Intervention Review

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Non-surgical interventions for the management of chronic pelvic pain

  1. Ying C Cheong1,*,
  2. Grisham Smotra1,
  3. Amanda C de C Williams2

Editorial Group: Cochrane Menstrual Disorders and Subfertility Group

Published Online: 5 MAR 2014

Assessed as up-to-date: 5 FEB 2014

DOI: 10.1002/14651858.CD008797.pub2


How to Cite

Cheong YC, Smotra G, Williams ACDC. Non-surgical interventions for the management of chronic pelvic pain. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD008797. DOI: 10.1002/14651858.CD008797.pub2.

Author Information

  1. 1

    University of Southampton, Obstetrics and Gynaecology, Southampton, UK

  2. 2

    University College London, Research Department of Clinical, Educational & Health Psychology, London, UK

*Ying C Cheong, Obstetrics and Gynaecology, University of Southampton, Level F, Princess Anne Hospital, Coxford Road, Southampton, SO16 5YA, UK. yingcheong@hotmail.com. Y.Cheong@soton.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 5 MAR 2014

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Characteristics of included studies [ordered by study ID]
Abbott 2006

MethodsRandomised controlled trial


ParticipantsN = 60 (30 each group)

Women aged 18 to 55 years who had more than two years of chronic pelvic pain that caused disruption to their daily activities

Women were excluded if they were breastfeeding, pregnant or desiring pregnancy during the study period, were unwilling to use contraception during the study period or had previously received botulinum toxin type A injections to the pelvic floor. Palpable pelvic pathology, current use of aminoglycoside antibiotics, history of neurological or bleeding disorders and known sensitivity to the formulation of botulinum toxin type A were also reasons for exclusion


InterventionsWomen were randomly assigned to receive 80 units of botulinum toxin type A at a concentration of 20 units/mL or saline injections (placebo group)

FU 26 weeks after injections


OutcomesVAS, EuroQOL-5D (EQ-5D), SF-12, Sexual Activities Questionnaire


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated sequence

Allocation concealment (selection bias)Low riskCentral telephone randomisation

Blinding of participants and personnel (performance bias)
All outcomes
Low riskPlacebo injection given

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskLess than 10% dropout

Two from placebo; one from botulinum group

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Brown 2002

MethodsMethod of allocation: unclear

Power calculation: yes

Exclusion postrandomisation: zero

Losses to follow-up: one

Intention-to-treat analysis: no

Source of funding: BIOflex Medical Magnets


ParticipantsCountry: USA

Number of participants: 32

Inclusion criteria: pelvic pain > six months despite other treatment, impaired social function, trigger/circumscribed tender point on examination, normal pelvic examination, normal cervical smears

Age: 18 to 50 years

Source of participants: gynaecology clinic

Exclusion criteria: pregnancy, breastfeeding, medical disorders, metal/electronic device, BMI > 35


InterventionsTreatment: static magnetic fields (n = 16)

Control: no treatment (n = 17)

Duration: two to four weeks


OutcomesThe McGill Pain Questionnaire, Pain Disability Index, Clinical Global Impression Scale


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot specified

Allocation concealment (selection bias)Unclear riskNot specified

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble-blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskDouble-blinded

Incomplete outcome data (attrition bias)
All outcomes
High riskVariable duration of study. Subgroup analysis of women who continued to have four weeks of treatment showed significance. High discontinuation between two and four weeks (41% attrition rate)

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Engel 1998

MethodsRandomisation: unclear

Method of allocation: unclear

Double-blinded

Exclusions postrandomisation: two

Losses to follow-up: zero

Unusual study design: cross-over design


ParticipantsCountry: USA

Number of participants: 25

Age: mean 29

Sex: F

Inclusion criteria: pelvic pain for longer than three months, no psychoactive medication for previous two weeks

Exclusion criteria: laparoscopy within three months, failed seven to 10-day placebo run-in phase


InterventionsTreatments: sertaline 50 mg twice daily

Control: placebo

Duration: six weeks

Follow-up: end of treatment


OutcomesComposite pain score

SF-36

Hamilton Depression Rating Scale

Social Adjustment Survey

Hopkins Symptoms Checklist Somatization items

Pin


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod not clearly specified

Allocation concealment (selection bias)Unclear riskNot specified

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble-blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskDouble-blinded

Incomplete outcome data (attrition bias)
All outcomes
Low risk25 randomly assigned, 23 completed the study

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Farquhar 1989

MethodsRandomisation: blocks of 12

Method of allocation: sealed envelopes

Exclusion postrandomisation: zero

Losses to follow-up: seven

Unusual study design (e.g. factorial)


ParticipantsCountry: England

Number of participants: 102

Age: mean 29.8

Sex: F

Inclusion criteria: pelvic pain for longer than six months, no pathology on laparoscopy, venogram score of five or higher

Exclusion criteria: recent psychiatric disease, history of thromboembolism

Postmenopausal, previous hysterectomy


InterventionsTreatments: medroxyprogesterone acetate (MPA) 50 mg daily (n = 25)

MPA and psychotherapy (n = 26)

Control: placebo (n = 25)

Placebo and psychotherapy (n = 26)

Duration: four months

Follow-up: nine months


OutcomesVisual analogue scale pain score

Pain improvement rating scale

Side effects


NotesNot blinded to psychotherapy. Quality score A


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation by random numbers table

Allocation concealment (selection bias)Low riskNumbered sealed envelopes for medications

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble-blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was recognised that the women might know whether they were receiving MPA because of its effect on their menstrual cycle. Therefore, all were told that both treatments— MPA and placebo—could induce amenorrhoea or irregular vaginal bleeding or have no obvious effect. In addition, women were asked to stop all forms of hormonal or intrauterine contraception and to use barrier methods throughout the 13 months of the trial

Incomplete outcome data (attrition bias)
All outcomes
High riskOf 102 women, 84 completed the full study (18% attrition). Of the other 18 women, 12 withdrew during the treatment period and six during the follow-up. Reasons cited were pregnancy, failure to attend the clinic and inability to maintain trial protocol

Selective reporting (reporting bias)Low riskLess than 10% loss to follow-up

Other biasLow riskNil

Ghaly 1994

MethodsClosed envelope system

Losses to follow-up: 10


ParticipantsCountry: Scotland

Number of participants: 100 (50 each group)

Age: 21 to 55

Sex: F

Inclusion criteria: > six months' pain, negative laparoscopy

Exclusion criteria: previous malignant disease, mental retardation, medical treatment for pelvic pain at first visit, suspicion of malignant disease on pelvic examination, abnormal pelvic examination


InterventionsTreatments: US scan and education/counselling sessions

Control: 'wait and see' policy (standard treatment)

Duration: four to nine months' reassessment


OutcomesMcGill Pain Scale score: at least five-point improvement

Hospital Anxiety Depression Scale: improvement in category (normal, borderline, depressed)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot specified, quote: 'random allocation to groups'

Allocation concealment (selection bias)Low riskClosed envelope system

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot possible because of the nature of the study

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessed blind to allocation

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOf 100 randomly assigned, 10 failed to attend for follow-up

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Haugstad 2008

MethodsRandomised trial


ParticipantsWomen between the ages of 20 and 50 years with deep pelvic pain lasting between one and 10 years


InterventionsTreatment group received 10 treatment sessions with the Mensendieck therapist (Haugstad 2007) of one hour’s duration over 90 days, and the control group received standard gynaecological advice at inclusion and again during the treatment period. This therapeutic approach can be seen as a mixture of physiotherapy and psychotherapy. It teaches patients to change their posture, breathing patterns and the way they move to reduce their pain. It uses a cognitive approach to allow women to have an improved understanding and experience of their body

Treatment period: three months

FU: one year

16 study groups, 18 controls


OutcomesVAS, GHQ-30


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Low riskRandomisation occurred by drawing a folded piece of paper with the participant's name from a jar, thus allocating the name to a previously chosen treatment group. Randomisation was performed by a person external to the study

Blinding of participants and personnel (performance bias)
All outcomes
Low riskNot possible in this case, unclear whether assessors blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
High riskNo attrition figures stated, but at one year, only 13 women in each group had completed the questionnaires

Selective reporting (reporting bias)Low risk

Other biasLow riskNil

Heyman 2006

MethodsAllocation concealment: sealed envelope system, blocks of four (balanced)

Blinding: no

Exclusion postrandomisation: zero

Losses to follow-up: five (three/two)

Power calculation: yes

Intention-to-treat analysis: none


ParticipantsCountry: Sweden

No. of participants: 50 (25 each group)

Age: median 33 (19 to 54)

Sex: F

Inclusion criteria: pelvic pain in fertile women > 19 years of age with a duration of at least six months, continuous or intermittent pain at least two days/wk

Exclusion criteria: known disease of abdomen, pelvis or lumbar spine; pregnancy; STI; severe mental illness; substance abuse; previous treatment with distension of painful structures in the pelvic floor


InterventionsTreatment: The participant lay in a prone position; the physician placed his index finger deep into the participant's rectum, and previously identified painful structures were treated in the following order: At a point two finger-widths lateral of the sacrum, the physician used his index finger to exert strong pressure against the sacrotuberous/spinal ligaments for 15 s to elicit pain. Thereafter, the musculature of the pelvic floor and the joint between the coccyx and the sacrum were concurrently forcefully distended dorsally for 60 s with the index finger. This procedure was repeated after two to three weeks

Control: standard care (counselling)

Duration: four to six weeks


OutcomesVAS


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomisation method not stated

Allocation concealment (selection bias)Low riskBy drawing an envelope, assignment to treatment or control group was performed in blocks of four (i.e. the number of participants in each group was balanced after each fourth participant)

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not possible, unclear whether assessors blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
High riskThree of 25 (> 10%) dropped out from each group

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Norman 2004

MethodsMethod of allocation: randomly assigned in blocks of two

Power calculation: no

Intention-to-treat analysis: no


ParticipantsCountry: United States

Number of participants: 48 (28 disclosure, 20 control)

Age: 18 to 64

Sex: F


InterventionsTreatments: Two groups of women wrote about their positive (control group) and their negative (disclosure group) experience of pain and had their health status assessed at the end of two months


OutcomesMcGill Pain Questionnaire


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'Randomised in blocks of 2' into sealed packets

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: 'interviewer was blind to group assignment'

Incomplete outcome data (attrition bias)
All outcomes
High risk60 randomly assigned, 12 dropped out (four intervention, eight control group). Reasons obtained; > 10% attrition

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Peters 1991

MethodsMethods of allocation: sealed envelope

Outcome assessor blind to allocation

Losses to follow-up: six unsuitable for laparoscopy


ParticipantsCountry: Netherlands

Participants: 106 (57 treatment, 49 control)

Age: 16 to 58

Sex: F

Inclusion criteria: chronic pelvic pain > three months, no problem with Dutch, no mental retardation

Exclusion criteria: no malignancy/disease requiring prompt gynaecological intervention, no history of psychiatric/psychotherapeutic treatment for abdominal pain, no elaborate medical analysis re abdominal pain in the past two years


InterventionsTreatment: integrated (guided by pain model by Loeser 1980, which comprises four components: nociception, pain sensation, pain suffering and pain behaviour; equal attention was devoted to possible organic, psychological, dietary and environmental causes of pain)

Control: standard treatment (includes laparoscopy)

Duration of treatment: six months

Follow-up: one year


OutcomesGeneral pain experience

Disturbance of daily activities

Associated symptoms

McGill VAS score


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Low riskQuote: 'randomisation was done by means of closed envelope procedure'

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not possible, but unclear whether assessors blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessor blind to allocation

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo dropouts

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Sator-Katzenschlager 2005

MethodsRandomisation methods not specified


ParticipantsCPP longer than six months


InterventionsGabapentin (n = 20), amytriptyline (n = 20) or combination (n = 16)

Dose of amytriptyline was increased from an initial dose of 25 mg per day up to a maximum dose of 150 mg per day in 25-mg increments each week until sufficient pain relief or the occurrence of side effects such as somnolence, dizziness, orthostatic hypotension, palpitations, dry mouth and weight gain. The dose of gabapentin was increased from 300 mg per day up to a maximum dose of 3600 mg per day in 300-mg increments each week until sufficient pain relief or the occurrence of side effects


OutcomesVAS


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded as open-label trial, unclear whether assessors blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
High riskSeven participants dropped out because of side effects; > 10% dropout

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasUnclear riskSeven participants excluded after randomisation, so not analysed by intention-to-treat, but same number of dropouts from gabapentin (three) or amytriptyline group (three)

Soysal 2001

MethodsMethod of allocation: computer-generated numbered opaque sealed envelopes


ParticipantsCountry: Turkey

47 women with pelvic pain and venographically demonstrated pelvic congestion


InterventionsGoserelin 3.6 mg subcutaneous implant monthly for six months versus medroxyprogesterone acetate tablets 30 mg daily for six months


OutcomesVenography score; pelvic symptom and physical examination score (modified from Biberoglu and Behrman); Hospital Anxiety, Depression and Total scores; revised Sabbatsberg Sexual Rating Scale


NotesNote: NO dropouts


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence

Allocation concealment (selection bias)Low riskOpaque sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskBlinding: some outcomes assessed double-blind. Participants not blind owing to modes of drug administration

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAt final assessment of periuterine venography, operators were blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskExclusion postrandomisation: zero

Losses to follow-up: zero

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Stones 2001

MethodsSealed envelope system. Double-blinded

Power calculation: yes

Number of participants randomly assigned: 39


ParticipantsCountry: England

Number of participants: 39

Age: 25 to 35

Sex: F

Inclusion criteria: pelvic pain > six months, laparoscopy identified no pathology

Exclusion criteria: hysterectomised women


InterventionsTreatment: lofexidine 200 mcg twice daily, increasing to 600 mcg twice daily (first three weeks)

Control: placebo tablets

Duration: eight weeks

Follow-up: until the end of treatment


OutcomesVisual analogue scale pain score. Participant's self rating of pain as worst, unchanged, somewhat relieved, considerably relieved or completely relieved


NotesNote high dropout rate in treatment group (nine of 19 completed eight weeks of treatment)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Women were randomised using a sealed envelope system to receive lofexidine hydrochloride or placebo''

Allocation concealment (selection bias)Low riskSealed envelope

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble-blinded, unclear whether assessors blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
High riskHigh dropout rate, > 10% dropout

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

Walton 1992

MethodsMethods of allocation: not stated.

Blinding: not stated

Exclusion postrandomisation: zero


ParticipantsCountry: UK

Number of participants: 165

Age: not given

Sex: F

Inclusion criteria: pelvic pain for longer than six months

No pathology on laparoscopy

Exclusion criteria not given


InterventionsTreatment: medroxyprogesterone acetate 50 mg daily

Control: placebo tablets

Duration: four months

Follow-up: only until end of treatment


OutcomesVisual analogue scale pain score

Pain improvement rating: better/not better


NotesNote very high dropout rate in MPA and placebo groups. Published report does not give SD for mean VAS, so data entered in Table are the numbers reporting 50% reduction in VAS at completion of the study. This allowed comparison with Farquhar 1989, as the drug, dose and duration of therapy are the same. Complete study report obtained by the review authors


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Two patients were allocated, at random, to the treatment group for each one given placebo"

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
High riskHigh dropout rate, reasons obtained; commonest is non-compliance; losses to follow-up: 64% of those taking active drug and 57% of those taking placebo completed the study

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNil

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Brown 2008Open-label trial. Lack of placebo control group, lack of randomisation

Elcombe 1997Participants entered and evaluated at different time points in control and active groups, making comparison between groups difficult

Fenton 2008Cross-over trial with no washout period

Onwude 2004Includes surgery

Pearce 1986Abstract only. No data available

Reginald 1987Not an RCT

Simsek 2007Randomised cross-over trial without washout period

 
Characteristics of studies awaiting assessment [ordered by study ID]
Horne 2012

MethodsRandomised controlled trial (pilot feasibility study)

Participantsn = 60 women recruited from NHS UK hospital

InterventionsWomen randomly assigned to gabapentin versus placebo

OutcomesPrimary objective is to assess recruitment and retention rates. Secondary objectives are to determine the effectiveness and acceptability to participants of proposed methods of recruitment and randomisation, drug treatments and assessment tools and to perform a pretrial cost-effectiveness assessment of treatment with gabapentin

Notes

 
Comparison 1. Medical treatment versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Progesterone versus placebo2Peto Odds Ratio (Peto, Fixed, 95% CI)Subtotals only

    1.1 Improvement in pain score at end of treatment
2204Peto Odds Ratio (Peto, Fixed, 95% CI)3.00 [1.70, 5.31]

    1.2 Improvement in pain score (up to nine months after treatment)
2204Peto Odds Ratio (Peto, Fixed, 95% CI)2.09 [1.18, 3.71]

    1.3 Weight gain
185Peto Odds Ratio (Peto, Fixed, 95% CI)7.82 [3.28, 18.65]

    1.4 Bloatedness
185Peto Odds Ratio (Peto, Fixed, 95% CI)3.20 [1.37, 7.47]

    1.5 Other medical events—leg colour change, breast lumps
164Peto Odds Ratio (Peto, Fixed, 95% CI)1.74 [0.52, 5.82]

 2 Lofexidine versus placebo1Peto Odds Ratio (Peto, Fixed, 95% CI)Subtotals only

    2.1 Improvement in pain score
139Peto Odds Ratio (Peto, Fixed, 95% CI)0.42 [0.11, 1.61]

    2.2 Drowsiness/lethargy
139Peto Odds Ratio (Peto, Fixed, 95% CI)3.80 [1.09, 13.26]

    2.3 Dry mouth
139Peto Odds Ratio (Peto, Fixed, 95% CI)8.60 [2.44, 30.31]

    2.4 Dizziness
139Peto Odds Ratio (Peto, Fixed, 95% CI)4.47 [1.29, 15.46]

    2.5 Headache/migraine
139Peto Odds Ratio (Peto, Fixed, 95% CI)0.33 [0.09, 1.16]

 
Comparison 2. Medical treatment: head-to-head comparison

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Goserelin versus progestogen1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 Improvement in pelvic pain score at one year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 rSSRS score
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 HADS total score at one year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Gabapentin versus amytriptyline1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 VAS pain score at 24 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 3. Psychological therapy versus control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Improvement in pain scores5Peto Odds Ratio (Peto, Fixed, 95% CI)Subtotals only

    1.1 Ultrasound scan and counselling session versus 'wait and see'
190Peto Odds Ratio (Peto, Fixed, 95% CI)6.77 [2.83, 16.19]

    1.2 Somatocognitive therapy (Mensendieck) versus standard gynaecological clinical care
140Peto Odds Ratio (Peto, Fixed, 95% CI)3.38 [0.97, 11.80]

    1.3 Integrated approach (somatic, psychological, dietary, environmental and physiotherapeutic factors) versus standard care
1106Peto Odds Ratio (Peto, Fixed, 95% CI)1.52 [0.71, 3.27]

    1.4 Writing therapy (disclosure of pain) versus non-disclosure
148Peto Odds Ratio (Peto, Fixed, 95% CI)4.47 [1.41, 14.13]

    1.5 Psychotherapy versus placebo: at end of treatment
151Peto Odds Ratio (Peto, Fixed, 95% CI)0.79 [0.24, 2.59]

    1.6 Psychotherapy versus placebo: nine months post-treatment
151Peto Odds Ratio (Peto, Fixed, 95% CI)0.46 [0.14, 1.49]

 2 Depression/negative mood scores2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 Physiotherapy and psychotherapy versus standard gynaecological advice
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Writing therapy (disclosure of pain) versus non-disclosure
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 4. Complementary therapy versus control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Distension of painful pelvic structures versus counselling1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 Intensity of pelvic pain: change in pain score
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Painful intercourse: change in pain score
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Magnetic therapy versus control magnet1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 Pelvic Pain Index
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Clinical Global Impression-Severity
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 Pain Disability Index
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Summary of findings for the main comparison. Medical treatment compared with placebo for the management of chronic pelvic pain

Medical treatment compared with placebo for the management of chronic pelvic pain

Population: women with chronic pelvic pain

Setting: any
Intervention: medical treatment
Comparison: placebo

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No. of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

PlaceboMedical treatment

Improvement in pain score at end of treatment: progesterone versus placebo24/85541 per 1000
(401 to 676)
Peto OR 3.00 (1.70 to 5.31)204
(two studies)
⊕⊕⊕⊝
moderate1,2
Improvement defined as ≥ 50% reduction in VAS pain score

Improvement in pain score (up to nine months after treatment): progesterone versus placebo27/85493 per 1000
(355 to 633)
Peto OR 2.09 (1.18 to 3.71)204
(two studies)
⊕⊕⊕⊝
moderate1
Improvement defined as ≥ 50% reduction in VAS pain score

Weight gain: progesterone versus placebo14/40808 per 1000
(638 to 909)
Peto OR 7.82 (3.28 to 18.65)85
(one study)
⊕⊕⊕⊕
high

Bloatedness: progesterone versus placebo14/40633 per 1000
(425 to 801)
Peto OR 3.20 (1.37 to 7.47)85
(one study)
⊕⊕⊕⊕
high

Improvement in pain score: lofexidine versus placeboeight/20219 per 1000
(68 to 518)
Peto OR 0.42 (0.11 to 1.61)39
(one study)
⊕⊕⊝⊝
low1,2,3
Improvement defined as ≥ 50% reduction in VAS pain score

Drowsiness/lethargy: lofexidine versus placeboeight/20717 per 1000
(421 to 898)
Peto OR 3.80 (1.09 to 13.26)39
(one study)
⊕⊕⊕⊝
moderate2

Dry mouth: lofexidine versus placebothree/20603 per 1000
(301 to 842)
Peto OR 8.60 (2.44 to 30.31)39
(one study)
⊕⊕⊕⊝
moderate2

*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 140% dropout rate in one of the two studies.
2> 10% dropout rate.
3Wide confidence intervals compatible with no effect or with higher rates of improvement in placebo group.
 
Summary of findings 2. Medical treatment of chronic pelvic pain: head-to-head comparisons

Medical treatment of chronic pelvic pain: head-to-head comparisons

Patient or population: management of chronic pelvic pain
Settings: any
Intervention: medical treatment: head-to-head comparison

OutcomesMedical treatment: head-to-head comparisonNo. of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Improvement in pelvic pain at one year: goserelin versus progestogenImprovement in mean pelvic pain score in the goserelin group was three points greater than in the progestogen group (95% CI 2.08 higher to 3.92 higher)47
(one study)
⊕⊕⊕⊝
moderate1
Improvement in pelvic pain score measured on a scale of one to 100

Pain at 24 months: gabapentin versus amytriptylineMean pain score in the gabapentin group was 1.5 points lower than in the amytriptyline group (95% CI 2.06 lower to 0.94 lower)40
(one study)
⊕⊕⊝⊝
low1,2
Pain score measured on a VAS scale of zero to 10

CI: Confidence interval.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Participants not blinded.
2> 10% attrition.
 
Summary of findings 3. Psychological therapy compared with control interventions for the management of chronic pelvic pain

Psychological therapy compared with control interventions for the management of chronic pelvic pain

Population: women with chronic pelvic pain

Setting: any
Intervention: psychological therapy
Comparison: control intervention

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No. of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPsychological therapy

Improvement in pain scores—Ultrasound scan and counselling session versus 'wait and see'113 per 1000465 per 1000
(266 to 675)
Peto OR 6.77 (2.83 to 16.19 )90
(one study)
⊕⊕⊕⊝
low1,2,6
Improvement defined as a change of five or more points on McGill Pain Questionnaire

Improvement in pain scores—Somatocognitive therapy (Mensendieck) versus standard gynaecological clinical care250 per 1000530 per 1000
(244 to 797)
Peto OR 3.38 (0.97 to 11.80 )40
(one study)
⊕⊝⊝⊝
very low3,4,5
Improvement defined as ≥ 50% reduction in VAS pain score

Improvement in pain scores—Integrated approach (somatic, psychological, dietary, environmental and physiotherapeutic factors) versus standard care510 per 1000613 per 1000
(425 to 773)
Peto OR 1.52 (0.71 to 3.27 )106
(one study)
⊕⊕⊝⊝
low2,5,6
Improvement defined as ≥ 50% reduction in VAS pain score

Improvement in pain scores—Writing therapy (disclosure of pain) versus non-disclosure200 per 1000528 per 1000
(261 to 779)
Peto OR 4.47 (1.41 to 14.13 )48
(one study)
⊕⊕⊝⊝
very low2,7,8,9
Improvement considered an improvement of at least one point on a zero to five pain scale

Improvement in pain scores—Psychotherapy versus placebo, measured at end of treatment320 per 1000271 per 1000
(101 to 549)
Peto OR 0.79 (0.24 to 2.59 )51
(one study)
⊕⊕⊕⊝
low10,11
Improvement defined as ≥ 50% reduction in VAS pain score

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 110% attrition.
2Sequence generation method not described.
3No attrition figures stated, but at one year, only 13 women in each group had completed the questionnaires.
4Unblinded.
5Wide confidence intervals compatible with no effect or with benefit from intervention.
6Participants not blinded.
720% loss to follow-up.
8Allocation concealment methods not described.
9Unclear whether participants blinded.
10Wide confidence intervals compatible with no effect or with increased pain from intervention.
1118% attrition.
 
Summary of findings 4. Complementary therapy compared with control interventions for the management of chronic pelvic pain

Complementary therapy compared with control interventions for the management of chronic pelvic pain

Population: women with chronic pelvic pain
Settings: any
Intervention: complementary therapy
Comparison: control intervention

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No. of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlComplementary therapy

Reduction in pain score: distension of painful pelvic structures versus counselling23Mean reduction in pain score in the intervention group was 35.8 higher (23.08 higher to 48.52 higher)-48
(one study)
⊕⊕⊕⊝
moderate1
Reduction in pain score, measured on a self assessed one to 100 VAS scale

Pain score after treatment: magnetic therapy versus control magnet11Mean pelvic pain score in the intervention group was 0.5 lower (1.92 lower to 0.92 higher)-19
(one study)
⊕⊝⊝⊝
very low2,3
Post-treatment pelvic pain score on a zero to five-point scale, where 0 = no pain and 5 = excruciating pain

*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Unclear whether blinded, 12% attrition.
241% dropout rate at two to four weeks.
3Wide confidence interval compatible with no effect or benefit from magnetic therapy.
 
Table 1. Change in pain, depression, somatisation and functional status

Engel 1998

Composite pain intensitySF-36 functioning-emotional subscaleHealth perception

-0.02, 95% CI -0.6 to 0.6-30.4, 95% CI -50.3 to -10.63.0, 95% CI 0.3 to 5.7