Home > Uses of Ibuprofen: Period Pain > Summary of clinical trials

Comparisons with aspirin
1. The effect of ibuprofen in the treatment of dysmenorrhoea

Study design
Ibuprofen (2 x 200 or 2 x 400 mg 4-hourly) and aspirin (2 x 650 mg 4-hourly) were compared in 72 women with moderate to severe primary dysmenorrhoea. The dose was taken at the onset of symptoms. 56 women completed 4 cycles.

This study was:
randomised
double-blind
placebo-controlled
crossover

Summary of results
Both ibuprofen doses were more effective than aspirin. Women preferred ibuprofen to aspirin; there was no difference in efficacy between the ibuprofen doses. Fewer women required additional analgesia when taking ibuprofen 200mg than either aspirin or ibuprofen 400 mg. Side effects were minor and equally common in all treatment groups.

Reference
Shapiro SS, Diem K. The effect of ibuprofen in the treatment of dysmenorrhoea. Curr Ther Res 1981;30:327-34

2. Ibuprofen therapy for dysmenorrhoea

Study design
Ibuprofen (800 mg 4-hourly) and aspirin (1.3 g 4-hourly) were compared in 33 women with dysmenorrhoea over 3 consecutive cycles. The dose was taken at the onset of symptoms.

This study was:
randomised
double-blind
placebo-controlled
crossover

Summary of Results
Ibuprofen was more effective than aspirin in relieving pain; more patients preferred ibuprofen than aspirin. Only one side effect was reported (with placebo).

Reference
Corson SL, Bolognese RJ. Ibuprofen therapy for dysmenorrhoea. J Reprod Med 1978;20:246-53

Comparisons with other drugs
3. Dysmenorrhoea: treatment with an antiprostaglandin

Study Design
Ibuprofen (400 mg) and propoxypheneb (64 mg) were compared over 3 cycles in 22 women with severe dysmenorrhoea. Treatment was taken after the onset of pain.

This study was:
randomised
double-blind
placebo-controlled
crossover

Summary of results
Ibuprofen was more effective than propoxyphene in relieving pain and more women ranked it preferable. Fewer women required additional analgesia after ibuprofen compared with propoxyphene.

Reference
Larkin RM et al. Dysmenorrhoea: treatment with an antiprostaglandin. Obstet Gynecol 1979;54:456-60

4. Analgesic efficacy of ibuprofen for treatment of primary dysmenorrhoea.

Study Design
Ibuprofen (400 mg) and propoxypheneb (64 mg) were compared over 3 consecutive cycles in 51 women with dysmenorrhoea. The dose was taken at the onset of symptoms.

This study was:
randomised
double-blind
placebo-controlled
crossover

Summary of results
Ibuprofen was more effective than propoxyphene in relieving pain and enabling women to carry out normal daily functions. Women preferred ibuprofen.

Reference
Morrison JC et al. Analgesic efficacy of ibuprofen for treatment of primary dysmenorrhoea. South Med J 1980;73:999-1002

5. Effect of ibuprofen, naproxen sodium and paracetamol on intrauterine pressure and menstrual pain in dysmenorrhoea

Study Design
Single doses of ibuprofen (400 mg), naproxen sodium (250 mg) and paracetamol (500 mg) were compared in 12 women with dysmenorrhoea. Intrauterine pressure was measured to assess effects on uterine contraction.

This study was:
double-blind
parallel group

Summary of results
Ibuprofen reduced intrauterine pressure and the frequency of pressure cycles; this was associated with a reduction in pain intensity. Neither paracetamol nor naproxen sodium reduced intrauterine pressure or pain.

Reference
Milsom I, Andersch B. Effect of ibuprofen, naproxen sodium and paracetamol on intrauterine pressure and menstrual pain in dysmenorrhoea. Br J Obstet Gynaecol 1984;91:1129-35

6. Ibuprofen and naproxen-sodium in the treatment of primary dysmenorrhea: a double-blind cross-over study

Study Design
Ibuprofen (400 mg three times daily) was compared with naproxen sodium (250 mg twice daily) in 57 women with dysmenorrhoea for 5 days per cycle over two consecutive cycles.

This study was:
double-blind
crossover

Summary of resutls
Both drugs reduced pain intensity but ibuprofen was more effective than naproxen as pain relief.

Reference
Milsom I, Andersch B. Ibuprofen and naproxen-sodium in the treatment of primary dysmenorrhea: a double-blind cross-over study. Int J Gynaecol Obstet 1985;23:305-10

7. Comparative efficacy of ibuprofen, indomethacin, and placebo in the treatment of primary dysmenorrhea

Study design
Ibuprofen (400 mg three times daily) was compared with indomethacin (25 mg three times daily) in 31 women with dysmenorrhoea over three successive painful cycles.

This study was:
double-blind
placebo-controlled
crossover

Summary of results
Patients ranked ibuprofen highest in terms of pain relief and preferred it to indomethacin. During treatment with ibuprofen, women required fewer additional analgesics and the duration and amount of bleeding was lowest. While taking ibuprofen, more women were able to carry out normal daily functions compared with placebo but no such difference with indomethacin. Four patients reported side effects, all with indomethacin.

Reference
Gookin KS et al. Comparative efficacy of ibuprofen, indomethacin, and placebo in the treatment of primary dysmenorrhea. South Med J 1983;76:1361-2, 1367

Notes
a: Note that in some studies the doses of ibuprofen are higher than those recommended for over-the-counter use.

b: Available in the UK as dextropropoxyphene.

Some of these drugs are available only on prescription. These studies have shown that ibuprofen is equally or more effective than other analgesics in relieving period pain. In addition, it was shown to be well tolerated in this patient population

The recommended dose of ibuprofen to relieve period pain is 200 - 400 mg 4-hourly, up to a maximum of 1200 mg per day.