Adenomyosis treatment options: what the evidence shows

Adenomyosis is a condition in which tissue like the uterine lining is found within the muscular wall of the uterus ^[3]. It is associated with painful periods, heavy menstrual bleeding and, in some studies, lower pregnancy rates ^[2][29]. Treatment research is thinner than the number of available options suggests. Most trials are small, run for 3 to 12 months, and come from a handful of countries ^[2]. Hormonal treatments, uterine artery embolization, thermal ablation, uterus-sparing surgery and hysterectomy have each been studied, mostly in different groups of patients and with different outcome measures, so direct comparisons are scarce. This article describes what those studies found, who was in them, and where the evidence is weak or conflicting. It does not recommend any treatment.

What adenomyosis is, and why treatment studies are hard to compare

Adenomyosis is defined by the presence of endometrial glands and stroma within the myometrium. Historically it could be confirmed only by examining a uterus removed at hysterectomy. A review of the epidemiology notes that this limited research to women who had already had the operation, which creates problems of sample selection ^[3]. Imaging has since become the main way adenomyosis is identified in clinical care, and the Asian Society guideline describes transvaginal ultrasound and magnetic resonance imaging as the mainstay ^[2].

The symptoms are not specific. The Asian Society guideline reports that painful periods occur in 50% to 93% of affected patients, heavy menstrual bleeding in 27% to 65%, and that about one third are reported to have no symptoms ^[2]. A systematic review of 16 studies found prevalence estimates ranging from 20% to 88.8% among symptomatic women, with most diagnoses made between ages 32 and 38 and large differences between studies in diagnostic criteria and patient populations ^[5]. The same review points out that endometriosis often coexists, which makes it hard to say which condition is causing pelvic pain ^[5].

A United States cohort illustrates how often other conditions are recorded alongside adenomyosis. In 333,693 women enrolled in one health system between 2006 and 2015, 18.0% of those with an adenomyosis diagnosis code also had an endometriosis code and 47.6% had a fibroid code. Diagnosis codes were confirmed as adenomyosis in 78.5% of cases that chart review could assess ^[4]. Treatment trials often enroll mixed groups, and the results may not apply to adenomyosis alone.

Two features of the research field matter for everything below. First, there are few randomized trials, and a guideline from the Asian Society of Endometriosis and Adenomyosis states that few have compared drugs head to head ^[2]. Second, the studies measure results in different ways, which is taken up in a later section ^[33].

How guidelines organize the options

The Society of Obstetricians and Gynaecologists of Canada published a guideline on diagnosis and management of adenomyosis in 2023. According to its abstract, the guideline searched several databases through 2022, rated evidence with the GRADE approach, and addresses people of reproductive age with a uterus. It states that treatment options should be tailored to symptoms (heavy menstrual bleeding, pain, infertility) and lists medical options (nonsteroidal anti-inflammatory drugs, tranexamic acid, combined oral contraceptives, the levonorgestrel intrauterine system, dienogest, other progestins and gonadotropin-releasing hormone analogues), an interventional option (uterine artery embolization) and surgical options (endometrial ablation, excision of adenomyosis and hysterectomy) ^[1]. The individual recommendations and their strength are in the full guideline text, which this article did not have access to, so they are not described here.

The Asian Society guideline, also published in 2023, describes medical treatment as the usual first step, with surgery for refractory disease or when long-term medical treatment is unsuitable. It states that relapse after stopping medical treatment is expected, and it lists the factors that influence choice: age, symptoms and their severity, desire for future pregnancy, coexisting conditions such as endometriosis or fibroids, side effects, cost and availability, and the patient's wishes ^[2]. A narrative review of medical therapy reaches a similar view that standardized guidelines for medical management are lacking and that evidence on long-term effects and on pregnancy outcomes is limited ^[6].

Guidelines in this area rest on limited trial data. The Asian Society authors describe published trials as few, often short, and rarely head to head ^[2]. For that reason, much of what follows comes from small randomized trials, observational series and reviews of them.

Pain relievers and tranexamic acid

Nonsteroidal anti-inflammatory drugs and tranexamic acid appear on the Canadian guideline's list of medical options ^[1]. A narrative review of medical therapy states that these drugs provide limited support for mild symptoms or for symptoms that flare during hormonal treatment ^[6]. That review is a narrative synthesis rather than a systematic one, and this article found no randomized trial that tested either drug specifically in adenomyosis. The evidence for these drugs in adenomyosis therefore seems to rest mainly on expert description.

Progestins: dienogest and the levonorgestrel intrauterine system

Progestins are the most studied hormonal group. The Asian Society guideline says the levonorgestrel-releasing intrauterine system is used worldwide as a first-line medical treatment and describes dienogest as effective for painful symptoms, while also stating that long-term data are limited ^[2].

Dienogest

The main placebo-controlled trial of dienogest was a phase III study in Japan. It randomized 67 patients with adenomyosis to dienogest or placebo for 16 weeks. Pain scores and visual analogue scale scores fell significantly more with dienogest than with placebo. Almost all participants taking dienogest had irregular uterine bleeding, and one had mild anemia. The authors conclude that dienogest was effective and well tolerated in adenomyosis not complicated by severe uterine enlargement or severe anemia ^[7].

A 52-week open-label extension in 130 Japanese patients, without a comparison group, reported that pain scores fell further at 24 and 52 weeks. Irregular bleeding was the most common adverse reaction, reported by 96.9%, and hot flushes were reported by 7.7%. The investigators recorded no serious adverse events ^[8]. A retrospective series from one hospital followed 18 patients receiving dienogest for long periods. Twelve (66.7%) continued until menopause or for more than 80 months, and four (22.2%) stopped because of severe irregular bleeding ^[9]. The numbers are very small, and patients who stayed on treatment are a selected group.

A later series of 140 patients aged 18 to 45 treated with a progestin for at least three years reported that dienogest kept lowering pain and heavy bleeding scores in most patients over three years. After the first year, 49% of the dienogest group changed to other treatments because of side effects or a need for contraception. The same series described outcomes for the levonorgestrel intrauterine device, desogestrel and drospirenone, with 15% switching in the intrauterine device group and a higher stopping rate with desogestrel ^[10]. The report did not randomize patients to treatments, so differences between groups may reflect who was given which drug.

Levonorgestrel intrauterine system versus combined oral contraceptive

A randomized trial in 62 participants compared the levonorgestrel intrauterine system with a low-dose combined oral contraceptive over six months. Pain on a visual analogue scale fell in both groups, from 6.23 to 1.68 with the intrauterine system and from 6.55 to 3.90 with the pill. Bleeding days and uterine volume also fell in both groups, with larger changes in the intrauterine system group ^[11]. The trial was short and relatively small.

Dienogest versus the combined oral contraceptive

A randomized trial in Egypt compared dienogest with a combined oral contraceptive in women with symptomatic adenomyosis over six months. Pain scores fell in both groups, with a larger fall in the dienogest group, and uterine volume fell with dienogest. The dienogest group reported more side effects ^[12]. The Asian Society guideline says that in several studies dienogest was equal or superior to combined pills for painful periods but less effective for reducing uterine volume or inducing absence of periods, with more side effects reported ^[2]. That summary comes from a mix of study types.

Dienogest versus the levonorgestrel intrauterine system

Trials comparing these two have not agreed on a winner. An open-label single-center randomized trial in India followed patients for 12 weeks. Pain scores fell from about 6.4 to 3.4 with the intrauterine system and to 3.1 with dienogest. More patients in the intrauterine system group had lighter bleeding (90% versus 77.2%), while quality-of-life scores improved more in the dienogest group. The authors note that neither product is approved for adenomyosis ^[13]. A Chinese trial randomized 117 women, with 48 assigned to the intrauterine system and 79 to dienogest, and followed them for 36 months. Both groups had lower pain scores at three months, and the dienogest group later reported lower scores. Neither treatment significantly reduced uterine volume, though dienogest was associated with less growth in volume ^[14]. The groups were of unequal size, and the abstract describes the design only briefly, which limits interpretation.

A review of 28 studies of the intrauterine system, used alone or with other treatments, found no clear evidence to recommend any single drug for pain and quality of life within 12 months. It reported that the intrauterine system combined with a gonadotropin-releasing hormone agonist did better than the intrauterine system alone on several measures, as did the intrauterine system combined with surgical excision compared with excision alone ^[15]. The abstract reports pooled mean differences across many small studies of varying design, and this article could not assess the quality of each one.

Other hormonal and drug therapies studied

Mifepristone

A multicenter, double-blind, placebo-controlled trial in 10 Chinese hospitals randomized 134 patients with adenomyosis and painful periods to mifepristone or placebo for 12 weeks. The change in visual analogue scale pain was -6.63 with mifepristone and -0.95 with placebo. Effective remission of painful periods was reported in 91.8% of the mifepristone group and 23.1% of the placebo group, and hemoglobin rose more in the mifepristone group ^[16]. The primary end point was measured at 12 weeks, and all participants had painful periods, so the results say little about longer use or about adenomyosis without pain ^[16].

Ulipristal acetate

A double-blind phase 2 pilot trial in five teaching hospitals randomized 40 women with abnormal uterine bleeding and imaging-diagnosed adenomyosis, in a 3 to 1 ratio, to ulipristal acetate or placebo for 12 weeks. In the 28 days after treatment, 95.24% of women in the ulipristal group had a bleeding chart score below 75, compared with none in the placebo group. At six months the groups no longer differed in bleeding or pain ^[17]. The trial was small, and the benefit did not last.

Aromatase inhibitors

Letrozole has been tested in small randomized trials against gonadotropin-releasing hormone agonists. A pilot trial of 156 symptomatic women awaiting in vitro fertilization compared letrozole with goserelin over three months. Pain and bleeding scores fell in both groups. Women taking letrozole kept regular cycles, while most women taking goserelin stopped menstruating ^[18]. The narrative review of medical therapy states that aromatase inhibitors show promise for bleeding and pain but that their safety needs study, with use limited to trials in patients who have not responded to other treatment ^[6].

Gonadotropin-releasing hormone agonists and antagonists

The Asian Society guideline states that agonists reduce uterine size and improve pain after about six months, but it does not recommend long-term use because of low-estrogen effects, including bone loss, and suggests restricting them to patients who have not responded to other medicines or who cannot have surgery ^[2]. The same guideline describes antagonists as promising. It lists high cost, wide variation in individual response, an open question about how to set the dose for each person, and an inadequately assessed possibility of malignant transformation as limitations ^[2].

One recent analysis relates to an oral antagonist-based combination. A post hoc analysis of two phase III trials of relugolix combination therapy included 111 women (18.2% of the trial population) who had both fibroids and ultrasound-diagnosed adenomyosis, among those with heavy menstrual bleeding. Among completers with adenomyosis, 83.8% on the combination met the response definition, compared with 27.6% on placebo, and amenorrhea was reported in 64.9% versus 6.9%. Uterine volume fell by 22.2% versus 5.8% over 24 weeks ^[19]. Because this was a subgroup analysis of trials designed for fibroids, it cannot be read as a trial in adenomyosis alone.

Danazol and combined oral contraceptives

The same review notes that danazol is effective but limited by androgenic side effects, and that combined oral contraceptives may be less effective than progestins but are an option when contraception is also wanted in younger patients ^[6].

Uterine artery embolization

Uterine artery embolization blocks blood flow to the uterus through a catheter. A systematic review and meta-analysis of studies in adenomyosis reported symptom improvement in 83.1% of 1,049 patients and reduced uterine volume at three months. Symptom reduction was greater when fibroids were also present ^[20]. The studies were mostly uncontrolled, and the authors describe the results as encouraging rather than conclusive.

The Asian Society guideline cautions that embolization can affect ovarian function and endometrial receptivity and describes it as contraindicated in women planning pregnancy ^[2].

Two recent studies compared embolization with other treatments. The QUESTA study, registered in the Netherlands, offered embolization as an alternative to hysterectomy for symptomatic adenomyosis in patients eligible for hysterectomy. It began as a randomized trial and was converted to a prospective cohort, with 51 participants choosing hysterectomy and 50 embolization. Health-related quality-of-life scores rose significantly in both groups at one year. The study did not demonstrate that embolization was non-inferior within its prespecified margin. Pain improvement was larger after hysterectomy, and satisfaction was 95% after hysterectomy and 73% after embolization ^[21]. Because participants chose their own treatment, differences at baseline and in preferences may have affected results, although the authors adjusted for several baseline differences.

A single-center randomized trial of 60 patients with MRI-confirmed adenomyosis compared embolization with dienogest at six months. Complete resolution of chronic pelvic pain was reported in 93.3% after embolization versus 66.7% after dienogest, and complete resolution of heavy bleeding in 90.0% versus 56.7% ^[22]. The trial was small, lasted six months, and compared a procedure with a drug that has to be taken continuously, so it says little about longer-term results.

Thermal ablation: focused ultrasound, radiofrequency and microwave

High-intensity focused ultrasound, radiofrequency ablation and microwave ablation heat and destroy targeted adenomyotic tissue. The Asian Society guideline says that all published studies of these methods are retrospective, that no randomized trial existed at the time of writing, and that none had compared them with hysterectomy or adenomyomectomy. It also notes that the recurrence risk appears to be high and that the methods may be harder to apply to diffuse disease ^[2].

A systematic review and meta-analysis of focused ultrasound reported large reductions in uterine volume and painful periods at 12 months and improved quality of life. Adverse reactions were reported in 55.9% of patients. The authors describe the included studies as few and nonuniform, state that no randomized comparisons with other conservative treatments existed, and say that data on fertility and pregnancy were insufficient ^[23]. A narrative review of the three ablation techniques describes them as effective and safe on the basis of reduced lesion size and symptoms, while calling for comparisons with traditional therapy ^[24]. Narrative reviews can reflect which studies the authors chose to include.

Uterus-sparing surgery and hysterectomy

Excision and cytoreduction

Surgeons may remove adenomyotic tissue while leaving the uterus, either fully (adenomyomectomy, mostly used for focal disease) or partially for diffuse disease. The Asian Society guideline summarizes a systematic review of conservative surgery. In five studies of complete excision (612 patients), pain and heavy bleeding improved by 70% to 90% and 70% to 92%, and uterine volume fell by 65%. In seven studies of partial excision (559 patients), pain and bleeding improvement ranged from 41% to 90% and 48% to 89% ^[2]. The guideline also reports cases of uterine rupture during pregnancy after such surgery and emphasizes careful repair of the uterine wall ^[2].

A review of conservative surgery states that these operations are effective for bleeding, pain and uterine volume but carry postoperative risks and obstetric complications, and that cytoreductive surgery can be complex enough that experienced surgeons in dedicated centers should perform it, particularly when endometriosis coexists ^[26]. The guideline authors add that more than 95% of fertility-sparing adenomyomectomies worldwide are performed in Asia, which limits how well published results apply elsewhere ^[2].

Recurrence and repeat treatment across uterus-sparing options

A systematic review pooled 42 studies with 5,877 patients and compared the rate of symptom or lesion recurrence after uterus-sparing interventions. Recurrence was 12.6% after adenomyomectomy, 29.5% after uterine artery embolization and 10.0% after image-guided thermal ablation. Reintervention was 2.6%, 12.8% and 8.2%. The authors point out that patients treated with embolization had larger uteri and larger lesions, so selection bias may explain some of the difference, and all included studies were single-arm ^[25].

Hysterectomy

The Asian Society guideline describes hysterectomy as the most effective way to control symptoms, with high satisfaction, and limits that statement to people who have no fertility need or no wish to keep the uterus ^[2]. The Canadian guideline lists it as a surgical option ^[1]. In the QUESTA cohort described above, satisfaction was 95% at one year after hysterectomy ^[21]. In the U.S. health-system cohort, 82.0% of women with an adenomyosis diagnosis had a hysterectomy, though this reflects care patterns in one system and not outcomes ^[4]. This article did not locate a randomized trial comparing hysterectomy with medical treatment in adenomyosis.

Treatment and pregnancy

Several reviews describe worse reproductive outcomes in women with adenomyosis. A meta-analysis of 17 observational studies found a lower clinical pregnancy rate (odds ratio 0.69) and a higher miscarriage rate (odds ratio 2.17) after assisted reproduction, and associations with pre-eclampsia, preterm delivery and other obstetric complications ^[29]. A separate meta-analysis of in vitro fertilization studies found a lower live birth rate (odds ratio 0.59) in women with adenomyosis and noted that most studies did not separate focal from diffuse disease ^[30]. A meta-analysis of six observational studies (322 women with adenomyosis and 9,420 without) found higher odds of preterm birth, small-for-gestational-age infants and pre-eclampsia, although the confidence interval for pre-eclampsia was wide (odds ratio 4.35, 95% CI 1.07 to 17.72) ^[32]. These are associations in observational data, in which differences in age and other factors can influence results.

Evidence on treatment before assisted reproduction is mixed. One meta-analysis of 10 studies found that long-term agonist treatment before fresh embryo transfer was associated with a higher clinical pregnancy rate (odds ratio 1.49) but not a higher live birth rate, and there was no significant benefit before frozen transfer ^[31]. Another meta-analysis found that agonist treatment did not improve in vitro fertilization outcomes and that surgical treatment may increase natural conception, with only two studies informing the surgical finding ^[30]. The Asian Society guideline does not recommend thermal ablation methods for women who want to conceive because of limited data ^[2].

Pooled estimates after uterus-sparing surgery vary. A meta-analysis of 13 studies including 1,319 patients with adenomyosis (795 wishing to conceive) reported pregnancy rates of 40% after excisional treatment and 51% after non-excisional treatment, with miscarriage rates of 21% and 22%. Differences were not statistically significant ^[27]. A meta-analysis of 10 studies of focused ultrasound in 557 patients wishing to conceive pooled a pregnancy rate of 53.4% and a live birth rate of 35.2%, with substantial heterogeneity. The authors call the evidence very weak ^[28]. Because women who choose surgery or ablation to conceive differ from those who do not, and none of these studies were randomized, the figures cannot show that a procedure caused a pregnancy.

Why the studies are hard to compare

A systematic review of outcome reporting in uterus-sparing adenomyosis treatment studies identified 38 studies (6 randomized trials and 32 cohort studies, 5,175 participants). Together they reported 203 outcomes using 133 outcome measures. Fourteen different measures were used for painful periods and 17 for heavy bleeding. Quality of life was reported in 24% of studies, and patient satisfaction in 3%. A clear primary outcome was stated in 18%. The review judged the studies to have a high risk of bias ^[33].

To address this, an international group used a two-round Delphi process with 150 health professionals, 17 researchers and 334 people with lived experience of adenomyosis or their partners, from 48 countries. It produced a core outcome set of 24 specific and 26 generic outcomes across nine domains, including pain, uterine bleeding, reproductive outcomes, life impact and adverse events. The authors note that patients outside Europe were under-represented and that only 58% of participants completed the second round ^[34]. If future trials adopt this set, results should become easier to pool.

What this does not tell you

This article summarizes published research. It cannot say which option suits any individual, whether a person has adenomyosis, or what would happen if a person tried any treatment. Most trials are small, last 3 to 12 months and come from few countries, so results may not carry over to other groups, to longer use, or to people with coexisting endometriosis or fibroids. Comparisons between a drug and a procedure, or between studies, are indirect unless a trial randomized participants to both. Percentages from different studies use different definitions of improvement and cannot be set side by side. Many cited reviews pool uncontrolled studies and describe association rather than cause. No study cited here shows a cure, and guidelines describe symptom return after stopping medical treatment as expected ^[2]. Several sources are narrative reviews or guidelines whose full recommendations were not available for this article, and not every statement in them could be checked against primary data. Questions about care belong with a clinician who knows the whole clinical picture.

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