Table 9.1Surgery as first-line treatment for HMB – comparative studies

Bibliographic informationStudy type and evidence levelNo. of patientsPatient characteristicsIntervention and comparisonFollow-upOutcome measuresEffect sizeSource of funding and additional comments
Barrington 2003260randomised

EL = 1+
50: 25 LNG-IUS; 25 Thermal balloon ablation. 2 LNG-IUS discontinued, 2 were lost to follow-up. 2 TBA lost to follow-up.Population characteristics: women; menorrhagia; no pathology; cervical cavity > 12 cm

Country: UK
LNG-IUS; thermal balloon ablation

treatment vs baseline
6 monthsMBLPBACMBL (mean): IUS pre-treatment = 107 ml vs 31 ml post-insertion (−71%); Ablation pre-treatment = 122 ml vs 61 ml post-surgery (−50%). No difference between groups (P = 0.689).

MBL (median): IUS pre-treatment = 75 ml vs 19 ml post-insertion; Ablation pre-treatment = 101 ml vs 27 ml post-surgery.
Funding source: not stated

Study summary: Study shows LNG-IUS and thermal ablation are equivalent.
Cooper 1999243Randomised; concealed

EL = 1++
272 eligible, 187 recruited, 94 randomised to medical treatment, 93 to TCRE. By 2 years 86 medical and 87 TCRE patients remained in the study.Population characteristics: Women; referred due to HMB; completed family; < 10 weeks size uterus; normal uterine pathology; referred for surgery.

Baseline characteristics (medical vs TCRE):

Age = 41.4 vs 41.9
Haemoglobin (g/dl) = 12.79 vs 12.61

Menstrual symptom rating:

mild/moderate = 6 vs 4
Severe = 54 vs 52
Very severe = 26 vs 32
Bleeding score = 24.7 vs 24.8

Country: UK
Medical treatment; TCRE2 yearsQoL (SF-36); patient satisfaction; menstrual status; bleeding scoreOutcomes for medical vs TCRE.

QoL (SF-36):

Baseline:

Physical functioning = 78.67 vs 82.33
Social functioning = 68.35 vs 70.03
Role: physical = 53.01 vs 56.98
Role: emotional = 57.43 vs 55.03
Mental health = 58.20 vs 59.43
Energy/fatigue = 40.36 vs 41.49
Pain = 53.55 vs 58.14
General health = 68.17 vs 65.90

Change by 2 years:

Physical functioning = 3.73 vs 5.00
Social functioning = 3.94 vs 10.59
Role: physical = 12.95 vs 18.60
Role: emotional = 11.25 vs 22.48
Mental health = 7.17 vs 9.98
Energy/fatigue = 10.06 vs 14.58
Pain = 11.38 vs 12.34
General health = −0.67 vs 1.69

No significant difference between groups.

Patient satisfaction:

Totally or generally satisfied with treatment = 48 (57%) vs 68 (79%), P = 0.002
Cure or acceptable improvement = 53 (61%) vs 69 (81%), P = 0.017
Treatment acceptable = 65 (77%) vs 79 (93%), P = 0.004

Menstrual status:

No bleeding or light = 36 (42%) vs 50 (58%), P = 0.04
Unchanged or heavier = 16 (18%) vs 5 (6%), P = 0.02
Bleeding score = 6.8 (SD 9.9) vs 5.4 (SD 8.1)
Funding source: Scottish Office Department of Health

Study summary: The results at 2 years consolidate the findings and conclusions based on the four-month follow up data. A policy of early TCRE is effective and safe and does not result in an increase in hysterectomies. It should not be routinely withheld in an effort to try alternative medical therapies.
Crosignani 1997263randomised; open; prospective

EL = 1+
97 assessed. 27 refused entry. 70 accepted entry to study – 35 in IUD group, 35 in endometrial resection group.Population characteristics: women; 38 years or older; referred for hysterectomy; confirmed menorrhagiaPBAC > 100; pregnant or breast feeding excluded; using hormonal treatment in last 3 months; serious concomitant condition excluded.

IUD group – age 43.8, parity = 1.8, BMI = 25.3

Endometrial resection group – age = 45.4, parity = 1.6, BMI = 24.0

Country: Italy
LNG-IUS; endometrial resection12 months – 6 and 12 monthsMBLPBAC; SF-36MBL outcome: LNG-IUS (n = 30) baseline = 184.8 ml (SD 62.2), 12 months = 38.8 (SD 37.1) (P < 0.001). Endometrial resection (n = 30) baseline = 203.2 (SD 77.4), 12 months = 23.5 (SD 32.6) (P < 0.001).

Difference between LNG-IUS and resection P = 0.015.

Patient satisfaction:

LNG-IUS: 29 (85%) satisfied. Endometrial resection: 33 (94%) satisfied.

Mean SF-36 scores at 12 months (LNG-IUS vs Resection):

Physical functioning = 78.0 vs 79.2.
Role limitation = 72.5 vs 74.2
Bodily pain = 58.9 vs 70.3
General health = 64.1 vs 70.3
Vitality = 56.3 vs 54.8
Social functioning = 69.8 vs 69.7
Role limitation = 61.3 vs 72.4
Mental health = 60.1 vs 59.6

Side effects reported by 19 of 34 in IUS group and 9 of 35 in resection group.

1 LNG-IUS patient lost to follow-up.

4 LNG and 3 resection patients had persistent menorrhagia after treatment and sought other treatment.
Funding source: National Research Council (Rome)

Study summary: LNG-IUS produces slightly less satisfactory results than resection at 12 months.
Halmesmaki 2004264randomised; prospective

EL = 1+
119 LNG-IUS vs 117 hysterectomy. 81 IUDs at 12 months – 24 hysterectomy, 10 removed, 5 used ERT.
107 hysterectomies undertaken at 12 months.
Population characteristics: Women; 35–49; menstruating; completed family. No fibroids, endometrial polyps, urinary or bowel symptoms, ovarian pathology.

Hysterectomy: age 43.1, parity = 2.1, BMI = 26.6.

LNG-IUS: age = 43.0, parity = 2.1, BMI = 25.1

Country: Finland
LNG-IUS; Hysterectomy

Treatment vs baseline; treatment vs treatment
12 monthsFSH serum levels; Kupperman index – menopausal symptoms- hot flushes etcFSH levels increased from 8.4 iu/ml at baseline to 13.8 iu/ml at 12 months vs 8.7 to 9.2 in LNG-IUS groups. (P = 0.005).

No difference between or within groups on Kupperman index at 12 months (based on treatment use not intention-to-treat). Hot flushes increased in hysterectomy (P = 0.02) but not IUD; no difference between groups.
Funding source: Not stated

Study summary: Hysterectomy may impair ovarian function.
Istre 2001266Randomised

EL = 1+
60: 30 LNG-IUS; 30 resection – 6 discontinued treatment by 12 months.Population characteristics: women; menorrhagia (PBAC > 75); pre-menopausal; 30–49 years; regular uterine cavity < 10 cm; no pregnant or wanting to become so, breast feeding; large fibroid > 40 cm; pelvic disease; DVT; cancer; endometritis; liver disease; hormone therapy in 3 months

Country: Norway
LNG-IUS; endometrial resection

treatment vs baseline; treatment vs treatment
12 monthsMBL = PBAC; duration of menstruation; haematological test; side effectsMBL (mean) – PBAC: LNG-IUSbaseline = 420 (SD 352), 12 months = 42 (SD 99) (−90%). TCREbaseline = 404 (SD 480), 12 months = 7 (SD 15) (−98%).

PBAC < 75 in 67% of LNG-IUS and 90% of TCRE patients at 12 months. (P = 0.005)

Side effects: LNG-IUS 13 reported events – bleeding, abdominal pain, breast tenderness, headache, mood change.

6 discontinued treatment due to irregular bleeding, pain and acne.
Funding source: Leiras Oy

Study summary: Resection reduces MBL more than IUS-LNG but only marginally.
Kupperman 2004326RCT

EL = 1+
63 in total, 31 (2 lost to follow-up) to hysterectomy and 32 (2 lost to follow-up) to medical treatmentPopulation characteristics: Women; failed medical treatmentmedroxyprogesterone; 30 to 50 years of age; minimum of 2 months AUB; no hyperplasia on biopsy; excluded if – wanted future fertility desired, pregnant, or coagulopathy; long-acting treatments within 6 months; COC or IUD within 3 months; pelvic pathology for which surgery was indicated.

Average age: hysterectomy = 42, medicine = 40

Health insurance = 65%, 81%

< high school education = 39%, 38%

<$25000 income = 42%, 53%

Uterine fibroids = 65%, 63%

Previous treatment:

hysterectomy = COC 39%,
Prostaglandin inhibitors 13%, GnRH-a 10%, D&C 19%, myomectomy 6%, endometrial ablation 3%

Medicine = COC 50%, Prostaglandin inhibitors 19%, GnRH-a 6%, D&C 38%, myomectomy 0%, endometrial ablation 0%

Country: USA
Hysterectomy; expanded medical treatment

treatment vs treatment; treatment vs baseline
24 monthsSF-36; Body image and sexual functioning; Mental health; General healthBaseline QoL scores (all on 0 to 100 scale, with 100 being optimal health):

SF-36 MCS score: hysterectomy = 45 (SD 11), Medicine = 45 (SD 10)
SF-36 PCS score: hysterectomy = 43 (SD 8), Medicine = 42 (SD 9)
Body image score: hysterectomy = 59 (SD 28), medicine = 62 (SD 22)
Satisfaction with sex: hysterectomy = 45 (SD 31), Medicine = 56 (SD 32)
Psychological well-being score: hysterectomy = 73 (SD 17), Medicine = 71 (SD 18)
Overall health score: hysterectomy = 58 (SD 19), Medicine = 59 (SD 18)
Satisfaction with health: hysterectomy = 38 (SD 22), Medicine = 39 (SD 24)

Change in QoL scores from baseline to 6 months using intention to treat (hysterectomy, medicine, P value for difference between groups):

SF-36 MCS score: hysterectomy = 8, Medicine = 2, P = 0.04
SF-36 PCS score: hysterectomy = 6, Medicine = 3, P = 0.21
Body image score: hysterectomy = 15, Medicine = 5, P = 0.07
Satisfaction with sex: hysterectomy = 20, Medicine = 10, P = 0.19
Psychological well-being score: hysterectomy = 8, Medicine = 0.2, P = 0.07
Overall health score: hysterectomy = 12, Medicine = 2, P = 0.006
Satisfaction with health: hysterectomy = 31, Medicine = 14,P −0.01
Symptom resolution: hysterectomy = 75, medicine = 29, P < 0.001
Satisfaction with symptom level: hysterectomy = 44, medicine = 7, P < 0.001
By 24 months 17 (53%) of medical group had undergone hysterectomy

Change in QoL scores from baseline to 24 months using intention to treat (hysterectomy, medicine, P value for difference between groups):

SF-36 MCS score: hysterectomy = 7, Medicine = 4, P = 0.25
SF-36 PCS score: hysterectomy = 7, Medicine = 9, P = 0.19
Body image score: hysterectomy = 11, Medicine = 12, P = 0.97
Satisfaction with sex: hysterectomy = 17, Medicine = 18, P = 0.89
Psychological well-being score: hysterectomy = 7, Medicine =3, P = 0.24
Overall health score: hysterectomy = 11, Medicine = 9, P = 0.64
Satisfaction with health: hysterectomy = 27, Medicine = 25, P = 0.68
Symptom resolution: hysterectomy = 70, medicine = 256, P = 0.09
Satisfaction with symptom level: hysterectomy = 46, medicine = 40, P = 0.36

Change in QoL scores from baseline to 24 months using as treated (hysterectomy, medicine, P value for difference between groups):

SF-36 MCS score: hysterectomy = 7, Medicine = 2
SF-36 PCS score: hysterectomy = 7, Medicine = 11
Body image score: hysterectomy = 12, Medicine = 8
Satisfaction with sex: hysterectomy = 17, Medicine = 13
Psychological well-being score: hysterectomy = 7, Medicine = 0.6

Overall health score: hysterectomy = 11, Medicine = 5
Satisfaction with health: hysterectomy = 27, Medicine = 20
Symptom resolution: hysterectomy = 71, medicine = 35
Satisfaction with symptom level: hysterectomy = 47, medicine = 31
Funding source: Agency for Healthcare Research and Quality grant

Study summary: Hysterectomy was superior to expanded medical treatment at 6 months in study population, at 24 months there was no difference by half of women in medical group had had hysterectomy.
Learman 2004119randomised – block; non-blinded; concealment

EL = 1+
63 in total, 31 (2 lost to follow-up) to hysterectomy and 32 (2 lost to follow-up) to medical treatmentPopulation characteristics: Women; failed medical treatmentmedroxyprogesterone; 30 to 50 years of age; minimum of 2 months AUB; no hyperplasia on biopsy; excluded if – wanted future fertility desired, pregnant, or coagulopathy; long-acting treatments within 6 months; COC or IUD within 3 months; pelvic pathology for which surgery was indicated.

Average age: hysterectomy = 42, medicine = 40

Health insurance = 65%, 81%

< high school education = 39%, 38%

<$25000 income = 42%, 53%

Uterine fibroids = 65%, 63%

Previous treatment:

hysterectomy = COC 39%, Prostaglandin inhibitors 13%, GnRH-a 10%, D&C 19%, myomectomy 6%, endometrial ablation 3%

Medicine = COC 50%, Prostaglandin inhibitors 19%, GnRH-a 6%, D&C 38%, myomectomy 0%, endometrial ablation 0%

Country: USA
medical treatment; hysterectomy

treatments vs baseline
2 yearsMenstrual bleeding; Pelvic discomfort; urinary symptoms; menopausal symptomsBaseline symptomology figures:

Hysterectomy group = pelvic pain 74%, pelvic or bladder pressure 55%, low back pain 68%, Hot flushes 19%, Urinary symptoms – urgency 26%, frequent urination 26%, stress incontinence 29%.

Continued vaginal bleeding at 6 months was 87% for medicine and 11% for hysterectomy (P < 0.001).

Continued vaginal bleeding at 24 months was 37% for medicine and 7% for hysterectomy (P < 0.001).

Continued bleeding in hysterectomy group due to cross-over between treatments.

Medicine group = pelvic pain 88%, pelvic or bladder pressure 84%, low back pain 72%, Hot flushes 41%, Urinary symptoms – urgency 44%, frequent urination 41%, stress incontinence 25%.

Change in symptom frequency fro baseline at 6 months (intention-to-treat):

Pelvic pain: hysterectomy = −2.3, medicine = −0.7, P < 0.01
Urinary urgency: hysterectomy = −0.7, medicine = 0.0, P = 0.03
Urinary incomplete emptying: hysterectomy = −0.6, medicine = +0.1, P = 0.03
Breast pain: hysterectomy = −1.3, medicine = −0.5, P = 0.02
No difference for other pelvic, urinary or menopausal symptoms.

Change in symptom frequency fro baseline at 2 years (intention-to-treat):

Urinary incomplete emptying: hysterectomy = −0.8, medicine = −0.3, P = 0.04
Hot flushes: hysterectomy = −0.6, medicine = 0.5, P < 0.01
No difference for other pelvic, urinary or menopausal symptoms.

Change in symptoms for groups as treated:

Hysterectomy only groups produced significant reduction in symptoms, except for stress incontinence (P = 0.34) and urge incontinence (P = 0.74).
Medicine then hysterectomy group produced same results, except hot flushes not significant (P = 0.13).
Medicine only group produced significant reductions in symptoms for pelvic pain, pelvic pressure, and stress incontinence (P < 0.05), all other changes were non-significant.
Funding source: Agency of HealthCare Research and Quality grant

Study summary: Hysterectomy was more effective treatment than additional medical treatment in this selected patient group.
Marjoribanks 2004325Systematic review<

EL = 1++
8 RCTs including 821 womenPopulation characteristics: Cochrane Menstrual Disorders and Subfertility Group trial register (September 2005), the Cochrane Central Register of Controlled Trials (CENTRAL/CCTR) on The Cochrane Library (Issue 3, 2005), MEDLINE (1966 to September 2005), EMBASE (1980 to September 2005), Current Contents (1993 to September 2005), Biological Abstracts (1969 to September 2005), PsycINFO (1985 to September 2005), CINAHL (1982 to September 2005), and reference lists of articles

Country:
Surgical vs medical therapiesMBL – objective and PBAC; QoL; Additional treatment; Adverse eventsTwo trials comparing oral pharmaceuticals with endometrial ablation.

Control of bleeding (cure or improvement):

4 months (n = 186) Surgery 77/93 vs medical 29/93; OR = 10.62 (5.3 to 21.27) in favour of surgery.

2 year (n = 173) Surgery 69/87 vs medical 53/86; OR = 2.39 (1.21 to 4.70) in favour of surgery.

5 years (n = 140) Surgery 61/71 vs medical 52/69; OR = 1.99 (0.84 to 4.73) in favour of surgery.

Amenorrhoea rates:

4 months (n = 186) Surgery 34/93 vs medical 3/93; OR = 17.29 (5.08 to 58.87) in favour of surgery

2 year (n = 173) Surgery 33/87 vs medical 26/86; OR = 1.41 (0.75 to 2.65) in favour of surgery

5 years (n = 140) Surgery 41/71 vs medical 47/73; OR = 0.76 (0.39 to 1.48) in favour of surgery

Bleeding score:

4 months (n = 183) WMD = 1.12.70 (115.04 to −10.36) in favour of surgery

2 years (n = 173) WMD = −1.40 (−4.10 to 1.30)

Pre-menstrual symptoms (breast discomfort, bloating, irritability, headaches, depression) – At 4 months all less likely in surgery than medical treatment. At 2 years and 5 years no difference between medical and surgical groups.

Patient satisfaction:

4 months (n = 183) – OR = 8.28 (4.29 to 15.97) in favour of surgery
2 year (n = 173) OR = 2.83 [ 1.46, 5.50 ] in favour of surgery

5 years (n = 140)- OR = 1.69 (0.77 to 3.70) in favour of surgery

Extra surgery received:

2 year (n = 236) OR = 0.12 [0.06, 0.22] in favour of surgery
5 years (n = 140)- OR = 0.11 (0.06 to 0.22) in favour of surgery

Physical function:

4 months + 10.16 (SD 16.51) + 4.84 (SD 16.72) P = < 0.05

2 years + 5.00 (SD 18.97) + 3.73 (SD 17.19) P = 0.65

5 years + 7.75 (SD 16.39) + 1.06 (SD 23.81) P = 0.10

Social function:

4 months + 17.44 (SD 16.51) + 7.57 (SD 26.26) P = < 0.05

2 years + 10.59 (SD 26.52) + 3.94 (SD 25.26) P = 0.10

5 years + 10.24 (SD 24.49) + 2.96 (SD 27.22) P = 0.10

Physical role:

4 months + 32.26 (SD 38.23) + 15.32 (SD 46.78) P = < 0.01

2 years + 18.60 (SD + 12.95 (SD 44.58) P = 0.42

5 years + 31.62 (SD 33.15) + 15.14 (SD 39.77) P = 0.06

Emotional role:

4 months + 31.54 (SD 45.94) + 8.96 (SD 49.93) P = < 0.01

2 years + 22.48 (SD 50.47) + 11.25 (SD 45.17) P = 0.13

5 years + 33.81 (SD 34.11) + 14.35 (SD 40.61) P = 0.02

Mental health:

4 months + 15.01 (SD 19.00) + 4.78 (SD 16.69) P = < 0.01

2 years + 9.98 (SD 19.14) + 7.17 (SD 19.20) P = 0.35

5 years + 13.26 (SD 16.94) + 3.62 (SD 18.21) P = 0.01

Energy/fatigue:

4 months + 20.53 (SD 20.76) + 7.07 (SD 20.23) P = < 0.01

2 years + 14.58 (SD 21.96) + 10.06 (SD 19.57) P = 0.17

5 years + 17.31 (SD 22.35) + 10.62 (SD 18.79) P = 0.07

Pain:

4 months + 21.62 (SD 31.33) + 8.84 (SD 26.39) P = < 0.01

2 years + 12.34 (SD 27.20) + 11.38 (SD 28.51) P = 0.82

5 years + 14.81 (SD 25.35) + 11.98 (SD 23.66) P = 0.6

General health:

4 months + 10.49 (SD 20.85) −0.25 (SD 15.99) P = < 0.01

2 years + 1.69 (SD 18.83) −0.67 (SD 13.90) P = 0.36

5 years + 6.97 (SD 23.10) −3.88 (SD 20.13) P = 0.01

Four RCTs included comparing surgery (hysterectomy, ablation) with LNG-IUS.

Objective MBL (1 RCT, n = 223) OR 25.72 [1.5, 439.98] at 12 months in favour surgery. Subjective MBL (3 RCTs, n = 189) – OR = 3.99 [1.53, 10.38] at 12 months in favour of surgery.

Amenorrhoea rates:

6 months (1 RCT, n = 46) OR 0.63 [0.10, 4.21]
1 year (2 studies, n = 120) OR 1.90 (0.76 to 4.73) in favour of surgery
2 years (n = 43) OR = 1.60 (0.42 to 6.03)
3 years (n = 40) OR 1.63 (0.44 to 5.95)

Mean reduction in PBAC:

12 months (n = 127) – WMD = 44.07 [ 33.01, 55.12 ] in favour of surgery.

QoL: SF-36:

General health (3 RCTs, n = 354) WMD = 1.83 [−2.13, 5.78]
physical function (n = 274) WMD = 2.91 (−1.36 to 7.19);
mental health (n = 277) WMD = 2.97 (−1.21 to 7.16);
vitality (n = 275) WMD = 2.77 (−2.03 to 7.57);
physical role limitation (n = 271) WMD = 3.64 (−3.58 to 10.86);
emotional role (n = 269) WMD = 9.67 (1.65 to 17.69) in favour of surgery;
social function (n = 274) WMD = 3.64 (−1.14 to 8.43);
bodily pain (n = 274) WMD = 6.98 (1.68 to 12.29) in favour of surgery.
Satisfaction at 12 months OR 1.91 [0.82, 4.48] in favour of surgery.
Adverse events at 12 months OR 0.24 [0.11, 0.49] in favour of surgery.

Additional surgery at 12 months:

(n = 423) OR = 0.11 (0.04 to 0.30) in favour of surgery.

Additional surgery at 24 months (1 RCT, n = 79) OR 0.69 [0.20, 2.40]
Funding source: No funding

Study summary: Surgery, especially hysterectomy, reduces menstrual bleeding at one year more than medical treatments but LNG-IUS appears equally effective in improving quality of life. The evidence for longer term comparisons is weak and inconsistent. Oral medication suits a minority of women long term.
Rauramo 2004268randomised; open; equivalence

EL = 1+
60: 30 LNG-IUS; 29 endometrial resection – 1 not randomised. 12 months – 6 LNG IUS vs 1 ablation discontinued or treatment failure. 36 months 5 vs 7 discontinued or treatment failure. 19 vs 22 at 36 months.Population characteristics: women; menorrhagia; not pregnant or lactating; finished family; normal uterine cavity; abnormal uterine bleeding; pathology.

LNG-IUS: 41.4 years, 73.4 kg.
TCRE: 42.1 years, 70.4 kg.

Country: Norway
LNG-IUS; endometrial resection

treatment vs treatment; treatment vs baseline
3 yearsMBL = PBAC; duration of menstruation; haematological test; side effects

Analysis based on intention-to-treat.
MBL:

LNG-IUS (median)- baseline (n = 30) = 261.5 (60–1503), 1 year (n = 24) = 12, 2 years (n = 20) = 8.5, 3 years (n = 19) = 7.

Resectionbaseline (n = 29) = 311 (81–2506), 1 year (n = 28) = 8.5, 2 years (n = 24) = 10, 3 years (n = 22) = 4.
Difference between groups not significant.

Adverse events: 1 oedema from LNG, plus 3 endometritis, 2 PID, 1 expulsion. 1 endometritis, 1 bleeding and pain from resection, plus 1 stroke
Funding source: Schering AG

Study summary: Both treatments effectively reduced MBL.
Soysal 2002270randomised; blind

EL = 1+
72: 36 ablation vs 36 IUD. 1 ablation and 5 IUD not included in analysis due to treatment failure.Population characteristics: Women; > 40 years; completed family; menorrhagia; no pathology; no cancer.

LNG-IUS: 44.1 years. TBA: 43.8 years.

Country: Turkey
Thermal balloon ablation after GnRH-a; LNG IUD (20 μg daily)

Treatment vs baseline; treatment vs treatment
12 monthsMBLPBAC; QoL; Side effectsMBL: TBA – baseline PBAC = 417 (SD 81.4), 12 month PBAC = 21.8 (SD 14) (P < 0.0001). LNG-IUD – baseline PBAC = 408 (SD 101), 12 month PBAC = 55 (SD 11) (P < 0.001). TBA vs LNG = 388.2 vs 343 reduction (P < 0.001).

QoL: SF-36 and HADs no difference between groups, except on role limitation where TBA better. No baseline data shown.

Patient satisfaction: would recommend treatment = 70% for TBA vs 96% for LNG-IUD.

Side effects: 21 of 36 LNG patients reported 1 or more side effects vs 8 of 36 in TBA group. (P < 0.05).

Discontinuation: 5 LNG-IUS vs 1 TBA discontinued due to treatment failure.
Funding source: Not stated

Study summary: Study shows that LNG-IUS and TBA are equivalent.

From: Evidence Tables

Cover of Heavy Menstrual Bleeding
Heavy Menstrual Bleeding.
NICE Clinical Guidelines, No. 44.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2007 Jan.
Copyright © 2007, National Collaborating Centre for Women's and Children's Health.

No part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK [www.cla.co.uk]. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.