Original Article
Fixed
Dose Botulinum toxin therapy for Blepharospasm
Muhammad
Moin, Saher Khalid
Pak J Ophthalmol 2016, Vol. 32 No. 2
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See end of article for authors affiliations …..……………………….. Correspondence to: Saher Khalid Post-graduate Resident Department of
Ophthalmology Ameer ud Din Medical
College Postgraduate Medical
Institute Lahore Email. viakhan123@gmail.com Received: December 14, 2015 Accepted: June 5, 2016 |
Purpose: To find the efficacy of a fixed dose of Botulinum toxin A for
the treatment of Blepharospasm. Study
Design: Quasi experimental
study. Place
and Duration of study: Yaqin
Vision Clinic, Lahore from (August
2010 – August 2015). Material and Methods: All patients of Blepharospasm treated with
botulinum toxin included in the study were assessed on first visit for the
presence of blepharospasm and graded into 4 patterns from mild to severe.
Ocular examination was done to rule out any cause of secondary blepharospasm
due to trichiasis or entropion. CT or MRI scan was performed to rule out any
neurological cause of the disease. Injections were given at 7 periocular
sites in a fixed dose. Follow up was done at 2 weeks, 6 weeks and 3 months. Results: There were 53 cases of blepharospasm, 27 males and 26 females,
which were treated with botulinum toxin. Average age of the patients was 55.3
+/- 8.4. Out of these only 34 patients (64%) had regular injections while 19
patients (36%) had only one injection and did not turn up for further
treatment. Average number of injections given to each patient was 5.5 +/-
4.7. The average duration of relief of symptoms was 3.1 +/- 1 month with 25
units of Botulinum toxin at 7 periocular sites on each side. Relief of
symptoms started after 3.6 +/- 1.8 days in most of the patients. Pre-op 23
patients had moderate and 11 had severe spasms. Average spasms at 1 month
post injection were slight to mild with better response in patient with
moderate pre-op spasms. One patient each had post injection headache and
drooping of lid after injection. Conclusion: Fixed dose therapy gives satisfactory results in patients with
moderate blepharospasm. Key words: To Severe Botolinum Toxin, Blepharospasm, Injections. |
Blepharospasm is characterized by abnormal, involuntary over
contraction of orbicular muscle and occasionally underlying aetiology is basal
ganglia disease1. Blepharospasm affects women more commonly than men
by a 3:1 ratio and has an onset in the sixth decade2.
Increased frequency of blinking, eyelid spasm, mid facial or lower facial
spasm, eyelid tics and involuntary chronic contractions affecting both eyes are
the main symptoms of blepharospasm. In cases with blepharospasm, reading,
writing and driving becomes difficult for the patient because of spasms of the
orbicular muscle causing closure of both eyelids3 leading to a
disaster effect on the quality of life4.
Botulinum toxin A (Botox A, Allergan) prevents acetylcholine
secretion from pre synaptic vesicles thus causing neuromuscular blockade. Due
to its efficacy and safety, Botulinum toxin A is the only best therapy for
Blepharospasm now-a-days5.
Botulinum
toxin is an expensive drug therapy for patients with blepharospasm in our
country. Therefore the rationale of our study was to assess the results of
fixed dose (50 units for both sides) therapy with Botulinum toxin in all
patients presenting with Blepharospasm. This treatment regimen is the most
economical as the injection cost can be shared between two patients.
MATERIALS AND METHODS
The
study was prospective case series conducted in the last 5 years (August
2010-August 2015) at Yaqin Vision clinic, Lahore. Patients of all ages with
essential blepharospasm) were included in the study Patients who were
non-willing, had neurologic or psychiatric disease, and had history of eyelid
surgery on initial presentation were excluded from the study. Pre-injection
CT/MRI was done in all patients to rule out any neurological cause of the
disease. Informed consent was taken from all the patients and they were
explained about the procedure and the study. Standard precautions of injecting
Botox injection were taken and 7 periocular sites were selected e.g. nasally and
temporally in upper brow, upper lid (Pre-tarsal area), lower lid (pre-tarsal
area) and one below lateral canthus on the orbital rim. These patients were
seen on follow up after one week, 6 weeks and at 3 months.
RESULTS
There
were 53 cases of blepharospasm, 27 males and 26 females, which were treated
with botulinum toxin. Average age of the patients was 55.3 +/- 8.4. Severity of
blepharospasm at initial visit and average 4 years response at 1 month is given
in table 1 and grade of orbicularis tone is given in table 2. Twenty five units
of botulinum toxin were distributed over 7 periocular sites in fixed doses (Fig.
1). Out of these only 34 patients (64%) had regular injections while 19
patients (36%) had only one injection and did not turn up for further
treatment. Average number of injections given to each patient was 5.5 +/- 4.7 (Fig.
2). The average duration of relief of symptoms was 3.1 +/- 1 month with 25
units of Botulinum toxin at 7 periocular sites on each side. Relief of symptoms
started after 3.6 +/- 1.8 days in most of the patients. Average spasms at 1 month post
injection were slight to mild with better response in patient with moderate
pre-op spasms. One patient had post injection headache. One
patient had drooping of lid after injection.
Table 1: Severity of Blepharospam pre op and post
injection after 1 month.
Grade |
Clinical Features |
Pre-op n (%) |
Average Post-op |
0 |
None |
0 |
21 (61) |
1 |
Slight. Increase blinking in response
to external stimulus |
0 |
10 (30) |
2 |
Mild, spontaneous lid flutter |
0 |
3 (9) |
3 |
Moderate, very noticeable spasm of
eyelids only |
23 (67) |
|
4 |
Severe, incapacitating eyelids and
facial muscles spasm. |
11 (32) |
|
Table
2: Grades of Orbicularis tone at initial Presentation.
Grade |
Clinical Features |
No. of Patients n (%) |
0 |
Incomplete closure of eyelids |
0 |
1 |
Eyelids just closing with minimal
resistance |
0 |
2 |
Good eyelids closure with some
resistance |
0 |
3 |
Strong eyelids closure but can be
overcome with difficulty |
0 |
4 |
Very strong closure of eyelids that
cannot be overcome |
18
(100) |
DISCUSSION
Benign essential blepharospasm (BEB) is 2 – 3 times more common in
women than men and more so in people over the age of 50 years6. But
in our study we found males were affected slightly more probably due to easy
access of males to medical examination. Post-menopausal women using
phenothiazine’s and with thyroid dysfunction are more prone to develop BEB7. Incidence
of blepharospasm in USA is 2000 cases annually while prevalence is
1.6-30/100,0008.
Fig 1: Periocular
sites for botulinum toxin injection.
Fig. 2:
Number of injections in each patient (n = 34).
Clostridium botulinum is the bacterium which produces
Botulinumtoxin. The FDA approved its usage in the late 1980s when they
discovered that Botulinum toxin could help in diseases like blepharospasm
(uncontrolled blinking) and strabismus (lazy eye)9. In April 2002,
FDA approved it for the treatment of glabellar lines as well10. But
it can be used for other areas of the face as well. Blepharospasm and dystonia
of muscles of the face and neck are not only the source of physical discomfort
but also result in significant social blemishers. Best available treatment is
botulinum toxin injection into the muscles11. Response is best in
pure essential blepharospasm. Duration of action is variable ranging from 6
weeks to 6 months. Because of financial constraints, many patients cannot
afford to have repeated injections. Oral medication including tri-cyclic
anti-depressants and anti-cholinergic have been tried but the results are not
very encouraging12. In our study some of the patients had tried
these medications with poor results.
Botulinum toxin is available in Pakistan13. One vial contains 100 units for one patient
and is quite expensive. We shared one vial between 2 patients by using a fixed
dose treatment of 50 units which was more economical for the patient. Other
studies have reported this as well13. It is injected in pretarsal and
preseptal regions of the eyelids for the treatment of blepharospasm. One of its
complication is that when we inject it in the upper lid, it can migrate to the
orbit and can lead to temporary ptosis. It is highly recommended that the toxin
dose should not exceed 200 IU in a 1 month period and the injection should not
be repeated before 90 days. We preferred the pre-tarsal injection as in other
studies because with site of injection there are few complications due to less
diffusion into the levator muscle14. It has been stated in different
studies that the initial dose of Botulinum toxin is between 1.25 – 5 units for
the treatment of blepharospasm at each site15. In our patients, the
dose that was enough for all patients was 2.5 to 5 units at each site.
In our study, although the treatment needed to be repeated after
every 90 days but we found Botulinum very effective in the control of
blepharospasm. The sign and symptom free duration with every injection remained
same over the long term treatment. Almost same results are found in studies
carried out by Ainsworth, Burns and Czyz16. Our patients were
satisfied because of better quality of life, both socially and physically due
to its long symptom free periods. Our experience was similar from studies
carried out at other centers where Blepharospasm Disability Index (BSDI)
scoring was done17. A national study having 4 patients of
belpharospasm found botulinum toxin effective in its treatment.13
Same results were also shown by Iwashige18, Parsuad R19
and Park YC20.
Our
study has some limitations like low patient compliance, due to infrequent
referrals from other centres of the country.
CONCLUSION
The
therapeutic use of botulinum toxin for the diseases of the face and periocular
region is safe, repeatable and temporarily effective. Patients should be
selected carefully and before injection potential complications should be
discussed with the patient thoroughly. Botulinum toxin type A is the standard
treatment of choice as the first line therapy for essential blepharospasm. The
only drawback is that the effect wears off in about 3 months and the injections
need to be repeated every 12 weeks. This demands good counselling by the doctor
and patients’ motivation and affordability.
Author’s Affiliation
Prof. Muhammad Moin
Department
of Ophthalmology
Ameer
ud Din Medical College
Postgraduate Medical Institute Lahore
Dr. Saher Khalid
PGR
Ophthalmology
Lahore
General Hospital, Lahore
Role of Authors
Prof.
Dr. Muhammad Moin
Data collection, Data Analysis, Critical review
Dr.
Saher Khalid
Manuscript
writing and Literature review
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