Evidence map›Paper›PMID 27105601›Full record

Trial reportBiomedical journal2016

A randomized, open-label, standard controlled, parallel group study of efficacy and safety of baclofen, and chlordiazepoxide in uncomplicated alcohol withdrawal syndrome.

K Girish, K Vikram Reddy, Lakshmi V Pandit, H P Pundarikaksha, R Vijendra, K Vasundara, R Manjunatha, Moulya Nagraj, R Shruthi

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Biomedical journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 12% 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

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Baclofen for alcohol withdrawal.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Baclofen for alcohol withdrawal.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Diagnosis and Management of Alcohol Use Disorder in Patients with Liver Disease: Lights and Shadows.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
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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

9 authors at 1 institution in 1 country.

K GirishDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
K Vikram ReddyDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India. Electronic address: vikramred777@gmail.com.
Lakshmi V PanditDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India; Department of Psychiatry, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
H P PundarikakshaDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
R VijendraDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
K VasundaraDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
R ManjunathaDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
Moulya NagrajDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
R ShruthiDepartment of Pharmacology, KIMS Hospital and Research Center, Bengaluru, Karnataka, India.
Kempegowda Institute of Medical Sciences · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlcohol withdrawal syndrome (AWS) is a distressing condition, generally controlled by benzodiazepines (BZD's). Baclofen, a gamma-aminobutyric acid-B (GABAB) agonist, has also shown promising results in controlling AWS. As there are few studies comparing the efficacy and tolerability of chlordiazepoxide with baclofen, the present study was taken up. The objective of this study was to compare efficacy and tolerability of baclofen with chlordiazepoxide in uncomplicated AWS.

methodsSixty subjects with uncomplicated AWS were randomized into two groups of 30 each, to receive baclofen (30 mg) or chlordiazepoxide (75 mg) in decremented fixed dose regime for 9 days. Clinical efficacy was assessed by Clinical Institute Withdrawal Assessment for Alcohol-Revised Scale (CIWA-Ar) and tolerability by the nature and severity of adverse events. Lorazepam was used as rescue medication. Secondary efficacy parameters were Clinical Global Impression scores, symptom-free days, and subject satisfaction as assessed by visual analog scale. This study was registered with Clinical Trial Registry-India (CTRI/2013/04/003588), also subsequently registered with WHO's ICTRP clinical trial portal.

resultsBoth baclofen and chlordiazepoxide showed a consistent reduction in the total CIWA-Ar scores. However, chlordiazepoxide showed a faster and a more effective control of anxiety and agitation requiring lesser lorazepam supplementation, and also showed a better subject satisfaction compared to baclofen. Both the drugs showed good tolerability with mild self-limiting adverse events.

conclusionThe present study demonstrates that baclofen is not as good as chlordiazepoxide in the treatment of uncomplicated AWS. However, baclofen might be considered as an alternative.

Indexed as

AdultAlcohol DrinkingBaclofenChlordiazepoxideDiazepamHumansLorazepamMaleMiddle AgedSubstance Withdrawal SyndromeTreatment OutcomeBaclofenChlordiazepoxideDiazepamLorazepamAlcohol withdrawal syndromeBaclofenChlordiazepoxideClinical Global Impression scoresClinical Institute Withdrawal Assessment for Alcohol-Revised Scale

Identifiers

PMID27105601
PMCPMC6138810
OpenAlexW2320539563

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.