Continuous low-level topical heat in the treatment of dysmenorrhea1,

https://doi.org/10.1016/S0029-7844(00)01163-7Get rights and content

Abstract

Objective: To compare the efficacy of topically applied heat for menstrual pain with oral ibuprofen and placebo treatment.

Methods: We conducted a randomized placebo and active controlled (double dummy), parallel study using an abdominal patch (heated or unheated) for approximately 12 consecutive hours per day and oral medication (placebo or ibuprofen 400 mg) three times daily, approximately 6 hours apart for 2 consecutive days. Pain relief and pain intensity were recorded at 17 time points. There was at least 85% power to detect a true one-unit difference in the 2-day pain relief treatment means for comparisons with the unheated patch plus oral placebo group using a one-tailed test at the .05 level of significance, based on an observed within-group standard deviation of 1.147.

Results: Eighty-four patients were enrolled and 81 completed the study protocol. Over the 2 days of treatment, the heated patch plus placebo tablet group (mean 3.27, P < .001), the unheated patch plus ibuprofen group (mean 3.07, P = .001), and the combination heated patch plus ibuprofen group (mean 3.55, P < .001) had significantly greater pain relief than the unheated patch plus placebo group (mean 1.95). Greater pain relief was not observed for the combination heated patch plus ibuprofen group compared with the unheated patch plus ibuprofen group (P = .096); however, the time to noticeable pain relief was statistically significantly shorter for the heated patch plus ibuprofen group (median 1.5 hours) compared with the unheated patch plus ibuprofen group (median 2.79 hours, P = .01).

Conclusion: Continuous low-level topical heat therapy was as effective as ibuprofen for the treatment of dysmenorrhea.

Section snippets

Materials and methods

Women were selected from volunteers presenting for routine care and those responding to an advertisement soliciting women with dysmenorrhea for possible study involvement. Nonpregnant women of menstrual age who predictably suffered moderate or greater menstrual pain (four of last six cycles) were considered for inclusion. To be further considered, the women must have been at least 18 years of age, with a history and physical examination consistent with the diagnosis of primary dysmenorrhea.

Results

Eighty-four women (of 108 screened) enrolled in the study, and their ages ranged from 21 to 50 years. All patients had to have moderate or greater pain at the start of treatment (by protocol), and baseline pain assessments were not significantly different in any of the four study groups. Of the 81 subjects who completed the study, two were excluded from the efficacy analyses, performed on per-protocol (evaluable) subjects. Specifically, one subject (heated patch plus ibuprofen group) was

Discussion

The findings of this study support the traditional use of topical heat for the relief of the pain associated with menstruation. Heat therapy using this medical device will cost approximately $2.50–3.00 per heat patch. The benefits of this treatment offset the costs. Several women indicated that this heat therapy was of high value because it provided pain relief similar to that of ibuprofen with a significant increase in quality of life. Of importance, the heat patch therapy is a nondrug

References (17)

  • M.P Jensen et al.

    The measurement of clinical pain intensityA comparison of six methods

    Pain

    (1986)
  • R.P Smith

    Objective changes in intrauterine pressure during placebo therapy of primary dysmenorrhea

    Pain

    (1987)
  • Beckmann CRB, Ling FW, Herbert WNP, Laube DW, Smith RP, Barzansky BM. Obstetrics and gynecology. 3rd ed. Baltimore:...
  • Lehman JF, de Lateur BJ. Ultrasound, shortwave, microwave, laser superficial heat, and cold in the treatment of pain....
  • A.R Vance et al.

    Microwave diathermy treatment for primary dysmenorrhea

    Phys Ther

    (1996)
  • Spilker B. Guide to clinical trials. New York: Raven Press,...
  • K Weingand et al.

    Topical heat provides pain relief of delayed onset muscle soreness of the distal quadriceps muscles

    Med Sci Sports and Exerc

    (1999)
  • S Thys-Jacobs et al.

    Comparative analysis of three PMS assessment instruments—The identification of premenstrual syndrome with core symptoms

    Psychopharmacol Bull

    (1995)
There are more references available in the full text version of this article.

Cited by (140)

  • Selecting the most promising local treatments: retrospective treatment-outcome surveys and reverse pharmacology

    2022, Medicinal Plants as Anti-infectives: Current Knowledge and New Perspectives
  • Pain management for in-office hysteroscopy. A practical decalogue for the operator

    2021, Journal of Gynecology Obstetrics and Human Reproduction
  • The use of home remedies and complementary health approaches in endometriosis

    2019, Reproductive BioMedicine Online
    Citation Excerpt :

    In this study, topical heat was the modality applied most often and perceived to be most effective by the affected women. Although a systematic evaluation of the effect of this well-known home remedy on pain reduction and its underlying physiology is missing (Akin et al., 2001), this approach seems to be as effective as NSAID use (Osayande et al., 2014). Repose has a prevalence of 43.0% in this study and 70.0% of its users consider this approach helpful.

  • Benign Uterine Diseases

    2019, Yen &amp; Jaffe's Reproductive Endocrinology: Physiology, Pathophysiology, and Clinical Management: Eighth Edition
View all citing articles on Scopus

Dr. Akin is a contractual employee of Health Quest Therapy and Research Institute, and authors Weingand, Hengehold, Goodale, and Hinkle are employees of Procter and Gamble.

1

The Procter and Gamble Company supplied study devices and materials.

View full text