Evidence map›Paper›PMID 25119571›Full record

Trial reportPloS one2014

A preliminary pilot randomized crossover study of uzara (Xysmalobium undulatum) versus ibuprofen in the treatment of primary dysmenorrhea.

Karim H I Abd-El-Maeboud, Mohamed A M F Kortam, Mohamed S Ali, Mostafa I Ibrahim, Radwa M M Z Mohamed

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
1.9field-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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Dietary supplements for dysmenorrhoea.The Cochrane database of systematic reviews · 2016
    Pooled it
  3. Article
  4. Article
  5. 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

5 authors at 1 institution in 1 country.

Karim H I Abd-El-MaeboudDepartment of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Mohamed A M F KortamDepartment of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Mohamed S AliDepartment of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Mostafa I IbrahimDepartment of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Radwa M M Z MohamedDepartment of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Ain Shams University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePreliminary evaluation of efficacy and safety of uzara use in treatment of moderate and severe primary dysmenorrhea in comparison to ibuprofen. MATERIALS AND

methodsThis randomized, comparative two way cross-over study comprised 60 single female students at Faculty of Medicine, Ain Shams University, Egypt, aged 19-28 years with moderate (n = 46) or severe (n = 14) primary dysmenorrhea. Participants were randomized to take either uzara (80 mg/8 hours for two doses, then 40 mg/8 hours) then ibuprofen (400 mg/6 hours) in two subsequent cycles or vice versa. The pain intensity, using VAS, was recorded immediately before taking the medication (0 hour) and after 4, 12, 24, 48-60, 96-120 hours. Main outcome measures included effectiveness of pain relief defined as drop of VAS to 3 or less, patient's global evaluation of the drug, absence from school, the use of a rescue medication, and, in those who continued the treatment, the pain intensity difference (PID) at different points after start of medication and its sum (SPID).

resultsUzara was comparably effective to ibuprofen (78.3% vs. 86.7% of cycles; respectively), with comparable rates of effectiveness on global evaluation (being around 50% for either drug), and rates of school absences (11.7% vs. 13.3%; respectively). The need for rescue medication was different (18.3% and 10%; respectively), albeit with no statistical significance. The means of PID at different time points and SPID were comparable, with significantly lower average mean of VAS scores compared to that felt with no medication (1.6 vs. 6.8, p<0.001). Side effects were less with uzara than ibuprofen (0% vs. 8.3%, p<0.05).

conclusionsUzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects. These findings need to be confirmed by a properly designed trial with a larger sample size.

trial registrationCurrent Controlled Trials ISRCTN25618258.

Indexed as

AdultApocynaceaeCross-Over StudiesDysmenorrheaEgyptFemaleHumansIbuprofenPain MeasurementPilot ProjectsPlant ExtractsRandom AllocationTime FactorsIbuprofenPlant Extracts

Identifiers

PMID25119571
PMCPMC4131898
OpenAlexW2142844116

What OpenQuestion holds

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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.