PSP capsules are made and extracted by modern scientific methods from the deep layer cultivation of the mycelia of the traditional herb Yun-zhi. In November 1991, in accordance with the approval document No.(91) ZL-15 of the Ministry of Public Health, the Shanghai Public Health Bureau appointed the following hospitals to undertaken phase II clinical trials: the affiliated Long-hua Hospital and Shu-guang Hospital of Shanghai Institute of Chinese Medicine, Cancer Hospital of Shanghai Medical University, Shanghai Thorax Hospital, the affiliated Ren-Ji Hospital of Shanghai Second Medical University, and the Third Hospital of Shanghai Textile Industrial Bureau. From February to July 1992, in combination with chemotherapy or radiotherapy, PSP was given to 485 patients with cancers of esophagus, stomach and primary lung cancer; 274 of these cases were randomize into two groups using the double-blind method to make up the PSP and control sides. 211 cases were given PSP openly as self-control groups. The results showed that PSP has the function of improving the following symptoms of cancer patients after chemotherapy and radiotherapy, such as deficiency of vital energy and insufficiency of body fluid with irritability, thirst, constipation, etc. and the deficiency of heart and spleen. Besides it has protective and improving effects on immunological functions as well as on the blood picture. As an adjuvant therapeutic drug for cancer patients, the overall tumor response rate of PSP is 82.96% and that of the control group using shark liver alcoholate is 45.18%. The difference between the two groups is very significant (P<0.001). The detailed report on the results of the clinical trials is as follows:
1. Source of cases:
The cases of this group were out- and in-patients from February to July 1992. The number of in-patients was 299 cases and out-patients 186 cases, a total of 485 cases. Of these, there were 58 from the Long-hua Hospital, 34 from the Shu-guang Hospital, 90 from the Cancer Hospital, 63 from the Thorax Hospital, 70 from the Ren-ji Hospital, 73 from the Chang-hai Hospital, 45 from the Chang-zheng Hospital, and 52 from the No.3 Hospital of Textile Industrial Bureau. The diagnosis for all the cases were proved by pathology.2. Analysis of clinical data:
A. Sex:In the 485 cases, 351 were male and 134 female, the ratio was 2.62:1. See Table 1 for details.
Table 1 Sex distribution Group No. of cases Male Female Ratio of male/female 9101 135 100 35 2.86:1 9102 138 99 40 2.48:1 PSP open 211 152 59 2.58:1 Total 485 351 134 2.62:1
B. Age:Of the 485 cases, No.9101 group had 135 cases, their average age 59.89 (27-80); No.9102 group 139 cases, their average age 60.60 (38-87); and PSP open group 211 cases, their average age 58.04 (27-81). Statistical analysis of No.9101 and No.9102 groups did not show any differences (P>0.05). See Table 2.
Table 2 Distribution by age of the 485 cases Group <30 30- 40- 50- 60- Total 9101 1 6 16 84 28 135 9102 0 3 16 93 27 139 PSP open 4 14 26 139 28 211 Total 5 23 58 316 83 485C. Status of the cases:a) Pathology and clinical staging:Before treatment, in all of the 485 cases, the diagnoses were verified by cell pathology (see Table 3). Of which esophagus cancer 172, stomach cancer 162 (operated 99 cases and non-operated 63 cases), primary lung cancer 151 cases (operated 93, non-operated 58). The clinical staging was made according to the UICC method (see Table 4). 47% of the cases were found to be in Stage III.
Table 3 Pathological Diagnosis Type of
Pathology No. of
Esophagus Squamous Cell
172 56 56 60 Stomach Adenocarincoma 149 36 34 79 Undifferentiated 13 3 5 5 Lung Squamous Cell 73 20 23 30 Adenocarcinoma 78 20 21 37 Total 485 135 139 211
Table 4 Clinical Staging* Group Kind of disease I II III IV Total 9101 Lung cancer 6 2 25 7 40 Stomach cancer 1 15 14 9 39 Esophagus cancer 3 35 18 0 56 9102 Lung cancer 18 15 59 10 111 Stomach cancer 3 48 38 34 123 Esophagus cancer 19 56 41 0 116* Lung and esophagus cancers according to TNM classification specified by UICC in 1986; and that of stomach cancer according to that of AJCC in 1988.b) Dialectical division of types in Chinese Medicine:There has not yet been any unified standard of dialectical division of types in Chinese medicine for esophagus, stomach and lung cancers. Basing ourselves on the dialectical divisions of types in Chinese medicine as put forth in "Guiding Principles of treatment" in the "Tentative Teaching Materials" of medical colleges in China and new Chinese drugs, we conducted the dialectical division by using the 4 diagnosis (Observation, auscultation and olfaction, interrogation and pulse feeling and palpation) of Chinese Medicine before the treatment of the diseases (see Table 5).
Table 5 Analysis of the dialectical division of types in Chinese Medicine before the treatment of the esophagus, stomach and lung cancers Dialectical division of types 9101
Total ESOPHAGUS CANCER Deficiency of vital energy and body fluid 36 35 38 109 Phlegm and breath obstruction 15 8 14 37 Phlegm, silt 1 1 2 4 Heat and toxic damaging body fluid 2 7 7 16 Deficiency of vital energy and blood 3 6 3 12 STOMACH CANCER Disharmony of liver and stomach 2 3 6 11 Obstruction of phlegm and food 3 1 5 9 Deficiency of heat and spleen 13 11 9 33 Deficiency and coldness of spleen and stomach 1 1 5 7 Deficiency of vital energy and body fluid 20 23 59 102 LUNG CANCER Deficiency of spleen and humidity of phlegm 10 16 8 34 Deficiency of body fluid and inner heat 14 13 18 45 Deficiency of vital energy and body fluid 14 14 38 66 Obstruction of breath and silting of blood 2 1 2 5 Strong heat and toxin 0 0 1 1 After statistical analysis of the two groups, there were no obvious differences (P>0.05).
D. Analysis of Symptoms:The cases of this group were mostly in the middle and late stages. The stomach and lung cancer patients were observed after operation, and especially after chemotherapy, while the esophagus cases had radiotherapy. The symptoms were paleness, weakness, loss of weight, anorexia, dryness of throat and mouth, asthma, palpitation, irritation, insomnia, spontaneous and night sweat, pain in abdomen and heart, and red swollen tongue, indented with teeth marks at its sides, weak pulse. They were the symptoms of deficiency of vital energy and body fluid and of heart and spleen (see Table 6).
According to the dialectical and symptomatic comparison and analysis by sex, age, type and stage of disease, there was no differences in the two groups and were therefore comparable.
|Symptoms||9101 Group||9102 Group||PSP open Group|
|Weak and tired||107||79.26||125||89.93||176||83.41|
|Loss of appetite||106||78.52||114||82.01||164||77.73|
|Dryness of mouth and throat||58||42.96||78||56.11||77||36.49|
|Palpitation and asthma||69||51.11||75||53.96||81||38.39|
|Irritation and insomnia||80||59.26||91||65.47||108||51.18|
|Spontaneous and night sweat||43||31.85||56||40.29||39||18.48|
|Vomiting and nausea||31||22.96||44||31.65||45||21.33|
|Loss of weight||62||45.93||64||46.04||96||45.50|
|Red tongue and indented|
with teeth marks
|Thin and taut pulse||110||81.48||108||77.70||178||84.36|
/... to be continued (coming soon)