Perception of cancer patients of their disease, self-efficacy and locus of control and usage of complementary and alternative medicine.

PURPOSE: A high percentage of cancer patients use complementary and alternative medicine (CAM). The aim of our study was to learn more about the association of CAM usage, information needs, perceived impact of disease, locus of control and self-efficacy of cancer patients. METHODS: We asked patients attending a series of lectures on CAM using a standardized questionnaire which integrated questions on information needs, CAM and validated short questionnaires on self-efficacy, perception of the disease and locus of control of reinforcement. RESULTS: One hundred and eighty-five patients answered the questionnaire, from whom 45 % used CAM. Sixty percentage disclosed using CAM to the general practitioner and 57 % to the oncologist. Physicians and nurses, print media and the Internet are the most important source of information on CAM (used by 20-25 % each). Impact on neither daily life, perceived personal control nor coherence was associated with CAM usage, disclosure to physicians or sources of information. There also was no association between CAM usage and self-efficacy. In contrast, there was a significant association between CAM user rate and a high external locus of control. CONCLUSION: While CAM usage is agreed upon by many physicians due to the idea that it helps patients to become active and feel more in control of the disease, our data are in favor of the contrary. A strong perception of external locus of control seems to be a driver of CAM usage. Physicians should be aware of this association when counseling on CAM.

Correlations of headache diary parameters, quality of life and disability scales.

OBJECTIVE: We aimed to investigate (1) to which extent headache diary variables correlate among each other; (2) to which extent they correlate with generic measures of quality of life and disability; (3) and whether correlations vary over time. METHODS: We performed a secondary analysis of data from 301 patients suffering from migraine and 270 patients suffering from tension-type headache collected in 2 randomized trials of acupuncture. We calculated product-moment correlation coefficients. RESULTS: Correlations between diary parameters varied to a great extent. Attack frequency, a measure recommended by the International Headache Society as a primary outcome measure for migraine prophylaxis trials, correlated only moderately with other diary outcomes. At baseline the parameters measured in the headache diary correlated only weakly with the generic outcome measures. After 12 weeks these correlations had increased considerably. CONCLUSION: Our findings suggest that participants in headache trials "learn" to fill in diaries and generic instruments in a more consistent manner during the course of the study.

Randomized trial vs. observational study of acupuncture for migraine found that patient characteristics differed but outcomes were similar.

OBJECTIVE: To compare patient characteristics and outcomes between a randomized controlled trial (RCT) and an observational study (OS) of acupuncture treatment in patients with migraine. STUDY DESIGN AND SETTING: Within the framework of a research program for acupuncture for chronic pain, both an RCT and an OS of routine care were performed in patients with migraine. One hundred forty-five patients received acupuncture in the RCT and 732 in the OS. All patients completed a pain questionnaire, including instruments evaluating disability, quality of life, and depression, at baseline and at 6-month follow-up. RESULTS: At baseline, patients participating in the RCT had a significantly longer history of complaints and more headache days but better quality of life and fewer depressive symptoms than patients participating in the OS. In unadjusted analyses, improvements after 6 months were more pronounced in the OS than in the RCT. After adjustment for potential confounders, the differences decreased but were still significant for several outcomes. CONCLUSION: Participants of the RCT were probably not representative of migraine patients undergoing acupuncture treatment in routine care under current regulations in Germany. However, changes after treatment were similar in the RCT and the OS of routine care.

Acupuncture for chronic low back pain in routine care: a multicenter observational study.

OBJECTIVE: To investigate patient characteristics and outcomes after undergoing acupuncture treatment for chronic low back pain (cLBP) in Germany and to analyze chronification, pain grading, and depression as predictors for treatment outcomes. PATIENTS AND METHODS: Patients with cLBP (ICD-10 diagnoses M54.4 or M54.5) who underwent acupuncture therapy (mean number of sessions 8.7+/-2.9) within the framework of a reimbursement and research program sponsored by German statutory sickness funds were included in an observational study. Patients were asked to complete detailed questionnaires that included questions on intensity and frequency of pain and instruments measuring functional ability, depression, and quality of life (SF-36) before and after treatment and 6 months after beginning acupuncture. Participating physicians assessed pain chronification in patients. RESULTS: A total of 2564 patients (mean age 57.7+/-14.0 y, 78.7% female), who were treated by 1607 physicians, were included in the main analysis. After 6 months (6-mo follow-up), 45.5% of patients demonstrated clinically significant improvements in their functional ability scores. The mean number of days with pain was decreased by half (from 21 to 10 d/mo). Employed patients (employed patient subgroup analysis) reported a 30% decrease from baseline in days of work lost. In all, 8.1% of patients reported adverse events, the majority of which were minor. Subgroup analyses focusing on pain severity, stage of chronification, and depression revealed statistically significant relationships both to baseline measures and to reduction of pain after acupuncture. CONCLUSIONS: Acupuncture treatment is associated with clinically relevant improvements in patients suffering from cLBP of varying degrees of chronification and/or severity.

Effectiveness and tolerability of acupuncture compared with metoprolol in migraine prophylaxis.

OBJECTIVES: In a randomized controlled multicenter trial extending over 24 weeks, we investigated whether acupuncture is as effective and safe as metoprolol in the prophylactic treatment of migraine under conditions similar to routine care. METHODS: One hundred fourteen migraine patients could be randomized to treatment over 12 weeks either with acupuncture (8 to 15 sessions) or metoprolol (100 to 200 mg daily). Main outcome measure was the difference in the number of migraine days between baseline and the weeks 9 to 12 after randomization (derived from a headache diary). RESULTS: Two of 59 patients randomized to acupuncture withdrew prematurely from the study compared to 18 of 55 randomized to metoprolol. The number of migraine days decreased by 2.5 +/- 2.9 days (baseline 5.8 +/- 2.5 days) in the acupuncture group compared to 2.2 +/- 2.7 days (baseline 5.8 +/- 2.9 days) in the metoprolol group (P= .721). The proportion of responders (reduction of migraine attacks by > or =50%) was 61% for acupuncture and 49% for metoprolol. Both physicians and patients reported fewer adverse effects in the acupuncture group. CONCLUSIONS: Due to missing the recruitment target (480 patients) and the high drop-out in the metoprolol group the results must be interpreted with caution. Still, they suggest that acupuncture might be an effective and safe treatment option for patients unwilling or unable to use drug prophylaxis.

Treatment in a randomized multicenter trial of acupuncture for migraine (ART migraine).

BACKGROUND: This paper aims to describe the characteristics of physicians and interventions of a large, multicenter randomized trial of acupuncture for migraine (ART Migraine) in order to enable acupuncturists to assess the study interventions. PATIENTS AND METHODS: 302 patients suffering from migraine were randomized to 12 sessions of semi-standardized acupuncture (6 predefined basic points, recommendations for optional individual choice of additional points given), standardized minimal acupuncture (superficial needling of at least 5 of 10 predefined, distant non-acupuncture points) or a waiting list. 30 physicians trained and experienced in acupuncture from 18 centers in Germany participated in the trial. RESULTS: The median duration of acupuncture training of trial physicians was 500 h (range 140-1350). Physicians had acupuncture experience for 10 (<1 to 25) years and had treated 200 (60 to >1000) patients with acupuncture in the year preceding trial participation. The 6 basic points were needled in 76-93% of sessions. Compliance with treatment instructions varied considerably among centers in the acupuncture group. In contrast, compliance with the minimal acupuncture protocol was very good. 6 of the 30 physicians stated that they would have treated patients somewhat differently outside the trial, 1 completely differently. The trial found a significant effect of those treated with acupuncture compared to those on the waiting list for treatment, but minimal acupuncture was as effective as acupuncture. CONCLUSIONS: The treatment protocols for acupuncture and minimal acupuncture in ART Migraine appeared an adequate compromise in the specific situation and for the predefined purposes. However, a relevant minority of participating physicians would have treated patients differently outside the trial.

Acupuncture for chronic headaches--an epidemiological study.

OBJECTIVE: To investigate the characteristics and outcomes of patients undergoing acupuncture treatment for chronic headaches under conditions of routine care provided within the framework of statutory health insurance in Germany. Furthermore, we investigated correlations between different outcomes. PATIENTS AND METHODS: Patients with migraine, episodic or chronic tension-type headache (TTH), or several other forms of chronic headache (cluster, vascular, drug-induced headache; other specific headaches) treated with acupuncture (mean number of sessions 8.6 +/- 3.0) were included into an observational study. Detailed questionnaires including questions on headache days and instruments measuring disability (Pain Disability Index) and quality of life (SF-36) were completed before treatment, after treatment, and at 6 months after inclusion. RESULTS: A total of 2,022 patients (732 with migraine, 351 with episodic and 440 with chronic TTHs, and 499 with other diagnoses) treated by 1,418 physicians were included in the main analysis. Sociodemographic and baseline characteristics differed considerably in the four diagnostic groups. Statistically highly significant and clinically relevant improvements were seen for all clinical outcome measures in all diagnostic groups. In 52.6% of patients headache frequency decreased by at least 50% compared to baseline. The comparison of headache frequency, pain intensity, and generic outcome measures showed that some of these outcomes correlate only weakly. CONCLUSIONS: In this epidemiological study, headache patients reported clinically relevant improvements after receiving acupuncture. Randomized trials performed in parallel to this study confirm the relevant overall effect, however, the effect may largely be due to potent unspecific needling and placebo effects.

Acupuncture in patients with tension-type headache: randomised controlled trial.

OBJECTIVE: To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. DESIGN: Three armed randomised controlled multicentre trial. SETTING: 28 outpatient centres in Germany. PARTICIPANTS: 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache. INTERVENTIONS: Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks. MAIN OUTCOME MEASURE: Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries. RESULTS: The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group. CONCLUSIONS: The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache. TRIAL REGISTRATION NUMBER: ISRCTN9737659.

Acupuncture for patients with migraine: a randomized controlled trial.

CONTEXT: Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce. OBJECTIVE: To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine. DESIGN, SETTING, AND PATIENTS: Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany. INTERVENTIONS: Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization. MAIN OUTCOME MEASURES: Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization. RESULTS: Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, -0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group. CONCLUSION: Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control.

The acupuncture randomised trial (ART) for tension-type headache--details of the treatment.

OBJECTIVE: The goal of this paper is to describe the characteristics of physicians and their interventions in a large, multicentre randomised trial of acupuncture for tension-type headache known as ART TTH, in order to enable acupuncturists to assess the study interventions. METHODS: Participating physicians were recruited whose qualifications met or surpassed those of physicians currently accredited for providing acupuncture by state health funding agencies in Germany. Semi-standardised treatment strategies for acupuncture and minimal acupuncture were developed in a consensus process with acupuncture experts. A total of 270 patients suffering from episodic or chronic tension-type headache were randomised to 12 sessions of semi-standardised acupuncture (three predefined 'basic' points, recommendations for additional points given, but individual choice of additional points possible), standardised minimal acupuncture (superficial needling of at least 5 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list. Forty two physicians, trained and experienced in acupuncture, from 28 centres in Germany participated in the trial. RESULTS: The median duration of acupuncture training of trial physicians was 500 hours (range 140 to 1350 hours). Physicians had 10 (< 1 to 25) years acupuncture experience. The three 'basic' points (GB20, GB21 and LR3) were treated in 96%, 82% and 97% of sessions, respectively. Frequently treated optional points included LI4 (67%), SP6 (50%) and ST36 (46%). Ten of the 42 physicians stated that they would have treated patients differently outside the trial. The trial found a significant effect of acupuncture over waiting list but not over minimal acupuncture. CONCLUSIONS: In general, trial physicians complied well with the predefined interventions. A relevant minority of participating trial physicians stated that they would have treated patients differently outside the trial.