Qi 2013.
Study characteristics | ||
Methods |
Study design: parallel randomised controlled trial Number randomised: total 104 participants, acupuncture plus conventional treatment group: 52; conventional treatment alone group: 52 Exclusions after randomization: 0 Number analyzed: 102, conventional treatment alone group: 51; acupuncture plus conventional treatment group: 51 Unit of analysis: individual Losses to follow‐up: 2 participants Missing data handling: 2 participants dropped out after randomization and were therefore excluded from the analysis. Another 4 participants changed to other treatment due to adverse events, and were included in per‐protocol analysis. Reported power calculation: 90% power; effect size (proportion of participants with complete resolution of acute hordeolum) was 97% for acupuncture plus conventional treatment group, 75.5% for conventional treatment group; sample size was calculated as 104 participants (information obtained from study investigator's master thesis). Unusual study design: four participants stopped their initial treatment and started other treatments; two participants in topical antibiotic group used acupuncture at the 3rd and 4th day respectively; two patients in acupuncture plus topical antibiotic group used systematic antibiotics at the 3rd day; the four participants were analyzed as they were randomised. |
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Participants |
Country: China Setting: ophthalmology department (outpatient clinic), the first affiliated hospital to Xinjiang Medical University; not a Traditional Chinese Medicine institution Age (mean ± SD): 28 ± 9.5 in total; 29 ± 10 in acupuncture plus conventional treatment group; 27 ± 9 in conventional treatment alone group Age range: not reported; the authors stated that participants age 6 to 65 years were included. Duration: 0.5 to 3 days Gender: total: men 32/102 (31%), women 70/102 (69%); acupuncture plus conventional treatment group: men 17 (33.3%), women 34 (66.7%); conventional treatment alone group: men 15 (29.4%), women 36 (70.6%) Inclusion criteria: age 6 to 65 years; patients diagnosed with hordeolum early with duration with symptoms of redness and swelling of 0.5 to 3 days, no abscess present Exclusion criteria: people age under 6 or above 65; taking oral hormone, antibiotics, or immunosuppressant; people with coagulation disorders or abscess of ears; people with history of drug allergy (levofloxacin hydrochloride eyedrops or erythromycin eye ointment); pregnant women or planned to become pregnant during the trial Equivalence of baseline characteristics: yes |
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Interventions |
Intervention 1: acupuncture (bloodletting) plus conventional treatment; topical antibiotics (ofloxacin eyedrops + erythromycin ointment) + warm compresses N allocated to acupuncture: 52 (51 were analyzed) Point selection: fixed formula Points stimulated: bloodletting at ipsilateral Erjian (EX‐HN6) at the ear apex, and withdrew 5 ~ 6 drops of blood Total length of treatment period: 3 days Number of sessions target (mean): 3 sessions Times per day: 1 Number of points used: 1 Insertion depth: 2 ~ 3 mm using a syringe needle Was De qi reportedly sought?: NA Duration (minutes): not reported Method of stimulation: bloodletting Intervention 2: conventional treatment: topical antibiotics (ofloxacin eyedrops + erythromycin ointment) + warm compresses N allocated to conventional treatment group: 52 (51 were analyzed) Total length of treatment period: 3 days Length of follow‐up: Planned: 7 days after diagnosis Actual: 7 days after diagnosis |
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Outcomes |
Primary outcome, as defined in study reports: the proportion of participants with complete early resolution of a hordeolum (7 days after diagnosis)
Secondary outcomes, as defined in study reports: not reported Adverse events reported: “no obvious adverse events occurred in acupuncture group. Local adverse events such as red, swollen, inflammation, or abscess at the treatment area were absent in acupuncture group, which indicated that bloodletting was as safe as conventional treatment for external hordeolum.” "Two participants withdrew in both groups due to exacerbation of symptom (e.g., enlarged area of redness and abscess)" Intervals at which outcomes assessed: 3, 5, 7 days |
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Notes |
Trial registry record: The RCT was registered in Chinese Clinical Trial Registry (registration number: ChiCTR‐TRC‐12002201). (Information was obtained from study investigator's master thesis.) Type of study: published Funding sources: This RCT was reported not funded (information was provided during phone communication with study investigator on 15 March 2015). Disclosures of interest: not reported Study period: April 2011 to October 2012 Reported subgroup analyses: no KC contacted the study investigator Chen XY by phone for further information on 15 March 2015. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | We assume the trial investigators had a column of participants ids (from 1 to 104). They then generated a second column of random numbers, order the columns by the generated random number, assigned the first half of participant ids to the acupuncture group, and the second half of the participants ids to the conventional treatment group. Finally, reorder the columns by the participant ids. Translated from Chinese: "The sequence of 104 was generated by a statistician using software. The sequence was divided into 2 groups in terms of the size of number. The numbers of smaller size were allocated to A (bloodletting) group, the numbers of larger size were allocated to B (conventional treatment) group. 52 cases were allocated to each group." pg149 |
Allocation concealment (selection bias) | High risk | One outpatient nurse prepared and distributed the envelops containing the treatment assignment, therefore may be aware of the allocation sequence. The outpatient nurse prepared the sequentially numbered sealed opaque envelops. If the participant met the RCT inclusion/exclusion criteria, the outpatient nurse would distribute the number of the envelops to the participants (information was obtained from study investigator's master thesis and during a phone call with the study investigator on 15 March 2015). |
Masking of participants and personel (performance bias) | Unclear risk | Acupuncture plus conventional treatment vs conventional treatment was assessed in this study. Due to the nature of the treatments, participants and personnel could not be masked. We are not sure weather the resolution of a hordeolum could be influenced by knowing the treatment group assignment. |
Masking of outcome assessment (detection bias) | Low risk | The outpatient nurse who assessed the outcome was not the one who distribute the number and was masked to the group assignment. (Information was provided during phone communication with study investigator on 15 March 2015). . |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two participants dropped out after randomization due to exacerbation of symptoms. Another four participants used other treatment due to the poor effects and were included in per‐protocol analysis. That is, two patients in topical antibiotic group used acupuncture at the 3rd and 4th day respectively; two patients in acupuncture plus topical antibiotic group used systematic antibiotic at the 3rd day. The four participants were included in per‐protocol analysis. The proportion was less than 10% in each group. The reason and number of dropouts were reported and balanced across groups. |
Selective reporting (reporting bias) | Unclear risk | Although study protocol is not available, the primary outcome (i.e. proportion of participants with complete early resolution of a hordeolum) and other outcomes (size of stye and VAS pain severity after the 1st treatment, 3, 5, and 7 days after diagnosis) prespecified in the methods section were reported in the results. |
Other bias | Unclear risk |
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