skin and muscular temperature, improve blood circulation and improve the performance of muscle movement, and enhance neck holding., Considering CP nearby to Vatavyadhi in Ayurveda, Abhyanga and Swedana has specified role in pacifying elevated Vata dosha.Abhyanga also produces a typical “Mass reflex” which helps in proper defecation and urination of spastic children which relieves undue stress of constipation. This reflex is especially seen in person with chronic paraplegia in which “Excitatory or inhibitory effects may spread up and down with spinal cord producing discharge of many neurons.” Stimulus generated from Abhyanga and Swedana (fomentation) creates an additional reflex of urination, defecation, and sweating along with their withdrawal response. This additional reflex help in micturition and defecation. In addition to that, some previous researches also show that massage therapy alleviates physical symptoms related to CP and boosts the development process.
Shirodhara relaxes the mind and body and thus lowering the sympathetic tone of the body and inducing relief in spasticity.Matravasti with Prasarni oil locally nourishes the pelvic area due to the lipophilic nature of the rectal mucosa.Vasti is regarded as the Ardhachikitsa (half of the treatment) in Ayurveda, it pacifies Vata dosha in its Moola Pradesh (main region) that is Kati (pelvic region). Pacification of Vata ensures normal function of that region. Short-chain fatty acids of oil medicated with Prasarni (Paederia foetida L.) allow direct absorption of the medicine from epithelial linings to blood capillaries showing its preferred effect. This augments the sitting function in CP-affected children.
Patta Bandhana(PB) is a useful procedure in the management of Kunchana (spastic), Rujarta (painful), and Stabdhagatra (rigidity) conditions of the body. It helps in maintaining proper alignment of hand and legs to support the body weight against gravity as a result of extending body growth in the right direction a proper sitting and standing. Standing is the most difficult and top task in the management of CP to enhance ambulation and was assisted with the proper PB at the spastic lower limbs resulting in appropriate alignment supporting body weight against the reactionary gravitational force. It provides the beneficial advantage of modern bracing when tied with PVC supports preserving its natural functions or reliving rigidity and spasticity.PB especially along with other procedures assisted in proper stretching and thus preventing further contractures and deformities. Modern techniques like “Kinesio taping” are used in CP work by stimulating proprioceptors relieving spasticity and helping in improving gait and ambulatory functions in CP-affected children. These effects are very much similar to the effects of PB.
Gp. C having PT and PK along with syrup-based oral drug, maximum benefits observed in this group due to surplus advantage of evidenced-based oral drugs. Spastic muscle is also a weak muscle due to the regular phase of contraction.Ashwagandha and Tagar help in the relaxation of these muscles.,Ashwagandha and Vidarikanda provide proper nutrition to weaken spastic muscles.,Ashwagandha, Vidarikanda, and Mandookparni help with peripheral nerve regeneration, synaptic reconstruction, nerve elongation, and neuroprotective properties.,, These properties enhance the development of a brain function called neuronal plasticity in CP children in which healthy neurons take up the functions of the damaged nerve fiber.Bramhi with cognitive improving functions and anti-convulsive effect of Amalaki helps in the pacification of convulsion which is present as an associated symptom in 50% of CP cases.,Shobhanjan and Pippali among all the drugs have a nice immune buildup activity; additionally Pippali provides a benefit of improving the bioavailability of all these drugs thus increasing their therapeutic effect., Conjunct Ayurveda modalities were found significant over gp. A the intergroup comparison which leads to achievement of defined objectives and improving their functional capacities. The study included all the types of delayed milestone patients in the entire group due to limitation of time, duration of interventions and financial assistance. Further division into subgroups that have only unachievable milestones to be assessed and the impact of interventions to be pursued in further research would be preferable.
| Conclusion|| |
The observed changes in Gp. C were maximal compared to Gp A and Gp B, with noreported adverse effects of modalities across trials. The safe and effective modalities of Ayurveda along with the standard available treatment process provide better results than standard therapy alone. The results offer a new definition of the multimodal treatment plan for a crippling disorder that impairs growth and development in CP children.
Financial Support and Sponsorship
The drug mentioned was prepared by the Pharmacy of NIA Jaipur, Rajasthan.
Conflicts of Interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]