Nervousness and depression attributed to oral contraceptives: A double-blind, placebo-controlled study

Goldzieher, Joseph W.; Moses, Louis E.; Averkin, E. G.; Scheel, Cora; Taber, Ben Z.

doi:10.1016/0002-9378(71)90096-2

Cited by 58 publications

(10 citation statements)

References 33 publications

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“…Second, there have been examples of diffi cult experiences with research and researchers among these communities. [15][16][17][18][19] Third, a primary care, practice-based research network involving these communities now exists. We were particularly interested in what community members thought about the type of low-risk and health services research that such networks typically undertake.…”

mentioning

confidence: 99%

Ethics of Health Research in Communities: Perspectives From the Southwestern United States

Williams

Willging²,

Quintero³

et al. 2010

The Annals of Family Medicine

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PURPOSEThe increasing attention paid to community-based research highlights the question of whether human research protections focused on the individual are adequate to safeguard communities. We conducted a study to explore how community members perceive low-risk health research, the adequacy of human research protection processes, and the ethical conduct of community-based research.METHODS Eighteen focus groups were conducted among rural and urban Hispanic and Native American communities in New Mexico using a semistructured guide. Group transcriptions were analyzed using iterative readings and coding, with review of the analytic summary by group members.RESULTS Although participants recognized the value of health research, many also identifi ed several adverse effects of research in their communities, including social (community and individual labeling, stigmatization, and discrimination) and economic (community job losses, increased insurance rates, and loss of community income). A lack of community benefi cence was emphasized by participants who spoke of researchers who fail to communicate results adequately or assist with follow-through. Many group members did not believe current human research and data privacy processes were adequate to protect or assist communities.CONCLUSIONS Ethical review of community-based health research should apply the Belmont principles to communities. Researchers should adopt additional approaches to community-based research by engaging communities as active partners throughout the research process, focusing on community priorities, and taking extra precautions to assure individual and community privacy. Plans for meaningful dissemination of results to communities should be part of the research design. Ann Fam Med 2010;8:433-439. doi:10.1370/afm.1138. INTRODUCTIONC onverging organizational, conceptual, and funding developments during the last decade have raised the profi le of health and medical research conducted in communities. At the same time, the number of practice-based research networks, organizations that specifi cally undertake research in primary care and community settings, has grown rapidly. [1][2][3][4][5] With these developments, there has been increasing interest in the concept of community-based participatory research, whereby community members have more involvement in all stages of the research process. 6,7 More recently, the National Institutes of Health's Clinical and Translational Science Awards program has included explicit expectations for community engagement in research and for development of research that can directly benefi t communities. E T HIC S OF HE A LT H R ESE A RCH IN COMMUNIT IESThis growing interest in conducting research that directly or indirectly involves communities raises a concern about the adequacy of research protections. Human research protections established and expanded during the last 60 years have centered on the rights and safety of the individual in the research process. Indeed, the 3 principles of The Belmont Report (re...

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confidence: 99%

Ethics of Health Research in Communities: Perspectives From the Southwestern United States

Williams

Willging²,

Quintero³

et al. 2010

The Annals of Family Medicine

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“…Common effects such as nausea, headache, irregular bleedings, painful breasts, etc. The majority of these effects occur almost as frequently after placebo treatment (Goldzieher 1971). They can hardly be studied in animals and hence do not require a discussion in this paper.…”

Section: Animal Toxicology and Human Studiesmentioning

confidence: 98%

Special Requirements for Toxicity Testing of Oral Compounds Administered Continuously or Cyclically

Overbeek¹,

Hornstra²,

Julsingha³

et al. 1974

Acta Endocrinologica

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The authors feel that several reasons exist for considering contraceptives as a special class of drugs, which therefore require special safety studies. Apart from the usual short and long term studies, particular attention should be paid to the reversibility of the induced infertility, and to its possible consequences for subsequent offspring. A possible risk of damage to the foetus is partially outweighed by the low risk of pregnancy during the treatment periods with oral contraceptives. The procedures used in the Organon laboratories are briefly described. Principles on which we base the choice of dose levels and the duration of the various studies are discussed. The paucity of available data from toxicity studies in animals has prevented the presentation of a summary allowing an appraisal of the predictive value of the current methods in toxicology. Nevertheless, a few examples are given which demonstrate the need for more predictive methods. The present lack of knowledge on side effects in humans after prolonged treatment with oral contraceptives has created a feeling of uneasiness. This in its turn has resulted in some excessive regulatory requirements for very long term animal studies. In our opinion, the predictive value of these studies is extremely low because of the inadequacy of the available animal models.More value can be attached to the monitoring of side effects in humans and efforts in this direction should be increased. The Organon system of monitoring the side effects of its marketed preparations is briefly described. It is not considered feasible to standardize regulatory toxicity requirements for the time being, which should not prevent us from aiming at reasonable, more generally accepted methods of study.

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“…Die erste placebokontrollierte Studie wurde von Goldzieher [9] Eine aktuellere, placebokontrollierte Studie an Adoleszentinnen fand eine Verbesserung auf der Center for Epidemiologic Studies Depression Scale (CES-D), die depressive Symptome erfasst, sowohl in der Placebogruppe als auch unter Einnahme eines Kombinationspräparats [14].…”

Section: Neuere Studienunclassified

Orale Kontrazeptiva und Depression

Bitzer

2011

Gynäkologische Endokrinologie

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Nervousness and depression attributed to oral contraceptives: A double-blind, placebo-controlled study

Cited by 58 publications

References 33 publications

Ethics of Health Research in Communities: Perspectives From the Southwestern United States

Ethics of Health Research in Communities: Perspectives From the Southwestern United States

Special Requirements for Toxicity Testing of Oral Compounds Administered Continuously or Cyclically

Orale Kontrazeptiva und Depression

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