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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Comparative safety and effectiveness of TCu380A versus MLCu375: a systematic review of randomized trials

J Wen, Y Li, YP Li, and L Wang.

Review published: 2009.

Link to full article: [Journal publisher]

CRD summary

This review of 16 low-quality RCTs concluded that TCu380A was a more effective intrauterine device than MLCu375 and had a similar side effect profile, although removals for bleeding and infection were higher. There is some uncertainty regarding the reliability of these conclusions.

Authors' objectives

To compare the relative effectiveness and side effects of two intrauterine devices (IUDs), TCu380A and Multiload Cu375.


PubMed, EMBASE, The Cochrane library, POPLINE, SCOPUS and Chinese Biomedical Literature Database were searched to December 2008 without language restrictions. Search terms were reported. Reference lists of retrieved papers were examined.

Study selection

Randomised controlled trials (RCTs) that compared TCu380A and Multiload Cu375 IUDs were eligible for inclusion. Recording outcomes were pregnancy, continuation, removal, expulsion, infection, pain, abnormal menstruation, uterine perforation and other adverse events.

Studies with greater than 20% loss to follow-up in the first year were excluded

Characteristics of included trials were variable, particularly in terms of insertion time of the IUD and the duration of follow-up, which was less than the five-year life of the IUD in 12 of the 16 trials. Mean age of participants in individual trials was between 20 and 30 years old.

Two reviewers independently selected studies for inclusion. Discrepancies were resolved by consensus following consultation with a third reviewer.

Assessment of study quality

Trial validity was assessed using Cochrane Collaboration 2006 guidelines for randomisation, blinding, allocation concealment, loss to follow-up and comparability of baselines.

Two reviewers independently assessed validity.

Data extraction

Numbers of events and sample sizes were used to calculate relative risks (RR) or risk differences (RD) for each outcome based on intention-to-treat.

Methods of synthesis

Pooled effects were calculated using Mantel-Haenszel fixed-effect models. Subgroup analysis was performed to separate Chinese and non-Chinese study populations. Funnel plots were presented for pregnancy and continuation outcomes.

Results of the review

Sixteen trials (15,236 patients) were included. Most trials had at least one potential bias associated with methodology, which resulted in moderate to high risk of bias in 15 of the 16 included trials.

There were significantly fewer pregnancies with TCu380A compared to MLCu375 at all time points including five-year follow-up (RR 0.49, 95% CI 0.33 to 0.72; 16 trials). There were significantly fewer expulsions with TCu380A compared to MLCu375 at five years (RR 0.63, 95% CI 0.45 to 0.89; 16 trials) and at three years, but not at earlier follow-up.

There were more removals with TCu380A than MLCu375 for bleeding and/or pain at three years (RR 1.83, 95% CI 1.28 to 2.62; 13 trials) and at three months and two years, but not at six months, one year or five years.

There was higher risk of pelvic inflammatory disease when using TCu380A compared to MLCu375 when all studies that measured pelvic inflammatory disease were pooled irrespective of length of follow-up (RR 1.47, 95% CI 1.03 to 2.11; eight trials). There were no significant differences in continuation rates, uterine perforation or removal for bleeding at any measured follow-up.

Visual examination of the funnel plots for pregnancy and continuation outcomes showed no discrimination in effects between large and small studies.

Authors' conclusions

TCu380A was more effective than MLCu375 and had a similar side-effect profile

CRD commentary

The review addressed a well-defined question. Appropriate methods were used to minimise biases during the search and selection of studies. Study validity was assessed and appropriate methods of pooling data were adopted. The generation of effects based on intention-to-treat assumed that drop-outs experienced the best outcome for both treatments. Sensitivity analysis based on worst outcome would reduce uncertainty regarding potential risk of bias. Use of multiple outcomes and end points increased the risk of generating statistically significant results by chance alone.

Methodological issues and the poor quality of the original trials resulted in some uncertainty about the robustness of both the results and conclusions.

Implications of the review for practice and research

The authors did not state any implications for practice or further research.


National Tenth Five-year Key Technology R&D Program Project (2004BA72032); National Eleventh Five-year Key Technology R&D Program Project (2006BAI15B07).

Bibliographic details

Wen J, Li Y, Li YP, Wang L. Comparative safety and effectiveness of TCu380A versus MLCu375: a systematic review of randomized trials. Journal of Evidence-Based Medicine 2009; 2(4): 226-241. [PubMed: 21349021]

Indexing Status

Subject indexing assigned by CRD


Female; Humans; Intrauterine Devices; Intrauterine Devices, Copper



Database entry date


Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 21349021


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