TY - JOUR
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 This paper focuses on previously unpublished effects of the same extract on major PMS symptoms.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 This paper focuses on previously unpublished effects of the same extract on major PMS symptoms.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 -