Botulinum toxin injection in the management of chronic migraine: the Saudi experience with a proposal for a new protocol

DOI: https://doi.org/10.1007/s13760-020-01521-0

Abstract-Summary There are no data from Saudi Arabia about the use of botulinum toxin for migraine prevention.

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4 Treatment

We aim to study the clinical profile, safety, and response to treatment with botu-

linum toxin injection for migraine patients.

We aim to share our experience with the use of botulinum toxin modified injec- tion protocol (5/20/100 protocol) in the management of migraine in Saudi patients. The protocol for botulinum toxin injection for migraine in our hospital consisted of injecting five muscles with a total of 20 injection sites consuming 100 units of Onabotulinumtoxin A (BOTOX®, Allergan, Inc., Irvine, CA).

The mean frequency of migraine days showed a significant reduction from base- line at 15.61 ± 10.92 days per month to 6.14 ± 6.16 days (9.47 days reduction) after botulinum toxin injection (39.3% reduction; paired t test = 5.177; p = 0.0001).

Only three patients (10%) had adverse events from botulinum toxin injection. Botulinum toxin is an effective, safe, and well-tolerated treatment option for the

prevention of chronic migraine.

Extended: We did not differentiate between chronic daily headache with or with-

out medication overuse.

We ask the patient to contract the injected muscles if possible by frowning, shrugging the shoulder, etc The motive behind using this protocol and the rubbing technique was the results of a survey done to our patients, which showed major concerns with three different complaints.

Only three patients (10%) had adverse events from botulinum toxin injection in the form of localized pain in the head at the injection site, numbness at the injection site, and neck pain and rigidity.

Introduction Chronic migraine is defined as a headache occurring on 15 or more days per month for more than 3 months, of which ≥8 days have the features of migraine headaches. The main goal in the treatment of chronic migraine is to keep migraine attacks as

rare and short as possible with no or little impact on patients’ life [307].

There are many studies comparing botulinum toxin with placebo on both chronic

and episodic migraine.

The reduction is significant in chronic migraine but non-significant in episodic

migraine [308].

There are no data from Saudi Arabia about the use of botulinum toxin for

migraine prevention.

We aim to study the clinical profile, safety, and response to treatment with botu-

linum toxin injection for migraine patients.

We aim to share our experience with the use of botulinum toxin modified injec- tion protocol (5/20/100 protocol) in the management of migraine in Saudi patients.

Methods The inclusion criteria consisted of all adult (18 years and above) patients fulfilling criteria for chronic migraine who received botulinum toxin injection for a minimum of three treatments.

The eligibility for botulinum toxin injection for migraine treatment in our hospi- tal was patients with chronic migraine (15 or more days per month) with headache lasting 4 or more hours.

4.3 Results

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In patients with chronic migraine and concomitant medication overuse, botuli- num toxin was administered, aiming for detoxifying the patient if therapy is effec- tive and detoxification feasible.

For each patient, we collected: age, gender, age of onset, brain imaging features, number of migraine attacks before and after botulinum toxin injection, the fre- quency of using acute headache medication before and after botulinum toxin injec- tion, previous preventative therapies used, and proportion of headache-free patients. Patients who had more than 30% reduction in headache days per month after

botulinum toxin injection were considered as responders.

Results A total of 30 patients were included in our study.

The mean frequency of migraine days showed a significant reduction from base- line at 15.61 ± 10.92 days per month to 6.14 ± 6.16 days (9.47-day reduction) after botulinum toxin injection (39.3% reduction; paired t test = 5.177; p = 0.0001).

Five patients (16.7%) had no reduction in the frequency of migraine attacks after

botulinum toxin injection.

The frequency of using abortive medications was reduced in 19 patients (63.3%),

while it remained the same in 11 patients (36.7%).

Only four patients (13.3%) achieved a headache-free status after botulinum toxin

injection.

Only three patients (10%) had adverse events from botulinum toxin injection in the form of localized pain in the head at the injection site, numbness at the injection site, and neck pain and rigidity.

Discussion Our study is the first study done in the Middle East to explore the benefits and adverse events of botulinum toxin injection in patients with chronic migraine using a protocol that suits the culture and improves the acceptance of botulinum toxin as a modality of treatment.

This protocol was initiated based on a survey of all patients who have received botulinum toxin for the management of chronic migraine using the standard proto- col (7 muscles and 31 sites of injection).

In the PREEMPT II study [150], botulinum toxin significantly improved differ-

ent headache-related variables including headache- related disability.

Within the PREEMPT patient population [149, 150], botulinum toxin was effec- tive in patients with chronic migraine with concomitant medication overuse headache.

Since botulinum toxin injections are extremely safe with no significant long- term hazards reported, it is used repeatedly for our chronic migraine patients who are responders.

Conclusion Botulinum toxin is an effective, safe, and well-tolerated treatment option for the prevention of chronic migraine.

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4 Treatment

Treatment of co-morbid conditions using multidisciplinary care is mandatory to

ensure the success of botulinum toxin therapy.

Utilizing less amount of botulinum toxin will also drive down costs, which is a

big hurdle for getting funding under the public health system in many countries.

Acknowledgement A machine generated summary based on the work of Algahtani, Hussein; Shirah, Bader; Sukkar, Ghassan; Bukhari, Hatim; Meftah, Ibraheem; Alhazmi, Asim; Alshareef, Abid; Algethami, Abdulmohsin; Alshanqiti, Ammar; Andeejani, Mahmoud. 2020 in Acta Neurologica Belgica.

Triptan efficacy does not predict onabotulinumtoxinA efficacy but improves with onabotulinumtoxinA response in chronic migraine patients