A double-blind, randomised, crossover study of two doses of a single-tablet combination of ibuprofen/paracetamol and placebo for primary dysmenorrhoea

Eccles, Ronald; Holbrook, Amanda; Jawad, Martez

doi:10.1185/03007995.2010.525028

Cited by 16 publications

(5 citation statements)

References 31 publications

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“…Current understanding of the pathogenesis in primary dysmenorrhea implicates excessive imbalanced amounts of prostanoids and possibly eicosanoids released from the endometrium [21,22]. The majority of subjects benefit from administration of nonsteroidal anti-inflammatory drugs (NSAIDs) [13,23]. A strong negative correlation between dairy product intake and dysmenorrhea and its associated symptoms among university female students was demonstrated whereby the severity of primary dysmenorrhea decreased with increasing daily intake of dairy products [24].…”

Section: Introductionmentioning

confidence: 99%

Premenstrual Symptoms in Dysmenorrheic College Students: Prevalence and Relation to Vitamin D and Parathyroid Hormone Levels

Obeidat

Alchalabi

Abdul‐Razzak

et al. 2012

IJERPH

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Objectives: To determine the prevalence of premenstrual symptoms (PMS) due to primary dysmenorrhea among a sample of university female students, and to explore possible association with vitamin D and parathyroid (PTH) levels, as well as frequency of consumption of dairy products. Design: A cross-sectional study. Setting: One Jordanian university. Subjects: A total of 177 female students aged between 18 and 24 years who experienced primary dysmenorrhea participated in the study and completed a self administered questionnaire to collect information concerning demographics, menstruation- related information, associated specified premenstrual symptoms, and consumption of dairy products. Plasma 25-hydroxyvitamin vitamin D level and intact parathyroid hormone level were measured. Results: Of the 177 participants 91.5% had two or more symptoms among which fatigue, mood swings, anxiety, abdominal bloating, and depression were the most prevalent symptoms. There was no evident association between presence of symptoms and vitamin D status, PTH level or dairy products consumption. Headaches and social withdrawal were significantly lower in those women who consumed high amounts of dairy products. Conclusion: Premenstrual symptoms are very common in young women with primary dysmenorrhea. PMS has no relation to levels of vitamin D, parathyroid hormone or dairy products consumption. Headache and social withdrawal may be affected by dairy product consumption.

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Section: Introductionmentioning

confidence: 99%

Premenstrual Symptoms in Dysmenorrheic College Students: Prevalence and Relation to Vitamin D and Parathyroid Hormone Levels

Obeidat

Alchalabi

Abdul‐Razzak

et al. 2012

IJERPH

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“…They found that naproxen was significantly more effective than placebo in producing moderate to excellent relief of pain (OR 3.67, 95%CI, 2.94 to 4.58). Fixed dose combinations of paracetamol with NSAIDs also resulted in significant pain relief in women with primary dysmenorrhea [22]. A systematic literature review suggests that a combination of paracetamol and an NSAID may offer superior analgesia for acute pain than either drug alone [23].…”

Section: Discussionmentioning

confidence: 99%

Safety and Effectiveness of Naproxen 220 mg + Paracetamol 300 mg + Pamabrom 25 mg Fixed Dose Combination in Women with Premenstrual Syndrome: A Post-Marketing, Open-Label, Uncontrolled, Prospective, Multicenter, Observational Study

Peña-Jiménez,

Benitez-Aguilar,

Villegas

et al. 2024

Women

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Premenstrual syndrome is characterized by pain and related symptoms that negatively affect women’s quality of life. Our aim was to evaluate the safety and effectiveness of a specific oral fixed dose combination of naproxen 220 mg + paracetamol 300 mg + pamabrom 25 mg in tablet form. A prospective, open-label, multicenter, uncontrolled, observational post-marketing study was conducted from December 2017 to December 2019 consisting of 270 women over 18. The primary outcome was the number and severity of adverse effects. Secondary outcomes were pain intensity, number and intensity of other premenstrual symptoms, and the proportion of patients with a pain score reduction of at least 50%. The mean age of participants was 28.9 ± 8.8 years. We found that 8 women (3%) experienced adverse events, namely headache (5/8), gastritis (2/8) dyspepsia (1/8), diarrhea (1/8), and nausea (1/8). In three of the eight women, the study was discontinued due to adverse effects. Pain intensity was reduced (−4.5, 95%CI; −5, −4, p < 0.001). The proportion of patients with pain reduction of at least 50% was 70.7%. The study results suggest that the combination of drugs used in this formulation is safe and effective for premenstrual symptoms.

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“…Dawood and Khan-Dawood [39] proved that paracetamol and ibuprofen were effective in reducing pain associated with PD; however, ibuprofen was more effective with lower pain scores. Another RCT found that a combination of paracetamol and ibuprofen was more effective than each drug used alone for pain relief in patients with PD [40].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Intravenous Tramadol versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial

Ghamry

Ali

Shareef

et al. 2020

Gynecol Obstet Invest

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Introduction: Many pharmaceutical, surgical, and complementary medical interventions are used for primary dysmenorrhea treatment. However, no consensus has been reached about the most effective intervention. Objective: To compare the efficacy and safety of IV tramadol versus IV paracetamol in relieving acute pain of primary dysmenorrhea. Methods: This randomized controlled trial was conducted in a tertiary referral hospital and included 100 patients between 18 and 35 years old diagnosed with primary dysmenorrhea. Patients received either 1-g paracetamol or 100-mg tramadol in 100-mL normal saline as an IV infusion over 10 min. Pain intensity was measured by using a visual analog scale at 15, 30, 60 min, and 2 h. We recorded drug side effects and requirements for rescue analgesics. Results: Pain scores were significantly lower in the tramadol group compared with the paracetamol group at 15, 30, 60 min, and 2 h (p < 0.001). Fewer patients in the tramadol group needed rescue analgesics compared with the paracetamol group (p = 0.04). No significant differences were reported in side effects between both groups. Conclusions: IV tramadol is superior to IV paracetamol in relieving acute pain of primary dysmenorrhea with a comparable side effect profile.

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A double-blind, randomised, crossover study of two doses of a single-tablet combination of ibuprofen/paracetamol and placebo for primary dysmenorrhoea

Abstract: One or two tablets of a single-tablet combination of ibuprofen 200 mg/paracetamol 500 mg is well-tolerated and provides superior analgesic efficacy to placebo in patients with primary dysmenorrhoea.

Cited by 16 publications

References 31 publications

Premenstrual Symptoms in Dysmenorrheic College Students: Prevalence and Relation to Vitamin D and Parathyroid Hormone Levels

Premenstrual Symptoms in Dysmenorrheic College Students: Prevalence and Relation to Vitamin D and Parathyroid Hormone Levels

Safety and Effectiveness of Naproxen 220 mg + Paracetamol 300 mg + Pamabrom 25 mg Fixed Dose Combination in Women with Premenstrual Syndrome: A Post-Marketing, Open-Label, Uncontrolled, Prospective, Multicenter, Observational Study

Efficacy and Safety of Intravenous Tramadol versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial

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