Explore (New York, N.Y.) · 2024
Individualized homeopathic medicines in the treatment of premenstrual syndrome: A double-blind, randomized, placebo-controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Sahoo Sanjib, Nayak Chintamani, Rath Prasanta, Bhattacharya Soumya, Mukherjee Suranjana, Dutta Abhijit
Аннотация
INTRODUCTION: Background: Premenstrual syndrome (PMS) is a common disorder among female population that adversely affects their physical and emotional well-being. Conventional treatments for PMS may have limitations and side effects, prompting a need for complementary therapeutic approaches. This double-blind, randomized, placebo-controlled trial aimed to investigate the efficacy of individualized Homeopathic medicines (IH) in treating PMS symptoms in comparison to placebo (PL).
METHODS: This study recruited female participants of reproductive age who had been experiencing premenstrual syndrome (PMS) for >3 months, from the Outpatient Department. The participants were randomly assigned to receive either IH or PL. The measured outcomes included the Shortened Premenstrual Assessment Form (SPAF) questionnaire as the primary outcome, and the Premenstrual Tension Syndrome Visual Analogue Scale (PMTS-VAS) and the Premenstrual Tension Syndrome Observer Rating Scale - Revised (PMTS-OR) as secondary outcomes. These measures were assessed at baseline and every month for 3 months.
RESULTS: The results showed a statistically significant reduction in total SPAF scores for the IH group compared to the placebo group (F = 11.340; P < 0.001) at month 2 (-5.5 ± 1.8, P = 0.003), and month 3 (-6.6 ± 2.0, P = 0.002). Additionally, there were significant reductions in PMTS-VAS and PMTS-OR scores in the IH compared to placebo group. Natrum muriaticum (n = 4/30, 13.3 %) was the most frequently indicated medicines in the study. Four adverse events (13.33 %) occurred in the IH group, and six adverse events (16.67 %) in the Placebo group, with no serious events reported, and no additional medicinal treatment was required for participants during the study period.
CONCLUSIONS: Individualized Homeopathic medicines were found to be significantly effective, compared to placebo in reducing PMS symptoms. Further independent replication is warranted to validate and corroborate these findings, as well as to identify the most effective Homeopathic medicines for treating PMS symptoms. Until then, clinicians may consider these findings when exploring personalized and holistic therapeutic strategies for managing PMS.
TRIAL REGISTRATION: CTRI/2020/11/028,796, dt. 02/11/2020.
METHODS: This study recruited female participants of reproductive age who had been experiencing premenstrual syndrome (PMS) for >3 months, from the Outpatient Department. The participants were randomly assigned to receive either IH or PL. The measured outcomes included the Shortened Premenstrual Assessment Form (SPAF) questionnaire as the primary outcome, and the Premenstrual Tension Syndrome Visual Analogue Scale (PMTS-VAS) and the Premenstrual Tension Syndrome Observer Rating Scale - Revised (PMTS-OR) as secondary outcomes. These measures were assessed at baseline and every month for 3 months.
RESULTS: The results showed a statistically significant reduction in total SPAF scores for the IH group compared to the placebo group (F = 11.340; P < 0.001) at month 2 (-5.5 ± 1.8, P = 0.003), and month 3 (-6.6 ± 2.0, P = 0.002). Additionally, there were significant reductions in PMTS-VAS and PMTS-OR scores in the IH compared to placebo group. Natrum muriaticum (n = 4/30, 13.3 %) was the most frequently indicated medicines in the study. Four adverse events (13.33 %) occurred in the IH group, and six adverse events (16.67 %) in the Placebo group, with no serious events reported, and no additional medicinal treatment was required for participants during the study period.
CONCLUSIONS: Individualized Homeopathic medicines were found to be significantly effective, compared to placebo in reducing PMS symptoms. Further independent replication is warranted to validate and corroborate these findings, as well as to identify the most effective Homeopathic medicines for treating PMS symptoms. Until then, clinicians may consider these findings when exploring personalized and holistic therapeutic strategies for managing PMS.
TRIAL REGISTRATION: CTRI/2020/11/028,796, dt. 02/11/2020.