In Korea, human placental extract (HPE) is apparently used to treat various illnesses. In most other countries, it is considered an alternative and complementary therapy as there is little formal evidence to support its use, and this may be why the FDA in the US keeps a watching brief (read more). HPE is extracted from human placentas collected at full-term delivery, using heat and acid hydrolysis, and is said to consist of proteins, minerals, amino acids, and steroid hormones. The rationale for its use seems to lie in traditional Chinese medicine, and in the belief that dysfunction in a part of the body can be treated by eating the equivalent part of the body of animal, for example, eating animal kidneys as a treatment for kidney disease. In illnesses of unknown cause associated with a range of symptoms, however, it can be difficult to identify an appropriate animal part to consume, and it seems that extracts of placenta are suitable in these cases, on the basis that they may include basic nutrients.
A new paper in the Biological and Pharmaceutical Bulletin (read more) reports on a randomised clinical trial of HPE – manufactured by GCJBP Corporation of Korea which also provided funding for the study – in patients with chronic fatigue, some fulfilling the Fukuda criteria for CFS (ME/CFS group) and some not (idiopathic chronic fatigue group; ICF). In total, 78 patients with fatigue were recruited; 40 with ME/CFS and 38 with ICF. All were randomly assigned to receive a subcutaneous injection of either HPE or normal saline (placebo) three times a week for 6 weeks. The patients had a variety of clinical outcomes measured, including three different measures of fatigue (Fatigue Severity Scale; Visual Analog Scale; and Multidimensional Fatigue Inventory).
The results can be simply stated. Compared with the start of the study, the ME/CFS patients’ fatigue scores were reduced in both the HPE and placebo groups after 6 weeks, but the reduction in fatigue (on all three measures) was significantly greater (albeit modest; around 10% more) after HPE than after placebo. This effect was not seen in ICF patients; HPE had no greater effect on their fatigue than placebo after 6 weeks. Other measures such as blood pressure and serum biochemistry variables were unchanged, and adverse events were similar in both groups. The researchers’ conclusion was that HPE was more effective than placebo in reducing fatigue in people with ME/CFS but not in patients with ‘simple’ chronic fatigue. They suggest that the anti-inflammatory properties of HPE may be improving the chronic inflammation underlying ME/CFS, and/or that cytokines present in HPE may be improving the immune function.
The same researchers at Ajou University have previously reported health improvements after subcutaneous injections of HPE in elderly Koreans (read more) and in in middle-aged Korean women with menopausal symptoms (read more), so they have something of a track record in studying the effect of HPE within a Korean culture that accepts placental products. Whether the modestly positive effects reported for HPE in this study would translate to other cultures in a moot point, and there remains the burning question of the underlying mechanism of action of a shallow injection of HPE under the skin – could it have the anti-inflammatory effects claimed, and if so, how?
ME Research UK sometimes gets phone calls from patients asking what to make of smallish, one-off and often unusual reports, like this one from Korea. Sadly, very little can be concluded about effectiveness from any single study, particularly as the scientific literature is replete with one-off smallish studies that overwhelmingly report positive outcomes for various interventions in various illnesses. For instance, a quick look at the ME/CFS literature on complementary and alternative therapies (see review) alone reveals small studies showing ‘beneficial’ outcomes for qigong plus meditation (fatigue); massage (fatigue, pain and insomnia); tuina and tai chi (general symptoms); NADH (various symptoms); acetyl-L-carnitine (fatigue, pain and concentration); essential fatty acids (symptoms and general heath), and so on…. Are they all reporting true therapeutic effects? Were they published because their outcomes were positive, while the ‘negative’ studies were kept in a file drawer? No-one will ever know unless other researchers try to replicate the findings. Independent replication by other groups at other institutions is where the rubber meets the road; it’s a vital part of the scientific process, and without it the meaning of an isolated finding is anyone’s guess, particularly where the ‘treatment’ is unusual.