Scolaris Content Display Scolaris Content Display

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 1.1

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 1 2500 U BtB versus Placebo.

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 1.2

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 2 5000 U BtB versus Placebo.

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 1.3

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 3 10,000 U BtB versus Placebo.

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 4 BtB (2500‐10,000U) versus Placebo.
Figuras y tablas -
Analysis 1.4

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 4 BtB (2500‐10,000U) versus Placebo.

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 5 BtB (2500‐5000 U) versus BNT/B (10,000 U).
Figuras y tablas -
Analysis 1.5

Comparison 1 Improvement of at least 20% in TWSTRS‐Total score at week 4, Outcome 5 BtB (2500‐5000 U) versus BNT/B (10,000 U).

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 2.1

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 1 2500 U BtB versus Placebo.

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 2.2

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 2 5000 U BtB versus Placebo.

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 2.3

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 3 10,000 U BtB versus Placebo.

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 2.4

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 2.5

Comparison 2 Improvement of at least 20% in TWSTRS‐Total score at week 8, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 3.1

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 1 2500 U BtB versus Placebo.

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 3.2

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 2 5000 U BtB versus Placebo.

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 3 10,000 U BtB vs Placebo.
Figuras y tablas -
Analysis 3.3

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 3 10,000 U BtB vs Placebo.

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 4 BtB (2500‐10,000U) versus Placebo.
Figuras y tablas -
Analysis 3.4

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 4 BtB (2500‐10,000U) versus Placebo.

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 3.5

Comparison 3 Improvement of at least 20% in TWSTRS‐Total score at week 12, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 4.1

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 1 2500 U BtB versus Placebo.

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 4.2

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 2 5000 U BtB versus Placebo.

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 4.3

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 3 10,000 U BtB versus Placebo.

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 4.4

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 4.5

Comparison 4 Improvement of at least 20% in TWSTRS‐Total score at week 16, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 5.1

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 1 2500 U BtB versus Placebo.

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 5.2

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 2 5000 U BtB versus Placebo.

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 5.3

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 3 10,000 U BtB versus Placebo.

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 5.4

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 5.5

Comparison 5 Improvement in TWSTRS‐Severity score at week 4, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 6.1

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 1 2500 U BtB versus Placebo.

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 2 5000 U BtB versuss Placebo.
Figuras y tablas -
Analysis 6.2

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 2 5000 U BtB versuss Placebo.

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 6.3

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 3 10,000 U BtB versus Placebo.

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 6.4

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 6.5

Comparison 6 Improvement in TWSTRS‐Disability score at week 4, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 7.1

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 1 2500 U BtB versus Placebo.

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 7.2

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 2 5000 U BtB versus Placebo.

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 7.3

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 3 10,000 U BtB versus Placebo.

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 4 BtB (2500‐10,000U) versus Placebo.
Figuras y tablas -
Analysis 7.4

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 4 BtB (2500‐10,000U) versus Placebo.

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 7.5

Comparison 7 Improvement in TWSTRS‐Pain score at week 4, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 8 TWSTRS‐Total score at week 4, Outcome 1 10,000U BtB versus Placebo.
Figuras y tablas -
Analysis 8.1

Comparison 8 TWSTRS‐Total score at week 4, Outcome 1 10,000U BtB versus Placebo.

Comparison 8 TWSTRS‐Total score at week 4, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 8.2

Comparison 8 TWSTRS‐Total score at week 4, Outcome 2 5000 U BtB versus Placebo.

Comparison 8 TWSTRS‐Total score at week 4, Outcome 3 10,000U BtB versus 5000 U BoNT/B.
Figuras y tablas -
Analysis 8.3

Comparison 8 TWSTRS‐Total score at week 4, Outcome 3 10,000U BtB versus 5000 U BoNT/B.

Comparison 9 TWSTRS‐Total score at week 8, Outcome 1 10,000U BtB versus Placebo.
Figuras y tablas -
Analysis 9.1

Comparison 9 TWSTRS‐Total score at week 8, Outcome 1 10,000U BtB versus Placebo.

Comparison 9 TWSTRS‐Total score at week 8, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 9.2

Comparison 9 TWSTRS‐Total score at week 8, Outcome 2 5000 U BtB versus Placebo.

Comparison 9 TWSTRS‐Total score at week 8, Outcome 3 10,000 U BtB versus 5000 U BtB.
Figuras y tablas -
Analysis 9.3

Comparison 9 TWSTRS‐Total score at week 8, Outcome 3 10,000 U BtB versus 5000 U BtB.

Comparison 10 TWSTRS‐Total score at week 12, Outcome 1 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 10.1

Comparison 10 TWSTRS‐Total score at week 12, Outcome 1 10,000 U BtB versus Placebo.

Comparison 10 TWSTRS‐Total score at week 12, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 10.2

Comparison 10 TWSTRS‐Total score at week 12, Outcome 2 5000 U BtB versus Placebo.

Comparison 10 TWSTRS‐Total score at week 12, Outcome 3 10,000U BtB versus 5000 U BtB.
Figuras y tablas -
Analysis 10.3

Comparison 10 TWSTRS‐Total score at week 12, Outcome 3 10,000U BtB versus 5000 U BtB.

Comparison 11 TWSTRS‐Total score at week 16, Outcome 1 10,000U BtB versus Placebo.
Figuras y tablas -
Analysis 11.1

Comparison 11 TWSTRS‐Total score at week 16, Outcome 1 10,000U BtB versus Placebo.

Comparison 11 TWSTRS‐Total score at week 16, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 11.2

Comparison 11 TWSTRS‐Total score at week 16, Outcome 2 5000 U BtB versus Placebo.

Comparison 11 TWSTRS‐Total score at week 16, Outcome 3 10,000 U BtB versus 5000 U BtB.
Figuras y tablas -
Analysis 11.3

Comparison 11 TWSTRS‐Total score at week 16, Outcome 3 10,000 U BtB versus 5000 U BtB.

Comparison 12 TWSTRS‐Severity score at week 4, Outcome 1 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 12.1

Comparison 12 TWSTRS‐Severity score at week 4, Outcome 1 10,000 U BtB versus Placebo.

Comparison 13 TWSTRS‐Disability score at week 4, Outcome 1 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 13.1

Comparison 13 TWSTRS‐Disability score at week 4, Outcome 1 10,000 U BtB versus Placebo.

Comparison 14 TWSTRS‐Pain score at week 4, Outcome 1 10,000,U BtB versus Placebo.
Figuras y tablas -
Analysis 14.1

Comparison 14 TWSTRS‐Pain score at week 4, Outcome 1 10,000,U BtB versus Placebo.

Comparison 15 Patient Global Assessment of Change at week 4, Outcome 1 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 15.1

Comparison 15 Patient Global Assessment of Change at week 4, Outcome 1 10,000 U BtB versus Placebo.

Comparison 15 Patient Global Assessment of Change at week 4, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 15.2

Comparison 15 Patient Global Assessment of Change at week 4, Outcome 2 5000 U BtB versus Placebo.

Comparison 15 Patient Global Assessment of Change at week 4, Outcome 3 10,000U BtB versus 5000 U BtB.
Figuras y tablas -
Analysis 15.3

Comparison 15 Patient Global Assessment of Change at week 4, Outcome 3 10,000U BtB versus 5000 U BtB.

Comparison 16 Principal Investigator Global Assessment of Change at week 4, Outcome 1 10,000U BtB versus Placebo.
Figuras y tablas -
Analysis 16.1

Comparison 16 Principal Investigator Global Assessment of Change at week 4, Outcome 1 10,000U BtB versus Placebo.

Comparison 16 Principal Investigator Global Assessment of Change at week 4, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 16.2

Comparison 16 Principal Investigator Global Assessment of Change at week 4, Outcome 2 5000 U BtB versus Placebo.

Comparison 16 Principal Investigator Global Assessment of Change at week 4, Outcome 3 10,000 U BtB versus 5000 U BtB.
Figuras y tablas -
Analysis 16.3

Comparison 16 Principal Investigator Global Assessment of Change at week 4, Outcome 3 10,000 U BtB versus 5000 U BtB.

Comparison 17 Patient Analog Pain Assessment at week 4, Outcome 1 10,000U BtB versus Placebo.
Figuras y tablas -
Analysis 17.1

Comparison 17 Patient Analog Pain Assessment at week 4, Outcome 1 10,000U BtB versus Placebo.

Comparison 17 Patient Analog Pain Assessment at week 4, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 17.2

Comparison 17 Patient Analog Pain Assessment at week 4, Outcome 2 5000 U BtB versus Placebo.

Comparison 17 Patient Analog Pain Assessment at week 4, Outcome 3 10,000 U BtB versus 5000 U BtB.
Figuras y tablas -
Analysis 17.3

Comparison 17 Patient Analog Pain Assessment at week 4, Outcome 3 10,000 U BtB versus 5000 U BtB.

Comparison 18 Any Adverse Event, Outcome 1 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 18.1

Comparison 18 Any Adverse Event, Outcome 1 5000 U BtB versus Placebo.

Comparison 18 Any Adverse Event, Outcome 2 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 18.2

Comparison 18 Any Adverse Event, Outcome 2 10,000 U BtB versus Placebo.

Comparison 18 Any Adverse Event, Outcome 3 BtB (5000‐10,000 U) vs Placebo.
Figuras y tablas -
Analysis 18.3

Comparison 18 Any Adverse Event, Outcome 3 BtB (5000‐10,000 U) vs Placebo.

Comparison 18 Any Adverse Event, Outcome 4 BtB (5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 18.4

Comparison 18 Any Adverse Event, Outcome 4 BtB (5000 U) versus BtB (10,000 U).

Comparison 19 Dry Mouth Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 19.1

Comparison 19 Dry Mouth Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 19 Dry Mouth Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 19.2

Comparison 19 Dry Mouth Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 19 Dry Mouth Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 19.3

Comparison 19 Dry Mouth Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 19 Dry Mouth Adverse Event, Outcome 4 BtB (2500‐10,000 U) vs Placebo.
Figuras y tablas -
Analysis 19.4

Comparison 19 Dry Mouth Adverse Event, Outcome 4 BtB (2500‐10,000 U) vs Placebo.

Comparison 19 Dry Mouth Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 19.5

Comparison 19 Dry Mouth Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 20 Dysphagia Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 20.1

Comparison 20 Dysphagia Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 20 Dysphagia Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 20.2

Comparison 20 Dysphagia Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 20 Dysphagia Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 20.3

Comparison 20 Dysphagia Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 20 Dysphagia Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 20.4

Comparison 20 Dysphagia Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 20 Dysphagia Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 20.5

Comparison 20 Dysphagia Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 21 Pain secondary to CD Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 21.1

Comparison 21 Pain secondary to CD Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 21 Pain secondary to CD Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 21.2

Comparison 21 Pain secondary to CD Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 21 Pain secondary to CD Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 21.3

Comparison 21 Pain secondary to CD Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 21 Pain secondary to CD Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 21.4

Comparison 21 Pain secondary to CD Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 21 Pain secondary to CD Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 21.5

Comparison 21 Pain secondary to CD Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 22 Infection Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 22.1

Comparison 22 Infection Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 22 Infection Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 22.2

Comparison 22 Infection Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 22 Infection Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 22.3

Comparison 22 Infection Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 22 Infection Adverse Event, Outcome 4 BtB (2500‐10,000U) versus Placebo.
Figuras y tablas -
Analysis 22.4

Comparison 22 Infection Adverse Event, Outcome 4 BtB (2500‐10,000U) versus Placebo.

Comparison 22 Infection Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 22.5

Comparison 22 Infection Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 23 Injection site pain Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 23.1

Comparison 23 Injection site pain Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 23 Injection site pain Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 23.2

Comparison 23 Injection site pain Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 23 Injection site pain Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 23.3

Comparison 23 Injection site pain Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 23 Injection site pain Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 23.4

Comparison 23 Injection site pain Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 23 Injection site pain Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 23.5

Comparison 23 Injection site pain Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 24 Headache Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 24.1

Comparison 24 Headache Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 24 Headache Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 24.2

Comparison 24 Headache Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 24 Headache Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 24.3

Comparison 24 Headache Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 24 Headache Adverse Event, Outcome 4 BtB (2500‐10,000U) versus Placebo.
Figuras y tablas -
Analysis 24.4

Comparison 24 Headache Adverse Event, Outcome 4 BtB (2500‐10,000U) versus Placebo.

Comparison 24 Headache Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 24.5

Comparison 24 Headache Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 25 Flu syndrome Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 25.1

Comparison 25 Flu syndrome Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 25 Flu syndrome Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 25.2

Comparison 25 Flu syndrome Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 25 Flu syndrome Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 25.3

Comparison 25 Flu syndrome Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 25 Flu syndrome Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 25.4

Comparison 25 Flu syndrome Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 25 Flu syndrome Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 25.5

Comparison 25 Flu syndrome Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 26 Nausea Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 26.1

Comparison 26 Nausea Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 26 Nausea Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 26.2

Comparison 26 Nausea Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 26 Nausea Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 26.3

Comparison 26 Nausea Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 26 Nausea Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 26.4

Comparison 26 Nausea Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 26 Nausea Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 26.5

Comparison 26 Nausea Adverse Event, Outcome 5 BtB (2500‐5000 U) versus BtB (10,000 U).

Comparison 27 Pain Adverse Event, Outcome 1 2500 U BtB versus Placebo.
Figuras y tablas -
Analysis 27.1

Comparison 27 Pain Adverse Event, Outcome 1 2500 U BtB versus Placebo.

Comparison 27 Pain Adverse Event, Outcome 2 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 27.2

Comparison 27 Pain Adverse Event, Outcome 2 5000 U BtB versus Placebo.

Comparison 27 Pain Adverse Event, Outcome 3 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 27.3

Comparison 27 Pain Adverse Event, Outcome 3 10,000 U BtB versus Placebo.

Comparison 27 Pain Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 27.4

Comparison 27 Pain Adverse Event, Outcome 4 BtB (2500‐10,000 U) versus Placebo.

Comparison 27 Pain Adverse Event, Outcome 5 BtB (2500‐5000 U) vs BtB (10,000 U).
Figuras y tablas -
Analysis 27.5

Comparison 27 Pain Adverse Event, Outcome 5 BtB (2500‐5000 U) vs BtB (10,000 U).

Comparison 28 Dyspepsia Adverse Event, Outcome 1 5000 U BtB versus Placebo.
Figuras y tablas -
Analysis 28.1

Comparison 28 Dyspepsia Adverse Event, Outcome 1 5000 U BtB versus Placebo.

Comparison 28 Dyspepsia Adverse Event, Outcome 2 10,000 U BtB versus Placebo.
Figuras y tablas -
Analysis 28.2

Comparison 28 Dyspepsia Adverse Event, Outcome 2 10,000 U BtB versus Placebo.

Comparison 28 Dyspepsia Adverse Event, Outcome 3 BtB (5000‐10,000 U) versus Placebo.
Figuras y tablas -
Analysis 28.3

Comparison 28 Dyspepsia Adverse Event, Outcome 3 BtB (5000‐10,000 U) versus Placebo.

Comparison 28 Dyspepsia Adverse Event, Outcome 4 BtB (5000 U) versus BtB (10,000 U).
Figuras y tablas -
Analysis 28.4

Comparison 28 Dyspepsia Adverse Event, Outcome 4 BtB (5000 U) versus BtB (10,000 U).

Comparison 1. Improvement of at least 20% in TWSTRS‐Total score at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.45 [1.26, 9.41]

1.1 BtA responder patients

1

44

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.57 [1.10, 11.56]

1.2 BtA resistant or non‐responder patients

1

17

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.14 [0.45, 21.72]

2 5000 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.03 [1.48, 10.97]

2.1 BtA responder patients

1

46

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.98 [0.94, 9.48]

2.2 BtA resistant or non‐responder patients

1

15

Peto Odds Ratio (Peto, Fixed, 95% CI)

9.89 [1.34, 73.12]

3 10,000 U BtB versus Placebo Show forest plot

1

60

Peto Odds Ratio (Peto, Fixed, 95% CI)

6.93 [2.55, 18.83]

3.1 BtA responder patients

1

40

Peto Odds Ratio (Peto, Fixed, 95% CI)

5.81 [1.71, 19.79]

3.2 BtA resistant or non‐responder patients

1

20

Peto Odds Ratio (Peto, Fixed, 95% CI)

9.85 [1.75, 55.34]

4 BtB (2500‐10,000U) versus Placebo Show forest plot

1

122

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.69 [2.06, 10.69]

4.1 BtA responder patients

1

88

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.90 [1.46, 10.37]

4.2 BtA resistant or non‐responder patients

1

34

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.35 [1.60, 33.78]

5 BtB (2500‐5000 U) versus BNT/B (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.50 [0.20, 1.25]

5.1 BtA responder patients

1

67

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.52 [0.18, 1.56]

5.2 BtA resistant or non‐responder patients

1

25

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.43 [0.08, 2.43]

Figuras y tablas -
Comparison 1. Improvement of at least 20% in TWSTRS‐Total score at week 4
Comparison 2. Improvement of at least 20% in TWSTRS‐Total score at week 8

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.60 [0.84, 8.07]

2 5000 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.30 [1.11, 9.84]

3 10,000 U BtB versus Placebo Show forest plot

1

60

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.88 [1.70, 13.97]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

1

122

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.13 [1.34, 7.34]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.56 [0.23, 1.33]

Figuras y tablas -
Comparison 2. Improvement of at least 20% in TWSTRS‐Total score at week 8
Comparison 3. Improvement of at least 20% in TWSTRS‐Total score at week 12

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.70 [0.39, 7.42]

2 5000 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.27 [0.93, 11.44]

3 10,000 U BtB vs Placebo Show forest plot

1

60

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.42 [0.97, 11.99]

4 BtB (2500‐10,000U) versus Placebo Show forest plot

1

122

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.43 [0.89, 6.61]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.68 [0.25, 1.84]

Figuras y tablas -
Comparison 3. Improvement of at least 20% in TWSTRS‐Total score at week 12
Comparison 4. Improvement of at least 20% in TWSTRS‐Total score at week 16

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.48 [0.05, 4.85]

2 5000 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.99 [0.68, 13.07]

3 10,000 U BtB versus Placebo Show forest plot

1

60

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.60 [0.54, 12.40]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

1

122

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.86 [0.51, 6.75]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.63 [0.17, 2.27]

Figuras y tablas -
Comparison 4. Improvement of at least 20% in TWSTRS‐Total score at week 16
Comparison 5. Improvement in TWSTRS‐Severity score at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.59 [0.91, 7.38]

2 5000 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.60 [1.68, 12.60]

3 10,000 U BtB versus Placebo Show forest plot

1

60

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.09 [1.09, 8.76]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

1

122

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.18 [1.39, 7.24]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.14 [0.48, 2.71]

Figuras y tablas -
Comparison 5. Improvement in TWSTRS‐Severity score at week 4
Comparison 6. Improvement in TWSTRS‐Disability score at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.30 [1.54, 12.01]

2 5000 U BtB versuss Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.07 [1.06, 8.88]

3 10,000 U BtB versus Placebo Show forest plot

1

60

Peto Odds Ratio (Peto, Fixed, 95% CI)

6.48 [2.35, 17.84]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

1

122

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.10 [1.80, 9.34]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.51 [0.21, 1.23]

Figuras y tablas -
Comparison 6. Improvement in TWSTRS‐Disability score at week 4
Comparison 7. Improvement in TWSTRS‐Pain score at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.31 [0.85, 6.26]

2 5000 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.63 [0.97, 7.13]

3 10,000 U BtB versus Placebo Show forest plot

1

60

Peto Odds Ratio (Peto, Fixed, 95% CI)

6.07 [2.16, 17.03]

4 BtB (2500‐10,000U) versus Placebo Show forest plot

1

122

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.48 [1.49, 8.13]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.39 [0.15, 0.99]

Figuras y tablas -
Comparison 7. Improvement in TWSTRS‐Pain score at week 4
Comparison 8. TWSTRS‐Total score at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000U BtB versus Placebo Show forest plot

2

150

Mean Difference (IV, Fixed, 95% CI)

‐5.92 [‐9.61, ‐2.23]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

‐7.40 [‐12.38, ‐2.42]

1.2 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

‐4.10 [‐9.61, 1.41]

2 5000 U BtB versus Placebo Show forest plot

1

72

Mean Difference (IV, Fixed, 95% CI)

‐2.20 [‐8.44, 4.04]

2.1 BtA responder patients

1

72

Mean Difference (IV, Fixed, 95% CI)

‐2.20 [‐8.44, 4.04]

3 10,000U BtB versus 5000 U BoNT/B Show forest plot

1

73

Mean Difference (IV, Fixed, 95% CI)

‐1.90 [‐8.23, 4.43]

3.1 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

‐1.90 [‐8.23, 4.43]

Figuras y tablas -
Comparison 8. TWSTRS‐Total score at week 4
Comparison 9. TWSTRS‐Total score at week 8

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000U BtB versus Placebo Show forest plot

2

150

Mean Difference (IV, Fixed, 95% CI)

‐4.46 [‐8.19, ‐0.73]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

‐5.5 [‐10.26, ‐0.74]

1.2 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

‐2.80 [‐8.81, 3.21]

2 5000 U BtB versus Placebo Show forest plot

1

72

Mean Difference (IV, Fixed, 95% CI)

‐1.90 [‐8.30, 4.50]

2.1 BtA responder patients

1

72

Mean Difference (IV, Fixed, 95% CI)

‐1.90 [‐8.30, 4.50]

3 10,000 U BtB versus 5000 U BtB Show forest plot

1

73

Mean Difference (IV, Fixed, 95% CI)

‐0.90 [‐7.13, 5.33]

3.1 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

‐0.90 [‐7.13, 5.33]

Figuras y tablas -
Comparison 9. TWSTRS‐Total score at week 8
Comparison 10. TWSTRS‐Total score at week 12

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000 U BtB versus Placebo Show forest plot

2

150

Mean Difference (IV, Fixed, 95% CI)

‐1.72 [‐5.57, 2.13]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

‐3.70 [‐8.95, 1.55]

1.2 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

0.60 [‐5.07, 6.27]

2 5000 U BtB versus Placebo Show forest plot

1

72

Mean Difference (IV, Fixed, 95% CI)

0.70 [‐5.10, 6.50]

2.1 BtA responder patients

1

72

Mean Difference (IV, Fixed, 95% CI)

0.70 [‐5.10, 6.50]

3 10,000U BtB versus 5000 U BtB Show forest plot

1

73

Mean Difference (IV, Fixed, 95% CI)

‐0.10 [‐5.75, 5.55]

3.1 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

‐0.10 [‐5.75, 5.55]

Figuras y tablas -
Comparison 10. TWSTRS‐Total score at week 12
Comparison 11. TWSTRS‐Total score at week 16

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000U BtB versus Placebo Show forest plot

2

150

Mean Difference (IV, Fixed, 95% CI)

1.54 [‐2.21, 5.30]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

‐1.30 [‐6.40, 3.80]

1.2 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

4.90 [‐0.65, 10.45]

2 5000 U BtB versus Placebo Show forest plot

1

72

Mean Difference (IV, Fixed, 95% CI)

2.20 [‐3.77, 8.17]

2.1 BtA responder patients

1

72

Mean Difference (IV, Fixed, 95% CI)

2.20 [‐3.77, 8.17]

3 10,000 U BtB versus 5000 U BtB Show forest plot

1

73

Mean Difference (IV, Fixed, 95% CI)

2.80 [‐2.39, 7.99]

3.1 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

2.80 [‐2.39, 7.99]

Figuras y tablas -
Comparison 11. TWSTRS‐Total score at week 16
Comparison 12. TWSTRS‐Severity score at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000 U BtB versus Placebo Show forest plot

1

77

Mean Difference (IV, Fixed, 95% CI)

‐2.10 [‐4.39, 0.19]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

‐2.10 [‐4.39, 0.19]

Figuras y tablas -
Comparison 12. TWSTRS‐Severity score at week 4
Comparison 13. TWSTRS‐Disability score at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000 U BtB versus Placebo Show forest plot

1

77

Mean Difference (IV, Fixed, 95% CI)

‐1.60 [‐3.77, 0.57]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

‐1.60 [‐3.77, 0.57]

Figuras y tablas -
Comparison 13. TWSTRS‐Disability score at week 4
Comparison 14. TWSTRS‐Pain score at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000,U BtB versus Placebo Show forest plot

1

77

Mean Difference (IV, Fixed, 95% CI)

‐3.70 [‐5.64, ‐1.76]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

‐3.70 [‐5.64, ‐1.76]

Figuras y tablas -
Comparison 14. TWSTRS‐Pain score at week 4
Comparison 15. Patient Global Assessment of Change at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000 U BtB versus Placebo Show forest plot

2

150

Mean Difference (IV, Fixed, 95% CI)

20.84 [14.22, 27.45]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

20.70 [11.73, 29.67]

1.2 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

21.00 [11.20, 30.80]

2 5000 U BtB versus Placebo Show forest plot

1

72

Mean Difference (IV, Fixed, 95% CI)

17.0 [6.93, 27.07]

2.1 BtA responder patients

1

72

Mean Difference (IV, Fixed, 95% CI)

17.0 [6.93, 27.07]

3 10,000U BtB versus 5000 U BtB Show forest plot

1

73

Mean Difference (IV, Fixed, 95% CI)

4.00 [‐5.85, 13.85]

3.1 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

4.00 [‐5.85, 13.85]

Figuras y tablas -
Comparison 15. Patient Global Assessment of Change at week 4
Comparison 16. Principal Investigator Global Assessment of Change at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000U BtB versus Placebo Show forest plot

2

150

Mean Difference (IV, Fixed, 95% CI)

12.52 [7.97, 17.08]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

12.70 [7.04, 18.36]

1.2 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

12.20 [4.50, 19.90]

2 5000 U BtB versus Placebo Show forest plot

1

72

Mean Difference (IV, Fixed, 95% CI)

13.30 [5.10, 21.50]

2.1 BtA responder patients

1

72

Mean Difference (IV, Fixed, 95% CI)

13.30 [5.10, 21.50]

3 10,000 U BtB versus 5000 U BtB Show forest plot

1

73

Mean Difference (IV, Fixed, 95% CI)

‐1.10 [‐8.92, 6.72]

3.1 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

‐1.10 [‐8.92, 6.72]

Figuras y tablas -
Comparison 16. Principal Investigator Global Assessment of Change at week 4
Comparison 17. Patient Analog Pain Assessment at week 4

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 10,000U BtB versus Placebo Show forest plot

2

150

Mean Difference (IV, Fixed, 95% CI)

19.63 [11.69, 27.56]

1.1 BtA resistant patients

1

77

Mean Difference (IV, Fixed, 95% CI)

20.40 [9.90, 30.90]

1.2 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

18.60 [6.50, 30.70]

2 5000 U BtB versus Placebo Show forest plot

1

72

Mean Difference (IV, Fixed, 95% CI)

18.0 [5.69, 30.31]

2.1 BtA responder patients

1

72

Mean Difference (IV, Fixed, 95% CI)

18.0 [5.69, 30.31]

3 10,000 U BtB versus 5000 U BtB Show forest plot

1

73

Mean Difference (IV, Fixed, 95% CI)

0.60 [‐11.33, 12.53]

3.1 BtA responder patients

1

73

Mean Difference (IV, Fixed, 95% CI)

0.60 [‐11.33, 12.53]

Figuras y tablas -
Comparison 17. Patient Analog Pain Assessment at week 4
Comparison 18. Any Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 5000 U BtB versus Placebo Show forest plot

1

72

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.58 [0.42, 5.96]

2 10,000 U BtB versus Placebo Show forest plot

2

150

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.90 [0.72, 4.99]

3 BtB (5000‐10,000 U) vs Placebo Show forest plot

2

186

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.10 [0.84, 5.24]

4 BtB (5000 U) versus BtB (10,000 U) Show forest plot

1

73

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.83 [0.51, 6.52]

Figuras y tablas -
Comparison 18. Any Adverse Event
Comparison 19. Dry Mouth Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.97 [0.06, 15.84]

2 5000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.55 [0.99, 12.76]

3 10,000 U BtB versus Placebo Show forest plot

3

210

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.76 [3.87, 15.54]

4 BtB (2500‐10,000 U) vs Placebo Show forest plot

3

307

Peto Odds Ratio (Peto, Fixed, 95% CI)

5.19 [2.69, 10.03]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

2

167

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.19 [0.09, 0.40]

Figuras y tablas -
Comparison 19. Dry Mouth Adverse Event
Comparison 20. Dysphagia Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

8.23 [1.34, 50.56]

2 5000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.77 [1.15, 19.74]

3 10,000 U BtB versus Placebo Show forest plot

3

210

Peto Odds Ratio (Peto, Fixed, 95% CI)

6.20 [2.87, 13.37]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

3

308

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.37 [2.18, 8.79]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

2

165

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.42 [0.18, 0.98]

Figuras y tablas -
Comparison 20. Dysphagia Adverse Event
Comparison 21. Pain secondary to CD Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.70 [0.15, 3.35]

2 5000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.09 [0.46, 2.56]

3 10,000 U BtB versus Placebo Show forest plot

3

210

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.22 [0.63, 2.33]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

3

308

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.10 [0.60, 1.99]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

2

165

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.71 [0.33, 1.56]

Figuras y tablas -
Comparison 21. Pain secondary to CD Adverse Event
Comparison 22. Infection Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.94 [1.06, 59.29]

2 5000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.39 [0.55, 3.49]

3 10,000 U BtB versus Placebo Show forest plot

3

210

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.97 [0.46, 2.07]

4 BtB (2500‐10,000U) versus Placebo Show forest plot

3

308

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.16 [0.61, 2.24]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

2

165

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.59 [0.66, 3.81]

Figuras y tablas -
Comparison 22. Infection Adverse Event
Comparison 23. Injection site pain Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.70 [0.39, 7.42]

2 5000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.34 [0.44, 4.07]

3 10,000 U BtB versus Placebo Show forest plot

3

210

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.84 [0.80, 4.21]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

3

308

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.66 [0.79, 3.48]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

2

165

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.84 [0.33, 2.16]

Figuras y tablas -
Comparison 23. Injection site pain Adverse Event
Comparison 24. Headache Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.48 [0.24, 9.10]

2 5000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.34 [0.82, 6.69]

3 10,000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.84 [0.61, 5.54]

4 BtB (2500‐10,000U) versus Placebo Show forest plot

2

231

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.92 [0.81, 4.59]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

2

165

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.25 [0.50, 3.09]

Figuras y tablas -
Comparison 24. Headache Adverse Event
Comparison 25. Flu syndrome Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.40 [0.45, 121.11]

2 5000 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.66 [0.77, 76.54]

3 10,000 U BtB versus Placebo Show forest plot

1

60

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.93 [0.79, 79.26]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

1

122

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.09 [0.78, 21.44]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.96 [0.22, 4.15]

Figuras y tablas -
Comparison 25. Flu syndrome Adverse Event
Comparison 26. Nausea Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.77 [0.37, 20.69]

2 5000 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.97 [0.06, 15.84]

3 10,000 U BtB versus Placebo Show forest plot

2

137

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.28 [0.73, 7.12]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

2

199

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.03 [0.70, 5.86]

5 BtB (2500‐5000 U) versus BtB (10,000 U) Show forest plot

1

92

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.61 [0.12, 3.11]

Figuras y tablas -
Comparison 26. Nausea Adverse Event
Comparison 27. Pain Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 2500 U BtB versus Placebo Show forest plot

1

61

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.97 [0.13, 7.22]

2 5000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.69 [0.21, 2.23]

3 10,000 U BtB versus Placebo Show forest plot

2

133

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.82 [0.68, 4.82]

4 BtB (2500‐10,000 U) versus Placebo Show forest plot

2

231

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.17 [0.48, 2.87]

5 BtB (2500‐5000 U) vs BtB (10,000 U) Show forest plot

2

165

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.38 [0.14, 1.03]

Figuras y tablas -
Comparison 27. Pain Adverse Event
Comparison 28. Dyspepsia Adverse Event

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 5000 U BtB versus Placebo Show forest plot

1

72

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.35 [0.05, 2.61]

2 10,000 U BtB versus Placebo Show forest plot

1

73

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.33 [0.28, 6.23]

3 BtB (5000‐10,000 U) versus Placebo Show forest plot

1

109

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.81 [0.18, 3.70]

4 BtB (5000 U) versus BtB (10,000 U) Show forest plot

1

73

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.29 [0.05, 1.75]

Figuras y tablas -
Comparison 28. Dyspepsia Adverse Event