RESUMO
Context: Kundur, Boswellia serrata Roxb. ex Colebr., is prescribed by Unani (Greco-Arab) scholars clinically under conditions similar to vulvovaginal candidiasis (VVC) and has been supported by recent pharmacological studies, but scientific evidence is scarce. Objectives: The study intended to investigate the drug's scientific parameters and to compare its efficacy and safety to that of Miconazole nitrate (2% w/w) in treatment of VVC. Design: The research team designed a randomized controlled trial (RCT). Setting: The RCT was performed in the Department of Ilmul Qabalat wa Amraze Niswan at Luqman Unani Medical College Hospital and Research Center in Vijaypura, India, between November 2018 and March 2020. Participants: Participants were 40 married women, aged 18 to 45 years, who had been clinically examined and diagnosed with VVC. Interventions: Participants were randomly allocated to the Boswellia serrata (Kundur) group, the intervention group (n = 20), or to the miconazole group, the control group (n = 20). The Kundur group took a one-gram tablet of Kundur as a vaginal insert every day at bedtime for 21 days, while the control group used vaginal suppositories with 100 mg of miconazole (2% w/w) every day at bedtime for seven days. Outcome Measures: The primary outcome measures were changes: (1) in vulval itching (pruritus), (2) in vaginal discharge, (3) in painful urination (dysuria), (4) in recurrent genital pain (dyspareunia), and (5) in quality of life (QoL). The secondary outcome measures were mycological clearing on a potassium hydroxide (KOH) test and a per-speculum pelvic examination for the presence or absence of curdy discharge, vulval erythema, and vulval swelling. Results: The response to the intervention was greater than that of the control in reducing pruritus vulvae and vaginal discharge. However, both drugs were equally effective in improving the rest of the parameters, including QoL. Conclusion: The VVC symptoms were equally and significantly improved in both the intervention and the control groups, and Boswellia serrata Roxb. ex Colebr. was shown to be efficacious in the management of VVC. Further studies with a rigorous design and larger sample size are needed to reinforce scientific evidence.
Assuntos
Boswellia , Candidíase Vulvovaginal , Descarga Vaginal , Adolescente , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Adulto Jovem , Antifúngicos/efeitos adversos , Boswellia/efeitos adversos , Candidíase Vulvovaginal/tratamento farmacológico , Índia , Miconazol/efeitos adversos , Descarga Vaginal/tratamento farmacológicoRESUMO
OBJECTIVES: Menorrhagia can be defined as heavy uterine bleeding which comes at regular intervals or uterine bleeding extending more than seven days during menses which has become a considerable problem for females, causing discomfort, anxiety, and poor quality of life. In this study we aimed to compare the effect of Myrtus communis fruits with tranexamic acid in the treatment of menorrhagia. METHODS: In this prospective patient blinded standard controlled study, 40 patients of menorrhagia were randomly assigned to receive either test drug (powdered M. communis fruits) or active control drug (tranexamic acid) for first five days of menstrual cycle consecutively for two cycles. The primary outcome measure was reduction in heavy flow during menses determined by pictorial blood loss assessment chart (PBAC), while improvements in quality of life (QOL) by using short form-36 questionnaire and increase in hemoglobin percentage were kept as secondary outcome measures. RESULTS: Both the groups were similar at baseline. Test and control drugs significantly reduced the PBAC score during treatment cycles with p-value <0.001 and these changes were not significantly different between the groups. During second treatment cycle significant difference was found in PBAC score (p = 0.024) between the groups. After treatment significant improvement in hemoglobin percentage was noted and marked improvement in overall quality of life was observed in both the groups. CONCLUSION: These data suggest that M. communis fruits can be an effective alternate in reducing heavy menstrual bleeding. There is need to confirm these results by designing a trial on large number of patients. TRIAL REGISTRATION NO: CTRI/2017/09/009937.