Daijiworld Media Network – Mumbai
Mumbai, Jul 21: A research paper by Tata Memorial Hospital (TMH) claiming that papaya leaf extract tablets help increase platelet counts in chemotherapy patients has come under international scrutiny, with the publishing journal launching an investigation following concerns raised by experts over the study's methodology and data analysis.
The study, recently published in the peer-reviewed Journal of Global Oncology, is being reviewed after Kochi-based hepatologist Dr Cyriac Abby Philips, popularly known on social media as "The Liver Doc", requested the journal to examine the findings.
The online version of the paper now carries an editorial notice stating: "The journal has been alerted to potential concerns regarding the reproducibility and clinical interpretation of the reported findings in this article and is currently investigating. Readers should interpret with caution."
The research initially enrolled 219 chemotherapy patients but excluded several participants, leaving a final study population of 198, including 69 in the placebo group. The authors concluded that papaya leaf extract tablets could be an affordable treatment for chemotherapy-induced thrombocytopenia (low platelet count) and may help patients continue chemotherapy at the intended intensity, while acknowledging that longer follow-up was needed.
However, Dr Philips questioned the validity of the analysis, alleging that patients who did not recover in the papaya extract group were excluded before the final calculations were made.
He claimed that while the number of patients who recovered remained unchanged at 83, the total number of participants in the treatment group was progressively reduced from 146 to 129, thereby increasing the apparent recovery rate from about 57 per cent to 64 per cent without any additional recoveries.
He also alleged that some patients in the placebo group who had recovered were excluded from the final analysis, raising further concerns about the integrity of the results.
Responding to the criticism, the study's lead author, Dr Vikas Ostwal, said the journal had sought clarifications, which the research team was addressing as part of the standard review process.
"We are confident in our research. Our patients have been receiving the extract pills, and their platelet counts have consistently risen by day four, give or take a day," he said.
The papaya leaf extract tablets used in the trial were supplied by Micro Labs Private Ltd, while the research received extramural funding from Zydus Pharma Pvt Ltd and Lupin Pharma Pvt Ltd. Lupin also markets papaya leaf extract tablets under the brand name Caripapa.
Dr Ostwal said the researchers were aware of the funding support but were unaware that one of the funding companies marketed the product used in the study.
Dr Philips also questioned the researchers' decision to change the trial's primary endpoint from platelet recovery on day seven to day four.
According to him, the trial had originally been registered with platelet recovery by day seven as its primary endpoint, while day four was intended only as an interim assessment.
He argued that changing the primary endpoint after analysing the data undermines scientific credibility because researchers could selectively highlight favourable outcomes rather than those predetermined before the trial began.
A retired biostatistician from a public health institution described the post-analysis change in the primary endpoint, together with participant exclusions in both study groups, as a "red flag" that casts doubt on the reliability of the findings.
The expert said there may have been genuine clinical observations supporting the treatment, but the statistical presentation raised important concerns.
Dr Amar Jesani, co-founder of the Indian Journal of Medical Ethics and a former member of Tata Memorial Hospital's ethics committee, said scientific disagreements are normal but stressed that any allegations of unscientific practices must be objectively established.
He suggested that one way to resolve the controversy would be for Tata Memorial Hospital to publicly release anonymised raw data from the study for independent scrutiny.
Medical experts said the outcome of the journal's investigation would be important, but added that an independent clinical trial would ultimately be required to conclusively establish whether papaya leaf extract is effective in increasing platelet counts among chemotherapy patients.
TMH Director Dr Sudeep Gupta was unavailable for comment on the matter.