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Fármacos antiinflamatorios no esteroideos para el dolor en mujeres con endometriosis

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Referencias

Referencias de los estudios incluidos en esta revisión

Kauppila 1979 {published data only}

Kauppila A, Puolakka J, Ylikorkala O. Prostaglandin biosynthesis inhibitors and endometriosis. Prostaglandins 1979;18(4):655‐61. CENTRAL
Ylikorkala O, Viinikka L. Postaglandins and endometriosis. Acta Obstetrica et Gynecologica Scandinavica 1983;113 Suppl:105‐7. CENTRAL

Kauppila 1985 {published data only}

Kauppila A, Ronnberg L. Naproxen sodium in dysmenorrhoea secondary to endometriosis. Obstetrics and Gynaecology 1985;65(3):379‐83. CENTRAL

Referencias de los estudios excluidos de esta revisión

Cobellis 2004 {published data only}

Cobellis L, Razzi S, De Simone S, Sartini A, Fave A, Danero S, et al. The treatment with a COX‐2 specific inhibitor is effective in the management of pain related to endometriosis. European Journal of Obstetrics, Gynecology, and Reproductive Biology 2004;116:100‐2. CENTRAL

Barbieri 1990

Barbieri RL. Endometriosis 1990 ‐ current treatment approaches. Drugs 1990;39(4):502‐10.

Berube 1998

Berube S, Marcoux S, Maheux R, Graves G, Wrixon W, O'Keane J, et al. Characteristics related to the prevalence of minimal or mild endometriosis in infertile women. Epidemiology 1998;9(5):504‐10.

Canavan 2000

Canavan TP, Radosh L. Managing endometriosis. Strategies to minimize pain and damage. Postgraduate Medicine 2000;107(3):213‐6, 222‐4.

Davies 2003

Davies B. The best practice in treatment. Living with Endometriosis ‐ The Way Forward (oral presentation, London, UK)2003; Vol. April 30.

Dawood 1986

Dawood MY. Current concepts in the etiology and treatment of primary dysmenorrhea. Acta Obstetricia et Gynecologica Scandinavica 1986;138 Suppl:7‐10.

Elbourne 2002

Elbourne DR, Altman DG, Higgins JPT, Curtin F, Worthington HV. Meta‐analyses involving cross‐over trials: methodological issues. International Journal of Epidemiology 2002;31:140‐9.

Hart 1984

Hart FD, Huskisson EC. Non‐steroidal anti‐inflammatory drugs. Current status and rational therapeutic use. Drugs 1984;27(3):232‐55.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane‐handbook.org.

Jones 2002

Jones GL, Kennedy SH, Jenkinson C. Health‐related quality of life measurement in women with common benign gynecologic conditions: a systematic review. American Journal of Obstetrics and Gynecology 2002;187(2):501‐11.

Kennedy 2003

Kennedy S. International links. Living with Endometriosis ‐ The Way Forward (oral presentation, London, UK)2003; Vol. April 30.

Marjoribanks 2015

Marjoribanks J, Ayeleke RO, Farquhar C, Proctor M. Nonsteroidal anti‐inflammatory drugs for dysmenorrhoea. Cochrane Database of Systematic Reviews 2015, Issue 7. [DOI: 10.1002/14651858.CD001751.pub3]

Murphy 2002

Murphy AA. Clinical aspects of endometriosis. Annals of the New York Academy of Sciences 2002;955:1‐10, Discussion 34‐6, 396‐406.

Prentice 2003

Prentice A, Deary AJ, Bland E. Progestogens and anti‐progestogens for pain associated with endometriosis (Cochrane Review). Cochrane Database of Systematic Reviews 2003, Issue 3. [DOI: 10.1002/14651858.CD002122]

rAFS 1985

Revised American Fertility Society classification of endometriosis. Revised American Fertility Society classification of endometriosis. Fertility and Sterility 1985;43:351‐2.

RevMan 2014 [Computer program]

Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Rice 2002

Rice VM. Conventional medical therapies for endometriosis. Annals of the New York Academy of Sciences 2002;955:343‐52, Discussion 389‐93, 396‐406.

Vessy 1992

Vessey MP, Villard‐Mackintosh L, Painter R. Epidemiology of endometriosis in women attending family planning clinics. BMJ 1992;306(6871):182‐4.

Referencias de otras versiones publicadas de esta revisión

Allen 2004

Allen C, Hopewell S, Prentice A. Non‐steroidal anti‐inflammatory drugs for pain in women with endometriosis. Cochrane Database of Systematic Reviews 2004, Issue 2. [DOI: 10.1002/14651858.CD004753]

Allen 2005

Allen C, Hopewell S, Prentice A, Gregory D. Non‐steroidal anti‐inflammatory drugs for pain in women with endometriosis. Cochrane Database of Systematic Reviews 2005, Issue 4. [DOI: 10.1002/14651858.CD004753.pub2]

Allen 2009

Allen C, Hopewell S, Prentice A, Gregory D. Nonsteroidal anti‐inflammatory drugs for pain in women with endometriosis. Cochrane Database of Systematic Reviews 2009, Issue 2. [DOI: 10.1002/14651858.CD004753.pub3]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Kauppila 1979

Methods

Trial design: 2‐period, 4‐treatment cross‐over trial

Participants

24 women randomised; 18 analysed

Mean age: 33 (22‐43) years

Inclusion criteria: women with symptomatic endometriosis (stage and severity not described). Endometriosis was diagnosed by laparoscopy (n = 13) and by pelvic examination (n = 5).
Exclusion criteria: not clear

Setting: Finland

Timing: unclear

Interventions

Group 1: indomethacin 25 mg given 3 × daily for 2 menstrual cycles, then cross‐over to acetylsalicylic acid, tolfenamic acid and placebo for 2 menstrual cycles each (n = 6)

Group 2: acetylsalicylic acid 500 mg given 3 × daily for 2 menstrual cycles, then cross‐over to tolfenamic acid, placebo and indomethacin for 2 menstrual cycles each (n = 6)

Group 3: tolfenamic acid 200 mg given 3 × daily for 2 menstrual cycles, then cross‐over to placebo, indomethacin and acetylsalicylic acid for 2 menstrual cycles each (n = 6)

Group 4: placebo given 3 × daily for 2 menstrual cycles, then cross‐over to indomethacin, acetylsalicylic acid and tolfenamic acid for 2 menstrual cycles each (n = 6)

Outcomes

These were self‐reported by questionnaire, which was completed by the participant immediately after each menstrual cycle.

Pain relief: pelvic pain, lower back pain, pain in walking, dyspareunia, pain on defecation, headache; number not reported but described as more common with placebo and indomethacin
Quality of life: not reported
Effect on daily activities: not reported
Absence from work or school: not reported
Unintended effects of treatment: gastrointestinal complaints (nausea and vomiting), number not reported but described as more common with indomethacin; psychic complaints (insomnia and nervousness), number not reported but described as more common with indomethacin
Number of women requiring more invasive treatment: not reported
Requirements for additional medication: not reported
Participant satisfaction with treatment: not reported

Notes

Drugs for use in the trial were provided by Medica Ltd, Helsinki, Finland. "The authors wish to thank Medica Ltd, Helsinki, Finland, for the drugs."

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described

Allocation concealment (selection bias)

Unclear risk

Not described

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

"placebo‐controlled double‐blind trial"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

"Twenty‐four patients...volunteered for this study. Eighteen women completed the trial; the remaining six terminated treatment for a variety of personal reasons."

Selective reporting (reporting bias)

Unclear risk

Prespecified primary and secondary outcomes were not clearly defined.

Other bias

Unclear risk

Insufficient information was provided to enable a judgement of low risk of bias.

Kauppila 1985

Methods

Trial design: 2‐period, 2‐treatment cross‐over trial

Participants

24 women randomised; 20 analysed

Mean age: group 1, 32 years; group 2, 35 years

Inclusion criteria: women with endometriosis classified by the American Fertility Society (mild endometriosis, n = 7; moderate endometriosis, n = 8; severe endometriosis, n = 6). Endometriosis was diagnosed by pelvic examination, history of menstrual distress and direct visualisation of pelvic regions at laparoscopy or laparotomy.
Exclusion criteria: not clear
Setting: Finland

Timing: unclear

Interventions

Group 1: naproxen sodium (nonsteroidal anti‐inflammatory drug (NSAID)) 275 mg (102 tablets) 4 × daily for 2 menstrual cycles, then cross‐over to placebo for 2 menstrual cycles (n = 12)
Additional interventions: Additional analgesia was allowed if no relief was noted after the first 2 doses of NSAID.

Group 2: placebo given for 2 menstrual cycles, then cross‐over to naproxen sodium (NSAID) for 2 menstrual cycles (n = 12)

Additional interventions: Additional analgesia was allowed if no relief was noted after first 2 doses.

Outcomes

All were self‐reported by questionnaire, which was completed by the participant immediately after each menstrual cycle.

Pain relief: measured after each menstrual cycle (score 3 to ‐1)
Quality of life: not reported
Effects on daily activities: activity of participant (score 4 to 0)
Absence from work or school: not reported
Unintended effects of treatment: fatigue, light‐headedness, eye lid oedema and chest pain (n = 4 while taking naproxen sodium); hypomenorrhoea, diarrhoea, increased diuresis, headache, epigastric pain, nausea and vomiting, tremor and dizziness (n = 7 while taking placebo)
Number of women requiring more invasive treatment: not reported
Requirements for additional medication: Supplemental analgesia was more common in the placebo group (14) than in the NSAID group (2).
Participant satisfaction with treatment: not reported

Notes

Drugs used in the trial were supplied by Syntex Research, Maidenhead, England. "The study drugs were kindly supplied by Syntex Research, Maidenhead, England."

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described

Allocation concealment (selection bias)

Unclear risk

Not described

Blinding (performance bias and detection bias)
All outcomes

Low risk

"The study was conducted according to a randomized, double‐blind, four‐period crossover design."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

"Twenty‐four patients...entered the present study...One patient became pregnant before the first treatment, one patient had psychiatric problems that rendered her responses unreliable, and two patients were lost to follow‐up for unknown reasons during the trial."

Selective reporting (reporting bias)

Unclear risk

Prespecified primary and secondary outcomes were not clearly defined.

Other bias

Unclear risk

Information provided was insufficient to enable a judgement of low risk of bias.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Cobellis 2004

This trial assessed use of the cyclo‐oxygenase (COX)‐2‐specific inhibitor (rofecoxib) for management of pain related to endometriosis. However, this drug was withdrawn from the marketplace in November 2004 on safety grounds; therefore, it is inappropriate to assess the efficacy of the product in this review. If the drug is re‐launched, we will review this decision at the time the review would be updated.

Data and analyses

Open in table viewer
Comparison 1. NSAID versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Overall pain relief Show forest plot

1

odds ratio (Fixed, 95% CI)

3.27 [0.61, 17.69]

Analysis 1.1

Comparison 1 NSAID versus placebo, Outcome 1 Overall pain relief.

Comparison 1 NSAID versus placebo, Outcome 1 Overall pain relief.

2 Unintended effects of treatment Show forest plot

1

odds ratio (Fixed, 95% CI)

0.46 [0.09, 2.47]

Analysis 1.2

Comparison 1 NSAID versus placebo, Outcome 2 Unintended effects of treatment.

Comparison 1 NSAID versus placebo, Outcome 2 Unintended effects of treatment.

3 Requirements for additional medication Show forest plot

1

odds ratio (Fixed, 95% CI)

0.12 [0.01, 1.29]

Analysis 1.3

Comparison 1 NSAID versus placebo, Outcome 3 Requirements for additional medication.

Comparison 1 NSAID versus placebo, Outcome 3 Requirements for additional medication.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 NSAID versus placebo, Outcome 1 Overall pain relief.
Figuras y tablas -
Analysis 1.1

Comparison 1 NSAID versus placebo, Outcome 1 Overall pain relief.

Comparison 1 NSAID versus placebo, Outcome 2 Unintended effects of treatment.
Figuras y tablas -
Analysis 1.2

Comparison 1 NSAID versus placebo, Outcome 2 Unintended effects of treatment.

Comparison 1 NSAID versus placebo, Outcome 3 Requirements for additional medication.
Figuras y tablas -
Analysis 1.3

Comparison 1 NSAID versus placebo, Outcome 3 Requirements for additional medication.

Summary of findings for the main comparison. NSAID compared with placebo for pain in women with endometriosis

NSAID compared with placebo for pain in women with endometriosis

Patient or population: women with endometriosis
Setting: Finland
Intervention: nonsteroidal anti‐inflammatory drugs (NSAIDs)
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with NSAID

Pain relief assessed with: overall pain relief score follow‐up: median 2 months

50 per 100

77 per 100
(38 to 95)

OR 3.27
(0.61 to 17.69)

24
(1 RCT)

⊕⊝⊝⊝
Very lowa,b

Unintended effects from treatment follow‐up: median 2 months

58 per 100

39 per 100
(11 to 78)

OR 0.46
(0.09 to 2.47)

24
(1 RCT)

⊕⊝⊝⊝
Very lowa,b

Quality of life: not reported

Effects on daily activities: not reported

Absence from work or school: not reported

Number of women requiring more invasive treatment: not reported

Requirements for additional medication follow‐up: median 2 months

83 per 100

38 per 100
(5 to 87)

OR 0.12
(0.01 to 1.29)

24
(1 RCT)

⊕⊝⊝⊝
Very lowa,b

Participant satisfaction with treatment: not reported

*The risk in the intervention group (and its 95% confidence interval) is based on 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: We are very confident that the true effect lies close to the estimate of effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

aDowngraded one level owing to overall unclear risk of bias for included trial.

bDowngraded two levels for imprecision because confidence interval is wide, consistent with benefit and harm and evidence based on a single small trial.

Figuras y tablas -
Summary of findings for the main comparison. NSAID compared with placebo for pain in women with endometriosis
Comparison 1. NSAID versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Overall pain relief Show forest plot

1

odds ratio (Fixed, 95% CI)

3.27 [0.61, 17.69]

2 Unintended effects of treatment Show forest plot

1

odds ratio (Fixed, 95% CI)

0.46 [0.09, 2.47]

3 Requirements for additional medication Show forest plot

1

odds ratio (Fixed, 95% CI)

0.12 [0.01, 1.29]

Figuras y tablas -
Comparison 1. NSAID versus placebo