The development of the Ketsumeisei formula

Ketsumeisei, a liquid extract of several herbs, has been developed according to traditional Chinese medicine theory and is an adaptation of earlier Chinese herbal formulas for diabetes. The term of "Xiao Ke" originated in The Yellow Emperor's Inner Classic, an ancient text of Chinese medical theory. This text, also known as The Neijing, provides a detailed description of Xiao Ke, which literally means "wasting thirst syndrome", that closely mirrors the western diagnosis of uncontrolled diabetes. The Xiao Ke syndrome is characterized by the presence of polyuria (frequent urination), polydipsia (excessive thirst) and polyphagia (increased appetite). The syndrome Xiao Ke, has been described by its physical manifestations as "three excess and one less" (excess thirst, urination, and hunger, with emaciation). According to the Plain Questions (Su Wen), a part of The Neijing, diabetes arises from eating too much rich food and it typically occurs among wealthy people: "this is usually caused by rich and tasty food. One (who has Xiao Ke) must have often eaten fatty, rich and sweet food. Fatty food generates heat in the interior and sweet food causes fullness, leading to Xiao Ke" [13]. It has also been pointed out that the medical treatment for diabetes is not likely to succeed without proper diet: "you ask them to refrain from a rich diet, advice which they resist." [14] Several ancient texts have documented the sweet quality of the urine in a diabetic. Most explain that patients with Xiao Ke has intense thirst, emaciation, and urine output. Some suggest that the urine of diabetes patients could be oily or sometimes not, tastes "as sweet as wheat", and suggest that it should be tested daily (by tasting for sweetness) to determine the progress of the disease and its treatment [14-16].

Xiao Ke has multiple causes ranging from poor diet, emotional disturbances and congenital weakness, to overindulgence in sex [14,15]. The theory of how diabetes progresses, beginning with a deficiency of yin has been described by many Chinese scholars [16,17]. The underlying Chinese pathology of Xiao Ke is yin deficiency causing deficiency of body fluids and accumulation of heat in the body. The organs most affected are the lungs, spleen/stomach and kidneys. Traditional Chinese medicine identifies three types of diabetes: the upper depletion, the middle depletion, and lower depletion [18,19]. With upper depletion thirst is predominant, with middle depletion hunger is predominant, and with lower depletion urination is predominant. Each stage is a progression of this condition of yin deficiency, until ultimately qi & yang are also depleted and the patient presents with symptoms of internal heat as well as symptoms of cold [20].

It was observed that, following the initial period of wasting and thirst, late stage diabetes (after a period of about 8 years) results from a deficiency of qi, yin and yang, and often occurs with obesity. This seems contradictory to the appearance of the modern diabetic patient, who often shows obese constitution and low metabolism at the onset of disease; signs that would correspond to excess yin and deficency of yang [16].

Modern Chinese medicine doctors have added an additional category to explain the clinical picture that follows qi, yin and yang depletion. Over time, prolonged depletion/deficiency of yin, qi and yang leads to stasis of blood, since the blood can not move without the force of qi behind it. Blood stasis in vessels, eyes and nerves can manifest as atherosclerosis, retinopathy and neuropathy [16].

The Ketsumeisei formula contains herbs indicated for each stage of Xiao Ke syndrome. The formula is very eclectic, such that a person experiencing any of the symptoms along the spectrum of diabetes would likely see some amelioration. The formula is designed to clear heat from the lungs, stomach, and kidneys, nourish yin, moisten lungs and promote production of body fluids, relieve thirst, tonify spleen/stomach, tonify yang, replenish qi, and to even invigorate blood circulation to prevent and/or combat stasis causing negative sequelae. In addition, several of the herbs in the formula have evidence for their hypoglycemic and or insulin-sensitizing effects. [21-26]