Non-Cochrane · intervention · PM37828600
The effectiveness and safety of botulinum toxin injections for the treatment of sialorrhea with Parkinson's disease: a systematic review and meta-analysis.
Yang Chun-Lan, Huang Jia-Peng, Tan Ying-Chao, et al. · BMC pharmacology & toxicology · 2023 · PubMed · doi:10.1186/s40360-023-00694-7
Full textEvery question was extracted from the full text, figures and supplements by two independent LLM extractors, disagreements adjudicated. Rows cite where in the review the value comes from.
Questions
6
current version
GRADE rated
2
No studies
0
Included studies
8
linked below
No studies 0 · 0%Ungraded 4 · 66.7%Very low 0 · 0%Low 1 · 16.7%Moderate 0 · 0%High 1 · 16.7%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Patients diagnosed with sialorrhea (drooling) caused by Parkinson's disease | Adults with Parkinson's disease and sialorrhea; 8 included articles / 10 treatment cohorts, 259 patients (n=8 studies) |
| Intervention | Botulinum toxin (BoNT) injection | BoNT injection: type A (BoNt-A) and type B (BoNt-B); doses 100-4000 U; delivered by anatomic landmarks or ultrasound guidance (n=8 studies) |
| Comparison | Placebo | Placebo injection (n=8 studies) |
| Outcomes | Primary: Drooling Severity and Frequency Scale (DSFS) score; Secondary: adverse events (AEs) | DSFS meta-analyzed in 9 study-comparisons (SMD -0.98, 95% CI -1.27 to -0.70; COE high); adverse events in 10 study-comparisons (RD 0.15, 95% CI 0.05 to 0.24; COE low) |
| Study designs | Randomized controlled trials or randomized crossover trials | 8 RCTs / randomized crossover trials (multi-dose arms of one trial split into separate comparisons) |
| Timing | Not specified | Outcomes mostly assessed ~1 month post-injection; one study ~1 week |
Search date: April 2022. Databases: PubMed; Scopus; Cochrane CENTRAL; Embase; Web of Science; plus Google Scholar and ClinicalTrials.gov
Questions and results
Botulinum toxin (BoNT) injection into salivary glands vs Placebo injection
Population: Adults with Parkinson's disease and sialorrhea (drooling)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Drooling Severity and Frequency Scale (DSFS) score Approximately 1 month post-injection (one study ~1 week) Botulinum toxin injection reduces Drooling Severity and Frequency Scale scores versus placebo in Parkinson's disease sialorrhea (SMD -0.98, 95% CI -1.27 to -0.70; high certainty). Source: Abstract; Results 'Outcome of DSFS'; Fig. 4 (forest plot, overall diamond) · same question in other reviews | SMD -0.98 [-1.27, -0.70] | 9 studies · 224 participants | High |
Drooling Severity and Frequency Scale (DSFS) score Approximately 1 month post-injection (one study ~1 week) · BoNT type A Type A botulinum toxin significantly reduced DSFS scores versus placebo (SMD -0.80, 95% CI -1.25 to -0.36; ungraded subgroup). Source: Results 'Outcome of DSFS'; Fig. 4 (forest plot, subgroup 1.1.2 BoNt-A) · same question in other reviews | SMD -0.80 [-1.25, -0.36] | 4 studies · 88 participants | Ungraded |
Drooling Severity and Frequency Scale (DSFS) score Approximately 1 month post-injection (one study ~1 week) · BoNT type B Type B botulinum toxin significantly reduced DSFS scores versus placebo (SMD -1.11, 95% CI -1.48 to -0.74; ungraded subgroup); no significant difference between types A and B (p=0.30). Source: Results 'Outcome of DSFS'; Fig. 4 (forest plot, subgroup 1.1.3 BoNt-B) · same question in other reviews | SMD -1.11 [-1.48, -0.74] | 5 studies · 136 participants | Ungraded |
Adverse events (participants with >=1 adverse event) Approximately 1 month post-injection (one study ~1 week) · BoNT type A Type A botulinum toxin showed a borderline, non-significant increase in adverse events versus placebo (RD 0.10, 95% CI 0.00 to 0.21; ungraded subgroup). Source: Results 'Outcome of adverse events'; Fig. 6 (forest plot, subgroup 2.1.2 BoNt-A) · same question in other reviews | RD 0.10 [0.00, 0.21] | 5 studies · 117 participants | Ungraded |
Adverse events (participants with >=1 adverse event) Approximately 1 month post-injection (one study ~1 week) Botulinum toxin injection increases the risk of adverse events versus placebo in Parkinson's disease sialorrhea (RD 0.15, 95% CI 0.05 to 0.24; low certainty); most events were mild and self-limited. Source: Abstract; Results 'Outcome of adverse events'; Fig. 6 (forest plot, overall diamond) · same question in other reviews | RD 0.15 [0.05, 0.24] | 10 studies · 249 participants | Low |
Adverse events (participants with >=1 adverse event) Approximately 1 month post-injection (one study ~1 week) · BoNT type B Type B botulinum toxin significantly increased adverse events versus placebo (RD 0.18, 95% CI 0.04 to 0.33; ungraded subgroup); no significant difference between types A and B (p=0.37). Source: Results 'Outcome of adverse events'; Fig. 6 (forest plot, subgroup 2.1.3 BoNt-B) · same question in other reviews | RD 0.18 [0.04, 0.33] | 5 studies · 132 participants | Ungraded |
AMSTAR 2 appraisal
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Yes | yes |
| 2Protocol established before the reviewcritical | Partial Yes | Partial Yes | yes |
| 3Choice of study designs explained | Yes | No | no |
| 4Comprehensive literature searchcritical | Partial Yes | Yes | no |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | No | No | yes |
| 8Included studies described in detail | Partial Yes | Yes | no |
| 9Risk of bias assessed satisfactorilycritical | RCT: Yes · NRSI: N/A | NRSI: N/A · RCT: Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: Yes · NRSI: N/A | NRSI: N/A · RCT: Yes | no |
| 12Impact of risk of bias on the pooled results | No | No | yes |
| 13Risk of bias accounted for in interpretationcritical | No | No | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | Yes | Yes | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Critically Low | Critically Low | yes |
Included primary studies 8
Open as a trial list| Study | Also included by | Outcomes it informs here | Trial PICO | Results |
|---|---|---|---|---|
| Tiigimae-Saar 2018 Saliva changes in Parkinson’s disease patients after injection of Botulinum neurotoxin type A DOI:10.1007/s10072-018-3279-4 | 1 other review | not stated | not extracted yet | not extracted yet |
| Chinnapongse 2012 Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: A prospective double‐blind trial DOI:10.1002/mds.23929 | this review only | not stated | not extracted yet | not extracted yet |
| Lagalla 2006 Botulinum toxin type A for drooling in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study DOI:10.1002/mds.20793 | this review only | not stated | not extracted yet | not extracted yet |
| Lagalla 2009 Long-lasting benefits of botulinum toxin type B in Parkinson’s disease-related drooling DOI:10.1007/s00415-009-0085-1 | this review only | not stated | not extracted yet | not extracted yet |
| Mancini 2003 Double‐blind, placebo‐controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in… DOI:10.1002/mds.10420 | this review only | not stated | not extracted yet | not extracted yet |
| Narayanaswami 2015 Poster Presentations DOI:10.1002/mds.26295 | this review only | not stated | not extracted yet | not extracted yet |
| Narayanaswami 2016 Drooling in Parkinson’s disease: A randomized controlled trial of incobotulinum toxin A and meta-analysis of Botulinum toxins DOI:10.1016/j.parkreldis.2016.07.001 | this review only | not stated | not extracted yet | not extracted yet |
| Ondo 2004 A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson’s disease DOI:10.1212/01.wnl.0000101713.81253.4c | this review only | not stated | not extracted yet | not extracted yet |
Overlap with other reviews
Reviews that include the same primary studies are not independent evidence. Shared counts match studies by PMID, DOI or NCT, and otherwise by author and year (a probable match).
| Review | Shared studies | Jaccard |
|---|---|---|
| Oral health effects of botulinum toxin treatment for drooling: a systematic review. (2021) | 1 | 0.07 |