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Meta-Analysis
. 2015 Jul 30;2015(7):CD001751.
doi: 10.1002/14651858.CD001751.pub3.

Nonsteroidal anti-inflammatory drugs for dysmenorrhoea

Jane Marjoribanks  1 , Reuben Olugbenga Ayeleke, Cindy Farquhar, Michelle Proctor
Affiliations
Meta-Analysis

Nonsteroidal anti-inflammatory drugs for dysmenorrhoea

Jane Marjoribanks et al. Cochrane Database Syst Rev. .

Abstract

Background: Dysmenorrhoea is a common gynaecological problem consisting of painful cramps accompanying menstruation, which in the absence of any underlying abnormality is known as primary dysmenorrhoea. Research has shown that women with dysmenorrhoea have high levels of prostaglandins, hormones known to cause cramping abdominal pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) are drugs that act by blocking prostaglandin production. They inhibit the action of cyclooxygenase (COX), an enzyme responsible for the formation of prostaglandins. The COX enzyme exists in two forms, COX-1 and COX-2. Traditional NSAIDs are considered 'non-selective' because they inhibit both COX-1 and COX-2 enzymes. More selective NSAIDs that solely target COX-2 enzymes (COX-2-specific inhibitors) were launched in 1999 with the aim of reducing side effects commonly reported in association with NSAIDs, such as indigestion, headaches and drowsiness.

Objectives: To determine the effectiveness and safety of NSAIDs in the treatment of primary dysmenorrhoea.

Search methods: We searched the following databases in January 2015: Cochrane Menstrual Disorders and Subfertility Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, November 2014 issue), MEDLINE, EMBASE and Web of Science. We also searched clinical trials registers (ClinicalTrials.gov and ICTRP). We checked the abstracts of major scientific meetings and the reference lists of relevant articles.

Selection criteria: All randomised controlled trial (RCT) comparisons of NSAIDs versus placebo, other NSAIDs or paracetamol, when used to treat primary dysmenorrhoea.

Data collection and analysis: Two review authors independently selected the studies, assessed their risk of bias and extracted data, calculating odds ratios (ORs) for dichotomous outcomes and mean differences for continuous outcomes, with 95% confidence intervals (CIs). We used inverse variance methods to combine data. We assessed the overall quality of the evidence using GRADE methods.

Main results: We included 80 randomised controlled trials (5820 women). They compared 20 different NSAIDs (18 non-selective and two COX-2-specific) versus placebo, paracetamol or each other. NSAIDs versus placeboAmong women with primary dysmenorrhoea, NSAIDs were more effective for pain relief than placebo (OR 4.37, 95% CI 3.76 to 5.09; 35 RCTs, I(2) = 53%, low quality evidence). This suggests that if 18% of women taking placebo achieve moderate or excellent pain relief, between 45% and 53% taking NSAIDs will do so.However, NSAIDs were associated with more adverse effects (overall adverse effects: OR 1.29, 95% CI 1.11 to 1.51, 25 RCTs, I(2) = 0%, low quality evidence; gastrointestinal adverse effects: OR 1.58, 95% CI 1.12 to 2.23, 14 RCTs, I(2) = 30%; neurological adverse effects: OR 2.74, 95% CI 1.66 to 4.53, seven RCTs, I(2) = 0%, low quality evidence). The evidence suggests that if 10% of women taking placebo experience side effects, between 11% and 14% of women taking NSAIDs will do so. NSAIDs versus other NSAIDsWhen NSAIDs were compared with each other there was little evidence of the superiority of any individual NSAID for either pain relief or safety. However, the available evidence had little power to detect such differences, as most individual comparisons were based on very few small trials. Non-selective NSAIDs versus COX-2-specific selectorsOnly two of the included studies utilised COX-2-specific inhibitors (etoricoxib and celecoxib). There was no evidence that COX-2-specific inhibitors were more effective or tolerable for the treatment of dysmenorrhoea than traditional NSAIDs; however data were very scanty. NSAIDs versus paracetamolNSAIDs appeared to be more effective for pain relief than paracetamol (OR 1.89, 95% CI 1.05 to 3.43, three RCTs, I(2) = 0%, low quality evidence). There was no evidence of a difference with regard to adverse effects, though data were very scanty.Most of the studies were commercially funded (59%); a further 31% failed to state their source of funding.

Authors' conclusions: NSAIDs appear to be a very effective treatment for dysmenorrhoea, though women using them need to be aware of the substantial risk of adverse effects. There is insufficient evidence to determine which (if any) individual NSAID is the safest and most effective for the treatment of dysmenorrhoea. We rated the quality of the evidence as low for most comparisons, mainly due to poor reporting of study methods.

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Conflict of interest statement

None known for any author

Figures

1
1
Study flow diagram.
2
2
Data extraction form
3
3
'Risk of bias' graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
4
4
'Risk of bias' summary: review authors' judgements about each methodological quality item for each included study.
5
5
Forest plot of comparison: 1 NSAIDs vs placebo, outcome: 1.1 Pain relief dichotomous data.
6
6
Funnel plot of comparison: 1 NSAIDs vs placebo, outcome: 1.1 Pain relief dichotomous data.
1.1
1.1. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 1 Pain relief dichotomous data.
1.2
1.2. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 2 Pain relief continuous data: % improvement in VAS pain score (scale 1 to 100).
1.3
1.3. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 3 Pain relief continuous data: total pain relief score difference.
1.4
1.4. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 4 Pain relief continuous data: final pain relief score difference (repeated 0 to 3 scale).
1.5
1.5. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 5 Pain relief continuous data: final pain relief score difference (one‐off scales).
1.6
1.6. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 6 Pain intensity continuous data: mean difference final scores (5‐point scale).
1.7
1.7. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 7 Pain intensity continuous data: mean difference final scores (4‐point scale).
1.9
1.9. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 9 All adverse effects.
1.10
1.10. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 10 Gastrointestinal adverse effects.
1.11
1.11. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 11 Neurological adverse effects.
1.12
1.12. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 12 Additional analgesics required.
1.13
1.13. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 13 Interference with daily activities.
1.14
1.14. Analysis
Comparison 1 NSAIDs vs placebo, Outcome 14 Absence from school/work.
2.1
2.1. Analysis
Comparison 2 Aspirin vs NSAIDs, Outcome 1 Pain intensity continuous data final pain relief score difference (0‐ to 3‐point scale).
2.2
2.2. Analysis
Comparison 2 Aspirin vs NSAIDs, Outcome 2 All adverse effects.
2.3
2.3. Analysis
Comparison 2 Aspirin vs NSAIDs, Outcome 3 Gastrointestinal adverse effects.
2.4
2.4. Analysis
Comparison 2 Aspirin vs NSAIDs, Outcome 4 Neurological adverse effects.
2.5
2.5. Analysis
Comparison 2 Aspirin vs NSAIDs, Outcome 5 Additional analgesics required.
2.6
2.6. Analysis
Comparison 2 Aspirin vs NSAIDs, Outcome 6 Interference with daily activities.
3.1
3.1. Analysis
Comparison 3 Etodolac vs NSAIDs, Outcome 1 All adverse events.
4.1
4.1. Analysis
Comparison 4 Ibuprofen vs NSAIDs, Outcome 1 Pain relief: dichotomous outcome.
4.2
4.2. Analysis
Comparison 4 Ibuprofen vs NSAIDs, Outcome 2 Pain relief continuous data: final pain relief score difference (time‐weighted TOPAR‐6 scale).
4.3
4.3. Analysis
Comparison 4 Ibuprofen vs NSAIDs, Outcome 3 All adverse effects.
4.4
4.4. Analysis
Comparison 4 Ibuprofen vs NSAIDs, Outcome 4 Additional analgesics required.
5.1
5.1. Analysis
Comparison 5 Mefenamic acid vs NSAIDs, Outcome 1 Pain relief: dichotomous data.
5.2
5.2. Analysis
Comparison 5 Mefenamic acid vs NSAIDs, Outcome 2 Pain relief (VAS).
5.3
5.3. Analysis
Comparison 5 Mefenamic acid vs NSAIDs, Outcome 3 All adverse effects.
5.4
5.4. Analysis
Comparison 5 Mefenamic acid vs NSAIDs, Outcome 4 Interference with daily activities.
6.1
6.1. Analysis
Comparison 6 Diclofenac vs NSAIDs, Outcome 1 Pain relief dichotomous data.
6.2
6.2. Analysis
Comparison 6 Diclofenac vs NSAIDs, Outcome 2 Pain relief: mean difference VAS reduction.
6.3
6.3. Analysis
Comparison 6 Diclofenac vs NSAIDs, Outcome 3 All adverse effects.
6.4
6.4. Analysis
Comparison 6 Diclofenac vs NSAIDs, Outcome 4 Gastrointestinal adverse effects.
6.5
6.5. Analysis
Comparison 6 Diclofenac vs NSAIDs, Outcome 5 Neurological adverse effects.
7.1
7.1. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 1 Pain relief: dichotomous outcome.
7.2
7.2. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 2 Pain intensity (SPID).
7.3
7.3. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 3 Pain relief: continuous data: total pain relief score difference.
7.4
7.4. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 4 Pain relief: continuous data: mean difference final scores 1 to 5 scale.
7.5
7.5. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 5 Pain relief: continuous data: mean difference change scores.
7.6
7.6. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 6 All adverse effects.
7.7
7.7. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 7 Gastrointestinal adverse effects.
7.8
7.8. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 8 Neurological adverse effects.
7.9
7.9. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 9 Additional analgesics required.
7.10
7.10. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 10 Interference with daily activities.
7.11
7.11. Analysis
Comparison 7 Naproxen vs NSAIDs, Outcome 11 Absence from work/school.
8.1
8.1. Analysis
Comparison 8 NSAIDs vs paracetamol, Outcome 1 Pain relief dichotomous data.
8.2
8.2. Analysis
Comparison 8 NSAIDs vs paracetamol, Outcome 2 All adverse effects.
8.3
8.3. Analysis
Comparison 8 NSAIDs vs paracetamol, Outcome 3 Gastrointestinal adverse effects.
8.4
8.4. Analysis
Comparison 8 NSAIDs vs paracetamol, Outcome 4 Neurological adverse effects.
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Update of

References

References to studies included in this review

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    1. Moggian G, Pellegri E, Tamburini E, Pini P, Tunidei U. A new pharmacologic treatment of primary dysmenorrhea [Un nuova trattamento farmacologico nella dismenorrea enenziale]. Clinica Terapeutica 1986;117:481‐92. - PubMed
Morrison 1979 {published data only}
    1. Morrison JC, Jenning JC. Primary dysmenorrhea treated with indomethacin. Southern Medical Journal 1979;72:425‐8. - PubMed
Morrison 1980 {published data only}
    1. Morrison JC, Ling FW, Forman EK, Bates GW, Blake PG, Vecchio TJ, et al. Analgesic efficacy of ibuprofen for treatment of primary dysmenorrhea. Southern Medical Journal 1980;73:999‐1002. - PubMed
Morrison 1999 {published data only}
    1. Morrison BW, Daniels SE, Kotey P, Cantu N, Seidenberg B. Rofecoxib, a specific cyclooxygenase‐2 inhibitor, in primary dysmenorrhea: a randomized controlled trial. Obstetrics and Gynecology 1999;94:504‐8. - PubMed
Nahid 2009 {published data only}
    1. Nahid K, Fariborz M, Ataolah G, Solokian S. The effect on an Iranian herbal drug on primary dysmenorrhea: a clinical controlled trial. Journal of Midwifery and Women's Health 2009;54:401‐4. - PubMed
Onatra 1994 {published data only}
    1. Onatra W, Bautista AA, Calis O. Double blind cross‐evaluation of effects and tolerance of etodolac versus piroxicam in the treatment of primary dysmenorrhea [Valoracion doble‐ciega cruzada de la eficacia y tolerancia de etodolac vs prioxicam en el tratamiento de la dismenorrea primaria]. Arquivos Brasileiros de Medicina 1994;68:199‐202.
Osathanondh 1985 {published data only}
    1. Osathanondh R, Caldwell BV, Kaul AF, Sokoloff BJ, White RM, Scavone JM, et al. Efficacy of fenoprofen in the treatment of primary dysmenorrhea. Journal of Reproductive Medicine 1985;30:915‐9. - PubMed
Osinusi 1986 {published data only}
    1. Osinusi BO, Bamgboye EA. Piroxicam in the symptomatic treatment of primary dysmenorrhea. Current Therapeutic Research 1986;39(5):715‐8.
Pasquale 1988 {published data only}
    1. Pasquale SA, Rathauser R, Dolese HM. A double‐blind, placebo‐controlled study comparing three single‐dose regimens of piroxicam with ibuprofen in patients with primary dysmenorrhea. American Journal of Medicine 1988;84:30‐4. - PubMed
Pauls 1978 {published data only}
    1. Pauls F. Naproxen in dysmenorrhea. Lancet 1978;2:159‐60. - PubMed
Pedron 1995 {published data only}
    1. Pedron Nuevo DN. Treatment of primary dysmenorrhea. Comparative study of ibuprofen and mefenamic acid [Tratamiento de la dismenorrea primeria. Estudio comparativo de ibuprofen y acido mefenamico]. Ginecologica y Obstetricia de Mexico 1995;63:4‐9. - PubMed
Powell 1981 {published data only}
    1. Powell JR, Smith RP. Mefenamic acid (Ponstel) for treating primary spasmodic dysmenorrhea. Current Therapeutic Research 1981;29(3):544‐50.
Pulkkinen 1987 {published and unpublished data}
    1. Pulkkinen MO. Alterations in intrauterine pressure, menstrual fluid prostaglandin F levels, and pain in dysmenorrheic women treated with nimesulide. Journal of Clinical Pharmacology 1987;27:65‐9. - PubMed
Riihiluoma 1981 {published data only}
    1. Riihiluoma P, Wuolijoki E, Pulkkinen MO. Treatment of primary dysmenorrhea with diclofenac sodium. European Journal of Obstetrics, Gynecology & Reproductive Biology 1981;12:189‐94. - PubMed
Rondel 1984 {published data only}
    1. Rondel RK, Eberhardt R, Koch J, Schurmann W. Treatment of primary essential dysmenorrhoea with nimesulide; a double‐blind cross over study. Current Therapeutic Research 1984;35(1):123‐9.
Salmalian 2014 {published data only}
    1. Salmalian H, Saghebi R, Moghadamnia AA, Bijani A, Faramarzi M, Nasiri Amiri F, et al. Comparative effect of Thymus vulgaris and ibuprofen on primary dysmenorrhea: a triple‐blind clinical study. Caspian Journal of Internal Medicine 2014;5(2):82‐8. - PMC - PubMed
Saltveit 1985 {published data only}
    1. Saltveit T. Piroxicam in primary dysmenorrhea. Acta Obstetricia et Gynecologica Scandinavica 1985;68:635‐7. - PubMed
    1. Saltveit T. Piroxicam in primary dysmenorrhoea (Abstract). Archives of Gynecology 1985;237:206.
Saltveit 1989 {published data only}
    1. Saltveit T. Piroxicam versus naproxen for primary dysmenorrhoea [Piroxicam versus naproxen ved primore dysmenore]. Tidskrift Norske Loegeforening 1989;109(5):576‐8. - PubMed
Sande 1978 {published data only}
    1. Sande HA, Salvesen T, Izu A. Treating dysmenorrhea with anti‐inflammatory agents: a double‐blind trial with naproxen sodium. International Journal of Gynaecology & Obstetrics 1978;16:240‐1. - PubMed
Soares 1993 {published data only}
    1. Soares A, Cabrera T. Clinical efficacy of nimesulide in the treatment of primary dysmenorrhoea [Tratamento clinico da dismenorreia primaria com nimesulide (um antiinflamatorio nao hormonal)]. Jornal Brasileiro de Ginecologia 1993;103(8):311‐3.
Villasenor 1984 {published data only}
    1. Villasenor FJM. Potassium diclofenac in the treatment of primary dysmenorrhea [Traramiento de la dismenorrea primaria con diclofenac potaico]. Investigacion Medica Internacional 1984;11(1):49‐52.
Wilhelmsson 1985a {published data only}
    1. Wilhelmsson L, Jonsson K, Halling L, Hermann M, Jaderling J, Lindell C, et al. Piroxicam in the treatment of primary dysmenorrhea. Acta Obstetricia et Gynecologica Scandinavica 1985;64:317‐21. - PubMed
Wilhelmsson 1985b {published data only}
    1. Wilhelmsson L, Jonsson K, Halling L, Hermann M, Jaderling J, Lindell C, et al. Piroxicam in the treatment of primary dysmenorrhea. Acta Obstetricia et Gynecologica Scandinavica 1985;64:317‐21. - PubMed
Yu 2014 {unpublished data only}
    1. Merck Sharp, Dohme Corp. Study to assess the safety and efficacy of etoricoxib versus ibuprofen in the treatment of dysmenorrhea (MK‐0663‐145 AM1). http://clinicaltrials.gov/ct2/show/record/NCT01462370?sect=X543012 2013.
    1. Yu Q, Zhu X, Zhang X, Zhang Y, Li X, Hua Q, et al. Etoricoxib in the treatment of primary dysmenorrhea in Chinese patients: a randomized controlled trial. Current Medical Research & Opinion 2014;30(9):1863‐70. - PubMed

References to studies excluded from this review

Al‐Waili 2001 {published data only}
    1. Al‐Waili NSD. Intramuscular tenoxicam to treat primary dysmenorrhea: double‐blind study. Current Opinion in Clinical Experimental Research 2001;3(2):108‐22.
Anderson 1978 {published data only}
    1. Anderson AB, Haynes PJ, Fraser IS, Turnbull AC. Trial of prostaglandin‐synthetase inhibitors in primary dysmenorrhoea. Lancet 1978;1(8060):345‐8. - PubMed
Baldi 1983 {published data only}
    1. Baldi C, D'Ajello M, Balbi GC. Treatment of dysmenorrhea with pyrasanone [Trattamento della dismenorrea con pyrasanone]. Minerva Ginecologica 1983;35:247‐50. - PubMed
Baracat 1991 {published data only}
    1. Baracat EC, Motta ELA, Lima GR. Clinical evaluation of the efficacy and tolerability of nimesulide versus piroxicam in the therapeutic of primary dysmenorrhea [Avaliacao clinica da eficacia e tolerabilidade do nimesulide versus piroxicam na terapeutica da dismenorreia primaria]. Jornal Brasileiro de Ginecologia 1991;101(10):467‐70.
Barbosa 2007 {published data only}
    1. Barbosa IC, Fernandes CE, Filho CI, Tadini V, Camargos AF, Finotti MCCF, et al. Comparative study of the efficacy and safety of valdecoxib and piroxicam in the treatment of patients with primary dysmenorrhea [Comparacao de eficacia e seguranca de valdecoxibe e piroxicam no tratamento da dismenorreia primaria]. Revista Brasileira de Medicina 2007;64(7):318‐22.
    1. NCT00649415. A double blind, double dummy, randomized, comparative study of the efficacy and safety of valdecoxib 40 mg twice daily, as needed in the first menstrual cycle day and then once a day, and piroxicam 40 mg once a day in the treatment of patients with primary dysmenorrhea. http://clinicaltrials.gov/ct2/show/NCT00649415 2008.
Bonnar 1996 {published data only}
    1. Bonnar J, Sheppard B. Treatment of menorrhagia during menstruation: randomised controlled trial of ethamsylate, mefanamic acid and tranexamic acid. BMJ 1996;313:579‐82. - PMC - PubMed
Bowen 1996 {published data only}
    1. Bowen AJ, Fillingim JM, Macy VL, McDonald TA, McNeil QA. Comparison of bromfenac sodium and placebo in women with primary dysmenorrhea. Advances in Therapy 1996;13(3):167‐77.
Budoff 1982 {published data only}
    1. Budoff PW. Zomepirac sodium in the treatment of primary dysmenorrhea syndrome. New England Journal of Medicine 1982;307:714‐9. - PubMed
Buttram 1979 {published data only}
    1. Buttram V, Izu A, Henzl MR. Naproxen sodium in uterine pain following intrauterine contraceptive device insertion. American Journal of Obstetrics & Gynaecology 1979;134:575‐8. - PubMed
Campana 1986 {published data only}
    1. Campana A, Ruspa M. Therapeutic efficacy of naproxen‐lysine in dysmenorrhoea. Clinical Trials Journal 1986;23(4):249‐56.
Catalan 1991 {published data only}
    1. Catalan M, Azanza JR, Suarez JR, Honorato J. Piroxicam in the treatment of primary dysmenorrhea. Cross‐over comparative study with ibuprofen [Piroxicam en el tratamiento de la dismenorrea primaria. Estudio comparativo cruzado frente a ibuprofeno]. Clinica e Investigacion en Ginecologia y Obstetricia 1991;18(7):270‐5.
Chan 1979 {published data only}
    1. Chan W, Dawood MY, Fuchs F. Prostaglandins in primary dysmenorrhea. American Journal of Medicine 1981;70:535‐41. - PubMed
    1. Chan WY, Dawood MY, Fuchs F. Relief of dysmenorrhea with the prostaglandin synthetase inhibitor ibuprofen: effect on prostaglandin levels in menstrual fluid. American Journal of Obstetrics & Gynaecology 1979;135:102‐8. - PubMed
Chan 1980 {published data only}
    1. Chan WY, Dawood MY. Prostaglandin levels in menstrual fluid of nondysmenorrheic and of dysmenorrheic subjects with and without oral contraceptive or ibuprofen therapy. Advances in Prostaglandin & Thromboxane Research 1980;8:1443‐7. - PubMed
Cornely 1978 {published data only}
    1. Cornely M, Beutnagel H, Schonhofer PS. Symptomatic therapy of primary dysmenorrhoea by inhibition of prostaglandin synthesis with indomethacin [Symptomatische therapie der primaren dysmenorrhoe durch prostaglandinsynethesehemmung mit indomethacin]. Geburtshilfe und Fraeenheikunder 1978;38:18‐24. - PubMed
Corson 1978 {published data only}
    1. Corson SL, Bolognese RJ. Ibuprofen therapy for dysmenorrhea. Journal of Reproductive Medicine 1978;20:246‐52. - PubMed
Csapo 1977 {published data only}
    1. Csapo AI, Pulkkinen MO, Henzl MR. The effect of naproxen‐sodium on the intrauterine pressure and menstrual pain of dysmenorrheic patients. Prostaglandins 1977;13(1):193‐9. - PubMed
Daniels 2005 {published data only (unpublished sought but not used)}
    1. Daniels SE, Torri S, Desjardins PJ. Valdecoxib for treatment of primary dysmenorrhoea. Journal of General Internal Medicine 2005;20(1):62‐7. - PMC - PubMed
Dawood 1988 {published data only}
    1. Dawood MY. Efficacy and safety of suprofen in the treatment of primary dysmenorrhea: a multicentre, randomized, double‐blind study. Current Therapeutic Research 1988;44:257‐66.
Dawood 2007a {published data only}
    1. Dawood MY, Khan‐Dawood FS. Differential suppression of menstrual fluid prostaglandin F2a, prostaglandin E2, 6‐keto prostaglandin F1a and thromboxan B2 by suprofen in women with primary dysmenorrhea. Prostaglandins and other Lipid Mediators 2007;83:146‐53. - PubMed
De Almeida Prado 2004 {published data only}
    1. Almeida Prado RA, Silva EN, Guterman T, Leite TG. Meloxicam clinical trial, in carriers of primary dysmenorrhea, compared to rofecoxib [Ensaio clinico de meloxicam em muleres portadoras de dismenorreia primaria, comparado ao rofecoxib]. Revista Brasileira de Medicina 2004.;61(10):672‐5.
De la Boullaye 1971 {published data only}
    1. Boullaye H, Liesse AE, Cavrot E, Lamiroy H, Broeckhoven J. [Etude comparative en double insu de l'alclofenac et d'un placebo dans le traitement symtomatique re la dysmenorrhee]. Revue Francaise de Gynecologie et d'Obstetrique 1971;66(8‐9):525‐9. - PubMed
DeLia 1982 {published data only}
    1. DeLia JE, Emery MG, Taylor RH, Scott JR. Flurbiprofen in dysmenorrhea. Clinical Pharmacology & Therapeutics 1982;32:76‐80. - PubMed
Di Girolamo 1996 {published data only}
    1. Girolamo G, Zmijanovich R, Santos AR, Marti ML, Terrangno A. Lysine clonixinate in the treatment of primary dysmenorrhea. Acta Physiologica Pharmacologica et Therapeutica Latinamericana 1996;46(4):223‐32. - PubMed
Donadio 1987 {published data only}
    1. Donadio N. A double‐blind study with floctafenin, mefenamic acid, diclofenac and piroxicam in patients with primary dysmenorrhea [Estudo duplo‐cego entre a floctafenina, ac. mefenamico, diclofenac e piroxicam em pacientes com dismenorreia primaria]. Jornal Brasileiro de Ginecologia 1987;97(8):435‐9.
Doubova 2007 {published data only}
    1. Doubova SV, Morales HR, Hernandez SF, Martinez‐Garcia MC, Cossio Ortiz MG, Chavez Soto MA, et al. Effect of a Psidii guajavae folium extract in the treatment of primary dysmenorrhea: a randomized clinical trial. Journal of Ethnopharmacology 2007;110:305‐10. - PubMed
Dreher 1980 {published data only}
    1. Dreher E, Fischer B. Treatment of primary dysmenorrhea and dysmenorrhea because of IUP with PG‐synthetase inhibitors. Advances in Prostaglandin, Thromboxane and Leukotriene Research 1980;8:1487‐93. - PubMed
Du Rant 1985 {published data only}
    1. Du Rant RH, Jay MS, Shoffitt T, Linder CW, Taylor W. Factors influencing adolescents' responses to regimens of naproxen for dysmenorrhea. American Journal of Diseases of Children 1985;139(5):489‐93. - PubMed
DuRant 1988 {published data only}
    1. DuRant RH, Jay S, Jerath R, Fink S. The influence of anxiety and locus of control on adolescents' response to naproxen sodium for mild to moderate pain. Journal of Adolescent Health Care 1988;9:424‐30. - PubMed
Eccles 2010 {published data only}
    1. Eccles R, Holbrook A, Jawad M. A double‐blind, randomised, crossover study of two doses of a single‐tablet combination of ibuprofen/paracetamol and placebo for primary dysmenorrhoea. Current Medical Research and Opinion 2010;26(11):2689‐99. - PubMed
Ertungealp 1985 {published data only}
    1. Ertungealp E, Colgar U, Arvas M, Topcuoglu D. The treatment of primary dysmenorrhoea with naproxen [Primer dismenore tedavisinde Naproksen]. Cerrahpaşa Tip Fakültesi Dergisi 1985;16:141‐8.
EUCTR2004‐003809‐25‐HU {unpublished data only}
    1. Sanofi‐Synthelabo Co. Ltd. Comparison of the efficacy and tolerability of drotaverine 80 mg or ibuprofen 400 mg administered alone with their combination for the treatment of primary and secondary dysmenorrhea. http://apps.who.int/trialsearch/Trial.aspx?TrialID=EUCTR2004‐003809‐25‐HU 2004.
EUCTR2008‐006762‐29‐GB {unpublished data only}
    1. Reckitt Benckiser Healthcare (UK) Ltd. A double‐blind, randomised, crossover, single dose, single centre, study examining the analgesic efficacy and tolerability of fixed‐dose combinations of ibuprofen 200mg and acetaminophen 500mg, ibuprofen 400mg and acetaminophen 1,000mg and placebo in primary dysmenorrhoea. http://apps.who.int/trialsearch/Trial.aspx?TrialID=EUCTR2008‐006762‐29‐GB 2008.
Frank 1983 {published data only}
    1. Frank GJ, Keford RH. Report of a double‐blind crossover study to compare flurbiprofen with paracetamol in the treatment of primary dysmenorrhoea. Journal of International Medicine 1983;11 Suppl(2):6‐10. - PubMed
Fraser 1987 {published and unpublished data}
    1. Fraser IS, McCarron G. Ibuprofen is a useful treatment for primary dysmenorrhoea. Australian & New Zealand Journal of Obstetrics & Gynaecology 1987;27(27):244‐7. - PubMed
Fuchs 1979 {published data only}
    1. Fuchs F, Chan WY, Dawood MY. Suppression of menstrual prostaglandins and relief of dysmenorrhea with ibuprofen. Acta Obstetricia et Gynecologica Scandinavica Supplementum 1979;87:91‐2. - PubMed
Gookin 1983 {published data only}
    1. Gookin KS, Forman ES, Vecchio TJ, Wiser WL, Morrison JC. Comparative efficacy of ibuprofen, indomethacin and placebo in the treatment of primary dysmenorrhoea. Southern Medical Journal 1983;76(11):1361. - PubMed
Grossi 1986 {published data only}
    1. Grossi E, Borghi C. Randomized multicentre study on the use of diclofenac in the treatment of primary dysmenorrhea. An analysis of the data relative to the 878 patients [Studio multicentrico randomizzato sull'impiego del diclofenac nel trattamento della dismenorrea primaria. Un'analisi dei dati relativi z 878 pazienti]. Minerva Ginecologica 1986;38:637‐45. - PubMed
Halbert 1978 {published data only}
    1. Halbert DR, Demers LM. A clinical trial of indomethacin and ibuprofen in dysmenorrhea. Journal of Reproductive Medicine 1978;21:219‐22. - PubMed
Hamann 1977 {published data only}
    1. Hamann GO, Laursen B. Primary dysmenorrhea treated with indomethacin [Primaer dysmenore behandlet med indometacin]. Ugeskrift for Laeger 1977;139:1899‐901. - PubMed
Hanson 1982 {published data only}
    1. Hanson FW. Naproxen sodium, ibuprofen and a placebo in dysmenorrhoea. Journal of Reproductive Medicine 1982;27(7):423‐7. - PubMed
Hebert 1986 {published data only}
    1. Hebert JG, Morvan P, Bourgouin J. Double‐blind comparison of ketoprofen and mefenamic acid in the treatment of primary dysmenorrhea. Clinical Therapeutics 1986;8:329‐35. - PubMed
Henzl 1977a {published data only}
    1. Henzl MR, Buttram V, Segre EJ, Bessler S. The treatment of dysmenorrhea with naproxen sodium: a report on two independent double‐blind trials. American Journal of Obstetrics & Gynecology 1977;127:818‐23. - PubMed
Henzl 1979 {published data only}
    1. Henzl MR, Izu A. Naproxen and naproxen sodium in dysmenorrhea: development from in vitro inhibition of prostaglandin synthesis to suppression of uterine contractions in women and demonstration of clinical efficacy. Acta Obstetricia et Gynecologica Scandinavica Supplementum 1979;87:105‐17. - PubMed
Henzl 1979b {published data only}
    1. Henzl MR, Ortega‐Herrera E, Rodriguez C, Izu A. Anaprox in dysmenorrhea: reduction of pain and intrauterine pressure. American Journal of Obstetrics & Gynecology 1979;135:445‐60. - PubMed
Henzl 1980 {published data only}
    1. Henzl MR, Massey S, Hanson FW, Buttram VC, Rosenwaks Z, Pauls FD. Primary dysmenorrhea: the therapeutic challenge. Journal of Reproductive Medicine 1980;25:226‐35. - PubMed
Ingemanson 1981 {published data only}
    1. Ingemanson CA, Carringtom B, Sikstrom B, Bjorkman R. Diclofenac in the treatment of primary dysmenorrhoea. Current Therapeutic Research 1981;30(5):632‐9.
IRCT201304096790N4 {unpublished data only}
    1. IRCT201304096790N4. The effect of celecoxib and ibuprofen on the treatment of primary dysmenorrhea on students of lam University of Medical Sciences. http://apps.who.int/trialsearch/Trial.aspx?TrialID=IRCT201304096790N4 2013.
Islas Perez 1981 {published data only}
    1. Islas Perez M, Rodriguez S. Mefenamic acid in primary dysmenorrhea [Acido mefenamico en dismenorrea primaria]. Ginecologia y Obstetricia de Mexico 1981;48(291):33‐6. - PubMed
ISRCTN32847177 {unpublished data only}
    1. Bell D, Plethora Solutions Ltd (UK). A multi‐centre, double‐blind, placebo‐controlled, multiple‐dose crossover proof of concept study to compare the efficacy of mefenamic acid administered vaginally and orally in healthy menstruating women with primary dysmenorrhoea requiring analgesia. http://apps.who.int/trialsearch/Trial.aspx?TrialID=ISRCTN32847177 2007.
Iyagba 1987 {published data only}
    1. Iyagba N, Agboola A. Controlled, single blind crossover study of piroxicam and placebo in primary dysmenorrhoea. Current Therapeutic Research 1987;42(1):48‐54.
Jakubowicz 1984 {published data only}
    1. Jakubowicz DL, Godard E, Dewhurst J. The treatment of premenstrual tension with mefanamic acid: analysis of prostaglandin concentrations. British Journal of Obstetrics & Gynaecology 1984;91:78‐84. - PubMed
Janbu 1978 {published data only}
    1. Janbu T, Lokken P, Nesheim BI. Effect of acetylsalicylic acid, paracetamol, and placebo on pain and blood loss in dysmenorrhoeic women. Acta Obstetricia et Gynecologica Scandinavica Supplementum 1979;87:81‐5. - PubMed
    1. Janbu T, Lokken P, Nesheim BI. Effect of acetylsalicylic acid, paracetamol, and placebo on pain and blood loss in dysmenorrhoeic women. European Journal of Clinical Pharmacology 1978;14(6):413‐6. - PubMed
Jansen 1984 {published data only}
    1. Jansen CH, Spinelli CAP, Santos AG, Martins ACP, Mendez‐Villasenor J. Efficacy and tolerability evaluation for diclofenac potassium in patients with primary dysmenorrhoea [Avaliacao da eficacia e da tolerabilidade do diclofenaco potassico em pacientes com dismenorreia primaria]. Arquivos Brasileiros de Medicina 1984;58(4):267‐71.
Jay 1986 {published data only}
    1. Jay MS, Durant RH, Shoffitt T, Linder CW. Differential response by adolescents to naproxen sodium therapy for spasmodic and congestive dysmenorrhea. Journal of Adolescent Health Care 1986;7:395‐400. - PubMed
Joelsson 1979 {published data only}
    1. Joelsson I, Lalos O. The effect of inhibitors of prostaglandin synthesis in primary dysmenorrhea studied with hysterometry. Acta Obstetricia et Gynecologica Scandinavica Supplementum 1979;87:45‐9. - PubMed
Kajanoja 1979 {published data only}
    1. Kajanoja P, Vestano T. Naproxen and indomethacin in the treatment of primary dysmenorrhea. Acta Obstetricia et Gynecologica Scandinavica Supplementum 1979;87:87‐9. - PubMed
Kapadia 1987 {published data only}
    1. Kapadia L. A study of naproxen sodium and ibuprofen in primary dysmenorrhoea. Journal of the Society of Occupational Medicine 1987;37:777‐80. - PubMed
Kauppila 1977 {published data only}
    1. Kauppila A, Ylikorkala O. Indomethacin and tolfenamic acid in primary dysmenorrhea. European Journal of Obstetrics Gynecology & Reproductive Biology 1977;7(2):59‐64.
Kauppila 1979 {published data only}
    1. Kauppila A, Puolakka J, Ylikorkala O. The relief of primary dysmenorrhea by ketoprofen and indomethacin. Prostaglandins 1979;18:647‐53. - PubMed
Kauppila 1979b {published data only}
    1. Kauppila A, Puolakka J, Ylikorkala P. Prostaglandin biosynthesis inhibitors and endometriosis. Prostaglandins 1979;18:655‐61. - PubMed
Kauppila 1985 {published data only}
    1. Kauppila A, Ronnberg L. Naproxen sodium in dysmenorrhea secondary to endometriosis. Obstetrics & Gynaecology 1985;65(3):379‐83. - PubMed
Kauppila 1986 {published data only}
    1. Kauppila A, Makila UM, Makarainen L, Puolakka J, Seppala A. Tiaprofenic acid in the treatment of primary dysmenorrhoea. European Journal of Obstetrics, Gynaecology & Reproductive Biology 1986;22:359‐63. - PubMed
Kemp 1972 {published data only}
    1. Kemp JH. "Buscopan" in spasmodic dysmenorrhoea. Current Medical Research & Opinion 1972;1:19‐25. - PubMed
Killick 1990 {published data only}
    1. Killick S, Faragher B, Elstein M. Azapropazone: an alternative agent for the treatment of primary dysmenorrhoea. Journal of Obstetrics & Gynaecology 1990;10:406‐10.
Kintis 1980 {published data only}
    1. Kintis GA, Coutifaris B. Treatment of primary dysmenorrhea with mefenamic acid. International Journal of Gynaecology & Obstetrics 1980;18:172‐5. - PubMed
Klein 1981 {published data only}
    1. Klein JR, Litt IF, Rosenberg A, Udall L. The effect of aspirin on dysmenorrhea in adolescents. Journal of Pediatrics 1981;98:987‐90. - PubMed
Kollenz 2009 {published data only}
    1. Kollenz C, Phleps W, Kaehler ST. ADIDAC trial: analgesia with dexibuprofen versus ibuprofen in patients suffering from primary dysmenorrhea: a crossover trial. Gynecologic and Obstetric Investigation 2009;67:25‐31. - PubMed
Krishna 1980 {published data only}
    1. Krishna UR, Naik S, Mandlkar A, Gupta KC, Kulkarni VN, Sheth UK. Flurbiprofen in the treatment of primary dysmenorrhoea. British Journal of Clinical Pharmacology 1980;9:605‐8. - PMC - PubMed
Kunz 1981 {published data only}
    1. Kunz J, Schneider W. Therapy of dysmenorrhea with prostaglandin synthetase inhibitors: experiences with fluproquazone. Schweizerische Medizinische Wochenschrift. Journal Suisse de Medecine 1981;111(39):1451‐5. - PubMed
Lalos 1983 {published data only}
    1. Lalos O, Nilsson B. Dysmenorrhea in women with intrauterine contraceptive device: treatment with a prostaglandin synthetase inhibitor, naproxen. International Journal of Gynaecology & Obstetrics 1983;21:33‐7. - PubMed
Langrick 1982 {published data only}
    1. Langrick AF, Gunn AD. A comparison of naproxen sodium and a dextropropoxyphene/paracetamol combination in the treatment of primary dysmenorrhoea in University Health Centres. British Journal of Clinical Practice 1992;36:181‐4. - PubMed
Langrick 1983 {published data only}
    1. Langrick AF. A study of naproxen sodium and mefenamic acid in primary dysmenorrhoea. British Journal of Clinical Practice 1985;35(10):342‐7. - PubMed
Langrick 1989 {published data only}
    1. Langrick AF, Gunn AD, Livesy H, Whitehead AM. A double‐blind placebo‐controlled crossover study of mebeverine and mefenamic acid in the treatment of primary dysmenorrhoea. British Journal of Clinical Practice 1989;3:317‐21. - PubMed
Larkin 1979 {published data only}
    1. Larkin RM, Orden DE, Poulson AM, Scott JR. Dysmenorrhea: treatment with an antiprostaglandin. Obstetrics & Gynecology 1979;54:456‐60. - PubMed
Lundstrom 1978 {published data only}
    1. Lundstrom V. Treatment of primary dysmenorrhea with prostaglandin synthetase inhibitors ‐ a promising therapeutic alternative. Acta Obstetricia et Gynecologica Scandinavica 1978;57:421‐8. - PubMed
Lundstrom 1979 {published data only}
    1. Lundstrom V, Green K, Svanborg K. Endogenous prostaglandins in dysmenorrhea and the effect of prostaglandin synthetase inhibitors (PGSI) on uterine contractility. Acta Obstetricia et Gynecologica Scandinavica Supplementum 1979;87:51‐6. - PubMed
Maclean 1983 {published data only}
    1. Maclean D. A comparison of flurbiprofen and paracetamol in the treatment of primary dysmenorrhoea. Journal of International Medical Research 1983;11 Suppl(2):1‐5. - PubMed
Makarainen 1983 {published data only}
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Milsom 2002b {published and unpublished data}
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Milsom 2002c {published and unpublished data}
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Montrull 1987 {published data only}
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NCT00380627 2006 {unpublished data only}
    1. Merck Sharp, Dohme Corp. Quality of life with arcoxia in women with dysmenorrhea. http://clinicaltrials.gov/ct2/show/NCT00380627 2006.
Nor Azlin 2008 {published data only}
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Ozgoli 2009 {published data only}
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Peixoto 1984 {published data only}
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Pendergrass 1984 {published data only}
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Pirhonen 1986 {published data only}
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Rosenwaks 1981 {published data only}
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Schulman 1985 {published data only}
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Serfaty 1986 {published data only}
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Smith 1980 {published data only}
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Szigeti 1981 {published data only}
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Tilyard 1992 {published data only}
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Villasenor 1985 {published data only}
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Von Graffenried 1981 {published data only}
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Williams 1982 {published data only}
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References to studies awaiting assessment

CTRI2188 {unpublished data only}
    1. Patel JC. Comparative efficacy, safety and cost effectiveness of lornoxicam with ibuprofen in patient with primary dysmenorrhoea: a randomized, double‐blind, active‐controlled study. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3443 Registered 2/12/2011, retrospectively.

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References to other published versions of this review

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