Vitex agnus castus L. preparatı ile retrospektif bir çalışma

Amaç: Türkiye'de pazarlanan ve Vitex agnus castus (VAC) ekstresi içeren preparatın mutat dozlarda çeşitli jinekolojik endikasyonlar için kullanımının kısa-orta dönemde geriye dönük değerlendirilmesidir. Gereç ve Yöntem: Bir yıllık süre içinde tek bir merkezde en az ay süre ile VAC meyve ekstresi içeren preparat kullanan kadınlar çalışma grubunu (n=215); aynı döneminde dismenore nedeniyle nonsteroidal anti-inflamatuvar ilaç (NSAİİ) reçete edilenler ise kontrol grubunu (n=108) oluşturdu. Dosyalardan demografik veriler ve birincil tanılar kaydedildi. Altıncı ve 12inci haftalarda şikâyetlerin devam edip etmediği (var/ yok olarak) gruplandırıldı. Karşılaştırmalarda ki-kare testi ve "student's t-test" kullanıldı. Bulgular: Gruplar arasında demografik değişkenler açısından fark yoktu. Tedavinin 6ıncı haftasında VAC grubundakilerin %83'ünde kontrollerin ise %80'inde şikayetlerinin gerilediği saptandı (p=0.72). On ikinci haftada ise VAC kullananların %87'si "şikayetlerinin geçtiğini" belirtirken, bu oran kontrol grubunda %50'de kaldı (p=0.009). Kaydedilen yan etkiler (%36) hafif (karın ve baş ağrısı) ve geçiciydi. Sonuç: Jinekolojik hasta grubunda VAC tedavisi, kabul edilebilir yan etki profili ile belirgin semptomatik düzelme sağlayabilmektedir. Bunun, plasebo etkisine bağlı olup olmadığı çift--kör randomize ve çapraz geçişli klinik çalışmalar ile araştırılmalıdır.

A retrospective study on Vitex agnus castus L. preperation

Aim: To retrospectively evaluate short- and medium-term use of a preparation marketed in Turkey containingVitex agnus castus at ordinary doses for various gynecologic indications.Materials and methods: The study group consisted of women using VAC fruit extract preparation for at least3 months throughout a 1-year-period (n=215). Women prescribed non-steroidal anti-inflammatory drugs(NSAID) for dysmenorrhea during the same period served as controls (n=108). Demographic data andprimary diagnoses were retrieved from the files. Persistence of symptoms (present/absent) at week 6 and12 were classified. Chi-square and student s t-test were used for comparisons.Results: There were no differences among groups considering demographic variables. At week 6, 83% ofwomen in the VAC group versus 80% of the controls had reported symptom regression (p=0.72). At week12, 87% of the VAC users stated resolution of symptoms , whereas this figure remained at 50% in the controlgroup (p=0.009). Mild and transient side effects (stomachache and headache) were recorded (3.6%).Conclusion: VAC treatment can induce symptomatic relief with an acceptable side effect profile in gynecologicpatients. Double-blind randomized clinical trials with a cross-over design are warranted to reveal whetherthis is a placebo effect or not.

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