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DOI: http://dx.doi.org/10.18203/issn.2454-5929.ijohns20171202
Original Research Article
*Correspondence:
Dr. Kushal Sarda,
E-mail: kushal.sarda@abbott.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background: The objective was to evaluate the clinicoetiological pattern and pharmacotherapy practices of new
onset vertigo in India.
Methods: This multicentre, prospective, registry was conducted in adult patients across 37 centres. Enrolled patients
were followed at week 1, month 1 and 3 to assess clinicoetiological characteristics, prescribed pharmacotherapy,
safety and effectiveness of treatment.
Results: Of the 1520 patients enrolled, 1428 (93.95%) completed the study. The mean (SD) age was 50.2 (±15.37)
years and 53.2% were women. Of 202 patients reporting co-morbidities, 55.4% had cardiovascular disease and 38.6%
had diabetes mellitus. Peripheral causes were predominant in majority (74.3%); benign paroxysmal positional vertigo
(BPPV) being the most frequent (67.58%). Migraine affected 68.9% (80/116) patients, .as the central cause.
Betahistine (74.6%) and prochlorperazine (21.75%) were the top two drugs of choice irrespective of origin, preferred
by all treating specialists. Both the drugs significantly prevented recurrence by week 1 (prochlorperazine: 76.6%;
betahistine: 64.2%) (p<0.001) and over 3 months. A lower daily dose of betahistine (15.6±5.26 mg) was preferred.
Almost half complained of nausea and vomiting; prochlorperazine significantly reduced recurrence of both within a
week (p<0.001). The treatments were well-tolerated with no reported adverse drug reactions.
Conclusions: The study demonstrates vestibular vertigo, BPPV to be the dominant type in Indian patients with new
onset vertigo. Betahistine and prochlorperazine top the physicians’ preference list, with equal benefits in preventing
recurrence. Prochlorperazine has an additional antinausea and antiemetic property, thereby may improve patient
satisfaction. Prescription of a lower dose of betahistine calls for the need to sensitize physicians.
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Vertigo has a multicausative etiology; the most common After obtaining approval from an independent ethics
cause is vestibular disorders - benign paroxysmal committee, the study was conducted in compliance with
positional vertigo (BPPV), Ménière’s disease (MD), the protocol, the Declaration of Helsinki (2000),
vestibular neuritis (VN), labyrinthitis, migraine and International Conference on Harmonization-Good
cervical migraine and anxiety disorders.2,9 Peripheral Clinical Practice guidelines, Indian Council of Medical
vestibular diseases were reported to constitute a majority Research ethical guidelines for biomedical research on
of the self-reported cases of vertigo during a 10-year human participants, amended Schedule Y, and other
period in Africa.10 BPPV was the most common cause of applicable regulatory guidelines. A written informed
vertigo reported in India.11 authorization was obtained from all the patients for
voluntary participation. Study related information was
Patients are affected differently depending on the recorded on the case report forms. At baseline, following
underlying cause. In BPPV, vertigo is of sudden onset, data were collected: demography, history of vertigo with
lasts for approximately 1 min and is typically induced by clinical presentation (including episodes and recurrence),
changes of the head or body position. However, attacks co-morbid conditions, clinical diagnostics, physical
can last up to several hours in MD.11 Vertigo becomes examination findings, anti-vertigo treatment prescribed
more prevalent with increasing age and the reported and concomitant medications. Patients were asked to
frequency is higher in women.12-15 The subjective nature attend a total of 3 follow-up visits for assessment of
of vertigo demands clinicians to follow a multi- response to the prescribed anti-vertigo treatment at
dimensional approach to management including attention around week 1 and around months 1 and 3. During these
to detailed history, vestibular assessment using clinic visits, data pertaining to effectiveness of the anti-
otolaryngological diagnostics, and treatment algorithms.3 vertigo treatment (prevention of recurrences) were
With a fluctuating episodic pattern of symptoms, vertigo recorded along with treatment change, if any. All patients
treatment aims to minimize or eliminate the number and were advised to visit the center anytime apart from the
severity of acute attacks, reduce tinnitus, and prevent recommended visits for any health-related issues or
impaired vestibular functions. Medications useful in adverse drug reactions (ADRs).
treatment and prophylaxis include anticholinergics,
antihistamines, benzodiazepines, calcium channel Study endpoints
antagonists, dopamine receptor antagonists and H1
agonists.1,16 The usage pattern and long-term Endpoints included clinico-etiological characteristics,
effectiveness of these antivertigo drugs have not been preferred anti-vertigo treatment per the cause, and
widely reported in routine clinical settings. The frequency of recurrence of symptoms from base-
unavailability of information on treatment effects on line. Reports of ADRs were accrued from the safety
vertigo elucidated the need for such a large registry of population.
new onset vertigo patients in India.
Statistical analysis
This study was conducted to determine the prevalent
causes, clinical presentation, and management of vertigo, All statistical analyses were performed using SAS®
a relatively common condition in India. The study also version 9.4 (SAS Institute Inc., Cary, NC, USA).
reports pharmacotherapy practices as per etiological Demographics and baseline characteristics, including
patterns and disease characteristics along with its safety patient’s medical history, clinical presentation, causes of
and effectiveness. vertigo, and treatment prescribed, are summarized
descriptively in terms of the number of patients (n),
METHODS mean, standard deviation for continuous parameters, and
count (n) and percentage (%) for categorical variables.
Study population Recurrence of vertigo at follow-up visits was analyzed
for its association with cause and anti-vertigo treatment
Men and women aged ≥18 years, diagnosed with new received, using chi-square or Fischer exact test at 5%
onset vertigo of known or unknown origin, were enrolled. level of significance.
Pregnant or lactating women, treatment-experienced
patients, and individuals requiring hospitalization for any RESULTS
cause were excluded.
Patient disposition
Study design
A total of 1520 patients were enrolled, of which 1428
This was a multicenter, prospective, noninterventional, (93.9%) patients completed the study (considered per
observational registry (CTRI/2016/01/006500) of patients protocol population); all 1520 were included in the
with newly diagnosed vertigo, recruited at 37 centers (17 intention to treat analysis. The most common reason for
ENTs, 10 neurologists, and 10 consulting physicians study discontinuation was loss to follow-up (4.21%)
between June-2015 and May-2016. (Figure 1).
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Figure 2: Treatment prescribed for peripheral causes of vertigo per study visits.
N: number of patients
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Two-thirds of the patients presented with either “feeling prochlorperazine were prescribed equally (54.6% vs.
like falling on right side” and/or “feeling like spinning or 43.7%). Irrespective of the peripheral cause, the number
turning right side” as the 2 most common vertigo of patients requiring treatment with betahistine or
symptoms (492, 32.4% and 478, 31.4%, respectively). prochlorperazine reduced considerably month-on-month.
The mean daily frequency of episodes was ~5 episodes (Table 2 and Figure 2). The prescription practices were
for the most frequently reported symptoms as shown in similar across all specialists, preferring betahistine and
Table 1. “Loss of balance or feeling like falling forward” prochlorperazine as the top 2 drugs of choice (Figure 3).
was more often reported in women (p=0.0058). Of 934 There were no reported changes in the prescription
(61.4%) patients reporting triggering factors for vertigo pattern at subsequent follow-up visits.
onset (a sudden specific action), the 2 most frequent
triggers were “sudden turning of the head” (786, 51.7%) Effectiveness outcomes
and “standing up” (502, 33.0%) (data not shown).
Symptom reduction and recurrence
Anti-vertigo treatment prescribed
Percentage changes (reductions) in each symptom are
Betahistine (1134, 74.6%) and prochlorperazine (330, shown in Figure 4 (comparison at each visit versus
21.75%) were the 2 most frequently prescribed drugs baseline). Both betahistine and prochlorperazine showed
irrespective of the origin (peripheral, central or significant benefits in preventing a recurrence of all
idiopathic). Cinnarizine was prescribed in about 9.14% of symptoms at subsequent visits from baseline (p<0.001)
patients. The mean daily dose and frequency for (Table 3). The mean improvements in all symptoms were
betahistine were 15.6 (±5.26) mg and 2.2 (±0.69); for numerically larger in the first month with gradual and
prochlorperazine were 6.5 (±5.00) mg and 1.9 (±0.76) mg consistent reductions until month 3. Prochlorperazine
respectively. Betahistine was the preferred drug for prevented recurrence in 73% (241/330) of patients at
treatment initiation followed by prochlorperazine in week 1. Betahistine also showed a significant
BPPV (86.1%; 12.7%), MD (60%; 21.8%), and VN improvement (no recurrence) in all symptoms within 1
(60%; 30%). In labyrinthitis, betahistine and week of treatment in 62.9% (713/1134) patients
(p<0.001). A further statistically significant symptom
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reduction occurred at month 1 with only 2 patients of peripheral causes including BPPV, labyrinthitis, VN,
reporting recurrence (p<0.001). However, higher and MD (data not shown). Symptoms with the highest
recurrence was reported in patients on cinnarizine, 42.4% mean daily frequencies of ~5 episodes reduced to ~3
(59/139) compared with prochlorperazine and betahistine. episodes per day by week 1. Symptoms of feeling like
falling backward, blackouts, feeling like swaying,
The overall reductions in each symptom were consistent uncertainty, and stuffy feeling in the ear got resolved
in men and women and across the diagnostic categories completely at month 3 (Figure 5).
Table 2: Summary of antivertigo treatment at different visits.
Antivertigo
Visit 1 (N=1520) Visit 2 (N=1495) Visit 3 (N=1478) Visit 4 (N=1428)
treatment
n (%) 1134 (74.6) 646 (43.2) 428 (28.96) 310 (21.47)
Dose (mg)
15.6 (5.26) 14.5 (4.39) 14.5 (3.75) 15.5 (2.76)
Betahistine mean (SD)
Daily frequency
2.2 (0.69) 1.9 (0.82) 2.1 (0.51) 2.7 (0.54)
mean (SD)
Duration in days 88.8 (9.94)
23.3 (31.09) 46.5(38.58) 76.5 (29.40)
mean (SD)
n (%) 330 (21.71) 191 (12.78) 141 (9.54) 135 (9.45)
Dose (mg)
6.5 (5.00) 6.0 (4.26) 5.2 (1.75) 5.1 (0.44)
mean (SD)
Prochlorperazine Daily frequency
1.9 (0.76) 1.2 (0.45) 2.0 (0.29) 2.9 (0.29)
mean (SD)
Duration in days
38.3 (39.44) 75.9 (29.85) 87.7 (13.11) 90.0 (0.00)
mean (SD)
n (%) 139 (9.14) 68 (4.55) 17 (1.15) 4.0 (0.28)
Dose (mg)
26.3 (11.75) 24.3(7.10) 21.9 (4.48) 15.0 (0.00)
mean (SD)
Cinnarizine Daily frequency
2.3 (0.59) 2.0(0.53) 2.0 (0.35) 2.0 (0.00)
mean (SD)
Duration in days
8.6 (6.01) 18.8 (5.63) 20.0 (14.14) 0
mean (SD)
n: number of patients in a given category; N: number of patients in a specific main category; SD: standard deviation
Other associated symptoms and treatment nausea and vomiting in 156/201 (77.61%) and 94/114
(82.46%) patients, respectively (p<0.001). patients with
At baseline, 764 (50.3%) and 299 (19.7%) patients nausea and 114 (7.50%) patients with vomiting. Both
reported nausea and vomiting, respectively. these symptoms improved significantly within 1-week
Prochlorperazine was the preferred drug in 201 (13.2%) treatment with no reported recurrence of nausea and
patients with nausea and 114 (7.50%) patients with vomiting in 156/201 (77.61%) and 94/114 (82.46%)
vomiting. Both these symptoms improved significantly patients, respectively (p<0.001).
within 1-week treatment with no reported recurrence of
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Few patients were also prescribed other medications such treatment with ondansetron (2) and esomeprazole,
as rabeprazole (42), domperidone (13), pantoprazole (06), pantoprazole, and rabeprazole (1 each) for vomiting.
and ondansetron (07) for nausea, and 5 patients received
Of 95 (6.25%) patients with migraine/headache, 29 month 1). Twenty patients received treatment for anxiety
(30.5%) were prescribed treatment; very few reported and the drug of choice for half of the patients was
headache recurrence (2 patients at week 1 and 1 patient at alprazolam.
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Safety and tolerability consistent across all types of vertigo and gender. Within 3
months of treatment, feeling like falling backward,
No ADRs, serious adverse events, or deaths were blackouts, feeling like swaying, uncertainty, and stuffy
reported during the study. feeling in ear(s) resolved completely (Figure 4).
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