Phase II Clinical Trial for PSP Capsules

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.

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	485

C. 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 Cancer	Pathology	No. of cases	9101 Group	9102 Group	PSP Open Group
Esophagus	Squamous Cell Carcinoma	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 Group	9102 Group	PSP Open Group	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.

Table 6   Analysis of the symptoms according to Chinese Medicine^*

Symptoms	9101 Group		9102 Group		PSP open Group
	cases	%	cases	%	cases	%
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
Pain	69	51.11	67	48.20	100	47.39
Red tongue and indented with teeth marks	59	43.70	55	39.57	85	40.28
Weak pulse	19	14.07	30	21.58	10	4.74
Thin and taut pulse	110	81.48	108	77.70	178	84.36