Botulinum toxin injection reduces pain at 2–4, 8–12, and ≥ 16 week follow-ups compared with saline injection (standardized mean differences (SMD) -0.729, -0.446, and -0.543, respectively). A short-term (2–4 or 8–12 week) reduction of grip strength is possible compared with saline.
The results were based on 4 RCTs
Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
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«Lin YC, Wu WT, Hsu YC ym. Comparative effectivenes...»1 | MA of RCTs |
321 Adult patients from 6 RCTs up to 2/2017 with symptoms of epicondylitis more than 3 months, pain in palpation and resisted wrist dorsiflexion. Case studies or -series, and single arm studies without comparison group were excluded. | Botulinum toxin injection 20–60 IU (Botox 20–50 IU in 3 studies, Dysport 60 IU in 3 studies) compared with placebo (saline) (4 studies) or corticosteroid injection (2 studies, (triamcinolone acetonide 40 mg) | Primary outcome: Reduction of pain (VAS) measured before and 2–4 week, and
8–12 weeks, and > 16 weeks after the treatment Secondary outcome: Grip strength |
Moderate |
«Creuzé A, Petit H, de Sèze M. Short-Term Effect of...»2 | RCT | 60 consecutive adult patients from one center with lateral epicondylar tendinopathy resistant to treatment for > 6 months. 29 patients in the Botulinum toxin A group and 28 patients in the placebo group | 40 IU Botulinum toxin A from a 500 IU flask diluted in 5 ml of saline; Placebo 0.4 ml saline. Injected intramuscularly to extensor carpi radialis brevis muscle aided by EMG stimulation | Pain reduction (VAS). Secondary outcomes: Pain continuity (occasional, regular, constant), grip strength, impact of pain on quality of life (VAS), number of patients on sick leave, number of patients requesting additional therapies at day 90. |
Low |
RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis
Reference | Comments |
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«Lin YC, Wu WT, Hsu YC ym. Comparative effectivenes...»1 | 4 studies were two-armed RCTs compared with botulinum toxin with saline injections, one two-armed study compared botulinum with corticosteroid injection. Possible risk of bias due randomization (allocation concealment and random sequence generation). Heterogeneity was not reported. |
«Creuzé A, Petit H, de Sèze M. Short-Term Effect of...»2 | Of the 60 patients, 33 were male and 27 female; mean age, 47.0 ± 7 years. The mean duration of chronic symptoms of lateral epicondylar tendinopathy was 18.7 ± 20 months, and the mean initial VAS score for pain was 56.1 ± 19 mm. The average impact on the patient's quality of life was assessed as 50.8 ± 18 mm on the VAS. |
Results
Reference | Number of studies and number of patients (I/C) | Follow-up time | Standardized mean difference (95% CI) | *Number of patients (%) with a > 50% reduction in initial pain intensity (95% CI) I/C |
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Level of evidence: moderate The level of evidence is downgraded due to imprecision and inconsistency. |
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Botulinum toxin vs placebo | ||||
«Lin YC, Wu WT, Hsu YC ym. Comparative effectivenes...»1 | 3 RCTs Botulinum toxin vs placebo: 122/116 | 2–4 weeks | -0.729 (-1.286, -0.171) | |
«Creuzé A, Petit H, de Sèze M. Short-Term Effect of...»2 | 29/30 | 30 days | *9 (31%) (15% to 51%) / 5 (16,7%) (6% to 35%) | |
«Lin YC, Wu WT, Hsu YC ym. Comparative effectivenes...»1 | 4 RCTs Botulinum toxin vs placebo: 143/135 | 8–12 weeks | -0.446 (-0.740, -0.152) | |
«Creuzé A, Petit H, de Sèze M. Short-Term Effect of...»2 | 29/28 | 90 days | *15 (51,7%) (33% to 71%) / 7 (25%) (10% to 44%), | |
«Lin YC, Wu WT, Hsu YC ym. Comparative effectivenes...»1 | 2 RCTs Botulinum toxin vs placebo: 92/86 | 16 weeks or more | -0.543 (-0.978. -0.107) |
I= intervention; C=comparison; CI=confidence interval
Reference | Number of studies and number of patients (I/C) | Follow-up time | Standardized mean difference (95% CI) |
---|---|---|---|
Level of evidence: moderate. In the short-term RCT «Creuzé A, Petit H, de Sèze M. Short-Term Effect of...»2, the change of grip strength was not properly analysed. |
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«Lin YC, Wu WT, Hsu YC ym. Comparative effectivenes...»1 |
3 RCTs Botulinum toxin vs placebo: 122/116 | 2–4 weeks | -0.334 (-0.591, -0.078) |
4 RCTs Botulinum toxin vs placebo: 143/135 | 8–12 weeks | -0.057 (-0.517, 0.403) | |
2 RCTs Botulinum toxin vs placebo: 92/86 | 16 weeks or more | 0.084 (-0.211, 0.378) | |
Grip strength (N) (I/C, p-value) | |||
«Creuzé A, Petit H, de Sèze M. Short-Term Effect of...»2 |
30/30 | 0 days | 36.5 ± 19 / 30.2 ± 12, p=0.139 |
29/30 | 30 days | 32.4 ± 19.0/30.3 ± 11.0, p=0.081 | |
29/28 | 90 days | 34.3 ± 16/34.2 ± 19, p=0.491 |
I= intervention; C=comparison; CI=confidence interval