Evidence map›Paper›PMID 20668549›Full record

Trial reportPLoS neglected tropical diseases2010

Randomised controlled double-blind non-inferiority trial of two antivenoms for saw-scaled or carpet viper (Echis ocellatus) envenoming in Nigeria.

Isa S Abubakar, Saidu B Abubakar, Abdulrazaq G Habib, Abdulsalam Nasidi, Nandul Durfa, Peter O Yusuf, Solomon Larnyang, John Garnvwa, Elijah Sokomba, Lateef Salako and 5 more

Open access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 5 pooled it
5.3field-weighted citation impact, top 4% 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

65 citing papers in PubMed, 5 syntheses or guidelines pooled it, 141 citations in OpenAlex.

  1. Pooled it
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  5. Snake antivenom for snake venom induced consumption coagulopathy.The Cochrane database of systematic reviews · 2015
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  13. Observational
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  18. [Abdominal bleeding caused by pit viper bite: a case report and literature review].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2024
    Review
  19. Article
  20. Article

5 more citing papers are in PubMed but not listed here.

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

15 authors at 8 institutions in 2 countries.

Isa S AbubakarDepartment of Community Medicine, Bayero University of Kano, Kano, Nigeria.
Saidu B Abubakar
Abdulrazaq G Habib
Abdulsalam Nasidi
Nandul Durfa
Peter O Yusuf
Solomon Larnyang
John Garnvwa
Elijah Sokomba
Lateef Salako
R David G Theakston
Ed Juszczak
Nicola Alder
David A Warrell
Nigeria-UK EchiTab Study Group
Liverpool School of Tropical Medicine · GBUniversity of Oxford · GBBayero University Kano · NGFederal Ministry of Health · NGAhmadu Bello University · NGGombe State University · NGUniversity of Ibadan · NGUniversity of Jos · NG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn West Africa, envenoming by saw-scaled or carpet vipers (Echis ocellatus) causes great morbidity and mortality, but there is a crisis in supply of effective and affordable antivenom (ISRCTN01257358).

methodsIn a randomised, double-blind, controlled, non-inferiority trial, "EchiTAb Plus-ICP" (ET-Plus) equine antivenom made by Instituto Clodomiro Picado was compared to "EchiTAb G" (ET-G) ovine antivenom made by MicroPharm, which is the standard of care in Nigeria and was developed from the original EchiTAb-Fab introduced in 1998. Both are caprylic acid purified whole IgG antivenoms. ET-G is monospecific for Echis ocellatus antivenom (initial dose 1 vial) and ET-Plus is polyspecific for E. ocellatus, Naja nigricollis and Bitis arietans (initial dose 3 vials). Both had been screened by pre-clinical and preliminary clinical dose-finding and safety studies. Patients who presented with incoagulable blood, indicative of systemic envenoming by E. ocellatus, were recruited in Kaltungo, north-eastern Nigeria. Those eligible and consenting were randomly allocated with equal probability to receive ET-Plus or ET-G. The primary outcome was permanent restoration of blood coagulability 6 hours after the start of treatment, assessed by a simple whole blood clotting test repeated 6, 12, 18, 24 and 48 hr after treatment. Secondary (safety) outcomes were the incidences of anaphylactic, pyrogenic and late serum sickness-type antivenom reactions.

findingsInitial doses permanently restored blood coagulability at 6 hours in 161/194 (83.0%) of ET-Plus and 156/206 (75.7%) of ET-G treated patients (Relative Risk [RR] 1.10 one-sided 95% CI lower limit 1.01; P = 0.05). ET-Plus caused early reactions on more occasions than did ET-G [50/194 (25.8%) and 39/206 (18.9%) respectively RR (1.36 one-sided 95% CI 1.86 upper limit; P = 0.06). These reactions were classified as severe in 21 (10.8%) and 11 (5.3%) of patients, respectively.

conclusionAt these doses, ET-Plus was slightly more effective but ET-G was slightly safer. Both are recommended for treating E. ocellatus envenoming in Nigeria.

trial registrationCurrent Controlled Trials ISRCTN01257358.

Indexed as

AdolescentAdultAnimalsAntiveninsBlood Coagulation TestsChildDouble-Blind MethodFemaleHumansMaleMiddle AgedNigeriaPoisoningTreatment OutcomeViperidaeViper VenomsAntiveninsViper Venoms

Identifiers

PMID20668549
PMCPMC2910709
OpenAlexW2032009841

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.