Subjects, study design and interventions
We included patients >17 years of age with sinusitis symptoms for >3 months and sinus swelling, fluid retention, or opacification on CT after screening >500 patients with sinusitis. We excluded patients if they were pregnant, had previously had acupuncture treatment, had been operated on for chronic sinusitis, had polypous sinusitis or pansinusitis, or used medication that could influence the results of the study. In total, 66 patients were included between 1996 and 2000. We recruited patients from one ear-nose-throat practice and advertised the study in local newspapers and a magazine. One otorhino-laryngologist examined and included all patients. He allocated them to one of three groups according to a six-block randomization algorithm, by first assigning a patient number to each patient. He then phoned one of the acupuncturists to receive information about the group allocation for that particular patient [10]. The groups were (1) conventional medical therapy, (2) traditional Chinese acupuncture (TCA), or (3) minimal acupuncture at non-acupoints (sham). No patients were included between February and September to avoid influence from seasonal allergies.
All patients in the conventional medical therapy group used xylometazoline as local vasoconstrictor, and 0.9% sodium chloride solution locally for one week, and oral corticosteroids for 14 days. In addition, 14 patients used cefalexin 1500 mg daily for 10 days and six used azithromycin 500 mg for 7 days.
Both acupuncture groups had 10 treatments with bilateral acupoints over 4 weeks, performed by the same experienced acupuncturists with 4–10 years of experience and with experience in the treatment of chronic sinusitis. The TCA group patients had individual TCM diagnoses and treatment using 1.0–1.5 cun needles (Ø 0.28 mm, length 25–40 mm). The needles were inserted to from 0.5 cun (facial/hand/feet area) to a maximum of 1.3 cun (arms/legs/trunk area) depth to achieve a good needle sensation, stimulated manually using reducing or reinforcing methods and left in the acupoints for 25 minutes [10, 11].
In the sham treatment group, the patients were given minimal acupuncture at non-acupoints outside the meridians. One point was situated on each shoulder between LI 15 and TE 14, one on each thigh 3 cun above the midpoint of the patella, and two bilateral points were situated 2.5 cun lateral to the umbilicus. For the sham group, we used 0.5 cun needles (Ø 0.25 mm, length 13 mm) A shallow, superficial insertion of the needle (maximum depth 0.25 cun) and minimal needle sensation was emphasized. The needles were left in the points for 25 minutes[10, 12]. We applied the same sham points during each treatment session. In all treatment groups, medication used for other indications remained unchanged.
Outcome assessment
The participants responded to a questionnaire in the physician's office at baseline and after 12 weeks, including the Chronic sinusitis survey and Short Form 36 questionnaires.
Chronic sinusitis survey
The Chronic sinusitis survey (CSS) is a 6-item duration-based, sinus-specific questionnaire with a symptom and a medication subscale for use in chronic sinusitis [4, 5, 13]. Scores were reported on a 0–100 scale, where 100 represents minimal symtoms or medication use. The Norwegian version of the CSS has only recently been validated [14].
Short form 36
The Short form 36 (SF-36) assesses eight dimensions of health status including physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health [15, 16]. The scales were scored from 0 (lowest level of functioning) to 100 (highest level of functioning). The SF-36 has been extensively validated [15, 16] and used in subjects with chronic rhinosinusitis [13, 17–19]. We used the Norwegian standard SF-36 version 1.2 [20].
Statistical analysis
Descriptive statistics are presented with means and SDs, or percentages. We compared changes in HRQoL from baseline to 12 weeks between groups using one-way analysis of variance with post-hoc Tukey's test because of multiple comparisons.
The required sample size was initially estimated to two groups of 22 patients, to detect a group difference of 0.85 SD on a visual analog scale, with power 0.8 and a 5% confidence level. Before study start, the study protocol was adjusted to include a third arm with 22 patients [10].
We omitted pairwise comparisons of changes on the CSS medication effects and total scales involving the conventional treatment group, because medication was part of the protocol for this group.
We chose a 5% confidence level, using two-sided tests. The Regional Committee for Medical Research Ethics and The Norwegian Data Inspectorate approved the study.