Oral contraceptive pill for primary dysmenorrhoea

Chooi L Wong; Cindy Farquhar; Helen Roberts; Michelle Proctor

doi:10.1002/14651858.CD002120.pub3

Píldora anticonceptiva oral para la dismenorrea primaria

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Referencias

References to studies included in this review

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estudios excluidos
otras referencias
otras versiones publicadas

Bassol S, Alvarado A, Celis C, Cravioto MC, Peralta O, Montano R, et al. Latin American experience with two low‐dose oral contraceptives containing 30µg ethinylestradiol/75µg gestodene and 20µg ethinyl estradiol/150µg desogestrel. Contraception 2000;62(3):131‐5.

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References to studies excluded from this review

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estudios incluidos
otras referencias
otras versiones publicadas

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Additional references

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References to other published versions of this review

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estudios incluidos
estudios excluidos
otras referencias

Proctor ML, Roberts H, Farquhar CM. Combined oral contraceptive pill (OCP) as treatment for primary dysmenorrhoea. Cochrane Database of Systematic Reviews 2001, Issue 2. [DOI: 10.1002/14651858]

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Bassol 2000

Methods	Randomisation list was prepared with random number tables. Open trial 342 participants randomised which included 156 women with dysmenorrhoea. Withdawals: 98(44 from gestodene group and 54 from desogestrel group)
Participants	Inclusion: aged 18 to 35 years old, require contraception for at least 12 months, sexually active, healthy. Exclusion: unclassified genital bleeding, pregnancy, pathologic conditions, used parental depot‐contraceptives during the previous 6 months. Age: Argentina: 24.79 +/‐ 4.8, Brazil: 25.13 +/‐ 5.5, Chile: 26.63 +/‐ 4.91, Mexico: 24.53 +/‐ 3.9 Location: Argentina, Brazil, Chile, Mexico
Interventions	1. Ethinyl estradiol 0.03mg, 0.075mg gestodene 2. Ethinyl estradiol 0.02mg, 0.15mg desogestrel Duration: 12 cycles
Outcomes	Dysmenorrhoea (slight, moderate, severe) Adverse events.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Random list of 20 blocks of 20 and 5 blocks of 10.
Allocation concealment?	Low risk	Women received a package of pills they agreed to use in accordance with a progressive random number of the list.
Blinding? All outcomes	High risk	Open
Incomplete outcome data addressed? All outcomes	Unclear risk	Although there were 98 dropouts it is unclear if they were included in the final analysis
Free of selective reporting?	Low risk
Power calculations	Low risk
Dropouts reported	Low risk	98 dropouts (44 from the 30 mcg/gestodene group and 54 in the 20 mcg/150 mcg group).
Baseline comparability	Low risk

Buttram 1969a

Methods	Random ‐ unstated Double blind, parallel trial 40 participants randomised
Participants	Inclusion: severe primary dysmenorrhoea (incapacitating pain for 2 or more days per cycle), pelvic exam to confirm no pathology. Exclusion: mild pain, dysmenorrhoea due to organic causes Age: groups 1 and 2 ‐ average 20; group 3 ‐ average 22 Location: USA
Interventions	1. Norinyl 2 ‐ norethindrone 2mg with mestranol 0.1mg from day 5 to 25 (equivalent to 70mcg of ethinyl oestradiol) 2. Sequential regimen with mestranol 0.08mg from day 5 for 11 days then chlormadinone acetate 2mg added for last 10 days of cycle. (This is equivalent to 56 mcg of ethinyl oestradiol) 3. Placebo ‐ day 5 to 25 Duration: 3 cycles
Outcomes	Duration and severity of dysmenorrhoea ‐ measured pre, during and post. No adverse events were collected.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	No method stated
Allocation concealment?	Unclear risk	B ‐ Unclear, stated randomised
Blinding? All outcomes	Low risk	Double blind
Incomplete outcome data addressed? All outcomes	High risk
Free of selective reporting?	Low risk
Power calculations	High risk
Dropouts reported	High risk
Baseline comparability	Low risk

Buttram 1969b

Methods	Random ‐ unstated Double blind, parallel trial 40 participants randomised
Participants	Inclusion: severe primary dysmenorrhoea (incapacitating pain for 2 or more days per cycle), pelvic exam to confirm no pathology. Exclusion: mild pain, dysmenorrhoea due to organic causes Age: groups 1 and 2 ‐ average 20; group 3 ‐ average 22 Location: USA
Interventions	1. Norinyl 2 ‐ norethindrone 2mg with mestranol 0.1mg from day 5 to 25 (equivalent to 70mcg of ethinyl oestradiol) 2. Sequential regimen with mestranol 0.08mg from day 5 for 11 days then chlormadinone acetate 2mg added for last 10 days of cycle. (This is equivalent to 56 mcg of ethinyl oestradiol) 3. Placebo ‐ day 5 to 25 Duration: 3 cycles
Outcomes	Duration and severity of dysmenorrhoea ‐ measured pre, during and post. No adverse events were collected.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	No method stated
Allocation concealment?	Unclear risk	B ‐ Unclear, stated randomised
Blinding? All outcomes	Low risk	Double blind
Incomplete outcome data addressed? All outcomes	Unclear risk	No data provided
Free of selective reporting?	Unclear risk	No data provided
Power calculations	Unclear risk	No data provided
Dropouts reported	Unclear risk	No data provided
Baseline comparability	Unclear risk	No data provided

Cullberg 1972

Methods	Randomisation was done statistically by the pharmaceutical company, allocation concealment was via a secure code not broken until after all data was collected. Double blind 322 women initially randomised, 23 drop outs (5 pregnancies, 6 disappeared, 4 somatic complaints such as bleeding skin troubles or nausea, 3 interfering illness, 4 change of mind). 213 of the initial group randomised had dysmenorrhoea, with 203 women with dysmenorrhoea analysed.
Participants	Inclusion: women aged between 18 to 45, absence of actual known disease, normal menstrual cycle, no actual or planned pregnancy. Exclusion: use of oral contraceptive in last 3 months Age: 27.5 (7.7) Source: female personnel from the general post office, the general telephone company, 4 nursing schools, 2 hospitals, the psychological institute at the local university Location: Stockholm, Sweden.
Interventions	1. norgestrel 1mg, ethinyl oestradiol 0.05mg 2. norgestrel 0.5mg, ethinyl oestradiol 0.05mg (Ovral) 3. norgestrel 0.06mg, ethinyl oestradiol 0.05mg 4. placebo Treatment was for 2 months and 1 tablet free month follow up.
Outcomes	Dysmenorrhoea (improved, worse, unchanged, none prior to treatment)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Pharmaceutical company provided the sequence
Allocation concealment?	Low risk	A ‐ Adequate, via a secure code not broken until after all data was collected.
Blinding? All outcomes	Low risk	Double
Incomplete outcome data addressed? All outcomes	High risk
Free of selective reporting?	Unclear risk	No data provided
Power calculations	High risk
Dropouts reported	High risk
Baseline comparability	Low risk

Davis 2005

Methods	Randomisation list was prepared with random number tables. Double blind 76 participants randomised, 74 analysed.
Participants	Inclusion: aged 19 years or younger with moderate or severe dysmenorrhoea, regular menstrual cycles for at least 1 year, 21 to 35 days of menstrual cycle length, condom users. 300 adolescents were screened for eligibility. Exclusion: pregnancy, history of pelvic pathology, abnormal genital bleeding, recent miscarriage or abortion, use of other medications likely to interfere with metabolisms of oral contraceptives. Age: OC group: 16.7 +/‐ 2, Placebo group: 16.9 +/‐ 2 Source: medical centre, college campuses Location: USA
Interventions	1. Ethinyl estradiol 0.02mg, 0.1mg levonorgestrel 2. Placebo Duration: 3 cycles
Outcomes	Pain severity (5 point scale) Rating of worst pain intensity Use of analgesic medication Absence from work or study Adverse events Discontinuation rate
Notes	3 publications from one study
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Random numbers table
Allocation concealment?	Low risk	A ‐ Adequate
Blinding? All outcomes	Low risk	Double
Incomplete outcome data addressed? All outcomes	Low risk	76 randomised and 74 analysed
Free of selective reporting?	Low risk
Power calculations	Low risk	Sample size was calculated for power to detect differences in main outcome of dysmenorrhoea between the OC group and the placebo group
Dropouts reported	Low risk	7/ 150 (4 from OCP and 3 from placebo group)
Baseline comparability	Low risk

Endrikat 1999

Methods	Randomisation method not stated. Open trial 1563 participants randomised which included women with no dysmenorrhoea. Withdawals: 449(228 from gestodene group and 221 from desogestrel group)
Participants	Inclusion: aged 18 to 35 years old, desire for contraception for at least 12 months Exclusion: contraindications to OC use, various pathologies, unclassified genital bleeding, history of migraine accompanying menstrual bleeding, pregnancy. Age: GSD group ‐ 25.5, DSG group ‐ 25.1 Location: France, Austria, United Kingdom, the Netherlands, Switzerland and Italy.
Interventions	1. Ethinyl estradiol 0.02mg, 0.15mg desogestrel 2. Ethinyl estradiol 0.02mg, 0.075mg gestodene Duration: 12 cycles
Outcomes	Dysmenorrhoea (did or did not experience pain relief)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	No information provided
Allocation concealment?	Unclear risk	B ‐ Unclear
Blinding? All outcomes	High risk	Open
Incomplete outcome data addressed? All outcomes	High risk	87 women were excluded from the analysis because of protocol violations
Free of selective reporting?	Unclear risk	Did not report adverse events
Power calculations	Low risk
Dropouts reported	Low risk	449/1563 (228 from gestodene group and 221 from desogestrel group)
Baseline comparability	Low risk

GPRG 1968

Methods	Administration of medicine was random however due to error each treatment had different numbers so were not identical Double blind 93 participants randomised
Participants	Inclusion: all cases of dysmenorrhoea except mild pain Age: 10 to 40 Location: UK
Interventions	1. Norinyl 1 ‐ norethisterone 1mg, mestranol 0.05mg 2. Placebo Duration: 2 cycles
Outcomes	Relief of pain Duration of pain Days off work/in bed Analgesics required Side effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Unequal numbers because of errors
Allocation concealment?	Unclear risk	B
Blinding? All outcomes	Low risk	Double blinding but the placebo group had packaging that was different different from treatment group although the patients were unaware which group they were assigned to
Incomplete outcome data addressed? All outcomes	High risk
Free of selective reporting?	Low risk
Power calculations	High risk
Dropouts reported	High risk
Baseline comparability	Low risk

Hendrix 2002

Methods	Randomisation list was generated by computer. Double blind 77 participants randomised, 59 analysed.
Participants	Inclusion: history of Grade 2 or Grade 3 dysmenorrhoea for at least 4 cycles, regular menstrual cycles, pelvic exam to confirm no pathology, no older than 32 years old. Exclusion: secondary dysmenorrhoea, suspected pregnancy, drugs use, sexually transmitted disease. Age: mean 24.2 +/‐ 4.9 Location: USA
Interventions	1. 21 days of desogestrel 0.15mg, ethinyl estradiol 0.02mg followed by 2 days of placebo and 5 days of ethinyl estradiol 0.01mg 2. Placebo Duration: 4 cycles
Outcomes	Pain severity (5 point scale)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Computer generated list
Allocation concealment?	Low risk	A ‐ Adequate
Blinding? All outcomes	Low risk	Double
Incomplete outcome data addressed? All outcomes	Low risk
Free of selective reporting?	Unclear risk	No adverse events
Power calculations	High risk
Dropouts reported	Low risk	25/77 (14 from the desogestrel group and 11 from the placebo group)
Baseline comparability	Low risk

Nakano 1971

Methods	Randomisation by 'envelope method' Double blind 22 participants randomised, 18 analysed
Participants	Inclusion: severe primary dysmenorrhoea that required absence from duty Location: Japan
Interventions	1. SH‐850 ‐ 0.5mg norgestrel, 0.05mg ethinyl estradiol from day 5‐25 2. Placebo Duration: 44 cycles experimental group, 31 cycles placebo group (between 3‐6 cycles for each participant)
Outcomes	Degree of symptomatic relief ‐ 3 point scale for each women and cycle Menstrual flow
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	No data provided
Allocation concealment?	Low risk	A "envelope method"
Blinding? All outcomes	Low risk	Double
Incomplete outcome data addressed? All outcomes	High risk
Free of selective reporting?	Unclear risk	No adverse events
Power calculations	High risk
Dropouts reported	Low risk	4/22
Baseline comparability	Low risk

Serfaty 1998

Methods	Randomisation method not stated. Open trial ‐ no blinding used. 1016 women initially randomised, 182 drop outs ( bleeding irregularities, adverse effects, ). 213 of the initial group randomised had dysmenorrhoea, with 173 women with dysmenorrhoea analysed.
Participants	Inclusion: regular menstrual cycles (24‐35 days cycles), aged 18‐45 years old, BMI of 18‐29 kg/m2 Exclusion: smokers, contraindications to OC use, drugs use, women who had just given birth or had an abortion. Age: DSG group ‐ 26.2, GSD group ‐ 26.3 Location: France
Interventions	1. Ethinyl estradiol 0.02mg, 0.15mg desogestrel 2. Ethinyl estradiol 0.02mg, 0.075mg gestodene Duration: 6 cycles.
Outcomes	Dysmenorrhoea (mild, moderate, severe)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	No data provided
Allocation concealment?	Unclear risk	B ‐ Unclear
Blinding? All outcomes	High risk
Incomplete outcome data addressed? All outcomes	Unclear risk	No data provided
Free of selective reporting?	Unclear risk	No adverse events
Power calculations	Low risk
Dropouts reported	Low risk	182/1016 (85 from desogestrel and 97 from gestodene group)
Baseline comparability	Low risk

Winkler 2003

Methods	Randomisation list was generated by computer. Open trial 1027 women initially randomised, 239 dropouts (unacceptable bleeding problems, adverse events). 349 of the initial group randomised had dysmenorrhoea and no dropouts reported.
Participants	Inclusion: aged 18 to 45 years old, BMI of 18 to 29 kg/m2 Exclusion: smoking, concomitant medication or addictive drugs, psychiatric disorders, using injectable hormonal contraceptives within 6 months of enrolment Age: DSG group ‐ 28.2, LNG group ‐ 28.5 Location: Germany and the Netherlands
Interventions	1. Ethinyl estradiol 0.02mg and 0.15mg desogestrel 2. Ethinyl estradiol 0.02mg and 0.01mg levonorgestrel Treatment was for 6 months and 5 months follow up
Outcomes	Dysmenorrhoea (improved/ not improved)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Computer generated
Allocation concealment?	Unclear risk	B ‐
Blinding? All outcomes	High risk	Open
Incomplete outcome data addressed? All outcomes	Low risk
Free of selective reporting?	Unclear risk	No adverse events reported
Power calculations	High risk
Dropouts reported	Low risk	239/1027
Baseline comparability	Low risk

Characteristics of excluded studies [ordered by study ID]

Ir a:

estudios incluidos

Study	Reason for exclusion
Creatsas 1998	Study participants did not have dysmenorrhoea
Foidart 2000	Only small number of women with dysmenorrhoea included in the study.
Iannotti 1991	Not a randomised or controlled clinical trial. No information on the oestrogen/progestagen compound used. Trial published in Italian, translated by Riccardo Fontani.
Karasawa 1968	Trial compared norethindrone/mestranol combination with placebo, however combination of OCP studied is no longer available. 2mg norethindrone, 0.1mg mestranol. Trial published in Japanese.
Kaunitz 2000	Only small number of women with dysmenorrhoea included in the study.
Kremser 1971	Trial compared Norinyl ‐ norethisterone 2mg and mestranol 0.1mg combination with placebo, this combination of OCP is no longer available.
Kristjansdottir 2000	Not a randomised or controlled clinical trial.
Kwiecien 2003	Only small number of women with dysmenorrhoea included in the study.
La Guardia 2003	The objective of the study was to compare the efficacy and safety of 5 different OCPs and only reported dysmenorrhoea as an adverse event in approximately 25% of patients. (Table 3)
Matthews 1968	Not a randomised controlled trial
Moore 1999	Only small number of women with dysmenorrhoea included in the study.
Reisman 1999	No women clearly with dysmenorrhea in the study
Tallian 1994	Not an RCT. Allocation to treatment groups was retrospective. Trial published in Hungarian, methods and results sections translated by Gabor Kovacs.

Data and analyses

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Comparison 1. Combined OCP versus placebo or no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain improvement Show forest plot	7	497	Odds Ratio (M‐H, Fixed, 95% CI)	2.01 [1.32, 3.08]
Open in figure viewer Analysis 1.1 Comparison 1 Combined OCP versus placebo or no treatment, Outcome 1 Pain improvement.
1.1 low dose oestrogen and 1st/2nd generation progestagen	1	76	Odds Ratio (M‐H, Fixed, 95% CI)	1.83 [0.69, 4.83]
1.2 low dose oestrogen and 3rd generation progestagen	1	73	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 medium dose oestrogen and 1st/2nd generation progestagen	5	348	Odds Ratio (M‐H, Fixed, 95% CI)	2.06 [1.28, 3.30]
2 Pain score (mean change) Show forest plot	2	150	Mean Difference (IV, Fixed, 95% CI)	‐0.29 [‐0.46, ‐0.12]
Open in figure viewer Analysis 1.2 Comparison 1 Combined OCP versus placebo or no treatment, Outcome 2 Pain score (mean change).
2.1 Low dose oestrogen and 1st/2nd generation progesterone	1	74	Mean Difference (IV, Fixed, 95% CI)	1.50 [‐0.78, 3.78]
2.2 Low dose oestrogen and 3rd generation progestagen	1	76	Mean Difference (IV, Fixed, 95% CI)	‐0.3 [‐0.47, ‐0.13]
2.3 Medium dose oestrogen and 1st/2nd generation progestagen	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Additional analgesia required Show forest plot	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.3 Comparison 1 Combined OCP versus placebo or no treatment, Outcome 3 Additional analgesia required.
3.1 low dose oestrogen and 1st/2nd generation progestagen	1	74	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.13, 0.85]
3.2 low dose oestrogen and 3rd generation progestagen	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 medium dose oestrogen and 1st/2nd generation progestagen	1	89	Odds Ratio (M‐H, Fixed, 95% CI)	1.76 [0.66, 4.72]
4 Absence from school or work Show forest plot	2	148	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.17, 0.88]
Open in figure viewer Analysis 1.4 Comparison 1 Combined OCP versus placebo or no treatment, Outcome 4 Absence from school or work.
4.1 low dose oestrogen and 1st/2nd generation progestagen	1	59	Odds Ratio (M‐H, Fixed, 95% CI)	0.18 [0.01, 3.92]
4.2 medium dose oestrogen and 1st/2nd generation progestagen	1	89	Odds Ratio (M‐H, Fixed, 95% CI)	0.42 [0.18, 0.99]
5 Withdrawals from treatment Show forest plot	2	134	Odds Ratio (M‐H, Fixed, 95% CI)	2.06 [0.18, 23.72]
Open in figure viewer Analysis 1.5 Comparison 1 Combined OCP versus placebo or no treatment, Outcome 5 Withdrawals from treatment.
5.1 low dose oestrogen and 1st/2nd generation progestagen	1	74	Odds Ratio (M‐H, Fixed, 95% CI)	2.06 [0.18, 23.72]
5.2 low dose estrogen and 3rd generation progestagen	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.3 medium dose oestrogen and 1st/2nd generation progestagen	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Adverse events Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.6 Comparison 1 Combined OCP versus placebo or no treatment, Outcome 6 Adverse events.
6.1 Nausea	3	225	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.41, 2.03]
6.2 Headaches	2	135	Odds Ratio (M‐H, Fixed, 95% CI)	1.56 [0.67, 3.67]
6.3 Weight gain	1	76	Odds Ratio (M‐H, Fixed, 95% CI)	2.17 [0.71, 6.65]
6.4 Experienced any side effect	2	165	Odds Ratio (M‐H, Fixed, 95% CI)	1.45 [0.71, 2.94]

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Comparison 2. Combined low dose OCP versus Combined low doseOCP

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain improvement Show forest plot	3		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.1 Comparison 2 Combined low dose OCP versus Combined low doseOCP, Outcome 1 Pain improvement.
1.1 3rd generation progestagens: 75mcg gestodene vs150mcg desogestrel	2	626	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.11 [0.79, 1.57]
1.2 2nd generation versus 3rd generation progestagens100mcg levonorgestrel vs 150mcg desogestrel	1	349	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.44 [0.23, 0.84]
2 Withdrawals from treatment Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.2 Comparison 2 Combined low dose OCP versus Combined low doseOCP, Outcome 2 Withdrawals from treatment.
2.1 3rd generation progestagens: 75mcg gestodene vs150mcg desogestrel	2	626	Odds Ratio (M‐H, Fixed, 95% CI)	1.15 [0.72, 1.83]
2.2 2nd generation versus 3rd generation progestagens: 100mcg levonorgestrel vs 150mcg desogestrel	1	349	Odds Ratio (M‐H, Fixed, 95% CI)	4.41 [1.23, 15.77]

Figure 1

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

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Figure 2

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

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Figure 3

Forest plot of comparison: 1 Combined OCP versus placebo or no treatment, outcome: 1.1 Pain improvement.

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Figure 4

Forest plot of comparison: 1 Combined OCP versus placebo or no treatment, outcome: 1.2 Pain score (mean change).

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Figure 5

Forest plot of comparison: 1 Combined OCP versus placebo or no treatment, outcome: 1.3 Additional analgesia required.

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Figure 6

Forest plot of comparison: 1 Combined OCP versus placebo or no treatment, outcome: 1.4 Absence from school or work.

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Figure 7

Forest plot of comparison: 1 Combined OCP versus placebo or no treatment, outcome: 1.5 Withdrawals from treatment.

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Figure 8

Forest plot of comparison: 1 Combined OCP versus placebo or no treatment, outcome: 1.6 Adverse events.

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Figure 9

Forest plot of comparison: 2 Combined low dose OCP versus Combined low doseOCP, outcome: 2.1 Pain improvement.

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Figure 10

Forest plot of comparison: 2 Combined low dose OCP versus Combined low doseOCP, outcome: 2.2 Withdrawals from treatment.

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Analysis 1.1

Comparison 1 Combined OCP versus placebo or no treatment, Outcome 1 Pain improvement.

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Analysis 1.2

Comparison 1 Combined OCP versus placebo or no treatment, Outcome 2 Pain score (mean change).

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Analysis 1.3

Comparison 1 Combined OCP versus placebo or no treatment, Outcome 3 Additional analgesia required.

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Analysis 1.4

Comparison 1 Combined OCP versus placebo or no treatment, Outcome 4 Absence from school or work.

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Analysis 1.5

Comparison 1 Combined OCP versus placebo or no treatment, Outcome 5 Withdrawals from treatment.

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Analysis 1.6

Comparison 1 Combined OCP versus placebo or no treatment, Outcome 6 Adverse events.

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Analysis 2.1

Comparison 2 Combined low dose OCP versus Combined low doseOCP, Outcome 1 Pain improvement.

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Analysis 2.2

Comparison 2 Combined low dose OCP versus Combined low doseOCP, Outcome 2 Withdrawals from treatment.

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Comparison 1. Combined OCP versus placebo or no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain improvement Show forest plot	7	497	Odds Ratio (M‐H, Fixed, 95% CI)	2.01 [1.32, 3.08]

1.1 low dose oestrogen and 1st/2nd generation progestagen	1	76	Odds Ratio (M‐H, Fixed, 95% CI)	1.83 [0.69, 4.83]
1.2 low dose oestrogen and 3rd generation progestagen	1	73	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 medium dose oestrogen and 1st/2nd generation progestagen	5	348	Odds Ratio (M‐H, Fixed, 95% CI)	2.06 [1.28, 3.30]
2 Pain score (mean change) Show forest plot	2	150	Mean Difference (IV, Fixed, 95% CI)	‐0.29 [‐0.46, ‐0.12]

2.1 Low dose oestrogen and 1st/2nd generation progesterone	1	74	Mean Difference (IV, Fixed, 95% CI)	1.50 [‐0.78, 3.78]
2.2 Low dose oestrogen and 3rd generation progestagen	1	76	Mean Difference (IV, Fixed, 95% CI)	‐0.3 [‐0.47, ‐0.13]
2.3 Medium dose oestrogen and 1st/2nd generation progestagen	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Additional analgesia required Show forest plot	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 low dose oestrogen and 1st/2nd generation progestagen	1	74	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.13, 0.85]
3.2 low dose oestrogen and 3rd generation progestagen	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 medium dose oestrogen and 1st/2nd generation progestagen	1	89	Odds Ratio (M‐H, Fixed, 95% CI)	1.76 [0.66, 4.72]
4 Absence from school or work Show forest plot	2	148	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.17, 0.88]

4.1 low dose oestrogen and 1st/2nd generation progestagen	1	59	Odds Ratio (M‐H, Fixed, 95% CI)	0.18 [0.01, 3.92]
4.2 medium dose oestrogen and 1st/2nd generation progestagen	1	89	Odds Ratio (M‐H, Fixed, 95% CI)	0.42 [0.18, 0.99]
5 Withdrawals from treatment Show forest plot	2	134	Odds Ratio (M‐H, Fixed, 95% CI)	2.06 [0.18, 23.72]

5.1 low dose oestrogen and 1st/2nd generation progestagen	1	74	Odds Ratio (M‐H, Fixed, 95% CI)	2.06 [0.18, 23.72]
5.2 low dose estrogen and 3rd generation progestagen	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.3 medium dose oestrogen and 1st/2nd generation progestagen	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Adverse events Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 Nausea	3	225	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.41, 2.03]
6.2 Headaches	2	135	Odds Ratio (M‐H, Fixed, 95% CI)	1.56 [0.67, 3.67]
6.3 Weight gain	1	76	Odds Ratio (M‐H, Fixed, 95% CI)	2.17 [0.71, 6.65]
6.4 Experienced any side effect	2	165	Odds Ratio (M‐H, Fixed, 95% CI)	1.45 [0.71, 2.94]

Comparison 1. Combined OCP versus placebo or no treatment

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Comparison 2. Combined low dose OCP versus Combined low doseOCP

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain improvement Show forest plot	3		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only

1.1 3rd generation progestagens: 75mcg gestodene vs150mcg desogestrel	2	626	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.11 [0.79, 1.57]
1.2 2nd generation versus 3rd generation progestagens100mcg levonorgestrel vs 150mcg desogestrel	1	349	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.44 [0.23, 0.84]
2 Withdrawals from treatment Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 3rd generation progestagens: 75mcg gestodene vs150mcg desogestrel	2	626	Odds Ratio (M‐H, Fixed, 95% CI)	1.15 [0.72, 1.83]
2.2 2nd generation versus 3rd generation progestagens: 100mcg levonorgestrel vs 150mcg desogestrel	1	349	Odds Ratio (M‐H, Fixed, 95% CI)	4.41 [1.23, 15.77]

Comparison 2. Combined low dose OCP versus Combined low doseOCP

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Referencias

References to studies included in this review

Bassol 2000 {published data only}

Buttram 1969a {published data only}

Buttram 1969b {published data only}

Cullberg 1972 {published data only}

Davis 2005 {published and unpublished data}

Endrikat 1999 {published data only}

GPRG 1968 {published data only}

Hendrix 2002 {published data only}

Nakano 1971 {published data only}

Serfaty 1998 {published data only}

Winkler 2003 {published and unpublished data}

References to studies excluded from this review

Creatsas 1998 {published data only}

Foidart 2000 {published data only}

Iannotti 1991 {published data only}

Karasawa 1968 {published data only}

Kaunitz 2000 {published data only}

Kremser 1971 {published data only}

Kristjansdottir 2000 {published data only}

Kwiecien 2003 {published data only}

La Guardia 2003 {published data only}

Matthews 1968 {published data only}

Moore 1999 {published data only}

Reisman 1999 {published data only}

Tallian 1994 {published data only}

Additional references

Brill 1991

Chan 1981

Coco 1999

Dawood 1984

Dawood 1990

Dawood 2006

Gauthier 1992

Goldzieher 1971

Goldzieher 1995

Karnaky 1975

Melzack 1994

Milsom 1984

Milsom 1990

Smith 1993

References to other published versions of this review

Proctor 2001

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

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