Evidence map›Paper›PMID 12535478›Full record

SynthesisThe Cochrane database of systematic reviews2003

Skin patch and vaginal ring versus combined oral contraceptives for contraception.

M F Gallo, D A Grimes, K F Schulz

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in The Cochrane database of systematic reviews, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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, 21 citations in OpenAlex.

  1. High levels of women's satisfaction and compliance with transdermal contraception: results from a European multinational, 6-month study.Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology · 2011
    Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

M F GalloClinical Research Department, Family Health International, Research Triangle Park, PO Box 13950, North Carolina 27713, USA. mgallo@fhi.org
D A Grimes
K F Schulz
Family Health International 360 · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over those administered via the traditional oral route. The skin patch and vaginal ring could possibly require a lower dose due to increased bioavailability and improved user compliance.

objectivesThe review's objective is to compare the contraceptive efficacy, cycle control, compliance, and safety of the contraceptive skin patch versus combination oral contraceptives and the contraceptive vaginal ring versus combination oral contraceptives. SEARCH STRATEGY: We searched the computerized databases MEDLINE, Popline, Cochrane Controlled Trials Register, EMBASE, and LILACS for trials of the contraceptive patch or the contraceptive ring. We also searched the references of the publications identified for inclusion. We contacted the manufacturers of the skin patch and the contraceptive ring in an attempt to identify published or unpublished trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials in any language comparing the combination contraceptive skin patch with a combination oral contraceptive or the combination contraceptive vaginal ring with a combination oral contraceptive. DATA COLLECTION AND ANALYSIS: Titles and abstracts identified from the literature searches were assessed for potential inclusion. Data were abstracted by both the primary and second reviewers to ensure accuracy and were entered into RevMan 4.1. Peto odds ratios with 95% confidence intervals were calculated for all outcomes. Six- and 13-cycle Kaplan-Meier pregnancy rates were also entered into "Additional Tables." No sensitivity analyses were conducted since the eligible trials used different comparison oral contraceptives. The trials were critically appraised by examining the following factors: the study design; blinding; randomization method; group allocation concealment; exclusions after randomization; loss-to-follow-up; and early discontinuation. MAIN

resultsWe found three trials of the skin patch and no eligible randomized controlled trials of the combination contraceptive vaginal ring. The six-cycle and 13-cycle Kaplan-Meier cumulative probabilities of pregnancy showed that the combination contraceptive skin patch was similar to the control combination oral contraceptive in contraceptive efficacy. One trial found that patch users discontinued early from the trial more often than oral contraceptive users (OR 1.6; 95% CI, 1.3-2.0) but a second trial found no differences in discontinuation between the groups (OR 2.6; 95% CI, 1.0-6.7). Patch users had more self-reported cycles of compliance than oral contraceptive users; the odds ratio of compliance was 2.1 (95% CI, 1.8-2.3). Patch users were more likely to report breast discomfort than oral contraceptive users with an odds ratio of 3.1 (95% CI, 2.3-4.2). The remaining commonly reported adverse events did not differ by group assignment. One trial found that women assigned to use the patch were more likely to discontinue due to adverse events than those assigned to use the oral contraceptive (OR 2.3; 95% CI, 1.6-3.3), but a second trial found no difference (OR 2.8; 95% CI, 0.7-11.3). Few serious adverse events occurred that were considered possibly or likely related to the use of the patch or oral contraceptive. REVIEWER'S

conclusionsThe randomized controlled trials comparing a combination contraceptive skin patch to a combination oral contraceptive showed similar efficacy rates for the two methods. The patch group had better self-reported compliance than the oral contraceptive group. On the other hand, breast tenderness was more common among those randomized to the patch. The patch might lead to early discontinuation (overall and due to adverse events), but the trial results on this outcome were mixed. No conclusions can be drawn regarding the vaginal ring as no eligible trials were available.

Indexed as

Contraceptive Devices, FemaleDrug ImplantsContraceptive Agents, FemaleContraceptives, Oral, CombinedFemaleHumansPregnancyRandomized Controlled Trials as TopicContraceptive Agents, FemaleContraceptives, Oral, CombinedDrug Implants

Identifiers

PMID12535478
OpenAlexW4255750017

What OpenQuestion holds

Textmetadata
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.