Centchroman - A Magical Pill or a Myth

Thakur, Natasha

doi:10.18535/jmscr/v5i2.133

Cited by 5 publications

(4 citation statements)

References 16 publications

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“…Several Western pharmaceutical companies have been criticised for incomplete disclosure of trial designs (5). Vaccine approvals by the Indian drug regulator did not follow established pathways and decision-making processes were opaque (6). Chinese companies in particular have been criticised for only releasing partial trial results (7, 8).…”

Section: Introductionmentioning

confidence: 99%

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Publication status and disclosure gaps in a cohort of 71 clinical trials assessing the safety and efficacy of 3 COVID-19 vaccines developed by Chinese biopharmaceutical companies: An observational cohort study

Bruckner,

Chen,

Cruz

et al. 2024

Preprint

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Transparency shortcomings can undermine confidence in the safety and efficacy of vaccines. This study assesses the publication status of 95 clinical trials of 3 COVID-19 vaccines developed by Chinese companies that received a World Health Organization Emergency Use Listing (EUL) and have been marketed globally. We searched trial registries and the scientific literature to assess current trial status and the public availability of results. After excluding 2 withdrawn trials, we found that at least 62/93 trials (67%) involving 307,933 patients had verifiably been completed or terminated. Only 44 of those 62 trials (71%) had published results in a peer-reviewed journal; none had tabular summary results available on a trial registry. The results of 18/62 (29%) verifiably completed or terminated trials remained unpublished. The trial status information stated in trial registries was often incorrect. Our findings reveal a substantial gap between the disclosure practices of the 3 Chinese companies and global best practice benchmarks. Transparency and global public trust in Chinese biopharmaceutical products could be improved by aligning Chinese legal disclosure requirements with those prevalent in more mature markets, or by the voluntary adoption of stronger transparency practices by Chinese companies.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Publication status and disclosure gaps in a cohort of 71 clinical trials assessing the safety and efficacy of 3 COVID-19 vaccines developed by Chinese biopharmaceutical companies: An observational cohort study

Bruckner,

Chen,

Cruz

et al. 2024

Preprint

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“…concluded in their study that at 12 weeks, 87.0% of females experienced a decrease in pain score <3, while Gandhi A demonstrated that pain steadily decreased over 3 months of Centchroman treatment (from 5.8 to 0.86). [ 14 15 ] Additionally, in this study, the number of mastalgia patients experiencing tender nodularity after treatment was significantly lower in the Centchroman group (11.8%) compared to the evening primrose oil group (44.4%) ( P = .035).…”

Section: Discussionmentioning

confidence: 50%

A Study Comparing Centchroman and Evening Primrose Oil in the Treatment of Benign Breast Disease

Sinha,

Tajdar,

Pankaj

et al. 2024

Journal of Pharmacy and Bioallied Sciences

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Introduction: Females seeking medical attention at breast clinics commonly present with nonmalignant breast conditions, including nonspecific breast pain or distinct masses like fibroadenomas. Due to its variability, it may be difficult to quantify breast pain. The purpose of the research was to compare centchroman and evening primrose oil to identify a cost-effective, secure, and efficient treatment for benign breast disease. Material and Methods: In this prospective hospital-based observational study, 100 breast diseases with or without lumpiness for 1 year were included and divided into two groups with 50 cases each, Group-A (Centchroman) and Group-B (Evening primrose oil). Results: Centchroman exhibited a significantly greater treatment response for alleviating pain-free mastalgia compared to evening primrose oil. Additionally, centchroman showed an excellent response (P < .05). Among participants with mastalgia, centchroman significantly reduced the number of mastalgia patients with tender nodularity post-treatment (P = .035) than evening primrose oil. On the basis of fibroadenoma, partial and complete response was significantly seen in higher number of cases in the centchroman group (P = .007). Conclusion: Centchroman therapy demonstrates that the treatment for benign breast disease is safe, effective, and economical.

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“…On follow up for 6 months, 83.92% were symptom free. 9 Rathi et al show centchroman significantly alleviated mastalgia with minimal side effects. Overall patients reporting to be pain free at 12 weeks were 88 and 85% at end of 24 weeks.…”

Section: Discussionmentioning

confidence: 99%

A comparative study of centchroman versus evening primrose oil in treatment of mastalgia

2020

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Background: Breast pain or mastalgia is one of the most common symptoms presenting to general surgeons. Approximately 60-70% of the women experience some type of breast pain at some point of their lives. Mastalgia may be classified as cyclical and non-cyclical. In cyclical mastalgia the pain intensity is changing during the menstrual cycle. In non-cyclical mastalgia there is no other obvious cause present, the pain is considered to be originating from the breast and the pain remains unchanged during the menstrual cycle. If the pain persists there are a variety of pharmacological agents for treatment of mastalgia. These include 3-6 months course of low dose tamoxifen (10 mg) or evening primrose oil. Other agents include bromocriptine and danazol but are obsolete now days. Newer treatments include centchroman and topical non-steroidal anti-inflammatory preparations. In pursuit of finding an effective safe and economical agent to treat it, plan to compare centchroman to evening primrose oil as treatment of mastalgia.Methods: In this study, two groups with 40 patients each will be taken and treatment will be given for 12 weeks and follow up to 24 weeks will be done without medication to assess sustained response or recurrence of mastalgia.Results: Centchroman is a non-steroidal drug found to be effective in the treatment of mastalgia with early and better relief in a time period of 3 months with minimal side effects as compared to evening primrose oil.Conclusions: This study has demonstrated that Centchroman therapy offers safe, effective and economical alternative to Evening Primrose oil for treatment of mastalgia.

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Centchroman - A Magical Pill or a Myth

Abstract: MASTALGIA is a common symptom experienced by most of the females and most common

Cited by 5 publications

References 16 publications

Publication status and disclosure gaps in a cohort of 71 clinical trials assessing the safety and efficacy of 3 COVID-19 vaccines developed by Chinese biopharmaceutical companies: An observational cohort study

Publication status and disclosure gaps in a cohort of 71 clinical trials assessing the safety and efficacy of 3 COVID-19 vaccines developed by Chinese biopharmaceutical companies: An observational cohort study

A Study Comparing Centchroman and Evening Primrose Oil in the Treatment of Benign Breast Disease

A comparative study of centchroman versus evening primrose oil in treatment of mastalgia

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