General Obstetrics and Gynecology: GynecologyEvening primrose oil and fish oil for severe chronic astalgia: A randomized, double-blind, controlled trial☆,☆☆
Section snippets
Recruitment, screening, and randomization
The study was conducted in Amsterdam from 1993 through 1996. The study was approved by the Ethical Committee of the Vrije Universiteit University Medical Centre.
Patients were recruited by general practitioners and surgeons and by posters and through patient organizations and publications in a broad spectrum of Dutch magazines. Six hundred fifteen women applied for information on the study, and 367 of them returned a completed questionnaire.
Inclusion criteria were (1) cyclic or noncyclic
Baseline characteristics and rates of discontinuation
A total of 120 patients entered the trial; 94 patients were classified as cyclic, and 26 patients were classified as noncyclic. In the cyclic stratum, groups FC (fish oil and control) and EF (evening primrose oil and fish oil) each comprised 23 patients; groups EC (evening primrose oil and control) and CC (2 control oils) each comprised 24 patients. In the noncyclic stratum, groups FC and EF each comprised 7 patients, and groups EC and CC each comprised 6 patients.
The mean age of the patients
Comment
In our study population of women with mastalgia (n = 120 women), we found no difference in the effect of evening primrose oil or fish oil with control oils. Fish oil was, as far as we know, not used as a treatment for mastalgia before; therefore, its effects cannot be compared with the effects in other studies. No systematic review has been published about studies of evening primrose oil for mastalgia. For evening primrose oil, our outcomes are in contrast with the results of open studies4, 21
Acknowledgements
We thank Mrs L. Kok-Noorman (scientific editor, Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam) for her editorial support and F. J. Voorhorst (epidemiologist, Department of Clinical Epidemiology and Biostatistics, Vrije Universiteit, University Medical Center) and H. Tobi (assistant professor, Department of Social Pharmacy and Pharmacoepidemiology, Research Institute of Pharmacy, University of Groningen) for their critical appraisal.
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2017, European Journal of Obstetrics and Gynecology and Reproductive BiologyCitation Excerpt :Extracted data are summarized in Tables 1–3. The included studies were published between 1978 and 2016, with 18 RCT’s [7,16,22–29,33,37,39–43,47] and three prospective-cohort-designs [38,44,46] next to one case-series [45] and one case-report [1] both on surgical cases. There were 18 level-II studies [7,16,22–29,37,39–43,47], three level-III studies [38,44,46] and two level-IV studies [1,45] involving a total of 2100 patients (n = 1100 for cyclical-hormonal, n = 841 for cyclical-non-hormonal, n = 65 for non-cyclical-hormonal, n = 90 for non-cyclical-non-hormonal and n = 4 for non-cyclical-Surgery).
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Supported by ZorgOnderzoek Nederland (CareResearch Netherland, formerly: Praeventiefonds), Postbus 93245, 2509 AE The Hague, grant No. 28-2363.
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Reprint requests: E. S. M. de Lange-de Klerk, Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands. E-mail: [email protected]