Article 30: Traditional Chinese Medicine Treatment (Part 3): Clinical Research on Lipid-Lowering Tablets (Part 2) and Jin Duo Target Weight Loss Products

(10) Summary and Discussion

① A summary of 5,000 outpatient cases proved that the lipid-lowering tablets had a weight loss efficacy rate of 93.3%, with an average weight loss of 5.8 kg and a reduction in abdominal circumference of 5.5 cm in 3 months. The efficacy was more significant for overweight and mild obesity, and it also had a good effect on coexisting conditions such as hypertension and fatty liver.

② A large-scale randomized controlled trial involving 200 patients demonstrated that the efficacy of the lipid-lowering tablets was similar to that of fenfluramine (p>0.05) and superior to that of the traditional Chinese medicine for weight loss, Xiaopangmei (p<0.05). Compared with the 135-patient control group, the lipid-lowering tablet group (137 patients) showed a significant difference in weight loss after one week of treatment, with an average difference of 0.93 kg.

③ Pharmacodynamic studies of five control groups (high, medium, and low doses of lipid-lowering tablets) have shown that the weight-loss effect of the medium-dose lipid-lowering tablet group exceeds that of the Western medicine fenfluramine. This also corroborates the scientific validity of the traditional Chinese medicine saying that "the secret of traditional Chinese medicine lies in dosage." It also enhances our understanding that the dosage of medications used to treat obesity should emphasize the principle of individualization.

④ The lipid-lowering tablets are safe and non-toxic: No toxicity was found in toxicity tests and clinical toxicology tests. Having 2-3 loose stools per day after taking the medication is within the physiological range and harmless to the human body. Recent long-term toxicity tests (6 months) and some genetic toxicology tests also proved its safety and non-toxicity.

(11) Exploration of factors affecting the efficacy of weight loss

Factors affecting the effectiveness of weight loss treatment are mainly related to diet, activity, unhealthy lifestyle habits, and adherence to medication. In addition, the following factors also play a role:

① Origin and Variety of Rhubarb: There are over 60 varieties of rhubarb worldwide, with over 40 in my country. Due to differences in variety and origin, the efficacy and side effects can vary greatly. To ensure clinical efficacy and research results, it is essential to secure a high-quality source of rhubarb and conduct scientific extraction; otherwise, all previous efforts will be wasted. To this end, I traveled to major rhubarb-producing areas throughout my country for investigation and filmed a special television documentary on the origins of rhubarb. I selected genuine rhubarb from a specific region and scientifically extracted it to produce tablets, which serve as a unified source of medicine for both clinical use and research, ensuring the stability of clinical efficacy and the reliability of research results.

② Dosage: The dosage of rhubarb extract tablets (lipid-lowering tablets) for oral administration must vary from person to person, strictly adhering to the principle of individualization. Different ages, genders, and conditions require different dosages. Even for the same person, the dosage should vary under different circumstances. For example, after a large meal, rich or fatty foods, or if there is a cold or fever, the oral dosage must be increased. The dosage should adhere to the principle of "rhubarb dilution," meaning the standard for achieving dilution is 2-3 bowel movements per day. Insufficient dosage will not achieve dilution and will affect efficacy; excessive dosage (indicated by watery stools) will also reduce efficacy. Particularly noteworthy is my experience with patients with colitis who, after taking one lipid-lowering tablet, experienced more than 10 bowel movements in one day. Conversely, a patient with severe acute pancreatitis took 100 of the same lipid-lowering tablets within 10 hours and had no bowel movements at all. Therefore, precise dosage control is crucial in treating various ailments; improper dosage will affect efficacy. The saying goes, "Water can carry a boat, but it can also capsize it." Traditional Chinese medicine views rhubarb as having a nourishing effect in small doses, but harmful effects in excessive doses. This dual-regulating effect of rhubarb-both nourishing and detrimental, capable of both purging and constipating-is closely related to dosage. Therefore, we must diligently explore and refine the dosage of rhubarb according to individual differences and specific conditions, which is crucial for improving therapeutic efficacy.

③ The relationship between therapeutic efficacy and the timing and season of medication:

A. Taking lipid-lowering tablets half an hour before meals can affect appetite to varying degrees. For a considerable number of people, it can slightly reduce their appetite, thereby improving the weight loss effect. Therefore, it is advisable to take the medication before meals if you want to lose weight. If you have stomach problems, it is better to take it after meals.

B. Based on the results of 1270 obese patients treated for 3 months, the influence of different months and seasons on the effectiveness of weight loss was analyzed. According to the month of treatment, the highest effectiveness rate was in May (94.5%), and the lowest was in December. Analysis of the treatment curve by month showed that the effectiveness rate was 81.6% in January, gradually rising to 94.5% in May, then fluctuating, reaching its lowest point in December (64.2%).

C. Analysis of the relationship between season and weight loss efficacy shows that the highest effectiveness rate was in the second quarter (90.3%). This may be because treatment in the second quarter mostly takes place during the hot summer, and the bitter and cold properties of rhubarb can "release qi," which aligns with the "response to summer qi," resulting in the best clinical weight loss efficacy during this period. In contrast, treatment in the fourth quarter mostly takes place in winter, when muscles are less active and basal metabolism is lower, leading to reduced calorie consumption and thus relatively poor weight loss efficacy.

D. The effectiveness of weight loss is closely related to the patient's subjective awareness. In summer, people are more likely to find that some clothes, pants, and skirts no longer fit after gaining weight, so their desire to lose weight is stronger. They can actively cooperate in drug treatment, dietary adjustments, and increased activity to carry out comprehensive treatment, thereby achieving better results.

④ The combination of different routes of administration can improve efficacy: Some overweight or mildly obese patients do not like to take pills, but are very interested in abdominal massage. We should cater to the needs of these patients.

A. My colleagues and I used a method of applying rhubarb ointment to the abdomen, followed by manual massage and then passive massage using a physiotherapy machine (referred to as external treatment), which achieved good results.

B. We divided people with similar degrees of obesity and basically similar diets and activities into three groups and treated them with three different methods for two weeks. The results showed that both external treatment and taking lipid-lowering tablets (referred to as internal treatment) could reduce weight and waist circumference.

C. Internal treatment is preferred for weight loss, while external treatment is preferred for reducing abdominal circumference. Combining external and internal treatments can achieve complementary advantages and synergistic effects.

D. Treating internal diseases externally involves applying medicine externally to achieve the desired effect internally. For medicine to reach the inside from the outside, it needs certain functions. Combining it with sound, light, electricity, and magnetism can not only exert the therapeutic efficacy of sound, light, electricity, and magnetism themselves, but also use their energy to promote the entry of medicine from the outside into the inside.

E. The passive massage performed by the aforementioned physiotherapy machine relies on the combination of the machine's sound, light, electricity, and magnetism with the effects of medication to achieve a complementary effect.

F. Wu Shiji, a famous physician and expert in external treatment in ancient my country, once said: "At first, I dared not say that external treatment would necessarily be effective. But after personally examining tens of thousands of people, I realized that plasters are no different from decoctions in treating diseases. If used properly, they will have an immediate effect."

G. Transdermal patches, which are popular internationally in modern times, are an advanced form of treating internal diseases from the outside.

H. Why can internal diseases be treated externally? Traditional Chinese medicine believes that "the principle of internal treatment is the same as the principle of external treatment." This means that rhubarb ointment, when applied externally, is transmitted through the meridians, penetrates the skin, and is absorbed into the bloodstream via the mucous membranes, exerting its pharmacological effects locally and throughout the body. Our experimental research results demonstrate that rhubarb is particularly sensitive to adipose tissue in the abdominal mesentery compared to other areas, exhibiting exceptionally good efficacy. Specifically, it has a particularly strong focal dissolving effect on fat, resulting in a significant reduction in abdominal circumference after external treatment.

⑤ Exploration of the relationship between weight loss efficacy and the cause of obesity: According to the statistics of 2880 cases, there is no significant relationship between the cause and the efficacy. Regardless of the cause, the weight loss efficacy is above 90.8%.

⑥ Relationship between efficacy and obesity type: According to statistics of 2880 cases, there was no significant difference in efficacy between generalized obesity and generalized obesity with abdominal enlargement as the main symptom.

⑦ The relationship between therapeutic effect and degree of obesity:

A. A summary analysis of the effects of weight loss in 2880 cases revealed that, based on the overall effective rate and average weight loss and waist circumference reduction, the efficacy had little impact on the degree of obesity.

B. However, the number of people who returned to normal weight after weight loss decreased as the degree of obesity increased. For example, among 1014 overweight cases, 217 (21.4%) returned to normal weight after 3 months of treatment; among 908 mildly obese cases, 7 (0.77%); among 1320 moderately obese cases, only 2 (0.15%); and among 682 severely obese cases, only 1 (0.14%) returned to normal weight after more than 3 months of treatment.

C. Analyzing the data using the percentage of actual weight loss relative to the total number of overweight individuals (referred to as the weight loss percentage), a study of 908 mildly obese, 1320 moderately obese, and 682 severely obese individuals showed that after 3 months of treatment, the weight loss percentages were 38.5% (4721 ÷ 12260.4), 27.7% (7505.6 ÷ 27111.1), and 19.5% (4411 ÷ 22668.8), respectively. In conclusion, the effectiveness of weight loss decreases as the degree of obesity increases. Therefore, early prevention and treatment of obesity are crucial. Starting treatment during the overweight stage yields the best results and can achieve twice the effect with half the effort.

⑧ Obesity course and efficacy: According to the efficacy statistics of 1014 cases of overweight and mild obesity treated for 3 months, the weight loss of patients with a disease course of less than 5 years and 10 years or more was 3.6 to 3.9 kg, so the difference was not significant and the efficacy was similar.

⑨ The relationship between coexisting symptoms and treatment efficacy:

A. Among the 5000 cases mentioned above, 137 cases had hypertension and relatively complete data. After 4.5 months of weight loss treatment, the effective rate of weight loss reached 76.8%, which was lower than the overall effective rate of 3464 cases. The average weight loss was 7.3 kg, which was higher than the average weight loss.

B. The efficacy rate of lowering high blood pressure is 97.4%. Compared with the efficacy of other coexisting diseases, its efficacy ranks first. Accompanying symptoms such as heat intolerance, excessive sweating, fatigue, edema, palpitations and shortness of breath are also reduced or disappeared.

C. Among the above weight loss cases, 13.7% had menstrual disorders. Among them, 45 cases with relatively complete data had their menstrual disorders basically regulated after 4.4 months of weight loss treatment, and 37 cases with delayed menstruation had their periods on time.

D. The weight loss effect of 45 cases reached 100%, with an average weight loss of 10.4 kg and a reduction in waist circumference of 7.5 cm.

E. For obese patients with hypertension, the effectiveness of weight-loss drugs in lowering blood pressure and improving symptoms is higher than that in patients who lose weight.

F. Obese women with menstrual disorders have high efficacy in both regulating menstruation and losing weight, achieving the best of both worlds.

⑩ Syndrome Differentiation and Therapeutic Effects: Obese individuals are classified into three syndrome differentiation types.

A. Empirical evidence: Obesity accompanied by constipation, headache, thirst and preference for drinking, or symptoms such as fullness in the chest and epigastrium and amenorrhea, with a yellow and greasy tongue coating and a wiry pulse.

B. Deficiency syndrome: Obesity accompanied by symptoms such as fatigue, sore waist and weak legs, dizziness and blurred vision, pale red tongue or teeth marks on the tongue edge, thin white coating, and deep or deep and slippery pulse.

C. Mixed symptoms of deficiency and excess: It presents with both the above-mentioned symptoms of excess and the symptoms of deficiency.

After randomly selecting 230 obese patients for syndrome differentiation, 111 cases were classified as excess syndrome, 64 cases as deficiency syndrome, and 55 cases as mixed excess and deficiency syndrome. After 3 months of treatment, the efficacy of the three types was similar, with average weight loss of 3.4 kg, 3.7 kg, and 3.8 kg respectively, and average reductions in abdominal circumference of 5.1 cm, 4.8 cm, and 4.5 cm respectively. Therefore, the efficacy of lipid-lowering tablets for weight loss is not significantly related to syndrome differentiation analysis. In traditional Chinese medicine, syndrome differentiation and medication dosage are more closely related, and syndrome differentiation-based medication affects the efficacy of weight loss. Therefore, syndrome differentiation-based treatment still has important practical significance and value.

⑪ Gender and therapeutic effect: According to statistics of 2880 cases, there is no significant relationship between gender and therapeutic effect.

⑫ Relationship between age and efficacy: 72 patients aged 6-12 years and 216 patients aged 60-81 years with complete data were randomly selected from the weight loss clinic. Statistical analysis showed that the effective rate of weight loss in children was 88.0% and the effective rate of weight loss in the elderly was 88.9%. Therefore, the efficacy of the two was similar, which is about 5% lower than the total effective rate of 93% for 3464 patients in the outpatient clinic.

⑬ Identifying diseases and syndromes begins with identifying diseases.

Although over 99% of obesity cases are simple obesity, it is still very important to accurately diagnose the underlying cause. For example...

A. There was one case where secondary obesity was suspected based on medical history and physical examination, but was later diagnosed as pituitary microadenoma by CT scan.

B. Han XX, female, worker, born on December 16, 1947. She was hospitalized on February 13, 1992, for suspected obesity and weight loss. Over the past year, she had gradually gained weight due to overeating and lack of exercise, and had never received treatment. She had no other medical history, but her father had a history of obesity. Physical examination upon admission: height 160 cm, weight 68.5 kg, general condition relatively good, presenting as apple-shaped obesity with predominantly abdominal enlargement. No abnormalities were found in the heart and lungs. The abdomen was full, palpation was unsatisfactory, the liver and spleen were not palpable, and percussion revealed suspicious shifting dullness in the abdomen, confirmed by ultrasound. Abdominal paracentesis was performed, revealing bloody ascites. Further ultrasound and CT scans confirmed ovarian cancer, and surgical treatment confirmed the diagnosis. Therefore, in cases of obesity with predominantly abdominal distension, it is crucial to distinguish whether the abdominal cavity contains ascites or fat.

C. During outpatient treatment of obesity using massage techniques, it is important to frequently check for hepatosplenomegaly or other masses. In one case, due to thick abdominal wall fat, liver palpation was unsatisfactory; liver enlargement was discovered as the fat decreased.

Based on the aforementioned research results, we combined the weight-loss mechanism research conducted by Professor Jin Huiming of Shanghai Medical University with the long-term toxicology research results conducted by the Shanghai Institute of Biomedical Engineering and Technology, submitted the materials to the Municipal Health Bureau for approval, and passed the expert appraisal in Shanghai in 1997. It was considered that the clinical and experimental research on Jinghuang tablets for treating obesity had reached the leading level in China. In 1998, another group of experts organized by Shanghai Municipality agreed with the above conclusions and therefore awarded the Shanghai Municipal Government Science and Technology Progress Award. In October of the same year, this achievement was sent to Beijing to participate in the National Science and Technology Achievements Exhibition commemorating the 20th anniversary of reform and opening up, where it received high praise.

8. Jin Duobai Weight Loss and Lipid-Lowering Capsules or Tablets: In June 1998, the Shanghai Municipal People's Government promulgated the "Several Provisions of Shanghai Municipality on Promoting the Transformation of High-tech Achievements," consisting of 18 articles (hereinafter referred to as the 18 Articles). These provisions encouraged scientific and technological personnel to break with traditional concepts, explore new paths for the transformation of achievements, dare to devote themselves to new undertakings, and rightfully accept remuneration for their creative labor. The 18 Articles also stipulated the need to break with traditional notions such as "distributing equity or income from job-related achievements to individuals will cause the loss of state-owned assets" and "scientific and technological personnel engaging in part-time work will affect their primary job," encouraging more scientific and technological personnel to engage in innovative labor related to the transformation of scientific and technological achievements. Encouraged by the 18 Articles, I organized several long-term partners, centered around the company (Shanghai Hengda Technology Development Company), to successfully develop Jin Duobai Lipid-Lowering Capsules based on the aforementioned achievements. These capsules were launched on the market in April 1999. In the winter of 1999, the Shanghai Municipal Government organized experts to evaluate the Jin Duobai Weight Loss and Lipid-Lowering product. They unanimously agreed that the product's clinical and experimental research had reached the international advanced level, and therefore awarded it the Shanghai Municipal Class A series of technology transfer projects, for the following reasons:

(1) The weight loss function test of the obese animal model conducted by the municipal health bureau has proven that its weight loss effect is definite. Then, a trial of 33 patients taking Jin Duoba for 6 weeks was conducted jointly by the central health department and the designated tertiary-level hospitals. The results showed that the weight loss effect of Jin Duoba was similar to that of Jinghuang tablets for 3 months (Table 21). Therefore, it can be seen that the weight loss effect of Jin Duoba exceeds that of the first generation of weight loss products. In the year since Jin Duoba was launched, we have set a new record of 6 obese patients losing more than 50 kg each, and it has also achieved significant effects on obese patients with cardiomegaly and heart failure.

(2) Test results from the Food Hygiene Supervision and Inspection Institute of the Ministry of Health using a human body composition analyzer proved that taking Jin Duobai weight loss mainly reduces body fat, not water, and will not cause dehydration (Table 22).

(3) According to the test results of the Food Hygiene Supervision and Inspection Institute of the Ministry of Health using advanced instruments, Jin Duoba weight loss will not reduce the body's endurance, so taking Jin Duoba weight loss will not cause fatigue.

(4) After taking Jinduoben, there is no loss of appetite. An increase of 1 to 2 times of pasty stool per day is within the normal physiological range. In summary, taking Jinduoben will not cause loss of appetite, fatigue, or diarrhea.

(5) Long-term use of Jinduoben is safe and non-toxic. We have conducted acute and subacute toxicity tests on the main components of Jinduoben, as well as long-term toxicity tests. We have also conducted general toxicology tests and some genetic toxicology tests (i.e., carcinogenicity, teratogenicity, and mutagenicity). In addition to animal experiments, we have also conducted clinical toxicology observations in humans. The results of the above tests consistently prove that it is safe and non-toxic. Therefore, long-term use of Jinduoben is safe and non-toxic.

(6) Mechanism study of multi-target weight loss and lipid reduction. Some results reached the cellular level, and the main contents include:

①When food enters the stomach, Jinduobai can slow down gastric peristalsis, prolong the time that food stays in the stomach, and make the feeling of hunger disappear faster, thus reducing appetite.

②When food enters the small intestine for absorption, the presence of substances that inhibit pancreatic lipase in the product reduces the digestion and absorption of fat.

③ When undigested fats enter the colon, they can cause the colon to contract, thus expelling these undigested fats with feces.

④ We know that the pathological change in obesity is the increase in the size of fat cells. Jin Duoban can shrink the size of fat cells and reduce adipose tissue, thus playing a role in weight loss at the source. At the same time, Jin Duoban can also enhance insulin sensitivity and correct hyperinsulinemia. Hyperinsulinemia is the breeding ground for hypertension, hyperlipidemia, diabetes, coronary heart disease, etc. Jin Duoban can lower high insulin levels until they return to normal, which in turn plays a multi-target health care role at the source.

⑤ Jin Duobai can reduce the concentration of endotoxin in rabbits and reduce the production of TNF (tumor necrosis factor), thus Jin Duobai has the effect of detoxification and blood purification.

⑥ Using contact microscopy to observe changes in skin microcirculation in obese patients, it was found that taking Jinduoben had the effect of improving blood flow in skin capillaries.

⑦ In obese rats, serum leptin concentration was low, while leptin expression in adipocytes was enhanced. Our experimental study found that gavage administration of Jinduoben increased serum leptin concentration and weakened leptin expression in adipocytes in obese rats, which may be one of the mechanisms by which Jinduoben has a significant weight-loss effect.

Comparison data of efficacy among treatment groups (omitted)

Data on the effect of Jin Duobai Weight Loss and Lipid-Lowering Capsules on body water content (omitted)