Review question
Cochrane authors considered the evidence for effectiveness and safety of non-surgical treatrments for managing chronic pelvic pain in women.
Background
Chronic pelvic pain in women is a common problem. Specific causes are often difficult to identify, even after investigation with ultrasound and inspection of the pelvis with key hole surgery. Treatment is frequently limited to relief of symptoms obtained with a concoction of medicines. Cochrane review authors examined the evidence about non-surgical interventions for the management of chronic pelvic pain.
Study characteristics
Twenty-one randomised controlled studies were identified, of which 13 were included. Eight studies were excluded. The studies included a total of 750 women—406 women in the intervention groups and 344 women in the control groups. The interventions assessed included medical treatment and psychological, cognitive, behavioural, complementary and physical therapies. The evidence is current to February 2014.
Key results
The review concludes that evidence shows improvement of pain in women given a high dose of progestogen (50 mg medroxyprogesterone acetate) immediately post-treatment and for up to nine months after treatment. However, progestogen was associated with adverse effects such as weight gain and bloating. Women who underwent reassurance ultrasound scans and who received counselling were more likely to report improved pain than those whose treatment involved a 'wait and see' policy. Some evidence of benefit was seen with writing disclosure therapy and with distension of painful pelvic structures. No good evidence of benefit was noted with other interventions when compared with standard care or placebo.
The quality of the evidence was low or moderate for most comparisons, and in most cases evidence was derived from single small studies. Moreover, we were unable to draw meaningful conclusions on quality of life and physical and functional outcomes because of the large variation in outcome measures used by the included studies. Many interventions identified in this review involved only single studies with small sample sizes. Additional studies will be required in the future to replicate results obtained with the use of specific medical interventions.
Evidence of moderate quality supports progestogen as an option for chronic pelvic pain, with efficacy reported during treatment. In practice, this option may be most acceptable among women unconcerned about progestogenic adverse effects (e.g. weight gain, bloatedness—the most common adverse effects). Although some evidence suggests possible benefit of goserelin when compared with progestogen, gabapentin as compared with amytriptyline, ultrasound versus 'wait and see' and writing therapy versus non-disclosure, the quality of evidence is generally low, and evidence is drawn from single studies.
Given the prevalence and healthcare costs associated with chronic pelvic pain in women, RCTs of other medical, lifestyle and psychological interventions are urgently required.
Chronic pelvic pain is a common and debilitating condition; its aetiology is multifactorial, involving social, psychological and biological factors. The management of chronic pelvic pain is challenging, as despite interventions involving surgery, many women remain in pain without a firm gynaecological diagnosis.
To assess the effectiveness and safety of non-surgical interventions for women with chronic pelvic pain.
We searched the Menstrual Disorders and Subfertility Group Specialised Register. We also searched (from inception to 5 February 2014) AMED, CENTRAL, MEDLINE, EMBASE, PsycINFO, CINAHL and LILACS. We handsearched sources such as citation lists, trial registers and conference proceedings.
Randomised controlled trials (RCTs) on non-surgical management of chronic pelvic pain were eligible for inclusion. We included studies of women with a diagnosis of pelvic congestion syndrome or adhesions but excluded those with pain known to be caused by endometriosis, primary dysmenorrhoea (period pain), active chronic pelvic inflammatory disease or irritable bowel syndrome. We considered studies of any non-surgical intervention, including lifestyle, physical, medical and psychological treatments.
Study selection, quality assessment and data extraction were performed independently by two review authors. Meta-analysis was performed using the Peto odds ratio (Peto OR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). The primary outcome measure was pain relief, and secondary outcome measures were psychological outcomes, quality of life, requirement for analgesia and adverse effects. The quality of the evidence was assessed by using GRADE methods.
Twenty-one RCTs were identified that involved non-surgical management of chronic pelvic pain: 13 trials were included in the review, and eight were excluded. The studies included a total of 750 women—406 women in the intervention groups and 344 in the control groups. Included studies had high attrition rates, and investigators often did not blind adequately or did not clearly describe randomisation procedures.
Medical treatment versus placebo
Progestogen (medroxyprogesterone acetate (MPA)) was more effective than placebo at the end of treatment in terms of the number of women achieving a greater than 50% reduction in visual analogue scale (VAS) pain score immediately after treatment (Peto OR 3.00, 95% CI 1.70 to 5.31, two studies, n = 204, I2 = 22%, moderate-quality evidence). Evidence of benefit was maintained up to nine months after treatment (Peto OR 2.09, 95% CI 1.18 to 3.71, two studies, n = 204, I2 = 0%, moderate-quality evidence). Women treated with progestogen reported more adverse effects (e.g. weight gain, bloatedness) than those given placebo (high-quality evidence). The estimated effect of lofexidine on pain outcomes when compared with placebo was compatible with benefit and harm (Peto OR 0.42, 95% CI 0.11 to 1.61, one study, 39 women, low-quality evidence). Women in the lofexidine group reported more adverse effects (including drowsiness and dry mouth) than women given placebo (moderate-quality evidence).
Head-to-head comparisons of medical treatments
Head-to-head comparisons showed that women taking goserelin had greater improvement in pelvic pain score (MD 3, 95% CI 2.08 to 3.92, one study, n = 47, moderate-quality evidence) at one year than those taking progestogen. Women taking gabapentin had a lower VAS pain score than those taking amytriptyline (MD -1.50, 95% CI -2.06 to -0.94, n = 40, low-quality evidence). Study authors reported that no statistically significant difference was observed in the rate of adverse effects among women taking gabapentin compared with women given amytriptyline. The study comparing goserelin versus progestogen did not report on adverse effects.
Psychological treatment
Women who underwent reassurance ultrasound scans and received counselling were more likely to report improved pain than those treated with a standard 'wait and see' policy (Peto OR 6.77, 95% CI 2.83 to 16.19, n = 90, low-quality evidence). Significantly more women who had writing therapy as a disclosure reported improvement in pain than those in the non-disclosure group (Peto OR 4.47, 95% CI 1.41 to 14.13, n = 48, very low-quality evidence). No difference between groups in pain outcomes was noted when other psychological therapies were compared with standard care or placebo (quality of evidence ranged from very low to low). Studies did not report on adverse effects.
Complementary therapy
Distension of painful pelvic structures was more effective for pain when compared with counselling (MD 35.8, 95% CI 23.08 to 48.52 on a zero to 100 scale, one study, n = 48, moderate-quality evidence). No difference in pain levels was observed when magnetic therapy was compared with use of a control magnet (very low-quality evidence). Studies did not report on adverse effects.
The results of studies examining psychological and complementary therapies could not be combined to yield meaningful results.