Homeopathy for seasonal allergic rhinitis: rationale, design and methods of the three-armed randomized controlled HOMEOSAR trial.

BACKGROUND: Patients with seasonal allergic rhinitis (SAR) frequently use homeopathic therapy. Although there is some evidence that homeopathy may be effective in treating symptoms of SAR, there is a lack of high-quality clinical trials. Therefore, the aim of the homeopathy for SAR (HOMEOSAR) trial is to determine the efficacy of individualized or standardized homeopathic drug treatment compared to placebo regarding rhinitis-related quality of life in patients with SAR. METHODS: This randomized, placebo-controlled, double-blind, three-armed intervention study will be conducted at two university hospital outpatient clinics for complementary and integrative medicine in Berlin and in 12 office-based practices specializing in homeopathic treatment in Germany. A total of 270 patients with clinical symptoms of SAR and positive allergy test to birch and grass pollen will receive homeopathic anamnesis and subsequently be randomized into (a) standardized homeopathic drug treatment with Galphimia Glauca (potency D6), (b) individualized homeopathic drug treatment (D6), or (c) placebo. All three groups can receive on-demand rescue medication as needed. Treatment will consist of two consultations and daily intake of the study medication for 4 weeks during the pollen season. The primary outcome is the mean overall score of the Rhinitis Quality of Life Questionnaire (RQLQ) in weeks 3 and 4, analyzed using analysis of covariance (adjusted for baseline RQLQ overall score and study center). A closed testing procedure will be used to control the overall type I error comparing the 3 treatment groups. Secondary outcomes include the overall RQLQ and its seven domain scores, responder status (decrease in RQLQ overall score of at least 0.5 points compared to the baseline value), use of rescue medication, intensity of total and individual SAR symptoms based on visual analog scale, generic health-related quality of life, safety, utilization of health care resources and associated costs. In addition, a qualitative data analysis is planned. CONCLUSION: The results of our study will contribute to clarifying the possible therapeutic effects of homeopathic drug treatment for patients with SAR. TRIAL REGISTRATION: This study has been registered in the German Clinical Trial Registry with trial ID DRKS00018081 on June 09, 2020.

Experiences and Perceived Effects of Rosary Praying: A Qualitative Study.

The aim of this study is to explore experiences and perceived effects of the Rosary on issues around health and well-being, as well as on spirituality and religiosity. A qualitative study was conducted interviewing ten Roman Catholic German adults who regularly practiced the Rosary prayer. As a result of using a tangible prayer cord and from the rhythmic repetition of prayers, the participants described experiencing stability, peace and a contemplative connection with the Divine, with Mary as a guide and mediator before God. Praying the Rosary was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness and devotion.

Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial.

BACKGROUND: Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. METHODS: This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. DISCUSSION: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. TRIAL REGISTRATION: ClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.

Can complementary medicine enhance doctor-patient communication skills? Insights from an international medical student project.

INTRODUCTION: Communication is an essential component of patient care, and although medical schools provide training on this topic, patients and physicians alike express the need to improve their communication skills. An international medical student collaboration explored whether complementary medicine (CM) has the ability to further enhance patient-doctor communication. METHODS: Twenty-two medical students, nine mentors and two public representatives from Israel and Germany participated in this 18-month international group project. The goal was to explore CM methods that could enrich doctor-patient communication in several aspects. The group eventually chose to focus on four CM modalities, which included Chinese medicine; Mind-Body medicine; Touch therapies; Mindfulness and Herbal medicine. One workshop took place in Haifa and two workshops in Berlin, with continued inter-group work in-between. The workshops included interactive group formats such as "World Café", self-experience sessions in CM, working in small groups and delivering presentations to the entire group. RESULTS: Besides benefitting from cultural exchange and networking, students learned various aspects of CM, with a particular focus on their relevance for enriching their communication skills. The main CM aspects that were highlighted included patient characterization in the context of Chinese medicine diagnosis, mindfulness, anamnesis regarding herbal use, and a physical exam based on concepts from touch therapies. Students summarized and condensed their observations into five educational modules, which are available online: http://www.b-zion.org.il/pages_e/6683.aspx. CONCLUSION: The cultural exchange and explorative process in this international medical student collaboration led to insights regarding the potential contribution of CM to patient-doctor communication. The outcomes of this international collaboration, specifically the educational modules it produced, should be further explored by medical schools, and assessed in clinical trials.

Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial.

BACKGROUND: We aimed to investigate the effectiveness of two different forms of dry pulsatile cupping in patients with chronic low back pain (cLBP) compared to medication on demand only in a three-armed randomized trial. METHODS: 110 cLBP patients were randomized to regular pulsatile cupping with 8 treatments plus paracetamol on demand (n = 37), minimal cupping with 8 treatments plus paracetamol on demand (n = 36) or the control group with paracetamol on demand only (n = 37). Primary outcome was the pain intensity on a visual analogue scale (VAS, 0-100 mm) after 4 weeks, secondary outcome parameter included VAS pain intensity after 12 weeks, back function as measured with the 'Funktionsfragebogen Hannover Rücken' (FFbH-R) and health related quality of life questionnaire Short form 36 (SF-36) after 4 and 12 weeks. RESULTS: The mean baseline-adjusted VAS after 4 weeks was 34.9 mm (95% CI: 28.7; 41.2) for pulsatile cupping, 40.4 (34.2; 46.7) for minimal cupping and 56.1 (49.8; 62.4) for control group, resulting in statistically significant differences between pulsatile cupping vs. control (21.2 (12.2; 30.1); p < 0.001) and minimal cupping vs. control (15.7 (6.9; 24.4); p = 0.001). After 12 weeks, mean adjusted VAS difference between pulsatile cupping vs. control was 15.1 ((3.1; 27.1); p = 0.014), and between minimal cupping vs. control 11.5 ((- 0.44; 23.4); p = 0.059). Differences of VAS between pulsatile cupping and minimal cupping showed no significant differences after 4 or 12 weeks. Pulsatile cupping was also better (- 5.8 (- 11.5;-0.1); p = 0.045) compared to control for back function after 4 weeks, but not after 12 weeks (- 5.4 (- 11.7;0.8); p = 0.088), pulsatile cupping also showed better improvements on SF-36 physical component scale compared to control at 4 and 12 weeks (- 5.6 (- 9.3;-2.0); p = 0.003; - 6.1 (- 9.9;-2.4); p = 0.002). For back function and quality of life minimal cupping group was not statistically different to control after 4 and 12 weeks. Paracetamol intake did not differ between the groups (cupping vs. control (7.3 (- 0.4;15.0); p = 0.063); minimal cupping vs. control (6.3 (- 2.0;14.5); p = 0.133). CONCLUSIONS: Both forms of cupping were effective in cLBP without showing significant differences in direct comparison after four weeks, only pulsatile cupping showed effects compared to control after 12 weeks. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (identifier: NCT02090686 ).

Hypnosis in patients with perceived stress - a systematic review.

BACKGROUND: Although hypnosis and hypnotherapy have become more popular in recent years, the evidence for hypnosis to influence perceived stress is unclear. In this systematic review we searched and evaluated randomized clinical studies investigating the effect of hypnosis on perceived stress reduction and coping. METHODS: The Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Review of Effects, EMBASE, Medline, PsycINFO, PSYNDEX and PubMed were systematically screened from their inception until December 2015 for randomized controlled trials (RCTs) reporting about hypnosis or hypnotherapy for stress reduction in healthy participants. Risk of Bias was assessed according the Cochrane Collaboration recommendations. RESULTS: Nine RCTs with a total of 365 participants met the inclusion criteria and were included in this review. Most included participants were medical students, predominantly female (n = 211). Mean age of participants ranged in most studies between 20 and 25 years, in three studies the mean ages were between 30 and 42 years. Perceived stress was measured by a wide range of psychological questionnaires including Face Valid Stress Test, Stress Thermometer, and immunological data was collected. All nine included studies used explorative designs and showed a high risk of bias. Six out of nine studies reported significant positive effects of hypnosis for stress reduction in the main outcome parameter compared to control groups (3 active controls, 3 no therapy controls). Immunological outcomes were assessed in six studies, the results were inconclusive. CONCLUSIONS: Due to exploratory designs and high risk of bias, the effectiveness of hypnosis or hypnotherapy in stress reduction remains still unclear. More high quality clinical research is urgently needed.

Mindful walking in psychologically distressed individuals: a randomized controlled trial.

Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress. Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen's Perceived Stress Scale (CPSS) after 4 weeks between intervention and control. Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were -8.8 [95% CI: -10.8; -6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and -1.0 [-2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001). Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.

Efficacy, effectiveness and cost-effectiveness of acupuncture for allergic rhinitis - An overview about previous and ongoing studies.

In general, allergic rhinitis can be divided into seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). In the following sections a summary of efficacy and effectiveness studies is presented. For this narrative review we selected studies based on the following parameters: publication in English, sample size ≥30 patients, and at least 6 acupuncture sessions. Most studies aimed to evaluate the specific effects of acupuncture treatment. Only one study evaluated effectiveness and cost-effectiveness of additional acupuncture treatment. The studies which compared acupuncture with sham acupuncture always used a penetrating sham control. A medication control group was used in only two studies and one study combined acupuncture and Chinese herbal medicine. This overview shows that the trials on efficacy and on effectiveness of acupuncture are very heterogeneous. Although penetrating sham controls were used predominantly, these also varied from superficial penetration at acupuncture points to superficial insertion at non-acupuncture points. Although there is some evidence that acupuncture as additional treatment is beneficial and relatively cost-effective, there is insufficient evidence for an acupuncture specific effect in SAR. In contrast, there is some evidence that acupuncture might have specific effects in patients with PAR. However, all of the published efficacy studies are small and conclusions should be made with care. Further studies with a larger sample size are urgently needed to draw more rigorous conclusions and the results of the ongoing trials will provide us with further information within the next two years.

Moxa sticks: thermal properties and possible implications for clinical trials.

OBJECTIVES: The aim of the study was to examine the infrared spectrum and the irradiance of different types of moxa sticks to develop a basis for a moxa stick control therapy. DESIGN: An IR radiometer was used to measure the spectral infrared irradiance of seven glowing moxa sticks of different types in dependence of distance to the heat. RESULTS: All sticks investigated showed a similar spectral distribution of the emitted IR radiation with maxima of about 83.5-87.5% in the range long-wavelength IR radiation (IR-C) and with small contributions of both short wavelength IR radiation (IR-A) between 2.2% and 5.5% and of middle wavelength IR radiation (IR-B) between 9.0% and 12.1% of the total IR emission. CONCLUSIONS: Study results showed that only a small proportion of the IR radiation emitted by moxa sticks is capable of affecting subepidermal tissue. This finding indicates that thermal effects of moxa sticks are caused primarily by superficial effects on the skin. Because most heat receptors are located in the superficial skin, it thus appears impossible to separate the effects of moxa sticks from the sensation of heat. These results should be taken into account while developing placebo or sham moxibustion devices.

Acupuncture in patients with headache.

We aimed to investigate the effectiveness of acupuncture in addition to routine care in patients with primary headache (> 12 months, two or more headaches/month) compared with treatment with routine care alone and whether the effects of acupuncture differ in randomized and non-randomized patients. In a randomized controlled trial plus non-randomized cohort, patients with headache were allocated to receive up to 15 acupuncture sessions over 3 months or to a control group receiving no acupuncture during the first 3 months. Patients who did not consent to randomization received acupuncture treatment immediately. All subjects were allowed usual medical care in addition to study treatment. Number of days with headache, intensity of pain and health-related quality of life (SF-36) were assessed at baseline, and after 3 and 6 months using standardized questionnaires. Of 15,056 headache patients (mean age 44.1 +/- 12.8 years, 77% female), 1613 were randomized to acupuncture and 1569 to control, and 11,874 included in the non-randomized acupuncture group. At 3 months, the number of days with headache decreased from 8.4 +/- 7.2 (estimated mean +/-s.e.) to 4.7 +/- 5.6 in the acupuncture group and from 8.1 +/- 6.8 to 7.5 +/- 6.3 in the control group (P < 0.001). Similarly, intensity of pain and quality of life improvements were more pronounced in the acupuncture vs. control group (P < 0.001). Treatment success was maintained through 6 months. The outcome changes in non-randomized patients were similar to those in randomized patients. Acupuncture plus routine care in patients with headache was associated with marked clinical improvements compared with routine care alone.

Cost-effectiveness of acupuncture treatment in patients with headache.

The aim was to assess costs and cost-effectiveness of additional acupuncture treatment in patients with headache compared with patients receiving routine care alone. A randomized, controlled trial was conducted, including patients (> or =18 years old) with primary headache (more than 12 months, at least two headaches/month). Outcome parameters were quality of life (Short Form 36), direct and indirect costs differences during the 3-month study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. A total of 3182 patients (1613 acupuncture; 1569 controls) with headache were included (77.4% women, mean age and standard deviation 42.6 +/- 12.3; 22.6% men, 47.2 +/- 13.4). Over 3 months costs were higher in the acupuncture group compared with the control [euro857.47; 95% confidence interval 790.86, 924.07, vs. euro527.34 (459.81, 594.88), P < 0.001, mean difference: euro330.12 (235.27, 424.98)]. This cost increase was primarily due to costs of acupuncture [euro365.64 (362.19, 369.10)]. The ICER was euro11 657 per QALY gained. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment in patients with primary headache.

Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients with osteoarthritis of the knee.

OBJECTIVE: The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. DESIGN: Three-armed, randomised, controlled multicentre trial with 1-year follow-up. SETTING: Twenty-eight outpatient centres in Germany. INTERVENTIONS: A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture). OUTCOME: Participating trial physicians and interventions. RESULTS: Forty-seven physicians specialised in acupuncture (mean age 43+/-8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was 350 h (range 140-2508). The total number of needles used was 17.4+/-4.8 in the acupuncture group compared to 12.9+/-3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing). CONCLUSIONS: Our documentation of the trial interventions shows that semi-standardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

Homeopathic arnica therapy in patients receiving knee surgery: results of three randomised double-blind trials.

OBJECTIVES: We investigated the effectiveness of homeopathic Arnica montana on postoperative swelling and pain after arthroscopy (ART), artificial knee joint implantation (AKJ), and cruciate ligament reconstruction (CLR). DESIGN: Three randomised, placebo-controlled, double-blind, sequential clinical trials. SETTING: Single primary care unit specialised in arthroscopic knee surgery. PARTICIPANTS: Patients suffering from a knee disease that necessitated arthroscopic surgery. INTERVENTIONS: Prior to surgery, patients were given 1 x 5 globules of the homeopathic dilution 30x (a homeopathic dilution of 1:10(30)) of arnica or placebo. Following surgery, 3 x 5 globules were administered daily. PRIMARY OUTCOME MEASURES: The primary outcome parameter was difference in knee circumference, defined as the ratio of circumference on day 1 (ART) or day 2 (CLR and AKJ) after surgery to baseline circumference. RESULTS: A total of 227 patients were enrolled in the ART (33% female, mean age 43.2 years;), 35 in the AKJ (71% female, 67.0 years), and 57 in the CLR trial (26% female; 33.4 years). The percentage of change in knee circumference was similar between the treatment groups for ART (group difference Delta=-0.25%, 95% CI: -0.85 to 0.41, p=0.204) and AKJ (Delta=-1.68%, -4.24 to 0.77, p=0.184) and showed homeopathic arnica to have a beneficial effect compared to placebo in CLR (Delta=-1.80%, -3.30 to -0.30, p=0.019). CONCLUSIONS: In all three trials, patients receiving homeopathic arnica showed a trend towards less postoperative swelling compared to patients receiving placebo. However, a significant difference in favour of homeopathic arnica was only found in the CLR trial.

[Acupuncture. Clinical studies on efficacy and effectiveness in patients with chronic pain]. / Akupunktur: Klinische Studien zur Wirksamkeit bei Patienten mit chronischen Schmerzen.

In Germany, acupuncture is one of the most frequently used complementary and alternative therapies. In the year 2000, we initiated three large projects in co-operation with statutory health insurance companies to assess the effectiveness, safety and costs of acupuncture in patients with chronic headache, low back pain and pain due to osteoarthritis. Our findings showed that acupuncture was more effective than conventional standard treatment, treatment without acupuncture or a waiting list control. A significant difference between acupuncture and sham acupuncture was only seen for arthritis of the knee; for the other diagnoses, both forms of acupuncture showed similar effects. Whether the effects of acupuncture are due primarily to specific or unspecific mechanisms appears to depend on the diagnosis and should be investigated in further studies.

Acupuncture in patients with osteoarthritis of the knee: a randomised trial.

BACKGROUND: Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee. METHODS: Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat. RESULTS: 294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08). INTERPRETATION: After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.

Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trial.

BACKGROUND: Patients with allergic rhinitis (AR) increasingly use complementary medicine. The aim of this study was to determine whether traditional Chinese therapy is efficacious in patients suffering from seasonal AR. METHODS: Fifty-two patients between the ages of 20 and 58 who had typical symptoms of seasonal AR were assigned randomly and in a blinded fashion to (i) an active treatment group which received a semi-standardized treatment of acupuncture and Chinese herbal medicine, and (ii) a control group which received acupuncture applied to non-acupuncture points in addition to a non-specific Chinese herbal formula. All patients received acupuncture treatment once per week and the respective Chinese herbal formula as a decoction three times daily for a total of 6 weeks. Assessments were performed before, during, and 1 week after treatment. The change in severity of hay fever symptoms was the primary outcome measured on a visual analogue scale (VAS). RESULTS: Compared with patients in the control group, patients in the active treatment group showed a significant after-treatment improvement on the VAS (P = 0.006) and Rhinitis Quality of Life Questionnaire (P = 0.015). Improvement on the Global Assessment of Change Scale was noted in 85% of active treatment group participants vs 40% in the control group (P = 0.048). No differences between the two groups could be detected with the Allergic Rhinitis Symptom Questionnaire. Both treatments were well-tolerated. CONCLUSIONS: The results of this study suggest that traditional Chinese therapy may be an efficacious and safe treatment option for patients with seasonal AR.

An overview of two Cochrane systematic reviews of complementary treatments for chronic asthma: acupuncture and homeopathy.

BACKGROUND: Acupuncture and homeopathy are commonly used complementary treatments for chronic asthma. This review summarizes two recently updated Cochrane systematic reviews that assess the safety and efficacy of homeopathy or acupuncture in individuals with chronic stable asthma. INCLUSION CRITERIA: Only randomized-controlled trials were considered for inclusion. Statistical aggregation of the data was undertaken where possible. SEARCH STRATEGY: Searches for both reviews were done with the assistance of the Cochrane Airways Group, and through electronic alerts. RESULTS: ACUPUNCTURE: 11 studies with 324 participants met the inclusion criteria. Trial reporting was poor, and the trial quality was deemed inadequate to generalize the findings. There was variation in the type of active and sham acupunctures, the outcomes assessed and the time points measured. The points used in the sham arm of some studies are used for the treatment of asthma according to traditional Chinese medicine. Two studies used individualized treatment strategies, and one study used a combination strategy of formula acupuncture with the addition of individualized points. No statistically significant or clinically relevant effects were found for acupuncture compared with sham acupuncture. When data from two small studies were pooled, no difference in lung function was observed (post-treatment FEV1): standardized mean difference 0.12, 95% confidence interval 0.31 to 0.55). CONCLUSION: ACUPUNCTURE: There is not enough evidence to recommend the use of acupuncture in the treatment of asthma. Further research needs to be undertaken, and this should take into account the different types of acupuncture practiced. RESULTS: HOMEOPATHY: Six trials with a total of 556 people were included in the review. These trials were all placebo-controlled and double-blind, but were of variable quality. Standardized treatments in these trials are unlikely to represent common homeopathic practice where treatment tends to be individualized. The results of the studies are conflicting in terms of effects on lung function. There has been only a limited attempt to measure a "package of care" effect (i.e. the effect of the medication as well as the consultation, which is considered a vital part of individualized homeopathic practice). CONCLUSION: HOMEOPATHY: There is not enough evidence to reliably assess the possible role of homeopathy in the treatment of asthma. Further studies could assess whether individuals respond to a "package of care" rather than the homeopathic intervention alone.