Evidence map›Paper›PMID 35266085›Full record

Trial reportAdvances in therapy2022

A Double-Blind, Placebo-Controlled Study of Appropriate Site of Botulinum Toxin Therapy in Hemifacial Spasm.

Suthipun Jitpimolmard, Bandit Thinkhamrop, Somsak Tiamkao, Suwanna Arunpongpaisal, Preeda Arayavichanon, Weerachai Kosuwan, Siriya Jitpimolmard, Kittisak Sawanyawisuth

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Suthipun JitpimolmardDepartment of Medicine, Faculty of Medicine, Khon Kaen University, 123 Mitraparp Rd., Khon Kaen, 40002, Thailand.
Bandit ThinkhamropDepartment of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University, Khon Kaen, Thailand.
Somsak TiamkaoDepartment of Medicine, Faculty of Medicine, Khon Kaen University, 123 Mitraparp Rd., Khon Kaen, 40002, Thailand. somtia@kku.ac.th.
Suwanna ArunpongpaisalDepartment of Psychiatry, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Preeda ArayavichanonDepartment of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Weerachai KosuwanDepartment of Orthopedics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Siriya JitpimolmardSchool of Communication Arts, Bangkok University, Pathum Thani, Thailand.
Kittisak SawanyawisuthDepartment of Medicine, Faculty of Medicine, Khon Kaen University, 123 Mitraparp Rd., Khon Kaen, 40002, Thailand. kittisak@kku.ac.th.ORCID http://orcid.org/0000-0003-3570-8474
Khon Kaen University · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHemifacial spasm (HFS) is a condition causing poor quality of life. Treatment with botulinum toxin A (BTX) injection is effective. Only one randomized controlled trial with a single-blind fashion has evaluated if oral injection is needed in HFS. The present study aimed to evaluate the necessity of oral BTX injection in HFS by a randomized, double-blind, placebo-controlled method.

methodsWe conducted a double-blind, placebo-controlled trial in patients with HFS who never received BTX treatment. Eligible patients randomly received either 15 units of BTX around the eye and normal saline around the mouth (group A) or 15 units of BTX around both the eye and the mouth (group B). The primary outcomes were self-reported symptoms and observed frequency of spasms, while the secondary outcome was the duration of improvement or the time between the injection and the recurrence of symptoms to the same condition as before treatment. Student t test and survival analyses were used to compare the duration of symptoms between both groups. The mean changes were compared to secondary outcomes between the two groups.

resultsThere were 60 patients enrolled, half in each group. Baseline characteristics between both groups were similar. The mean (SD) of the duration of improvement in group A and B was 22.97 (18.85) and 17.53 (14.90) weeks, respectively (p = 0.220). There was no difference between both groups by survival analysis. Group B had a higher percentage of mouth improvement but there was no difference in the percentage of eye improvement, visual analog scale of eye and mouth spasm, or frequency of eye and mouth spasm. Group B had a higher incidence of side effects particularly mouth drooping (30% vs 10%) than group A (p = 0.053).

conclusionThe mouth injection of BTX may not be necessary for HFS. It may be beneficial to reduce mouth symptoms with a higher rate of mouth drooping.

Indexed as

Botulinum Toxins, Type AHemifacial SpasmNeuromuscular AgentsHumansQuality of LifeSingle-Blind MethodTreatment OutcomeBotulinum Toxins, Type ANeuromuscular AgentsBotoxBotulinum toxinDoseHemifacial spasmSite

Identifiers

PMID35266085
OpenAlexW4220774878

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.