Methods |
Study design: parallel group randomised trial. Study dates: April 2002 to March 2004. Setting: outpatient. Country: China. |
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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. |
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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. |
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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. |
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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. |