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. 2018 Jan 26;2018(1):CD012551. doi: 10.1002/14651858.CD012551.pub2
Methods Study design: parallel group randomised trial.
Study dates: April 2002 to March 2004.
Setting: outpatient.
Country: China.
Participants Inclusion criteria: participants undertook 'Meares‐Stamey' test, the initial urine, midstream urine, EPS, and post‐prostatic massage urine routine test and bacterial culture and then diagnosed with CP/CPPS. Classified as type IIIa or type IIIb CP by NIH‐CPSI classification.
Exclusion criteria: acute prostatitis or chronic bacterial prostatitis; could not attend hospital regularly or had poor compliance; had undertaken repeated sessions of prostate radiofrequency, thermotherapy or other physical therapies; had undertaken repeated sessions of intraprostate injection of antibiotics.
Sample size: 112.
Age (years):
Group 1: range 22˜47, mean: 33.6.
Group 2: range 24˜52, mean: 34.
Baseline NIH‐CPSI score: not available.
Sex: men.
Interventions Group 1 (n = 56): He‐Ne laser.
Treated using He‐Ne laser equipment every other day. Optic fibre inserted from urethra and ending located at prostatic urethra.
Output power of optic fibre ending: 10 mW.
Energy of irradiation: 18 J each time.
1 course of treatment: 10 times of radiation (2 sessions weekly).
Discontinued all other treatments, except for some participants where short‐term sulpha‐drugs were administered temporarily to prevent infection.
Group 2 (n = 56): drug combination.
Routine therapy for CP:
Antibiotics: compound sulfamethoxazole, 2 tablets, orally, twice daily, 60 days of fluoroquinolones such as levofloxacin 0.2 g, twice daily, 14 days.
Adjuvant drugs: pollen drugs such as Prostat; Chinese patent drugs such as salvianolic acid B and saponins of panax notoginseng mixture (SalB/PNS).
Physical therapy: hot water bath.
Changes of lifestyle.
Cointerventions: not available.
Outcomes Prostatitis symptoms
How measured: changes in NIH‐CPSI.
Time points measured: before and after treatment.
Time points reported: after treatment.
Subgroups: none.
Adverse events
How measured: narratively.
Funding sources Not mentioned.
Declarations of interest Not mentioned.
Notes None.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: '112 patients were randomly divided into laser therapy group and combination drug therapy group' (in Chinese); however, unclear what method used.
Allocation concealment (selection bias) Unclear risk Allocation concealment not described.
Blinding of participants and personnel (performance bias) Subjective outcomes High risk Masking of participants and personnel not described. Considering the visibly different interventions, blinding was unlikely.
Blinding of outcome assessment (detection bias) All outcomes High risk All outcomes (participant‐reported outcomes): blinding unlikely (see above).
Incomplete outcome data (attrition bias) All outcomes Low risk All outcomes: outcome data available for all randomised participants.
Selective reporting (reporting bias) Unclear risk Unclear whether there was selective outcome reporting (protocol not available).
Other bias Low risk No other sources of bias identified.