A double-blinded, randomized, placebo controlled, parallel study of pollen pistil extract (Sèrèlys) on women reporting irritability as predominant PMS symptom

Kaj Winther; Joan Campbell-Tofte; Alzahraa M. Motawei; Frank Pedersen; Signe Barfod Roos; Anne Sophie Vinther Hansen; Gitte Gleerup Fornitz; Marianne Killi; Gerhardt Gerhardsen

doi:10.1016/j.hermed.2018.02.002

A double-blinded, randomized, placebo controlled, parallel study of pollen pistil extract (Sèrèlys) on women reporting irritability as predominant PMS symptom

Kaj Winther^*, Joan Campbell-Tofte, Alzahraa M. Motawei, Frank Pedersen, Signe Barfod Roos, Anne Sophie Vinther Hansen, Gitte Gleerup Fornitz, Marianne Killi, Gerhardt Gerhardsen

^*Corresponding author for this work

1 Citation (Scopus)

Abstract

Introduction: A pollen pistil extract Sèrèlys (formerly Femal) was reported earlier to alleviate symptoms of premenstrual syndrome (PMS), including sleep disturbances. This paper focuses on previously unpublished effects of the same extract on major PMS symptoms.

Methods: 101 women, diagnosed with PMS, were randomly treated with either placebo (51) or Sèrèlys (50) for four (4) months. 50 of the study participants reported irritability as their predominant PMS symptom, while 34 women indicated dysphoria as their main symptom. The remaining volunteers specified several different symptoms as their major concern. Premenstrual tension observer evaluation was performed according to Steiner and the women also gave their personal evaluation scores (Visual Analogue Scale: VAS) of different PMS symptoms including irritability, tender breasts, bloating, retention of water, mood swings, raw luteal phase score and headaches.

Results: There were significant reductions in Steiner observer evaluation symptom scores in both groups but no differences comparing groups. In the patients’ self-evaluation there was a significant reduction in headache and water retention as a result of Sèrèlys treatment. When comparing observer-generated Steiner and self-reported VAS symptom scores for patients reporting irritability as their main PMS symptom there was a significant 47% and 50% symptom reduction with Sèrèlys treatment, which was absent in placebo (p < 0.027 and p < 0.001, respectively, comparing groups). By contrast, the dysphoria subset of patients showed no differences when comparing treatment and placebo groups.

Conclusion: In patients reporting irritability as their most predominant PMS symptom, Sèrèlys significantly lowered the PMS-indicators, as reflected in both observer and patientś self-evaluation symptoms’ scores.

Original language	English
Journal	Journal of Herbal Medicine
Volume	12
Pages (from-to)	23-32
Number of pages	10
ISSN	2210-8033
DOIs	https://doi.org/10.1016/j.hermed.2018.02.002
Publication status	Published - 2018

Keywords

Herbal medicine
Irritability
PMS
Premenstrual symptoms
SSRI
Sèrèlys

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10.1016/j.hermed.2018.02.002

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Winther, K., Campbell-Tofte, J., Motawei, A. M., Pedersen, F., Roos, S. B., Hansen, A. S. V., Fornitz, G. G., Killi, M., & Gerhardsen, G. (2018). A double-blinded, randomized, placebo controlled, parallel study of pollen pistil extract (Sèrèlys) on women reporting irritability as predominant PMS symptom. Journal of Herbal Medicine, 12, 23-32. https://doi.org/10.1016/j.hermed.2018.02.002

A double-blinded, randomized, placebo controlled, parallel study of pollen pistil extract (Sèrèlys) on women reporting irritability as predominant PMS symptom. / Winther, Kaj; Campbell-Tofte, Joan; Motawei, Alzahraa M. et al.

In: Journal of Herbal Medicine, Vol. 12, 2018, p. 23-32.

Research output: Contribution to journal › Journal article › Research › peer-review

Winther, K, Campbell-Tofte, J, Motawei, AM, Pedersen, F, Roos, SB, Hansen, ASV, Fornitz, GG, Killi, M & Gerhardsen, G 2018, 'A double-blinded, randomized, placebo controlled, parallel study of pollen pistil extract (Sèrèlys) on women reporting irritability as predominant PMS symptom', Journal of Herbal Medicine, vol. 12, pp. 23-32. https://doi.org/10.1016/j.hermed.2018.02.002

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abstract = "Introduction: A pollen pistil extract S{\`e}r{\`e}lys (formerly Femal) was reported earlier to alleviate symptoms of premenstrual syndrome (PMS), including sleep disturbances. This paper focuses on previously unpublished effects of the same extract on major PMS symptoms. Methods: 101 women, diagnosed with PMS, were randomly treated with either placebo (51) or S{\`e}r{\`e}lys (50) for four (4) months. 50 of the study participants reported irritability as their predominant PMS symptom, while 34 women indicated dysphoria as their main symptom. The remaining volunteers specified several different symptoms as their major concern. Premenstrual tension observer evaluation was performed according to Steiner and the women also gave their personal evaluation scores (Visual Analogue Scale: VAS) of different PMS symptoms including irritability, tender breasts, bloating, retention of water, mood swings, raw luteal phase score and headaches. Results: There were significant reductions in Steiner observer evaluation symptom scores in both groups but no differences comparing groups. In the patients{\textquoteright} self-evaluation there was a significant reduction in headache and water retention as a result of S{\`e}r{\`e}lys treatment. When comparing observer-generated Steiner and self-reported VAS symptom scores for patients reporting irritability as their main PMS symptom there was a significant 47% and 50% symptom reduction with S{\`e}r{\`e}lys treatment, which was absent in placebo (p < 0.027 and p < 0.001, respectively, comparing groups). By contrast, the dysphoria subset of patients showed no differences when comparing treatment and placebo groups. Conclusion: In patients reporting irritability as their most predominant PMS symptom, S{\`e}r{\`e}lys significantly lowered the PMS-indicators, as reflected in both observer and patient{\'s} self-evaluation symptoms{\textquoteright} scores.",

keywords = "Herbal medicine, Irritability, PMS, Premenstrual symptoms, SSRI, S{\`e}r{\`e}lys",

author = "Kaj Winther and Joan Campbell-Tofte and Motawei, {Alzahraa M.} and Frank Pedersen and Roos, {Signe Barfod} and Hansen, {Anne Sophie Vinther} and Fornitz, {Gitte Gleerup} and Marianne Killi and Gerhardt Gerhardsen",

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doi = "10.1016/j.hermed.2018.02.002",

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T1 - A double-blinded, randomized, placebo controlled, parallel study of pollen pistil extract (Sèrèlys) on women reporting irritability as predominant PMS symptom

AU - Winther, Kaj

AU - Campbell-Tofte, Joan

AU - Motawei, Alzahraa M.

AU - Pedersen, Frank

AU - Roos, Signe Barfod

AU - Hansen, Anne Sophie Vinther

AU - Fornitz, Gitte Gleerup

AU - Killi, Marianne

AU - Gerhardsen, Gerhardt

N1 - CURIS 2018 NEXS 447

PY - 2018

Y1 - 2018

N2 - Introduction: A pollen pistil extract Sèrèlys (formerly Femal) was reported earlier to alleviate symptoms of premenstrual syndrome (PMS), including sleep disturbances. This paper focuses on previously unpublished effects of the same extract on major PMS symptoms. Methods: 101 women, diagnosed with PMS, were randomly treated with either placebo (51) or Sèrèlys (50) for four (4) months. 50 of the study participants reported irritability as their predominant PMS symptom, while 34 women indicated dysphoria as their main symptom. The remaining volunteers specified several different symptoms as their major concern. Premenstrual tension observer evaluation was performed according to Steiner and the women also gave their personal evaluation scores (Visual Analogue Scale: VAS) of different PMS symptoms including irritability, tender breasts, bloating, retention of water, mood swings, raw luteal phase score and headaches. Results: There were significant reductions in Steiner observer evaluation symptom scores in both groups but no differences comparing groups. In the patients’ self-evaluation there was a significant reduction in headache and water retention as a result of Sèrèlys treatment. When comparing observer-generated Steiner and self-reported VAS symptom scores for patients reporting irritability as their main PMS symptom there was a significant 47% and 50% symptom reduction with Sèrèlys treatment, which was absent in placebo (p < 0.027 and p < 0.001, respectively, comparing groups). By contrast, the dysphoria subset of patients showed no differences when comparing treatment and placebo groups. Conclusion: In patients reporting irritability as their most predominant PMS symptom, Sèrèlys significantly lowered the PMS-indicators, as reflected in both observer and patientś self-evaluation symptoms’ scores.

AB - Introduction: A pollen pistil extract Sèrèlys (formerly Femal) was reported earlier to alleviate symptoms of premenstrual syndrome (PMS), including sleep disturbances. This paper focuses on previously unpublished effects of the same extract on major PMS symptoms. Methods: 101 women, diagnosed with PMS, were randomly treated with either placebo (51) or Sèrèlys (50) for four (4) months. 50 of the study participants reported irritability as their predominant PMS symptom, while 34 women indicated dysphoria as their main symptom. The remaining volunteers specified several different symptoms as their major concern. Premenstrual tension observer evaluation was performed according to Steiner and the women also gave their personal evaluation scores (Visual Analogue Scale: VAS) of different PMS symptoms including irritability, tender breasts, bloating, retention of water, mood swings, raw luteal phase score and headaches. Results: There were significant reductions in Steiner observer evaluation symptom scores in both groups but no differences comparing groups. In the patients’ self-evaluation there was a significant reduction in headache and water retention as a result of Sèrèlys treatment. When comparing observer-generated Steiner and self-reported VAS symptom scores for patients reporting irritability as their main PMS symptom there was a significant 47% and 50% symptom reduction with Sèrèlys treatment, which was absent in placebo (p < 0.027 and p < 0.001, respectively, comparing groups). By contrast, the dysphoria subset of patients showed no differences when comparing treatment and placebo groups. Conclusion: In patients reporting irritability as their most predominant PMS symptom, Sèrèlys significantly lowered the PMS-indicators, as reflected in both observer and patientś self-evaluation symptoms’ scores.

KW - Herbal medicine

KW - Irritability

KW - PMS

KW - Premenstrual symptoms

KW - SSRI

KW - Sèrèlys

U2 - 10.1016/j.hermed.2018.02.002

DO - 10.1016/j.hermed.2018.02.002

M3 - Journal article

AN - SCOPUS:85044169096

SN - 2210-8033

VL - 12

SP - 23

EP - 32

JO - Journal of Herbal Medicine

JF - Journal of Herbal Medicine

ER -

A double-blinded, randomized, placebo controlled, parallel study of pollen pistil extract (Sèrèlys) on women reporting irritability as predominant PMS symptom

Abstract

Keywords

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