This RCT of a Chinese herbal mixture makes a mockery of science and medical ethics

Difficulties breastfeeding?

Some say that Chinese herbal medicine offers a solution.

This Chinese multi-centre RCT included 588 mothers considering breastfeeding. The intervention group received the Chinese herbal mixture Zengru Gao, while the control group received no therapy. The primary outcomes were the percentages of fully and partially breastfeeding mothers, and a secondary outcome was baby’s daily formula intake.

At day 3 and 7 after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding. At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant. No statistically significant differences were detected on primary measures at day. While intake of formula differed between groups at day 1 and 3, this difference did not achieve statistical significance, but this difference was apparent by day 7.

The authors concluded that the Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation.

To the naïve observer, this study might look rigorous, but it is a seriously flawed RCT. Here are just some of its most obvious limitations:

• All we get in the methods section is this explanation: Participants were randomly allocated to the blank control group or the intervention group: Zengru Gao, orally, 30 g a time and 3 times a day. This seems to indicate that the control group got no treatment at all which means there was no blinding nor placebo control. The authors even comment on this point in the discussion section of their paper stating that because we included new mothers who received no treatment as a control group, we were able to prove that the improvement in breastfeeding was not due to the placebo effect. However, this is a totally nonsensical argument.
• The experimental treatment is not reproducible. The authors state: Zengru Gao, a Chinese herbal formula, which is composed of 8 herbs: Semen Vaccariae, Medulla Tetrapanacis, Radix Rehmanniae Praeparata, Radix Angelicae Sinensis, Radix Paeoniae Alba,Rhizoma Chuanxiong, Herba Leonuri, Radix Trichosanthis. This is not enough information to replicate the study outside China where the mixture is not commercially available.
• The primary outcome was the percentage of fully, and partially breastfeeding mothers. Breastfeeding was defined as mother’s milk given by direct breast feeding. Full breastfeeding meant that no other types of milk or solids were given. Partially breastfeeding meant that sustained latch with deep rhythmic sucking through the length of the feed, with some pause, on either/ or both breasts. We are not being told how the endpoint was quantified. Presumably women kept diaries. We cannot guess how accurate this process was.
• As far as I can see, there was no correction for multiple testing for statistical significance. This means that some or all of the significant results might be false-positive.
• There is insufficient data to show that the herbal mixture is safe for the mothers and the babies. At the very minimum, the researchers should have measured essential safety parameters. This omission is a gross violation of research ethics.
• Towards the end of the paper, we find the following statement: The authors would like to thank the Research and Development Department of Zhangzhou Pien Tze Huang Pharmaceutical co., Ltd. … The authors declare that they have no competing interests. And the 1st and 3rd authors are “affiliated with” Guangzhou Hipower Pharmaceutical Technology Co., Ltd, Guangzhou, China, i. e. work for the manufacturer of the mixture. This does clearly not make any sense whatsoever.

I have seen too many flawed studies of alternative medicine to be shocked or even surprised by this level of incompetence and nonsense. Yet, I still find it lamentable. But, in my view, the worst is that supposedly peer-reviewed journals such as ‘BMC Complement Altern Med’ publish such overt rubbish.

It would be easy to shrug one’s shoulder and bin the paper. But the effect of such fatally flawed research is too serious for that. In our recent book MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE, we discuss that such flawed science amounts to a violation of medical ethics:  CAM journals allocate peer review tasks to a narrow range of CAM enthusiasts who often have been chosen by the authors of the article in question. The raison d’être of CAM journals and CAM researchers is inextricably tied to a belief in CAM, resulting in a self-referential situation which is permissive to the acceptance of weak or flawed reports of clinical effectiveness… Defective research—whether at the design, execution, analysis, or reporting stage—corrupts the repository of reliable medical knowledge. Ultimately, this leads to suboptimal and erroneous treatment decisions…