Efficacy and safety of Chinese herbal medicine for chronic prostatitis associated with damp-heat and blood-stasis syndromes: a meta-analysis and literature review

Figures & data

Figure 1 Study selection flow diagram for inclusion in the review.

Abbreviations: CHM, Chinese herbal medicine; CP, chronic prostatitis; RCT, randomized controlled trial.

Figure 2 Risk of bias graph.

Figure 3 Risk of bias summary: review of authors’ judgments about each risk of bias item for each included study.

Table 1 RCTs of CHM for CP associated with damp-heat and blood-stasis syndromes with modified Jadad score ≥4

No	First author (year)	Country/type of case	Ages, years mean (range)	Diagnostic system	TCM pattern diagnosis	Design	Follow-up	Sample size (CHM/control)	Treatment intervention (duration)	Control intervention	Outcome measure	Results reported	Modified Jadad score
1	Gao (2012)^Citation28	China/outpatients with CP	36.15 (19–50)	CRG + USW	Damp-heat and blood-stasis syndrome	Three parallel arms (low dose of CHM; high dose of CHM; placebo)	Nil	206 (68/68/70)	Longbi Xintong granule 8 g, qd/8 g, bid (4 weeks)	Placebo	NIH-CPSI, effective rate, SI-CM, EPS-WBC	CHM significantly > placebo	5
2	Mao (2014)^Citation29	China/outpatients with CP	30.59 (23–45)	CRG + USW	Heat stasis type	Two parallel arms (CHM; placebo)	Nil	74 (54/20)	Longbi Xintong granule 8 g, bid (4 weeks)	Placebo	NIH-CPSI, effective rate, SI-CM, EPS	CHM significantly > placebo	4
3	Zhang (2014)^Citation30	China/outpatients with CP	34.84 (18–50)	CRG	Damp-heat and blood-stasis syndrome	Three parallel arms (low dose of CHM; high dose of CHM; placebo)	Nil	254 (86/83/85)	Compound Huangkui granule 9 g/12 g, tid (8 weeks)	Placebo	NIH-CPSI, effective rate, SI-CM	CHM significantly > placebo	7
4	Jin (2011)^Citation31	China/outpatients with CP	NR (18–50)	HJS + CDT + CRG	Damp-heat and stagnation syndrome	Two parallel arms (CHM; placebo)	4 weeks	225 (113/112)	Qianlie Xiaoyan Zhitong tablet 1.48 g, tid (28 days)	Placebo	NIH-CPSI, effective rate, SI-CM, EPS	CHM significantly > placebo	5
5	Zhou (2002)^Citation32	China/outpatients with CP	NR (20–50)	CRG	Damp-heat and blood stasis	Two parallel arms (CHM; placebo)	Nil	62 (32/30)	Qianliean tablet 7 g, tid (4 weeks)	Placebo	NIH-CPSI, effective rate, SI-CM, EPS	CHM significantly > placebo	7
6	Gao (2010a)^Citation33	China/outpatients with CP	33 (18–50)	CRG	Type of damp-heat and blood stasis	Two parallel arms (CHM; placebo)	Nil	442 (336/106)	Longqing tablet 3.6 g, bid (4 weeks)	Placebo	NIH-CPSI, effective rate, SI-CM, EPS	CHM significantly > placebo	4
7	Hou (2011)^Citation34	China/outpatients with CP	NR (18–50)	CRG + USW	Damp-heat mixed blood	Two parallel arms (CHM; placebo)	Nil	74 (38/36)	Amber capsule 1.76 g, bid (4 weeks)	Placebo	NIH-CPSI, effective rate, SI-CM, EPS	CHM significantly > placebo	7
8	Xu (2005)^Citation35	China/outpatients with CP	NR (20–55)	NIH-CPSI ≥4 points	NR	Two parallel arms (CHM; placebo)	Nil	116 (59/57)	Wenglitong tablet 1.2 g, bid (4 weeks)	Placebo	NIH-CPSI, effective rate	CHM significantly > placebo	5
9	Guo (2007)^Citation36	China/outpatients with CPPS by CP	24.5 (19–55)	USW	NR	Two parallel arms (CHM; placebo)	Nil	197 (99/98)	Qianlie Antong tablet 1.9 g, tid (4 weeks)	Placebo	NIH-CPSI, effective rate, EPS-WBC	CHM significantly > placebo	5
10	Gao (2010b)^Citation37	China/outpatients with CP	33 (18–50)	CRG	Moist heat stagnant blood stasis	Three parallel arms (CHM; placebo)	Nil	229 (58/113/58)	Prostant 2 g/Qianlie Miniao Shuan 2.5 g qn (4 weeks)	Placebo	NIH-CPSI, effective rate, SI-CM	CHM significantly > placebo	4
11	Li (2003)^Citation38	China/outpatients with CP	32.7 (20–50)	NIH-CPSI ≥10 points	NR	Two parallel arms (CHM; placebo)	Nil	124 (64/60)	Prostant 2 g, qn (1 month)	Placebo	NIH-CPSI, effective rate, EPS-WBC	CHM significantly > placebo	4
12	Xu (2002)^Citation39	China/outpatients with CP	NR (20–55)	NIH-CPSI ≥10 points	NR	Two parallel arms (CHM; placebo)	Nil	70 (35/35)	Prostant 2 g, qn (1 month)	Placebo	NIH-CPSI, effective rate, EPS-WBC	CHM significantly > placebo	5
13	Yao (2008)^Citation40	China/outpatients with CP	30.1 (20–55)	NIH-CPSI ≥10 points + CIM + SC	Damp-heat stagnation	Two parallel arms (CHM; placebo)	Nil	40 (20/20)	Prostant 2 g, qn (4 weeks)	Placebo	NIH-CPSI, effective rate, EPS-WBC	CHM significantly > placebo	4

Notes: Qianlie Xiaoyan Zhitong tablet and Qianliean tablet with the same formula and different names were handled within subgroup analysis. In the case of three numbers, the first two are different treatment group, the third is control group.

Abbreviations: CHM, Chinese herbal medicine; CIM, Chinese internal medicine; CPPA, chronic pelvic pain syndrome; CP, chronic prostatitis; HJS, Huang Jiasi surgery; IPSS, International Prostate Symptom Score; NIH-CPSI, National Institutes of Health chronic prostatitis symptom index; NR, not reported; SC, surgery of Chinese; WBC, white blood cell; bid, twice daily; CDT, criteria of diagnosis and therapeutic effect of diseases and syndromes in traditional Chinese medicine; CRG, clinical research guidelines of new CHM; USW, urological surgery written by Wu Jie-Ping; RCTs, randomized controlled trials.

Figure 4 Efficacy rate when using CHM and placebo for CP associated with damp-heat and blood-stasis syndromes.

Abbreviations: CHM, Chinese herbal medicine; CI, confidence interval; CP, chronic prostatitis; SE, standard error; OR, odds ratio.

Figure 5 NIH-CPSI score when using CHM and placebo for CP associated with damp-heat and blood-stasis syndromes.

Abbreviations: CHM, Chinese herbal medicine; CI, confidence interval; CP, chronic prostatitis; NIH-CPSI, National Institutes of Health chronic prostatitis symptom index; Std, standard; SD, standard deviation.

Figure 6 SI-CM score when using CHM and placebo for CP associated with damp-heat and blood-stasis syndromes.

Abbreviations: CHM, Chinese herbal medicine; CI, confidence interval; CP, chronic prostatitis; SI-CM, symptom index of Chinese medicine for chronic prostatitis; SD, standard deviation; Std, standard.

Figure 7 Likelihood of adverse events when using oral CHM and placebo.

Abbreviations: CHM, Chinese herbal medicine; CI, confidence interval; M–H, Mantel–Haenszel method; RR, risk ratio.

Figure 8 Likelihood of adverse events when using Prostant and placebo.

Abbreviations: CI, confidence interval; M–H, Mantel–Haenszel method; RR, risk ratio.

Table 2 RR of all reported adverse events in studies comparing CHM with placebo

Adverse event	Total event/group total		RR (95% CI)	No of studies	Heterogeneity (I^2)%
	CHM	Placebo
	Oral CHM	Placebo
Stomach upset	7/680	5/407	0.80 (0.27–2.39)	5	0.0
Nausea	2/518	2/227	0.75 (0.18–3.18)	4	0.0
Mild stomachache	1/86	1/85	0.99 (0.06–15.55)	1	NA
Mild abdominal distention	3/145	1/142	2.28 (0.34–15.30)	2	0.0
Mild diarrhea	6/185	5/180	1.15 (0.41–3.27)	3	0.0
Severe diarrhea	1/36	1/36	3.00 (0.13–71.28)	1	NA
Urticaria	1/113	0/112	2.97 (0.12–72.23)	1	NA
Cold/sore throat	3/113	2/112	1.49 (0.25–8.73)	1	NA
Abnormal liver function	0/113	2/112	0.20 (0.01–4.08)	1	NA
Pruritus	1/59	0/57	2.90 (0.12–69.75)	1	NA
	Prostant	Placebo
Anal discomfort	41/183	25/183	1.63 (1.06–2.49)	4	0.0
Archorrhagia	1/64	0/64	3.00 (0.12–72.29)	1	NA
Loose stool	3/20	1/20	3.00 (0.34–26.45)	1	NA

Abbreviations: CHM, Chinese herbal medicine; CI, confidence interval; NA, not applicable; RR, risk ratio.

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