Behavioural interventions for primary and secondary dysmenorrhoea.

BACKGROUND: Dysmenorrhoea refers to the occurrence of painful menstrual cramps of uterine origin and is a common gynaecological condition with considerable morbidity. The behavioural approach assumes that psychological and environmental factors interact with, and influence, physiological processes. Behavioural interventions for dysmenorrhoea may include both physical and cognitive procedures and focus on both physical and psychological coping strategies for dysmenorrhoeic symptoms rather than modification of any underlying organic pathology. OBJECTIVES: To determine the effectiveness of any behavioural interventions for the treatment of primary or secondary dysmenorrhoea when compared to each other, placebo, no treatment, or conventional medical treatments for example non-steroidal anti-inflammatory drugs (NSAIDs). SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched April 2005), Cochrane Central Register of Controlled Trials (CENTRAL on The Cochrane Library, Issue 2, 2005), MEDLINE (1966 to April 2005), EMBASE (1980 to April 2005), Social Sciences Index (1980 to April 2005), PsycINFO (1972 to April 2005) and CINAHL (1982 to April 2005) and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials comparing behavioural interventions with placebo or other interventions in women with dysmenorrhoea. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. MAIN RESULTS: Five trials involving 213 women were included. Behavioural intervention vs control: One trial of pain management training reported reduction in pain and symptoms compared to a control. Three trials of relaxation compared to control reported varied results, two trials showed no difference in symptom severity scores however one trial reported relaxation was effective for reducing symptoms in menstrual sufferers with spasmodic symptoms. Two trials reported less restriction in daily activities following treatment with either relaxation of pain management training compared to a control. One trial also reported less time absent from school following treatment wit pain management training compared to a control. Behavioural intervention vs other behavioural interventions: Three trials showed no difference between behavioural interventions for the outcome of improvement in symptoms. One trial showed that relaxation resulted in a decrease in the need for resting time compared to the relaxation and imagery. AUTHORS' CONCLUSIONS: There is some evidence from five RCTs that behavioural interventions may be effective for dysmenorrhoea however results should be viewed with caution as they varied greatly between trials due to inconsistency in the reporting of data, small trial size, poor methodological quality and age of the trials.

A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding.

OBJECTIVE: To compare the levonorgestrel intrauterine system (LNG-IUS) (Mirena); Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoice; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding. DESIGN: An open, pragmatic, prospective randomised trial. SETTING: A menstrual disorders clinic at National Women's Hospital, Auckland, New Zealand. POPULATION: Seventy-nine women with heavy menstrual bleeding randomised to the LNG-IUS (40 women) or the thermal balloon ablation (39 women). METHODS: Women were randomised to treatment with the LNG-IUS or thermal balloon ablation and followed up by a postal and telephone questionnaire. MAIN OUTCOME MEASURES: Menstrual loss measured by a pictorial bleeding assessment chart (PBAC) at 3, 6, 12 and 24 months. Patient satisfaction, quality of life and menstrual symptoms were assessed by questionnaire administered at 3, 6, 12 and 24 months. Treatment side effects and treatment failures were also recorded. RESULTS: Both the treatments resulted in a significant reduction in PBAC scores. At 12 and 24 months, median PBAC scores were significantly lower in women treated with the LNG-IUS compared with women treated by thermal balloon ablation (11.5 versus 60.0 at 12 months [P= 0.002]; 12.0 versus 56.5 [P= 0.002] at 24 months). At 24 months, nine (35%) women still using the LNG-IUS had amenorrhoea compared with one (5%) woman successfully treated by thermal balloon ablation (P = 0.025). There were no significant differences in patient satisfaction between two treatments during follow up. Treatment failed in 11 (28%) women using the LNG-IUS and in 10 (26%) women treated with thermal balloon ablation. Overall, women in both groups showed an increased quality of life as a result of the treatment, with Short Form-36 scores increasing from 63.7 at randomisation to 76.1 at 24 months. CONCLUSIONS: At 12 and 24 months of follow up, women with heavy menstrual bleeding treated with the LNG-IUS have significantly lower PBAC scores than women treated with thermal balloon ablation. Both the treatments resulted in a significant increase in overall quality of life, but there were no significant differences between either treatment in quality of life, patient satisfaction or the number of women requesting an alternative treatment during 24 months of follow up.

The FLUSH trial--flushing with lipiodol for unexplained (and endometriosis-related) subfertility by hysterosalpingography: a randomized trial.

BACKGROUND: To assess the effectiveness of flushing with the oil-soluble contrast medium lipiodol in women with unexplained infertility. METHODS: An open randomized controlled trial design in a single centre secondary and tertiary level infertility service setting. A total of 158 women with unexplained infertility were stratified into two populations: 96 women without confirmed endometriosis and 62 women with endometriosis who had normal Fallopian tubes and ovaries. Randomization was computer-generated, with allocation concealment by opaque sequentially numbered envelopes. Lipiodol flushing was tested versus no intervention. The main outcome measures were clinical pregnancy (assessed at 6 months following randomization) and live birth. RESULTS: Lipiodol flushing resulted in a significant increase in pregnancy [48.0 versus 10.8%, relative risk (RR) 4.44, 95% confidence interval (CI) 1.61-12.21] and live birth (40.0 versus 10.8%, RR 3.70, 95% CI 1.30-10.50) rates versus no intervention for women with endometriosis, although there was no significant difference in pregnancy (33.3 versus 20.8%, RR 1.60, 95% CI 0.81-3.16) or live birth (27.1 versus 14.6%, RR 1.86, 95% CI 0.81-4.25) rates for women with unexplained infertility without confirmed endometriosis. CONCLUSIONS: Lipiodol flushing is an effective treatment for couples with unexplained infertility (based on meta-analysis data), but is particularly effective for women with endometriosis who have normal Fallopian tubes and ovaries.

Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea.

BACKGROUND: Dysmenorrhoea is the occurrence of painful menstrual cramps of the uterus. Medical therapy for dysmenorrhoea commonly consists of nonsteroidal anti-inflammatory drugs or the oral contraceptive pill both of which work by reducing myometrial (uterine muscle) activity. However, these treatments are accompanied by a number of side effects, making an effective non-pharmacological method of treating dysmenorrhoea of potential value. Transcutaneous electrical nerve stimulation (TENS) is a treatment that has been shown to be effective for pain relief in a variety of conditions. Electrodes are placed on the skin and electric current applied at different pulse rates (frequencies) and intensities is used to stimulate these areas so as to provide pain relief. In dysmenorrhoea. TENS is thought to work by alteration of the body's ability to receive or perceive pain signals rather than by having a direct effect on the uterine contractions. Acupuncture may also be indicated as a useful, non-pharmacological method for treating dysmenorrhoea. Acupuncture is thought to excite receptors or nerve fibres which, through a complicated interaction with mediators such as serotonin and endorphins, blocks pain impulses. Acupuncture typically involves penetration of the skin by fine, solid metallic needles, which are manipulated manually or by electrical stimulation. OBJECTIVES: To determine the effectiveness of high and low frequency transcutaneous electrical nerve stimulation and acupuncture when compared to each other, placebo, no treatment, or medical treatment for primary dysmenorrhoea. SEARCH STRATEGY: Electronic searches of the Cochrane Menstrual Disorders and Subfertility Group Register of controlled trials, CCTR (Cochrane Library Issue 3, 2001), MEDLINE, EMBASE, CINAHL, Bio extracts, PsycLIT and SPORTDiscus were performed in August 2001 to identify relevant randomised controlled trials (RCTs). The Cochrane Complementary Medicine Field's Register of controlled trials (CISCOM) was also searched. Attempts were also made to identify trials from the UK National Research Register, the Clinical Trial Register and the citation lists of review articles and included trials. In most cases, the first or corresponding author of each included trial was contacted for additional information. SELECTION CRITERIA: The inclusion criteria were randomised controlled trials of transcutaneous electrical nerve stimulation and acupuncture that compared these treatments to each other, placebo, no treatment, or medical treatment for primary dysmenorrhoea. Exclusion criteria were: mild, infrequent or secondary dysmenorrhoea and dysmenorrhoea associated with an IUD. DATA COLLECTION AND ANALYSIS: Nine RCTs were identified that fulfilled the inclusion criteria for this review, seven involving TENS, one acupuncture, and one both treatments. Quality assessment and data extraction were performed independently by two reviewers. Meta analysis was performed using odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes. Data unsuitable for meta-analysis was reported as descriptive data and was also included for discussion. The outcome measures were pain relief (dichotomous, visual analogue scales, descriptive), adverse effects, use of analgesics additional to treatment and absence from work or school. MAIN RESULTS: Overall high frequency TENS was shown to be more effective for pain relief than placebo TENS. Low frequency TENS was found to be no more effective in reducing pain than placebo TENS. There were conflicting results regarding whether high frequency TENS is more effective than low frequency TENS. One small trial showed acupuncture to be significantly more effective for pain relief than both placebo acupuncture and two no treatment control groups. REVIEWER'S CONCLUSIONS: High frequency TENS was found to be effective for the treatment of dysmenorrhoea by a number of small trials. The minor adverse effects reported in one trial requires further investigation. There is insufficient evidence to determine the effectiveness of low frequency TENS in reducing dysmenorrhoea. There is also insufficient evidence to determine the effectiveness of acupuncture in reducing dysmenorrhoea, however a single small but methodologically sound trial of acupuncture suggests benefit for this modality.

Short-term effects of high dose oral medroxyprogesterone acetate on bone density in premenopausal women.

Despite the widespread use of the C21 progestin medroxyprogesterone acetate (MPA) in hormone replacement therapy and gynecological practice, its effects on bone density are uncertain, with contradictory reports in the literature. We have examined the short term changes in bone density at the lumbar spine (a predominantly trabecular site) and the femoral neck (a predominantly cortical site) in 13 premanopausal women prescribed high dose MPA (50 mg/day) for gynecological disorders and in 12 control subjects. Compared to basal values, lumbar spine bone mineral density (measured by dual energy x-ray absorptiometry) fell progressively by a mean 2.4% at 6 months and 4.1% at 12 months (both P < 0.01); in five subjects who continued the drug, it had fallen by a mean 5.9% at 20 months (P < 0.002). The spinal bone loss in the MPA users was significantly greater than that in controls (P < 0.005 at 6 months; P < 0.01 at 12 months) and occurred despite a significant gain in body weight in the women using MPA (median, 3.5 kg at 6 months; P < 0.01). In four subjects in whom bone density was measured 6 months after cessation of MPA, spinal bone density showed significant recovery (mean increment, 2.8%; P < 0.025). Femoral neck bone density measurements did not differ between the groups. MPA induced amenorrhea in all subjects who continued with it beyond 6 months, and the amenorrheic subjects were estrogen deficient (median plasma estradiol, 70 pmol/L). We conclude that, when given in doses sufficient to induce hypogonadism, MPA use is associated with significant early loss of trabecular bone, which is probably the consequence of estrogen deficiency.