J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website https://jocmr.elmerjournals.com

Original Article

Volume 16, Number 11, December 2024, pages 527-535

Direct Comparison of Treatment Outcome Between the Botulinum Toxin and Calcitonin Gene-Related Peptide Monoclonal Antibody in Migraine Patients

Figure 1. Comparison between two groups for the effectiveness of the intervention. CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment.

Figure 2. Comparison of patient-reported “adverse drug reactions” between the botulinum and anti-CGRP groups. *P-value: 0.006. CGRP: calcitonin gene-related peptide.

**Table 1.** General Characteristics of the Pain in Migraineurs (N = 80)
Demographic characteristics	N (%) or mean ± SD
BoNT: botulinum neurotoxin; CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment; MPSQ: migraine pain scale questionnaire; SD: standard deviation.
Total duration for which the patient has been suffering from migraine
Less than 6 months	3 (3.8%)
6 - 12 months	10 (12.5%)
12 - 24 months	14 (17.5%)
More than 24 months	53 (66.3%)
Intensity of pain (average pain score by MPSQ scale)	8.72 ± 1.387
MIDAS total scores	45.3 ± 46.641
HIT-6 total scores	65.30 ± 6.846
Number of days in the last 3 months when the patient missed work or school because of the headache	6.89 ± 10.87
Number of days in the last 3 months when patients missed family, social or leisure activities because of headaches	9.24 ± 13.002
Number of days in the last 3 months when patients had headaches (PRE-MIDAS A)	14.63 ± 19.546
Previously used medication for migraine (other than anti-CGRP and botulinum)
Yes	68 (85%)
No	12 (15%)
Average duration of previously used medications for migraine in years (other than anti-CGRP and botulinum)	2.26 ± 2.014
Currently using any medication for migraine (other than anti-CGRP and BoNT)
Yes	24 (30%)
No	58 (70%)

Table 1. General Characteristics of the Pain in Migraineurs (N = 80)

Demographic characteristics

N (%) or mean ± SD

BoNT: botulinum neurotoxin; CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment; MPSQ: migraine pain scale questionnaire; SD: standard deviation.

Total duration for which the patient has been suffering from migraine

Less than 6 months

3 (3.8%)

6 - 12 months

10 (12.5%)

12 - 24 months

14 (17.5%)

More than 24 months

53 (66.3%)

Intensity of pain (average pain score by MPSQ scale)

8.72 ± 1.387

MIDAS total scores

45.3 ± 46.641

HIT-6 total scores

65.30 ± 6.846

Number of days in the last 3 months when the patient missed work or school because of the headache

6.89 ± 10.87

Number of days in the last 3 months when patients missed family, social or leisure activities because of headaches

9.24 ± 13.002

Number of days in the last 3 months when patients had headaches (PRE-MIDAS A)

14.63 ± 19.546

Previously used medication for migraine (other than anti-CGRP and botulinum)

Yes

68 (85%)

12 (15%)

Average duration of previously used medications for migraine in years (other than anti-CGRP and botulinum)

2.26 ± 2.014

Currently using any medication for migraine (other than anti-CGRP and BoNT)

Yes

24 (30%)

58 (70%)

**Table 2.** Comparison of the Demographic Characteristics of Migraineurs Between the Botulinum and Anti-CGRP Groups
Demographic characteristics	Botulinum group (N = 40)	Anti-CGRP group (N = 40)	P value
*A P-value of < 0.05 is considered statistically significant. CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment; MPSQ: migraine pain scale questionnaire.
Gender
Male	10 (25%)	9 (22.5%)
Female	30 (75%)	31 (77.5%)	0.793
Average age	39.43 ± 9.642	38.73 ± 10.476	0.757
Total duration for which the patient has been suffering from migraine
Less than 6 months	1 (2.5%)	2 (5%)
6 - 12 months	8 (20%)	2 (5%)
12 - 24 months	8 (20%)	6 (15%)
More than 24 months	23 (57.5%)	30 (75%)	0.162
Intensity of pain (average pain score by MPSQ scale)	8.63 ± 1.102	8.83 ± 1.631	0.523
MIDAS total scores	26.68 ± 26.436	63.93 ± 54.737	0.000*
HIT-6 total scores	63.98 ± 7.298	66.63 ± 6.171	0.083
Number of days (in last 3 months) where the productivity of the patient was affected due to migraine headache	5.63 ± 12.994	13.2 ± 14.342	0.015*
How often do the headaches limit daily activities
Always	7 (17.5%)	13 (32.5%)
Very often	10 (25%)	18 (45%)
Sometimes	21 (52.5%)	9 (22.5%)
Rarely	2 (5%)	0 (0%)	0.012*
Previously used medication for migraine (other than anti-CGRP and botulinum)
Yes	32 (80%)	36 (90%)	0.210
No	8 (20%)	4 (10%)
Average duration of previously used medications for migraine (other than anti-CGRP and botulinum)	2.59 ± 2.089	1.92 ± 1.902	0.137
Currently using any medication for migraine (other than anti-CGRP and botulinum)
Yes	12 (30%)	12 (30%)	1.0
No	28 (70%)	28 (70%)

Table 2. Comparison of the Demographic Characteristics of Migraineurs Between the Botulinum and Anti-CGRP Groups

Demographic characteristics

Botulinum group (N = 40)

Anti-CGRP group (N = 40)

P value

*A P-value of < 0.05 is considered statistically significant. CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment; MPSQ: migraine pain scale questionnaire.

Gender

Male

10 (25%)

9 (22.5%)

Female

30 (75%)

31 (77.5%)

0.793

Average age

39.43 ± 9.642

38.73 ± 10.476

0.757

Total duration for which the patient has been suffering from migraine

Less than 6 months

1 (2.5%)

2 (5%)

6 - 12 months

8 (20%)

2 (5%)

12 - 24 months

8 (20%)

6 (15%)

More than 24 months

23 (57.5%)

30 (75%)

0.162

Intensity of pain (average pain score by MPSQ scale)

8.63 ± 1.102

8.83 ± 1.631

0.523

MIDAS total scores

26.68 ± 26.436

63.93 ± 54.737

0.000*

HIT-6 total scores

63.98 ± 7.298

66.63 ± 6.171

0.083

Number of days (in last 3 months) where the productivity of the patient was affected due to migraine headache

5.63 ± 12.994

13.2 ± 14.342

0.015*

How often do the headaches limit daily activities

Always

7 (17.5%)

13 (32.5%)

Very often

10 (25%)

18 (45%)

Sometimes

21 (52.5%)

9 (22.5%)

Rarely

2 (5%)

0 (0%)

0.012*

Previously used medication for migraine (other than anti-CGRP and botulinum)

Yes

32 (80%)

36 (90%)

0.210

8 (20%)

4 (10%)

Average duration of previously used medications for migraine (other than anti-CGRP and botulinum)

2.59 ± 2.089

1.92 ± 1.902

0.137

Currently using any medication for migraine (other than anti-CGRP and botulinum)

Yes

12 (30%)

1.0

28 (70%)

**Table 3.** Comparison of the MIDAS, HIT-6, and Pain Scale Scores Between the Botulinum and Anti-CGRP Groups Before and After Treatment
Questionnaire used for	Before treatment (mean ± SD)	After treatment (mean ± SD)	P-value^a
^aPaired sample t-test. *A P-value of < 0.05 is considered statistically significant. CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment; SD: standard deviation.
Botulinum group
Average MIDAS scores	26.68 ± 26.436	26.5 ± 28.068	0.970
Average HIT-6 scores	63.98 ± 7.298	57.75 ± 12.251	0.005
Average pain scale scores	8.63 ± 1.102	5.95 ± 2.669	0.000*
Anti-CGRP group
Average MIDAS scores	63.93 ± 54.737	43.08 ± 64.547	0.097
Average HIT-6 scores	66.63 ± 6.171	54.90 ± 12.266	0.00*
Average pain scale scores	8.83 ± 1.631	4.90 ± 2.489	0.00*

Table 3. Comparison of the MIDAS, HIT-6, and Pain Scale Scores Between the Botulinum and Anti-CGRP Groups Before and After Treatment

Questionnaire used for

Before treatment (mean ± SD)

After treatment (mean ± SD)

P-value^a

^aPaired sample t-test. *A P-value of < 0.05 is considered statistically significant. CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment; SD: standard deviation.

Botulinum group

Average MIDAS scores

26.68 ± 26.436

26.5 ± 28.068

0.970

Average HIT-6 scores

63.98 ± 7.298

57.75 ± 12.251

0.005

Average pain scale scores

8.63 ± 1.102

5.95 ± 2.669

0.000*

Anti-CGRP group

Average MIDAS scores

63.93 ± 54.737

43.08 ± 64.547

0.097

Average HIT-6 scores

66.63 ± 6.171

54.90 ± 12.266

0.00*

Average pain scale scores

8.83 ± 1.631

4.90 ± 2.489

0.00*

**Table 4.** Comparison Between Two Groups for Effectiveness of the Intervention
Groups	Within-group difference (Δ) between pre- and post-intervention values
^aIndependent sample t-test. CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment.
Botulinum group	0.18 ± 29.321	6.23 ± 13.086	2.68 ± 2.973
Anti-CGRP group	20.85 ± 77.557	11.73 ± 14.146	3.93 ± 3.133
P-value^a	0.121	0.075	0.07

Table 4. Comparison Between Two Groups for Effectiveness of the Intervention

Groups

Within-group difference (Δ) between pre- and post-intervention values

MIDAS scores

HIT-6 scores

Average pain scores

^aIndependent sample t-test. CGRP: calcitonin gene-related peptide; HIT-6: headache impact test; MIDAS: migraine disability assessment.

Botulinum group

0.18 ± 29.321

6.23 ± 13.086

2.68 ± 2.973

Anti-CGRP group

20.85 ± 77.557

11.73 ± 14.146

3.93 ± 3.133

P-value^a

0.121

0.075

0.07

**Table 5.** Comparison of Patient-Reported “Adverse Drug Reactions” Between the Botulinum and Anti-CGRP Groups
Patient-reported adverse drug reactions	Botulinum group, N (%)	Anti-CGRP group, N (%)	P value
*A P-value of < 0.05 is considered statistically significant. CGRP: calcitonin gene-related peptide.
Nausea
Yes	10 (25%)	8 (20%)	0.592
No	30 (75%)	32 (80%)
Vomiting
Yes	6 (15%)	7 (17.5%)	0.762
No	34 (85%)	33 (82.5%)
Headache (different from migraine headache)
Yes	18 (45%)	16 (40%)	0.651
No	22 (55%)	24 (60%)
Visual problems
Yes	10 (25%)	5 (12.5%)	0.152
No	30 (75%)	35 (87.5%)
Backpain
Yes	7 (17.5%)	12 (30%)	0.189
No	33 (82.5%)	28 (70%)
Tingling
Yes	6 (15%)	11 (27.5%)	0.172
No	34 (85%)	29 (72.5%)
Dry mouth
Yes	4 (10%)	10 (25%)	0.077
No	36 (90%)	30 (75%)
Upper respiratory tract infection
Yes	3 (7.5%)	2 (5%)	0.644
No	37 (92.5%)	38 (95%)
Urinary tract infection
Yes	3 (7.5%)	4 (10%)	0.692
No	37 (92.5%)	36 (90%)
Fatigue
Yes	9 (22.5%)	9 (22.5%)	1.000
No	31 (77.5%)	31 (77.5%)
Joint stiffness
Yes	0 (0%)	7 (17.5%)	0.006*
No	40 (100%)	33 (82.5%)
Liver toxicity
Yes	2 (5%)	0 (0%)	0.152
No	38 (95%)	40 (100%)
Hypertension
Yes	2 (5%)	1 (2.5%)	0.556
No	38 (95%)	39 (97.5%)
Pain at the site of injection
Yes	11 (27.5%)	13 (32.5%)	0.626
No	29 (72.5%)	27 (67.5%)

Table 5. Comparison of Patient-Reported “Adverse Drug Reactions” Between the Botulinum and Anti-CGRP Groups

Patient-reported adverse drug reactions

Botulinum group, N (%)

Anti-CGRP group, N (%)

P value

*A P-value of < 0.05 is considered statistically significant. CGRP: calcitonin gene-related peptide.

Nausea

Yes

10 (25%)

8 (20%)

0.592

30 (75%)

32 (80%)

Vomiting

Yes

6 (15%)

7 (17.5%)

0.762

34 (85%)

33 (82.5%)

Headache (different from migraine headache)

Yes

18 (45%)

16 (40%)

0.651

22 (55%)

24 (60%)

Visual problems

Yes

10 (25%)

5 (12.5%)

0.152

30 (75%)

35 (87.5%)

Backpain

Yes

7 (17.5%)

12 (30%)

0.189

33 (82.5%)

28 (70%)

Tingling

Yes

6 (15%)

11 (27.5%)

0.172

34 (85%)

29 (72.5%)

Dry mouth

Yes

4 (10%)

10 (25%)

0.077

36 (90%)

30 (75%)

Upper respiratory tract infection

Yes

3 (7.5%)

2 (5%)

0.644

37 (92.5%)

38 (95%)

Urinary tract infection

Yes

3 (7.5%)

4 (10%)

0.692

37 (92.5%)

36 (90%)

Fatigue

Yes

9 (22.5%)

1.000

31 (77.5%)

Joint stiffness

Yes

0 (0%)

7 (17.5%)

0.006*

40 (100%)

33 (82.5%)

Liver toxicity

Yes

2 (5%)

0 (0%)

0.152

38 (95%)

40 (100%)

Hypertension

Yes

2 (5%)

1 (2.5%)

0.556

38 (95%)

39 (97.5%)

Pain at the site of injection

Yes

11 (27.5%)

13 (32.5%)

0.626

29 (72.5%)

27 (67.5%)