Evaluation of Impact on Health-Related Quality of Life and Cost Effectiveness of Traditional Chinese Medicine: A Systematic Review of Randomized Clinical Trials

Abstract

Background:

Traditional Chinese Medicine (TCM), an important part of health care in China and with increased popularity worldwide, has received extensive attention from governments at all levels. With the current emphasis on clinical efficacy and cost-effectiveness, TCM, as indeed do all other treatments, requires rigorous evidence to be considered in reimbursement decision-making. Nevertheless, despite the fact that TCM treatment has always been considered to possess the advantage of improving the health-related quality of life (HRQOL) of patients, there is a lack of systematic study about available evidence to assess the impact of TCM treatments on HRQOL of patients.

Objectives:

The current study aimed to perform a review of available literature to evaluate whether sufficient evidence existed to allow an assessment of the impact on HRQOL and cost effectiveness of TCM treatments. This information would support a recommendation for wider use of TCM in the clinical setting as well as its consideration for reimbursement.

Methods:

A structured search was performed using data sources including MEDLINE,^® Cumulative Index for Allied Health and Nursing (CINAHL), PubMed, Cochrane database, EBSCO, SciSearch, Embase, and Google Scholar from 2000 to 2010. The search was supplemented with manual search after relevant articles were retrieved.

Results:

After culling, a total 31 articles covering a range of TCM therapies applied to a variety of conditions were retrieved. The measurement tools used in these studies to assess impact in patient's HRQOL were mainly SF-36-based scales, but the results of HRQOL/patient preference studies were inconsistent and inconclusive. Of the 10 articles of cost-effectiveness evaluation of TCM treatments, the majority reported that TCM treatments resulted in better outcomes at a higher cost, but the incremental cost-effectiveness ratio was below the usually recommended thresholds. The overall results showed acupuncture and t'ai chi to be the most studied TCM-related therapies.

Conclusions:

The current review showed that there is a relative lack of cost-effectiveness research in TCM. For those few empirical research available, the major emphasis is for acupuncture or t'ai chi showing the acceptance of these branches of TCM that are better understood by the scientific community. The current results also showed the need for studies with better designs and longer duration to ascertain the actual impact of TCM on patients' HRQOL as well as a need for a generic HRQOL instrument that is specific for TCM.

Introduction

T raditional Chinese Medicine (TCM) as practiced in China and several Asian countries including Korea, Japan, and many Southeast Asian countries can be viewed as a major component of complementary and alternative medicine (CAM). Globally, treatment with TCM has been gaining increasing popularity over the last several decades. TCM is the one of the most valuable treasures in human civilization, and its practice is enriched continuously from the long practical experience in maintaining wellness and treating diseases.^1
–3 In fact, acupuncture and moxibustion have been inscribed in 2010 on the Representative List of the Intangible Cultural Heritage of Humanity by United Nations Educational, Scientific and Cultural Organization.

Due to its long history and contribution to human health care, the World Health Organization (WHO) Resolution on Traditional Medicine WHA 62.13 passed by the World Health Assembly in May 2009 urged all member states to make policies on integration of traditional medicine into the national health care system.⁴ In order to provide the policy and technical support to the member states for this purpose, WHO has organized many workshops on health service delivery and monitoring system of traditional medicine.⁵ Currently, China is one of the few countries that have fully integrated traditional medicine into the national health care system.⁶ However, with the increased emphasis on efficiency and clinical efficacy under the current environment of resource constraints and increased demands for health care, TCM, as indeed do all other treatments, should be required to have evidence to verify their cost-effectiveness during reimbursement decisions, whether from public finance or private health insurance. This requirement is becoming even more pertinent and pressing during the medical reform in China today. One of the outcomes of the medical reform that started in 2009 was the establishment of a national formulary to be subsidized by the government. The formulary contains a substantial number of TCM products and hence the assessment of their cost-effectiveness would be an important consideration for their inclusion.

Besides cost-effectiveness information, the use of patients' reported outcome assessment for assessing efficacy of TCM is logical as patient preference or health-related quality of life (HRQOL) has become the second standard for formulary decisions,⁷ and theoretically congruent with the holistic disease management concept of TCM.

In this article, the authors review published studies reporting cost effectiveness and patient preference or HRQOL analyses of acupuncture, t'ai chi, qigong, therapeutic massage, integrative medicine (which combines conventional Western medicine with alternative or complementary treatments), in the treatment of various diseases with the aim to describe and evaluate the current development of research on cost effectiveness and HRQOL evaluation of TCM. This information will allow an assessment on the adequacy of current approaches in further evaluating the cost effectiveness of TCM and contribute to the eventual development of standards for such evaluation for formulary inclusion and reimbursement decision process.

Literature Retrieval and Assessment

Data sources

A literature search was conducted to identify published articles of patient preference, HRQOL studies and economic evaluation in TCM using 7 electronic databases including MEDLINE,^® Cumulative Index for Allied Health and Nursing (CINAHL), Cochrane database, EBSCO, SciSearch, Embase, and Google Scholar from January 1, 2000 to October 2010.

Review methods

The literature search was performed using combinations of the following terms: complementary medicine, alternative medicine, integrative medicine, QALY, cost-effectiveness, pharmacoeconomic, economic, utility, cost-utility, quality of life, Traditional Chinese Medicine, Massage, Tai chi, herbal medicine, acupuncture, Skin scraping, Qi gong, herbal remedy, bloodletting therapy, and Fire Cupping.

Study inclusion criteria

Criteria for inclusion of articles required that they (1) were published in a peer-reviewed English language journal between 2000 and 2010; (2) were cited in medical, nursing, pharmacy, or psychologic literature; (3) were designed to test the cost-effectiveness and HRQOL of TCM (including TCM therapies and Chinese herbal medicine treatments) and included the use of a scale instrument; (4) used a randomized controlled trial (RCT) research design; and (5) were available as full text.

Data abstraction

Abstracts of potential articles were read and full articles were retrieved after this preliminary process. The retrieved articles were examined, and when appropriate, the results were entered into a table according to criteria established by the authors for categorization and evaluation of the studies and outcomes. The reference sections of the included articles were scanned for any additional articles that may meet the inclusion criteria. Any uncertainty was resolved through consensus among the authors.

Results

Search results and culling process

The search unveiled 164 original articles. Most failed to meet several of the inclusion criteria, but only the first reason for exclusion identified was recorded (Fig. 1). These were as follows: not TCM (n=9), not RCT in design (n=53), not HRQOL research (n=12), were reviews or commentaries (n=48), or not available as full text (n=1).

FIG. 1.

Literature search process. HRQOL, health-related quality of life; TCM, Traditional Chinese Medicine; CAM, complementary and alternative medicine.

The 41 remaining full-text articles were examined and a further 11 articles^{8

–16} were excluded because one did not include research on TCM⁸; 2 did not have HRQOL evaluation,^9,10 6 were not trial-based research,^11

–16 and 2 were publications addressing different aspects of the same study.^17,18

Furthermore, through hand-searching the full-text articles, four additional articles were retrieved, but after careful verification, three were eliminated as one study simulated and predicted the cost effectiveness of acupuncture on patients through modeling,¹⁹ and two studies^20,21 used a combination of TCM treatment (e.g., acupuncture or massage) plus other therapies (e.g., relaxation training or Alexander technique lessons, etc.). The search and culling process is detailed as per Figure 1.

Types of TCM evaluated

TCM treatments assessed by the studies included 14 on t'ai chi exercise,^{25

–39} 10 on acupuncture,^{22,23,43

–50} 2 on massage,^24,51 1 on Kuntai capsule (a traditional Chinese patent medicine),⁵² 1 on naturopathic, 2 on qigong, ^40,41 and 1 on integrative medicine.⁴²

Condition treated by TCM

Many medical conditions were touched upon in these studies. With the exception of two studies on the outcome of doing t'ai chi exercises with no mention of disease being targeted,^28,30 the conditions of other studies involved chronic pain,^{22,34,42,46,47,48,49,50} chronic sinusitis,²³ end-stage renal disease,²⁴ osteoporosis,²⁵ frail institutionalized elderly,²⁶ idiopathic Parkinson's disease,²⁷ type 2 diabetes,^29,33 vaccine-stimulated levels of cell-mediated immunity to varicella zoster virus infection,³² traumatic brain injury,³⁵ rheumatoid arthritis,³⁶ HIV/AIDS,³⁷ breast cancer,^38,50 mild essential hypertension,⁴⁰ depression in elderly with chronic physical illnesses,⁴¹ allergic rhinitis,⁴³ dysmenorrhea,⁴⁴ osteoarthritis of the knee or hip,^31,39,45 constipation,⁵¹ and menopausal syndrome.⁵²

HRQOL instruments used

In these 31 studies, patients' preference/HRQOL was one of the outcomes being measured. The main measurement tool was SF-36; 13 of the studies used different versions of SF-36,^{22

–25,29,30,32

–36,40,42,43

–48,50} of which 3 studies^22,23,36 used SF-36 in combination with EQ-5D. SF-12 was used in three studies,^26,28,31 and the WHO Quality of Life Questionnaire (Brief ) (QOL-BREF)⁴¹ was used in one study. EQ-5D was used in three studies,^49,51,52 of which one study⁴⁹ was in combination with SF-6D. There were many disease-specific scales used to assess the Patients preference/HRQOL alone^27,37,38,39 or in combination with other scales,^22,31,35 such as Northwick Park Neck Pain Questionnaire (NPQ), Arthritis Impact Measurement Scales (AIMS), Parkinson's Disease Questionnaire (PDQ-39), Depression Anxiety Stress Scale (DASS-21), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT–F), Abnormal Involuntary Movement Scale (AIMS).

Evaluation of study results

All 31 articles evaluated the impact of TCM treatment on Patient's Preference/HRQOL. In addition, 10 of these studies further evaluate the cost effectiveness of TCM therapies using cost-utility analysis to compare the cost per quality-adjusted life years (QALY) between treatment and control groups. A summary of the studies reporting impact of TCM treatments on HRQOL, and cost-effectiveness of TCM treatments is presented in Tables 1 and 2, respectively.

Table 1.

Patient Preference and HRQOL Studies of TCM

Source	Subjects	Condition	Exercise duration	Evaluation tool of HRQOL	Treatment group	Control group	Reported outcomes
Liang Z, et al. 2011²²	178 patients	Chronic neck pain	3 weeks	NPQ, VAS, SF-36	Acupuncture treatment	Placebo acupuncture on the sham points	The scores of NPQ, VAS, and SF-36 were improved after the intervention and during 3 months and follow-up (p<0.0). The patients in the study group had significantly better outcomes in NPQ, VAS, and in the VT, SF and MH domains of SF-36 (p<0.05).
Rössberg E, et al., 2005²³	65 patients	Chronic sinusitis	12 weeks	SF-36, VAS	Acupuncture treatment	Sham acupuncture	Only a nonsignificant difference in symptom score change over 4 and 12 weeks was shown between conventional medication, sham acupuncture, and TCA on any of the SF-36 scales.
Tsay SL, et al., 2003²⁴	98 patients	End-stage renal disease	4 weeks	SF-36	Acupressure	Usual care or a sham acupressure	There was significant improvement in the adjusted means for, BP, VT, SF, role function, total physical component, and total mental component in the acupressure group compared with the control group. The sham acupressure group only showed some but non-significant improvements compared with the control group.
Chyu MC, et al., 2010²⁵	61 elderly females Patients (mean age 65 years)	Osteopenia	24 weeks	SF-36	T'ai chi	Elemental calcium+vitamin D and maintain regular diet	Compared with the control group, after 24 weeks of intervention subjects in the tai chi group reported a significant improvement in general health, VT and BP than those in the control group. However, there was no significant difference in other domains of quality of life including PF, RP, SF, RE, MH, PCS, and MCS.
Deschamps A, et al., 2009²⁶	52 participants (58% women) age 65–94	Frail institutionalized elderly	24 weeks	SF-12	T'ai chi exercises	Cognition	PCS improved from 33.6±6.7 to 51±4.8 in the TC group and from 30.6±9.9 to 45.1±10.2 in the CA group (p<0.001). MCS of SF-12 (p<0.001), FES (p<0.001), and exercise self-efficacy (p<0.01) were enhanced significantly in both groups. Adapted CA programs and T'ai chi were both efficient in improving HRQOL of frail elderly.
Hackney ME, et al., 2009²⁷	75 participants >40 years of age	Idiopathic Parkinson disease	12 weeks	PDQ-39	T'ai chi	No Intervention	There were no significant differences between pre and post in Waltz/Foxtrot, t'ai chi or No Intervention.
Lee LY, et al., 2009²⁸	139 residents >65 years of age	Not mentioned	26 weeks	SF-12	T'ai chi program	Usual daily activities	A significant difference in the change of the composite effect of the physical and mental components of HRQOL between the two groups across the 26-week study period (p<0.05). But the significant group difference across time was mainly attributable to the composite rather than the individual effect of the two dependent variables.
Lam P, et al., 2008²⁹	43 patients ≥30 years of age	Type 2 diabetes	6 months	SF-36	T'ai chi	wait list	There was a significant improvement in three of the subscales of the SF-36, role due to physical function (p=0.04), social function (p=0.024), and general health (p=0.044) with t'ai chi from baseline to follow-up but the difference between the two groups was not significant.
Ho TJ, et al., 2007³⁰	140 seniors (77 males and 63 females, aged 40–70 years)	Not mentioned	Have been practicing TCC for at least 1 year	SF-36	T'ai chi chuan (TCC)	general population	TCC group showed significantly higher QOL scores than the control group in each of the 8 domains of SF-36 with the exception of the bodily pain scales. Using multiple linear regression adjusted for covariates, TCC group had significantly higher scores in physical functioning, physical roles, general health, vitality, and social-functioning scales than the control group. The scores in vitality and social-functioning domains of the TCC group remained unchanged or even improved with increased age.
Fransen M, et al., 2007³¹	152 older persons	Chronic symptomatic hip or knee Osteoarthritis	24 weeks	SF-12 DASS21	Hydrotherapy or t'ai chi	Orthopedic surgery Waiting	The hydrotherapy group improved significantly in the SF-12 PCS, subscales, but t'ai chi classes did not result in any significant improvements in these objective measures.
Irwin MR, et al., 2007³²	112 healthy older adults aged 59 to 86	vaccine-stimulated levels of CMI to VZV	25 weeks	SF-36	T'ai chi	Health education	The t'ai chi group showed higher levels of VZV-CMI than the health education group (p<0.05), with a significant rate of increase (p<0.001) that was nearly twice that found in the health education group. The t'ai chi group showed significant improvements in SF-36 scores for physical functioning, bodily pain, vitality, and mental health.
Tsang T, et al., 2007³³	38 older adults	Type 2 diabetes	16 weeks.	SF-36	T'ai chi	Sham exercise	A significant effect was observed in Social Function subscale score of SF-36, with t'ai chi improving their score by 6.6 and controls worsening by 14.2. But this difference was attenuated and no longer significant after change of total body fat and physical activity levels. None of the other domains measured in SF-36 score were significantly changed after the intervention over time or between groups.
Abbott RB, et al., 2007³⁴	47 participants	Tension Headaches	15 weeks	SF-36	T'ai chi	wait-list	Statistically significant (p<0.05) improvements in the intervention group were present for the SF-36 pain, energy/fatigue, SF, emotional well-being, and mental health summary scores. T'ai chi practice was effective in reducing headache impact and also effective in improving perceptions of some aspects of physical and mental health.
Gemmell C, et al. 2006³⁵	18 patients	Traumatic brain injury	6 weeks	SF-36, RSES, VAMS	T'ai chi	Waiting list	Results for SF-36 and RSES were not significantly different from the wait-list group, except at follow-up where the t'ai chi group (M=19.04, SD=26.22) reported that usual-role activities were significantly less impaired because of emotional problems than the waiting-list group (M=t(1, 14)=3.217, p<0.007).
Wang C, et al., 2005³⁶	20 patients	Rheumatoid arthritis	12 weeks	EQ-5D SF-36	T'ai chi	Stretching and Wellness Education	T'ai chi group improved in all 25 secondary outcomes, while the control group improved in only some. But significant improvement only on the vitality subscale of SF-36 (p=0.01).
Galantino ML, et al., 2005³⁷	38 Men ages of from 20 to 60years	HIV/AIDS	8 weeks	MOS-HIV	T'ai chi	normal daily activities	The MOS-HIV showed a significant difference on the subscale of overall health (p=0.04).
Mustian KM, et al., 2004³⁸	21 women patients	Breast cancer	12 weeks	FACIT–F	T'ai chi	Psychosocial support therapy	There was a statistically significant difference between the two treatment groups in terms of improvement in self-esteem and HR-QOL at the week-12 assessment. But there were not any improvements but declines in PST group
Hartman CA, et al., 2000³⁹	33 participants (mean age 68)	Osteoarthritis	12 weeks	AIMS	T'ai chi	Usual physical activities and routine care	Several outcomes approached statistical significance (p<0.10) and may warrant further interpretation. The pre–post effect sizes for all outcomes indicated that the t'ai chi group experienced greater physical and psychologic improvements The t'ai chi participants experienced moderate reductions in pain and mood disturbance, while those in the control group reported a small increase in pain.
Cheung BM, et al., 2005⁴⁰	88 patients	mild essential hypertension	16 weeks	SF-36	Qigong	Conventional exercise	General health, bodily pain, social functioning, and depression also improved in both groups, and there were no significant differences including scores in the SF-36. Guolin qigong and conventional exercise have similar effects on blood pressure in patients with mild hypertension.
Tsang HW, et al., 2003⁴¹	50 geriatric patients	Depression in elderly with chronic physical illnesses	12 weeks	WHOQOL-BREF[HK]	Qigong	Traditional remedial rehabilitation activities	Qigong group participants expressed improvement in physical health, ADL, psychologic health, social relationship, and health in general. But results were not significant in the generalization measures, it may be due to small effect size, small sample size, and short intervention period.
Sundberg T, et al., 2009⁴²	80 patients	Back and neck pain	16 weeks	SF-36	Integrative medicine (IM)	Conventional primary care	SF-36 domain showed a clinically relevant difference between groups by a small distribution-based effect size, which was in favor of IM.

HRQOL, health-related quality of life; NPQ, Northwick Park Neck Pain Questionnaire; VAS, Visual Analogue Scales; VT, Vitality; SF, Social functioning; TCA, traditional Chinese acupuncture; RP, role physical; BP, body pain; PF, physical function; RE, role-emotional; MH, mental health. RSES, Rosenberg Self-Esteem Scale; PCS, physical component summary, VZV, varicella zoster virus ; VZV-CMI, varicella zoster virus cell-mediated immunity; FACIT–F, Functional assessment of chronic illness therapy–fatigue ; SF-36, Medical Outcome Scale Short Form 36; TCC, t'ai chi chuan, a Westernized, standardized version of t'ai chi; MOS-HIV, Medical Outcome Study-HIV Health Survey; FES, Falls Efficacy Scale; MCS, mental component score; AIMS, Arthritis Impact Measurement Scales; PDQ-39, Parkinson's Disease Questionnaire; DASS-21, Depression Anxiety Stress Scale; WHOQOL-BREF[HK], World Health Organization Quality of Life Questionnaire (Brief ) Hong Kong; ADL, activities of daily living; SD, standard deviation.

Table 2.

Cost Effectiveness Studies of Traditional Chinese Medicine

Source	Subjects	Condition	Perspective	Exercise duration	Evaluation tool of HRQOL	Treatment group	Control group	Reported outcomes
Witt CM, et al., 2009⁴³	981 patients (mean age 43.2 years)	Allergic rhinitis	Societal	3 months	SF-36	Additional acupuncture treatment based on usual care	Usual care	For patients with allergic rhinitis, acupuncture compared with routine care alone was associated with a better QALY as well as higher costs. The overall ICER, adjusted for baseline values, was €17,377 per QALY and proved robust in additional sensitivity analyses. When a threshold of €50,000 per QALY gained was adopted, acupuncture was therefore relatively cost effective. Acupuncture was more cost effective for women than for men (ICER€10,155 vs. €44,871).
Witt CM, et al., 2008⁴⁴	649 women (mean age 36.1±7.1 years)	Dysmenorrhea	Societal	6 months	SF-36	Immediate acupuncture treatment	Delayed acupuncture treatment	Acupuncture was associated with additional costs but was highly cost effective (overall ICER €3,011 per QALY) according to international threshold values of £30,000 or $50,000 per QALY gained. Acupuncture should be considered as a viable option in the management of these patients.
Reinhold T, et al., 2008⁴⁵	489 patients	Osteoarthritis of the knee or hip	Societal	3 months	SF-36	Acupuncture treatment	Routine care	ICER was €17,845 per QALY gained. The degree of cost effectiveness was influenced by gender, with female patients achieving a better CER than men. Acupuncture was a cost-effective treatment strategy in patients with chronic osteoarthritis pain.
Witt CM, et al., 2008⁴⁶	3182 patients (77.4% women, mean age 42.6±12.3; 22.6% men, mean age 47.2±13.4)	Headache	Societal	3 months	SF-36	Immediate acupuncture treatment	Delay acupuncture treatment	Costs were higher in the acupuncture group compared with the control (€857.47 vs. €527.34, mean difference: €330.12). The ICER was €11,657 per QALY gained. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment in patients with primary headache.
Willich SN et al., 2006⁴⁷	3451 patients (31% men, age 53.5±12.9 years; 69% women, 49.2±12.7 years)	Chronic neck pain	Societal	3 months	SF-36	Additional acupuncture treatment based on usual care	Usual care	Acupuncture treatment was associated with significantly higher costs compared to routine care (€925.53±1,551.06 vs. €648.06±1,459.13; mean difference: €277.47). But the ICER was €12,469 per QALY gained and proved robust in additional sensitivity analyses. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment strategy in patients with chronic neck pain.
Witt CM et al., 2006⁴⁸	11,630 patients (mean age 52.9 years)	Chronic low- back pain	Societal	6 months	SF-36	Immediate acupuncture	Delayed acupuncture	The incremental cost-effectiveness ratio was €10,526 per QALY. Acupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost effective.
Thomas KJ et al., 2005⁴⁹	241 patients	Chronic low- back pain	Patient	24 months	SF-6D and EQ-5D	Acupuncture treatment	Usual care	The estimated cost per QALY was £4241 using the SF-6D scoring algorithm based on responses to the SF-36, and £3598 using the EQ-5D health status instrument. The NHS costs were greater in the acupuncture care group than in the usual-care group. However, the additional resource use was less than the costs of acupuncture treatment itself, suggesting that some usual-care resource use was offset.
Vickers AJ et al., 2004⁵⁰	401 patients	Chronic headache disorder, predominantly migraine	NHS and societal perspective	1 year	SF-36	Acupuncture treatment	Usual care	The incremental cost-effectiveness was estimated to be £9180 per QALY gained seems to be better value for money than several interventions that have been recommended by NICE.
Lämås K, et al., 2010⁵¹	60 participants	Constipation	Societal	9 weeks	EQ-5D	Abdominal massage	Using laxatives	Linear regression analysis showed that HR-QOL was statistically significantly increased after 8 weeks of abdominal massage. The cost–utility analysis shows that both implementation scenarios were initially expensive. But with sufficient improvement continue with abdominal massage, the cost per QALY will decrease. In the long run, the costs will drop to €28,000/QALY for professional massage and to €8300/QALY for self-massage. This implies that both scenarios could be cost-effective in the long-term if thresholds for acceptable cost effectiveness are about €50,000/QALY.
Zhou LL, et al., 2009⁵²	57 female patients	Menopausal syndrome in the early postmenopausal stage	Patient	1 year	Rating scale	Kuntai capsule (traditional Chinese patent medicine)	Premarin (conjugated estrogens)	The QOL obviously increased in both the groups, and Kuntai required longer treatment time than conjugated estrogens (Premarin) to take effect. The CUR of conjugated estrogens and Kuntai were 13,581.45 yuan/QALY and 25,105.12 yuan/QALY, respectively. Both incremental cost analysis and sensitivity analysis showed that Kuntai was more costly than conjugated estrogens.

HRQOL, health-related quality of life; NHS, National Health Service; LBP, low-back pain; NICE, National Institute for Health and Clinical Excellence; SF-36, Short Form 36; QALY, quality-adjusted life year; ICER, incremental cost-effectiveness ratio; 1 €, US $1.27; 1 yuan, US $ 0.146; SF-6D, Short Form 6D; EQ-5D, EuroQol 5 Dimension; CUR, cost–utility ratio.

Impact of TCM on patient's preference/ HRQOL

There were 21 studies that evaluated the impact of TCM treatment on patient's preference/ HRQOL. Some studies showed significant differences in patient preference/HRQOL between trial and control groups,^{22,24,26,30,32,34,37,38} but others detected no significant differences ^{23,27,31,35,40,41} or significant differences only in part of domains in the HRQOL instruments.^{25,28,29,36,39,42} Furthermore, some significant difference was attenuated and was no longer significant after controlling of some factors such as body fat or physical activity levels.³³

While the study by Liang et al.²² evaluated the HRQOL outcomes of acupuncture for patients with chronic neck pain and the study by Rössberg et al.²³ was for patients with chronic sinusitis, they obtained completely different results. Significant improvements of HRQOL scores were observed for acupuncture in neck pain but there was only a nonsignificant difference between the conventional medicine and the acupuncture groups for chronic sinusitis.

There are two studies in patients with type 2 diabetes,^29,33 where the efficacy of the “Tai Chi for Diabetes” forms for patients was tested. Both studies applied SF-36 to evaluate HRQOL/patient preference. In the study by Lam et al.,²⁹ significant improvement was found in three of the subscales of SF-36 (Physical Function, Social Function, and General Health) between baseline and follow-up, with the t'ai chi group, but nonsignificant differences between the t'ai chi group and control group. In the study Tsang et al., however,³⁰ a significant effect was observed only in the Social Function subscale score of SF-36, but this became nonsignificant after change in social function was adjusted for percentage of body fat and physical activity levels ( f=3.7, p=0.07).

In the trial by Mustian et al.,³⁸ 21 breast cancer survivors were randomly assigned to receive t'ai chi (TC) exercise or psychosocial support (PST). HRQOL of patients was assessed using FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue), and self-esteem was assessed via the Rosenberg Self-Esteem Scale. The TC group reported improvements in HRQOL and self-esteem at 6 and 12 weeks, and significant improvement at the week-12 assessment, while the PST group reported declines in HRQOL and self-esteem at both time points. The study by Galantino et al. reached similar results in the evaluation of the improvement of t'ai chi treatment for HIV/AIDS.³⁷ But it should be noted that disease-specific scales were used to evaluate the HRQOL and self-esteem (MOS-HIV, FACIT-F) but not a generic scale in these two studies.

The study by Sundberg et al. assessed the integrative medicine (IM) treatment of back and neck pain compared with conventional care from the perspective of Swedish primary health care.⁴² This is the only study about Chinese medicine in this literature search. They observed that the largest clinical differences displayed in SF-36 quality of life domain were of vitality and the decreased use of prescription and nonprescription analgesics. Thus, the authors concluded that IM would need to be considered in primary health care reform.

Cost effectiveness studies of TCM

A total of 10 articles were included for review for cost-effectiveness analysis on TCM treatment. All of them used cost utility analysis (CUA) to compare between treatment and control groups. In evaluation of cost effectiveness with CUA, the authors are interested in comparing the additional cost for the extra gain in outcomes (utility gained in this case) provided by TCM treatment. Of these 10 studies, 8 were evaluating the cost effectiveness of acupuncture. This shows the popularity of acupuncture, but on the other hand it also shows a lack of cost effectiveness research in other types of TCM practice.

Similar to the articles evaluating impact of TCM treatment on Patient's Preference/HRQOL research, the studies of cost-effectiveness of TCM treatments also showed grossly different results.

The three studies by Witt et al.^44,46,48 researched the effects of different treatment times of acupuncture and concluded that immediate acupuncture treatment was associated with additional costs but was highly cost effective for women with dysmenorrhea as well as in patients with headache and chronic low-back pain.

The study by Reinhold et al. compared the outcomes of acupuncture treatment in patients with osteoarthritis of the knee or hip with routine care.⁴⁵ They obtained interesting results showing that the degree of cost effectiveness was influenced by gender, with female patients achieving a better cost-effectiveness ratio than men.

The study by Thomas et al. compared the outcome of 10 individualized acupuncture treatments for patients with chronic low back pain with usual care using two instruments to evaluate the utility.⁴⁹ The estimated cost per QALY was £4241 using SF-6D, and £3598 using EQ-5D. Although the costs were greater in the acupuncture care group, the additional resource use in National Health Service (NHS) was less than the costs of acupuncture treatment itself in this study. Thus, they concluded that acupuncture by general practitioners, as well as by specialist physiotherapists, appears to be reasonably cost effective compared with usual care.

The study by Zhou et al. compared use of the Kuntai capsule (a traditional Chinese patent medicine) for female patients with menopausal syndrome in the early postmenopausal stage with conjugated estrogens (Premarin).⁵² This was the only study to compare between the pharmacologic forms of TCM. Both incremental cost analysis and sensitivity analysis showed Kuntai to be more costly.

Overall, most of these studies showed TCM therapies to be associated with additional and sometimes significantly higher costs compared with the control group. However, the TCM intervention (in these cases, acupuncture or massage) would appear to be cost effective according to international threshold values of £30,000 or $50,000 per QALY gained, and the results were proven to be robust in sensitivity analyses. This demonstrates that accepted pharmacoeconomic techniques can be used in the assessment of TCM as well as providing useful information for reimbursement decision-making.

Discussion

After an extensive search of the literature, 31 articles meeting the inclusion criteria were retrieved, with 10 of these articles further evaluating the cost-effectiveness of TCM therapies basing on Patient Preference/HRQOL research. This demonstrates a comparative lack of research efforts on HRQOL and cost-effectiveness analysis in TCM compared with other branches of medical practice.

Furthermore, among the relatively few research articles retrieved, the majority was for the assessment of acupuncture or other types of TCM-related exercises such as t'ai chi. For herbal medicine, which is a vital component of TCM, there was only one article on cost-effectiveness analysis, implying that pharmacologic therapies for TCM are much less well accepted and understood by conventional medical practitioners.⁵³ In view of the growing popularity of TCM and related practices and its growing sales volume internationally, there is definitely an urgent need for the scientific community to expend more efforts in this area.

However, for those branches of TCM such as acupuncture that are better accepted and understood by conventional medical practitioners, it is encouraging to observe that they are applied in a wide varieties of diseases and conditions. This indicates that there is a growing belief that TCM can be effective in a wide range of diseases and conditions that are mainly the domain of conventional medicine.

For the articles reporting patient preference/HRQOL evaluation in TCM, the results were seldom positive, with most reporting either no significant differences or the significant differences were not robust through the sensitivity analysis. This is a disappointing finding because the treatment philosophy of TCM aims for holistic management of the whole being and hence HRQOL, and to a lesser extent patient preference would be a logical outcome indicator in assessing the effectiveness of TCM.

Nevertheless, besides the obvious reason that the treatment chosen may not be effective, there could be several explanations for the lack of positive outcomes with the use of HRQOL/patient preference measures in assessing effectiveness of TCM.

First and foremost, the mechanisms of the benefits from TCM for any of the conditions studied may not be well understood by many researchers. Since most TCM treatments supposedly are intended to produce holistic improvement in the patient's condition in the long term, most RCTs in this review examined only short-term effect of TCM treatments (4–12 weeks). Currently, there is insufficient information to confirm whether TCM can improve patients' HRQOL in the long term. Therefore, long-term effects of TCM treatment are still unknown and remain to be elucidated by longer-term studies.⁵⁴ Well-defined studies, with adequate selection criteria, appropriate outcomes, and adequate follow-up are needed for proper evaluation of the effects and risks of TCM.⁵⁵

Another possible reason is that currently available HRQOL instruments, in particular the generic instruments such as EQ-5D and SF-36, may not be suitable or sensitive enough for measuring HRQOL changes in patients treated with TCM. This would arise from the fundamental theoretical underlying difference of TCM and conventional therapy.

Thus, it is recommended that in future studies about TCM, researchers should look closely at the measures they intend to use.⁵⁶ Furthermore, the measures employed will need to be specific to TCM. Deficits in current available generic HRQOL instruments such as Vital Essence and Vital Energy need to be taken into consideration for future studies.

Conclusions

The current study shows that the developmental obstacle for assessment of TCM lies in the vague and uncertain standard of evaluation of efficacy of TCM. Most current research in this area is probably of insufficient duration to capture sufficient information to allow an unbiased assessment of the efficacy of TCM.

Furthermore, there appears to be a need to develop and validate a generic HRQOL instrument specifically for use in TCM. Well-designed studies with sufficient duration and the use of such instruments would be necessary to confirm the efficacy and then the cost-effectiveness of TCM in comparison to conventional therapies. Such information is absolutely essential if TCM is to be used extensively in clinical settings or to be eligible for a reimbursement decision from public finance or health insurance.

Researchers would also need to tackle the complex issues in researching complementary medicine. Studies should be designed to enable a valid evaluation of complementary medicine, on multiple levels, in the human healing process. The challenge for better TCM research methodology is to fuse the philosophical concerns of stakeholders with the highest standards of methodological rigor.

Footnotes

Disclosure Statement

No competing financial interests exist.

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