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Original Article · Originalarbeit

Forsch Komplementmed 2013;20:104–111 Published online: April 15, 2013


DOI: 10.1159/000350047

Role of Reflexology and Antiepileptic Drugs in Managing


Intractable Epilepsy – a Randomized Controlled Trial
Krishna Dalala Elanchezhiyan Devarajana Ravindra Mohan Pandeyb Vivekanandan Subbiahc
Manjari Tripathid
a
Department of Biophysics,
b
Department of Biostatistics,
c
Department of Neuro-Biochemistry,
d
Department of Neurology, All India Institute of Medical Sciences, Ansarinagar, New Delhi, India

Keywords Schlüsselwörter
Refractory epilepsy͐Reflexology͐ Refraktäre Epilepsie͐Reflexzonenmassage͐
Indirect vagus nerve stimulation͐Lower limb pain͐ Indirekte Vagusstimulation͐Schmerzen in den unteren
Complementary therapy Gliedmaßen͐Komplementäre Behandlung

Summary Zusammenfassung
Background: This report is based on the results of a rand- Hintergrund: Wir berichten von den Ergebnissen einer rando-
omized parallel controlled trial conducted to determine the effi- misierten kontrollierten, klinischen Studie mit Parallel-Grup-
cacy of reflexology therapy in managing intractable epilepsy. pen zur Bestimmung der Wirksamkeit der Reflexzonenmassage
Methods: Subjects who failed epilepsy surgery or were not beim Management refraktärer Epilepsie. Methoden: Patienten,
candidates for epilepsy surgery or were non-responders of an- bei denen die chirurgische Behandlung erfolglos war bzw. nicht
tiepileptic drugs (AEDs) took part in this study. The trial was in Frage kam sowie Patienten, die nicht auf Antiepileptika (AE)
completed by 77 subjects randomly assigned to 2 arms: control ansprachen, wurden in die Studie aufgenommen. Insgesamt
(AEDs) and reflexology (AEDs + reflexology therapy). The hypo- nahmen 77 Personen an der Studie teil, die in 2 Gruppen rando-
thesis was that hand reflexology therapy could produce results misiert wurden: Kontrollgruppe (AE) und Studiengruppe (AE +
similar to those of vagus nerve stimulation, and foot reflexol- Reflexzonenmassage). Es wurde die Hypothese aufgestellt,
ogy therapy could maintain homeostasis in the functional sta- dass die Hand-Reflexzonenmassage ähnliche Ergebnisse wie
tus of individual body parts. Reflexology therapy was applied die Vagusstimulation erzielen und die Fuß-Reflexzonenmas-
by family members. The follow-up period was 1.5 years. Qual- sage die Homöostase des funktionellen Status individueller
ity of life in epilepsy patients was assessed with the QOLIE-31 Körperteile aufrecht erhalten kann. Die Reflexzonenmassage
instrument. Results: In the reflexology group, the median base- wurde von Familienmitgliedern durchgeführt. Follow-Up war
line seizure frequency decreased from 9.5 (range 2–120) to 2 1,5 Jahre. Zur Bewertung der Lebensqualität der Patienten
(range 0–110) with statistical significance (p < 0.001). In the con- wurde die QOLIE-31-Skala eingesetzt. Ergebnisse: In der Studi-
trol arm, the decrease was less than 25% with a baseline value engruppe ging die mittlere Grundfrequenz der epileptischen
of 16 (range 2–150). The pretherapy QOLIE-31 scores in the con- Anfälle von 9,5 (Spanne 2–120) auf 2 (Spanne 0–110) zurück.
trol group and the reflexology group were 41.05 ± 7 and 43.6 ± Der Rückgang war statistisch signifikant (p < 0,001). In der Kon-
8, respectively. Posttherapy data were 49.07 ± 6 and 65.4 ± 9, trollgruppe ging die Anfallsfrequenz um weniger als 25% mit
respectively (p < 0.002). The reflexology method allowed detec- einem Basiswert von 16 (Spanne 2–150) zurück. Die präthera-
tion of knee pain in 85% of the reflexology group patients (p < peutischen QOLIE-31-Ergebnisse der Kontroll- bzw. Studien-
0.001), and 85.3% of patients derived 81% relief from it (p < gruppe waren 41,05 ± 7 bzw. 43,6 ± 8. Nach der Therapie betru-
0.001). 4 reflexology group patients reported nausea/vomiting gen die Ergebnisse 49,07 ± 6 bzw. 65,4 ± 9 (p < 0,002). Mit der
(n = 1), change in voice (n = 2), and hoarseness (n = 1). Conclu- Reflexzonenmassage konnten bei 85% der Studiengruppenpati-
sion: Reflexology therapy together with AEDs may help reduc- enten Knieschmerzen nachgewiesen (p < 0,001) und bei 85,3%
ing seizure frequency and improving quality of life in individu- der Patienten eine 81%ige Linderung der Schmerzen (p < 0,001)
als with epilepsy. erzielt werden. 4 Patienten der Studiengruppe berichteten Übel-
keit (n = 1), Stimmveränderungen (n = 2) bzw. Heiserkeit (n = 1).
Schlussfolgerung: Reflexzonenmassage in Verbindung mit AE
könnte zur Verminderung der Anfallsfrequenz und Verbesse-
rung der Lebensqualität von Epilepsie-Patienten beitragen.
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© 2013 S. Karger GmbH, Freiburg Krishna Dalal, Ph. D.


1661-4119/13/0202-0104$38.00/0 Department of Biophysics
Fax +49 761 4 52 07 14 All India Institute of Medical Sciences, Ansari Nagar
Information@Karger.com Accessible online at: 110 029 New Delhi, India
www.karger.com www.karger.com/fok drkrishnadalal@gmail.com
Introduction the target body parts through neural pathways or through
hormone-like activity [20]. Thereby these impulses are able to
The worldwide prevalence of epilepsy is about 0.5–1% in the rectify corresponding abnormal functioning status. The work-
general population, with almost 80% of affected people being ing principle of reflexology may be comparable to acupunc-
from developing countries [1]. It has been reported that more ture techniques [21, 22]. The present trial was conducted
than 30% of people suffering from epilepsy either remain un- based on the hypothesis that the mechanical stimulations gen-
controlled despite the use of multiple anti-epileptic drugs erated by finger movements on foot reflexology areas would
(AEDs) [2], are not candidates for palliative surgery, or have restore homeostasis of the corresponding organ functions.
failed epilepsy surgery [3]. According to the existing literature, Hand reflexology therapy would achieve the effects of VNS
many side effects have been observed with AEDs, including [23, 24]. This trial endeavored to critically examine the effi-
sedation, dizziness, hyperammonemia, hepatotoxicity, vertigo, cacy of hand and foot reflexology therapy in treating epilepsy
coarsening of the facial features, confusion, ataxia, and hyper- patients who fulfill the criteria of intractability [25].
sensitivity syndrome [4, 5]. Palliative surgical interventions are
also used for controlling intractable epilepsy [6]. Furthermore,
implanted vagus nerve stimulation (VNS) is known to be a Methods
safe modality in treating epilepsy [7, 8]. Apart from being ex-
pensive, quite a number of side effects of VNS, such as brad- Sample Size Calculation
yarrhythmia, hoarseness, cough, dysphonia, voice changes, Sample size was computed considering the average seizure frequency as
paresthesia, nausea, and asystolia, are reported in the litera- the primary variable. It was anticipated that the mean ± standard devia-
ture [9]. In view of the associated risks of neuronal damage tion (SD) of the average seizure frequency in the control group would be
and loss of functions, many patients decide not to undergo sur- 5 ± 3 seizures per month, and with at least 20% improvement the ex-
gery. Additionally, the cost of surgery and availability of infra- pected mean ± SD of the average seizure frequency in the reflexology
group would be 4 ± 3 seizures per month. In order to detect at least 20%
structure and skilled neurosurgeons prevent its wide usage in difference in the average seizure frequency in the 2 groups with 95% con-
India. Due to this, many patients search for alternative thera- fidence level and 90% power, a sample size of 48 per group was therefore
pies to control seizures and improve quality of life. required.
Reflexology has emerged as a form of non-invasive and
non-pharmacological complementary therapy for several
Randomization
medical conditions [10–12]. It is the science of studying human
health through specific reflex/reflexology areas on the feet, A group of 144 diagnosed epilepsy patients, who were already under
hands, and ears. Based on the known beneficial effects of re- treatment in either the Clinical Department of the study institute or else-
flexology therapy on improving quality of life, reducing pain where, was screened to meet the criteria of intractability while reconfirm-
ing ongoing treatment compliance through monitoring serum drug levels.
and anxiety in cancer patients [13, 14], and improving pre-
The screening period was 6 months after enrollment in the trial. A sample
menstrual syndrome [15, 16], a clinical trial was launched to size of 115 was recruited after fulfilling the selection criteria. Patients
determine its efficacy in managing intractable epilepsy. It was were allocated blindly and randomly distributed into either the reflexol-
assumed that reflexology therapy could at least reduce the ogy group (AEDs + reflexology therapy) or the control group (AEDs
side effects of AEDs [17] and thereby could enhance quality alone) by computer-generated random number in block randomization
with 4 candidates per block. Each block was kept in a container without
of life in epilepsy [18]. Furthermore, it was to be determined if
any code so that it was blind to the person involved in the randomization.
it also could improve epilepsy itself. This process led to the recruitment of 58 and 57 subjects in the reflexol-
The theory of reflexology is that certain skin areas of the ogy and the control group, respectively. 20 patients withdrew from the
feet/hands/ears represent the functional status of the target control group immediately after randomization to seek other modes of
body parts. The physiological signatures corresponding to the therapy, while 18 reflexology group patients withdrew due to either a
long distance between their place of residence to the trial location or non-
functional status are exhibited on the reflexology areas and
availability of their caregivers. It is to be mentioned that the trial involved
are visible externally on the skin. The physically observed family caregiver-administered reflexology therapy. The final sample size
skin features are changes in color, texture, concavity and con- was 77 patients, with 40 patients in the reflexology group and 37 patients
vexity as well as tenderness, in response to pressure applied to in the control group. The mode of patient recruitment is depicted in
these areas. Either one or a combination of these features is figure 1.
assessed during the clinical evaluation of a patient to be
treated with reflexology therapy [19]. It may be mentioned Eligibility Criteria
that the physiological basis of reflexology may be used as a
method of determining the functional status of internal body Intractable epilepsy was defined as inadequate seizure control despite
appropriate medical therapy with at least 2 AEDs (1 being a newer drug
parts [20]. However, it cannot be applied to diagnose the type
[26, 27]) in maximally tolerated doses for 2 years, or inadequate seizure
of disease. The treatment procedure of reflexology therapy is control with unacceptable drug-related side effects. Patients those who
based on the theory that impulses generated on the reflexol- were not candidates for epilepsy surgery or had failed epilepsy surgery
ogy areas by external stimulation of definite intensity arrive at (Engel III/IV) were also declared intractable [28]. Patients suffering
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Role of Reflexology and AEDs in Intractable Forsch Komplementmed 2013;20:104–111 105


Epilepsy
Fig. 1. Consort diagram for patient recruit-
ment and follow-up.

from 1 or multiple of the following diseases were excluded from the


trial: malignancy of any kind, brain tumor, encephalitis, meningitis, tu-
berculosis, human immune deficiency virus infection, and any kind of
organ resection. Subjects with seizure frequencies of more than 200 sei-
zures per month were excluded based on the assumption that there
could have been an error in quantifying the seizure frequency.

Settings and Location

All subjects were recruited from the Neurology Outpatient Department


of a tertiary care medical institute located in New Delhi, India. The pa-
tients were referred to the Department of Biophysics of the same institute
for reflexology therapy. This trial was approved by the institutional ethics
review board.

Instructions for Both Patient Groups

Prior to trial enrolment, the theory and working principle of reflexology


therapy were verbally explained to the patients and their caregivers/at- Fig. 2. Reflex areas located on the foot. a Plantar view: 1. Energy bal-
tendants. Detailed instruction sheets were distributed to all caregivers or ance; 2. Solar plexus; 3. Adrenal glands; 4. Kidney; 5. Ureter; 6. Urinary
patients themselves, outlining therapy procedures as well as the protocol bladder; 7. Liver; 8. Stomach; 9. Sciatic nerve. The tips of the toes marked
to be followed for participation. This was to ensure uniformity in compli- with × were not stimulated. b Dorsal view: 1. Energy balance; 2. Lym-
ance with both the AEDs and therapy within the groups. Individual pa- phatic system. c Lateral view. d Medial view.
tients/caregivers were asked to keep a therapy compliance/seizure diary,
including the following items: i) date, time and duration of ictal phase, ii)
number of times AEDs were administered per day, iii) new symptoms
(absent at baseline), and iv) time of application of reflexology therapy. Study Design for Reflexology Group Patients
Compliance with AED administration was also monitored by pill count-
ing at every visit. The individual diaries were evaluated at baseline and at A foot reflexology therapy protocol was developed to treat the patients
the end of follow-up. Reflexology group patients were advised to con- holistically. The foot reflexology areas of the following body systems (fig.
tinue with the therapy even after completion of the 1.5 year-follow-up 2 a–d) were stimulated sequentially: energy balance [29], lymphatic sys-
period, since the effects of withdrawal of therapy were unknown. tem, urinary system, solar plexus [30], adrenal glands, spine, sciatic nerve,
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106 Forsch Komplementmed 2013;20:104–111 Dalal/Devarajan/Pandey/Subbiah/Tripathi


Administering AEDs for Both Groups

The policy of the study institute on the pharmacological management


protocol of intractable epilepsy in terms of number, types, and doses of
AEDs was followed. The patients of both groups received a combination
of 2–4 AEDs. The kind and doses of AEDs were maintained constant for
each individual throughout the trial period. In 2 control group patients,
the drug type and dosage were changed due to an emergency. There was
no such change in any of the reflexology group patients.

Evaluation of Treatment Compliance for Both Groups during Follow-Up

For the purpose of follow-up, the subjects were called twice every month
during the initial period of 6 months, and once every month for the rest of
the trial period. Compliance in both groups was critically monitored by i)
estimating the serum drug levels for all subjects, ii) application of the re-
flexology method, and iii) noting the performance of the caregivers while
applying therapy. An identical method of health monitoring of both the
groups was used which was carried out independently by clinicians out-
side of the reflexology laboratory. The follow-up period was 1.5 years for
both groups (including 2.5 months of training for the reflexology group).
Fig. 3. a Locations of KD1 areas. b Stimulation procedures for self- Patients were given the option to withdraw from the trial at any time.
application. c Stimulation procedures for application by caregivers. Stim- However, no withdrawals were encountered throughout the trial.
ulation procedure was comprised of applying alternate momentary pres-
sure and relaxation of a particular area.
Primary Outcome Measures and Response Calculations

The primary outcome measures were to determine the response of the


knee, hip, stomach, and liver. The hypothesis of this protocol was that patients in terms of i) reduction in seizure frequency and ii) improvement
stimulation at these specific areas on the feet would establish homeostasis of quality of life. The seizure frequency was the number of seizures per
in the functional status of the respective systems together with relieving month averaged over a period of the most recent 3 months. The response
mental stress [31, 32]. Stimulations on the tips of the toes representing of the patients was calculated in terms of % reduction in seizure fre-
brain reflexology areas (marked by × in fig. 2 a) were avoided with the quency (R) defined according to the following equation:
hypothesis that it could precipitate seizures. Foot reflexology maps were (Fpre-th – Fpost-th)
R = % reduction in seizure frequency = × 100 (1).
followed as per the standard descriptions of various publications [33–35]. Fpre-th
Hand reflexology areas marked by KD1 (reflexology areas (fig. 3 a) were
designed by KD with the assumption that stimulations on these areas Fpre-th and Fpost-th are the seizure frequencies at baseline and at the end of
would generate stimulations similar to that of VNS), and the method of follow-up, respectively. A positive or negative figure indicates either re-
applying stimulation on these areas is shown in figure 3 b–c. The initial duced or enhanced seizure frequency at the posttherapy session with re-
period of 2.5 months was devoted to training the caregivers of reflexology spect to baseline. This equation was also utilized to categorize patient re-
group patients following a predetermined training curriculum. The sub- sponses. Response categories were defined as follows: ‘no response’ 0% ≤
jects along with their caregivers were asked to attend once a week at the R < 25%; ‘moderate response’ 25% ≤ R < 50%; ‘good response’ 50% ≤ R
reflexology laboratory. Caregivers were trained under careful supervision < 75%, and ‘excellent response’ 75% ≤ R ≤ 100%. Improvement in over-
to ensure optimal and standardized training and quality of therapy appli- all subjective perception was assessed by the patients themselves using
cation. In order to ensure therapy compliance, the respective areas were the instrument QOLIE-31 (version 1.0) [37, 38]. The QOLIE-31 form
examined by the reflexology method of noting respective skin features as comprises 7 multiple-item subscales (Emotional Well-Being, Energy/Fa-
mentioned above. If compliance was satisfactory, abnormal skin features tigue, Cognitive Function, Seizure Worry, Medication Effects, Social
would have decreased. After successful completion of training in reflexol- Functioning, and Overall Quality of Life) and an Overall Score represent-
ogy therapy application, the patients’ trained attendants/caregivers were ing the weighted sum of the scale scores. The scores on each scale range
advised to apply therapy at their preferred places. Stimulation in the form from 1 to 100. The total score was calculated by weighing and summing
of mechanical pressure and relaxation on a particular reflexology area up the product of the subscale scores. Higher scores reflected better qual-
were uniformly produced by using both hands. One hand was used for ity of life and lower scores worse quality of life [39, 40]. 4 control subjects
producing stimulation and the other for holding the foot firmly against and 3 intervention group subjects belonged to the age group below 18
the pressure. Tolerable moderate pressure (30–40 N/cm2 as recorded years, and hence the QOLIE-31 score scale was used among 33 control
using the pedography system emed®-at/2, (Novel GmbH, Munich, Ger- subjects and 37 subjects in the reflexology group.
many) [36]) was used to generate stimulation. The areas were lubricated
with cream (of milk) without any additives before applying stimulation in
order to avoid any adverse effect on the skin due to friction. Each reflex- Secondary Outcome Measures
ology area was stimulated 15 times for approximately 20 s per session. 1
therapy session took approximately 30 min, and 2 therapy sessions took The secondary outcome was to determine pain intensity on a particular
place per day. KD1 stimulation was produced by thumbnail pressure by reflexology area in response to finger pressure stimulation as well as esti-
the patients themselves as well as by their caregivers (fig. 3 b and c). This mating knee/lower limb pain while performing different activities (stair-
process was prescribed for 5 sessions per day with 15 stimulations of ap- case climbing up/down, walking, sitting with crossed legs etc.). Tender-
proximately 20 s duration per session. ness was measured by the subject on a visual analogue scale (VAS) with a
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Epilepsy
Table 1. Patients’
Category AED Total Groups Patients, Response (R)a, n (%) pb
response according to
combination patients, n (%)
different combina- nonec mild to
n (%)
tions of AEDs (total excellentd
n = 77; reflexology
group n = 40, control 1 2 30 (38.9) reflexology 17 (42.5) 7 (41.1) 10 (58.8) 0.001
group n = 37) control 13 (35.1) 13 (100.0) 0 (0.0)

2 3 38 (49.3) reflexology 20 (50.0) 5 (25.0) 15 (75.0) 0.001


control 18 (48.6) 18 (100.0) 0 (0.0)

3 4 9 (11.6) reflexology 3 (7.5) 0 (0.0) 3 (100.0) 0.012


control 6 (16.2) 6 (100.0) 0 (0.0)
a
Refer to equation 1.
b
Fisher’s two-sided exact test.
c
0 ≤ R < 25%.
d
25%≤ R < 100%.

score range of 0–10 (‘0’ indicating no pain and ‘10’ indicating very severe and 16.0 for reflexology and control subjects, respectively,
pain) [41]. Another secondary outcome measure was to record the socio- were not statistically comparable. The socioeconomic status
economic status of the participants of both groups using Kuppuswamy’s
of the participants of both groups was statistically compara-
modified scale [42].
ble. The majority of patients belonged to the lower middle
and upper lower socioeconomic classes, with 65.5 and 64.8%
Data Analysis of the reflexology and control group, respectively.

Patient response in terms of reduced seizure frequency between the 2


groups was compared using the two-sample Wilcoxon rank-sum (Mann-
Whitney) test. Other baseline parameters such as age, duration of disease, Observations on Primary Outcome Measures
gender ratio, and seizure classifications were also compared using this
test. Within the groups, pre- and posttherapy % reduction in seizure fre- The results of the trial revealed that in the reflexology group,
quency as well as quality of life scores were compared by the Wilcoxon the median baseline seizure frequency had reduced from 9.5
signed-rank test. Quality of life scores between groups were compared
using the Student’s t-test. Between the groups, statistical significance of
(range 2–120) to 2 (range 0–110) at the end of follow-up with
the effects of the different combinations of AEDs and of the baseline sei- high statistical significance (p < 0.001). Control group patients
zure frequencies on the patient response categories was estimated using with a baseline seizure frequency of 16 (range 2–150) did not
Fisher’s two-sided exact test. The effects of reflexology therapy on other show any significant change in seizure frequency (R < 25%) at
symptoms which hampered the daily activities of reflexology group pa- the end of follow-up. In the reflexology group, 55% of pa-
tients were statistically analyzed with the help of McNemar’s chi-square
test. STATA 10.0 statistical software (StataCorp LP, College Station, TX,
tients exhibited excellent response; 5% good response; 10%
USA) was used for data analysis. P-values less than 0.05 were considered moderate response, and 30% no response, with statistical sig-
statistically significant. nificance (p < 0.01).
The responses of patients taking different combinations of
AEDs are depicted in table 1. It shows that reflexology group
Results subjects responded positively with statistical significance (p <
0.05) while taking any kind of AED combination. It was noted
Demographics that statistically significant responses of reflexology group pa-
tients were observed irrespective of the baseline seizure fre-
The distribution of statistical characteristics of the reflexology quencies (table 2). It was also observed that 59.25% of reflex-
and control group subjects, respectively, was as follows: age ology group patients with dyscognitive seizures and 92.30% of
23 years (range 13–49 years), 24 years (range 12–50 years); patients with seizures evolving to bilateral, convulsive seizures
duration of epilepsy 9 years (range 2–44 years), 7 years (range responded with statistical significance (p < 0.05).
2–26 years); male and female ratio 70:30, 64.9:35.1; dyscogni- The baseline QOLIE-31 scores for both groups were simi-
tive seizures [43] 67.5, 70.3; and seizures evolving to bilateral, lar; the mean ± SD values for the control group were 41.1 ± 7
convulsive seizures (involving tonic, clonic, or both compo- and for the reflexology group 43.1 ± 8. The posttherapy data
nents) [43] 32.5, 29.7. The baseline variables of these parame- for the control group were 49.1 ± 6 and for the reflexology
ters, i.e., age, duration of disease, gender ratio, and seizure group 65.0 ± 9. Quality of life scores in the reflexology group
classifications, were statistically comparable between the 2 improved more than in the control group with statistical sig-
groups; however, the median baseline seizure frequencies 9.5 nificance (p = 0.002).
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Table 2. Response
Baseline seizure Total Groups Patients, Response (R)a, n (%) pb
according to baseline
frequency patients, n (%)
seizure frequency nonec mild to
n (%)
(total n = 77; reflexol- excellentd
ogy group n = 40,
control group n = 37) 2 ≤ Fpre-th < 10 35 (45.4) reflexology 20 (57.1) 5 (25.0) 15 (75.0) <0.001
control 15 (42.8) 15 (100.0) 0 (0.0)

10 ≤ Fpre-th < 50 23 (29.8) reflexology 13 (56.5) 5 (38.4) 8 (61.5) 0.003


control 10 (43.4) 10 (100.0) 0 (0.0)

50 ≤ Fpre-th < 100 7 (9.09) reflexology 1 (14.2) 0 (0.0) 1 (100.0) 0.143


control 6 (85.7) 6 (100.0) 0 (0.0)

100 ≤ Fpre-th 12 (15.5) reflexology 6 (50.0) 2 (33.3) 4 (66.6) 0.061


control 6 (50.0) 6 (100.0) 0 (0.0)
a
Refer to equation equation 1.
b
Fisher’s two-sided exact test.
c
0 ≤ R < 25%.
d
25%≤ R < 100%.

Observations on Other Clinical Symptoms

Reflexology group patients were assessed for detecting nor-


mal and abnormal foot reflexology areas which were recorded
at baseline as well as at the end of follow-up. The observa-
tions on the reduced abnormality of the skin features were
used for estimating the severity of symptoms other than epi-
lepsy. The findings were clinically correlated in order to de-
termining the efficacy of reflexology therapy. A few examples
of abnormal reflexology areas are shown in figure 4. The
major goal in this regard was to detect lower limb pain in the
reflexology group patients, and this was confirmed by the pa-
tients upon enquiry. The observed features on the knee, hip,
and sciatic nerve reflexology areas were i) tenderness, ii) hy- Fig. 4. Observed abnormal reflexology areas and respective abnormali-
ties: 1. Knee-hip-sciatic nerve – hyperpigmentation with hollowness (con-
perpigmentation, and iii) concavity, and the areas are marked
cave area); 2. Memory – bulging area with hyperpigmentation; 3. Medulla
by 1 and 4 in figure 4. On the first day of assessing the reflex- oblongata – hyperpigmentation; 4. Knee – hyperpigmentation; 5. L4 to
ology areas in terms of abnormal skin features, it was ob- sacrum-coccyx – hyperpigmentation; 6. Urinary bladder – swollen/convex
served that 34 (85%) of reflexology group patients had been area; 7. Brain – pit-like structures (concavity formation).
suffering from lower limb pain. Abnormal skin features in
terms of hyperpigmentation, concavity, and tenderness were
observed on the knee, hip, and sciatic nerve reflexology areas. quiry. It was found that the subjects with abnormal reflexol-
The probability of pain occurring among epilepsy patients (n ogy areas had been suffering from 1 of the following symp-
= 44) was found to be highly statistically significant (p < toms: urinary incontinence, bed wetting, urine retention, or
0.001). Posttherapy data revealed that overall 85.3% patients passing urine during the ictal phase. At the posttherapy ses-
responded with 81% reduction in pain severity (p < 0.001) sion, 13 (46.4%) patients were free of the respective symp-
with respect to the pretherapy session. Another symptom to toms (p < 0.001). It may be mentioned that reflexology sub-
be detected through the reflexology method (in terms of con- jects were not treated with pharmacological drugs for these
vexity, tenderness, and hyperpigmentation on urinary bladder symptoms. During and at the end of follow-up, vomiting/nau-
reflexology areas) was an abnormal functional status of the sea (n = 1), changed voice (n = 2), and hoarseness (n = 1) had
urinary bladder (e.g., swollen reflexology areas marked by 6 developed among reflexology group patients who did not re-
in figure 4). These reflexology areas were also found to be port these symptoms at baseline. There was no change in any
tender (VAS score > 5) in response to moderate finger pres- kind of symptoms in the control group patients with the ob-
sure as described. It was found that at baseline, 28 (70%) re- servation that no new side effects were reported by this group
flexology subjects were suffering from an ailing status of the during the trial period as reported by the patients themselves
urinary bladder, the symptoms of which were noted upon en- and confirmed by their family members.
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Epilepsy
Discussion ogy group patients were given therapy holistically, and the
therapy application protocol was designed accordingly.
This was an unblinded clinical trial which was based on the as- Hence, it was important to note the responses in terms of
sumption that reflexology therapy intervention would achieve other symptoms for which the therapy was also applied. In
20% deviation from the result with ongoing AED therapy. this regard, reflexology group patients showed positive re-
The sample size was determined accordingly. The observed sponses in terms of reduced lower limb pain and improved
differences in seizure frequency reduction between the 2 symptoms associated with the urinary bladder. It was also
groups was 53.9% which was much more than the anticipated found that reflexology group subjects developed vomiting/
value (20%) used for sample size calculations. Hence the trial, nausea (n = 1 (2.5%)), changed voice (n = 1 (5%)), and
ending in a sample size of 77 which was much more than the hoarseness (n = 2 (2.5%)). These are symptoms similar to
effective sample size of 14.3 (range 11.0–17.6), had more than those of implanted VNS as reported by the vagus nerve study
90% power to achieve statistically significant impact. groups [44].
All patients were selected and enrolled in the trial accord-
ing to the criteria of intractability and were randomized
blindly irrespective of age, gender, socioeconomic status, sei- Conclusion
zure frequency, duration of epilepsy, and seizure classifica-
tion, as well as the number, type, and dose of ongoing AEDs. This report may conclude that reflexology therapy in conjunc-
Much attention was paid among the reflexology group pa- tion with AEDs may help to reduce seizure frequency, im-
tients to maintain quality and uniformity of standardized ther- prove quality of life, and bring holistic benefits to patients.
apy compliance. However, there could have been some varia- The application procedure of the therapy was economical but
tions in reflexology intervention received by the patients time-consuming and manual. The therapy induced a few ad-
through their caregivers administering the therapy at their verse effects which were much less clinically significant than
preferred places. This was the main limitation of the trial, as those of the invasive procedure of implanting VNS. The find-
reflexology therapy was applied lacking in quantification due ings of this trial shed light on the feasibility and potential effi-
to its manual and subjective nature. The corresponding error cacy of this novel intervention and pave the way for launching
was minimized by monitoring the performance of the caregiv- another clinical trial with different communities and environ-
ers on a regular basis, and quality assurance of therapy com- ments and a larger sample size.
pliance was provided by noting the status of the reflexology
areas in terms of tenderness, concavity/convexity, and pig-
mentation. This procedure did not involve any bias in deter- Acknowledgement
mining the subjects’ response because the seizure diary was
The work was carried out with the financial support of the Central
strictly maintained by a person other than the caregiver or the
Council for Yoga and Naturopathy, Department of AYUSH, Ministry
patient. of Health & Family Welfare, Government of India (Ref.: 12–6/
It may be recalled that only patients who did not show sig- CCRYN/2004–2005/Res./394, dated June 7, 2005). The authors gratefully
nificant reduction in seizure frequency with conventional acknowledge the assistance of Shiva Kumar, Kahlil Subramanian, Bhar-
medical treatments for a duration of more than 2 years were athi Maran, Vikas Bajpai, and Modupallur Sivaraman Visnudas in col-
lecting data, editing, and formatting the illustrations. The authors thank
enrolled in the trial. On completion of the trial, the clinical
Varupi Gupta for translating the summary of this article from English
status was compared between groups. It was observed that re- into German.
flexology group patients responded irrespective of pretherapy
seizure frequency, seizure classifications, and the number of
AEDs used. Control group patients did not show significant Disclosure Statement
response. Differences in the responses of the 2 groups were
found to be statistically significant (tables 1 and 2). Reflexol- The authors declare no conflict of interest.

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