Evidence map›Paper›PMID 24232445›Full record

Trial reportPsychopharmacology2014

The impact of missing data on clinical trials: a re-analysis of a placebo controlled trial of Hypericum perforatum (St Johns wort) and sertraline in major depressive disorder.

Anneke C Grobler, Glenda Matthews, Geert Molenberghs

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychopharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 25% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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 3 institutions in 2 countries.

Anneke C Grobler
Glenda Matthews
Geert Molenberghs
Centre for the AIDS Programme of Research in South Africa · ZAKU Leuven · BEUniversity of KwaZulu-Natal · ZA

Funding

COORDINATING CENTER FOR CLINICAL TRIAL OF HYPERICUM-278970007N01MH070007 · NIMH · DUKE UNIVERSITY · 1997 to 2003
$1.2M
NIMH NIH HHS N01 MH070007
6 · The paper itself

Abstract

RATIONALE AND

objectiveHypericum perforatum (St John's wort) is used to treat depression, but the effectiveness has not been established. Recent guidelines described the analysis of clinical trials with missing data, inspiring the reanalysis of this trial using proper missing data methods. The objective was to determine whether hypericum was superior to placebo in treating major depression.

methodsA placebo-controlled, randomized clinical trial was conducted for 8 weeks to determine the effectiveness of hypericum or sertraline in reducing depression, measured using the Hamilton depression scale.We performed sensitivity analyses under different assumptions about the missing data process.

resultsThree hundred forty participants were randomized, with 28 % lost to follow-up. The missing data mechanism was not missing completely at random. Under missing at random assumptions, some sensitivity analyses found no difference between either treatment armand placebo, while some sensitivity analyses found a significant difference from baseline to week 8 between sertraline and placebo (-1.28, 95 % credible interval [-2.48; -0.08]), but not between hypericum and placebo (0.56, [-0.64;1.76]). The results were similar when the missing data process was assumed to be missing not at random.

conclusionsThere is no difference between hypericum and placebo, regardless of the assumption about the missing data process. There is a significant difference between sertraline and placebo with some statistical-methods used. It is important to conduct an analysis that takes account of missing data using valid statistically principled methods. The assumptions about the missing data process could influence the results.

Indexed as

HypericumPhytotherapyAntidepressive AgentsDouble-Blind MethodFemaleFollow-Up StudiesHumansLongitudinal StudiesMajor Depressive DisorderMaleModels, StatisticalPatient DropoutsPlant ExtractsPsychiatric Status Rating ScalesSensitivity and SpecificitySertralineAntidepressive AgentsPlant ExtractsSertraline

Identifiers

PMID24232445
PMCPMC4248236
OpenAlexW2071391129

What OpenQuestion holds

Textmetadata
LicenceTDM
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.