Evidence map›Paper›PMID 23543804›Full record

Trial reportIndian journal of pharmacology

Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: a randomized controlled trial.

Niteeka Maroo, Avijit Hazra, Tapas Das

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Indian journal of pharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% 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, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017
    Guideline
  2. Pooled it
  3. Trial
  4. Trial
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  7. Article
  8. Article
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  11. A combination ofJournal of traditional and complementary medicine · 2020
    Article
  12. Plant Extracts for Sleep Disturbances: A Systematic Review.Evidence-based complementary and alternative medicine : eCAM · 2020
    Review
  13. Updates on Nutraceutical Sleep Therapeutics and Investigational Research.Evidence-based complementary and alternative medicine : eCAM · 2015
    Review
  14. Efficacy of Viola odorata in Treatment of Chronic Insomnia.Iranian Red Crescent medical journal · 2014
    Article
  15. 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

3 authors at 2 institutions in 1 country.

Niteeka MarooDepartment of Pharmacology, Institute of Postgraduate Medical Education and Research, 244B Acharya J C Bose Road, Kolkata, West Bengal, India.
Avijit Hazra
Tapas Das
Institute of Post Graduate Medical Education and Research · INKPC Medical College and Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the efficacy and safety of NSF-3, a polyherbal sedative-hypnotic (containing standardized extracts of Valeriana officinalis, Passiflora incarnate and Humulus lupulus), in comparison to zolpidem in primary insomnia. MATERIALS AND

methodsThe present study was designed as a parallel group, double- blind, randomized, controlled trial and registered with Clinical Trials Registry-India (CTRI/2011/12/002197). Patients diagnosed with primary insomnia with a perceived total sleep time of <6 hours per night and insomnia severity index >7 were included. They were treated with either NSF-3 (one tablet) or zolpidem (one 10 mg tablet) at bedtime for two weeks. Total sleep time, sleep latency and number of awakenings per night were assessed using a sleep diary. Quality of life and daytime sleepiness were evaluated by insomnia severity index and Epworth sleepiness score respectively. Vital signs, routine blood counts, liver and renal function tests, and treatment emergent adverse events were recorded for safety assessment.

resultsA total of 91 subjects were recruited, of which 39 in each group completed the study. There was significant improvement in total sleep time, sleep latency, number of nightly awakenings and insomnia severity index scores in both groups. However, no statistically significant difference was observed between the groups. Epworth sleepiness scores did not change significantly over the study period. Although 12 treatment emergent adverse events were reported with NSF-3 and 16 with zolpidem (commonest was drowsiness in both), most were mild and no serious adverse events were encountered.

conclusionsNSF-3 is a safe and effective short-term alternative to zolpidem for primary insomnia. It remains to be explored whether the benefits are sustained and whether there is dependence liability with this formulation upon long term use.

Indexed as

Plants, MedicinalAdultAgedFemaleHumansHumulusHypnotics and SedativesMaleMiddle AgedPassifloraPlant ExtractsPyridinesSeverity of Illness IndexSleepSleep Initiation and Maintenance DisordersTime FactorsHypnotics and SedativesPlant ExtractsPyridinesZolpidemHumulus lupulusinsomniaPassiflora incarnataValeriana officinaliszolpidem

Identifiers

PMID23543804
PMCPMC3608291
OpenAlexW1990783866

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.