Evidence
This page contains a snapshot of featured content which highlights evidence addressing key clinical questions including areas of uncertainty. Please see the main topic reference list for details of all sources underpinning this topic.
BMJ Best Practice evidence tables
Evidence tables provide easily navigated layers of evidence in the context of specific clinical questions, using GRADE and a BMJ Best Practice Effectiveness rating. Follow the links at the bottom of the table, which go to the related evidence score in the main topic text, providing additional context for the clinical question. Find out more about our evidence tables.
This table is a summary of the analysis reported in a guideline (underpinned by a systematic review) that focuses on the above important clinical question.
Confidence in the evidence is very low or low where GRADE has been performed and the intervention may be more effective/beneficial than the comparison for key outcomes. However, this is uncertain and new evidence could change this in the future.
Population: Women of reproductive age between menarche and menopause with heavy menstrual bleeding (including women with no identified pathology or fibroids)
Intervention: Levonorgestrel intrauterine device
Comparison: Other pharmacological or any surgical treatment for heavy menstrual bleeding
| Outcome | Effectiveness (BMJ rating)? | Confidence in evidence (GRADE)? |
|---|---|---|
Levonorgestrel intrauterine device versus tranexamic acid in women with no identified pathology | ||
Health-related quality of life (HRQoL) at 6 months: social domain | Favours comparison | Very Low |
HRQoL at 6 months: physical, psychosocial, or environmental domains | No statistically significant difference | Low to Very Low ᵃ |
Levonorgestrel intrauterine device versus progestogens in women with no identified pathology | ||
HRQoL at 6 months: social domain | Favours comparison | Very Low |
HRQoL at 6 months: physical, psychosocial, or environmental domains | No statistically significant difference | Low to Very Low ᵃ |
Vaginitis within 6 months/cycles of treatment | No statistically significant difference | Moderate |
Urinary tract infection within 6 months/cycles of treatment | No statistically significant difference | Low |
Levonorgestrel intrauterine device versus a combined oral contraceptive in women with no identified pathology | ||
HRQoL: self-rated health very good or excellent at 12 months | No statistically significant difference | Very Low |
HRQoL: no. of days in previous 30 days feeling physically unwell, change from baseline at 12 months | Favours intervention ᵇ | Very Low |
HRQoL: no. of days in previous 30 days feeling mentally unwell, change from baseline at 12 months | Favours comparison | Low |
HRQoL: no. of lost days in the previous 30 days, change from baseline at 12 months | Favours intervention | Low |
Levonorgestrel intrauterine device versus variety of pharmacological treatments ᶜ in women with no identified pathology | ||
HRQoL: change from baseline at 6 months, 12 months, and 2 years | Favours intervention | Moderate |
HRQoL: change from baseline at 5 years | No statistically significant difference | Moderate |
Levonorgestrel intrauterine device versus first-generation endometrial resection/ablation in women with no identified pathology | ||
Uterine perforation | No statistically significant difference | Low |
Infection post procedure (pelvic inflammatory disease, endometritis, vaginitis, myometritis) | No statistically significant difference | Low to Very Low ᵃ |
Levonorgestrel intrauterine device versus hysterectomy in women with no identified pathology | ||
Wound infection post procedure | Favours intervention | High |
Infection post procedure (peritonitis or infected pelvic haematoma) | No statistically significant difference | Low |
Internal organ injury (bowel perforation, bladder perforation, ureter lesion, or vesicovaginal fistula) | No statistically significant difference | Low |
Thromboembolic event | No statistically significant difference | Low |
Levonorgestrel intrauterine device versus norethisterone in women with suspected or diagnosed fibroids | ||
Reduction in blood loss (Pictorial Blood Loss Assessment Chart score): change from baseline at 6 months | Favours intervention | Very Low |
Levonorgestrel intrauterine device versus a combined oral contraceptive in women with fibroids | ||
Reduction in blood loss (Pictorial Blood Loss Assessment Chart score): change from baseline at 12 months | Favours intervention | Very Low |
Menstrual blood loss in ml (alkaline hematin method) change from baseline at 12 months | Favours intervention | Moderate |
HRQoL: self-rated health good or excellent at 12 months | No statistically significant difference | Very Low |
HRQoL: no. of days in previous 30 days feeling physically unwell, change from baseline at 12 months | Favours intervention | Very Low |
HRQoL: no. of days in previous 30 days feeling mentally unwell, change from baseline at 12 months | Favours intervention | Low |
HRQoL: no. of lost days in the previous 30 days, change from baseline at 12 months | Favours intervention | Low |
Recommendations as stated in the source guideline The National Institute for Health and Care Excellence (NICE) 2018 guideline on Heavy menstrual bleeding makes the following recommendation: Consider a levonorgestrel intrauterine device as the first treatment for heavy menstrual bleeding in women with: no identified pathology or fibroids less than 3 cm in diameter, which are not causing distortion of the uterine cavity or suspected or diagnosed adenomyosis.
Note Adverse events that only applied to levonorgestrel intrauterine devices (e.g., expulsion of device) were considered important but not critical for decision making by the guideline committee, therefore they have not been included in this table (see guideline for more information). From the direct evidence outlined in the table above and from indirect evidence from network meta-analyses (see guideline for more details), the guideline committee felt that for women with heavy menstrual bleeding and either no identified pathology, fibroids less than 3 cm in diameter, or suspected/diagnosed adenomyosis, the evidence showed that a levonorgestrel intrauterine device is as effective, or more effective, than other treatments in terms of improving health-related quality of life, treatment satisfaction, discontinuation rates, and blood loss. However, they agreed that there was a need for further research into the efficacy of the progestogen-only pill, injectable progestogens, or progestogen implants leading them to make a weak “consider” recommendation for a levonorgestrel intrauterine device as the first-line treatment. ᵃ Effectiveness was the same, but GRADE was either low or very low for the different outcomes listed. ᵇ This result was not thought to be clinically important by the guideline group (mean difference 0.9 days lower, 95% CI 1.59 lower to 0.21 lower) ᶜ Treatments in the comparison group were chosen according to the woman’s contraceptive needs and personal choice regarding hormone therapy. They included: mefenamic acid, tranexamic acid, norethisterone, COC or progestogen-only oral contraceptive pill, or medroxyprogesterone acetate injection.
This evidence table is related to the following section/s:
This table is a summary of the analysis reported in a Cochrane Clinical Answer that focuses on the above important clinical question.
Confidence in the evidence is very low or low where GRADE has been performed and the intervention may be more effective/beneficial than the comparison for key outcomes. However, this is uncertain and new evidence could change this in the future.
Population: Women (age 15-50 years where reported) with heavy menstrual bleeding (described by the women, Pictorial Blood Assessment Chart [PBAC] score >100‐130 for 2 months or >80 mL per cycle blood loss)
Intervention: Tranexamic acid
Comparison: Progestogens (medroxyprogesterone or norethisterone or levonorgestrel intrauterine system)
| Outcome | Effectiveness (BMJ rating)? | Confidence in evidence (GRADE)? |
|---|---|---|
Menstrual blood loss (follow up: 2-3 months): PBAC scores | No statistically significant difference | Very Low |
Menstrual blood loss (follow up: 2-3 months): number of women classified as having improved menstrual blood loss | Favours intervention | Low |
Quality of life: improvement in quality of life | No statistically significant difference | GRADE assessment not performed for this outcome |
Quality of life: SF-36 | No statistically significant difference | GRADE assessment not performed for this outcome |
Quality of life: heavy menstrual bleeding-specific scores | No statistically significant difference | Low |
Adverse events | Occurs more commonly with progestogens compared with tranexamic acid (favours intervention) | Low |
Note The Cochrane Clinical Answer (CCA) notes that while there is no evidence of a difference between treatment groups for quality of life, small numbers of women were included in these evaluations resulting in underpowered analyses. The Cochrane review which this CCA is based on also states that the oral administration of antifibrinolytic therapy, including tranexamic acid, does not seem to result in an increase in any major adverse events. However, most studies evaluated in the review did not include venous thromboembolism (VTE) as an endpoint. Those studies that did conclude there was no increased risk of VTE were underpowered, providing insufficient evidence when assessing the risk of thromboembolism due to antifibrinolytic treatment.
This evidence table is related to the following section/s:
Cochrane Clinical Answers
Cochrane Clinical Answers (CCAs) provide a readable, digestible, clinically focused entry point to rigorous research from Cochrane systematic reviews. They are designed to be actionable and to inform decision making at the point of care and have been added to relevant sections of the main Best Practice text.
- How do combined hormonal contraceptives compare with placebo for women with heavy menstrual bleeding?
- For women with heavy menstrual bleeding, how does tranexamic acid (TXA) compare with progestogens?
- For women with heavy menstrual bleeding, how do antifibrinolytics compare with placebo?
- How do different second‐generation endometrial ablation techniques compare after at least one year in women with heavy menstrual bleeding?
- How do first‐ and second‐generation endometrial ablation techniques compare at one year and later in women with heavy menstrual bleeding?
- How do ablation techniques compare with transcervical resection of the endometrium at one year and later in women with heavy menstrual bleeding?
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